Search

Your search keyword '"Karen Nugent"' showing total 99 results
Start Over Author "Karen Nugent"
99 results on '"Karen Nugent"'

1. Sacral nerve stimulation versus the magnetic sphincter augmentation device for adult faecal incontinence: the SaFaRI RCT

Author

David G Jayne, Annabelle E Williams, Neil Corrigan, Julie Croft, Alison Pullan, Vicky Napp, Rachel Kelly, David Meads, Armando Vargas-Palacios, Adam Martin, Claire Hulme, Steven R Brown, Karen Nugent, Jen Lodge, David Protheroe, Sushil Maslekar, Andrew Clarke, Pasha Nisar, and Julia M Brown

Subjects
faecal incontinence, sacral nerve stimulation, fenixtm, randomised controlled trial, surgery, health economics, Medical technology, R855-855.5
Abstract

Background: Preliminary studies using the FENIX™ (Torax Medical, Minneapolis, MN, USA) magnetic sphincter augmentation device suggest that it is safe to use for the treatment of adult faecal incontinence, but efficacy data are limited. Objective: To compare FENIX with sacral nerve stimulation for the treatment of adult faecal incontinence in terms of safety, efficacy, quality of life and cost-effectiveness. Design, setting and participants: Multicentre, parallel-group, unblinded, randomised trial comparing FENIX with sacral nerve stimulation in participants suffering moderate to severe faecal incontinence. Interventions: Participants were randomised on an equal basis to either sacral nerve stimulation or FENIX. Follow-up occurred 2 weeks postoperatively and at 6, 12 and 18 months post randomisation. Main outcome and measure: The primary outcome was success, defined as device in use and ≥ 50% improvement in Cleveland Clinic Incontinence Score at 18 months post randomisation. Secondary outcomes included complication rates, quality of life and cost-effectiveness. Between 30 October 2014 and 23 March 2017, 99 participants were randomised across 18 NHS sites (50 participants to FENIX vs. 49 participants to sacral nerve stimulation). The median time from randomisation to FENIX implantation was 57.0 days (range 4.0–416.0 days), and the median time from randomisation to permanent sacral nerve stimulation was 371.0 days (range 86.0–918.0 days). A total of 45 out of 50 participants underwent FENIX implantation and 29 out of 49 participants continued to permanent sacral nerve stimulation. The following results are reported, excluding participants for whom the corresponding outcome was not evaluable. Overall, there was success for 10 out of 80 (12.5%) participants, with no statistically significant difference between the two groups [FENIX 6/41 (14.6%) participants vs. sacral nerve stimulation 4/39 (10.3%) participants]. At least one postoperative complication was experienced by 33 out of 45 (73.3%) participants in the FENIX group and 9 out of 40 (22.5%) participants in the sacral nerve stimulation group. A total of 15 out of 50 (30%) participants in the FENIX group ultimately had to have their device explanted. Slightly higher costs and quality-adjusted life-years (incremental = £305.50 and 0.005, respectively) were observed in the FENIX group than in the sacral nerve stimulation group. This was reversed over the lifetime horizon (incremental = –£1306 and –0.23 for costs and quality-adjusted life-years, respectively), when sacral nerve stimulation was the optimal option (net monetary benefit = –£3283), with only a 45% chance of FENIX being cost-effective. Limitations: The SaFaRI study was terminated in 2017, having recruited 99 participants of the target sample size of 350 participants. The study is, therefore, substantially underpowered to detect differences between the treatment groups, with significant uncertainty in the cost-effectiveness analysis. Conclusions: The SaFaRI study revealed inefficiencies in the treatment pathways for faecal incontinence, particularly for sacral nerve stimulation. The success of both FENIX and sacral nerve stimulation was much lower than previously reported, with high postoperative morbidity in the FENIX group. Future work: Further research is needed to clarify the treatment pathways for sacral nerve stimulation and to determine its true clinical and cost-effectiveness. Trial registration: Current Controlled Trials ISRCTN16077538. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 18. See the NIHR Journals Library website for further project information.

Published
2021
Full Text
View/download PDF

2. The HubBLe Trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for symptomatic second- and third-degree haemorrhoids: a multicentre randomised controlled trial and health-economic evaluation

Author

Steven Brown, Jim Tiernan, Katie Biggs, Daniel Hind, Neil Shephard, Mike Bradburn, Allan Wailoo, Abualbishr Alshreef, Lizzie Swaby, Angus Watson, Simon Radley, Oliver Jones, Paul Skaife, Anil Agarwal, Pasquale Giordano, Marc Lamah, Mark Cartmell, Justin Davies, Omar Faiz, Karen Nugent, Andrew Clarke, Angus MacDonald, Phillip Conaghan, Paul Ziprin, and Rohit Makhija

Subjects
haemorrhoidal artery ligation, halo, thd, rubber band ligation, haemorrhoids, grade ii piles, grade iii piles, recurrence, haemorrhoid symptom severity score, eq-5d, vaizey score, Medical technology, R855-855.5
Abstract

Background: Optimal surgical intervention for low-grade haemorrhoids is unknown. Rubber band ligation (RBL) is probably the most common intervention. Haemorrhoidal artery ligation (HAL) is a novel alternative that may be more efficacious. Objective: The comparison of HAL with RBL for the treatment of grade II/III haemorrhoids. Design: A multicentre, parallel-group randomised controlled trial. Perspective: UK NHS and Personal Social Services. Setting: 17 NHS Trusts. Participants: Patients aged ≥ 18 years presenting with grade II/III (second- and third-degree) haemorrhoids, including those who have undergone previous RBL. Interventions: HAL with Doppler probe compared with RBL. Outcomes: Primary outcome – recurrence at 1 year post procedure; secondary outcomes – recurrence at 6 weeks; haemorrhoid severity score; European Quality of Life-5 Dimensions, 5-level version (EQ-5D-5L); Vaizey incontinence score; pain assessment; complications; and cost-effectiveness. Results: A total of 370 participants entered the trial. At 1 year post procedure, 30% of the HAL group had evidence of recurrence compared with 49% after RBL [adjusted odds ratio (OR) = 2.23, 95% confidence interval (CI) 1.42 to 3.51; p = 0.0005]. The main reason for the difference was the number of extra procedures required to achieve improvement/cure. If a single HAL is compared with multiple RBLs then only 37.5% recurred in the RBL arm (adjusted OR 1.35, 95% CI 0.85 to 2.15; p = 0.20). Persistence of significant symptoms at 6 weeks was lower in both arms than at 1 year (9% HAL and 29% RBL), suggesting significant deterioration in both groups over the year. Symptom score, EQ-5D-5L and Vaizey score improved in both groups compared with baseline, but there was no difference between interventions. Pain was less severe and of shorter duration in the RBL group; most of the HAL group who had pain had mild to moderate pain, resolving by 3 weeks. Complications were low frequency and not significantly different between groups. It appeared that HAL was not cost-effective compared with RBL. In the base-case analysis, the difference in mean total costs was £1027 higher for HAL. Quality-adjusted life-years (QALYs) were higher for HAL; however, the difference was very small (0.01) resulting in an incremental cost-effectiveness ratio of £104,427 per additional QALY. Conclusions: At 1 year, although HAL resulted in fewer recurrences, recurrence was similar to repeat RBL. Symptom scores, complications, EQ-5D-5L and continence score were no different, and patients had more pain in the early postoperative period after HAL. HAL is more expensive and unlikely to be cost-effective in terms of incremental cost per QALY. Limitations: Blinding of participants and site staff was not possible. Future work: The incidence of recurrence may continue to increase with time. Further follow-up would add to the evidence regarding long-term clinical effectiveness and cost-effectiveness. The polysymptomatic nature of haemorrhoidal disease requires a validated scoring system, and the data from this trial will allow further assessment of validity of such a system. These data add to the literature regarding treatment of grade II/III haemorrhoids. The results dovetail with results from the eTHoS study [Watson AJM, Hudson J, Wood J, Kilonzo M, Brown SR, McDonald A, et al. Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial. Lancet 2016, in press.] comparing stapled haemorrhoidectomy with excisional haemorrhoidectomy. Combined results will allow expansion of analysis, allowing surgeons to tailor their treatment options to individual patients. Trial registration: Current Controlled Trials ISRCTN41394716. Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 88. See the NIHR Journals Library website for further project information.

Published
2016
Full Text
View/download PDF

3. International Validation of the EORTC QLQ-ANL27, a Field Study to Test the Anal Cancer-Specific Health-Related Quality-of-Life Questionnaire

Author

Samantha C. Sodergren, Colin D. Johnson, Alexandra Gilbert, Anne-Sophie Darlington, Kim Cocks, Marianne G. Guren, Eleonor Rivin del Campo, Christine Brannan, Peter Christensen, William Chu, Hans Chung, Kristopher Dennis, Isacco Desideri, Duncan C. Gilbert, Rob Glynne-Jones, Michael Jefford, Mia Johansson, Anders Johnsson, Therese Juul, Dimitrios Kardamakis, Julia Lai-Kwon, Vicky McFarlane, Isalia M.C. Miguel, Karen Nugent, Femke Peters, Rachel P. Riechelmann, Nazim S. Turhal, Shun Wong, and Vassilios Vassiliou

Subjects
Cancer Research, Radiation, Oncology, Surveys and Questionnaires, Psychometrics/methods, Quality of Life, Humans, Reproducibility of Results, Surgical Stomas, Female, Radiology, Nuclear Medicine and imaging, Anus Neoplasms/radiotherapy
Abstract

PURPOSE: The European Organisation for Research and Treatment of Cancer (EORTC) health-related quality of life questionnaire for anal cancer (QLQ-ANL27) supplements the EORTC cancer generic measure (QLQ-C30) to measure concerns specific to people with anal cancer treated with chemoradiotherapy. This study tested the psychometric properties and acceptability of the QLQ-ANL27.METHODS AND MATERIALS: People with anal cancer were recruited from 15 countries to complete the QLQ-C30 and QLQ-ANL27 and provide feedback on the QLQ-ANL27. Item responses, scale structure (multitrait scaling, factor analysis), reliability (internal consistency and reproducibility) and sensitivity (known group comparisons and responsiveness to change) of the QLQ-ANL27 were evaluated.RESULTS: Data from 382 people were included in the analyses. The EORTC QLQ-ANL27 was acceptable, comprehensive, and easy to complete, taking an average 8 minutes to complete. Psychometric analyses supported the EORTC QLQ-ANL27 items and reliability (Cronbach's α ranging from 0.71-0.93 and test-retest coefficients above 0.7) and validity of the scales (particularly nonstoma bowel symptoms and pain/discomfort). Most scales distinguished people according to treatment phase and performance status. Bowel (nonstoma), pain/discomfort, and vaginal symptoms were sensitive to deteriorations over time. The stoma-related scales remained untested because of low numbers of people with a stoma. Revisions to the scoring and question ordering of the sexual items were proposed.CONCLUSIONS: The QLQ-ANL27 has good psychometric properties and is available in 16 languages for people treated with chemoradiotherapy for anal cancer. It is used in clinical trials and has a potential role in clinical practice.

Published
2023

4. Outcomes of Medical Therapy Plus PCI for Multivessel or Left Main CAD Ineligible for Surgery

Author

Adam C. Salisbury, J. Aaron Grantham, W. Morris Brown, William L. Ballard, Keith B. Allen, Ajay J. Kirtane, Michael Argenziano, Robert W. Yeh, Kamal Khabbaz, John Lasala, Puja Kachroo, Dimitri Karmpaliotis, Jeffrey Moses, William L. Lombardi, Karen Nugent, Ziad Ali, Kensey L. Gosch, John A. Spertus, and David E. Kandzari

Subjects
Cardiology and Cardiovascular Medicine
Published
2023

5. The Outcomes of Percutaneous RevascularizaTIon for Management of SUrgically Ineligible Patients With Multivessel or Left Main Coronary Artery Disease (OPTIMUM) Registry: Rationale and Design

Author

Adam C, Salisbury, Ajay J, Kirtane, Ziad A, Ali, J Aaron, Grantham, William L, Lombardi, Robert W, Yeh, Philippe, Genereux, Keith B, Allen, W Morris, Brown, Karen, Nugent, Kensey L, Gosch, Dimitri, Karmpaliotis, John A, Spertus, and David E, Kandzari

Subjects
Percutaneous Coronary Intervention, Treatment Outcome, Risk Factors, Humans, Coronary Artery Disease, Registries, General Medicine, Coronary Artery Bypass, Cardiology and Cardiovascular Medicine
Abstract

Guidelines endorse coronary artery bypass as the preferred revascularization strategy for patients with left main and/or multivessel coronary artery disease (CAD). However, many patients are deemed excessively high risk for surgery after Heart Team evaluation. No prospective studies have examined contemporary treatment patterns, rationale for surgical decision-making, completeness of revascularization with percutaneous coronary intervention (PCI), and outcomes in this high-risk population with advanced CAD.We designed the Outcomes of Percutaneous RevascularizaTIon for Management of SUrgically Ineligible Patients with Multivessel or Left Main Coronary Artery Disease (OPTIMUM) registry, a prospective, multicenter study of patients with "surgical anatomy" determined to be at prohibitive risk for bypass surgery. The primary outcome is comparison of observed to predicted 30-day mortality, with secondary outcomes of patient-reported health status and the association between completeness of revascularization and clinical outcomes. Patient characteristics driving surgical risk determinations will be reported, and peri-operative risk will be assessed using validated scoring methods. Angiograms will be assessed by an independent core laboratory, and clinical events will be adjudicated.Clinical outcomes assessments will include 30-day and 1-year cardiovascular events, health status at 1, 6 and 12-months, and 5-year mortality.OPTIMUM is the first prospective, multicenter study to examine treatment strategies and outcomes among multivessel CAD patients deemed ineligible for surgical revascularization after Heart Team assessment. This registry will provide unique insights into the clinical decision-making, revascularization practices, safety, effectiveness, and health status outcomes in this high-risk population.

