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1. Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation

Author

Michael A. Borger, Alan J Moskowitz, Friedhelm Beyersdorf, Steven F. Bolling, Lenard Conradi, Michael E Bowdish, Judy Hung, Pierre Voisine, Jessica Overbey, Eric A. Rose, John C. Mullen, Samantha Raymond, Annetine C. Gelijns, Neal Jeffries, Mariell Jessup, Karen O'Sullivan, Marissa A. Miller, James S. Gammie, Alexander Iribarne, Mary E. Marks, Arnar Geirsson, Michael J Mack, Ctsn Investigators, Babatunde Yerokun, Ellen Moquete, Emilia Bagiella, Richard D. Weisel, Marc Gillinov, Volkmar Falk, Markus Krane, Gorav Ailawadi, Patrick T. O'Gara, Michael W A Chu, Michael K. Parides, and Wendy C. Taddei-Peters

Subjects
Male, Reoperation, medicine.medical_specialty, Pacemaker, Artificial, macromolecular substances, Cardiac Valve Annuloplasty, Postoperative Complications, Internal medicine, medicine, Humans, In patient, cardiovascular diseases, Aged, Mitral regurgitation, business.industry, Mitral Valve Insufficiency, General Medicine, Survival Analysis, Tricuspid Valve Insufficiency, Intention to Treat Analysis, Concomitant, Regurgitation (digestion), cardiovascular system, Cardiology, Disease Progression, Quality of Life, Mitral Valve, Female, Tricuspid Valve, medicine.symptom, business, Dilatation, Pathologic, Follow-Up Studies
Abstract

Tricuspid regurgitation is common in patients with severe degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform tricuspid-valve repair during mitral-valve surgery in patients who have moderate tricuspid regurgitation or less-than-moderate regurgitation with annular dilatation.We randomly assigned 401 patients who were undergoing mitral-valve surgery for degenerative mitral regurgitation to receive a procedure with or without tricuspid annuloplasty (TA). The primary 2-year end point was a composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation by two grades from baseline or the presence of severe tricuspid regurgitation, or death.Patients who underwent mitral-valve surgery plus TA had fewer primary-end-point events than those who underwent mitral-valve surgery alone (3.9% vs. 10.2%) (relative risk, 0.37; 95% confidence interval [CI], 0.16 to 0.86; P = 0.02). Two-year mortality was 3.2% in the surgery-plus-TA group and 4.5% in the surgery-alone group (relative risk, 0.69; 95% CI, 0.25 to 1.88). The 2-year prevalence of progression of tricuspid regurgitation was lower in the surgery-plus-TA group than in the surgery-alone group (0.6% vs. 6.1%; relative risk, 0.09; 95% CI, 0.01 to 0.69). The frequencies of major adverse cardiac and cerebrovascular events, functional status, and quality of life were similar in the two groups at 2 years, although the incidence of permanent pacemaker implantation was higher in the surgery-plus-TA group than in the surgery-alone group (14.1% vs. 2.5%; rate ratio, 5.75; 95% CI, 2.27 to 14.60).Among patients undergoing mitral-valve surgery, those who also received TA had a lower incidence of a primary-end-point event than those who underwent mitral-valve surgery alone at 2 years, a reduction that was driven by less frequent progression to severe tricuspid regurgitation. Tricuspid repair resulted in more frequent permanent pacemaker implantation. Whether reduced progression of tricuspid regurgitation results in long-term clinical benefit can be determined only with longer follow-up. (Funded by the National Heart, Lung, and Blood Institute and the German Center for Cardiovascular Research; ClinicalTrials.gov number, NCT02675244.).

