Author: "Nicolas W, Shammas" - Searchworks@Jio Institute Digital Library Search Results

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1. Endovascular Treatment and Outcomes for Femoropopliteal In-Stent Restenosis: Insights from the XLPAD Registry

Author: Michael H. Vu, Glaiza-Mae Sande-Docor, Yulun Liu, Shirling Tsai, Mitul Patel, Chris Metzger, Mehdi H. Shishehbor, Emmanouil S. Brilakis, Nicolas W. Shammas, Peter Monteleone, and Subhash Banerjee
Subjects: Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Background. There is limited “real-world” evidence examining treatment modalities and outcomes in patients with symptomatic peripheral arterial disease undergoing endovascular treatment of femoropopliteal (FP) in-stent restenosis (ISR). Materials and Methods. We compared outcomes in 2,895 patients from the XLPAD registry (NCT01904851) between 2006 and 2019 treated for FP ISR (n = 347) and non-ISR (n = 2,548) lesions. Primary endpoint included major adverse limb events (MALE) at 1 year, a composite of all-cause death, target limb repeat revascularization, or major amputation. Results. ISR patients were more frequently on antiplatelet (94.5% vs 89.4%, p=0.007) and statin (68.9% vs 60.3%, p=0.003) therapies. Lesion length was similar (ISR: 145 ± 99 mm vs. non-ISR: 142 ± 99 mm, p=0.55). Fewer treated ISR lesions were chronic total occlusions (47.3% vs. 53.7%, p=0.02) and severely calcified (22.4% vs. 44.7%, p
Published: 2022
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2. Iatrogenic Intramural Hematoma Identified by Intravascular Ultrasound Following Selective Angiography of the Left Internal Mammary Artery

Author: Nicolas W. Shammas, MD, MS and Rusina Karia, MD
Subjects: iatrogenic, intramural hematoma, intravascular ultrasound, left internal mammary artery, stent, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: This case reports on iatrogenic intramural hematoma of the left internal mammary artery (LIMA) identified on intravascular ultrasound. This case illustrates the importance of intravascular imaging to identify the presence and extent of an intraluminal hematoma that is not visualized on angiography and that was the cause of ischemic symptoms following LIMA injection. (Level of Difficulty: Advanced.)
Published: 2019
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3. Jetstream Atherectomy with Paclitaxel-Coated Balloons: Two-Year Outcome of the Prospective Randomized JET-RANGER Study

Author: Nicolas W Shammas, Gail Shammas, Lori Christensen, and Sue Jones-Miller
Subjects: Endocrinology, Diabetes and Metabolism, Public Health, Environmental and Occupational Health, Pharmacology (medical), Hematology, General Medicine, Cardiology and Cardiovascular Medicine, Vascular Health and Risk Management
Abstract: Nicolas W Shammas, Gail Shammas, Lori Christensen, Sue Jones-Miller On behalf of the JET-RANGER InvestigatorsMidwest Cardiovascular Research Foundation, Davenport, IA, USACorrespondence: Nicolas W Shammas, Research Director, Midwest Cardiovascular Research Foundation, 630 E 4th Street, Suite A, Davenport, IA, 52801, USA, Email shammas@mchsi.comBackground: The JET-RANGER study (NCT03206762) was a multicenter (11 US centers) randomized trial, core lab adjudicated, designed to demonstrate the superiority of Jetstream + Paclitaxel coated balloon (JET+PCB) versus angioplasty (PTA) + PCB in treating femoropopliteal (FP) arterial disease. The one-year primary endpoint of JET-RANGER has been recently published. The 2-year outcome data are presented in this report.Methods: There were 43 patients who completed the 1-year follow-up. Two were lost to follow-up and one died prior to the 2-year follow-up, resulting in 40 patients. Fifteen patients were randomized to PTA+PCB and 25 patients to JET +PCB. Kaplan Meier Survival analysis was performed to estimate the freedom from TLR. Bailout stenting was not considered a TLR in this analysis. Statistical significance was determined by a p-value < 0.05.Results: Freedom from TLR was similar between the 2 groups at 2 years. There was also no significant difference in the change of ABI between the PTA + PCB and JET + PCB from baseline at 6-months, (p-value = 0.7890), 1-year (p-value = 0.4070), and 2-year (p-value=0.7410). There was also no statistical difference between the JET + PCB and PTA + PCB arms for RCC improvement by one or more category, (p-value= 1.000). There were no minor or major amputations for either arm throughout the 2-year follow up. One JET + PCB patient died before the 2-year specified window.Conclusion: JET + PCB had similar freedom from TLR and improvement in ABI and RCC at 2-year follow-up when compared to PTA + PCB with no difference in amputation or mortality between the 2 arms.Clinical Trial Registration: NCT03206762.Keywords: Jetstream, atherectomy, femoropopliteal, vessel prepping, drug coated balloons, Ranger, In.PACT, randomized trial, dissections, bailout stenting
Published: 2023
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4. Single-Center Study Evaluating Long-Term Major Adverse Outcomes with the Use of Paclitaxel-Coated Balloons in Treating Infrainguinal Arterial Disease

Author: Nicolas W. Shammas, Elizabeth Sharis, Gail A Shammas, and Susan Jones-Miller
Subjects: Cardiology and Cardiovascular Medicine
Abstract: Paclitaxel drug-coated balloons (DCB) have been shown to reduce target lesion revascularization (TLR) rate, but recently an association between paclitaxel and an increase in mortality at 5-year was reported. We reviewed the 5-year mortality and freedom from TLR rates from a single center among patients that received DCB. Consecutive patients that received DCB from July 8, 2015 to November 27, 2019 with follow-up obtained from medical records and review of official death certificates were reviewed. The primary objective was total mortality and TLR rates with cumulative exposure to paclitaxel-coated balloons. Demographic, angiographic, clinical, and procedural variables were collected. Causes of mortality were classified according to death certificates. Descriptive analysis was performed on all variables. Kruskal–Wallis test was used to compare the total length of DCBs in those who were alive and those who died by the end of study. Kaplan–Meier (KM) was used to plot the freedom from mortality up to 5 years. A total of 91 symptomatic patients received the Lutonix balloon at index to treat femoropopliteal arterial disease and subsequently received either Lutonix or in.PACT during the follow-up phase for additional procedures. Age was 68.4 ± 10.8 years (56.0% males). Critical limb ischemia was present in 20.9%. There was no statistical difference in mortality between the median total number of balloons used among patients who were alive versus those who died (2.5 vs. 3.0, p-value = 0.89). Also, there was no statistical difference in the total length of DCB balloons used between those who were alive and those who died at the end of the study (p-value = 0.39). There were no in-hospital amputation or death. At 5-year follow-up KM freedom from TLR was 78.5%. A total of 13 patients died during follow-up. Of these 10 received only the Lutonix balloon and 3 did receive both Lutonix and In.PACT. The yearly KM freedom from mortality for the Lutonix only cohort were 92.7, 89.1, 85.5, 83.6, and 81.8% at 1, 2, 3, 4, and 5 years, respectively. Freedom from TLR and mortality at 5 years appears to be favorable with the use of DCB, predominantly Lutonix balloon in this cohort. This data needs to be supported prospectively by a larger number of patients.
Published: 2023
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5. How Much Debulking with Atherectomy is Enough When Treating Infrainguinal Arterial Interventions? The Balance Between Residual Stenosis and Adventitial Injury

Author: Nicolas W Shammas
Subjects: Atherectomy, Endocrinology, Diabetes and Metabolism, Public Health, Environmental and Occupational Health, Constriction, Pathologic, Cytoreduction Surgical Procedures, Hematology, General Medicine, Vascular Health and Risk Management, Peripheral Arterial Disease, Treatment Outcome, Humans, Pharmacology (medical), Prospective Studies, Cardiology and Cardiovascular Medicine
Abstract: Nicolas W Shammas The Midwest Cardiovascular Research Foundation, Davenport, IA, USACorrespondence: Nicolas W Shammas, Research Director, Midwest Cardiovascular Research Foundation, 630 E 4th Street, Suite A, Davenport, IA, 52801, USA, Email shammas@mchsi.comAbstract: Atherectomy is an effective vessel prepping device but not all atherectomy devices are equal. The depth of vessel injury and residual narrowing vary considerably among atherectomy devices with significant implications on outcome. Precision imaging is critical to optimize outcome using atherectomy as a vessel prepping technique. Prospective trials need to test the hypothesis that precision imaging has a significant impact on how operators approach the treatment of infrainguinal arterial disease.Keywords: atherectomy, aggressive debulking, vessel prepping, dissections, residual narrowing, complications, adventitial injury
Published: 2022
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6. 1-Year Outcomes of Blinded Physiological Assessment of Residual Ischemia After Successful PCI

Author: Manesh R. Patel, Allen Jeremias, Akiko Maehara, Mitsuaki Matsumura, Zixuan Zhang, Joel Schneider, Kare Tang, Suneel Talwar, Koen Marques, Nicolas W. Shammas, Luis Gruberg, Arnold Seto, Habib Samady, Andrew S.P. Sharp, Ziad A. Ali, Gary Mintz, Justin Davies, and Gregg W. Stone
Subjects: Cardiology and Cardiovascular Medicine
Published: 2022
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7. A Regional Health System Journey from Volume to Value: Roadmap to the Recognition as a 15 Top Health System in the USA for Quality Excellence