Published
2022

6. Initial Invasive or Conservative Strategy for Stable Coronary Disease

Author

Maron D. J., Hochman J. S., Reynolds H. R., Bangalore S., O'Brien S. M., Boden W. E., Chaitman B. R., Senior R., Lopez-Sendon J., Alexander K. P., Lopes R. D., Shaw L. J., Berger J. S., Newman J. D., Sidhu M. S., Goodman S. G., Ruzyllo W., Gosselin G., Maggioni A. P., White H. D., Bhargava B., Min J. K., John Mancini G. B., Berman D. S., Picard M. H., Kwong R. Y., Ali Z. A., Mark D. B., Spertus J. A., Krishnan M. N., Elghamaz A., Moorthy N., Hueb W. A., Demkow M., Mavromatis K., Bockeria O., Peteiro J., Miller T. D., Szwed H., Doerr R., Keltai M., Selvanayagam J. B., Gabriel Steg P., Held C., Kohsaka S., Mavromichalis S., Kirby R., Jeffries N. O., Harrell F. E., Rockhold F. W., Broderick S., Bruce Ferguson T., Williams D. O., Harrington R. A., Stone G. W., Rosenberg Y, ISCHEMIA Research Group: Joseph Ricci, A Tello Montoliu, A I Robero Aniorte, Abbey Mulder, Abhay A Laddu, Abhinav Goyal, Abhishek Dubey, Abhishek Goyal, Abigail Knighton, Abraham Oomman, Adam J Jaskowiak, Adam Kolodziej, Adam Witkowski, Adnan Hameed, Adriana Anesini, Afshan Hussain, Agne Juceviciene, Agne Urboniene, Agnes Jakal, Agnieszka Szramowska, Ahmad Khairuddin, Ahmed Abdel-Latif, Ahmed Adel, Ahmed Aljzeeri, Ahmed Kamal, Ahmed Talaat, Aimee Mann, Aira Contreras, Ajit Kumar, V K Kumar, Akemi Furukawa, Akshay Bagai, Akvile Smigelskaite, Alain Furber, Alain Rheault, Alaine Melanie Loehr, Alan Rosen, Albert Varga, Albertina Qelaj, Alberto Barioli, Aldo Russo, Alec Moorman, Alejandro Gisbert, Aleksandra Fratczak, Aleksandras Laucevicius, Alena Kuleshova, Alessandro Sionis, Alexander A Sirker, Alexander M Chernyavskiy, Alexandra Craft, Alexandra Vazquez, Alexandre Ciappina Hueb, Alexandre S Colafranseschi, Alexandre Schaan de Quadros, Alexandre Tognon, Ali Alghamdi, Alice Manica Muller, Aline Nogueira Rabaça, Aline Peixoto Deiro, Alison Hallam, Allegra Stone, Allison Schley, Almudena Castro, Alvaro Rabelo Ales, Amanda Germann, Amanda O'Malley, Amar Uxa, Amarachi Ojajuni, Amarino C Oliveira Jr, Amber B Hull, Ambuj Roy, Amer Zarka, Amir Janmohamed, Ammani Brown, Ammy Malinay, Amparo Martinez Monzonis, Amy J Richards, Amy Iskandrian, Amy Ollinger, Ana D Djordjevic-Dikic, Ana Fernández Martínez, Ana Gomes Almeida, Ana Paula Batista, Ana Rita Francisco, Ana S Mladenovic, Ana Santana, Anam Siddiqui, Anastasia M Kuzmina-Krutetskaya, Andras Vertes, Andre S Sousa, Andre Gabriel, André Schmidt, Andrea M Lundeen, Andrea Bartykowszki, Andrea Lorimer, Andrea Mortara, Andrea Pascual, Andreia Coelho, Andreia Rocha, Andrés García-Rincón, Andrew G Howarth, Andrew J Moriarty, Andrew Docherty, Andrew Starovoytov, Andrew Zurick, Andrzej Łabyk, Andrzej Swiatkowski, Andy Lam, Anelise Kawakami, Angela Hoye, Angela Kim, Angelique Smit, Angelo Nobre, Anil V Shah, Anja Ljubez, Anjali Anand, Ankush Sachdeva, Ann Greenberg, Ann Luyten, Ann Ostrander, Anna Di Donato, Anna Cichocka-Radwan, Anna Fojt, Anna Plachcinska, Anna Proietti, Anna Teresinska, Anne Marie Webb, Anne Cartwright, Anne Heath, Anne Mackin, Anong Amaritakomol, Anong Chaiyasri, Anoop Chauhan, Anoop Mathew, Anthony Gemignani, Anto Luigi Andres, Antonia Vega, Antonietta Hansen, Antonino Ginel Iglesias, Antonio Carlos Carvalho, Antonio Di Chiara, Antonio Serra Peñaranda, Antonio Carvalho, Antonio Colombo, Antonio Fiarresga, Anupama Rao, Aquiles Valdespino-Estrada, Araceli Boan, Areef Ishani, Ariel Diaz, Arijit Ghosh, Arintaya Prommintikul, Arline Roberts, Arnold H Seto, Arnold P Good, Arshed Quyyumi, Arthur J Labovitz, Arthur Kerner, Arturo S Campos-Santaolalla, Arunima Misra, Ashok Mukherjee, Ashok Seth, Ashraf Seedhom, Asim N Cheema, Asker Ahmed, Atul Mathur, Atul Verma, Audrey W Leong, Axel Åkerblom, Axelle Fuentes, Aynun Naher, Badhma Valaiyapathi, Baljeet Kaur, Bandula Guruge, Barbara Brzezińska, Barbara Nardi, Bartosz Czarniak, Bebek Singh, Begoña Igual, Bela Merkely, Belen Cid Alvarez, Benjamin J Spooner, Benjamin J W Chow, Benjamin Cheong, Benoy N Shah, Bernard de Bruyne, Bernardas Valecka, Bernhard Jäger, Beth A Archer, Beth Abramson, Beth Jorgenson, Bethany Harvey, Betsy O'Neal, Bev Atkinson, Bev Bozek, Bevin Lang, Bijulal Sasidharan, Bin Yang, Bin Zhang, Binoy Mannekkattukudy Kurian, Bjoern Goebel, Bob Hu, Bogdan A Popescu, Bogdan Crnokrak, Bolin Zhu, Bonnie J Kirby, Brandi D Zimbelman, Brandy Starks, Branko D Beleslin, Brenda Hart, Brian P Shapiro, Brian McCandless, Brianna Wisniewski, Brigham R Smith, Brooks Mirrer, Bruce McManus, Bruce Rutkin, Bruna Edilena Paulino, Bruna Maria Ascoli, Bryn Smith, Byron J Allen, C Michael Gibson, C Noel Bairey Merz, Calin Pop, Cameron Hague, Camila Thais de Ormundo, Candace Gopaul, Candice P Edillo, Carísi A Polanczyk, Carita Krannila, Carla Vicente, Carl-Éric Gagné, Carlo Briguori, Carlos Peña Gil, Carlos Alvarez, Carly Ohmart, Carmen C Beladan, Carmen Ginghina, Carol M Kartje, Caroline Alsweiler, Caroline Brown, Caroline Callison, Caroline Pinheiro, Caroline Rodgers, Caroline Spindler, Carolyn Corbett, Carrie Drum, Casey Riedberger, Catherine Bone, Catherine Fleming, Catherine Gordon, Catherine Jahrsdorfer, Catherine Lemay, Catherine Weick, Cathrine Patten, Cecilia Goletto, Cezary Kepka, Chandini Suvarna, Chang Xu, Chantale Mercure, Charle A Viljoen, Charlene Wiyarand, Charles Jia-Yin Hou, Charles Y Lui, Charles Cannan, Charles Cornet, Charlotte Pirro, Chataroon Rimsukcharoenchai, Chen Wang, Cheng-Ting Tsai, Chen-Yen Chien, Cheryl A Allardyce, Chester M Hedgepeth, Chetan Patel, Chiara Attanasio, Chih-Hsuan Yen, Chi-Ming Chow, Ching Min Er, Ching-Ching Ong, Cholenahally Nanjappa Manjunath, Chris Beck, Chris Buller, Christel Vassaliere, Christian Hamm, Christiano Caldeira, Christie Ballantyne, Christina Björklund, Christine R Hinton, Christine Bergeron, Christine Masson, Christine Roraff, Christine Shelley, Christophe Laure, Christophe Thuaire, Christopher Kinsey, Christopher McFarren, Christopher Spizzieri, Christopher Travill, Chun-Chieh Liu, Chung-Lieh Hung, Chunguang Li, Chun-Ho Yun, Chunli Xia, Ciarra Heard, Cidney Schultz, Clare Venn-Edmonds, Claudia P Hochberg, Claudia Wegmayr, Claudia Cortés, Claudia Escobar, Cláudia Freixo, Claudio T Mesquita, Clemens T Kadalie, Colin Berry, Constance Philander, Corine Thobois, Costantino Costantini, Courtney Page, Craig Atkinson, Craig Barr, Craig Paterson, Cristina Bare, Cynthia Baumann, Cynthia Burman, Dalisa Espinosa, Damien Collison, Dan Deleanu, Dan Elian, Dan Gao, Dana Oliver, Daniel P Vezina, Daniel O'Rourke, Daniele Komar, Danielle Schade, Darrel P Francis, Dastan Malaev, David A Bull, David E Winchester, David P Faxon, David Booth, David Cohen, David DeMets, David Foo, David Schlichting, David Taggart, David Waters, David Wohns, Davis Vo, Dawid Teodorczyk, Dawn Shelstad, Dawn Turnbull, Dayuan Li, Dean Kereiakes, Deborah O'Neill, Deborah Yip, Debra K Johnson, Debra Dees, Deepak L Bhatt, Deepika Gopal, Deepti Kumar, Deirdre Mattina, Deirdre Murphy, Delano R Small, Delsa K Rose, Dengke Jiang, Denis Carl Phaneuf, Denise Braganza, Denise Fine, Derek Cyr, Desiree Tobin, Diana Cukali, Diana Parra, Diane Camara, Diane Minshall Liu, Diego Adrián Vences, Diego Franca de Cunha, Dimitrios Stournaras, Dipti Patel, Dongze Li, Donna Exley, Dorit Grahl, Dragana Stanojevic, Duarte Cacela, Dwayne S G Conway, E Pinar Bermudez, Eapen Punnoose, Edgar L Tay, Edgar Karanjah, Edoardo Verna, Eduardo Hernandez-Rangel, Edward D Nicol, Edward O McFalls, Edward T Martin, Edyta Kaczmarska, Ekaterina I Lubinskaya, Elena A Demchenko, Elena Refoyo Salicio, Eli Feen, Elihú Durán-Cortés, Elisabeth M Janzen, Elise L Hannemann, Elise van Dongen, Elissa Restelli Piloto, Eliza Kaplan, Elizabeta Srbinovska Kostovska, Elizabeth Capasso-Gulve, Elizabeth Congdon, Elizabeth Ferguson, Elizaveta V Zbyshevskaya, Ellen Magedanz, Ellie Fridell, Ellis W Lader, Elvin Kedhi, Emanuela Racca, Emilie Tachot, Emily DeRosa, Encarnación Alonso-Álvarez, Eric Nicollet, Eric Peterson, Erick Alexánderson Rosas, Erick Donato Morales, Erin Orvis, Ermina Moga, Estelle Montpetit, Estevao Figueiredo, Eugene Passamani, Eugenia Nikolsky, Eunice Yeoh, Evgeniy I Kretov, Ewa Szczerba, Ewelina Wojtala, Expedito Eustáquio Ribeiro Silva, F Marin Ortuño, Fabio R Farias, Fabio Fimiani, Fabrizio Rolfo, Fa-Chang Yu, Fadi Hage, Fadi Matar, Fahim Haider Jafary, Fang Feng, Fang Liu, Fatima Ranjbaran, Fatima Rodriguez, Fausto J Pinto, Fauzia Rashid, Federica Ramani, Fei Wang, Fernanda Igansi, Filipa Silva, Filippo Ottani, Fiona Haines, Firas Al Solaiman, Flávia Egydio, Flavio Lyra, Florian Egger, Fran Farquharson, Frances Laube, Francesc Carreras Costa, Francesca de Micco, Francesca Bianchini, Francesca Pezzetta, Francesca Pietrucci, Francesco Orso, Francesco Pisano, Francis Burt, Francisca Patuleia Figueiras, Francisco Fernandez-Aviles, Francois Pierre Mongeon, Frans Van de Werf, Franziska Guenther, Fraser N Witherow, Fred Mohr, Frederico Dall'Orto, Fumiyuki Otsuka, G De La Morena, G Karthikeyan, Gabor Dekany, Gabor Kerecsen, Gabriel Galeote, Gabriel Grossmann, Gabriel Vorobiof, Gabriela Sanchez de Souza, Gabriela Guzman, Gabriela Zeballos, Gabriele Gabrielli, Gabriele Jakl-Kotauschek, Gail A Shammas, Gail Brandt, Gang Chen, Gary E Lane, Gary J Luckasen, Gautam Sharma, Gelmina Mikolaitiene, Gennie Yee, Georg Nickenig, George E Revtyak, George J Juang, Gerald Fletcher, Gerald Leonard, Gerard Patrick Devlin, Gerard Esposito, Gergely Ágoston, Gervasio Lamas, Geza Fontos, Ghada Mikhail, Gia Cobb, Gian Piero Perna, Gianpiero Leone, Giles Roditi, Gilles Barone-Rochette, Girish Mishra, Giuseppe Tarantini, Glenda Wong, Glenn S Hamroff, Glenn Rayos, Gong Cheng, Gonzalo Barge-Caballero, Goran Davidović, Goran Stankovic, Gordana Stevanovic, Grace Jingyan Wang, Grace M Young, Graceanne Wayser, Graciela Scaro, Graham S Hillis, Graham Wong, Grazyna Anna Szulczyk, Gregor Simonis, Gregory Kumkumian, Gretchen Ann Peichel, Grzegorz Gajos, Gudrun Steinmaurer, Guilherme G Rucatti, Guilherme Portugal, Guilhermina Cantinho Lopes, Guillem Pons Lladó, Gunnar Frostfelt, Gurpreet S Wander, Gurpreet Gulati, Gustavo Pucci, Hafidz Abd Hadi, Haibo Zhang, Haitao Wang, Halina Marciniak, Han Chen, Hanan Kerr, Hani Najm, Hanna Douglas, Hannah Phillips, Hao Dai, Haojian Dong, Haqeel Jamil, Harikrishnan Sivadasanpillai, Harry Suryapranata, Hassan Reda, Hayley Pomeroy, Heather Barrentine, Heather Golden, Heather Hurlburt, Heidi Wilson, Helen C Tucker, Helene Abergel, Hemalata Siddaram, Hermine Osseni, Herwig Schuchlenz, Hesong Zeng, Hicham Skali, Hilda Solomon, Hollie Horton, Holly Hetrick, Holly Little, Holly Park, Hongjie Chi, Hossam Mahrous, Howard A Levite, Hristo Pejkov, Huajun Li, Hugo Bloise-Adames, Hugo Marques, Hui Zhong, Hui-Min Zhang, Humayrah Hashim, Hung-I Yeh, Hussien El Fishawy, Ian Webb, Iftikhar Kullo, Igor O Grazhdankin, Ihab Hamzeh, Ikraam Hassan, Ikuko Ueda, Ileana L Pina, Ilona Tamasauskiene, Ilse Bouwhuis, Imran Arif, Ina Wenzelburger, Inês Zimbarra Cabrita, Ines Rodrigues, Inga H Robbins, Inga Soveri, Ingela Schnittger, Iqbal Karimullah, Ira M Dauber, Iram Rehman, Irena Peovska Mitevska, Irene Marthe Lang, Irina Subbotina, Irma Kalibataite-Rutkauskiene, Irni Yusnida, Isabel Estela Carvajal, Isabella C Palazzo, Isabelle Hogan, Isabelle Roy, Ishba Syed, Ishita Tejani, Ivan A Naryshkin, Ivana Jankovic, Iwona Niedzwiecka, J David Knight, Jacek Kusmierek, Jackie M White, Jackie Chow, Jacob Udell, Jacqueline E Tamis-Holland, Jacqueline Fannon, Jacquelyn A Quin, Jacquelyn Do, Jaekyeong Heo, Jakub Maksym, James E Davies, James H O'Keefe Jr, James J Jang, James Cha, James Harrison, James Hirsch, James Stafford, James Tatoulis, Jamie Rankin, Jan Henzel, Jan Orga, Jana Tancredi, Janaina Oliveira, Jane Burton, Jane Eckstein, Jane Marucci, Janet P Knight, Janet Blount, Janet Halliday, Janetta Kourzenkova, Janitha Raj, Jan-Malte Sinning, Jaqueline Pozzibon, Jaroslaw Drozdz, Jaroslaw Karwowski, Jason D Glover, Jason Loh Kwok, Jason T Call, Jason Linefsky, Jassira Gomes, Jati Anumpa, Javier J Garcia, Javier Courtis, Jay Meisner, K Jayakumar, Jayne Scales, Jean E Denaro, Jean Michel Juliard, Jean Ho, Jeanette K Stansborough, Jean-Michel Juliard, Jeanne Russo, Jeannette J M Schoep, Jeet Thambyrajah, Jeff Leimberger, Jeffery A Breall, Jeffrey A Kohn, Jeffrey C Milliken, Jeffrey Anderson, Jeffrey Blume, Jeffrey Kanters, Jeffrey Lorin, Jeffrey Moses, Jelena J Stepanovic, Jelena Celutkiene, Jelena Djokic, Jelena Stojkovic, Jenne M Jose, Jenne Manchery, Jennifer A Mull, Jennifer H Czerniak, Jennifer L Stanford, Jennifer Gillis, Jennifer Horst, Jennifer Isaacs, Jennifer Langdon, Jennifer Thomson, Jennifer Tomfohr, Jennifer White, Jen-Yuan Kuo, Jeremy Rautureau, Jerome Fleg, Jessica Berg, Jessica Rodriguez, Jessica Waldron, Jhina Patro, Jia Li, Jiajia Mao, Jiamin Liu, Jian'an Wang, Jianhua Li, Jianxin Zhang, Jie Qi, Jihyun Lyo, Jill Marcus, Jim Blankenship, Jing Zhang, Jingjing Liu, Jing-Yao Fan, Jiun-Yi Li, Jiwan Pradhan, Jiyan Chen, J M Rivera Caravaca, Jo Evans, Joan Garcia Picart, Joan Hecht, Joanna Jaroch, Joanna Zalewska, Joanne Kelly, Joanne Taaffe, João Reynaldo Abbud, João V Vitola, Joaquín V Peñafiel, Jocelyne Benatar, Jody Bindeman, Joe Sabik, Joel Klitch, Johann Christopher, Johannes Aspberg, John D Friedman, John F Beltrame, John F Heitner, John Joseph Graham, John R Davies, John Doan, John Kotter, John Kurian, John Mukai, John Pownall, Jolanta Sobolewska, Jon Kobashigawa, Jonathan L Goldberg, Jonathan W Bazeley, Jonathan Byrne, Jonathan Himmelfarb, Jonathan Leipsic, Jonean Thorsen, Jorge F Trejo Gutierrez, Jorge Escobedo, Jorik Timmer, José A Ortega-Ramírez, José Antonio Marin-Neto, Jose D Salas, Jose Enrique Castillo, Jose Francisco Saraiva, José J Cuenca-Castillo, Jose L Diez, José Luis Narro Villanueva, José Luiz da Vieira, José M Flores-Palacios, Jose Ramon Gonzalez, Jose Seijas Amigo, Jose Fragata, Josep Maria Padró, Josheph F X McGarvey Jr, Joseph Hannan, Joseph Sacco, Joseph Sweeny, Joseph Wiesel, Josephine D Abraham, Joshua P Loh, Joy Burkhardt, Joyce R White, Joyce Riestenberg-Smith, Judit Sebo, Judith L Meadows, Judith Wright, Judy Mae Foltz, Judy Hung, Judy Otis, Juergen Stumpf, Jui-Peng Tsai, Julia S Dionne, Julia de Aveiro Morata, Julie Bunke, Julie Morrow, Julio César Figal, Jun Fujita, Jun Jiang, Junhua Li, Junqing Yang, Juntima Euathrongchit, Jyotsna Garg, K Manjula Rani, K Preethi, Kaatje Goetschalckx, Kai Eggers, Kamalakar Surineni, Kanae Hirase, T R Kapilamoorthy, Karen Calfas, Karen Gratrix, Karen Hallett, Karen Hultberg, Karen Nugent, Karen Petrosyan, Karen Swan, Karolina Kryczka, Karolina Wojtczak-Soska, Karolina Wojtera, Karsten Lenk, Karthik Ramasamy, Katarzyna Łuczak, Katarzyna Malinowska, Kate Pointon, Kate Robb, Katherine Martin, Kathleen Claes, Kathryn Carruthers, Kathy E Siegel, Katia Drouin, Katie Fowler-Lehman, Kavita Rawat, Kay Rowe, Keiichi Fukuda, Keith A A Fox, Ken Mahaffey, Kendra Unterbrink, Kenneth Giedd, Kerrie Van Loo, Kerry Lee, Kerstin Bonin, Kevin R Bainey, Kevin T Harley, Kevin Anstrom, Kevin Chan, Kevin Croce, Kevin Landolfo, Kevin Marzo, Keyur Patel, Khaled Abdul-Nour, Khaled Alfakih, Khaled Dajani, Khaled Ziada, Khaula Baloch, Khrystyna Kushniriuk, Kian-Keong Poh, Kim F Ireland, Kim Holland, Kimberly Ann Byrne, Kimberly E Halverson, Kimberly Elmore, Kimberly Miller-Cox, Kiran Reddy, Kirsten J Quiles, Kirsty Abercrombie, Klaus Matschke, Konrad Szymczyk, Koo Hui Chan, Kotiboinna Preethi, Kozhaya Sokhon, Krissada Meemuk, Kristian Thygesen, Kristin M Salmi, Kristin Newby, Kristina Wippler, Kristine Arges, Kristine Teoh, Krystal Etherington, Krystyna Łoboz-Grudzień, Krzysztof W Reczuch, Krzysztof Bury, Krzysztof Drzymalski, Krzysztof Kukuła, Kuo-Tzu Sung, Kurt Huber, Ladda Douangvila, Lance Sullenberger, Larissa Miranda Trama, Laszlone Matics, Laura Drew, Laura Flint, Laura Keinaite, Laura Sarti, Laurel Kolakaluri, Lawrence M Phillips, Lawrence Friedman, Lawrence Phillips, Lazar Velicki, Leah Howell, Leandro C Maranan, Leanne Cox, Ledjalem Daba, Lei Zhang, Lekshmi Dharmarajan, Leo Bockeria, Leonardo Pizzol Caetano, Leonardo Bridi, Leonid L Bershtein, Leszek Sokalski, Li Hai Yan, Li Li, Lia Nijmeijer, Lidia Sousa, Lihong Xu, Lihua Zhang, Lili Zhang, Lilia Schiavi, Lilian Mazza Barbosa, Lillian L Khor, Lina Felix-Stern, Linda L Hall, Linda M Hollenweger, Linda Arcand, Linda Davidson-Ray, Linda Schwarz, Lindsey N Sikora, Lingping Chi, Lino Patricio, Liping Zhang, Lisa Chaytor, Lisa Hatch, Lisa McCloy, Lisa Wong, Liselotte Persson, Lixin Jiang, Liz Low, Ljiljana Pupic, Loïc Bière, Lorenzo Monti, Lori Christensen, Lori Pritchard, Loriane Black, Lori-Ann Desimone, Lori-Ann Larmand, Lorraine McGregor, Louise Morby, Louise Thomson, Luc Harvey, Luciana de Pádua Baptista, Lucilla Garcia, Ludivine Eliahou, Ludmila Helmer, Luis F Smidt, Luis Bernanrdes, Luis Guzman, Luiz A Carvalho, Luyang Xiong, Lynette L Teo, Lynn M Neeson, Lynne Winstanley, M Barbara Srichai-Parsia, M Quintana Giner, M Sowjanya Reddy, M Valdés Chávarri, M Grazia Rossi, Maarten Simoons, Maayan Konigstein, Maciej Lesiak, Maciej Olsowka, Mafalda Selas, Magalie Corfias, Magdalena Madero Rovalo, Magdalena Łanocha, Magdalena Miller, Magdalena Misztal-Teodorczyk, Magdalena Rantinella, Magdy Abdelhamid, Magnolia Jimenez, Mahboob Alam, Mahevamma Mylarappa, Mahfouz El Shahawy, Mahmoud Mohamed, Mahmud Al-Bustami, Majo X Joseph, Malgorzata Frach, Małgorzta Celińska-Spodar, Malte Helm, Manas Chacko, Mandy Murphy, Manitha Vinod, Manjula Rani, Manu Dhawan, Manuela Mombelli, Marcel Weber, Marcello Galvani, Marcelo Jamus Rodrigues, Marcia F Dubin, Marcia F Werner Bayer, Marcin Szkopiak, Marco Antonio Monsalve, Marco Bizzaro Santos, Marco Magnoni, Marco Marini, Marco Sicuro, Marco Zenati, Marcos Valério Coimbra Resende, Marek Roik, Margalit Bentzvi, Margaret Gilsenan, Margaret Iraola, Margot C Quinn, Maria A Alfonso, Maria Antonieta Pereira Moraes, María Dolores Martínez-Ruíz, María Fernanda Canales, Maria Inês Caetano, Maria P Corral, Maria Pérez García, Maria Victoria Actis, Maria Aguirre, Maria Andreasson, Maria Aprile, Maria Colton, Maria Eugenia Martin, Maria Lasala, Maria Lorenzo, Maria Posada, Maria Shier, Maria Thottam, Mariana V Furtado, Mariana Yumi Okada, Marianna D A Dracoulakis, Marianne De Andrade, Mariano Rubio, Marie Essermark, Marielle Scherrer-Crosbie, Marija T Petrovic, Marija Zdravkovic, Marilyn Black, Marina Garcia, Mario J Garcia, Mariola Szulik, Marisa Orgera, Mark A de Belder, Mark Harbinson, Mark Hyun, Mark Peterson, Mark Xavier, Marlowe Mosley, Marta Capinha, Marta Marcinkiewicz-Siemion, Marta Swiderek, Martha Meyer, Martina Ceseri, Martina Tricoli, Marvin Kronenberg, Mary Williams, Mary Ann Champagne, Mary Colleen Rogge, Mary R Soltau, Mary Streif, Massimo Villella, Massoud Leesar, Matei Claudia, Mateusz Solecki, Matías Nicolás Mungo, Matthew Wall Jr, Matthew Budoff, Matthew Jezior, Matthew Luckie, Matthias Friedrich, Mauren P Haeffner, Maximilian Tscharre, Max-Paul Winter, Mayana Almeida, Mayil S Krishnam, Mayuri Patel, Meenakshi Mishra, Megan Manocchia, Meghana Kakade, Melanie J Munro, Melissa D Chaplin, Melissa LeFevre, Mervyn Andiapen, Michael A Gibson, Michael B Rubens, Michael C Turner, Michael D Shapiro, Michael W Lee, Michael Berlowitz, Michael Davidson, Michael Mack, Michael McDaniel, Michael Mumma, Michal Wlodarczyk, Michel G Khouri, Michel S Slama, Michele Rawlins, Michelle M Bonner, Michelle M Seib, Michelle Chang, Michelle Crowder, Michelle Dixon, Michelle Mayon, Michelle McEvoy, Michelle Yee, Miguel M Fernandes, Miguel Nobre Menezes, Miguel Souto Bayarri, Miguel Barrero, Mikhail T Torosoff, Milan R Dobric, Milan Dobric, Milica Nikola Dekleva, Milind Avdhoot Gadkari, Millie Gomez, Min