Published
2023

2. Progression of Tricuspid Regurgitation After Surgery for Ischemic Mitral Regurgitation

Author

Philippe B. Bertrand, Jessica R. Overbey, Xin Zeng, Robert A. Levine, Gorav Ailawadi, Michael A. Acker, Peter K. Smith, Vinod H. Thourani, Emilia Bagiella, Marissa A. Miller, Lopa Gupta, Michael J. Mack, A. Marc Gillinov, Gennaro Giustino, Alan J. Moskowitz, Annetine C. Gelijns, Michael E. Bowdish, Patrick T. O’Gara, James S. Gammie, Judy Hung, Wendy C. Taddei-Peters, Dennis Buxton, Ron Caulder, Nancy L. Geller, David Gordon, Neal O. Jeffries, Albert Lee, Claudia S. Moy, Ilana Kogan Gombos, Jennifer Ralph, Richard D. Weisel, Timothy J. Gardner, Eric A. Rose, Michael K. Parides, Deborah D. Ascheim, Ellen Moquete, Helena Chang, Melissa Chase, James Foo, Yingchun Chen, Seth Goldfarb, Katherine Kirkwood, Edlira Dobrev, Ron Levitan, Karen O’Sullivan, Jessica Overbey, Milerva Santos, Deborah Williams, Michael Weglinski, Paula Williams, Carrie Wood, Xia Ye, Sten Lyager Nielsen, Henrik Wiggers, Henning Malgaard, Michael Mack, Tracine Adame, Natalie Settele, Jenny Adams, William Ryan, Robert L. Smith, Paul Grayburn, Frederick Y. Chen, Anju Nohria, Lawrence Cohn, Prem Shekar, Sary Aranki, Gregory Couper, Michael Davidson, R. Morton Bolman, Anne Burgess, Debra Conboy, Rita Lawrence, Nicolas Noiseux, Louis-Mathieu Stevens, Ignacio Prieto, Fadi Basile, Joannie Dionne, Julie Fecteau, Eugene H. Blackstone, Pamela Lackner, Leoma Berroteran, Diana Dolney, Suzanne Fleming, Roberta Palumbo, Christine Whitman, Kathy Sankovic, Denise Kosty Sweeney, Carrie Geither, Kristen Doud, Gregory Pattakos, Pamela A. Clarke, Michael Argenziano, Mathew Williams, Lyn Goldsmith, Craig R. Smith, Yoshifumi Naka, Allan Stewart, Allan Schwartz, Daniel Bell, Danielle Van Patten, Sowmya Sreekanth, John H. Alexander, Carmelo A. Milano, Donald D. Glower, Joseph P. Mathew, J. Kevin Harrison, Stacey Welsh, Mark F. Berry, Cyrus J. Parsa, Betty C. Tong, Judson B. Williams, T. Bruce Ferguson, Alan P. Kypson, Evelio Rodriguez, Malissa Harris, Brenda Akers, Allison O'Neal, John D. Puskas, Robert Guyton, Jefferson Baer, Kim Baio, Alexis A. Neill, Pierre Voisine, Mario Senechal, François Dagenais, Kim O’Connor, Gladys Dussault, Tatiana Ballivian, Suzanne Keilani, Alan M. Speir, Patrick Magee, Niv Ad, Sally Keyte, Minh Dang, Mark Slaughter, Marsha Headlee, Heather Moody, Naresh Solankhi, Emma Birks, Mark A. Groh, Leslie E. Shell, Stephanie A. Shepard, Benjamin H. Trichon, Tracy Nanney, Lynne C. Hampton, Ralph Mangusan, Robert E. Michler, David A. D'Alessandro, Joseph J. DeRose, Daniel J. Goldstein, Ricardo Bello, William Jakobleff, Mario Garcia, Cynthia Taub, Daniel Spevak, Roger Swayze, Nadia Sookraj, Louis P. Perrault, Arsène-Joseph Basmadjian, Denis Bouchard, Michel Carrier, Raymond Cartier, Michel Pellerin, Jean François Tanguay, Ismail El-Hamamsy, André Denault, Philippe Demers, Sophie Robichaud Jonathan Lacharité, Keith A. Horvath, Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Margaret Iraola, Ann Greenberg, Chittoor Sai-Sudhakar, Ayseha Hasan, Asia McDavid, Bradley Kinn, Pierre Pagé, Carole Sirois, David Latter, Howard Leong-Poi, Daniel Bonneau, Lee Errett, Mark D. Peterson, Subodh Verma, Randi Feder-Elituv, Gideon Cohen, Campbell Joyner, Stephen E. Fremes, Fuad Moussa, George Christakis, Reena Karkhanis, Terry Yau, Michael Farkouh, Anna Woo, Robert James Cusimano, Tirone David, Christopher Feindel, Lisa Garrard, Suzanne Fredericks, Amelia Mociornita, John C. Mullen, Jonathan Choy, Steven Meyer, Emily Kuurstra, Cindi A. Young, Dana Beach, Robert Villanueva, Pavan Atluri, Y. Joseph Woo, Mary Lou Mayer, Michael Bowdish, Vaughn A. Starnes, David Shavalle, Ray Matthews, Shadi Javadifar, Linda Romar, Irving L. Kron, Karen Johnston, John M. Dent, John Kern, Jessica Keim, Sandra Burks, Kim Gahring, David A. Bull, Patrice Desvigne-Nickens, Dennis O. Dixon, Mark Haigney, Richard Holubkov, Alice Jacobs, Frank Miller, John M. Murkin, John Spertus, Andrew S. Wechsler, Frank Sellke, Cheryl L. McDonald, Robert Byington, Neal Dickert, John S. Ikonomidis, David O. Williams, Clyde W. Yancy, James C. Fang, Nadia Giannetti, Wayne Richenbacher, Vivek Rao, Karen L. Furie, Rachel Miller, Sean Pinney, William C. Roberts, Mary N. Walsh, Niamh Kilcullen, David Hung, Stephen J. Keteyian, Clinton A. Brawner, Heather Aldred, Jeffrey Browndyke, and Yanne Toulgoat-Dubois

Subjects
Male, Pacemaker, Artificial, medicine.medical_specialty, medicine.medical_treatment, Myocardial Ischemia, 030204 cardiovascular system & hematology, Severity of Illness Index, 03 medical and health sciences, 0302 clinical medicine, Recurrence, medicine, Humans, Clinical significance, Prospective Studies, 030212 general & internal medicine, Stroke, Aged, Heart Failure, Mitral valve repair, business.industry, Area under the curve, Mitral Valve Insufficiency, Atrial fibrillation, medicine.disease, Tricuspid Valve Insufficiency, Defibrillators, Implantable, Surgery, Hospitalization, Echocardiography, Heart failure, Disease Progression, Female, Tricuspid Valve, Tricuspid Valve Regurgitation, Cardiology and Cardiovascular Medicine, Mitral valve regurgitation, business, Follow-Up Studies
Abstract