Author: Nidal H Harb, Patricia A Said, Shirley L Gusta, Amanda M Wesson, Jordan D Brautigam, Jon H Lemke, Stephen T DeLessio, Douglas P Cropper, and Nicolas W Shammas
Subjects: Organizational Behavior and Human Resource Management, Leadership and Management, Journal of Healthcare Leadership, Public Health, Environmental and Occupational Health
Abstract: Nidal H Harb,1,2 Patricia A Said,1 Shirley L Gusta,1 Amanda M Wesson,1 Jordan D Brautigam,1 Jon H Lemke,1 Stephen T DeLessio,1 Douglas P Cropper,1 Nicolas W Shammas1,3 1Quality and Safety Department, Genesis Health System, Davenport, IA, USA; 2Cardiovascular Division, University of Iowa Hospitals and Clinics, Iowa City, IA, USA; 3Cardiology Research Unit, Midwest Cardiovascular Research Foundation, Davenport, IA, USACorrespondence: Nicolas W Shammas, Midwest Cardiovascular Research Foundation, 630 E 4th Street, Davenport, IA, 52801, USA, Tel +1 563-320-0263, Email shammas@mchsi.comAbstract: The 15 Top Health System program, an IBM Watson study, objectively measures health systemsâ performance overall on an annual basis using publicly reported data available from the Center for Medicare and Medicaid Services (CMS) and state data banks. Genesis Health System was recognized as an IBM Watson Health 15 Top Health System for two consecutive years in 2020 and 2021. A system-based approach with a âphysician-lead, professionally-managedâ framework, led to accomplishing the 15 Top Health System. The steps needed included adoption of the IBM Watson database to determine current status of certain key performance indicators, establishing a clinical effectiveness program and governance structure, and adopting Lean methodologies to analyze and determine appropriate interventions with long-term solution. The desire and willingness to accomplish this ambitious goal start with adoption by the Board and the administration of the health system while supplying appropriate financial and human resources that are dedicated to the success of the journey. In this manuscript, we describe the journey and steps implemented to accomplish the outcomes that led to the recognition as a 15 Top Health System for quality excellence.Keywords: 15 Top Health System, physician lead, clinical effectiveness, Lean methodology, Value of care
Published: 2022

8. 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 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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 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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
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9. Assessment of Time to Hospital Encounter after an Initial Hospitalization for Heart Failure: Results from a Tertiary Medical Center

Author: Nicolas W. Shammas, Ryan Kelly, Jon Lemke, Ram Niwas, Sarah Castro, Christine Beuthin, Jackie Carlson, Marti Cox, Gail A. Shammas, Terri DeClerck, Kathy Lenaghan, Sunny Arikat, and Marcia Erickson
Subjects: Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Background. Hospital inpatient readmissions for patients admitted initially with the primary diagnosis of heart failure (HF) can be as high as 20–25% within 30 days of discharge. This, however, does not include admissions for observations or emergency department (ED) visits within the same time frame and does not show a time-dependent hospital encounter following discharge after an index admission. We present data on time-dependent hospital encounter of HF patients discharged after an index admission for a primary diagnosis of HF. Methods. The study recruited patients from 2 hospitals within the same health system. 500 consecutive admissions with the ICD diagnosis of HF were reviewed by inclusion and exclusion screening criteria. The 166 eligible remaining patients were tracked for post hospital discharge encounters consisting of hospital admissions, observation stays, and ED visits. Only those with a primary diagnosis of heart failure were included. Demographics were recorded on all patients. Days until hospital inpatient readmissions or hospital encounters were displayed in Kaplan–Meier plots. Results. A total of 166 patients met inclusion criteria (mean age 79.3 years, males 54%). For the first 90 days following the index admission, there were a total of 287 follow-up visits (1.7 per patient), 1158 total hospitalization days (2.6 per visit, 7.0 per patient, and 8.6 per 100 days at risk), and 21 deaths (12.7%). At 30 days, 25% and 52% of patients had an inpatient readmission or a hospital encounter, respectively. The median time to inpatient readmission was 117 days and to hospital encounter was 27 days. Conclusion. Time-dependent excess days in acute care (unplanned inpatient admission, outpatient observation, and ED visit) rather than 30-day hospital inpatient readmission rate is a more realistic measure of the intensity of care required for HF patients after index admission.
Published: 2018
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10. Jetstream Atherectomy Followed by Paclitaxel-Coated Balloons versus Balloon Angioplasty Followed by Paclitaxel-Coated Balloons: Twelve-Month Exploratory Results of the Prospective Randomized JET-RANGER Study

Author: Nicolas W Shammas, Bhaskar Purushottam, W John Shammas, Lori Christensen, Gail Shammas, Desyree Weakley, and Sue Jones-Miller
Subjects: Atherectomy, Time Factors, Paclitaxel, Endocrinology, Diabetes and Metabolism, Public Health, Environmental and Occupational Health, COVID-19, Hematology, General Medicine, Vascular Health and Risk Management, Peripheral Arterial Disease, Treatment Outcome, Coated Materials, Biocompatible, Humans, Pharmacology (medical), Popliteal Artery, Prospective Studies, Cardiology and Cardiovascular Medicine, Angioplasty, Balloon, Vascular Patency
Abstract: Nicolas W Shammas,1 Bhaskar Purushottam,2 W John Shammas,1 Lori Christensen,1 Gail Shammas,1 Desyree Weakley,1 Sue Jones-Miller1 On behalf of the JET-RANGER Investigators1Midwest Cardiovascular Research Foundation, Davenport, IA, USA; 2Regional Health CR, Cardiovascular Medicine, Monument Health, Rapid City, SD, USACorrespondence: Nicolas W Shammas, Research Director, Midwest Cardiovascular Research Foundation, 630 East 4th Street, Suite A, Davenport, IA, USA, Email shammas@mchsi.comBackground: It is unknown at this time whether Jetstream atherectomy (JET) and paclitaxel-coated balloon (PCB) provides a superior outcome to balloon angioplasty (PTA) followed by PCB in treating femoropopliteal (FP) arterial disease.Methods: The JET-RANGER study was a multicenter (eleven US centers) randomized trial, core labâadjudicated, designed to demonstrate the superiority of JET + PCB versus PTA + PCB in treating FP arterial disease. The study intended to enroll 255 patients, but was stopped early because of poor enrollment due to COVID-19 and concerns about the association of paclitaxel with mortality. The data are thus considered exploratory. A total of 47 patients (48 lesions) with claudication (80.9%) or rest pain/ulcerations (19.2%) were randomly assigned 2:1 to JET + PCB (n=31) or PTA + PCB (n=16). The In.PACT (Medtronic) and Ranger (Boston Scientific) PCBs were used. Freedom from target-lesion revascularization (TLR) was evaluated at 1 year. Analysis was performed on intention to treat.Results: Mean lesion length was 10.8Â± 4.3 cm for JET + PCB and 11.2Â± 7.6 cm for PTA + PCB (P=0.858). There were no other differences in demographic or angiographic variables between the two groups. Procedural success was superior with JET + PCB (87.1%) vs PTA + PCB alone (52.9%; P=0.0147). Overall bailout stenting rate was 17% (0 JET + DCB versus 50% PCB, P< 0.0001). There was no distal embolization requiring treatment. There was no amputation or death in either group. Using KM analysis, the primary end point of freedom from TLR (bailout stent considered a TLR) at 1 year was 100% and 43.8% (P< 0.0001) for JET + PCB versus PTA + PCB, respectively. When bailout stent was not considered a TLR, freedom from TLR was 100% and 93.7%, respectively (P=0.327).Conclusion: A high rate of freedom from TLR was seen in the JET + PCB arm and the PTA + DCB arm at 1-year follow-up, with a significant reduction in bailout stenting following vessel prepping with the Jetstream.Keywords: Jetstream, atherectomy, femoropopliteal, vessel prepping, drug-coated balloons, Ranger, In.PACT, randomized trial, dissections, bailout stenting
Published: 2022

11. Intravascular Ultrasound Assessment and Correlation With Angiographic Findings of Arterial Dissections Following Auryon Laser Atherectomy and Adjunctive Balloon Angioplasty: Results of the iDissection Auryon Laser Study

Author: James T Torey, Susan Jones-Miller, Gail A. Shammas, Nicolas W. Shammas, and W John Shammas
Subjects: medicine.medical_specialty, Atherectomy, medicine.medical_treatment, Balloon, law.invention, Peripheral Arterial Disease, law, Angioplasty, Intravascular ultrasound, Humans, Medicine, Popliteal Artery, Radiology, Nuclear Medicine and imaging, Prospective Studies, Ultrasonography, Interventional, medicine.diagnostic_test, Arterial dissection, business.industry, Dissection, Lasers, Ultrasound, Limiting, Laser, Treatment Outcome, Surgery, Radiology, Cardiology and Cardiovascular Medicine, business, Angioplasty, Balloon
Abstract: Background Femoropopliteal arterial angiographic dissections with the use of the Auryon laser atherectomy system (previously the B-laser) have been infrequent and non–flow limiting. However, the pattern of these dissections (depth and arc) using intravascular ultrasound remains unknown. Materials and Methods We prospectively enrolled 29 patients in the iDissection Auryon study. The primary objective was to define the occurrence of new adventitial injury with intravascular ultrasound (IVUS). Secondary objectives included distal embolization and bailout stenting as judged by the operator because of 30% or more residual narrowing and/or NHLBI (National Heart, Lung, and Blood Institute) angiographic dissection C and higher. Core laboratory analysis was carried on all cases except for 1 patient (that crossed over to Jetstream atherectomy). Dissections were classified according to the iDissection classification as involving the intima (A), media (B), and adventitia (C) and ≤ 180-° arc (1) or >180-° arc (2). Overall, 22 of 29 patients had an embolic filter (per protocol). Results Median lesion and treated lengths were 100.0 and 150.0 mm, respectively. Vessel diameter by IVUS was 6.5 ± 1.5 mm. Chronic total occlusion (CTO) was present in 24.1% of cases. The arc of calcium was: no calcium in 27.6%, 180° in 34.4%. Lesion severity was reduced to a median of 14% post laser and adjunctive percutaneous transluminal angioplasty (PTA) from a baseline of 76%. Bailout stenting occurred in 6 of 28 (21.4%) patients (3 for dissections, 2 for residual >30%, and 1 for both) and primary stenting in 1 of 28 (3.6%). By IVUS, there were 9 new dissections post laser (1 adventitial; 3≥180°) and 21 new dissections post laser and PTA (3 adventitial; 1≥180°). No distal embolization requiring treatment was seen and no macrodebris ≥2 mm was recovered in the filters. Conclusion The Auryon laser atherectomy system had minimal rate of adventitial injury despite complex disease with relatively low bailout stent rate and no clinically significant macrodebris.
Published: 2021
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12. Education of Self-Radial Pulse Palpation and Atrial Fibrillation Signs and Symptoms