Tun Kyaw, Miriam Brooks, Miroslav Stevo Martinovic, Mitchel B Lustre, Mohammad Tariq Vakani, Mohammad El-Hajjar, Mohammed Al-Amoodi, Mohammed Hussain, Mohammed Saleem, Moisés Blanco-Calvo, Moisés Jiménez-Santos, Mona Bhatia, Monica Rosca, Monika Laukyte, Montserrat Gracida Blanca, Montserrat Vila Perales, Mouaz H Al-Mallah, Moysés de Oliveira Filho, Mpiko Ntsekhe, Muhamed Saric, Mulei Chen, Myriam Brousseau, Myrthes Emy Takiuti, Nada Cemerlic-Adjic, Nadia Asif, Nadia Gakou, Nafisa Hussain, Nana O Katamadze, Nancy L Clapp, Nancy Aedy, Nandita Nataraj, Nanette K Wenger, Naomi Uchida, Nasrul Ismail, Natalia S Oliveira, Natalia de Carvalho Maffei, Natalie Spitzer, Natasha C Putnam, Naved Aslam, Neamat Mowafy, Neeraj Pandit, Neeraj Parakh, Nevena Garcevic, Ngaire Meadows, Nhi N Tran, Nicholas Danchin, Nicki Lakeman, Nicola Johnston, Nicolas W Shammas, Nicole Saint Vrestil, Nicole Deming, Nier Zhong, Niket Patel, Nikola N Boskovic, Nikolaos Karogiannis, Nikos Werner, Nina Johnston, Ning Zhang, Ning Zhou, Niree Hindoyan, Nirmal Kumar, Nitika Chadha, Nitish Naik, Nodira Aripova, Noloyiso Mtana, Nona A Eskelson, Noor Syamira Mokhtar, Noppon Taksaudom, Nor Asiah Basri, Nora Marchelletta, Norma Hogg, Nungshi Jungla, Nuno Ferreira, Oksana A Lubyanaya, Olga B Nikolaeva, Olga Cañavate, Olga Sobrino, Olga Walesiak, Olga Walter, Olga Zdończyk, Olivia J Lim, Olivia Anaya, Olivia Mancilla, Olivier Dubourg, Olugbenga Bello, Omar Almousalli, Omar Thompson, Oni Olurinde, Or Harel, Osama Raheem, Oscar Méndiz, Óscar Prada-Delgado, Oz Shapira, P Christian Schulze, Pachara Panpunuan, Pal Maurovich-Horvat, Pallav Garg, Paloma Moraga, Pam Singh, Pamela Julian, Pamela Ouyang, Pamela Sigel, Pamela Woodard, Panpan Zhou, Paola Emanuela Poggio, Paola Smanio, Paolo Calabro, Paramjit Jeetley, Pascal Goube, Patricia K Nguyen, Patricia Alarie, Patricia Arakelian, Patricia Arsenault, Patricia Blaise, Patricia Brito, Patricia Cowper, Patricia Endsley, Patricia Mieses, Patrick B Alexander, Patrick Donnelly, Patrick Wilmot, Patrycja Lebioda, Paul C Gordon, Paul Der Mesropian, Paul Galiwango, Paul Hauptman, Paul Kennedy, Paula Beardsley, Paula García-González, Paulo Cury Rezende, Paulo Ricardo Caramori, Pavel S Kozlov, Pedro Canas Silva, Pedro Gabriel Melo Barros E Silva, Pedro Píccaro de Oliveira, Pedro Carvalho, Pedro Modas, Pedro Rio, Peeyush Jain, Peiyu He, Peter A McCullough, Peter H Stone, Peter M Pollak, Peter Douglass, Peter Henriksen, Peter OKane, Peter Ong, Philip Jones, Philip Rogal, Philippe Généreux, Philippe Menasche, Philippe Rheault, Phoebe Goold, Pierre Gervais, Pierre Michaud, Pilar Calvillo, Ping Chai, Piotr Jakubowski, Piotr Pruszczyk, Piotr Slomka, Piyamitr Sritara, Poay-Huan Loh, Poonam Sonawane, Pouneh Samadi, Pragnesh P Parikh, Prakash Deedwania, Pranav M Patel, Praneeth Polamuri, Pratiksha Sharma, Precilia Vasquez, Preeti Kamath, Prince Thomas, Priyadarshani Arambam, Puja K Mehta, Purvez Grant, Pushpa Naik, Qi Zhong, Qian Zhao, Qiang Zhou, Qianqian Yuan, Qin Yu, Qingxian Li, Qiulan Xie, Qiutang Zeng, R J Vindhya, R James Gerlach, Rachel King, Rada Vučić, Radmila Lyubarova, Radoslaw Pracon, Raewyn Fisher, Rafael Beyar, Rafael Diaz, Rafael Selgas, Raffaele Bugiardini, Raffaele Fanelli, Raisa Kavalakkat, V S Rajalekshmi, Rajat S Barua, Rajeev Menon, Rajesh Gopalan Nair, Rajesh Francis, Rajiv Narang, Rakesh Yadav, Ralph Alan Huston, T Ramakrishnan, Ramesh de Silva, Rami El Mahmoud, Ramiro Carvalho, Ramon de Jesús-Pérez, Ramona Stevens, Ran Leng, Ranjan Kachru, Ranjit Kumar Nath, Raquel Sanchez, Raven R Dwyer, Raven Lee, Ray Wyman, Raymond C Wong, Raymond W Little, Raymundo Ocaranza Sanchez, Rebecca J Wimmer, Rebecca Bariciano, Rebecca Otis, Rebekah R Herrmann, Reem Yunis, Reinette Hampson, Renato Abdala Karam, Renee C Hessian, Renee Kaneshiro, Reshma Ravindran, Reto Andreas Gamma, Reyna Bhandari, Reza Arsanjani, Ricardo L Lopes, Ricardo Mendes Oliveira, Ricardo Costa, Richa Bhatt, Richard F Davies, Richard H J Trimlett, Richard Goldweit, Rik Hermanides, Rine Nakanishi, Rinu R Sidh, Risha Patel, Rita Coram, Rizwan A Siddiqui, Rob S Beanlands, Robert J Hamburger, Robert K Riezebos, Robert M Donnino, Robert Bojar, Robert Chilton, Robert Guyton, Robert Henderson, Robert Kornberg, Robert Leber, Robert Mao, Robert Stenberg, Roberta P Santos, Roberto René Favaloro, Roberto Amati, Rodolfo G S D Lima, Rodrigo J Cerci, Rogerio Tumelero, Rohit Tandon, Roma Tewari, Romalisa Miranda-Peats, Ron Wald, Ronald A Mastouri, Ronald G Morford, Ronald G Schwartz, Ronald P Pedalino, Rongrong Hu, Ronnell A Hansen, Ronny A Cohen, Rory Hachamovitch, Rosa Homem, Rosa Sandonato, Rosane Laimer, Rosann Gans, Roxanne Yost, Roy Mathew, Rubén Baleón-Espinosa, Ruben Ramos, Rubine Gevorgyan, Rui Ferreira, Rui Jing, Ruth Pérez-Fernández, S K Dwivedi, S Ramakrishnan, Saadat Khan, Sabahat Bokhari, Sabu Thomas, Sadath Lubna, Sajeeda Parveen Khan, Sajeev Chakanalil Govindan, Saket Girotra, Saleem Kassam, Sallie Canada, Salvador Cruz-Flores, Samaa Mohamed, Samantha Ly, Sameh El Kaffas, Samia Massalha, Sampoornima Setty, Samuel Nwosu, Sandeep Seth, Sandeep Singh, Sander R Niehe, Sandra M Rivest, Sandra S Zier, Sandra Ahoud, Sandy Carr, Sanjay Ganapathi, Sanjay Shetty, Sanjeev Sharma, Santa Jimenez, Santhosh Satheesh, Santiago A Garcia, Sara Fernandez, Sara Karlsson, Sara Salkind, Sara Temiyasathit, Sarah Medina Rodriguez, Sarah Beaudry, Sarah Hadjih, Sarah Williams, Sarah Zahrani, Sarju Ralhan, Sasa Hinic, Sasko Kedev, Satinder Singh, Satoshi Yasuda, Satvic Cholenahally Manjunath, Sau Lee, Scott M Kaczkowski, Scott Kinlay, Sean W Hayes, Sebastian Sobczak, Senait Asier, Sergey A Sayganov, Seth I Sokol, Shaheen Pandie, Shaiful Azmi Yahaya, Shamir Mehta, Shao-Ping Nie, Sharad Chandra, Sharder Islam, Sharon Tai, Sheetal Rupesh Karwa, Sheri Ussery, Sheromani Bajaj, Sherron C Crook, Shigeyuki Nishimura, Shintaro Nakano, Shirin Heydari, Shiv Kumar Choudhary, Shivali Patel, Shobana Ganesan, Shruti Pandey, Shuyang Zhang, Shweta Hande, Siddharth Gadage, Sik-Yin V Tan, Silvia Zottis Poletti, Silvia Riera, Silvia Valbuena, Simon Walsh, Simona Maspoli, Simone Savaris, Si-Ting Feng, So Yang Cho, Solomon Yakubov, Songlin Zhu, Songtao Wang, Sonia Guerrero, Sonika Gupta, Sonja Salinger Martinovic, Sonya Brons, Sorin Brener, Sothinathan Gurunathan, Souheil Saba, Soundarya Nayak, Sowjanya Reddy, Srinivasa Potluri, Sriram Sudarshan, Srun Kuanprasert, Stacie Van Oosterhout, Stamatios Lerakis, Stanley E Cobos, Stefan C Bertog, Stefan M Simović, Stefan Weikl, Stefano Di Marco, Stefano Provasoli, Stephanie A Tirado, Stephanie C Boer, Stephanie M Lane, Stephanie Ferket, Stephanie Kelly, Stephanie Wasmiller, Stephen H McKellar, Stephen P Hoole, Stephen Fremes, Stephen Preston, Steve Leung, Steven A Fein, Steven J Lindsay, Steven P Sedlis, Steven Giovannone, Steven Michael, Steven Weitz, Stijn van Vugt, Subhash Banerjee, Sudhir Naik, Suellen Hosino, Sukie Desire, Sukit Yamwong, Suku T Thambar, Sulagna Mookherjee, Suman Singh, Sundeep Mishra, Sunil Kumar Verma, Supap Kulthawong, Supatchara Khwakhong, Surendra Naik, Suresh Babu, Surin Woragidpoonpol, Suryaprakash Narayanappa, Susan Derbyshire, Susan Gent, Susan Mathus, Susan Milbrandt, Susan Moore, Susan Regan, Susan Stinson, Susan Webber, Susana Silva, Susanna Stevens, Susanne Gruensfelder, Suthara Aramcharoen, Suvarna Kolhe, Suzana Tavares, Suzanne Arnold, Suzanne Welsh, Svetlana Apostolovic, Swapna Kunhunny, Ta-Chuan Hung, Taissa Zappernick, Tali Sharir, Talita Silva, Tamara Colaiácovo Soares, Tapan Umesh Pillay, Tarun K Mittal, Tatiana Trifonova, Tauane Bello Duarte, Tauqir Huk, Téodora Dutoiu, Terrance Chua, Terry Weyand, Thabitha Charles, Theodoros Kofidis, Theresa McCreary, Thierry Lefevre, Thippeekaa Arumairajah, Thitipong Tepsuwan, Thomas J Mulhearn, Thomas M Meyer, Thomas P Rocco, Thomas R Downes, Thomas Crain, Thomas Haldis, Thomas Mathew, Thomas Redick, Thounaojam Indira Devi, Thuraia Nageh, Tia Cauthren, Tiago Silva, Tiffany Little, Tijana Andric, Tina Harding, Titus Lau, Tiziana Formisano, Tiziano Moccetti, Tomasz Ciurus, Tomasz Mazurek, Tomasz Tarchalski, Toshiyuki Nagai, Tri Tran, Tricia Youn, Trish Tucker, Trudie Milner, Tuhina Bose, Tushar Kotecha, Udo Sechtem, Uma S Valeti, Umberto Cucchini, Umesh Badami, Upendra Kaul, V K Bahl, V S Narain, Valentina Casali, Valeria Godoy, Valerie Robesyn, Vamshi P Priya, Vandana Yadav, Vera McKinney, Veronica De Lenges, Veronica Tinnirello, Vicente Miro, Victor Navarro, Victoria Gumerova, Victoria Hernandez, Vidya Seeratan, Vijay Kumar, Vikentiy Y Kozulin, Viktoria Bulkley, Vilmar Veiga Jr, Vincent Setang, C P Vineeth, Virginai Pubull Nuñez, Virginia Fernández-Figares, Vitor Gomes, Viviana Gabriel, Viviane Dos Santos, Viviane Almeida, Vlad A Iliescu, Vladan Mudrenovic, Vladimir Dzavik, Vojislav L Giga, Walter Enrique Mogrovejo, Wan Xian Chan, Wanda C Marfori, Wanda Parker, Warangkana Mekara, Wassim Nona, Wayne Old, Wayne Pennachi, Weerachai Nawarawong, Wei Chen, Wei Su, Weibing Xing, Wei-Ren Lan, Wenda Crawford, Wendy L Stewart, Wendy Drewes, Wenhua Lin, William B Abernethy, William D Salerno, William F Fearon, William Vergoni, William Weintraub, Winnie C Sia, Wlodzimierz J Musial, Xacobe Flores-Ríos, Xavier Garcia-Moll Marimon, Xi Su, Xiang Ma, Xiangqiong Gu, Xiao Wang, Xiaomei Li, Xiaowei Yao, Xin Fu, Xin Su, Xin Zeng, Xinchun Yang, Xiuhong Li, Xuehua Fang, Xutong Wang, Yaming Geng, Yan Yan, Yanek Pépin-Dubois, Yanfu Wang, Yang Wang, Yanmeng Tian, Yaping Huang, Yechen Han, Yesenia Zambrano, Yi-Hsuan Yang, Ying Tung Sia, Yining Yang, Yitong Ma, Yolayfi Peralta, Yongjian Wu, Yu Kunwu, Yu Zhao, Yudong Peng, Yueh-Hung Lin, Yulan Zhao, Yumei Dong, Yunhai Zhao, Yutthaphan Wannasopha, Yvonne Taul, Zakir Sahul, Zalina Kudzoeva, Zbigniew Kalarus, Zeljko Z Markovic, Zhen Huang, Zheng Ji, Zhenyu Liu, Zhou Yue, Zhulin Zhang, Zhuxi Li, Zile Singh Meharwal, Ziliang Bai, Zixiang Yu, Zohra Huda, Zoltan Davidovits, Maron D.J., Hochman J.S., Reynolds H.R., Bangalore S., O'Brien S.M., Boden W.E., Chaitman B.R., Senior R., Lopez-Sendon J., Alexander K.P., Lopes R.D., Shaw L.J., Berger J.S., Newman J.D., Sidhu M.S., Goodman S.G., Ruzyllo W., Gosselin G., Maggioni A.P., White H.D., Bhargava B., Min J.K., John Mancini G.B., Berman D.S., Picard M.H., Kwong R.Y., Ali Z.A., Mark D.B., Spertus J.A., Krishnan M.N., Elghamaz A., Moorthy N., Hueb W.A., Demkow M., Mavromatis K., Bockeria O., Peteiro J., Miller T.D., Szwed H., Doerr R., Keltai M., Selvanayagam J.B., Gabriel Steg P., Held C., Kohsaka S., Mavromichalis S., Kirby R., Jeffries N.O., Harrell F.E., Rockhold F.W., Broderick S., Bruce Ferguson T., Williams D.O., Harrington R.A., Stone G.W., Rosenberg Y, and ISCHEMIA Research Group: Joseph Ricci, A Tello Montoliu, A I Robero Aniorte, Abbey Mulder, Abhay A Laddu, Abhinav Goyal, Abhishek Dubey, Abhishek Goyal, Abigail Knighton, Abraham Oomman, Adam J Jaskowiak, Adam Kolodziej, Adam Witkowski, Adnan Hameed, Adriana Anesini, Afshan Hussain, Agne Juceviciene, Agne Urboniene, Agnes Jakal, Agnieszka Szramowska, Ahmad Khairuddin, Ahmed Abdel-Latif, Ahmed Adel, Ahmed Aljzeeri, Ahmed Kamal, Ahmed Talaat, Aimee Mann, Aira Contreras, Ajit Kumar, V K Kumar, Akemi Furukawa, Akshay Bagai, Akvile Smigelskaite, Alain Furber, Alain Rheault, Alaine Melanie Loehr, Alan Rosen, Albert Varga, Albertina Qelaj, Alberto Barioli, Aldo Russo, Alec Moorman, Alejandro Gisbert, Aleksandra Fratczak, Aleksandras Laucevicius, Alena Kuleshova, Alessandro Sionis, Alexander A Sirker, Alexander M Chernyavskiy, Alexandra Craft, Alexandra Vazquez, Alexandre Ciappina Hueb, Alexandre S Colafranseschi, Alexandre Schaan de Quadros, Alexandre Tognon, Ali Alghamdi, Alice Manica Muller, Aline Nogueira Rabaça, Aline Peixoto Deiro, Alison Hallam, Allegra Stone, Allison Schley, Almudena Castro, Alvaro Rabelo Ales, Amanda Germann, Amanda O'Malley, Amar Uxa, Amarachi Ojajuni, Amarino C Oliveira Jr, Amber B Hull, Ambuj Roy, Amer Zarka, Amir Janmohamed, Ammani Brown, Ammy Malinay, Amparo Martinez Monzonis, Amy J Richards, Amy Iskandrian, Amy Ollinger, Ana D Djordjevic-Dikic, Ana Fernández Martínez, Ana Gomes Almeida, Ana Paula Batista, Ana Rita Francisco, Ana S Mladenovic, Ana Santana, Anam Siddiqui, Anastasia M Kuzmina-Krutetskaya, Andras Vertes, Andre S Sousa, Andre Gabriel, André Schmidt, Andrea M Lundeen, Andrea Bartykowszki, Andrea Lorimer, Andrea Mortara, Andrea Pascual, Andreia Coelho, Andreia Rocha, Andrés García-Rincón, Andrew G Howarth, Andrew J Moriarty, Andrew Docherty, Andrew Starovoytov, Andrew Zurick, Andrzej Łabyk, Andrzej Swiatkowski, Andy Lam, Anelise Kawakami, Angela Hoye, Angela Kim, Angelique Smit, Angelo Nobre, Anil V Shah, Anja Ljubez, Anjali Anand, Ankush Sachdeva, Ann Greenberg, Ann Luyten, Ann Ostrander, Anna Di Donato, Anna Cichocka-Radwan, Anna Fojt, Anna Plachcinska, Anna Proietti, Anna Teresinska, Anne Marie Webb, Anne Cartwright, Anne Heath, Anne Mackin, Anong Amaritakomol, Anong Chaiyasri, Anoop Chauhan, Anoop Mathew, Anthony Gemignani, Anto Luigi Andres, Antonia Vega, Antonietta Hansen, Antonino Ginel Iglesias, Antonio Carlos Carvalho, Antonio Di Chiara, Antonio Serra Peñaranda, Antonio Carvalho, Antonio Colombo, Antonio Fiarresga, Anupama Rao, Aquiles Valdespino-Estrada, Araceli Boan, Areef Ishani, Ariel Diaz, Arijit Ghosh, Arintaya Prommintikul, Arline Roberts, Arnold H Seto, Arnold P Good, Arshed Quyyumi, Arthur J Labovitz, Arthur Kerner, Arturo S Campos-Santaolalla, Arunima Misra, Ashok Mukherjee, Ashok Seth, Ashraf Seedhom, Asim N Cheema, Asker Ahmed, Atul Mathur, Atul Verma, Audrey W Leong, Axel Åkerblom, Axelle Fuentes, Aynun Naher, Badhma Valaiyapathi, Baljeet Kaur, Bandula Guruge, Barbara Brzezińska, Barbara Nardi, Bartosz Czarniak, Bebek Singh, Begoña Igual, Bela Merkely, Belen Cid Alvarez, Benjamin J Spooner, Benjamin J W Chow, Benjamin Cheong, Benoy N Shah, Bernard de Bruyne, Bernardas Valecka, Bernhard Jäger, Beth A Archer, Beth Abramson, Beth Jorgenson, Bethany Harvey, Betsy O'Neal, Bev Atkinson, Bev Bozek, Bevin Lang, Bijulal Sasidharan, Bin Yang, Bin Zhang, Binoy Mannekkattukudy Kurian, Bjoern Goebel, Bob Hu, Bogdan A Popescu, Bogdan Crnokrak, Bolin Zhu, Bonnie J Kirby, Brandi D Zimbelman, Brandy Starks, Branko D Beleslin, Brenda Hart, Brian P Shapiro, Brian McCandless, Brianna Wisniewski, Brigham R Smith, Brooks Mirrer, Bruce McManus, Bruce Rutkin, Bruna Edilena Paulino, Bruna Maria Ascoli, Bryn Smith, Byron J Allen, C Michael Gibson, C Noel Bairey Merz, Calin Pop, Cameron Hague, Camila Thais de Ormundo, Candace Gopaul, Candice P Edillo, Carísi A Polanczyk, Carita Krannila, Carla Vicente, Carl-Éric Gagné, Carlo Briguori, Carlos Peña Gil, Carlos Alvarez, Carly Ohmart, Carmen C Beladan, Carmen Ginghina, Carol M Kartje, Caroline Alsweiler, Caroline Brown, Caroline Callison, Caroline Pinheiro, Caroline Rodgers, Caroline Spindler, Carolyn Corbett, Carrie Drum, Casey Riedberger, Catherine Bone, Catherine Fleming, Catherine Gordon, Catherine Jahrsdorfer, Catherine Lemay, Catherine Weick, Cathrine Patten, Cecilia Goletto, Cezary Kepka, Chandini Suvarna, Chang Xu, Chantale Mercure, Charle A Viljoen, Charlene Wiyarand, Charles Jia-Yin Hou, Charles Y Lui, Charles Cannan, Charles Cornet, Charlotte Pirro, Chataroon Rimsukcharoenchai, Chen Wang, Cheng-Ting Tsai, Chen-Yen Chien, Cheryl A Allardyce, Chester M Hedgepeth, Chetan Patel, Chiara Attanasio, Chih-Hsuan Yen, Chi-Ming Chow, Ching Min Er, Ching-Ching Ong, Cholenahally Nanjappa Manjunath, Chris Beck, Chris Buller, Christel Vassaliere, Christian Hamm, Christiano Caldeira, Christie Ballantyne, Christina Björklund, Christine R Hinton, Christine Bergeron, Christine Masson, Christine Roraff, Christine Shelley, Christophe Laure, Christophe Thuaire, Christopher Kinsey, Christopher McFarren, Christopher Spizzieri, Christopher Travill, Chun-Chieh Liu, Chung-Lieh Hung, Chunguang Li, Chun-Ho Yun, Chunli Xia, Ciarra Heard, Cidney Schultz, Clare Venn-Edmonds, Claudia P Hochberg, Claudia Wegmayr, Claudia Cortés, Claudia Escobar, Cláudia Freixo, Claudio T Mesquita, Clemens T Kadalie, Colin Berry, Constance Philander, Corine Thobois, Costantino Costantini, Courtney Page, Craig Atkinson, Craig Barr, Craig Paterson, Cristina Bare, Cynthia Baumann, Cynthia Burman, Dalisa Espinosa, Damien Collison, Dan Deleanu, Dan Elian, Dan Gao, Dana Oliver, Daniel P Vezina, Daniel O'Rourke, Daniele Komar, Danielle Schade, Darrel P Francis, Dastan Malaev, David A Bull, David E Winchester, David P Faxon, David Booth, David Cohen, David DeMets, David Foo, David Schlichting, David Taggart, David Waters, David Wohns, Davis Vo, Dawid Teodorczyk, Dawn Shelstad, Dawn Turnbull, Dayuan Li, Dean Kereiakes, Deborah O'Neill, Deborah Yip, Debra K Johnson, Debra Dees, Deepak L Bhatt, Deepika Gopal, Deepti Kumar, Deirdre Mattina, Deirdre Murphy, Delano R Small, Delsa K Rose, Dengke Jiang, Denis Carl Phaneuf, Denise Braganza, Denise Fine, Derek Cyr, Desiree Tobin, Diana Cukali, Diana Parra, Diane Camara, Diane Minshall Liu, Diego Adrián Vences, Diego Franca de Cunha, Dimitrios Stournaras, Dipti Patel, Dongze Li, Donna Exley, Dorit Grahl, Dragana Stanojevic, Duarte Cacela, Dwayne S G Conway, E Pinar Bermudez, Eapen Punnoose, Edgar L Tay, Edgar Karanjah, Edoardo Verna, Eduardo Hernandez-Rangel, Edward D Nicol, Edward O McFalls, Edward T Martin, Edyta Kaczmarska, Ekaterina I Lubinskaya, Elena A Demchenko, Elena Refoyo Salicio, Eli Feen, Elihú Durán-Cortés, Elisabeth M Janzen, Elise L Hannemann, Elise van Dongen, Elissa Restelli Piloto, Eliza Kaplan, Elizabeta Srbinovska Kostovska, Elizabeth Capasso-Gulve, Elizabeth Congdon, Elizabeth Ferguson, Elizaveta V Zbyshevskaya, Ellen Magedanz, Ellie Fridell, Ellis W Lader, Elvin Kedhi, Emanuela Racca, Emilie Tachot, Emily DeRosa, Encarnación Alonso-Álvarez, Eric Nicollet, Eric Peterson, Erick Alexánderson Rosas, Erick Donato Morales, Erin Orvis, Ermina Moga, Estelle Montpetit, Estevao Figueiredo, Eugene Passamani, Eugenia Nikolsky, Eunice Yeoh, Evgeniy I Kretov, Ewa Szczerba, Ewelina Wojtala, Expedito Eustáquio Ribeiro Silva, F Marin Ortuño, Fabio R Farias, Fabio Fimiani, Fabrizio Rolfo, Fa-Chang Yu, Fadi Hage, Fadi Matar, Fahim Haider Jafary, Fang Feng, Fang Liu, Fatima Ranjbaran, Fatima Rodriguez, Fausto J Pinto, Fauzia Rashid, Federica Ramani, Fei Wang, Fernanda Igansi, Filipa Silva, Filippo Ottani, Fiona Haines, Firas Al Solaiman, Flávia Egydio, Flavio Lyra, Florian Egger, Fran Farquharson, Frances Laube, Francesc Carreras Costa, Francesca de Micco, Francesca Bianchini, Francesca Pezzetta, Francesca Pietrucci, Francesco Orso, Francesco Pisano, Francis Burt, Francisca Patuleia Figueiras, Francisco Fernandez-Aviles, Francois Pierre Mongeon, Frans Van de Werf, Franziska Guenther, Fraser N Witherow, Fred Mohr, Frederico Dall'Orto, Fumiyuki Otsuka, G De La Morena, G Karthikeyan, Gabor Dekany, Gabor Kerecsen, Gabriel Galeote, Gabriel Grossmann, Gabriel Vorobiof, Gabriela Sanchez de Souza, Gabriela Guzman, Gabriela Zeballos, Gabriele Gabrielli, Gabriele Jakl-Kotauschek, Gail A Shammas, Gail Brandt, Gang Chen, Gary E Lane, Gary J Luckasen, Gautam Sharma, Gelmina Mikolaitiene, Gennie Yee, Georg Nickenig, George E Revtyak, George J Juang, Gerald Fletcher, Gerald Leonard, Gerard Patrick Devlin, Gerard Esposito, Gergely Ágoston, Gervasio Lamas, Geza Fontos, Ghada Mikhail, Gia Cobb, Gian Piero Perna, Gianpiero Leone, Giles Roditi, Gilles Barone-Rochette, Girish Mishra, Giuseppe Tarantini, Glenda Wong, Glenn S Hamroff, Glenn Rayos, Gong Cheng, Gonzalo Barge-Caballero, Goran Davidović, Goran Stankovic, Gordana Stevanovic, Grace Jingyan Wang, Grace M Young, Graceanne Wayser, Graciela Scaro, Graham S Hillis, Graham Wong, Grazyna Anna Szulczyk, Gregor Simonis, Gregory Kumkumian, Gretchen Ann