Whether to repair nonsevere tricuspid regurgitation (TR) during surgery for ischemic mitral valve regurgitation (IMR) remains uncertain.The goal of this study was to investigate the incidence, predictors, and clinical significance of TR progression and presence of ≥moderate TR after IMR surgery.Patients (n = 492) with untreated nonsevere TR within 2 prospectively randomized IMR trials were included. Key outcomes were TR progression (either progression by ≥2 grades, surgery for TR, or severe TR at 2 years) and presence of ≥moderate TR at 2 years.Patients' mean age was 66 ± 10 years (67% male), and TR distribution was 60% ≤trace, 31% mild, and 9% moderate. Among 2-year survivors, TR progression occurred in 20 (6%) of 325 patients. Baseline tricuspid annular diameter (TAD) was not predictive of TR progression. At 2 years, 37 (11%) of 323 patients had ≥moderate TR. Baseline TR grade, indexed TAD, and surgical ablation for atrial fibrillation were independent predictors of ≥moderate TR. However, TAD alone had poor discrimination (area under the curve, ≤0.65). Presence of ≥moderate TR at 2 years was higher in patients with MR recurrence (20% vs. 9%; p = 0.02) and a permanent pacemaker/defibrillator (19% vs. 9%; p = 0.01). Clinical event rates (composite of ≥1 New York Heart Association functional class increase, heart failure hospitalization, mitral valve surgery, and stroke) were higher in patients with TR progression (55% vs. 23%; p = 0.003) and ≥moderate TR at 2 years (38% vs. 22%; p = 0.04).After IMR surgery, progression of unrepaired nonsevere TR is uncommon. Baseline TAD is not predictive of TR progression and is poorly discriminative of ≥moderate TR at 2 years. TR progression and presence of ≥moderate TR are associated with clinical events. (Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting [CABG] Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation, NCT00806988; Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation, NCT00807040).

Published
2021

3. Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO):a randomised controlled trial