Author: Yuhning Hu, Jon H. Lemke, Kelsey Lisius, Nicolas W. Shammas, Edmund P. Coyne, Maripat King, Kathryn J. VanderZwan, and Cara M. Voelliger
Subjects: Adult, Male, Self-Assessment, medicine.medical_specialty, Population, Signs and symptoms, Palpation, Radial pulse, 03 medical and health sciences, 0302 clinical medicine, Patient Education as Topic, Heart Rate, Atrial Fibrillation, Humans, Medicine, 030212 general & internal medicine, education, Aged, Aged, 80 and over, Community and Home Care, education.field_of_study, 030505 public health, Recall, medicine.diagnostic_test, business.industry, Public Health, Environmental and Occupational Health, Atrial fibrillation, Middle Aged, medicine.disease, Physical therapy, Female, 0305 other medical science, business
Abstract: The purpose of this evidence-based education initiative was to increase A Fib detection in a cardiovascular diseased population in which participants were taught radial pulse palpation and signs/symptoms of A Fib. Participants were evaluated after initial education on performance of radial pulse palpation and teach back of signs/symptoms of the arrhythmia and again at three weeks on adherence to daily self-screening and recall of signs/symptoms of A Fib. Post initial education, 88% of eligible participants learned pulse-palpation and 93% could verbalize at minimum one sign/symptom. After three weeks, 94.7% reported daily self-screening, but only 44.7% could verbalize at minimum one sign/symptom. This indicated that participants were continuing to self-screen, but in need of booster education sessions. Educating individuals on self-screening and signs/symptoms of A Fib is clinically feasible.
Published: 2021
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13. Acute Kidney Injury Following In-Patient Lower Extremity Vascular Intervention

Author: Kevin F. Kennedy, David M. Safley, Adam C. Salisbury, Thomas T. Tsai, John A. Spertus, Lawrence A. Garcia, R. Kevin Rogers, Anand Prasad, Kenneth Rosenfield, Nicolas W. Shammas, Matthew A. Cavender, Eric A. Secemsky, and Faisal Latif
Subjects: medicine.medical_specialty, urogenital system, business.industry, Incidence (epidemiology), medicine.medical_treatment, Acute kidney injury, Renal function, 030204 cardiovascular system & hematology, urologic and male genital diseases, medicine.disease, Logistic regression, female genital diseases and pregnancy complications, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Heart failure, Diabetes mellitus, medicine, Cardiology, 030212 general & internal medicine, Cardiology and Cardiovascular Medicine, Complication, business, Dialysis
Abstract: Objectives The authors analyzed data from the NCDR (National Cardiovascular Data Registry) PVI Registry and defined acute kidney injury (AKI) as increased creatinine of ≥0.3 mg/dl or 50%, or a new requirement for dialysis after PVI. Background AKI is an important and potentially modifiable complication of peripheral vascular intervention (PVI). The incidence, predictors, and outcomes of AKI after PVI are incompletely characterized. Methods A hierarchical logistic regression risk model using pre-procedural characteristics associated with AKI was developed, followed by bootstrap validation. The model was validated with data submitted after model creation. An integer scoring system was developed to predict AKI after PVI. Results Among 10,006 procedures, the average age of patients was 69 years, 58% were male, and 52% had diabetes. AKI occurred in 737 (7.4%) and was associated with increased in-hospital mortality (7.1% vs. 0.7%). Reduced glomerular filtration rate, hypertension, diabetes, prior heart failure, critical or acute limb ischemia, and pre-procedural hemoglobin were independently associated with AKI. The model to predict AKI showed good discrimination (optimism corrected c-statistic = 0.68) and calibration (corrected slope = 0.97, intercept of −0.07). The integer point system could be incorporated into a useful clinical tool because it discriminates risk for AKI with scores ≤4 and ≥12 corresponding to the lower and upper 20% of risk, respectively. Conclusions AKI is not rare after PVI and is associated with in-hospital mortality. The NCDR PVI AKI risk model, including the integer scoring system, may prospectively estimate AKI risk and aid in deployment of strategies designed to reduce risk of AKI after PVI.
Published: 2021
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14. Auryon Laser in Treating Symptomatic Infrainguinal Arterial Disease: 1-Year Outcome

Author: Nicolas W, Shammas, Gail A, Shammas, Sue, Jones-Miller, Venkat, Shankarraman, and Michele B, Corbet
Subjects: Aged, 80 and over, Male, Lasers, Middle Aged, Limb Salvage, Femoral Artery, Peripheral Arterial Disease, Treatment Outcome, Humans, Female, Popliteal Artery, Angioplasty, Balloon, Vascular Patency, Aged, Retrospective Studies
Abstract: The Auryon 355-nm laser atherectomy system (AngioDynamics, Inc) showed a low rate of target-lesion revascularization (TLR) at 6-month follow-up in the EX-PAD-03 investigational device exemption study and the Auryon single-center experience (SCE) in treating infrainguinal arteries. In this study, we present the 1-year outcomes of the Auryon SCE study on TLR in all comers at a single center.The Auryon SCE was a retrospective study that evaluated the outcomes of all comers treated with the Auryon laser for infrainguinal arterial disease. There was no TLR seen at 6-month follow-up. We present the TLR rate at 1 year in the same cohort of patients. TLR rates were obtained from medical record review of patients enrolled in the study who had completed office visit follow-up at 1 year. Secondary endpoints included unplanned major amputation and total mortality. Kaplan-Meier survival analysis was performed to estimate the freedom from TLR rate following index procedure. Statistical differences were analyzed for ankle-brachial index (ABI) between baseline and 1 year.A total of 56 patients (65 procedures, 70 lesions) were enrolled. The mean age was 70.9 ± 10 years, with 66.1% males, 48.2% diabetics, and 25% demonstrating limb ischemia. Of the 70 lesions, 31.4% had severe calcification, 38.6% were chronic total occlusions, and 48.6% were de novo disease (in-stent restenosis, 29.6%). Stenting was performed in 24/70 lesions (34.3%), with 11/70 (15.7%) bailout procedures. Embolic filters were used in 26/65 procedures (40%). The majority of treated lesions were femoropopliteal (90.0%); of all procedures, 29.2% had 2 or more prior interventions. Drug-coated balloon usage was 47.1% Lutonix (BD/Bard), 27.1% In.Pact (Boston Scientific), and 1.4% both in all lesions treated. Distal embolization occurred in 1/65 procedures (1.5%). At 1 year, mortality occurred in 3/56 patients (5.4%). Of 65 limbs treated, 2 (3.1%) had major amputation at 1 year. The probability of freedom from TLR was 83.7%.In a realworld cohort of patient with complex disease, the Auryon laser had excellent freedom from TLR at 1 year.
Published: 2022

15. Femoropopliteal Arterial Dissections Following FLEX VP and Balloon Angioplasty Versus Balloon Angioplasty Alone: Intravascular Ultrasound Assessment and Correlation With Angiographic Findings

Author: Nicolas W. Shammas, W. John Shammas, Gail A. Shammas, and Sue Jones-Miller
Subjects: Male, Femoral Artery, Peripheral Arterial Disease, Aortic Dissection, Treatment Outcome, Humans, Popliteal Artery, Calcium, General Medicine, Cardiology and Cardiovascular Medicine, Angioplasty, Balloon, Ultrasonography, Interventional, Vascular Patency
Abstract: The Flex VP is a longitudinal micro-incision catheter approved for vessel prepping of femoropopliteal arteries and arteriovenous fistulas. In this study, we evaluated the presence of deep dissections (adventitia) using IVUS in patients undergoing Flex VP followed by angioplasty (PTA) versus PTA alone.17 patients (20 limbs) with femoropopliteal artery (FP) disease were prospectively and consecutively included (10 limbs received PTA followed by 10 limbs that received FLEX VP microincision catheter treatment followed by adjunctive PTA). Dissections post PTA, FLEX VP and FLEX VP+ PTA were evaluated using intravascular ultrasound (iDissection classification) and angiographically (NHLBI classification) by core laboratory. The evaluated segment of the vessel was prespecified at 10 cm at the most severe lesion location. Statistical differences were analyzed between the 2 groups at each appropriate procedural point for dissections, minimal luminal diameter (MLD), minimal luminal area (MLA), and residual stenosis. Statistical significance was determined by a p-value0.05.Baseline demographics and angiographic variables were similar between the PTA vs FLEX VP + PTA groups with the exception of more males (87.5 % vs 33.3 %, p = 0.0274) and longer treated length (median 300 mm vs 150 mm, p = 0.0240) in the FLEX VP + PTA group. Lesion length, chronic total occlusions, angiographic and IVUS evaluated segment length for dissections, calcium severity and final balloon pressures and inflation duration were all similar between the 2 groups. Angiographic dissections were similar between the 2 groups but the increase in severe dissections from index to post POBA on IVUS (involving the adventitia) were significantly more for PTA when compared to FLEX VP + PTA (0 to 12 and 0 to 1 respectively, p = 0.0353). Bailout stenting was statistically similar for PTA as compared to FLEX VP + PTA per core lab evaluation (50 % vs 20 %, p = 0.3498). Minimal luminal area (MLA) gain by IVUS was similar between the 2 groups following FLEX VP + PTA vs PTA (7.4 mmVessel prepping with the FLEX VP + PTA vs PTA yielded lower rates of adventitial dissections as seen on IVUS. The long-term outcomes of these findings remain unclear.
Published: 2022