Peichel, Grzegorz Gajos, Gudrun Steinmaurer, Guilherme G Rucatti, Guilherme Portugal, Guilhermina Cantinho Lopes, Guillem Pons Lladó, Gunnar Frostfelt, Gurpreet S Wander, Gurpreet Gulati, Gustavo Pucci, Hafidz Abd Hadi, Haibo Zhang, Haitao Wang, Halina Marciniak, Han Chen, Hanan Kerr, Hani Najm, Hanna Douglas, Hannah Phillips, Hao Dai, Haojian Dong, Haqeel Jamil, Harikrishnan Sivadasanpillai, Harry Suryapranata, Hassan Reda, Hayley Pomeroy, Heather Barrentine, Heather Golden, Heather Hurlburt, Heidi Wilson, Helen C Tucker, Helene Abergel, Hemalata Siddaram, Hermine Osseni, Herwig Schuchlenz, Hesong Zeng, Hicham Skali, Hilda Solomon, Hollie Horton, Holly Hetrick, Holly Little, Holly Park, Hongjie Chi, Hossam Mahrous, Howard A Levite, Hristo Pejkov, Huajun Li, Hugo Bloise-Adames, Hugo Marques, Hui Zhong, Hui-Min Zhang, Humayrah Hashim, Hung-I Yeh, Hussien El Fishawy, Ian Webb, Iftikhar Kullo, Igor O Grazhdankin, Ihab Hamzeh, Ikraam Hassan, Ikuko Ueda, Ileana L Pina, Ilona Tamasauskiene, Ilse Bouwhuis, Imran Arif, Ina Wenzelburger, Inês Zimbarra Cabrita, Ines Rodrigues, Inga H Robbins, Inga Soveri, Ingela Schnittger, Iqbal Karimullah, Ira M Dauber, Iram Rehman, Irena Peovska Mitevska, Irene Marthe Lang, Irina Subbotina, Irma Kalibataite-Rutkauskiene, Irni Yusnida, Isabel Estela Carvajal, Isabella C Palazzo, Isabelle Hogan, Isabelle Roy, Ishba Syed, Ishita Tejani, Ivan A Naryshkin, Ivana Jankovic, Iwona Niedzwiecka, J David Knight, Jacek Kusmierek, Jackie M White, Jackie Chow, Jacob Udell, Jacqueline E Tamis-Holland, Jacqueline Fannon, Jacquelyn A Quin, Jacquelyn Do, Jaekyeong Heo, Jakub Maksym, James E Davies, James H O'Keefe Jr, James J Jang, James Cha, James Harrison, James Hirsch, James Stafford, James Tatoulis, Jamie Rankin, Jan Henzel, Jan Orga, Jana Tancredi, Janaina Oliveira, Jane Burton, Jane Eckstein, Jane Marucci, Janet P Knight, Janet Blount, Janet Halliday, Janetta Kourzenkova, Janitha Raj, Jan-Malte Sinning, Jaqueline Pozzibon, Jaroslaw Drozdz, Jaroslaw Karwowski, Jason D Glover, Jason Loh Kwok, Jason T Call, Jason Linefsky, Jassira Gomes, Jati Anumpa, Javier J Garcia, Javier Courtis, Jay Meisner, K Jayakumar, Jayne Scales, Jean E Denaro, Jean Michel Juliard, Jean Ho, Jeanette K Stansborough, Jean-Michel Juliard, Jeanne Russo, Jeannette J M Schoep, Jeet Thambyrajah, Jeff Leimberger, Jeffery A Breall, Jeffrey A Kohn, Jeffrey C Milliken, Jeffrey Anderson, Jeffrey Blume, Jeffrey Kanters, Jeffrey Lorin, Jeffrey Moses, Jelena J Stepanovic, Jelena Celutkiene, Jelena Djokic, Jelena Stojkovic, Jenne M Jose, Jenne Manchery, Jennifer A Mull, Jennifer H Czerniak, Jennifer L Stanford, Jennifer Gillis, Jennifer Horst, Jennifer Isaacs, Jennifer Langdon, Jennifer Thomson, Jennifer Tomfohr, Jennifer White, Jen-Yuan Kuo, Jeremy Rautureau, Jerome Fleg, Jessica Berg, Jessica Rodriguez, Jessica Waldron, Jhina Patro, Jia Li, Jiajia Mao, Jiamin Liu, Jian'an Wang, Jianhua Li, Jianxin Zhang, Jie Qi, Jihyun Lyo, Jill Marcus, Jim Blankenship, Jing Zhang, Jingjing Liu, Jing-Yao Fan, Jiun-Yi Li, Jiwan Pradhan, Jiyan Chen, J M Rivera Caravaca, Jo Evans, Joan Garcia Picart, Joan Hecht, Joanna Jaroch, Joanna Zalewska, Joanne Kelly, Joanne Taaffe, João Reynaldo Abbud, João V Vitola, Joaquín V Peñafiel, Jocelyne Benatar, Jody Bindeman, Joe Sabik, Joel Klitch, Johann Christopher, Johannes Aspberg, John D Friedman, John F Beltrame, John F Heitner, John Joseph Graham, John R Davies, John Doan, John Kotter, John Kurian, John Mukai, John Pownall, Jolanta Sobolewska, Jon Kobashigawa, Jonathan L Goldberg, Jonathan W Bazeley, Jonathan Byrne, Jonathan Himmelfarb, Jonathan Leipsic, Jonean Thorsen, Jorge F Trejo Gutierrez, Jorge Escobedo, Jorik Timmer, José A Ortega-Ramírez, José Antonio Marin-Neto, Jose D Salas, Jose Enrique Castillo, Jose Francisco Saraiva, José J Cuenca-Castillo, Jose L Diez, José Luis Narro Villanueva, José Luiz da Vieira, José M Flores-Palacios, Jose Ramon Gonzalez, Jose Seijas Amigo, Jose Fragata, Josep Maria Padró, Josheph F X McGarvey Jr, Joseph Hannan, Joseph Sacco, Joseph Sweeny, Joseph Wiesel, Josephine D Abraham, Joshua P Loh, Joy Burkhardt, Joyce R White, Joyce Riestenberg-Smith, Judit Sebo, Judith L Meadows, Judith Wright, Judy Mae Foltz, Judy Hung, Judy Otis, Juergen Stumpf, Jui-Peng Tsai, Julia S Dionne, Julia de Aveiro Morata, Julie Bunke, Julie Morrow, Julio César Figal, Jun Fujita, Jun Jiang, Junhua Li, Junqing Yang, Juntima Euathrongchit, Jyotsna Garg, K Manjula Rani, K Preethi, Kaatje Goetschalckx, Kai Eggers, Kamalakar Surineni, Kanae Hirase, T R Kapilamoorthy, Karen Calfas, Karen Gratrix, Karen Hallett, Karen Hultberg, Karen Nugent, Karen Petrosyan, Karen Swan, Karolina Kryczka, Karolina Wojtczak-Soska, Karolina Wojtera, Karsten Lenk, Karthik Ramasamy, Katarzyna Łuczak, Katarzyna Malinowska, Kate Pointon, Kate Robb, Katherine Martin, Kathleen Claes, Kathryn Carruthers, Kathy E Siegel, Katia Drouin, Katie Fowler-Lehman, Kavita Rawat, Kay Rowe, Keiichi Fukuda, Keith A A Fox, Ken Mahaffey, Kendra Unterbrink, Kenneth Giedd, Kerrie Van Loo, Kerry Lee, Kerstin Bonin, Kevin R Bainey, Kevin T Harley, Kevin Anstrom, Kevin Chan, Kevin Croce, Kevin Landolfo, Kevin Marzo, Keyur Patel, Khaled Abdul-Nour, Khaled Alfakih, Khaled Dajani, Khaled Ziada, Khaula Baloch, Khrystyna Kushniriuk, Kian-Keong Poh, Kim F Ireland, Kim Holland, Kimberly Ann Byrne, Kimberly E Halverson, Kimberly Elmore, Kimberly Miller-Cox, Kiran Reddy, Kirsten J Quiles, Kirsty Abercrombie, Klaus Matschke, Konrad Szymczyk, Koo Hui Chan, Kotiboinna Preethi, Kozhaya Sokhon, Krissada Meemuk, Kristian Thygesen, Kristin M Salmi, Kristin Newby, Kristina Wippler, Kristine Arges, Kristine Teoh, Krystal Etherington, Krystyna Łoboz-Grudzień, Krzysztof W Reczuch, Krzysztof Bury, Krzysztof Drzymalski, Krzysztof Kukuła, Kuo-Tzu Sung, Kurt Huber, Ladda Douangvila, Lance Sullenberger, Larissa Miranda Trama, Laszlone Matics, Laura Drew, Laura Flint, Laura Keinaite, Laura Sarti, Laurel Kolakaluri, Lawrence M Phillips, Lawrence Friedman, Lawrence Phillips, Lazar Velicki, Leah Howell, Leandro C Maranan, Leanne Cox, Ledjalem Daba, Lei Zhang, Lekshmi Dharmarajan, Leo Bockeria, Leonardo Pizzol Caetano, Leonardo Bridi, Leonid L Bershtein, Leszek Sokalski, Li Hai Yan, Li Li, Lia Nijmeijer, Lidia Sousa, Lihong Xu, Lihua Zhang, Lili Zhang, Lilia Schiavi, Lilian Mazza Barbosa, Lillian L Khor, Lina Felix-Stern, Linda L Hall, Linda M Hollenweger, Linda Arcand, Linda Davidson-Ray, Linda Schwarz, Lindsey N Sikora, Lingping Chi, Lino Patricio, Liping Zhang, Lisa Chaytor, Lisa Hatch, Lisa McCloy, Lisa Wong, Liselotte Persson, Lixin Jiang, Liz Low, Ljiljana Pupic, Loïc Bière, Lorenzo Monti, Lori Christensen, Lori Pritchard, Loriane Black, Lori-Ann Desimone, Lori-Ann Larmand, Lorraine McGregor, Louise Morby, Louise Thomson, Luc Harvey, Luciana de Pádua Baptista, Lucilla Garcia, Ludivine Eliahou, Ludmila Helmer, Luis F Smidt, Luis Bernanrdes, Luis Guzman, Luiz A Carvalho, Luyang Xiong, Lynette L Teo, Lynn M Neeson, Lynne Winstanley, M Barbara Srichai-Parsia, M Quintana Giner, M Sowjanya Reddy, M Valdés Chávarri, M Grazia Rossi, Maarten Simoons, Maayan Konigstein, Maciej Lesiak, Maciej Olsowka, Mafalda Selas, Magalie Corfias, Magdalena Madero Rovalo, Magdalena Łanocha, Magdalena Miller, Magdalena Misztal-Teodorczyk, Magdalena Rantinella, Magdy Abdelhamid, Magnolia Jimenez, Mahboob Alam, Mahevamma Mylarappa, Mahfouz El Shahawy, Mahmoud Mohamed, Mahmud Al-Bustami, Majo X Joseph, Malgorzata Frach, Małgorzta Celińska-Spodar, Malte Helm, Manas Chacko, Mandy Murphy, Manitha Vinod, Manjula Rani, Manu Dhawan, Manuela Mombelli, Marcel Weber, Marcello Galvani, Marcelo Jamus Rodrigues, Marcia F Dubin, Marcia F Werner Bayer, Marcin Szkopiak, Marco Antonio Monsalve, Marco Bizzaro Santos, Marco Magnoni, Marco Marini, Marco Sicuro, Marco Zenati, Marcos Valério Coimbra Resende, Marek Roik, Margalit Bentzvi, Margaret Gilsenan, Margaret Iraola, Margot C Quinn, Maria A Alfonso, Maria Antonieta Pereira Moraes, María Dolores Martínez-Ruíz, María Fernanda Canales, Maria Inês Caetano, Maria P Corral, Maria Pérez García, Maria Victoria Actis, Maria Aguirre, Maria Andreasson, Maria Aprile, Maria Colton, Maria Eugenia Martin, Maria Lasala, Maria Lorenzo, Maria Posada, Maria Shier, Maria Thottam, Mariana V Furtado, Mariana Yumi Okada, Marianna D A Dracoulakis, Marianne De Andrade, Mariano Rubio, Marie Essermark, Marielle Scherrer-Crosbie, Marija T Petrovic, Marija Zdravkovic, Marilyn Black, Marina Garcia, Mario J Garcia, Mariola Szulik, Marisa Orgera, Mark A de Belder, Mark Harbinson, Mark Hyun, Mark Peterson, Mark Xavier, Marlowe Mosley, Marta Capinha, Marta Marcinkiewicz-Siemion, Marta Swiderek, Martha Meyer, Martina Ceseri, Martina Tricoli, Marvin Kronenberg, Mary Williams, Mary Ann Champagne, Mary Colleen Rogge, Mary R Soltau, Mary Streif, Massimo Villella, Massoud Leesar, Matei Claudia, Mateusz Solecki, Matías Nicolás Mungo, Matthew Wall Jr, Matthew Budoff, Matthew Jezior, Matthew Luckie, Matthias Friedrich, Mauren P Haeffner, Maximilian Tscharre, Max-Paul Winter, Mayana Almeida, Mayil S Krishnam, Mayuri Patel, Meenakshi Mishra, Megan Manocchia, Meghana Kakade, Melanie J Munro, Melissa D Chaplin, Melissa LeFevre, Mervyn Andiapen, Michael A Gibson, Michael B Rubens, Michael C Turner, Michael D Shapiro, Michael W Lee, Michael Berlowitz, Michael Davidson, Michael Mack, Michael McDaniel, Michael Mumma, Michal Wlodarczyk, Michel G Khouri, Michel S Slama, Michele Rawlins, Michelle M Bonner, Michelle M Seib, Michelle Chang, Michelle Crowder, Michelle Dixon, Michelle Mayon, Michelle McEvoy, Michelle Yee, Miguel M Fernandes, Miguel Nobre Menezes, Miguel Souto Bayarri, Miguel Barrero, Mikhail T Torosoff, Milan R Dobric, Milan Dobric, Milica Nikola Dekleva, Milind Avdhoot Gadkari, Millie Gomez, Min Tun Kyaw, Miriam Brooks, Miroslav Stevo Martinovic, Mitchel B Lustre, Mohammad Tariq Vakani, Mohammad El-Hajjar, Mohammed Al-Amoodi, Mohammed Hussain, Mohammed Saleem, Moisés Blanco-Calvo, Moisés Jiménez-Santos, Mona Bhatia, Monica Rosca, Monika Laukyte, Montserrat Gracida Blanca, Montserrat Vila Perales, Mouaz H Al-Mallah, Moysés de Oliveira Filho, Mpiko Ntsekhe, Muhamed Saric, Mulei Chen, Myriam Brousseau, Myrthes Emy Takiuti, Nada Cemerlic-Adjic, Nadia Asif, Nadia Gakou, Nafisa Hussain, Nana O Katamadze, Nancy L Clapp, Nancy Aedy, Nandita Nataraj, Nanette K Wenger, Naomi Uchida, Nasrul Ismail, Natalia S Oliveira, Natalia de Carvalho Maffei, Natalie Spitzer, Natasha C Putnam, Naved Aslam, Neamat Mowafy, Neeraj Pandit, Neeraj Parakh, Nevena Garcevic, Ngaire Meadows, Nhi N Tran, Nicholas Danchin, Nicki Lakeman, Nicola Johnston, Nicolas W Shammas, Nicole Saint Vrestil, Nicole Deming, Nier Zhong, Niket Patel, Nikola N Boskovic, Nikolaos Karogiannis, Nikos Werner, Nina Johnston, Ning Zhang, Ning Zhou, Niree Hindoyan, Nirmal Kumar, Nitika Chadha, Nitish Naik, Nodira Aripova, Noloyiso Mtana, Nona A Eskelson, Noor Syamira Mokhtar, Noppon Taksaudom, Nor Asiah Basri, Nora Marchelletta, Norma Hogg, Nungshi Jungla, Nuno Ferreira, Oksana A Lubyanaya, Olga B Nikolaeva, Olga Cañavate, Olga Sobrino, Olga Walesiak, Olga Walter, Olga Zdończyk, Olivia J Lim, Olivia Anaya, Olivia Mancilla, Olivier Dubourg, Olugbenga Bello, Omar Almousalli, Omar Thompson, Oni Olurinde, Or Harel, Osama Raheem, Oscar Méndiz, Óscar Prada-Delgado, Oz Shapira, P Christian Schulze, Pachara Panpunuan, Pal Maurovich-Horvat, Pallav Garg, Paloma Moraga, Pam Singh, Pamela Julian, Pamela Ouyang, Pamela Sigel, Pamela Woodard, Panpan Zhou, Paola Emanuela Poggio, Paola Smanio, Paolo Calabro, Paramjit Jeetley, Pascal Goube, Patricia K Nguyen, Patricia Alarie, Patricia Arakelian, Patricia Arsenault, Patricia Blaise, Patricia Brito, Patricia Cowper, Patricia Endsley, Patricia Mieses, Patrick B Alexander, Patrick Donnelly, Patrick Wilmot, Patrycja Lebioda, Paul C Gordon, Paul Der Mesropian, Paul Galiwango, Paul Hauptman, Paul Kennedy, Paula Beardsley, Paula García-González, Paulo Cury Rezende, Paulo Ricardo Caramori, Pavel S Kozlov, Pedro Canas Silva, Pedro Gabriel Melo Barros E Silva, Pedro Píccaro de Oliveira, Pedro Carvalho, Pedro Modas, Pedro Rio, Peeyush Jain, Peiyu He, Peter A McCullough, Peter H Stone, Peter M Pollak, Peter Douglass, Peter Henriksen, Peter OKane, Peter Ong, Philip Jones, Philip Rogal, Philippe Généreux, Philippe Menasche, Philippe Rheault, Phoebe Goold, Pierre Gervais, Pierre Michaud, Pilar Calvillo, Ping Chai, Piotr Jakubowski, Piotr Pruszczyk, Piotr Slomka, Piyamitr Sritara, Poay-Huan Loh, Poonam Sonawane, Pouneh Samadi, Pragnesh P Parikh, Prakash Deedwania, Pranav M Patel, Praneeth Polamuri, Pratiksha Sharma, Precilia Vasquez, Preeti Kamath, Prince Thomas, Priyadarshani Arambam, Puja K Mehta, Purvez Grant, Pushpa Naik, Qi Zhong, Qian Zhao, Qiang Zhou, Qianqian Yuan, Qin Yu, Qingxian Li, Qiulan Xie, Qiutang Zeng, R J Vindhya, R James Gerlach, Rachel King, Rada Vučić, Radmila Lyubarova, Radoslaw Pracon, Raewyn Fisher, Rafael Beyar, Rafael Diaz, Rafael Selgas, Raffaele Bugiardini, Raffaele Fanelli, Raisa Kavalakkat, V S Rajalekshmi, Rajat S Barua, Rajeev Menon, Rajesh Gopalan Nair, Rajesh Francis, Rajiv Narang, Rakesh Yadav, Ralph Alan Huston, T Ramakrishnan, Ramesh de Silva, Rami El Mahmoud, Ramiro Carvalho, Ramon de Jesús-Pérez, Ramona Stevens, Ran Leng, Ranjan Kachru, Ranjit Kumar Nath, Raquel Sanchez, Raven R Dwyer, Raven Lee, Ray Wyman, Raymond C Wong, Raymond W Little, Raymundo Ocaranza Sanchez, Rebecca J Wimmer, Rebecca Bariciano, Rebecca Otis, Rebekah R Herrmann, Reem Yunis, Reinette Hampson, Renato Abdala Karam, Renee C Hessian, Renee Kaneshiro, Reshma Ravindran, Reto Andreas Gamma, Reyna Bhandari, Reza Arsanjani, Ricardo L Lopes, Ricardo Mendes Oliveira, Ricardo Costa, Richa Bhatt, Richard F Davies, Richard H J Trimlett, Richard Goldweit, Rik Hermanides, Rine Nakanishi, Rinu R Sidh, Risha Patel, Rita Coram, Rizwan A Siddiqui, Rob S Beanlands, Robert J Hamburger, Robert K Riezebos, Robert M Donnino, Robert Bojar, Robert Chilton, Robert Guyton, Robert Henderson, Robert Kornberg, Robert Leber, Robert Mao, Robert Stenberg, Roberta P Santos, Roberto René Favaloro, Roberto Amati, Rodolfo G S D Lima, Rodrigo J Cerci, Rogerio Tumelero, Rohit Tandon, Roma Tewari, Romalisa Miranda-Peats, Ron Wald, Ronald A Mastouri, Ronald G Morford, Ronald G Schwartz, Ronald P Pedalino, Rongrong Hu, Ronnell A Hansen, Ronny A Cohen, Rory Hachamovitch, Rosa Homem, Rosa Sandonato, Rosane Laimer, Rosann Gans, Roxanne Yost, Roy Mathew, Rubén Baleón-Espinosa, Ruben Ramos, Rubine Gevorgyan, Rui Ferreira, Rui Jing, Ruth Pérez-Fernández, S K Dwivedi, S Ramakrishnan, Saadat Khan, Sabahat Bokhari, Sabu Thomas, Sadath Lubna, Sajeeda Parveen Khan, Sajeev Chakanalil Govindan, Saket Girotra, Saleem Kassam, Sallie Canada, Salvador Cruz-Flores, Samaa Mohamed, Samantha Ly, Sameh El Kaffas, Samia Massalha, Sampoornima Setty, Samuel Nwosu, Sandeep Seth, Sandeep Singh, Sander R Niehe, Sandra M Rivest, Sandra S Zier, Sandra Ahoud, Sandy Carr, Sanjay Ganapathi, Sanjay Shetty, Sanjeev Sharma, Santa Jimenez, Santhosh Satheesh, Santiago A Garcia, Sara Fernandez, Sara Karlsson, Sara Salkind, Sara Temiyasathit, Sarah Medina Rodriguez, Sarah Beaudry, Sarah Hadjih, Sarah Williams, Sarah Zahrani, Sarju Ralhan, Sasa Hinic, Sasko Kedev, Satinder Singh, Satoshi Yasuda, Satvic Cholenahally Manjunath, Sau Lee, Scott M Kaczkowski, Scott Kinlay, Sean W Hayes, Sebastian Sobczak, Senait Asier, Sergey A Sayganov, Seth I Sokol, Shaheen Pandie, Shaiful Azmi Yahaya, Shamir Mehta, Shao-Ping Nie, Sharad Chandra, Sharder Islam, Sharon Tai, Sheetal Rupesh Karwa, Sheri Ussery, Sheromani Bajaj, Sherron C Crook, Shigeyuki Nishimura, Shintaro Nakano, Shirin Heydari, Shiv Kumar Choudhary, Shivali Patel, Shobana Ganesan, Shruti Pandey, Shuyang Zhang, Shweta Hande, Siddharth Gadage, Sik-Yin V Tan, Silvia Zottis Poletti, Silvia Riera, Silvia Valbuena, Simon Walsh, Simona Maspoli, Simone Savaris, Si-Ting Feng, So Yang Cho, Solomon Yakubov, Songlin Zhu, Songtao Wang, Sonia Guerrero, Sonika Gupta, Sonja Salinger Martinovic, Sonya Brons, Sorin Brener, Sothinathan Gurunathan, Souheil Saba, Soundarya Nayak, Sowjanya Reddy, Srinivasa Potluri, Sriram Sudarshan, Srun Kuanprasert, Stacie Van Oosterhout, Stamatios Lerakis, Stanley E Cobos, Stefan C Bertog, Stefan M Simović, Stefan Weikl, Stefano Di Marco, Stefano Provasoli, Stephanie A Tirado, Stephanie C Boer, Stephanie M Lane, Stephanie Ferket, Stephanie Kelly, Stephanie Wasmiller, Stephen H McKellar, Stephen P Hoole, Stephen Fremes, Stephen Preston, Steve Leung, Steven A Fein, Steven J Lindsay, Steven P Sedlis, Steven Giovannone, Steven Michael, Steven Weitz, Stijn van Vugt, Subhash Banerjee, Sudhir Naik, Suellen Hosino, Sukie Desire, Sukit Yamwong, Suku T Thambar, Sulagna Mookherjee, Suman Singh, Sundeep Mishra, Sunil Kumar Verma, Supap Kulthawong, Supatchara Khwakhong, Surendra Naik, Suresh Babu, Surin Woragidpoonpol, Suryaprakash Narayanappa, Susan Derbyshire, Susan Gent, Susan Mathus, Susan Milbrandt, Susan Moore, Susan Regan, Susan Stinson, Susan Webber, Susana Silva, Susanna Stevens, Susanne Gruensfelder, Suthara Aramcharoen, Suvarna Kolhe, Suzana Tavares, Suzanne Arnold, Suzanne Welsh, Svetlana Apostolovic, Swapna Kunhunny, Ta-Chuan Hung, Taissa Zappernick, Tali Sharir, Talita Silva, Tamara Colaiácovo Soares, Tapan Umesh Pillay, Tarun K Mittal, Tatiana Trifonova, Tauane Bello Duarte, Tauqir Huk, Téodora Dutoiu, Terrance Chua, Terry Weyand, Thabitha Charles, Theodoros Kofidis, Theresa McCreary, Thierry Lefevre, Thippeekaa Arumairajah, Thitipong Tepsuwan, Thomas J Mulhearn, Thomas M Meyer, Thomas P Rocco, Thomas R Downes, Thomas Crain, Thomas Haldis, Thomas Mathew, Thomas Redick, Thounaojam Indira Devi, Thuraia Nageh, Tia Cauthren, Tiago Silva, Tiffany Little, Tijana Andric, Tina Harding, Titus Lau, Tiziana Formisano, Tiziano Moccetti, Tomasz Ciurus, Tomasz Mazurek, Tomasz Tarchalski, Toshiyuki Nagai, Tri Tran, Tricia Youn, Trish Tucker, Trudie Milner, Tuhina Bose, Tushar Kotecha, Udo Sechtem, Uma S Valeti, Umberto Cucchini, Umesh Badami, Upendra Kaul, V K Bahl, V S Narain, Valentina Casali, Valeria Godoy, Valerie Robesyn, Vamshi P Priya, Vandana Yadav, Vera McKinney, Veronica De Lenges, Veronica Tinnirello, Vicente Miro, Victor Navarro, Victoria Gumerova, Victoria Hernandez, Vidya Seeratan, Vijay Kumar, Vikentiy Y Kozulin, Viktoria Bulkley, Vilmar Veiga Jr, Vincent Setang, C P Vineeth, Virginai Pubull Nuñez, Virginia Fernández-Figares, Vitor Gomes, Viviana Gabriel, Viviane Dos Santos, Viviane Almeida, Vlad A Iliescu, Vladan Mudrenovic, Vladimir Dzavik, Vojislav L Giga, Walter Enrique Mogrovejo, Wan Xian Chan, Wanda C Marfori, Wanda Parker, Warangkana Mekara, Wassim Nona, Wayne Old, Wayne Pennachi, Weerachai Nawarawong, Wei Chen, Wei Su, Weibing Xing, Wei-Ren Lan, Wenda Crawford, Wendy L Stewart, Wendy Drewes, Wenhua Lin, William B Abernethy, William D Salerno, William F Fearon, William Vergoni, William Weintraub, Winnie C Sia, Wlodzimierz J Musial, Xacobe Flores-Ríos, Xavier Garcia-Moll Marimon, Xi Su, Xiang Ma, Xiangqiong Gu, Xiao Wang, Xiaomei Li, Xiaowei Yao, Xin Fu, Xin Su, Xin Zeng, Xinchun Yang, Xiuhong Li, Xuehua Fang, Xutong Wang, Yaming Geng, Yan Yan, Yanek Pépin-Dubois, Yanfu Wang, Yang Wang, Yanmeng Tian, Yaping Huang, Yechen Han, Yesenia Zambrano, Yi-Hsuan Yang, Ying Tung Sia, Yining Yang, Yitong Ma, Yolayfi Peralta, Yongjian Wu, Yu Kunwu, Yu Zhao, Yudong Peng, Yueh-Hung Lin, Yulan Zhao, Yumei Dong, Yunhai Zhao, Yutthaphan Wannasopha, Yvonne Taul, Zakir Sahul, Zalina Kudzoeva, Zbigniew Kalarus, Zeljko Z Markovic, Zhen Huang, Zheng Ji, Zhenyu Liu, Zhou Yue, Zhulin Zhang, Zhuxi Li, Zile Singh Meharwal, Ziliang Bai, Zixiang Yu, Zohra Huda, Zoltan Davidovits