Author

Wesley H. Self, Uriel Sandkovsky, Cavan S. Reilly, David M. Vock, Robert L. Gottlieb, Michael Mack, Kevin Golden, Emma Dishner, Andrew Vekstein, Emily R. Ko, Tatyana Der, John Franzone, Eyad Almasri, Mohamed Fayed, Michael R. Filbin, Kathryn A. Hibbert, Todd W. Rice, Jonathan D. Casey, J. Awori Hayanga, Vinay Badhwar, Bradley G. Leshnower, Milad Sharifpour, Kirk U. Knowlton, Ithan D. Peltan, Elizieta Bakowska, Justyna Kowalska, Michael E. Bowdish, Jeffrey M. Sturek, Angela J. Rogers, D. Clark Files, Jarrod M. Mosier, Michelle N. Gong, David J. Douin, R. Duncan Hite, Barbara W. Trautner, Mamta K. Jain, Edward M. Gardner, Akram Khan, Jens-Ulrik Jensen, Michael A. Matthay, Adit A. Ginde, Samuel M. Brown, Elizabeth S. Higgs, Sarah Pett, Amy C. Weintrob, Christina C. Chang, Daniel D. Murrary, Huldrych F. Günthard, Ellen Moquete, Greg Grandits, Nicole Engen, Birgit Grund, Shweta Sharma, Huyen Cao, Rajesh Gupta, Suzette Osei, David Margolis, Qing Zhu, Mark N. Polizzotto, Abdel G. Babiker, Victoria J. Davey, Virginia Kan, B. Taylor Thompson, Annetine C. Gelijns, James D. Neaton, H. Clifford Lane, Jens D. Jundgren, John Tierney, Kevin Barrett, Betsey R. Herpin, Mary C. Smolskis, Susan E. Voge, Laura A. McNay, Kelly Cahill, Page Crew, Matthew Kirchoff, Ratna Sardana, Sharon Segal Raim, Joseph Chiu, Lisa Hensley, Josua Lorenzo, Rebecca Mock, Katy Shaw-Saliba, Judith Zuckerman, Stacey J. Adam, Judy Currier, Sarah Read, Eric Hughes, Laura Amos, Amy Carlsen, Anita Carter, Bionca Davis, Eileen Denning, Alain DuChene, Merrie Harrison, Payton Kaiser, Joseph Koopmeiners, Sue Meger, Thomas Murray, Kien Quan, Siu Fun Quan, Greg Thompson, Jamie Walski, Deborah Wentworth, Alan J. Moskowitz, Emilia Bagiella, Karen O'Sullivan, Mary E. Marks, Evan Accardi, Emily Kinzel, Gabriela Bedoya, Lopa Gupta, Jessica R. Overbey, Maria L. Padillia, Milerva Santos, Marc A. Gillinov, Marissa A. Miller, Wendy C. Taddei-Peters, Kathleen Fenton, Mezgebe Berhe, Clinton Haley, Christopher Bettacchi, Erin Duhaime, Madison Ryan, Sarah Burris, Felecia Jones, Samantha Villa, Samantha Want, Raven Robert, Tanquinisha Coleman, Laura Clariday, Rebecca Baker, Marian Hurutado-Rodriguez, Nazia Iram, Michelle Fresnedo, Allyson Davis, Kiara Leonard, Noelia Ramierez, Jon Thammavong, Krizia Duque, Emma Turner, Tammy Fisher, Dianna Robinson, Desirae Ransom, Erica Lusk, Aaron Killian, Adriana Palacious, Edilia Solis, Janet Jerrow, Matthew Watts, Heather Whitacre, Elizabeth Cothran, Peter K. Smith, Christina E. Barkauskas, Grace R. Dreyer, Marie Witte, Nilima Mosaly, Ahmad Mourad, Thomas L. Holland, Kathleen Lane, Andrew Bouffler, Lauren M. McGowan, Marry Motta, Gregory Tipton, Ben Stallings, Gennifer Stout, Beth McLendon-Arvik, Beth A. Hollister, Dana M. Giangiacomo, Sunil Sharma, Brian Pappers, Paul McCarthy, Troy Krupica, Arif Sarwari, Rebecca Reece, Lisa Fornaresio, Chad Glaze, Raquel Evans, Katarina Preamble, Lisa Giblin Sutton, Sabrina Buterbaugh, Elizabeth Berry Bartolo, Roger Williams, Robin Bunner, William Bender, Jeffrey Miller, Kim T. Baio, Mary K. McBride, Michele Fielding, Sonya Mathewson, Kristina Porte, Missy Maton, Chari Ponder, Elizabeth Haley, Christine Spainhour, Susan Rogers, Derrick Tyler, Noah Wald-Dickler, Douglass Hutcheon, Amytis Towfighi, May M. Lee, Meghan R. Lewis, Brad Spellberg, Linda Sher, Aniket Sharma, Anna P. Olds, Chris Justino, Edward Lozano, Chris Romero, Janet Leong, Valentina Rodina, Tammie Possemato, Jose Escobar, Charlene Chiu, Kevin Weissman, Andrew Barros, Kyle B. Enfield, Alexandra Kadl, China J. Green, Rachel M. Simon, Ashley Fox, Kara Thornton, Patrick E. Parrino, Stephen Spindel, Aditya Bansal, Katherine Baumgarten, Jonathan Hand, Derek Vonderhaar, Bobby Nossaman, Sylvia Laudun, DeAnna Ames, Shane Broussard, Nilmo Hernandez, Geralyn Isaac, Huan Dinh, Yiling Zheng, Sonny Tran, Hunter McDaniel, Nicolle Crovetto, Leslie Miller, Beth Schelle, Sherry McLean, Howard R. Rothbaum, Michael S. Alvarez, Shivam P. Kalan, Heather H. Germann, Jennifer Hendershot, Karen Maroney, Karen Herring, Sharri Cook, Pam Paul, Ronson J. Madathil, Joseph Rabin, Andrea Levine, Kapil Saharia, Ali Tabatabai, Christine Lau, James S. Gammie, Maya-Loren Peguero, Kimberley McKernan, Matthew Audette, Emily Fleischmann, Freshta Akbari, Maia Lee, Myounghee Lee, Andrew Chi, Hanna Salehi, Alan Pariser, Phuong Tran Nguyen, Jessica Moore, Adrienne Gee, Shelika Vincent, Richard A. Zuckerman, Alexander Iribarne, Sara Metzler, Samantha Shipman, Taylor Caccia, Haley Johnson, Crystallee Newton, Doug Parr, Vicente Rodriguez, Gordon Bokhart, Sharon M. Eichman, Crystal North, Cathryn Oldmixon, Nancy Ringwood, Laura Fitzgerald, Haley D. Morin, Ariela Muzikansky, Richard Morse, Roy G. Brower, Lora A. Reineck, Neil R. Aggarwal, Karen Bienstock, Peter Hou, Jay Steingrub, Mark A. Tidswell, Lori-Ann Kozikowski, Cynthia Kardos, Leslie DeSouza, Sherell Thornton-Thompson, Daniel Talmor, Nathan Shapiro, Valerie Banner-Goodspeed, Katherine L. Boyle, Sharon Hayes, Alan E. Jones, James Galbraith, Utsav Nandi, Rebekah K. Peacock, Blair Alden Parry, Justin D. Margolin, Kelsey Brait, Caroline Beakes, Kirsten N. Kangelaris, Kimberly J. Yee, Kimia Ashktorab, Alejandra E. Jauregui, Hanjing Zhuo, Gregory Hendey, Kinsley A. Hubel, Alyssa R. Hughes, Rebekah L. Garcia, Jennifer G. Wilson, Rosemary Vojnik, Jonasel