16. Auryon Laser in Peripheral Arterial Interventions: A Single-Center Experience (Auryon-SCE)

Author: Nicolas W, Shammas, Gail A, Shammas, Grace, Halupnik, Nicholas, Fedele, Katie, Comp, Emma-Marie, Taleb, Sue, Jones-Miller, Andrew N, Shammas, and Venkat, Shankarraman
Subjects: Aged, 80 and over, Male, Lasers, Constriction, Pathologic, Middle Aged, Femoral Artery, Peripheral Arterial Disease, Treatment Outcome, Coated Materials, Biocompatible, Humans, Female, Popliteal Artery, Angioplasty, Balloon, Vascular Patency, Aged, Retrospective Studies
Abstract: The Auryon 355-nm laser atherectomy system (AngioDynamics, Inc) showed a low rate of target-lesion revascularization (TLR) at 6-month follow-up in the investigational device exemption study. At present, real-world data are not available. In this study, we analyze major adverse events and 6-month outcomes with the Auryon laser system in treating infrainguinal arterial disease in all comers at a single center.Consecutive patients treated with the Auryon laser between September 2017 and March 2021 were retrospectively reviewed from a single operator at a single center. Demographic, procedural, angiographic, and outcome data were extracted from patients' medical records. Descriptive and survival analyses were performed. The study's primary endpoint was the assessment of freedom from TLR at 6-month follow-up. Secondary endpoints included acute procedural results, distal embolization, bailout stenting (dissection type D or higher by National Heart, Lung, and Blood Institute [NHLBI] classification, and/or residual narrowing30%), unplanned major amputation, death, or vascular complications.A total of 56 patients (65 procedures, 70 lesions) were enrolled. The mean age was 70.9 ± 10 years, 66.1% were males, 48.2% were diabetics, and 25% had limb ischemia. Of the 70 lesions, 31.4% had severe calcification, 38.6% were chronic total occlusions, and 48.6% were de novo disease (in-stent restenosis in 28.6%). The majority of treated vessels were femoropopliteal (88.6%) and 29.2% had 2 or more prior interventions. Mean stenosis was 91.3 ± 9.7% at baseline, 56.0 ± 17.3% post laser, and 11.4 ± 11.2% post final treatment. Lesion length was 117.1 ± 101.2 mm and treated length was 174.0 ± 116.0 mm. Bailout stenting occurred in 11/70 lesions (15.7%). There were no NHLBI type D dissections post laser and 1 type D dissection post laser + percutaneous transluminal angioplasty. A total of 47.1% received Lutonix drug-coated balloons (BD/Bard), 27.1% received In.Pact drug-coated balloons (Boston Scientific), and 1.4% received both. The probability of freedom from TLR per procedure was 95.6% at 6 months.In a real-world cohort of patients with complex disease, the Auryon laser had excellent freedom from TLR at 6 months, although these findings need to be replicated in a randomized trial.
Published: 2022

17. Shockwave™ Lithoplasty in Combination With Atherectomy in Treating Severe Calcified Femoropopliteal and Iliac Artery Disease: A Single-Center Experience

Author: Qais Radaideh, Nicolas W. Shammas, Gail A. Shammas, and W John Shammas
Subjects: medicine.medical_specialty, Atherectomy, medicine.medical_treatment, Perforation (oil well), Population, 030204 cardiovascular system & hematology, Single Center, Iliac Artery, Peripheral Arterial Disease, 03 medical and health sciences, 0302 clinical medicine, medicine.artery, medicine, Humans, Popliteal Artery, 030212 general & internal medicine, Embolization, education, Vascular Patency, Aged, Retrospective Studies, education.field_of_study, business.industry, General Medicine, medicine.disease, Popliteal artery, Surgery, Femoral Artery, Stenosis, Treatment Outcome, Amputation, Cardiology and Cardiovascular Medicine, business, Angioplasty, Balloon
Abstract: Background Calcium is a predictor of poor outcome in the treatment of infrainguinal arterial disease. Rotational atherectomy can effectively debulk atherosclerotic calcium but is less likely to significantly modify medial and adventitial calcinosis. Shockwave IVL provides circumferential sonic pressure waves capable of disrupting deeper calcium and theoretically complements the debulking process of atherectomy. We present acute and intermediate outcome data from patients with severe femoral or iliac artery calcified disease treated with the combination of rotational atherectomy and Shockwave IVL at a single center. Methods This is a retrospective study of prospectively collected data on rotational atherectomy (Jetstream (Boston Scientific) and orbital atherectomy (CSI)) from a single operator at a single center with core laboratory analysis of angiographic imaging. All patients that received the combination treatment of rotational atherectomy and Shockwave IVL were included in this study. Patient follow-up was done from medical records with data extracted by an experienced research coordinator. Primary safety endpoint was freedom from major adverse events including major dissection (NHLBI C or higher), perforation, distal embolization, or major amputation defined as amputation above the ankle. Primary effectiveness endpoint was procedural success (≤ 30% residual at end of procedure). 23/24 (95.8%) patients were treated with drug coated balloons (DCB) post combination therapy. Secondary endpoint on follow-up was target lesion revascularization (TLR). Results A total of 24 patients were included. Mean age was 70.7 ± 9.9 years. Lesions were in the femoropopliteal 79.1%, common femoral 12.5% and iliac 8.3% arteries. 87.0% were claudicants and 58.3% diabetics. Chronic total occlusion was 12.5%, severe calcium 100%, lesion length 84.5 ± 37.1 mm, baseline stenosis 57.1 ± 18.9% and baseline minimal luminal diameter (MLD) 2.2 ± 1.1 mm. Patients were treated with Jetstream (n = 19) or Orbital (n = 5) atherectomy. Embolic filter was used in 58.3% of cases. Post atherectomy stenosis was 36.4 ± 17.5%, post adjunctive IVL 21.1 + 15.7%, and final stenosis 13.0 ± 10.9%. Bailout stenting was 4.6% and primary stenting 13.6% (total stenting rate 18.2%). Final MLD was 4.7 ± 0.8 mm, resulting in an acute gain of 2.5 mm. No infrapopliteal embolization or amputation was noted. At a mean follow up of 591.4 ± 175.2 days, 2 patients died (unrelated to procedure or device). Target lesion revascularization (TLR) at 12 months occurred in 2 patients or 2/22 (9%). At 18-month of follow up TLR occurred in 7/22 (31%) patients. Conclusion The combination of atherectomy and shockwave IVL followed by adjunctive DCB is safe and appears to be effective in treating severe calcified disease with acceptable TLR on long term follow-up in a population of severe femoropopliteal disease.
Published: 2021
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18. JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study

Author: Nicolas W. Shammas, Nicholas Petruzzi, Steven Henao, Ehrin J. Armstrong, Thomas Shimshak, Subhash Banerjee, Faisal Latif, Britton Eaves, Thomas Brothers, Jaafer Golzar, Gail A. Shammas, Susan Jones-Miller, Lori Christensen, and W. John Shammas
Subjects: Male, medicine.medical_specialty, Atherectomy, medicine.medical_treatment, Rotational atherectomy, Coronary Restenosis, Peripheral Arterial Disease, Restenosis, medicine.artery, medicine, Humans, Popliteal Artery, Radiology, Nuclear Medicine and imaging, Prospective Studies, Vascular Patency, Aged, Retrospective Studies, Aged, 80 and over, Jet (fluid), business.industry, Superficial femoral artery, Middle Aged, medicine.disease, Popliteal artery, Femoral Artery, Treatment Outcome, Atherectomy device, Female, Surgery, Radiology, In stent restenosis, Cardiology and Cardiovascular Medicine, business, Angioplasty, Balloon
Abstract: Purpose: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). Materials and Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR ( ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). Results: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. Conclusion: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.
Published: 2020
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19. Sex-Related Differences in the Outcomes of Endovascular Interventions for Chronic Limb-Threatening Ischemia: Results from the LIBERTY 360 Study

Author: Stefanos Giannopoulos, Ian Cawich, George L. Adams, Nicolas W. Shammas, Cezar Staniloae, and Ehrin J. Armstrong
Subjects: medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Population, Ischemia, 030204 cardiovascular system & hematology, Revascularization, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Pharmacology (medical), 030212 general & internal medicine, Adverse effect, education, education.field_of_study, business.industry, Incidence (epidemiology), Hazard ratio, Public Health, Environmental and Occupational Health, Hematology, General Medicine, Critical limb ischemia, medicine.disease, Confidence interval, medicine.symptom, Cardiology and Cardiovascular Medicine, business
Abstract: Introduction Previous studies have suggested that women with chroniclimb-threatening ischemia (CLTI) may have worse outcomes than men. The aim of this study was to determine whether there are sex-related differences in outcomes of patients with CLTI undergoing endovascular treatment with current endovascular technologies. Patients and methods Data were derived from the LIBERTY 360 study (NCT01855412). Hazard ratios and the respective 95% confidence intervals were synthesized to examine the association between sex and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE) and major amputation/death up to 3 years of follow-up. Results A total of 689 patients with CLTI (female: N=252 vs male: N=437) treated with any FDA approved or cleared device were included. The mean lesion length was 126.9±117.3mm and 127.4±113.3mm for the female and male patients, respectively. Although a slightly higher incidence of in-hospital mortality was observed in the female group (1.2% vs 0.0%, p=0.049), there was no difference in female vs male survival rates during follow-up. However, the risk of major amputation at 18 months was higher for the male group (male vs female: HR: 2.36; 95% CI: 1.09-5.12; p=0.030). No difference between the two groups was detected in terms of TVR or MAE during follow-up. Discussion Data regarding sex-related disparity in outcomes after endovascular therapy of patients with CLTI are conflicting. Gender-related characteristics rather than biological sex characteristics might be the cause of these conflicting findings. Further studies are needed to evaluate the role of sex in revascularization outcomes among this high-risk population.
Published: 2020
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20. Optimal Vessel Sizing and Understanding Dissections in Infrapopliteal Interventions: Data From the iDissection Below the Knee Study