Subjects
Male, Cardiac Catheterization, Computed Tomography Angiography, medicine.medical_treatment, Myocardial Ischemia, Coronary Disease, Coronary Artery Disease, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Coronary Angiography, ISCHEMIA Research Group, law.invention, Angina, Coronary artery disease, 0302 clinical medicine, Randomized controlled trial, law, Cardiovascular Disease, Myocardial Revascularization, 030212 general & internal medicine, Coronary Artery Bypass, 11 Medical and Health Sciences, Cardiac catheterization, General Medicine, Middle Aged, humanities, Cardiovascular Diseases, Cardiology, Female, Human, medicine.medical_specialty, Ischemia, Article, 03 medical and health sciences, Geriatric cardiology, Percutaneous Coronary Intervention, General & Internal Medicine, Internal medicine, medicine, Humans, Angina, Unstable, Aged, business.industry, Coronary Artery Bypa, Percutaneous coronary intervention, Bayes Theorem, medicine.disease, Heart failure, Quality of Life, business
Abstract

BACKGROUND: Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS: We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS: Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS: Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).

Published
2020

7. Sacral nerve stimulation versus the magnetic sphincter augmentation device for adult faecal incontinence: the SaFaRI RCT

Author

Claire Hulme, Alison Pullan, Sushil Maslekar, Pasha Nisar, David Jayne, Neil Corrigan, Vicky Napp, Jen Lodge, Karen Nugent, Rachel Kelly, David Protheroe, Steven Brown, Andrew Clarke, Annabelle E Williams, Julia Brown, Julie Croft, Adam Martin, Armando Vargas-Palacios, and David Meads

Subjects
Adult, medicine.medical_specialty, Technology Assessment, Biomedical, lcsh:Medical technology, Cost-Benefit Analysis, faecal incontinence, 030230 surgery, law.invention, surgery, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Quality of life, law, medicine, Humans, health economics, business.industry, Magnetic Phenomena, Health Policy, Significant difference, fenixtm, Postoperative complication, Library website, medicine.anatomical_structure, lcsh:R855-855.5, Sacral nerve stimulation, 030220 oncology & carcinogenesis, Quality of Life, Physical therapy, Sphincter, sacral nerve stimulation, Quality-Adjusted Life Years, business, Complication, randomised controlled trial, Fecal Incontinence, Research Article
Abstract

Preliminary studies using the FENIX™ (Torax Medical, Minneapolis, MN, USA) magnetic sphincter augmentation device suggest that it is safe to use for the treatment of adult faecal incontinence, but efficacy data are limited.To compare FENIX with sacral nerve stimulation for the treatment of adult faecal incontinence in terms of safety, efficacy, quality of life and cost-effectiveness.Multicentre, parallel-group, unblinded, randomised trial comparing FENIX with sacral nerve stimulation in participants suffering moderate to severe faecal incontinence.Participants were randomised on an equal basis to either sacral nerve stimulation or FENIX. Follow-up occurred 2 weeks postoperatively and at 6, 12 and 18 months post randomisation.The primary outcome was success, defined as device in use and ≥ 50% improvement in Cleveland Clinic Incontinence Score at 18 months post randomisation. Secondary outcomes included complication rates, quality of life and cost-effectiveness. Between 30 October 2014 and 23 March 2017, 99 participants were randomised across 18 NHS sites (50 participants to FENIX vs. 49 participants to sacral nerve stimulation). The median time from randomisation to FENIX implantation was 57.0 days (range 4.0-416.0 days), and the median time from randomisation to permanent sacral nerve stimulation was 371.0 days (range 86.0-918.0 days). A total of 45 out of 50 participants underwent FENIX implantation and 29 out of 49 participants continued to permanent sacral nerve stimulation. The following results are reported, excluding participants for whom the corresponding outcome was not evaluable. Overall, there was success for 10 out of 80 (12.5%) participants, with no statistically significant difference between the two groups [FENIX 6/41 (14.6%) participants vs. sacral nerve stimulation 4/39 (10.3%) participants]. At least one postoperative complication was experienced by 33 out of 45 (73.3%) participants in the FENIX group and 9 out of 40 (22.5%) participants in the sacral nerve stimulation group. A total of 15 out of 50 (30%) participants in the FENIX group ultimately had to have their device explanted. Slightly higher costs and quality-adjusted life-years (incremental = £305.50 and 0.005, respectively) were observed in the FENIX group than in the sacral nerve stimulation group. This was reversed over the lifetime horizon (incremental = -£1306 and -0.23 for costs and quality-adjusted life-years, respectively), when sacral nerve stimulation was the optimal option (net monetary benefit = -£3283), with only a 45% chance of FENIX being cost-effective.The SaFaRI study was terminated in 2017, having recruited 99 participants of the target sample size of 350 participants. The study is, therefore, substantially underpowered to detect differences between the treatment groups, with significant uncertainty in the cost-effectiveness analysis.The SaFaRI study revealed inefficiencies in the treatment pathways for faecal incontinence, particularly for sacral nerve stimulation. The success of both FENIX and sacral nerve stimulation was much lower than previously reported, with high postoperative morbidity in the FENIX group.Further research is needed to clarify the treatment pathways for sacral nerve stimulation and to determine its true clinical and cost-effectiveness.Current Controlled Trials ISRCTN16077538.This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inFaecal incontinence is a distressing condition for patients, and surgery is recommended if symptoms are having an effect on quality of life. One of the treatments recommended for faecal incontinence by the National Institute for Health and Care Excellence is sacral nerve stimulation, which aims to improve continence by stimulating the nerves to the back passage. A newer treatment involves surgery to implant a string of magnetic beads around the anal canal using the FENIX™ device (Torax Medical, Minneapolis, MN, USA). The aim of this study was to assess the benefits and risks of the FENIX device compared with sacral nerve stimulation. The SaFaRI study aimed to recruit 350 participants with faecal incontinence, but was stopped early because of the manufacturer withdrawing the FENIX device for strategic reasons. In total, we recruited 99 participants. Fifty participants were allocated to receive the FENIX device and 49 participants were allocated to receive sacral nerve stimulation. The observed success rates with both devices were low: at 18 months following their entry into the study, 6 out of 41 (14.6%) participants in the FENIX group and 4 out of 39 (10.3%) participants in the sacral nerve stimulation group had the device both in use and producing a benefit. A total of 5 out of 50 (10.0%) participants allocated to receive the FENIX device did not have a device implanted, and 15 out of 45 (33.3%) participants who did have the FENIX device implanted needed to have it removed because of complications during the 18-month follow-up period. A total of 21 out of 49 (42.9%) participants allocated to receive sacral nerve stimulation did not have a permanent sacral nerve stimulation device implanted, and 0 of the 28 who did have a permanent sacral nerve stimulation device implanted needed to have it removed during the 18-month follow-up period. The costs associated with the FENIX device were higher because of a greater number of participants experiencing complications, meaning that the FENIX device is unlikely to be cost-effective in the treatment of faecal incontinence compared with sacral nerve stimulation.

Published
2021

8. Development and validation of a prediction model for angiographic perforation during chronic total occlusion percutaneous coronary intervention: <scp>OPEN‐CLEAN</scp> perforation score

Author

J A Grantham, William J. Nicholson, Taishi Hirai, Kensey Gosch, James Sapontis, William Lombardi, Jeffrey W. Moses, Adam C. Salisbury, Karen Nugent, and Dimitri Karmpaliotis

Subjects
medicine.medical_specialty, medicine.medical_treatment, Perforation (oil well), Renal function, 030204 cardiovascular system & hematology, Coronary Angiography, 03 medical and health sciences, Percutaneous Coronary Intervention, 0302 clinical medicine, Risk Factors, Internal medicine, Occlusion, medicine, Humans, Radiology, Nuclear Medicine and imaging, Prospective Studies, Registries, 030212 general & internal medicine, Adverse effect, Ejection fraction, business.industry, Percutaneous coronary intervention, General Medicine, Treatment Outcome, Coronary Occlusion, Chronic Disease, Conventional PCI, Cardiology, Cardiology and Cardiovascular Medicine, Complication, business
Abstract

BACKGROUND Perforation is the most frequent complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and is associated with adverse events including mortality. METHODS Among 1,000 consecutive patients enrolled in 12 center prospective CTO PCI study (OPEN CTO), all perforations were reviewed by the angiographic core-lab. Eighty-nine patients (8.9%) with angiographic perforation were compared to 911 patients without perforation. We sought to describe the clinical and angiographic predictors of angiographic perforation during CTO PCI and develop a risk prediction model. RESULTS Among eight clinically important candidate variables, independent risk factors for perforation included prior CABG (OR 2.0 [95% CI, 1.2-3.3], p

Published
2021

9. Outcomes of retrograde chronic total occlusion percutaneous coronary intervention: A report from the OPEN‐CTO registry

Author

Anthony Spaedy, Fotis Gkargkoulas, Darshan Doshi, Philip Jones, Yousif Ahmad, R. Michael Wyman, Emad Hakemi, Stephen Cook, John A. Spertus, J. Aaron Grantham, Ioanna Kosmidou, William J. Nicholson, Gregg W. Stone, Farouc A. Jaffer, Robert Federici, Juan J Russo, Adam C. Salisbury, Karen Nugent, Megha Prasad, Candido Batres, Robert F. Riley, David J. Cohen, Taishi Hirai, Raja Hatem, William Lombardi, Ajay J. Kirtane, Ziad A. Ali, James M. McCabe, Robert W. Yeh, James Sapontis, Manish Parikh, Dimitri Karmpaliotis, Akiko Maehara, Ashish Pershad, Martin B. Leon, Sanjog Kalra, Jeffrey W. Moses, and Steven P. Marso

Subjects
medicine.medical_specialty, medicine.medical_treatment, Perforation (oil well), Aftercare, 030204 cardiovascular system & hematology, Angina, 03 medical and health sciences, Percutaneous Coronary Intervention, 0302 clinical medicine, Quality of life, Internal medicine, medicine, Humans, Radiology, Nuclear Medicine and imaging, Registries, 030212 general & internal medicine, Myocardial infarction, Stroke, business.industry, Percutaneous coronary intervention, General Medicine, medicine.disease, Patient Discharge, Cardiac surgery, Treatment Outcome, Coronary Occlusion, Conventional PCI, Quality of Life, Cardiology, Cardiology and Cardiovascular Medicine, business
Abstract

OBJECTIVES We sought to assess in-hospital and long-term outcomes of retrograde compared with antegrade-only percutaneous coronary intervention for chronic total occlusion (CTO PCI). BACKGROUND Procedural and clinical outcomes following retrograde compared with antegrade-only CTO PCI remain unknown. METHODS Using the core-lab adjudicated OPEN-CTO registry, we compared the outcomes of retrograde to antegrade-only CTO PCI. Primary endpoints included were in-hospital major adverse cardiac and cerebrovascular events (MACCE) (all-cause death, stroke, myocardial infarction [MI], emergency cardiac surgery, or clinically significant perforation) and MACCE at 1-year (all-cause death, MI, stroke, target lesion revascularization, or target vessel reocclusion). RESULTS Among 885 single CTO procedures from the OPEN-CTO registry, 454 were retrograde and 431 were antegrade-only. Lesion complexity was higher (J-CTO score: 2.7 vs. 1.9; p

Published
2020

10. Sequential assessment of bowel function and anorectal physiology after anterior resection for cancer: a prospective cohort study

Author

Sally Gilbert, Thomas C. Dudding, Karen Nugent, Carl Richardson, John S. Knight, Alex H. Mirnezami, Andrew T. King, Rahul Bhome, Sophie A Pilkington, Scott Harris, Paul H. Nichols, and Nicholas E. Beck

Subjects
medicine.medical_specialty, Manometry, Colorectal cancer, medicine.medical_treatment, Anal Canal, Anastomosis, Internal anal sphincter, 03 medical and health sciences, 0302 clinical medicine, Endoanal ultrasound, medicine, Humans, Anorectal physiology, Prospective Studies, Defecation, Prospective cohort study, Rectal Neoplasms, business.industry, Anastomosis, Surgical, Gastroenterology, Cancer, medicine.disease, Surgery, Radiation therapy, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, business, Fecal Incontinence
Abstract

Aim: The aim of this study was to investigate changes in bowel function and anorectal physiology (ARP) after anterior resection for colorectal cancer. Method: Patients were recruited from November 2006 to September 2008. Cleveland Clinic Incontinence (CCI) scores and stool frequency were determined by patient questionnaires before surgery (t 0) and at three (t 3), six (t 6), nine (t 9) and 12 (t 12) months after restoration of intestinal continuity. ARP measurements were recorded at T 0, T 3 and T 12. Endoanal ultrasound was performed at T 0 and T 12. Results: Eighty-nine patients were included. CCI score increased postoperatively then normalized, whereas stool frequency did not change. Patients who had neoadjuvant radiotherapy or a lower anastomosis had increased incontinence and stool frequency in the postoperative period, whereas those with defunctioning stomas or open surgery had increased stool frequency alone. Maximum resting pressure, volume at first urge and maximum rectal tolerance were reduced throughout the postoperative period. Radiotherapy, lower anastomosis and defunctioning stoma (but not operative approach) altered manometric parameters postoperatively. Maximum rectal tolerance correlated with incontinence and first urge with stool frequency. The length of the anterior internal anal sphincter decreased postoperatively. Conclusions: Incontinence recovers in the first year after anterior resection. Radiotherapy, lower anastomosis, defunctioning stoma and open surgery have a negative influence on bowel function. ARP may be useful if bowel dysfunction persists beyond 12 months.

Published
2021

11. Chronic constipation in adults:Contemporary perspectives and clinical challenges. 1: Epidemiology, diagnosis, clinical associations, pathophysiology and investigation

Author

Adam D. Farmer, Charles H. Knowles, Asma Fikree, Mark A. Fox, Klaus Krogh, Rebecca E. Burgell, Alexander C. Ford, Karen Nugent, S. Mark Scott, Emma V. Carrington, Maura Corsetti, José María Remes-Troche, Eirini Dimidi, Marc A. Benninga, Kevin Whelan, Caroline L. Hoad, Philip G. Dinning, and Magnus Simren

Subjects
Adult, medicine.medical_specialty, Constipation, Physiology, diagnosis, chronic constipation, Quality of life (healthcare), Epidemiology, Prevalence, medicine, Humans, pathophysiology, Chronic constipation, investigation, Endocrine and Autonomic Systems, business.industry, Research, Gastroenterology, Disease Management, Clinical Practice, Hot topics, Family medicine, IBS-C, Chronic Disease, Quality of Life, epidemiology, medicine.symptom, business, Healthcare system
Abstract

BACKGROUND: Chronic constipation is a prevalent disorder that affects patients' quality of life and consumes resources in healthcare systems worldwide. In clinical practice, it is still considered a challenge as clinicians frequently are unsure as to which treatments to use and when. Over a decade ago, a Neurogastroenterology & Motility journal supplement devoted to the investigation and management of constipation was published (2009; 21 (Suppl.2)). This included seven articles, disseminating all themes covered during a preceding 2-day meeting held in London, entitled “Current perspectives in chronic constipation: a scientific and clinical symposium.” In October 2018, the 3rd London Masterclass, entitled “Contemporary management of constipation” was held, again over 2 days. All faculty members were invited to author two new review articles, which represent a collective synthesis of talks presented and discussions held during this meeting. PURPOSE: This article represents the first of these reviews, addressing epidemiology, diagnosis, clinical associations, pathophysiology, and investigation. Clearly, not all aspects of the condition can be covered in adequate detail; hence, there is a focus on particular “hot topics” and themes that are of contemporary interest. The second review addresses management of chronic constipation, covering behavioral, conservative, medical, and surgical therapies.

Published
2021

12. MANagement gUidelinEs for Low Anterior Resection Syndrome the MANUEL project

Author

Eloy Espin-Basany, Harald R. Rosen, Peter Christensen, Coen Im Baeten, Jacopo Martellucci, Frank Zerbib, Karen Nugent, Gianluca Pellino, Christensen, Peter, Im Baeten, Coen, Espín-Basany, Eloy, Martellucci, Jacopo, Nugent, Karen P, Zerbib, Frank, Pellino, Gianluca, and Rosen, Harald

Subjects
complications, Conference call, complication, LARS, Poor quality, Postoperative Complications, Nursing, rectal surgery, consensu, Humans, Medicine, Rectal surgery, Low Anterior Resection, Health professionals, business.industry, Rectal Neoplasms, Consensus Statement, Gastroenterology, Rectal Disease, SPECIAL SECTION ARTICLES: Special edition on functional outcomes after cancer surgery, Syndrome, Rectal Diseases, low anterior resection syndrome, consensus, colorectal surgery, Postoperative Complication, business, Working group, guidance, Human
Abstract

Aim: Little is known about the pathophysiology of low anterior resection syndrome (LARS), and evidence concerning the management of patients diagnosed with this condition is scarce. The aim of the LARS Expert Advisory Panel was to develop practical guidance for healthcare professionals dealing with LARS. Method: The ‘Management guidelines for low anterior resection syndrome’ (MANUEL) project was promoted by a team of eight experts in the assessment and management of patients with LARS. After a face-to-face meeting, a strategy was agreed to create a comprehensive, practical guide covering all aspects that were felt to be clinically relevant. Eight themes were decided upon and working groups established. Each working group generated a draft; these were collated by another collaborator into a manuscript, after a conference call. This was circulated among the collaborators, and it was revised following the comments received. A lay patient revised the manuscript, and contributed to a section containing a patient's perspective. The manuscript was again circulated and finalized. A final teleconference was held at the end of the project. Results: The guidance covers all aspects of LARS management, from pathophysiology, to assessment and management. Given the lack of sound evidence and the often poor quality of the studies, most of the recommendations and conclusions are based on the opinions of the experts. Conclusions: The MANUEL project provides an up-to-date practical summary of the available evidence concerning LARS, with useful directions for healthcare professional and patients suffering from this debilitating condition.

Published
2021

13. Intermediate procedural and health status outcomes and the clinical care pathways after chronic total occlusion angioplasty: A report from the <scp>OPEN‐CTO</scp> (outcomes, patient health status, and efficiency in chronic total occlusion hybrid procedures) study

Author

Craig Thompson, Jeffrey W. Moses, Anthony Spaedy, William J. Nicholson, Parag Doshi, Robert Federici, Christian Patterson, Taishi Hirai, Robert W. Yeh, Ashish Pershad, Adam C. Salisbury, Karen Nugent, William Lombardi, Stephen Cook, Dimitri Karmpaliotis, Benjamin Gans, James Sapontis, R. Michael Wyman, J. Aaron Grantham, and Kensey Gosch

Subjects
medicine.medical_specialty, medicine.medical_treatment, 030204 cardiovascular system & hematology, Total occlusion, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Internal medicine, Angioplasty, medicine, Radiology, Nuclear Medicine and imaging, cardiovascular diseases, 030212 general & internal medicine, Myocardial infarction, business.industry, Hazard ratio, Percutaneous coronary intervention, General Medicine, medicine.disease, surgical procedures, operative, Conventional PCI, Cardiology, Cardiology and Cardiovascular Medicine, Complication, business, therapeutics
Abstract

Background No previous reports have described the comprehensive care pathways involved in chronic total occlusion percutaneous coronary intervention (CTO PCI). Methods In a study of 1,000 consecutive patients undergoing CTO PCI using hybrid approach, a systematic algorithm of selecting CTO PCI strategies, the procedural characteristics, complication rates, and patient reported health status outcomes through 12 months were assessed. Results Technical success of the index CTO PCI was 86%, with 89% of patients having at least one successful CTO PCI within 12 months. A total of 13.8% underwent CTO PCI of another vessel or reattempt of index CTO PCI within 1 year. At 1 year, the unadjusted major adverse cardiac and cerebral event (MACCE) rate was lower in patients with successful index CTO PCI compared to patients with unsuccessful index CTO PCI (9.4% vs. 14.6%, p = .04). The adjusted hazard ratios of myocardial infarction and death at 12 months were numerically lower in patients with successful index CTO PCI, compared to patients with unsuccessful index CTO PCI. Patients with successful index CTO PCI reported significantly greater improvement in health status throughout 12-months compared to patients with unsuccessful index CTO PCI. Conclusion CTO-PCI in the real-world often require treatment of second CTO, non-CTO PCI or repeat procedures to treat initially unsuccessful lesions. Successful CTO PCI is associated with numerically lower MACCE at 1 year and persistent symptomatic improvement compared to unsuccessful CTO PCI. Understanding the relationship between the care pathways following CTO PCI and health status benefit requires further study.