Roque, Cynthia Perez, George W. Lim, Steven Y. Chang, Rebecca Beutler, Trisha Agarwal, Julia Vargas, Marc Moss, Amiran Baduashvili, Lakshmi Chauhan, Lani L. Finck, Michelle Howell, Robert C. Hyzy, Pauline K. Park, Kristine Nelson, Jake I. McSparron, Ivan N. Co, Bonnie R. Wang, Shijing Jia, Barbara Sullins, Sinan Hanna, Norman Olbrich, Lynne D. Richardson, Rahul Nair, Obiageli Offor, Brenda Lopez, Omowunmi Amosu, Hiwet Tzehaie, Thomas E. Terndrup, Herbert P. Wiedemann, Abhijit Duggal, Nirosshan Thiruchelvam, Kiran Ashok, Alexander H. King, Omar Mehkri, Kristin Hudock, Simra Kiran, Harshada More, Tammy Roads, Jamie Martinkovic, Sarah Kennedy, Bryce H. Robinson, Catherine L. Hough, Olivia F. Krol, Mistry Kinjal, Emmanuel Mills, Madeline McDougal, Rupali Deshmukh, Peter Chen, Sam S. Torbati, Yuri Matusov, June Choe, Niree A. Hindoyan, Susan E. Jackman, Emad Bayoumi, Timothy Wynter, Antonina Caudill, Ethan Pascual, Gregg J. Clapham, Lisa Herrera, Cristabelle Ojukwu, Shaunt Mehdikhani, D. Shane O'Mahony, Sonam T. Nyatsatsang, David M. Wilson, Julie A. Wallick, Chadwick Miller, Keven W. Gibbs, Lori S. Flores, Mary E. LaRose, Leigha D. Landreth, Peter E. Morris, Jamie L. Sturgill, Evan P. Cassity, Sanjay Dhar, Ashley A. Montgomery-Yates, Sara N. Pasha, Kirby P. Mayer, Brittany Bissel, Joseph Bledsoe, Samuel Brown, Michael Lanspa, Lindsey Leither, Brent P. Armbruster, Quinn Montgomery, Darrin Applegate, Naresh Kumar, Melissa Fergus, Erna Serezlic, Karah Imel, Ghazal Palmer, Brandon Webb, Valerie T. Aston, Jakea Johnson, Christopher Gray, Margaret Hays, Megan Roth, Adriana Sánchez, Laura Popielski, Heather Rivasplata, Melissa Turner, Michael Vjecha, Tianna Petersen, Dena Kamel, Laura Hansen, Claudia Sanchez Lucas, Natalie DellaValle, Sonia Gonzales, James Scott, David Wyles, Ivor Douglas, Jason Haukoos, Kevin Kamis, Caitlin Robinson, Jason V. Baker, Anne Frosch, Rachael Goldsmith, Hodan Jibrell, Melanie Lo, Jonathan Klaphake, Shari Mackedanz, Linh Ngo, Kelly Garcia-Myers, Norman Markowitz, Erika Pastor, Mayur Ramesh, Indira Brar, Emanuel Rivers, Princy Kumar, Maximiliano Menna, Kousick Biswas, Cristin Harrington, Alex Delp, Lavannya Pandit, Casey Hines-Munson, John Van, Laura Dillon, Yiqun Want, Paola Lichtenberger, Gio Baracco, Carol Ramos, Lauren Bjork, Melyssa Sueiro, Phyllis Tien, Heather Freasier, Theresa Buck, Hafida Nekach, Stephanie Nagy-Agren, Shikha Vasudeva, Tracy Ochalek, Brentin Roller, Chinh Nguyen, Amani Mikail, Dorthe Raben, Tomas O. Jensen, Bitten Aagaard, Charlotte B. Nielsen, Katharina Krapp, Bente Rosdahl Nykjær, Katja Lisa Kanne, Anne Louise Grevsen, Zillah Maria Joensen, Tina Bruun, Ane Bojesen, Frederik Woldbye, Nick E. Normand, Frederik V.L. Esmann, Clara Lundetoft Clausen, Nichlas Hovmand, Karen Brorup Pedersen, Louise Thorlacius-Ussing, Michaela Tinggaard, Dorthe S. Høgsberg, Ema Rastoder, Thobias Kamstrup, Christina Marisa Bergsøe, Lars Østergaard, Nina Breinholt Stærke, Isik S. Johansen, Fredrikke C. Knudtzen, Lykke Larsen, Mathias A. Hertz, Thilde Fabricius, Marie Helleberg, Jan Gerstoft, Tomas Østergaard Jensen, Birgitte Lindegaard, Thomas Ingemann Pedersen, Birgit Thorup Røge, Sandra Valborg Løfberg, Thomas Michael Hansen, Ariella Denize Nielsen, Sebastian Leicht von Huth, Henrik Nielsen, Rikke Krog Thisted, Daria Podlekareva, Stine Johnsen, Helle Frost Andreassen, Lars Pedersen, Cecilia Ebba Clara Ellinor Lindnér, Lothar Wiese, Lene Surland Knudsen, Nikolaj Julian Skrøder Nytofte, Signe Ravn Havmøller, Roger Paredes, Maria Exposito, Eduardo Fernández-Cruz, José Muñoz, Jose R. Arribas, Vicente Estrada, Juan P. Horcajada, Joaquin Burgos, Jose Luis Morales-Rull, Dominique L. Braun, Emily West, Khadija M'Rabeth-Bensalah, Mareile L. Eichinger, Manuela Grüttner-Durmaz, Christina Grube, Veronika Zink, Andrzej Horban, Agnieszka Bednarska, Natalia Jurek, Gerd Fätkenheuer, Jakob J. Malinm, Gail Matthews, Anthony Kelleher, Gesalit Cabrera, Catherine Carey, Sally Hough, Sophie Virachit, Amy Zhong, Barnaby E. Young, Po Ying Chia, Tau Hong Lee, Ray J. Lin, David Lye, Sean Ong, Ser Hon Puah, Tsin Wen Yeo, Shiau Hui Diong, Juwinda Ongko, Fleur Hudson, Mahesh KB Parmar, Anna Goodman, Jonathan Badrock, Adam Gregory, Nicola Harris, Giota Touloumi, Nikos Pantaz, Vicky Gioukari, Joseph Lutaakome, Cissy M. Kityo, Henry Mugerwa, Francis Kiweewa, Anu Osinusi, Craig Tipple, Angela Willis, Amanda Peppercorn, Helen Watson, Elizabeth Alexander, Erik Mogalian, Leo Lin, Xiao Ding, Li Yan, Jean-Luc Girardet, Ji Ma, Zhi Hong, Amy Adams, Sara Albert, Abby Balde, Michelle Baracz, Beth Baseler, Nancy Becker, Mona Bielica, Shere Billouin-Frazier, Jennifer Cash, Jay Choudhary, Suzanne Dolney, Mary Dixon, Carolyn Eyler, Leanna Frye, Michael Galcik, Jensen Gertz, Lisa Giebeig, Neelam Gulati, Liz Hankinson, Debbie Hissey, Debi Hogarty, Matt Hohn, H Preston Holley, Lisa Hoopengardner, Lynda Huber, Shirley Jankelevich, Gary Krauss, Eileen Lake, Jessica Linton, Leah MacDonald, Meryan Manandhar, Mary Spinelli-Nadzam, Charles Oluremi, Calvin Proffitt, Erin Rudzinski, Jen Sandrus, Marylu Schaffhauser, Adam Schechner, Connie Suders, Norman P. Gerry, Kenneth Smith, Courtney Solomon, Amanda Kubernac, Marium Rashid, Bhakti Patel, Robert Kubernac, Joseph Murphy, Marie L. Hoover, Craig Brown, Nadine DuChateau, Adam Flosi, Les Johnson, Amy Treagus, and Christine Wenner