Author: Gail A. Shammas, Qais Radaideh, Nicolas W. Shammas, James T Torey, W John Shammas, Ehrin J. Armstrong, and Susan Jones-Miller
Subjects: Male, medicine.medical_specialty, Atherectomy, Time Factors, Diameter measurement, medicine.medical_treatment, Psychological intervention, 030204 cardiovascular system & hematology, Radiography, Interventional, Risk Assessment, 030218 nuclear medicine & medical imaging, Peripheral Arterial Disease, 03 medical and health sciences, 0302 clinical medicine, Ischemia, Predictive Value of Tests, Risk Factors, Intravascular ultrasound, medicine, Humans, Popliteal Artery, Radiology, Nuclear Medicine and imaging, Tibial artery, Prospective Studies, Ultrasonography, Interventional, Vascular Patency, Aged, Aged, 80 and over, Leg, medicine.diagnostic_test, business.industry, Stent, Middle Aged, Vascular System Injuries, Limb Salvage, Vessel diameter, Dissection, Treatment Outcome, surgical procedures, operative, Chronic Disease, Angiography, cardiovascular system, Female, Surgery, Radiology, Cardiology and Cardiovascular Medicine, business, Angioplasty, Balloon
Abstract: Purpose: To investigate if imaging with intravascular ultrasound (IVUS) yields a more accurate estimate of vessel diameter and the presence of dissections than angiography after intervention in the infrapopliteal arteries. Materials and Methods: A prospective, single-center study enrolled 20 consecutive patients (mean age 74.1±12.4 years; 12 women) with infrapopliteal disease who were treated with percutaneous transluminal angioplasty (PTA; n=10) or orbital atherectomy (OA) followed by PTA (n=10). The majority of patients were hypertensive and half were diabetic. The overall lesion length was 7.3±6.3 cm, and the diameter stenosis was 80.3%±22.1%. The baseline characteristics did not differ between the groups. Vessel diameters were measured using IVUS from the internal elastic lamina (IEL) to the IEL. IVUS was performed at baseline, post PTA or OA, and post OA+PTA. Quantitative vascular angiography (QVA) and IVUS were analyzed by a core laboratory. Dissections on cine images were categorized based on the National Heart Lung and Blood Institute (NHLBI) classification, while the arc and depth were used to characterize dissections on IVUS images. Results: Mean vessel diameter by QVA was 2.9±0.6 vs 4.0±1.0 mm by IVUS according to the core laboratory (mean difference 1.1±0.9, pConclusion: In addition to underestimating the infrapopliteal vessel diameter by ~25%, angiography underappreciated the presence and severity of post-intervention dissections vs IVUS, particularly in the OA+PTA group.
Published: 2020
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21. Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study

Author: William Miller, Sahil A. Parikh, George L. Adams, Ehrin J. Armstrong, Alexandra Lansky, Nicolas W. Shammas, William A. Gray, Gunnar Tepe, Sarang Mangalmurti, Peter A. Soukas, and Nelson L. Bernardo
Subjects: Male, Time Factors, medicine.medical_treatment, Constriction, Pathologic, lithotripsy, 030204 cardiovascular system & hematology, Lithotripsy, Balloon, calcification, Atherectomy, 0302 clinical medicine, Ischemia, Prospective Studies, chronic total occlusion, Aged, 80 and over, Endovascular Procedures, stenosis, Middle Aged, infrapopliteal arteries, popliteal artery, Treatment Outcome, Lower Extremity, Female, Radiology, medicine.symptom, Cardiology and Cardiovascular Medicine, medicine.medical_specialty, Perforation (oil well), complication, occlusion, superficial femoral artery, Lower Limb Interventions, peripheral artery disease, Peripheral Arterial Disease, 03 medical and health sciences, medicine.artery, medicine, Humans, Radiology, Nuclear Medicine and imaging, Vascular Calcification, iliac artery, Aged, Arterial stenosis, business.industry, Intermittent Claudication, acute gain, medicine.disease, United States, Popliteal artery, Stenosis, common femoral artery, Chronic Disease, lithoplasty, Surgery, Claudication, business, 030217 neurology & neurosurgery
Abstract: Purpose: To evaluate the performance of peripheral intravascular lithotripsy (IVL) in a real-world setting during endovascular treatment of multilevel calcified peripheral artery disease (PAD). Materials and Methods: The Disrupt PAD III Observational Study ( ClinicalTrials.gov identifier NCT02923193) is a prospective, nonrandomized, multicenter, single-arm observational study assessing the acute safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of calcified, stenotic lower limb arteries. Patients were eligible if they had claudication or chronic limb-threatening ischemia and moderate or severe arterial calcification. Between November 2017 and August 2018, 200 patients (mean age 72.5±8.7 years; 148 men) were enrolled across 18 sites and followed through hospital discharge. Results: In the 220 target lesions, IVL was more commonly used in combination with other balloon-based technologies (53.8%) and less often with concomitant atherectomy or stenting (19.8% and 29.9%, respectively). There was a 3.4-mm average acute gain at the end of procedure; the final mean residual stenosis was 23.6%. Angiographic complications were rare, with only 2 type D dissections and a single perforation following drug-coated balloon inflation (unrelated to the IVL procedure). There was no abrupt closure, distal embolization, no reflow, or thrombotic event. Conclusion: Use of peripheral IVL to treat severely calcified, stenotic PAD in a real-world study demonstrated low residual stenosis, high acute gain, and a low rate of complications despite the complexity of disease.
Published: 2020
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22. An Overview of the Treatment of Symptomatic Common Femoral Artery Lesions with a Focus on Endovascular Therapy

Author: Rusina Karia, Nicolas W. Shammas, Rommy Khalafallah, and Amanda Abi Doumet
Subjects: medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Femoral artery, 030204 cardiovascular system & hematology, Endovascular therapy, law.invention, Atherectomy, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Angioplasty, medicine.artery, medicine, Pharmacology (medical), 030212 general & internal medicine, Endarterectomy, business.industry, Gold standard, Public Health, Environmental and Occupational Health, Stent, Hematology, General Medicine, Surgery, Cardiology and Cardiovascular Medicine, business
Abstract: Endarterectomy of common femoral artery lesions (CFA) carries favorable long-term results and is currently still considered the gold standard for treating these lesions. Although routine stenting has been considered an option for treating the CFA, it has yielded conflicting results and is currently reserved for a bailout of suboptimal endovascular results. Newer therapies with atherectomy or lithoplasty in conjunction with pharmacologic anti-proliferative therapies are promising with less bailout stenting and dissections but randomized trials are needed to confirm their effectiveness and safety.
Published: 2020
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23. The Role of Atherectomy in Vessel Prepping During Infrainguinal Arterial Interventions

Author: Andrew N. Shammas and Nicolas W. Shammas
Published: 2022
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24. Controlling Dissections in Peripheral Arterial Interventions

Author: Nicolas W. Shammas
Published: 2022
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25. Contributors

Author: Oliver G. Abela, George S. Abela, Amer Alaiti, Mazen S. Albaghdadi, Carlos E. Alfonso, Hilary F. Armstrong, Steven R. Bailey, Subhash Banerjee, Ori Belson, Navid Berenji, Gary N. Binyamin, Joao Braghiroli, Emmanouil S. Brilakis, Shmuel Chen, Michael Clifton, Jose F. Condado, Jennifer P. Connell, Michael Dangl, Kathryn Das, Makram R. Ebeid, Gabby Elbaz-Greener, Matthew C. Evans, Alexandre Ferreira, Aloke V. Finn, Nathan Frogge, Offer Galili, Samantha Gaston, Jessica Nathalia González, K. Jane Grande-Allen, Jelani K. Grant, Aashish Gupta, null Adrian Howansky, Dora Y. Huang, Kurt Jacobson, J. Stephen Jenkins, Thomas Johnson, Gregory K. Jones, Elysa Jui, Edo Kaluski, Vasili Katsadouros, Sameer Khandhar, Eitan Konstantino, Maya Konstantino, Alexandra Lansky, John Lasala, Neil Pendril Lewis, Alejandro Eric Macias, Michael Magarakis, Mark Mariathas, Cesar E. Mendoza, Ryan Merritt, Hayley Moore, Masayuki Mori, John Moscona, William B. Moskowitz, Liam Musto, Hoang Nguyen, Odunayo Olorunfemi, Takayuki Onishi, Yuko Onishi, Peter O'Kane, Purven Parikh, Samuel P. Powell, Marloe Prince, Furqan A. Rajput, Sarah Reeves, Prakash Saha, Tomas Antonio Salerno, Yu Sato, Megan Sattler, Sudhakar Sattur, Amit Shah, Nicolas W. Shammas, Venkat Shankarraman, Reema Sheth, Kavya L. Singampalli, Dilpreet Singh, George A. Stouffer, Bradley H. Strauss, Christopher B. Sylvester, Prashanth Thakker, Manoj Thangam, Thomas M. Todoran, Catalin Toma, On Topaz, Nirupama Vellanki, Renu Virmani, Xin Wei, Giora Weisz, Christopher J. White, Scott L. Willis, Iosif Xenogiannis, and Jeffrey P. Yourshaw
Published: 2022
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26. The Role of Exercise in Treating Symptomatic Claudication in Patients with Peripheral Arterial Disease

Author: Nicolas W. Shammas
Published: 2022
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27. Putting It All Together: An Algorithmic Approach to Treat Patients with Peripheral Arterial Disease

Author: Nicolas W. Shammas
Published: 2022
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28. Design and ablative properties of peripheral atherectomy lasers with a special emphasis on the Auryon system

Author: Nicolas W. Shammas, Hilary F. Armstrong, and Venkat Shankarraman
Published: 2022
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29. Pharmacologic Interventions in Patients with Peripheral Arterial Disease

Author: Qais Radaideh and Nicolas W. Shammas
Published: 2022
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30. Spontaneous Renal Artery Dissection in a Patient with Neurofibromatosis Type I