Published
2020

14. Intermediate procedural and health status outcomes and the clinical care pathways after chronic total occlusion angioplasty: A report from the OPEN-CTO (outcomes, patient health status, and efficiency in chronic total occlusion hybrid procedures) study

Author

James, Sapontis, Taishi, Hirai, Christian, Patterson, Benjamin, Gans, Robert W, Yeh, William, Lombardi, Dimitri, Karmpaliotis, Jeffrey, Moses, William J, Nicholson, Ashish, Pershad, R Michael, Wyman, Anthony, Spaedy, Stephen, Cook, Parag, Doshi, Robert, Federici, Craig A, Thompson, Karen, Nugent, Kensey, Gosch, J Aaron, Grantham, and Adam C, Salisbury

Subjects
Percutaneous Coronary Intervention, Time Factors, Treatment Outcome, Coronary Occlusion, Risk Factors, Health Status, Angioplasty, Chronic Disease, Humans, Registries
Abstract

No previous reports have described the comprehensive care pathways involved in chronic total occlusion percutaneous coronary intervention (CTO PCI).In a study of 1,000 consecutive patients undergoing CTO PCI using hybrid approach, a systematic algorithm of selecting CTO PCI strategies, the procedural characteristics, complication rates, and patient reported health status outcomes through 12 months were assessed.Technical success of the index CTO PCI was 86%, with 89% of patients having at least one successful CTO PCI within 12 months. A total of 13.8% underwent CTO PCI of another vessel or reattempt of index CTO PCI within 1 year. At 1 year, the unadjusted major adverse cardiac and cerebral event (MACCE) rate was lower in patients with successful index CTO PCI compared to patients with unsuccessful index CTO PCI (9.4% vs. 14.6%, p = .04). The adjusted hazard ratios of myocardial infarction and death at 12 months were numerically lower in patients with successful index CTO PCI, compared to patients with unsuccessful index CTO PCI. Patients with successful index CTO PCI reported significantly greater improvement in health status throughout 12-months compared to patients with unsuccessful index CTO PCI.CTO-PCI in the real-world often require treatment of second CTO, non-CTO PCI or repeat procedures to treat initially unsuccessful lesions. Successful CTO PCI is associated with numerically lower MACCE at 1 year and persistent symptomatic improvement compared to unsuccessful CTO PCI. Understanding the relationship between the care pathways following CTO PCI and health status benefit requires further study.

Published
2020

15. Ano-uro-genital mucosal melanoma UK national guidelines

Author

Martin Gore, Jonathan Smith, Sharon Capper, Myles Smith, Izhar Bagwan, Sarah Westwell, Jessica Glen, Pubudu Pathiraja, Sarah E. Coupland, Ruth E. Board, Antonia Mayberry, Miranda Payne, A. Muneer, Simon Rodwell, Susan Lalondrelle, Henry G. Smith, Ewan Wilson, Nancy Turnbull, Howard Peach, and Karen Nugent

Subjects
Male, 0301 basic medicine, Cancer Research, medicine.medical_specialty, Consensus, education, Nice, Medical Oncology, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, Penile cancer, Sex organ, Guideline development, Limited evidence, Melanoma, computer.programming_language, Mucous Membrane, business.industry, Mucosal melanoma, Guideline, Anus Neoplasms, medicine.disease, Dermatology, United Kingdom, Treatment Outcome, 030104 developmental biology, Oncology, 030220 oncology & carcinogenesis, Female, business, computer, Urogenital Neoplasms
Abstract

Ano-uro-genital (AUG) mucosal melanomas are rare cancers associated with poor outcomes and limited evidence-based management. The United Kingdom AUG mucosal melanoma guideline development group used an evidence-based systematic approach to make recommendations regarding the diagnosis, treatment and surveillance of patients diagnosed with AUG mucosal melanomas. The guidelines were sent for international peer review, and are accredited by The National Institute for Health and Clinical Excellence (NICE). A summary of the key recommendations is presented. The full documents are available on the Melanoma Focus website.

Published
2020

16. Less is more: a systematic review and meta-analysis of the outcomes of radical versus conservative primary resection in anorectal melanoma

Author

Nancy Turnbull, Howard Peach, Karen Nugent, Martin Gore, Myles Smith, Jessica Glen, Ruth E. Board, Henry G. Smith, and Miranda Payne

Subjects
0301 basic medicine, Cancer Research, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Risk Assessment, Disease-Free Survival, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, medicine, Humans, Melanoma, Digestive System Surgical Procedures, Abdominoperineal resection, business.industry, Primary resection, Wide local excision, Anus Neoplasms, Confidence interval, 030104 developmental biology, Oncology, 030220 oncology & carcinogenesis, Meta-analysis, Relative risk, Disease Progression, Quality of Life, Anorectal melanoma, Neoplasm Recurrence, Local, business, Rare disease
Abstract

IntroductionAnorectal melanoma (ARM) is a rare disease with a poor prognosis. There is no consensus as to the optimal primary surgical treatment for ARM, with advocates for both radical (abdominoperineal resection [APR]) and conservative strategies (wide local excision [WLE]). Here, we report a systematic review of studies comparing outcomes between these strategies.MethodsStudies comparing APR with WLE in patients with ARM were included, and a systematic review using the Grading of Recommendations, Assessment, Development and Evaluation methodology was performed. Outcomes deemed critical included overall survival, disease-free survival, local recurrence and quality of life.ResultsForty studies were identified, of which 27 were suitable for inclusion. Twenty-three studies compared overall survival between WLE and APR, with no difference in outcomes noted (risk ratio [RR]: 0.80, 95% confidence interval [CI]: 0.60–1.07, p = 0.13). Seven studies compared disease-free survival, with no difference in outcomes noted (RR: 1.08, 95% CI: 0.61–1.91, p = 0.79). A total of 19 studies compared local recurrence rates, with again no significant difference in outcomes noted (RR: 0.71, 95% CI: 0.44–1.14, p = 0.16). None of the studies identified reported quality of life–related outcomes.ConclusionThere is no evidence to suggest that a radical primary surgical strategy improves outcomes in ARM. Therefore, given the well-documented morbidity associated with APR, WLE with regular surveillance for local recurrence should be the primary strategy in most patients.

Published
2020

17. Faecal incontinence and anorectal dysfunction

Author

Karen Nugent

Abstract

Continence and normal defecation relies on the complex interaction of the colon (motility and consistency of stools), rectum (sensation, compliance, and anatomy), and the anus (sensation, structure, and function). The overriding complex neurological control is also important. A disorder of any of these may lead to faecal incontinence. This can affect over 10% of adults and at least 1–2% of patents will report these as major symptoms. In itself, faecal incontinence is not a disease but a symptom and it is necessary to take a full history and examine a patient to identify any underlying diseases or pathology that may need treatment before focusing on managing incontinence. The aim of any treatment for faecal incontinence is to improve the patient’s quality of life and give them some control back over their bowel function. Constipation is an increasing problem in the Western world and it is widely accepted that approximately 50% of adults are constipated at any point in time. Constipation encompasses a multitude of symptoms; the general mental health and social functioning of people with constipation is impaired when compared to health controls. The symptoms of constipation occur in a large percentage of the general population. The impact on quality of life when they occur for a long period of time is large. However, patients often have many coexisting other pelvic floor disorders. Although there are surgical options available, it is important to treat conservatively and understand the complexity of the other issues involved in patients presenting with constipation.

Published
2020

18. Impact of subintimal plaque modification procedures on health status after unsuccessful chronic total occlusion angioplasty

Author

Steven P. Marso, Tony Spaedy, William J. Nicholson, Parag Doshi, Ashish Pershad, James Sapontis, Jeffrey W. Moses, David Cohen, Stephen Cook, Adam C. Salisbury, Karen Nugent, Kensey Gosch, Dimitrios Karmpaliotis, R. Michael Wyman, Robert Federici, James Aaron Grantham, John A. Spertus, William Lombardi, and Taishi Hirai

Subjects
Male, medicine.medical_specialty, Time Factors, Health Status, medicine.medical_treatment, Technical failure, Coronary Artery Disease, 030204 cardiovascular system & hematology, Balloon, Total occlusion, Angina, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, Angioplasty, medicine, Humans, Radiology, Nuclear Medicine and imaging, Patient Reported Outcome Measures, Registries, Treatment Failure, 030212 general & internal medicine, Angioplasty, Balloon, Coronary, Aged, business.industry, fungi, Percutaneous coronary intervention, General Medicine, Middle Aged, medicine.disease, Coronary Vessels, Plaque, Atherosclerotic, United States, Surgery, Dissection, Coronary Occlusion, Chronic Disease, Conventional PCI, Cardiology, Female, Cardiology and Cardiovascular Medicine, Complication, business
Abstract

Objectives We sought to determine the impact of subintimal plaque modification (SPM) on early health status following unsuccessful chronic total occlusion (CTO) PCI. Background Intentionally dilating the subintimal space during unsuccessful CTO PCI to facilitate flow through dissection planes and improve success of repeat PCI attempts is a technique used by some hybrid operators, and may improve health status by restoring distal vessel flow despite unsuccessful CTO PCI. Methods We studied 138 patients who underwent unsuccessful CTO PCI in a 12-center CTO PCI registry. Safety was assessed by comparing in-hospital outcomes of patients undergoing unsuccessful CTO PCI with and without SPM. The association between SPM and health status was quantified using the Seattle Angina Questionnaire Summary Score (SAQ SS), and the association between SPM and SAQ SS was determined using multivariable regression. Results SPM was performed in 59 patients (42.8%). Complication rates were similar comparing those with and without SPM. At 1-month, patients treated with SPM had larger increases in SAQ SS compared to patients who were not (28.3 ± 21.7 vs. 16.8 ±20.2, P = 0.012), and SPM was associated with an adjusted mean 10.5 point (95% CI 1.4-19.7, P = 0.02) greater SAQ SS improvement through 30 days. Conclusion SPM was performed in almost half of unsuccessful CTO PCIs and was not associated with increased procedural complications. SPM was independently associated with better patient-reported health status at 30 days. Further studies are needed to assess the necessity of subsequent PCI in patients with significant health status improvements after SPM.

Published
2017

19. Early Procedural and Health Status Outcomes After Chronic Total Occlusion Angioplasty

Author

Robert Federici, Taishi Hirai, Stephen Cook, James M. McCabe, William J. Nicholson, James Sapontis, Anthony Spaedy, Craig R. Thompson, R. Michael Wyman, Dimitri Karmpaliotis, David J. Cohen, Steven P. Marso, Ashish Pershad, John A. Spertus, J. Aaron Grantham, William Lombardi, Kensey Gosch, Adam C. Salisbury, Karen Nugent, Jeffrey W. Moses, Parag Doshi, and Robert W. Yeh

Subjects
medicine.medical_specialty, business.industry, medicine.medical_treatment, Percutaneous coronary intervention, 030204 cardiovascular system & hematology, medicine.disease, Surgery, Coronary artery disease, Angina, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Informed consent, Angioplasty, Emergency medicine, Conventional PCI, Medicine, 030212 general & internal medicine, Cardiology and Cardiovascular Medicine, business, Complication
Abstract

Objectives This study sought to accurately describe the success rate, risks, and patient-reported benefits of contemporary chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Background In light of the evolving techniques to successfully revascularize CTO lesions, there remains a compelling need to more accurately quantify the success rates, risks, and benefits of these complex procedures. Methods Using a uniquely comprehensive, core-lab adjudicated, single-arm, multicenter registry of 1,000 consecutive patients undergoing CTO PCI by the hybrid approach, we evaluated the technical success rates, complication rates, and raw and adjusted health status benefits at 1 month among successfully as compared to unsuccessfully treated patients. Results Technical success was high (86%). In-hospital and 1-month mortality was 0.9% and 1.3%, respectively, and perforations requiring treatment occurred in 48 patients (4.8%). Among those who survived and completed the 1-month interview (n = 947), mean ± SEM Seattle Angina Questionnaire quality of life scores improved from 49.4 ± 0.9 to 75.0 ± 0.7 (p Conclusions Clarifying the success rates, risks, and benefits of CTO PCI will help to more accurately contextualize the informed consent process for these procedures so that patients with appropriate indications for CTO PCI can more effectively share in the decision to pursue this or other therapeutic options.

Published
2017

20. Patient Characteristics Associated With Antianginal Medication Escalation and De-Escalation Following Chronic Total Occlusion Percutaneous Coronary Intervention

Author

William J. Nicholson, David J. Cohen, Mohammed Qintar, Taishi Hirai, Dimitri Karmpaliotis, William Lombardi, Adam C. Salisbury, Karen Nugent, James Sapontis, J. Aaron Grantham, Kensey Gosch, Jeffrey W. Moses, and John A. Spertus

Subjects
medicine.medical_specialty, business.industry, medicine.medical_treatment, Percutaneous coronary intervention, Patient characteristics, medicine.disease, Total occlusion, Coronary artery disease, Quality of life, Internal medicine, parasitic diseases, Conventional PCI, medicine, Cardiology, Myocardial infarction, Cardiology and Cardiovascular Medicine, business, De-escalation
Abstract

Background: Prior research has shown that providers may infrequently adjust antianginal medications (AAMs) following chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Patient characteristics associated with AAM titration and the variation in postprocedure AAM management after CTO PCI across hospitals have not been reported. We sought to determine the frequency and potential correlates of AAM escalation and de-escalation after CTO PCI. Methods and Results: Using the 12-center OPEN CTO registry (Outcomes, Patient Health Status, and Efficiency iN Chronic Total Occlusion Hybrid Procedures), we assessed AAM use at baseline and 6 months after CTO PCI. Escalation was defined as any addition of a new class of AAM or dose increase, whereas de-escalation was defined as a reduction in the number of AAMs or dose reduction. Angina was assessed 6 months after the index CTO PCI attempt using the Seattle Angina Questionnaire Angina Frequency domain. Potential correlates of AAM escalation (vs no change) or de-escalation (vs no change) were evaluated using multivariable modified Poisson regression models. Adjusted variation across sites was evaluated using median rate ratios. AAMs were escalated in 158 (17.5%), de-escalated in 351 (39.0%), and were unchanged at 6-month follow-up in 392 (43.5%). Patient characteristics associated with escalation included lung disease, ongoing angina, and periprocedural major adverse cardiac and cerebral events (periprocedural myocardial infarction, stroke, death, emergent cardiac surgery, or clinically significant perforation), whereas de-escalation was more frequent among patients taking more AAMs, those treated with complete revascularization, and after treatment of non-CTO lesions at the time of the index procedure. There was minimal variation in either escalation (median rate ratio, 1.11; P =0.36) or de-escalation (median rate ratio, 1.10; P =0.20) compared to no change of AAMs across sites. Conclusions: Escalation or de-escalation of AAMs was less common than continuation following CTO PCI, with little variation across sites. Further research is needed to identify patients who may benefit from AAM titration after CTO PCI and develop strategies to adjust these medications in follow-up. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02026466.

Published
2019

21. Quality of Life Changes After Chronic Total Occlusion Angioplasty in Patients With Baseline Refractory Angina

Author

Jeffrey W. Moses, Adam C. Salisbury, Karen Nugent, Steven P. Marso, Anthony Spaedy, James Sapontis, Ashish Pershad, Robert Federici, William Lombardi, Taishi Hirai, William J. Nicholson, Parag Doshi, David J. Cohen, Dimitri Karmpaliotis, John A. Spertus, J. Aaron Grantham, Kensey Gosch, R. Michael Wyman, and Stephen Cook

Subjects
Male, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Health Status, Drug Resistance, Total occlusion, Angina Pectoris, Percutaneous Coronary Intervention, Quality of life, Risk Factors, Internal medicine, Angioplasty, Medicine, Humans, In patient, cardiovascular diseases, Prospective Studies, Registries, Aged, business.industry, Percutaneous coronary intervention, Cardiovascular Agents, Middle Aged, United States, Treatment Outcome, Coronary Occlusion, Conventional PCI, Chronic Disease, Cardiology, Quality of Life, Female, Cardiology and Cardiovascular Medicine, business, Refractory angina
Abstract

Background: Health status and quality of life improvement after chronic total occlusion (CTO) percutaneous coronary intervention (PCI) among patients with refractory angina has not been reported. We sought to determine the degree of quality of life improvement after CTO PCI in patients with refractory angina. Methods and Results: Among 1000 consecutive patients who underwent CTO PCI in a 12-center registry, refractory angina was defined as any angina (baseline Seattle Angina Questionnaire [SAQ] Angina Frequency score of ≤90) despite treatment with ≥3 antianginal medications. Health status at baseline and 1-year follow-up was quantified using the SAQ. Refractory angina was present at baseline in 148 patients (14.8%). Technical success was achieved in 120 (81.1%) at the initial attempt and major adverse cardiac and cerebral events occurred in 10 (6.8%). There were no procedural deaths. Refractory angina patients were highly symptomatic at baseline with mean SAQ Angina Frequency of 51.1±23.8, SAQ quality of life of 35.3±21.2, and SAQ Summary Score of 47.2±17.9, improving by 32.0±27.8, 35.7±23.9, and 32.1±20.1 at 1 year. Through 1-year follow-up, patients with successful CTO PCI had significantly larger degree of improvement of SAQ Angina Frequency and SAQ Summary Score (35.0±26.8 versus 18.8±28.9, P P Conclusions: Refractory angina was present in 1 of 7 patients in the OPEN-CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures) registry. Patients with refractory angina experienced large, clinically significant health status improvements that persisted through 12 months, and patients with successful CTO PCI had larger health status improvement than those without.

Published
2019

22. A Detailed Analysis of Perforations During Chronic Total Occlusion Angioplasty

Author

William J. Nicholson, Dimitri Karmpaliotis, Stephen Cook, Adam C. Salisbury, Karen Nugent, Taishi Hirai, William Lombardi, Robert Federici, Parag Doshi, Anthony Spaedy, James Sapontis, Jeffrey W. Moses, Steven P. Marso, Ashish Pershad, R. Michael Wyman, John A. Spertus, J. Aaron Grantham, and Kensey Gosch

Subjects
Male, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Perforation (oil well), 030204 cardiovascular system & hematology, Total occlusion, Pericardial effusion, Risk Assessment, Pericardial Effusion, 03 medical and health sciences, 0302 clinical medicine, Percutaneous Coronary Intervention, Risk Factors, Cardiac tamponade, Angioplasty, medicine, Humans, 030212 general & internal medicine, Hospital Mortality, Prospective Studies, Registries, Aged, Aged, 80 and over, business.industry, Incidence (epidemiology), Percutaneous coronary intervention, Middle Aged, medicine.disease, Coronary Vessels, United States, Surgery, Cardiac Tamponade, Treatment Outcome, Coronary Occlusion, Heart Injuries, Conventional PCI, Chronic Disease, Female, Cardiology and Cardiovascular Medicine, business
Abstract

Objectives This study sought to describe the angiographic characteristics, strategy associated with perforation, and the management of perforation during chronic total occlusion percutaneous coronary intervention (CTO PCI). Background The incidence of perforation is higher during CTO PCI compared with non-CTO PCI and is reportedly highest among retrograde procedures. Methods Among 1,000 consecutive patients who underwent CTO PCI in a 12-center registry, 89 (8.9%) had core lab–adjudicated angiographic perforations. Clinical perforation was defined as any perforation requiring treatment. Major adverse cardiac events (MAEs) were defined as in-hospital death, cardiac tamponade, and pericardial effusion. Results Among the 89 perforations, 43 (48.3%) were clinically significant, and 46 (51.7%) were simply observed. MAE occurred in 25 (28.0%), and in-hospital death occurred in 9 (10.1%). Compared with nonclinical perforations, clinical perforations were larger in size, more often at a collateral location, had a high-risk shape, and less likely to cause staining or fast filling. Compared with perforations not associated with MAE, perforations associated with MAE were larger in size, more proximal or at collateral location, and had a high-risk shape. When the core lab attributed the perforation to the approach used when the perforation occurred, 61% of retrograde perforations by other classifications were actually antegrade. Conclusions Larger size, proximal or collateral location, and high-risk shapes of a coronary perforation were associated with MAE. Six of 10 perforations occurred with antegrade approaches among patients who had both strategies attempted. These finding will help emerging CTO operators understand high-risk features of the perforation that require treatment and inform future comparisons of retrograde and antegrade complications.

Published
2019

23. The HubBLe Trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for symptomatic second- and third-degree haemorrhoids: a multicentre randomised controlled trial and health-economic evaluation

Author

Allan Wailoo, Neil Shephard, Pasquale Giordano, Rohit Makhija, Angus Watson, Anil Agarwal, Paul Skaife, Marc Lamah, Steven R Brown, Abualbishr Alshreef, Andrew Clarke, Karen Nugent, Mark T. Cartmell, S. Radley, Phillip Conaghan, Justin Davies, Katie Biggs, Omar Faiz, Jim Tiernan, Paul Ziprin, Lizzie Swaby, Angus MacDonald, Oliver Jones, Mike Bradburn, and Daniel Hind

Subjects
Adult, Male, medicine.medical_specialty, lcsh:Medical technology, Cost-Benefit Analysis, medicine.medical_treatment, Hemorrhoids, Severity of Illness Index, Rubber band ligation, law.invention, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Quality of life, Recurrence, EQ-5D, law, Pain assessment, Severity of illness, Humans, Medicine, Ligation, Aged, Pain, Postoperative, business.industry, Health Policy, Arteries, Odds ratio, Middle Aged, Surgery, Quality-adjusted life year, lcsh:R855-855.5, 030220 oncology & carcinogenesis, Quality of Life, Female, 030211 gastroenterology & hepatology, Quality-Adjusted Life Years, business, Fecal Incontinence, Research Article
Abstract

BackgroundOptimal surgical intervention for low-grade haemorrhoids is unknown. Rubber band ligation (RBL) is probably the most common intervention. Haemorrhoidal artery ligation (HAL) is a novel alternative that may be more efficacious.ObjectiveThe comparison of HAL with RBL for the treatment of grade II/III haemorrhoids.DesignA multicentre, parallel-group randomised controlled trial.PerspectiveUK NHS and Personal Social Services.Setting17 NHS Trusts.ParticipantsPatients aged ≥ 18 years presenting with grade II/III (second- and third-degree) haemorrhoids, including those who have undergone previous RBL.InterventionsHAL with Doppler probe compared with RBL.OutcomesPrimary outcome – recurrence at 1 year post procedure; secondary outcomes – recurrence at 6 weeks; haemorrhoid severity score; European Quality of Life-5 Dimensions, 5-level version (EQ-5D-5L); Vaizey incontinence score; pain assessment; complications; and cost-effectiveness.ResultsA total of 370 participants entered the trial. At 1 year post procedure, 30% of the HAL group had evidence of recurrence compared with 49% after RBL [adjusted odds ratio (OR) = 2.23, 95% confidence interval (CI) 1.42 to 3.51;p = 0.0005]. The main reason for the difference was the number of extra procedures required to achieve improvement/cure. If a single HAL is compared with multiple RBLs then only 37.5% recurred in the RBL arm (adjusted OR 1.35, 95% CI 0.85 to 2.15;p = 0.20). Persistence of significant symptoms at 6 weeks was lower in both arms than at 1 year (9% HAL and 29% RBL), suggesting significant deterioration in both groups over the year. Symptom score, EQ-5D-5L and Vaizey score improved in both groups compared with baseline, but there was no difference between interventions. Pain was less severe and of shorter duration in the RBL group; most of the HAL group who had pain had mild to moderate pain, resolving by 3 weeks. Complications were low frequency and not significantly different between groups. It appeared that HAL was not cost-effective compared with RBL. In the base-case analysis, the difference in mean total costs was £1027 higher for HAL. Quality-adjusted life-years (QALYs) were higher for HAL; however, the difference was very small (0.01) resulting in an incremental cost-effectiveness ratio of £104,427 per additional QALY.ConclusionsAt 1 year, although HAL resulted in fewer recurrences, recurrence was similar to repeat RBL. Symptom scores, complications, EQ-5D-5L and continence score were no different, and patients had more pain in the early postoperative period after HAL. HAL is more expensive and unlikely to be cost-effective in terms of incremental cost per QALY.LimitationsBlinding of participants and site staff was not possible.Future workThe incidence of recurrence may continue to increase with time. Further follow-up would add to the evidence regarding long-term clinical effectiveness and cost-effectiveness. The polysymptomatic nature of haemorrhoidal disease requires a validated scoring system, and the data from this trial will allow further assessment of validity of such a system. These data add to the literature regarding treatment of grade II/III haemorrhoids. The results dovetail with results from the eTHoS study [Watson AJM, Hudson J, Wood J, Kilonzo M, Brown SR, McDonald A,et al.Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial.Lancet2016, in press.] comparing stapled haemorrhoidectomy with excisional haemorrhoidectomy. Combined results will allow expansion of analysis, allowing surgeons to tailor their treatment options to individual patients.Trial registrationCurrent Controlled Trials ISRCTN41394716.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 88. See the NIHR Journals Library website for further project information.