Subjects
Adult, Male, Adolescent, SARS-CoV-2, Comment, COVID-19, Antibodies, Monoclonal, Articles, Middle Aged, Antibodies, Monoclonal, Humanized, Antibodies, Neutralizing, COVID-19/drug therapy, COVID-19 Drug Treatment, Hospitalization, Infectious Diseases, Antineoplastic Agents, Immunological, Treatment Outcome, Antibodies, Monoclonal, Humanized/therapeutic use, Double-Blind Method, Humans, Female, Aged
Abstract

BACKGROUND: We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19.METHODS: In this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978.FINDINGS: Between Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50-72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74-1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67-1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74-1·58]; BRII-196 plus BRII-198 1·00 [0·68-1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91-1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88-1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90.INTERPRETATION: Neither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19.FUNDING: US National Institutes of Health and Operation Warp Speed.

Published
2022

4. The impact of perioperative stroke and delirium on outcomes after surgical aortic valve replacement

Author

Steven R. Messé, Jessica R. Overbey, Vinod H. Thourani, Alan J. Moskowitz, Annetine C. Gelijns, Mark A. Groh, Michael J. Mack, Gorav Ailawadi, Karen L. Furie, Andrew M. Southerland, Michael L. James, Claudia Scala Moy, Lopa Gupta, Pierre Voisine, Louis P. Perrault, Michael E. Bowdish, A. Marc Gillinov, Patrick T. O'Gara, Maral Ouzounian, Bryan A. Whitson, John C. Mullen, Marissa A. Miller, James S. Gammie, Stephanie Pan, Guray Erus, Jeffrey N. Browndyke, Wendy C. Taddei-Peters, Neal O. Jeffries, Dennis Buxton, Nancy L. Geller, David Gordon, Catherine Burke, Albert Lee, Tyrone Smith, Claudia S. Moy, Ilana Kogan Gombos, Richard Weisel, Timothy J. Gardner, Eric A. Rose, Michael K. Parides, Deborah D. Ascheim, Emilia Bagiella, Ellen Moquete, Kinjal Shah, Helena Chang, Melissa Chase, Seth Goldfarb, Katherine Kirkwood, Edlira Dobrev, Ron Levitan, Karen O'Sullivan, Milerva Santos, Xia Ye, Michael Mack, Rachelle Winkle, Haley Boswell, Amanda Fenlon, Melissa Johnson, Jessica Jones, Megan Kolb, Sarah Lam, Lucy Miranda, Jackie Ward, Renessa Whitman, Brittany Zingler, William Ryan, Robert L. Smith, Paul Grayburn, Pedro Nosnik, Eugene H. Blackstone, Nader Moazami, Randall C. Starling, Benico Barzilai, Richard A. Grimm, Edward G. Soltesz, Irene Katzan, Brian Strippy, Shoi Smith, Michelle Garcia, Mary Alice bowman, Carrie Geither, Robert Wang, Michael Argenziano, Michael Borger, Hiroo Takayama, Martin B. Leon, Lyn Goldsmith, Allan Schwartz, Nadia Sookraj, Talaya McCright-Gill, Sowmya Sreekanth, Jock N. McCullough, Alexander Iribarne, Joseph P. DeSimone, Anthony W. DiScipio, Henry Stokes, Amanda St. Ivany, Gaylin Petty, Peter K. Smith, John H. Alexander, Carmelo A. Milano, Donald D. Glower, Joel Huber, Joel Morganlander, Joseph P. Mathew, Stacey Welsh, Sarah Casalinova, Victoria Johnson, Kathleen Lane, Derek Smith, Greg Tipton, Mark F. Berry, Judson B. Williams, Brian Englum, Matthew Hartwig, Robert Guyton, Omar Lattouf, Edward Chen, J. David Vega, Jefferson Baer, Duc Nguyen, Michael Halkos, Kim Baio, Tamara Prince, Natascha Cook, Alexis A. Neill, Mario Senechal, François Dagenais, Robert Laforce, Kim O'Connor, Gladys Dussault, Manon Caouette, Hugo Tremblay, Nathalie Gagne, Julie Dumont, Patricia Landry, Benjamin H. Trichon, Oliver A. Binns, Stephen W. Ely, Alan M. Johnson, Todd H. Hansen, John G. Short, Reid D. Taylor, Ralph Mangusan, Tracy Nanney, Holly Aubart, Kristin Cross, Leslie McPeters, Christina Riggsbee, Lucy Rixey, Robert E. Michler, Joseph J. DeRose, Daniel J. Goldstein, Ricardo A. Bello, Cynthia Taub, Daniel Spevack, Kathryn Kirchoff, Rebecca Meli, Juan Garcia, Jon Goldenberg, Lauren Kealy, Denis Bouchard, Jean François Tanguay, Eileen O'Meara, Jonathan Lacharité, Sophie Robichaud, Keith A. Horvath, Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Margaret Iraola, Ann Greenberg, Greg Kumkumian, Mark Milner, Zurab Nadareishvili, Ayesha Hasan, Asia McDavid, Denise Fadorsen, Terry Yau, Michael Farkouh, Anna Woo, Robert James Cusimano, Tirone David, Christopher Feindel, Nishit Fumakia, Shakira Christie, Asvina Bissonauth, Alexandra Hripko, Zahid Noor, Kristen Mackowick, Stephanie Deasey, Manal Al-Suqi, Julia Collins, Michael A. Acker, Steven Messé, James Kirkpatrick, Mary Lou Mayer, Caitlin McDonald, Holley Fok, Breanna Maffei, Stephen Cresse, Christine Gepty, Michael Bowdish, Vaughn A. Starnes, David Shavalle, Christi Heck, Amy Hackmann, Craig Baker, Fernando Fleischman, Mark Cunningham, Edward Lozano, Michelle Hernandez, Irving L. Kron, Karen Johnston, Ravi K. Ghanta, John M. Dent, John Kern, Leora Yarboro, Michael Ragosta, Brian Annex, Jim Bergin, Sandra Burks, Mike Cosner, China Green, Samantha Loya, Hye Ryun Kim, David A. Bull, Patrice Desvigne-Nickens, Dennis O. Dixon, Rebecca Gottesman, Mark Haigney, Richard Holubkov, Constantino Iadecola, Alice Jacobs, Eric M. Meslin, John M. Murkin, John A. Spertus, Frank Sellke, Cheryl L. McDonald, John Canty, Neal Dickert, John S. Ikonomidis, KyungMann Kim, David O. Williams, Clyde W. Yancy, Seemant Chaturvedi, Marc Chimowitz, James C. Fang, Wayne Richenbacher, Vivek Rao, Rachel Miller, Jennifer Cook, David D'Alessandro, Frederick Han, Sean Pinney, Mary N. Walsh, David Greer, Koto Ishida, Christian Stapf, Judy Hung, Xin Zeng, David Hung, Sudarat Satitthummanid, Michel Billelo, Christos Davatzikos, Lauren Karpf, Lisa Desiderio, Yanne Toulgoat-Dubois, Rachele Brassard, Renu Virmanu, Maria E. Romero, and Ryan Braumann