Author: Nicolas W. Shammas, Majid Z. Chammas, Jon Robken, and Edmund Coyne
Subjects: Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: We present a case of spontaneous renal artery dissection (SRAD) in a 28-year-old female with history of neurofibromatosis type I (NF-1) treated successfully with endovascular stenting. The clinical presentation, diagnostic testing, and treatment options are discussed. An endovascular approach with stenting was successfully performed after failure of medical treatment with subcutaneous low molecular weight heparin. Patient’s blood pressure and symptoms improved significantly. This may be the first reported case of SRAD in a patient with NF-1 successfully treated with endovascular stenting.
Published: 2016
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31. Epidemiology, classification, and modifiable risk factors of peripheral arterial disease

Author: Nicolas W Shammas
Subjects: Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Nicolas W ShammasMidwest Cardiovascular Research Foundation, Cardiovascular Medicine, PC, Davenport, IA, USAAbstract: Peripheral arterial disease (PAD) is part of a global vascular problem of diffuse atherosclerosis. PAD patients die mostly of cardiac and cerebrovascular-related events and much less frequently due to obstructive disease of the lower extremities. Aggressive risk factors modification is needed to reduce cardiac mortality in PAD patients. These include smoking cessation, reduction of blood pressure to current guidelines, aggressive low density lipoprotein lowering, losing weight, controlling diabetes and the use of oral antiplatelet drugs such as aspirin or clopidogrel. In addition to quitting smoking and exercise, cilostazol and statins have been shown to reduce claudication in patients with PAD. Patients with critical rest limb ischemia or severe progressive claudication need to be treated with revascularization to minimize the chance of limb loss, reduce symptoms, and improve quality of life.Keywords: peripheral arterial disease, epidemiology, risk factors, classification
Published: 2007

32. Atherectomy Plus Balloon Angioplasty for Femoropopliteal Disease Compared to Balloon Angioplasty Alone: A Systematic Review and Meta-analysis

Author: Waiel Abusnina, Ahmad Al-Abdouh, Qais Radaideh, Arun Kanmanthareddy, Mehdi H. Shishehbor, Christopher J. White, Itsik Ben-Dor, Nicolas W. Shammas, Aravinda Nanjundappa, Hady Lichaa, and Timir K. Paul
Published: 2022
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33. Three-Year Results From the Venovo Venous Stent Trial

Author: Nicolas W. Shammas
Subjects: General Medicine, Cardiology and Cardiovascular Medicine
Published: 2022
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34. Venovo Venous Stent in Treating Iliac Vein Compression: A Single-Center Experience

Author: Nicolas W, Shammas, Qais, Radaideh, Gail, Shammas, Sue, Jones-Miller, Shaddy, Khalafallah, Amanda, Abi Doumet, Rusina, Karia, Andrew N, Shammas, Sri, Kasula, Rommy, Khalafallah, and W John, Shammas
Subjects: Adult, Treatment Outcome, Humans, Female, Stents, Iliac Vein, Middle Aged, Vascular Patency, Aged, Retrospective Studies
Abstract: The Venovo venous stent (BD/Bard Peripheral Vascular) is indicated to treat iliofemoral veno-occlusive disease. We present our own experience with the Venovo venous stent in treating iliac vein compression (ILVC).In this retrospective cohort, we included consecutive patients treated with the Venovo venous stent for ILVC at our center. Stent deployment and sizing were guided by intravascular ultrasound (IVUS). Minimal luminal areas at the compression before and after treatment were measured by IVUS. Clinical improvement was determined by symptoms reported by patients and the Clinical Etiologic Anatomic and Pathophysiologic (CEAP) score. The primary safety endpoint was freedom from acute venothromboembolic disease, stent migration, perforation, acute/subacute closure, and vascular complications. The primary safety endpoint was target-lesion revascularization at 1 year.A total of 50 consecutive patients (57 Venovo stents, 36 women, mean age, 59.8 ± 16.3 years) were included. IVUS-measured mean percent stenosis at the compression site was 64.8% ± 12.8%. Mean total stent length and diameter were 78.0 ± 54.0 mm and 17.1 ± 1.9 mm, respectively. The primary safety endpoint was met in all subjects. Procedural technical success was 100% (successful deployment with no complications). At 1 year, 83.8% of patients reported improvement in their symptoms. Freedom from total occlusion at 1 year was 100% (data available for n = 30 patients). Target-lesion revascularization (TLR) was 2% at 1 year due to 1 patient who had stent explantation from worsening ipsilateral left leg and back pain.In this single-center experience, the Venovo venous stent was safe and effective in treating ILVC with 98% freedom from TLR at a follow-up of 1 year. Improvement in symptoms was reported in the majority of patients.
Published: 2021

35. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction

Author: Michael D. Dake, Michael Lichtenberg, Gerard J O'Sullivan, Richard A Settlage, Bibombe P. Mwipatayi, and Nicolas W. Shammas
Subjects: medicine.medical_specialty, Randomization, Iliofemoral venous obstruction, medicine.medical_treatment, Femoral vein, Iliac Vein, Revascularization, Post-thrombotic syndrome, medicine, Humans, Radiology, Nuclear Medicine and imaging, Clinical Investigation, Embolization, Prospective Studies, Vein, Adverse effect, Vascular Patency, Retrospective Studies, business.industry, Non-thrombotic iliac vein lesion, Stent, Correction, Percutaneous endovenous stent, Femoral Vein, medicine.disease, Surgery, medicine.anatomical_structure, Treatment Outcome, Iliac and femoral vein occlusive disease, Stents, Cardiology and Cardiovascular Medicine, business
Abstract: Purpose To assess safety and patency of the Venovo venous stent for the treatment of iliofemoral vein obstruction. Materials and Methods Twenty-two international centers enrolled 170 patients in the VERNACULAR study (93 post-thrombotic syndrome; 77 non-thrombotic iliac vein lesions). Primary outcome measures were major adverse events at 30 days and 12-month primary patency (freedom from target vessel revascularization, thrombotic occlusion, or stenosis > 50%). Secondary outcomes included the Venous Clinical Severity Score Pain Assessment and Chronic Venous Quality-of-Life Questionnaire assessments (hypothesis tested). Secondary observations included primary patency, target vessel and lesion revascularization (TVR/TLR), and assessment of stent integrity through 36 months. Results Freedom from major adverse events through 30 days was 93.5%, statistically higher than a pre-specified performance goal of 89% (p = 0.032) while primary patency at 12 months was 88.6%, also statistically higher than a performance goal of 74% (p p Conclusion The Venovo venous stent was successfully deployed in obstructive iliofemoral vein lesions and met the pre-specified primary outcome measures through 12 months. At 3 years, primary patency was 84%, reintervention rates were low, standardized quality-of-life and pain measures improved from baseline, and there was no stent migration or fractures. Level of Evidence Level 2—prospective, multicenter, controlled clinical study without a concurrent control or randomization. Pre-specified endpoints were hypothesis-tested to performance goals derived from peer-reviewed clinical literature. Registration clinicaltrials.gov Unique Identifier NCT02655887.
Published: 2021

36. CRT-300.08 Single-Center Study Evaluating Long-Term Major Adverse Outcomes With the Use of the Lutonix Drug-Coated Balloon in Treating Infrainguinal Arterial Disease

Author: Nicolas W. Shammas, Gail A. Shammas, Elizabeth Sharis, and Susan Jones-Miller
Subjects: Cardiology and Cardiovascular Medicine
Published: 2022
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37. Comparative Outcomes of Supera Interwoven Nitinol vs Bare Nitinol Stents for the Treatment of Femoropopliteal Disease: Insights From the XLPAD Registry

Author: Subhash Banerjee, Haekyung Jeon-Slaughter, Nicolas W. Shammas, Ravi S. Kahlon, Ehrin J. Armstrong, and Khusrow Niazi
Subjects: Male, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Prosthesis Design, Balloon, Lower risk, Risk Assessment, Peripheral Arterial Disease, Risk Factors, medicine.artery, Angioplasty, Alloys, medicine, Humans, Popliteal Artery, Radiology, Nuclear Medicine and imaging, Registries, Propensity Score, Vascular Patency, Aged, Retrospective Studies, business.industry, Endovascular Procedures, Stent, Retrospective cohort study, Middle Aged, medicine.disease, Popliteal artery, Surgery, Femoral Artery, Stenosis, Treatment Outcome, Propensity score matching, Female, Stents, Cardiology and Cardiovascular Medicine, business
Abstract: Purpose: To report a propensity score analysis comparing outcomes of the Supera interwoven nitinol stent to bare nitinol stents (BNS) in the femoropopliteal segment. Materials and Methods: A retrospective study was conducted utilizing data extracted from the Excellence in Peripheral Artery Disease (XLPAD) registry ( ClinicalTrials.gov identifier NCT01904851) on 871 patients (mean age 65.1 years; 713 men) who underwent femoropopliteal balloon angioplasty with either Supera stent implantation in 118 limbs or other contemporary BNS in 753 limbs between January 2006 and December 2016. All patients in both groups were matched for baseline demographic and clinical characteristics in a 1:1 propensity score matching using the nearest neighbor method to create the 118-patient matched BNS cohort. One-year outcomes included all-cause mortality, target vessel revascularization (TVR), and target limb revascularization (TLR). An additional core laboratory analysis was conducted to measure the deployed length of Supera stents. Results: In unmatched data, the Supera stent group had a numerically lower rate of TVR (7.6% vs 13.4%, p=0.08) and a significantly lower 1-year TLR rate (7.6% vs 16.2%, p=0.02) compared to the BNS group. Both groups had similar 1-year mortality (2.5% vs 2.7%, p=0.9). Kaplan-Meier analysis demonstrated that the Supera group had a significantly lower risk of TVR (p=0.02) and TLR (p=0.002) than the BNS group. After propensity matching, the 1-year TVR estimate was lower for Supera stents (7.6% vs 12.7%, p=0.08) and significantly lower for TLR (7.6% vs 13.6%, p=0.04) than the BNS group. There was no statistically significant association between Supera stent elongation (>10% of the labeled stent length) and 1-year risk of TLR (p=0.6). Conclusion: Supera stent usage in femoropopliteal intervention was associated with reduced risk of 1-year repeat target limb revascularization compared with BNS treatment in both unmatched and matched cohorts.
Published: 2019
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38. Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention

Author: Joel E. Schneider, Akiko Maehara, Habib Samady, Mitsuaki Matsumura, Manesh R. Patel, Justin E. Davies, Arnold H. Seto, Gregg W. Stone, Allen Jeremias, Ziad A. Ali, Koen M. Marques, Kare Tang, Luis Gruberg, Gary S. Mintz, Andrew Sharp, Nicolas W. Shammas, and Suneel Talwar
Subjects: medicine.medical_specialty, education.field_of_study, business.industry, medicine.medical_treatment, Population, Ischemia, Stent, Percutaneous coronary intervention, Fractional flow reserve, 030204 cardiovascular system & hematology, medicine.disease, Angina, Coronary artery disease, 03 medical and health sciences, surgical procedures, operative, 0302 clinical medicine, Internal medicine, Conventional PCI, Cardiology, Medicine, cardiovascular diseases, 030212 general & internal medicine, Cardiology and Cardiovascular Medicine, business, education
Abstract: Objectives This study sought to evaluate the incidence and causes of an abnormal instantaneous wave-free ratio (iFR) after angiographically successful percutaneous coronary intervention (PCI). Background Impaired coronary physiology as assessed by fractional flow reserve is present in some patients after PCI and is prognostically relevant. Methods DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) was a multicenter, prospective, observational study in which a blinded iFR pull back was performed after angiographically successful PCI in 562 vessels in 500 patients. Inclusion criteria were angina with either multivessel or multilesion coronary artery disease with an abnormal baseline iFR. The primary endpoint of the study was the rate of residual ischemia after operator-assessed angiographically successful PCI, defined as an iFR Results An average of 1.1 vessels per patient had abnormal baseline iFRs, with a mean value of 0.69 ± 0.22, which improved to 0.93 ± 0.07 post-PCI. Residual ischemia after angiographically successful PCI was present in 112 patients (24.0%), with a mean iFR in that population of 0.84 ± 0.06 (range 0.60 to 0.89). Among patients with impaired post-PCI iFRs, 81.6% had untreated focal stenoses that were angiographically inapparent, and 18.4% had diffuse disease. Among the focal lesions, 38.4% were located within the stent segment, while 31.5% were proximal and 30.1% were distal to the stent. Post-PCI vessel angiographic diameter stenosis was not a predictor of impaired post-procedural iFR. Conclusions Blinded post-PCI physiological assessment detected residual ischemia in nearly 1 in 4 patients after coronary stenting despite an operator-determined angiographically successful result. Most cases of residual ischemia were due to inapparent focal lesions potentially amenable to treatment with additional PCI. (Physiologic Assessment of Coronary Stenosis Following PCI [DEFINE PCI]; NCT03084367)
Published: 2019
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39. Novel laser‐based catheter for peripheral atherectomy: 6‐month results from the Eximo Medical B‐Laser™ IDE study

Author: Ian Cawich, Gino Sedillo, Arthur Lee, Nicolas W. Shammas, Luis Mariano Palena, John H. Rundback, Chris Metzger, Antonio Micari, Pradeep Chandra, Marianne Brodmann, and Barry S. Weinstock
Subjects: Male, Atherectomy, Time Factors, medicine.medical_treatment, Laser, Lasers, Solid-State, 030204 cardiovascular system & hematology, Lasers Solid-State, Peripheral Arterial Disease, 03 medical and health sciences, Clinical trials, 0302 clinical medicine, 80 and over, Humans, Medicine, Radiology, Nuclear Medicine and imaging, Prospective Studies, 030212 general & internal medicine, Vascular Patency, Target lesion revascularization, Aged, Aged, 80 and over, Peripheral artery disease, business.industry, Ultrasound, Peripheral atherectomy, General Medicine, Middle Aged, medicine.disease, United States, Peripheral, Europe, Catheter, Stenosis, Treatment Outcome, Atheroma, Female, Laser Therapy, Cardiology and Cardiovascular Medicine, business, Nuclear medicine, Clinical trials, Laser, Peripheral artery disease, Peripheral atherectomy, Aged, Aged, 80 and over, Atherectomy, Europe, Female, Humans, Laser Therapy, Lasers Solid-State, Male, Middle Aged, Peripheral Arterial Disease, Prospective Studies, Time Factors, Treatment Outcome, United States, Vascular Patency, Calcification
Abstract: BACKGROUND The B-Laser™ atherectomy system (Eximo Medical, Israel) is a 355 nm solid-state Nd:YAG short pulse laser for de-novo and restenotic infrainguinal PAD with enhanced affinity for atheroma and calcified plaque. METHODS The study was a prospective, single-arm, multi-center, international, open-label study assessing the B-Laser™ in symptomatic (Rutherford 2 to 4) infrainguinal peripheral artery disease. Primary core lab efficacy was mean reduction in diameter stenosis >20% by the B-Laser™ catheter alone. Cardiovascular death, major amputation, target lesion revascularization, WIQ, ABI and Rutherford class were obtained at baseline and out to 6 months. Duplex ultrasound patency (PSVR
Published: 2019
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40. The role of precise imaging with intravascular ultrasound in coronary and peripheral interventions

Author: Nicolas W, Shammas, Qais, Radaideh, W John, Shammas, Ghassan E, Daher, Rayan Jo, Rachwan, and Yazan, Radaideh
Subjects: Endovascular Procedures, Review, equipment and supplies, peripheral artery disease, Severity of Illness Index, plaque morphology, intravascular ultrasound, Peripheral Arterial Disease, Treatment Outcome, surgical procedures, operative, Predictive Value of Tests, Risk Factors, thrombus, stent apposition, cardiovascular system, Humans, Stents, cardiovascular diseases, vessel size, dissections, Ultrasonography, Interventional, coronary artery disease
Abstract: Angiography remains a widely utilized imaging modality during vascular procedures. Angiography, however, has its limitations by underestimating the true vessel size, plaque morphology, presence of calcium and thrombus, plaque vulnerability, true lesion length, stent expansion and apposition, residual narrowing post intervention and the presence or absence of dissections. Intravascular ultrasound (IVUS) has emerged as an important adjunctive modality to angiography. IVUS offers precise imaging of the vessel size, plaque morphology and the presence of dissections and guides interventional procedures including stent sizing, assessing residual narrowing and stent apposition and expansion. IVUS-guided treatment has shown to yield superior outcomes when compared to angiography-only guided therapy. The cost-effectiveness of the routine use of IVUS during vascular procedures needs to be further studied.
Published: 2019

41. The role of precise imaging with intravascular ultrasound in coronary and peripheral interventions

Author: Yazan Radaideh, Rayan Jo Rachwan, W John Shammas, Qais Radaideh, Nicolas W. Shammas, and Ghassan Daher
Subjects: medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, 030204 cardiovascular system & hematology, Post-intervention, 03 medical and health sciences, 0302 clinical medicine, Intravascular ultrasound, Medicine, Pharmacology (medical), Plaque morphology, cardiovascular diseases, 030212 general & internal medicine, Thrombus, medicine.diagnostic_test, business.industry, Public Health, Environmental and Occupational Health, Stent, Hematology, General Medicine, equipment and supplies, medicine.disease, Peripheral, Apposition, surgical procedures, operative, Angiography, cardiovascular system, Radiology, Cardiology and Cardiovascular Medicine, business
Abstract: Angiography remains a widely utilized imaging modality during vascular procedures. Angiography, however, has its limitations by underestimating the true vessel size, plaque morphology, presence of calcium and thrombus, plaque vulnerability, true lesion length, stent expansion and apposition, residual narrowing post intervention and the presence or absence of dissections. Intravascular ultrasound (IVUS) has emerged as an important adjunctive modality to angiography. IVUS offers precise imaging of the vessel size, plaque morphology and the presence of dissections and guides interventional procedures including stent sizing, assessing residual narrowing and stent apposition and expansion. IVUS-guided treatment has shown to yield superior outcomes when compared to angiography-only guided therapy. The cost-effectiveness of the routine use of IVUS during vascular procedures needs to be further studied.
Published: 2019
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42. Iatrogenic Intramural Hematoma Identified by Intravascular Ultrasound Following Selective Angiography of the Left Internal Mammary Artery

Author: Rusina Karia and Nicolas W. Shammas
Subjects: IVUS, intravascular ultrasound, medicine.medical_specialty, LIMA, left Internal mammary artery, medicine.medical_treatment, education, Case Report, left internal mammary artery, Clinical Case Series, SVG, saphenous vein graft, intravascular ultrasound, Hematoma, Intramural hematoma, Intravascular ultrasound, parasitic diseases, medicine, Diseases of the circulatory (Cardiovascular) system, intramural hematoma, Selective angiography, Left internal mammary artery, medicine.diagnostic_test, business.industry, iatrogenic, Stent, medicine.disease, surgical procedures, operative, LAD, left anterior descending artery, RC666-701, Angiography, stent, Radiology, Cardiology and Cardiovascular Medicine, business, Intravascular imaging
Abstract: The left internal mammary artery (LIMA) bypass grafts to the left anterior descending artery (LAD) are superior to saphenous venous grafts because of…, This case reports on iatrogenic intramural hematoma of the left internal mammary artery (LIMA) identified on intravascular ultrasound. This case illustrates the importance of intravascular imaging to identify the presence and extent of an intraluminal hematoma that is not visualized on angiography and that was the cause of ischemic symptoms following LIMA injection. (Level of Difficulty: Advanced.), Graphical abstract
Published: 2019