Published
2016

25. A sex stratified outcome analysis from the OPEN-CTO registry

Author

James Aaron Grantham, William J. Nicholson, Ashish Pershad, Open Cto Subgroup, Karen Nugent, Yuanyuan Tang, William Lombardi, James Sapontis, Martha Gulati, Jeffery W. Moses, and Dimitrios Karmpaliotis

Subjects
Male, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Clinical Decision-Making, 030204 cardiovascular system & hematology, Revascularization, Coronary Angiography, Risk Assessment, 03 medical and health sciences, 0302 clinical medicine, Percutaneous Coronary Intervention, Sex Factors, Quality of life, Risk Factors, Internal medicine, medicine, Humans, Radiology, Nuclear Medicine and imaging, 030212 general & internal medicine, Prospective Studies, Registries, Healthcare Disparities, Aged, business.industry, Regression analysis, General Medicine, Health Status Disparities, Middle Aged, United States, Treatment Outcome, Coronary Occlusion, Conventional PCI, Cohort, Propensity score matching, Observational study, Female, Cardiology and Cardiovascular Medicine, business, Mace
Abstract

Introduction Women have been under-represented in trials. Due to the dearth of information about CTO-PCI in women and discordance of previous results, sex differences in outcomes in the OPEN-CTO Trial were investigated. Methods OPEN-CTO is an investigator-initiated, multicenter, prospective observational registry of consecutive CTO patients undergoing PCI at 12 U.S. centers. The one-year outcomes of this trial stratified by sex were examined. Optimal propensity matching was performed to compare outcomes between sexes. Multivariate conditional logistic regression modeling for predictors of procedural success was performed. Results Women represented 19.6% of the cohort (196/1,000 patients). Women were more likely to report dyspnea as their predominant symptom. Women reported statistically worse physical limitation and poorer quality of life as compared to men. J-CTO scores were similar in males and females. Technical, procedural success and MACE rates were similar in both sexes. Contrast and radiation doses were however significantly lower in women. The SAQ- summary score, RDS, EQ-5D VAS, PHQ-8 scores were all improved to the same degree at 1 year in women as compared to men. Predictors of procedural success revealed that younger age, lower J-CTO score and absence of prior CABG were predictors of procedural success. Sex did not predict procedural success or 1-year MACE in this regression model. Conclusion This real-world registry revealed that women derive the same benefit from CTO-PCI as men without additional complications and with favorable health status outcomes at 1 year. Consideration of revascularization by PCI in symptomatic women should be considered as part of the treatment when appropriate.

Published
2018

26. A transvaginal approach to rectovaginal fistulae for the colorectal surgeon: technical notes and case series

Author

A. Monga, Rahul Bhome, and Karen Nugent

Subjects
Adult, medicine.medical_specialty, 030230 surgery, 03 medical and health sciences, 0302 clinical medicine, Healing rate, Procedure, Technical Note, Medicine, Humans, Major complication, Aged, Surgeons, Surgical approach, business.industry, General surgery, Gastroenterology, Rectovaginal Fistula, Transvaginal approach, Middle Aged, medicine.disease, Colorectal surgery, United Kingdom, Treatment Outcome, Rectovaginal fistula, Transvaginal, 030220 oncology & carcinogenesis, Vagina, Technique, Surgery, Female, business, Colorectal Surgery, Repair, Abdominal surgery
Abstract

Rectovaginal fistulae (RVF) are not uncommonly seen by the colorectal surgeon and gynaecologist, often debilitating for patients and typically managed with multiple operative procedures, achieving control rather than cure. Transvaginal repair is the least common surgical approach but has clear advantages and equivalent healing rates to other approaches. Here, we describe a simple, safe and effective flapless transvaginal technique for the repair of primary and recurrent low- and mid-level RVF of varying aetiology. We report 15 cases of RVF (nine recurrent) treated by this technique at a single UK centre. The healing rate was 67%. There were no major complications. Median follow-up was 48 months.

Published
2018

27. Phase I–III development of the EORTC QLQ-ANL27, a health-related quality of life questionnaire for anal cancer

Author

Kristopher Dennis, Krzysztof A. Tomaszewski, David Sebag-Montefiore, Vassilios Vassiliou, William Chu, Alexandra Gilbert, Dimitrios Kardamakis, Marianne Grønlie Guren, Hans T. Chung, Rob Glynne-Jones, Karen Nugent, Colin D. Johnson, Heike Schmidt, Isacco Desideri, and Samantha C. Sodergren

Subjects
Adult, Male, medicine.medical_specialty, Psychometrics, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Surveys and Questionnaires, Health care, medicine, Humans, Anal cancer, Radiology, Nuclear Medicine and imaging, Aged, Aged, 80 and over, Health related quality of life, business.industry, Chemoradiotherapy, Hematology, social sciences, Middle Aged, Anus Neoplasms, medicine.disease, humanities, Clinical trial, Clinical Practice, Oncology, Research Design, 030220 oncology & carcinogenesis, Family medicine, Quality of Life, Female, 030211 gastroenterology & hepatology, business
Abstract

Background and purpose: there is currently no health-related quality of life (HRQoL) measure specific to anal cancer. Our objective was to develop an anal cancer HRQoL module to supplement the EORTC QLQ-C30 questionnaire using EORTC Quality of Life Group Guidelines.Materials and method: in order to generate a list of HRQoL issues facing anal cancer patients treated with chemoradiotherapy (CRT), we systematically reviewed the literature and conducted semi-structured interviews with patients and health care professionals (HCPs). Our list was then operationalised into questions using the EORTC Item Library. The provisional question list was pilot tested alongside the EORTC QLQ-C30 with patients from 11 centres across 8 countries.Results: from our literature review and interviews with 43 patients, we generated a list of 197 issues. The list was then refined to 134 issues and reviewed by 34 HCPs and 10 patients. This review resulted in the retention of 65 issues which were used in the draft questionnaire tested by 100 patients. Our analyses led to the modification and removal of questions resulting in a 27 item questionnaire, the EORTC QLQ-ANL27.Conclusion: we have developed a 27 item questionnaire to supplement the EORTC QLQ-C30, for use with patients treated for anal cancer. This has been pilot tested and is now available upon request for use in clinical trials as well as clinical practice in 8 languages (http://groups.eortc.be/qol/).

Published
2018

28. Early Procedural and Health Status Outcomes After Chronic Total Occlusion Angioplasty: A Report From the OPEN-CTO Registry (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures)

Author

James, Sapontis, Adam C, Salisbury, Robert W, Yeh, David J, Cohen, Taishi, Hirai, William, Lombardi, James M, McCabe, Dimitri, Karmpaliotis, Jeffrey, Moses, William J, Nicholson, Ashish, Pershad, R Michael, Wyman, Anthony, Spaedy, Stephen, Cook, Parag, Doshi, Robert, Federici, Craig R, Thompson, Steven P, Marso, Karen, Nugent, Kensey, Gosch, John A, Spertus, and J Aaron, Grantham

Subjects
Male, Time Factors, Health Status, Recovery of Function, Middle Aged, Coronary Angiography, United States, Treatment Outcome, Coronary Occlusion, Risk Factors, Chronic Disease, Quality of Life, Humans, Female, Hospital Mortality, Patient Reported Outcome Measures, Prospective Studies, Registries, Angioplasty, Balloon, Coronary, Aged
Abstract

This study sought to accurately describe the success rate, risks, and patient-reported benefits of contemporary chronic total occlusion (CTO) percutaneous coronary intervention (PCI).In light of the evolving techniques to successfully revascularize CTO lesions, there remains a compelling need to more accurately quantify the success rates, risks, and benefits of these complex procedures.Using a uniquely comprehensive, core-lab adjudicated, single-arm, multicenter registry of 1,000 consecutive patients undergoing CTO PCI by the hybrid approach, we evaluated the technical success rates, complication rates, and raw and adjusted health status benefits at 1 month among successfully as compared to unsuccessfully treated patients.Technical success was high (86%). In-hospital and 1-month mortality was 0.9% and 1.3%, respectively, and perforations requiring treatment occurred in 48 patients (4.8%). Among those who survived and completed the 1-month interview (n = 947), mean ± SEM Seattle Angina Questionnaire quality of life scores improved from 49.4 ± 0.9 to 75.0 ± 0.7 (p 0.01), mean Rose Dyspnea Scale scores improved (decreased) from 2.0 ± 0.1 to 1.1 ± 0.1 (p 0.01), and physician health questionnaire (for depression) scores improved (decreased) from 6.2 ± 0.2 to 3.5 ± 0.1 (p 0.01) at 1 month. After adjusting for baseline differences the mean group difference in Seattle Angina Questionnaire quality of life between successful and unsuccessful CTO PCI was 10.8 (95% confidence interval: 6.3 to 15.3; p 0.001).Clarifying the success rates, risks, and benefits of CTO PCI will help to more accurately contextualize the informed consent process for these procedures so that patients with appropriate indications for CTO PCI can more effectively share in the decision to pursue this or other therapeutic options.

Published
2017

29. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A

Author

Johnny, Mahlangu, Jerry S, Powell, Margaret V, Ragni, Pratima, Chowdary, Neil C, Josephson, Ingrid, Pabinger, Hideji, Hanabusa, Naresh, Gupta, Roshni, Kulkarni, Patrick, Fogarty, David, Perry, Amy, Shapiro, K John, Pasi, Shashikant, Apte, Ivan, Nestorov, Haiyan, Jiang, Shuanglian, Li, Srividya, Neelakantan, Lynda M, Cristiano, Jaya, Goyal, Jurg M, Sommer, Jennifer A, Dumont, Nigel, Dodd, Karen, Nugent, Gloria, Vigliani, Alvin, Luk, Aoife, Brennan, Glenn F, Pierce, and Michael, Guerrera

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, Adolescent, Recombinant Fusion Proteins, Immunology, Population, Phases of clinical research, Hemorrhage, Hemophilia A, Biochemistry, Gastroenterology, Drug Administration Schedule, law.invention, Young Adult, Pharmacokinetics, Randomized controlled trial, law, Internal medicine, medicine, Humans, Child, education, Adverse effect, Aged, Emicizumab, education.field_of_study, Factor VIII, business.industry, Cell Biology, Hematology, Perioperative, Middle Aged, Immunoglobulin Fc Fragments, Surgery, Clinical trial, Treatment Outcome, business
Abstract

This phase 3 pivotal study evaluated the safety, efficacy, and pharmacokinetics of a recombinant FVIII Fc fusion protein (rFVIIIFc) for prophylaxis, treatment of acute bleeding, and perioperative hemostatic control in 165 previously treated males aged ≥12 years with severe hemophilia A. The study had 3 treatment arms: arm 1, individualized prophylaxis (25-65 IU/kg every 3-5 days, n = 118); arm 2, weekly prophylaxis (65 IU/kg, n = 24); and arm 3, episodic treatment (10-50 IU/kg, n = 23). A subgroup compared recombinant FVIII (rFVIII) and rFVIIIFc pharmacokinetics. End points included annualized bleeding rate (ABR), inhibitor development, and adverse events. The terminal half-life of rFVIIIFc (19.0 hours) was extended 1.5-fold vs rFVIII (12.4 hours; P < .001). Median ABRs observed in arms 1, 2, and 3 were 1.6, 3.6, and 33.6, respectively. In arm 1, the median weekly dose was 77.9 IU/kg; approximately 30% of subjects achieved a 5-day dosing interval (last 3 months on study). Across arms, 87.3% of bleeding episodes resolved with 1 injection. Adverse events were consistent with those expected in this population; no subjects developed inhibitors. rFVIIIFc was well-tolerated, had a prolonged half-life compared with rFVIII, and resulted in low ABRs when dosed prophylactically 1 to 2 times per week.

Published
2014

30. The Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures registry: rationale and design

Author

Parag Doshi, Ashish Pershad, William J. Nicholson, William Lombardi, James Sapontis, Craig A. Thompson, J A Grantham, Dimitri Karmpaliotis, Anthony Spaedy, David Cohen, Kensey Gosch, John A. Spertus, Stephen Cook, Jeffrey W. Moses, Steven P. Marso, Robert Federici, Karen Nugent, and Ray Wyman

Subjects
Research design, Male, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Cost-Benefit Analysis, Health Status, MEDLINE, Disease, 030204 cardiovascular system & hematology, Total occlusion, Risk Assessment, 03 medical and health sciences, 0302 clinical medicine, Percutaneous Coronary Intervention, Risk Factors, Angioplasty, medicine, Humans, 030212 general & internal medicine, Patient Reported Outcome Measures, Registries, Intensive care medicine, Aged, business.industry, Process Assessment, Health Care, General Medicine, Health Care Costs, Middle Aged, United States, Surgery, medicine.anatomical_structure, Treatment Outcome, Coronary Occlusion, Research Design, Chronic Disease, Female, Cardiology and Cardiovascular Medicine, Ischemic heart, Risk assessment, business, Artery
Abstract

Patients with chronic total occlusions of a coronary artery represent a complex, yet common, clinical conundrum among patients with ischemic heart disease. Chronic total occlusion angioplasty is increasingly being used as a treatment for these complex lesions. There is a compelling need to better quantify the safety, efficacy, benefits, and costs of the procedure.To address these gaps in knowledge, we designed the Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures (OPEN CTO) study, an investigator-initiated multicenter, single-arm registry including 12 centers with a planned enrollment of 1000 patients. To ensure the accuracy of our observations, we used a unique auditing process through the National Cardiovascular Disease Registries' Cath/PCI Registry, angiographic core lab analysis, clinical events adjudication, and a systematic collection of patient-reported outcomes and costs.Between 21 January 2014 and 22 July 2015, 1000 patients were enrolled in OPEN CTO. A total of 28 patients either refused (N=26) or were missed by the screening process (N=2). In the National Cardiovascular Disease Registry Cath/PCI registry audit, there were 1096 chronic total occlusion-percutaneous coronary intervention procedures that were performed by participating operators during the time they enrolled in OPEN CTO. Overall, 987 of those patients could be definitively matched to an OPEN CTO enrolled patient (enrolled group). The remaining 109 were considered to be not enrolled in OPEN CTO (not enrolled group). Compared with the enrolled group, the patients in the nonenrolled group were less frequently of White race and more frequently of Hispanic origin. Procedural outcomes including National Cardiovascular Disease Registry-defined technical success, procedural success, and major adverse coronary events rates were similar.OPEN CTO is the most comprehensive and rigorously collected dataset to date that will provide unique insights into the success, safety, benefits, and the costs of chronic total occlusion-percutaneous coronary intervention using a reproducible technical approach to patients with these complex lesions.

Published
2016

31. Appendicitis

Author

Nigel, D'Souza and Karen, Nugent

Subjects
Diagnosis, Differential, Acute Disease, Prevalence, Appendectomy, Humans, Appendicitis, Global Health, Anti-Bacterial Agents
Published
2016

32. Barium proctography vs magnetic resonance proctography for pelvic floor disorders: a comparative study

Author

D. S. Tarver, Andrew Clarke, Scott Harris, Michael Lamparelli, J. Brenner, Sophie A Pilkington, Karen Nugent, and C. Thomas

Subjects
medicine.medical_specialty, Supine position, Pelvic floor, medicine.diagnostic_test, business.industry, Radiation dose, Gastroenterology, Magnetic resonance imaging, medicine.disease, Patient preference, Pelvic Floor Disorders, medicine.anatomical_structure, Anismus, medicine, Rectal intussusception, Radiology, business
Abstract

Aim Accurate and reliable imaging of pelvic floor dynamics is important for tailoring treatment in pelvic floor disorders; however, two imaging modalities are available. Barium proctography (BaP) is widely used, but involves a significant radiation dose. Magnetic resonance (MR) proctography allows visualization of all pelvic midline structures but patients are supine. This project investigates whether there are measurable differences between BaP and MR proctography. Patient preference for the tests was also investigated. Methods Consecutive patients referred for BaP were invited to participate (National Research Ethics Service approved). Participants underwent BaP in Poole and MR proctography in Dorchester. Proctograms were reported by a consultant radiologist with pelvic floor subspecialization. Results A total of 71 patients were recruited. Both tests were carried out on 42 patients. Complete rectal emptying was observed in 29% (12/42) on BaP and in 2% (1/42) on MR proctography. Anismus was reported in 29% (12/42) on BaP and 43% (18/42) on MR proctography. MR proctography missed 31% (11/35) of rectal intussusception detected on BaP. In 10 of these cases no rectal evacuation was achieved during MR proctography. The measure of agreement between grade of rectal intussusception was fair (κ = 0.260) although MR proctography tended to underestimate the grade. Rectoceles were extremely common but clinically relevant differences in size were evident. Patients reported that they found MR proctography less embarrassing but harder to empty their bowel. Conclusions The results demonstrate that MR proctography under-reports pelvic floor abnormalities especially where there has been poor rectal evacuation.

Published
2012

33. Real-world lessons from the implementation of a depression screening protocol in acute myocardial infarction patients

Author

Lisa Riggs, Donna M. Buchanan, Kim G. Smolderen, Geri Seavey, John A. Spertus, Karen Nugent, Alpesh Amin, Kensey Gosch, and Medical and Clinical Psychology

Subjects
Male, medicine.medical_specialty, MEDLINE, Myocardial Infarction, ComputingMilieux_LEGALASPECTSOFCOMPUTING, 030204 cardiovascular system & hematology, Article, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Surveys and Questionnaires, Health care, medicine, Humans, Mass Screening, 030212 general & internal medicine, Myocardial infarction, Registries, Mass screening, Depression (differential diagnoses), Aged, business.industry, Depression, Incidence (epidemiology), Incidence, American Heart Association, Middle Aged, medicine.disease, United States, 3. Good health, Patient Health Questionnaire, Emergency medicine, Physical therapy, Female, Guideline Adherence, Cardiology and Cardiovascular Medicine, business
Abstract

Background— The American Heart Association (AHA) statement has recommended routine screening for depression in coronary artery disease with a 2-stage implementation of the Patient Health Questionnaire (PHQ). Because there is little evidence on feasibility, accuracy, and impact of such a program on depression recognition in coronary patients, the AHA recommendation has met substantial debate and criticism. Methods and Results— Before the AHA statement was released, the Mid America Heart and Vascular Institute (MAHVI) had implemented a depression screening protocol for patients with acute myocardial infarction that was virtually identical to the AHA recommendations. To (1) evaluate this MAHVI quality improvement initiative, (2) compare MAHVI depression recognition rates with those of other hospitals, and (3) examine health care providers' implementation feedback, we compared the results of the MAHVI screening program with data from a parallel prospective acute myocardial infarction registry and interviewed MAHVI providers. Depressive symptoms (PHQ-2, PHQ-9) were assessed among 503 MAHVI acute myocardial infarction patients and compared with concurrent depression assessments among 3533 patients at 23 US centers without a screening protocol. A qualitative summary of providers' suggestions for improvement was also generated. A total of 135 (26.8%) eligible MAHVI patients did not get screened. Among screened patients, 90.9% depressed (PHQ-9 ≥10) patients were recognized. The agreement between the screening and registry data using the full PHQ-9 was 61.5% for positive cases (PHQ-9 ≥10) but only 35.6% for the PHQ-2 alone. Although MAHVI had a slightly higher overall depression recognition rate (38.3%) than other centers not using a depression screening protocol (31.5%), the difference was not statistically significant ( P =0.31). Staff feedback suggested that a single-stage screening protocol with continuous feedback could improve compliance. Conclusions— In this early effort to implement a depression screening protocol, a large proportion of patients did not get screened, and only a modest impact on depression recognition rates was realized. Simplifying the protocol by using the PHQ-9 alone and providing more support and feedback may improve the rates of depression detection and treatment.

Published
2011

34. Open resection for colorectal cancer

Author

Karen Nugent and Anjay Talwar

Subjects
medicine.medical_specialty, Colorectal cancer, business.industry, Abdominoperineal resection, General surgery, Open surgery, medicine.disease, Colorectal surgery, Surgery, Open Resection, medicine, Hemicolectomy, business, Colorectal resection
Abstract

In the UK open colorectal surgery is becoming less frequent in many centres where laparoscopic colorectal resection is being offered to most patients. However, the principles governing surgery for colorectal cancers remain the same in both modalities of treatment. The purpose of this article is to give the reader an overview of the types of operation used and the factors that are considered in approaching open colorectal cancer resections.

Published
2011

35. Letter from the President

Author

Karen Nugent

Subjects
Gastroenterology, Humans, Congresses as Topic, Societies, Medical
Published
2014

36. STARR with Contour® Transtar™: prospective multicentre European study

Author

Oliver Schwandner, Jean-Jacques Tuech, Roland Scherer, David Jayne, Leonardo Lenisa, Franc H. Hetzer, F. Pigot, Angelo Stuto, Karen Nugent, Eloy Espin-Basany, and F. Corbisier

Subjects
Adult, Male, medicine.medical_specialty, Constipation, Anal Canal, Rectum, Young Adult, obstructive defecation syndrome, incontinence, medicine, Humans, Fecal incontinence, Aged, Aged, 80 and over, Sutures, business.industry, General surgery, Suture Techniques, Gastroenterology, Recovery of Function, Rectal Prolapse, Perioperative, Original Articles, constipation, Middle Aged, Anal canal, medicine.disease, Surgery, Europe, Rectal prolapse, STARR, medicine.anatomical_structure, rectocele, internal rectal prolapse, Defecation, Female, medicine.symptom, Obstructive defecation syndrome, business, Fecal Incontinence, Follow-Up Studies
Abstract

Objective The stapled transanal rectal resection (STARR) in patients with defecation disorders is limited by the shape and capacity of the circular stapler. A new device has been recently developed, the Contour® Transtar™ stapler, in order to improve the safety and effectiveness of the STARR technique. The study has been designed to confirm this declaration. Method From January to June 2007 a prospective European multicentre study of consecutive patients with defecation disorder caused by internal rectal prolapse underwent the new STARR technique. The assessment of perioperative morbidity and functional outcome after 6 weeks, 3 and 12 months was documented by different scores. Results In all 75 patients, median age 64, the Transtar procedure was performed with 9% intraoperative difficulties, 7% postoperative complications and no mortality. The mean reduction of the ODS score was −15.6 (95%−CI: −17.3 to −13.8, P

Published
2009

37. Decision-making Algorithm for the STARR procedure in Obstructed Defecation Syndrome: Position statement of the group of STARR Pioneers

Author

Jean-Jacques Tuech, Leonardo Lenisa, Fabrice Corbisier, Oliver Schwandner, Angelo Stuto, Franc H. Hetzer, David Jayne, François Pigot, Karen Nugent, Roland Scherer, and Eloy E. Basany

Subjects
Position statement, medicine.medical_specialty, Constipation, Decision Support Techniques, Surgical Stapling, medicine, Humans, In patient, Digestive System Surgical Procedures, business.industry, Patient Selection, Rectocele, Rectum, Rectal Prolapse, Syndrome, medicine.disease, Surgery, Rectal prolapse, Inclusion and exclusion criteria, Female, Objective evaluation, Obstructed defecation, medicine.symptom, Obstructive defecation syndrome, business, Algorithm, Algorithms
Abstract

Internal rectal prolapse (rectal intussusception) and rectocele are frequent clinical findings in patients suffering from refractory constipation that may be best characterized as obstructive defecation syndrome. However, there is still no clear evidence whether the stapled transanal rectal resection (STARR) procedure provides a safe and effective surgical option for symptom resolution in patients with obstructive defecation syndrome, as evidence-based guidelines and functional long-term results are still missing. On the basis of the need for objective evaluation, a European group of experts was founded (Stapled Transanal Rectal Resection Pioneers). Derived from 2 meetings (October 26-28, 2006, Gouvieux, France and November 28-29, 2007, St Gallen, Switzerland) a concept for treatment options in patients suffering from obstructive defecation syndrome was developed, including a clear decision-making algorithm specifically focusing on the role of the stapled transanal rectal resection procedure based on clinical symptoms and dynamic imaging and inclusion and exclusion criteria for the stapled transanal rectal resection procedure.

Published
2008

38. Acute Myocardial Infarction Patients' Information Needs Over the Course of Treatment and Recovery

Author

Karen Nugent, Connie Chen, Linda Garavalia, Carole Decker, Amy Shipman, Donna M Buchanan, and John A. Spertus

Subjects
Adult, Male, medicine.medical_specialty, Decision Making, Myocardial Infarction, MEDLINE, Information needs, Context (language use), Patient Education as Topic, Health care, medicine, Humans, Myocardial infarction, Intensive care medicine, Aged, Advanced and Specialized Nursing, Patient discharge, Conceptualization, business.industry, Focus Groups, Middle Aged, medicine.disease, Focus group, Patient Discharge, Female, Medical emergency, Patient Participation, Cardiology and Cardiovascular Medicine, business
Abstract

Background and research objective Healthcare guidelines promote including patients in healthcare decision making to optimize treatment and recovery. However, prior research varies widely in the clinical context and conceptualization of patient involvement. The current study focuses on describing cardiac patients' preferences for involvement in decision making in the context of the myocardial infarction event continuum. Subjects and methods Focus groups were conducted with 19 patients who had recently experienced a myocardial infarction and received care at a regional facility in the Midwest. Data were transcribed and analyzed qualitatively to identify themes related to patient's decision-making experiences. Results and conclusions Both the role of the patient in decision making and information needs change as the patient progresses from the acute event to recovery. However, this change seems to be curvilinear, rather than linear. To maximize outcomes, clinicians must assess preferences and increase awareness of evolving information needs throughout the myocardial infarction clinical situation.

Published
2007

39. Short-term Outcomes of a Randomized Pilot Trial of 2 Treatment Regimens of Transcutaneous Tibial Nerve Stimulation for Fecal Incontinence

Author

Craig Rimmer, Michael Lamparelli, Louise Hunt, Kathryn Gill, Ian Lindsey, Paul Durdey, Karen Nugent, and Charles H. Knowles

Subjects
Male, medicine.medical_specialty, Time Factors, Tibial nerve stimulation, Anal Canal, Pilot Projects, law.invention, fluids and secretions, Quality of life, Randomized controlled trial, law, Recurrence, medicine, Fecal incontinence, Humans, Tibial nerve, Aged, business.industry, Gastroenterology, General Medicine, Recovery of Function, Anal canal, Middle Aged, Neuromodulation (medicine), United Kingdom, medicine.anatomical_structure, Treatment Outcome, Ambulatory, Physical therapy, Quality of Life, Transcutaneous Electric Nerve Stimulation, Female, medicine.symptom, Symptom Assessment, Tibial Nerve, business, Fecal Incontinence
Abstract

Fecal incontinence is a socially disabling condition that affects ≤15% of adults. Neuromodulatory treatments for fecal incontinence are now well established. Less invasive, cheaper, and more ambulatory forms of neuromodulation are under exploration.The purpose of this study was to assess the acceptability and safety of a new ambulatory tibial nerve stimulation device and to determine clinical effect size for 2 differing regimens of therapy.This was a randomized, investigator-blinded, parallel-arm, 6-week pilot trial.The study was conducted at 7 United Kingdom trial centers. Patients were initially reviewed in the trial center, with subsequent applications of the device performed in the patients home setting.A total of 43 eligible patients (38 women) who failed conservative management of fecal incontinence were included in the study.The study intervention involved twice-weekly, 1- versus 4-hour transcutaneous tibial nerve stimulation for 6 weeks (total of 12 treatments).Standard fecal incontinence outcome tools (bowel diary, symptom severity score, and generic quality-of-life instruments) were used to collect data at baseline and at 2 weeks posttreatment cessation.A total of 22 patients were randomly assigned to the 1-hour group and 21 to the 4-hour group. Improvements in fecal incontinence outcomes were observed for both groups, including median urge incontinence episodes per week at baseline and posttreatment (1-hour group 2.0 to 0.5 versus 4-hour group 4.0 to 1.0) and deferment time (1-hour group 2.0 to 2.0 minutes versus 4-hour group 0.5 to 5.0 minutes). Accompanying changes were observed in physical functioning domains of quality-of-life instruments. There were no adverse events, and the treatment was highly acceptable to patients.Limitations included the pilot design and lack of control arm in the study. Future trials would need to address these limitations.This pilot study provides evidence that transcutaneous tibial nerve stimulation with a new ambulatory device is safe and acceptable for the management of fecal incontinence. Additional study is warranted to investigate clinical effectiveness.

Published
2015

40. Anoplasty

Author

Karen Nugent

Published
2015

41. TCT-303 Redefining Success in Hybrid Chronic Total Occlusion Angioplasty

Author

Ashish Pershad, John A. Spertus, Robert Federici, Robert W. Yeh, Stephen Cook, Tony Spaedy, William J. Nicholson, Karen Nugent, William Lombardi, Dimitri Karmpaliotis, Craig A. Thompson, Parag Doshi, R. Michael Wyman, James Sapontis, David Cohen, J. Aaron Grantham, Kensey Gosch, Jeffrey W. Moses, and Steven P. Marso

Subjects
medicine.medical_specialty, business.industry, medicine.medical_treatment, Technical success, Percutaneous coronary intervention, 030204 cardiovascular system & hematology, Coronary disease, Total occlusion, 03 medical and health sciences, surgical procedures, operative, 0302 clinical medicine, Quality of life, Angioplasty, Internal medicine, Conventional PCI, medicine, Cardiology, cardiovascular diseases, 030212 general & internal medicine, Cardiology and Cardiovascular Medicine, business, TIMI
Abstract

The goal of percutaneous coronary intervention (PCI) in stable coronary disease is to improve quality of life (QoL). Historically, technical success in chronic total occlusion (CTO) PCI has been defined by angiographic surrogates including final TIMI flow (FTF) of 3 and residual stenosis (RS) ≤ 30

Published
2016

42. Surgical Integrated Care Pathway Development: Compliance and Staff Satisfaction

Author

Laura M Miller and Karen Nugent

Subjects
medicine.medical_specialty, 030504 nursing, Leadership and Management, business.industry, Health Policy, General Medicine, Integrated care, Compliance (psychology), Staff satisfaction, 03 medical and health sciences, Nursing, 030502 gerontology, Family medicine, Medicine, 0305 other medical science, business
Published
2003

43. Long-acting recombinant factor IX Fc fusion protein (rFIXFc) for perioperative management of subjects with haemophilia B in the phase 3 B-LONG study

Author

Shashikant Apte, Margaret V. Ragni, Alvin Luk, Kathelijne Peerlinck, Lynda M. Cristiano, Alison Innes, Xuefeng Wang, Karen Nugent, Haiyan Jiang, John Pasi, Glenn F. Pierce, Cedric Hermans, David Perry, Shannon Jackson, Shuanglian Li, Hervé Chambost, Jerry S. Powell, Neil C. Josephson, Margareth C. Ozelo, G. Allen, Brian Robinson, Johnny Mahlangu, and Aoife Brennan

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Recombinant Fusion Proteins, Population, Hemorrhage, Haemophilia, Chemoprevention, Hemophilia B, Perioperative Care, Factor IX, Young Adult, Pharmacokinetics, medicine, Humans, Haemophilia B, Dosing, Young adult, education, Blood coagulation test, education.field_of_study, business.industry, Disease Management, Hematology, Middle Aged, medicine.disease, Hemostasis, Surgical, Surgery, Treatment Outcome, Anesthesia, Blood Coagulation Tests, business, medicine.drug
Abstract

In the phase 3 B-LONG (Recombinant Factor IX Fc Fusion Protein [rFIXFc] in Subjects With Haemophilia B) study, rFIXFc demonstrated a prolonged half-life compared with recombinant factor IX (rFIX), and safety and efficacy for prophylaxis and treatment of bleeding in subjects with moderately-severe to severe haemophilia B. In this B-LONG sub-analysis, rFIXFc was evaluated for efficacy in subjects requiring major surgery. Dosing was investigator-determined. Assessments included dosing, consumption, bleeding, transfusions and haemostatic response. A population pharmacokinetics model of rFIXFc was used to predict FIX activity. Twelve subjects underwent 14 major surgeries (including 11 orthopaedic surgeries); most subjects (11/12) received rFIXFc prophylaxis before surgery (range, ~2 weeks-12 months). Investigators/surgeons rated haemostatic responses as excellent (n = 13) or good (n = 1). In most surgeries (85·7%), haemostasis from the pre-surgical dose until the end of surgery was maintained with a single rFIXFc infusion. Blood loss was consistent with similar surgeries in subjects without haemophilia. The strong correlation (R(2) = 0·9586, P

Published
2014

44. The cost of anal cancer in England: retrospective hospital data analysis and Markov model

Author

Michael J Tempest, Stuart Carroll, Stephanie J. Stephens, Sarah T O'Dwyer, Karen Nugent, and Sam Keeping

Subjects
Male, Veterinary medicine, medicine.medical_specialty, Cost estimate, Databases, Factual, Resource use, Cost-Benefit Analysis, State Medicine, medicine, Anal cancer, Humans, Reimbursement, Aged, Retrospective Studies, Cost–benefit analysis, business.industry, Public Health, Environmental and Occupational Health, Retrospective cohort study, Middle Aged, Models, Theoretical, medicine.disease, Anus Neoplasms, Hospitalization, England, Payment by Results, Emergency medicine, Carcinoma, Squamous Cell, Observational study, Female, Biostatistics, business, Research Article
Abstract

Background Anal cancer requires a multidisciplinary approach to treatment with often complex interventions. Little is known regarding the associated costs and resource use. Methods Patient records were extracted from a national hospital database to estimate the number of patients treated for anal cancer in England. Identified resource use was linked to published UK cost estimates to quantify the reimbursement of treatment through the Payment by Results system. A mathematical model was developed simultaneously to validate findings and to calculate the average 10-year cost of treating a squamous cell anal carcinoma case from diagnosis. The model utilised data from the Association of Coloproctology of Great Britain and Ireland's anal cancer position statement. Results On average, 1,564 patients were admitted to hospital and 389 attended an outpatient facility per year. The average annual cost per inpatient and outpatient ranged from £4,562-£5,230 and £1,146-£1,335, respectively. Based on the model estimates, the inflated cost per case was between £16,470-£16,652. Results were most sensitive to the mode of admission for primary treatment and the costs of staging/diagnosis (inflated range: £14,309-£23,264). Conclusions Despite limitations in the available data, these results indicate that the cost of treating anal cancer is significant. Further observational work is required in order to verify these findings. Electronic supplementary material The online version of this article (doi:10.1186/1471-2458-14-1123) contains supplementary material, which is available to authorized users.

Published
2014

45. Accuracy of integrated total pelvic floor ultrasound compared to defaecatory MRI in females with pelvic floor defaecatory dysfunction

Author

Alison Hainsworth, Karen Nugent, A. B. Williams, Catherine Grierson, Sophie A Pilkington, Alexis Schizas, and Elizabeth Rutherford

Subjects
Adult, medicine.medical_specialty, Pelvic Floor Disorders, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Intussusception (medical disorder), medicine, Humans, Radiology, Nuclear Medicine and imaging, Defecation, Aged, Retrospective Studies, Ultrasonography, Aged, 80 and over, Pelvic floor, Full Paper, medicine.diagnostic_test, business.industry, Ultrasound, Reproducibility of Results, Magnetic resonance imaging, Pelvic Floor, General Medicine, Middle Aged, medicine.disease, Magnetic Resonance Imaging, body regions, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Rectocoele, Female, 030211 gastroenterology & hepatology, Radiology, business
Abstract

Defaecatory MRI allows multicompartmental assessment of defaecatory dysfunction but is often inaccessible. Integrated total pelvic floor ultrasound (transperineal, transvaginal, endoanal) may provide a cheap, portable alternative. The accuracy of total pelvic floor ultrasound for anatomical abnormalities when compared with defaecatory MRI was assessed.The dynamic images from 68 females who had undergone integrated total pelvic floor ultrasound and defaecatory MRI between 2009 and 2015 were blindly reviewed. The following were recorded: rectocoele, enterocoele, intussusception and cystocoele.There were 26 rectocoeles on MRI (49 rectocoeles on ultrasound), 24 rectocoeles with intussusception on MRI (19 rectocoeles on ultrasound), 23 enterocoeles on MRI (24 enterocoeles on ultrasound) and 49 cystocoeles on MRI (35 cystocoeles on ultrasound). Sensitivity and specificity of total pelvic floor ultrasound were 81% and 33% for rectocoele, 60% and 91% for intussusception, 65% and 80% for enterocoele and 65% and 84% for cystocoele when compared with defaecatory MRI. This gave a negative-predictive value and positive-predictive value of 74% and 43% for rectocoele, 80% and 79% for intussusception, 82% and 63% for enterocoele and 48% and 91% for cystocoele.Integrated total pelvic floor ultrasound may serve as a screening tool for pelvic floor defaecatory dysfunction; when normal, defaecatory MRI can be avoided, as rectocoele, intussusception and enterocoele are unlikely to be present. Advances in knowledge: This is the first study to compare integrated total pelvic floor ultrasound with defaecatory MRI. The results support the use of integrated total pelvic floor ultrasound as a screening tool for defaecatory dysfunction.

Published
2016

46. Phase 3 study of recombinant factor IX Fc fusion protein in hemophilia B

Author

Karen Nugent, Ross I. Baker, Jerry S. Powell, Margareth C. Ozelo, Alison Innes, Shuanglian Li, Jurg M. Sommer, Raymond S.M. Wong, Johnny Mahlangu, Neil C. Josephson, Glenn F. Pierce, Jennifer A. Dumont, Snejana Krassova, Alvin Luk, Jaya Goyal, Aoife Brennan, G. Allen, Marilyn J. Manco-Johnson, Leonard A. Valentino, K. John Pasi, Nicolas Novitzky, Lynda M. Cristiano, Shashikant Apte, Haiyan Jiang, Margaret V. Ragni, Godfrey Chi-Fung Chan, D. J. Perry, and Gloria Vigliani

Subjects
Adult, Male, medicine.medical_specialty, Pediatrics, Adolescent, Recombinant Fusion Proteins, Phases of clinical research, Hemorrhage, Gastroenterology, Hemophilia B, Factor IX, Young Adult, Pharmacokinetics, Internal medicine, medicine, Humans, Young adult, Child, Aged, business.industry, General Medicine, Perioperative, Middle Aged, Clinical trial, Fc fusion, Hemostasis, Female, business, medicine.drug, Half-Life
Abstract

Prophylactic factor replacement in patients with hemophilia B improves outcomes but requires frequent injections. A recombinant factor IX Fc fusion protein (rFIXFc) with a prolonged half-life was developed to reduce the frequency of injections required.We conducted a phase 3, nonrandomized, open-label study of the safety, efficacy, and pharmacokinetics of rFIXFc for prophylaxis, treatment of bleeding, and perioperative hemostasis in 123 previously treated male patients. All participants were 12 years of age or older and had severe hemophilia B (endogenous factor IX level of ≤2 IU per deciliter, or ≤2% of normal levels). The study included four treatment groups: group 1 received weekly dose-adjusted prophylaxis (50 IU of rFIXFc per kilogram of body weight to start), group 2 received interval-adjusted prophylaxis (100 IU per kilogram every 10 days to start), group 3 received treatment as needed for bleeding episodes (20 to 100 IU per kilogram), and group 4 received treatment in the perioperative period. A subgroup of group 1 underwent comparative sequential pharmacokinetic assessments of recombinant factor IX and rFIXFc. The primary efficacy end point was the annualized bleeding rate, and safety end points included the development of inhibitors and adverse events.As compared with recombinant factor IX, rFIXFc exhibited a prolonged terminal half-life (82.1 hours) (P0.001). The median annualized bleeding rates in groups 1, 2, and 3 were 3.0, 1.4, and 17.7, respectively. In group 2, 53.8% of participants had dosing intervals of 14 days or more during the last 3 months of the study. In groups 1, 2 and 3, 90.4% of bleeding episodes resolved after one injection. Hemostasis was rated as excellent or good during all major surgeries. No inhibitors were detected in any participants receiving rFIXFc; in groups 1, 2, and 3, 73.9% of participants had at least one adverse event, and serious adverse events occurred in 10.9% of participants. These events were mostly consistent with those expected in the general population of patients with hemophilia.Prophylactic rFIXFc, administered every 1 to 2 weeks, resulted in low annualized bleeding rates in patients with hemophilia B. (Funded by Biogen Idec; ClinicalTrials.gov number, NCT01027364.).

Published
2013

47. Quality of life in stoma patients

Author

Phyll Daniels, Beverley Stewart, Karen Nugent, R. Patankar, and Colin D. Johnson

Subjects
Adult, Counseling, Male, medicine.medical_specialty, Visual analogue scale, Sexual Behavior, medicine.medical_treatment, Stoma, Ileostomy, Quality of life, Surveys and Questionnaires, Adaptation, Psychological, Colostomy, Humans, Medicine, Life Style, Aged, Aged, 80 and over, Postoperative Care, Rehabilitation, business.industry, General surgery, Anastomosis, Surgical, Gastroenterology, General Medicine, Exanthema, Middle Aged, Colorectal surgery, Surgery, Distress, Quality of Life, Female, business, Attitude to Health, Follow-Up Studies
Abstract

BACKGROUND: Patients with stomas face many difficulties both physical and psychological. Little is known about the long-term problems and the impact on patient lifestyle of a permanent stoma. This study was designed to address the problems faced by patients with stomas. METHODS: Patients were identified from the Stoma Care Department records for the years 1985 to 1992 and were contacted by mail. A questionnaire was designed to assess postoperative care, quality of life issues, and equipment problems. Responses were recorded on either a visual analog scale, a choice of yes-or-no alternatives, or by selection from a list of responses. RESULTS: A total of 542 eligible patients were contacted, and 391 replies were received. Major stomal problems included rashes (51 percent), leakage (36 percent), and ballooning (90 percent of patients with ileostomy). The majority of patients experienced some change in lifestyle (80 percent), and more than 40 percent of patients had problems with their sex lives. CONCLUSION: Many patients cope extremely well with a stoma; however, some patients experience considerable difficulty and distress. Improved preoperative assessment and counseling with longer follow-up by the stoma department would be helpful in the management of these patients and probably would contribute to improvement in the quality of their lives.

Published
1999

48. Rectocele Pathophysiology and Presentation

Author

Karen Nugent

Subjects
Pelvic floor, business.industry, Rectum, Anatomy, medicine.disease, Vaginal wall, Pathophysiology, Rectal prolapse, Apposition, medicine.anatomical_structure, Vagina, medicine, Presentation (obstetrics), business
Abstract

A rectocele is defined as the herniation or bulging of the posterior vaginal wall. The posterior vaginal wall and the anterior rectal wall are in direct apposition, and this bulging may be thought of as the rectum pushing anteriorly into the vagina.

Published
2013

49. Abstract 334: Listening to a Diversity of Patient Voices To Design a High-Quality Peripheral Arterial Disease Registry Focusing on Patient-Centered Outcomes

Author

Kim Smolderen, Carole Decker, Brian Garavalia, Kathryn M Scott, Emily G Chhatriwalla, Karen Nugent, William C Daniel, Carlos Rivas-Gotz, Carlos Mena, Erica Spatz, Erik Stilp, and John A Spertus

Subjects
Cardiology and Cardiovascular Medicine
Abstract

Background: While peripheral arterial disease (PAD) greatly impacts patients’ health status (symptoms, function and quality of life) and risk for cardiovascular events, no prospective studies have examined the impact of treatments in routine clinical practice on these outcomes. To create a future, multi-center PAD registry focused on health status outcomes over time, we prospectively engaged PAD patients in a qualitative study to explore the optimal study design. Methods: In the PORTRAIT Phase I study, a multidisciplinary team (nurse, anthropologist, psychologist) conducted 6 focus groups in 2 US sites (May-Dec 2012). Groups were organized by their demographic characteristics: females, males, elderly mixed females/males, African-American females, African-American males, and Hispanic mixed females/males involving 22 PAD patients. Sessions were recorded, transcribed and coded using descriptive content analysis until thematic saturation occurred. Input was solicited on the patients’ experience with PAD (diagnosis, treatment, life-style impact), preferred outcomes, topics to measure, and study organization. Results: Participants’ ages ranged from 51-86 and included 12 females, 8 African Americans, and 3 Hispanics. Patients had undergone percutaneous (n=7), surgical (n=2), both (n=3) or neither (n=10) types of revascularization. Three main themes emerged: 1) PAD symptom unawareness in both patients and doctors caused significant delays in receiving both a diagnosis and treatment (e.g. a 56yo female: “He said you basically have no blood flow in either leg. If you would have waited another week, you would have lost both of your legs.”). 2) Patients reported substantial impact of PAD on daily functioning and prioritized symptom relief, improved walking and quality of life as key outcomes (e.g. a 52yo male said: “And then the improvement in quality of life¼ There was just no question about whether to do it [surgery]¼”). And 3) Inadequate patient-physician communication and information deficiency about treatment options and outcomes were frequently reported (e.g. an 85yo female said: “No, there was never any idea of what I should do or why I shouldn’t do it. Just if you want some stents, we’ll put them in.”). With regards to optimal study design, facilitators of study participation included encouragement by their doctor to participate, and phone follow-up, while barriers included the cost of transportation and time taken off by family member (e.g. an 82yo female stated: “My daughter does not work on Fridays, but doctors don’t want to give appointments on Fridays.”). Conclusion: Insights from a diverse sampling of PAD patients can guide registry development by defining what outcomes PAD patients value most, how best to develop the screening and research design, and how to be maximally inclusive of a wide variety of PAD patients.

Published
2013

50. Caffeine phenotyping of cytochrome P4501A2, N-acetyltransferase, and xanthine oxidase in patients with familial adenomatous polyposis

Author

K. C. R. Farmer, L. J. Notarianni, PN Bennett, Allan D. Spigelman, Karen Nugent, P. Dobrocky, SE Oliver, and Robin K. S. Phillips

Subjects
Adult, Male, Xanthine Oxidase, congenital, hereditary, and neonatal diseases and abnormalities, medicine.medical_specialty, Time Factors, Letter, Adolescent, Colorectal cancer, Adenomatous polyposis coli, N-acetyltransferase, Familial adenomatous polyposis, chemistry.chemical_compound, Cytochrome P-450 Enzyme System, Acetyltransferases, Cytochrome P-450 CYP1A2, Caffeine, Internal medicine, medicine, Humans, Xanthine oxidase, neoplasms, Colectomy, Carcinogen, Aged, biology, Gastroenterology, CYP1A2, Cytochrome P450, Middle Aged, medicine.disease, digestive system diseases, Phenotype, Endocrinology, Adenomatous Polyposis Coli, chemistry, biology.protein, Female, Oxidoreductases, Research Article
Abstract

Patients with familial adenomatous polyposis (FAP) and age and sex matched controls were tested for cytochrome P4501A2 (CYP1A2), N-acetyltransferase, and xanthine oxidase activities using caffeine urinary metabolites as a discriminator. FAP patients showed significant underactivity of N-acetyltransferase (which inactivates some carcinogens) and significant overactivity of CYP1A2 (which activates some carcinogens). Xanthine oxidase activity, which can generate free radicals and cause cellular damage, was significantly increased in the FAP patients. All but one of the FAP patients had undergone colectomy. A separate group of six patients was therefore assessed before and at an average time of eight weeks after colectomy. No effect on enzyme activity was seen. The differences in enzyme activities detected in this study could produce an excess of active carcinogenic metabolites in the bile of FAP patients and contribute to the high risk for intestinal cancer in FAP.

Published
1995

Catalog

Books, media, physical & digital resources
See catalog results