43. Iliac vein compression: epidemiology, diagnosis and treatment

Author: Neel M Patel, Qais Radaideh, and Nicolas W. Shammas
Subjects: medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Population, Venography, 030204 cardiovascular system & hematology, Magnetic resonance angiography, 03 medical and health sciences, 0302 clinical medicine, Epidemiology, Intravascular ultrasound, medicine, Pharmacology (medical), cardiovascular diseases, 030212 general & internal medicine, education, Computed tomography angiography, education.field_of_study, medicine.diagnostic_test, business.industry, Public Health, Environmental and Occupational Health, Stent, Hematology, General Medicine, Regimen, Radiology, Cardiology and Cardiovascular Medicine, business
Abstract: Iliac vein compression (LIVC) is a prevalent finding in the general population, but a smaller number of patients are symptomatic. ILVC should be considered in symptomatic patients with unexplained unilateral lower leg swelling. Patients typically complain of one or more of the following symptoms: lower leg pain, heaviness, venous claudication, swelling, hyperpigmentation and ulceration. ILVC can be thrombotic, combined with acute or chronic DVT, or non-thrombotic. ILVC is best diagnosed with intravascular ultrasound (IVUS), but computed tomography angiography (CTA) and magnetic resonance angiography (MRA) have emerged as valid screening tests. Venography underestimates the severity of ILVC but may provide insights into the anatomy and the presence of collaterals. Based on current available evidence, endovascular therapy with stenting remains the main treatment strategy for ILVC. Dedicated nitinol venous stents are currently under review by the Food and Drug Administration for potential approval in the United States. These stents have been released outside the US. There is no consensus to the optimal anticoagulation regimen post-ILVC stenting. Oral anticoagulants, however, remain a preferred therapy in patients with history of thrombotic ILVC.
Published: 2019
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44. Single-Center Study Evaluating Long-Term Major Adverse Outcomes With the Use of the Lutonix Drug-Coated Balloon in Treating Infrainguinal Arterial Disease

Author: Nicolas W. Shammas, Gail A. Shammas, Elizabeth Sharis, and Susan Jones-Miller
Subjects: General Medicine, Cardiology and Cardiovascular Medicine
Published: 2022
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45. Medical and Revascularization Management of Stable Ischemic Heart Disease: An Overview

Author: Ghassan Daher, Rayan Jo Rachwan, Nicolas W. Shammas, and Qais Radaideh
Subjects: medicine.medical_specialty, medicine.diagnostic_test, business.industry, medicine.medical_treatment, Ischemia, Percutaneous coronary intervention, Disease, 030204 cardiovascular system & hematology, medicine.disease, Revascularization, Review article, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Intravascular ultrasound, medicine, Cardiology, 030212 general & internal medicine, Risk factor, Cardiology and Cardiovascular Medicine, Ischemic heart, business
Abstract: Stable ischemic heart disease (SIHD) affects approximately 10 million Americans with 500,000 new cases diagnosed each year. Patients with SIHD are primarily managed in the outpatient setting with aggressive cardiovascular risk factor modification via medical therapy and lifestyle changes. Currently, this approach is considered as the mainstay of treatment. The recently published ISCHEMIA trial has established the noninferiority of medical therapy in comparison to coronary revascularization in patients with moderate to severe ischemia. Percutaneous coronary intervention is currently recommended for patients with significant left main disease, large ischemic myocardial burden, and patients with severe refractory angina despite maximal medical therapy.
Published: 2021

46. Peripheral Arterial Vessel Prepping With Intravascular Ultrasound and Atherectomy: An Interventionalist's Perspective

Author: Nicolas W, Shammas
Subjects: Atherectomy, Coronary, Peripheral Arterial Disease, Atherectomy, Treatment Outcome, Humans, Stents, Ultrasonography, Interventional, Ultrasonography
Abstract: Vessel prepping is an essential component of an optimal strategy in treating infrainguinal peripheral arterial disease. Vessel prepping with atherectomy can be aggressive in certain lesion morphologies, such as severe calcium, total occlusion, or in-stent restenosis, or can target vessel compliance without aggressive debulking. Drug elution is likely to be enhanced by vessel prepping. Optimal vessel prepping requires precise imaging of the vessel size, plaque morphology, and lesion severity/length which cannot be assessed adequately by angiography. Also, intravascular ultrasound provides information post treatment on minimal luminal area gain, residual dissections, geometric miss, and stent apposition and expansion.
Published: 2021

47. Predicting Significant Iliac Vein Compression Using a Probability Scoring System Derived From Minimal Luminal Area on Computed Tomography Angiography in Patients 65 Years of Age or Younger

Author: Nicolas W, Shammas, Sue, Jones-Miller, Torin, Kovach, Qais, Radaideh, Neel, Patel, Gail A, Shammas, Andrew N, Shammas, Srikanth R, Kasula, Rafat, Padaria, Istvan Z, Kovach, and W John, Shammas
Subjects: Adult, Computed Tomography Angiography, Predictive Value of Tests, Humans, Prospective Studies, Iliac Vein, Middle Aged, Coronary Angiography, Ultrasonography, Interventional, Probability, Retrospective Studies
Abstract: The presence of 50% or more stenosis on intravascular ultrasound (IVUS) is considered diagnostic of iliac vein compression (ILVC) by most operators. We have previously developed a scoring system combining minimal luminal area (MLA) at the compression site and age to predict ILVC as seen on IVUS. We present a revised and improved scoring system following an additional number of patients and limited to patients 65 years of age and younger.Patients were included from retrospective (n = 52) and prospective (n = 18) registries of consecutive patients who underwent computed tomography angiography (CTA) of the pelvis with venous filling and IVUS within a few weeks apart to evaluate for symptomatic ILVC at a single cardiovascular practice. Quantitative vascular analysis was performed on all images obtained. MLA and age were used to calculate a score derived from a previously published logistic regression formula. Patients65 years in age were excluded. The predicted findings from the score were compared with the actual presence of compression on IVUS. The revised scoring system is based on a score ofor ≥ 0.533824 and MLA (mm²) of140, ≥140 to200, and ≥200. The negative predictive value (NPV) and positive predictive value (NPV and PPV) of each cut-off in predicting ILVC on IVUS were calculated.A total of 70 symptomatic patients were included (mean age, 52.6 ± 12.3 years). The model offered the following: accuracy = 54/70 (77.1%); sensitivity = 51/52 (98.1%); specificity = 3/18 (16.7%); PPV = 51/66 (77.3%); and NPV = 3/4 (75.0%).A scoring system using MLA on CTA and age provides a fairly accurate diagnostic test to predict the presence of significant ILVC as seen on IVUS.
Published: 2021

48. Age Differences in Long Term Outcomes of Coronary Patients Treated with Drug Eluting Stents at a Tertiary Medical Center

Author: Nicolas W. Shammas, Gail A. Shammas, Peter Sharis, and Michael Jerin
Subjects: Geriatrics, RC952-954.6
Abstract: We evaluate differences in outcomes in younger (
Published: 2013
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49. Abstract 15071: Effect of Percutaneous Coronary Intervention on Death and Myocardial Infarction in Patients Withstable Coronary Artery Disease and Inducible Ischemia

Author: William E. Boden, Nicolas W. Shammas, Qais Radaideh, Babikir Kheiri, Mohammed Osman, Ghassan Bachuwa, Mahmoud Barbarawi, Ahmad Al-Abdouh, and Jacqueline E. Tamis-Holland
Subjects: medicine.medical_specialty, Interventional cardiology, business.industry, medicine.medical_treatment, Percutaneous coronary intervention, medicine.disease, Coronary artery disease, Survival benefit, Physiology (medical), Internal medicine, Conventional PCI, Cardiology, Medicine, Inducible ischemia, In patient, cardiovascular diseases, Myocardial infarction, Cardiology and Cardiovascular Medicine, business
Abstract: Introduction: There has been a continuous debate about the survival benefit of percutaneous coronary intervention (PCI) for the management of patients with stable coronary artery disease (CAD) and moderate to severe ischemia. To address this, we performed a meta-analysis of RCTs comparing PCI plus MT vs. MT alone in stable CAD patients to evaluate endpoints of all-cause mortality, cardiovascular (CV) mortality, and MI in a larger cohort of patients with objective evidence of myocardial ischemia. Methods: An electronic database search was conducted for RCTs that compared PCI on top of MT versus MT alone. A random effects model was used to calculate relative risk (RR) and 95% confidence intervals (CIs). Results: A total of 7 RCTs with 10,043 patients with a mean age of 62.54 ± 1.56 years and a median follow up of 3.9 years were identified. Among patients with (CAD) and moderate to severe ischemia by stress testing, PCI didn’t show any benefit for the primary outcome of all-cause mortality compared to MT(RR = 0.85; 95% CI 0.646-1.12; p= 0.639). There was also no benefit in cardiovascular (CV) death (RR = 0.88 ; 95% CI 0.71-1.09; p =0.18) or myocardial infarction (MI) (RR = 0.271 ; 95% CI 0.782-1.087; P =0.327) in the PCI group as compared to MT. Conclusions: Among patients with (CAD) and evidence of moderate to severe ischemia by stress testing, PCI on top of MT appears to add no mortality benefit as compared to with MT alone.
Published: 2020
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50. Worsening Back and Lower Leg Pain Post Stenting of the Common Iliac Vein: Is There Evidence it is Related to Stent Size?

Author: Nicolas W, Shammas
Subjects: Leg, Treatment Outcome, Humans, Pain, Stents, Iliac Vein, Vascular Patency, Retrospective Studies
Abstract: Sizing of iliac vein stents remains controversial. We present the first Venovo venous stent (BD/Bard) that was explanted because of worsening of back and leg pain post treatment and analyze data from the first 50 consecutive Venovo venous stents from our center. Stent size was obtained with intravascular ultrasound of the ipsilateral common iliac vein. The data indicate that there is no statistical relationship between the stent size and worsening or emergence of low back and leg pain. Patient-specific factors may be contributing to this extremely rare and persistent pain beyond the 30-day follow-up.
Published: 2020

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