Subjects
Pulmonary and Respiratory Medicine, Surgery, Cardiology and Cardiovascular Medicine
Abstract

The effects of stroke and delirium on postdischarge cognition and patient-centered health outcomes after surgical aortic valve replacement (SAVR) are not well characterized. Here, we assess the impact of postoperative stroke and delirium on these health outcomes in SAVR patients at 90 days.Patients (N = 383) undergoing SAVR (41% received concomitant coronary artery bypass graft) enrolled in a randomized trial of embolic protection devices underwent serial neurologic and delirium evaluations at postoperative days 1, 3, and 7 and magnetic resonance imaging at day 7. Outcomes included 90-day functional status, neurocognitive decline from presurgical baseline, and quality of life.By postoperative day 7, 25 (6.6%) patients experienced clinical stroke and 103 (28.5%) manifested delirium. During index hospitalization, time to discharge was longer in patients experiencing stroke (hazard ratio, 0.62; 95% confidence interval [CI], 0.42-0.94; P = .02) and patients experiencing delirium (hazard ratio, 0.68; 95% CI, 0.54-0.86; P = .001). At day 90, patients experiencing stroke were more likely to have a modified Rankin score2 (odds ratio [OR], 5.9; 95% CI, 1.7-20.1; P = .01), depression (OR, 5.3; 95% CI, 1.6-17.3; P = .006), a lower 12-Item Short Form Survey physical health score (adjusted mean difference -3.3 ± 1.9; P = .08), and neurocognitive decline (OR, 7.8; 95% CI, 2.3-26.4; P = .001). Delirium was associated with depression (OR, 2.2; 95% CI, 0.9-5.3; P = .08), lower 12-Item Short Form Survey physical health (adjusted mean difference -2.3 ± 1.1; P = .03), and neurocognitive decline (OR, 2.2; 95% CI, 1.2-4.0; P = .01).Stroke and delirium occur more frequently after SAVR than is commonly recognized, and these events are associated with disability, depression, cognitive decline, and poorer quality of life at 90 days postoperatively. These findings support the need for new interventions to reduce these events and improve patient-centered outcomes.

Published
2022

5. Medical management with interventional therapy versus medical management alone for unruptured brain arteriovenous malformations (ARUBA):final follow-up of a multicentre, non-blinded, randomised controlled trial

Author

Alessandra Biondi, Jessica Overbey, Michael K. Parides, Kirsty Harkness, Rustam Al-Shahi Salman, Richard B. Libman, Andreas Hartmann, H. Bart van der Worp, Rüdiger von Kummer, Charlotte Cordonnier, Ellen Moquete, Emmanuel Houdart, Christian Stapf, Helen Kim, Marco Antonio Stefani, Jay P. Mohr, Catharina J.M. Klijn, John Pile-Spellman, and Alan J. Moskowitz

Subjects
Adult, Intracranial Arteriovenous Malformations, Male, medicine.medical_specialty, Pediatrics, Radiosurgery, Stroke/epidemiology, Neurosurgical Procedures, law.invention, Intracranial Arteriovenous Malformations/drug therapy, 03 medical and health sciences, Embolization, 0302 clinical medicine, All institutes and research themes of the Radboud University Medical Center, Randomized controlled trial, law, medicine, Humans, Neurosurgical Procedures/methods, 030212 general & internal medicine, Radiosurgery/methods, Adverse effect, Stroke, Intention-to-treat analysis, business.industry, Incidence (epidemiology), Hazard ratio, Arteriovenous Fistula/drug therapy, Middle Aged, medicine.disease, Interim analysis, Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3], Embolization, Therapeutic, Treatment Outcome, Arteriovenous Fistula, Female, Neurology (clinical), Neurosurgery, Embolization, Therapeutic/methods, business, Therapeutic/methods, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract

BackgroundIn A Randomized trial of Unruptured Brain Arteriovenous malformations (ARUBA), randomisation was halted at a mean follow-up of 33·3 months after a prespecified interim analysis showed that medical management alone was superior to the combination of medical management and interventional therapy in preventing symptomatic stroke or death. We aimed to study whether these differences persisted through 5-years' follow-up.MethodsARUBA was a non-blinded, randomised trial done at 39 clinical centres in nine countries. Adults (age ≥18 years) diagnosed with an unruptured brain arteriovenous malformation, who had never undergone interventional therapy, and were considered by participating clinical centres to be suitable for intervention to eradicate the lesion, were eligible for inclusion. Patients were randomly assigned (1:1) by a web-based data collection system, stratified by clinical centre in a random permuted block design with block sizes of two, four, and six, to medical management alone or with interventional therapy (neurosurgery, embolisation, or stereotactic radiotherapy, alone or in any combination, sequence, or number). Although patients and investigators at a given centre were not masked to treatment assignment, investigators at other centres and those in the clinical coordinating centre were not informed of assignment or outcomes at any of the centres. The primary outcome was time to death or symptomatic stroke confirmed by imaging, assessed by a neurologist at each centre not involved in the management of participants' care, and monitored by an independent committee using an adaptive approach with interim analyses. Enrolment began on April 4, 2007, and was halted on April 15, 2013, after which follow-up continued until July 15, 2015. All analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT00389181.FindingsOf 1740 patients screened, 226 were randomly assigned to medical management alone (n=110) or medical management plus interventional therapy (n=116). During a mean follow-up of 50·4 months (SD 22·9), the incidence of death or symptomatic stroke was lower with medical management alone (15 of 110, 3·39 per 100 patient-years) than with medical management with interventional therapy (41 of 116, 12·32 per 100 patient-years; hazard ratio 0·31, 95% CI 0·17 to 0·56). Two patients in the medical management group and four in the interventional therapy group (two attributed to intervention) died during follow-up. Adverse events were observed less often in patients allocated to medical management compared with interventional therapy (283 vs 369; 58·97 vs 78·73 per 100 patient-years; risk difference −19·76, 95% CI −30·33 to −9·19).InterpretationAfter extended follow-up, ARUBA showed that medical management alone remained superior to interventional therapy for the prevention of death or symptomatic stroke in patients with an unruptured brain arteriovenous malformation. The data concerning the disparity in outcomes should affect standard specialist practice and the information presented to patients. The even longer-term risks and differences between the two therapeutic approaches remains uncertain.FundingNational Institute of Neurological Disorders and Stroke for the randomisation phase and Vital Projects Fund for the follow-up phase.

Published
2020

6. Risk for non-home discharge following surgery for ischemic mitral valve disease

Author

Anuradha Lala, Helena L. Chang, Xiaoyu Liu, Eric J. Charles, Babatunde A. Yerokun, Michael E. Bowdish, Vinod H. Thourani, Michael J. Mack, Marissa A. Miller, Patrick T. O'Gara, Eugene H. Blackstone, Alan J. Moskowitz, Annetine C. Gelijns, John C. Mullen, Lynne W. Stevenson, Joseph J. DeRose, Alice Wang, Peter K. Smith, Michael A. Acker, Gorav Ailawadi, Wendy C. Taddei-Peters, Dennis Buxton, Ron Caulder, Nancy L. Geller, David Gordon, Neal O. Jeffries, Albert Lee, Ilana Kogan Gombos, Jennifer Ralph, Richard D. Weisel, Timothy J. Gardner, Eric A. Rose, Michael K. Parides, Deborah D. Ascheim, Emilia Bagiella, Ellen Moquete, Helena Chang, Melissa Chase, James Foo, Yingchun Chen, Seth Goldfarb, Lopa Gupta, Katherine Kirkwood, Edlira Dobrev, Ron Levitan, Karen O'Sullivan, Jessica Overbey, Milerva Santos, Deborah Williams, Michael Weglinski, Paula Williams, Carrie Wood, Xia Ye, Sten Lyager Nielsen, Henrik Wiggers, Henning Malgaard, Michael Mack, Tracine Adame, Natalie Settele, Jenny Adams, William Ryan, Robert L. Smith, Paul Grayburn, Frederick Y. Chen, Anju Nohria, Lawrence Cohn, Prem Shekar, Sary Aranki, Gregory Couper, Michael Davidson, R. Morton Bolman, Anne Burgess, Debra Conboy, Rita Lawrence, Nicolas Noiseux, Louis-Mathieu Stevens, Ignacio Prieto, Fadi Basile, Joannie Dionne, Julie Fecteau, A. Marc Gillinov, Pamela Lackner, Leoma Berroteran, Diana Dolney, Suzanne Fleming, Roberta Palumbo, Christine Whitman, Kathy Sankovic, Denise Kosty Sweeney, Carrie Geither, Kristen Doud, Gregory Pattakos, Pamela A. Clarke, Michael Argenziano, Mathew Williams, Lyn Goldsmith, Craig R. Smith, Yoshifumi Naka, Allan Stewart, Allan Schwartz, Daniel Bell, Danielle Van Patten, Sowmya Sreekanth, John H. Alexander, Carmelo A. Milano, Donald D. Glower, Joseph P. Mathew, J. Kevin Harrison, Stacey Welsh, Mark F. Berry, Cyrus J. Parsa, Betty C. Tong, Judson B. Williams, T. Bruce Ferguson, Alan P. Kypson, Evelio Rodriguez, Malissa Harris, Brenda Akers, Allison O'Neal, John D. Puskas, Robert Guyton, Jefferson Baer, Kim Baio, Alexis A. Neill, Pierre Voisine, Mario Senechal, François Dagenais, Kim O'Connor, Gladys Dussault, Tatiana Ballivian, Suzanne Keilani, Alan M. Speir, Patrick Magee, Niv Ad, Sally Keyte, Minh Dang, Mark Slaughter, Marsha Headlee, Heather Moody, Naresh Solankhi, Emma Birks, Mark A. Groh, Leslie E. Shell, Stephanie A. Shepard, Benjamin H. Trichon, Tracy Nanney, Lynne C. Hampton, Ralph Mangusan, Robert E. Michler, David A. D'Alessandro, Daniel J. Goldstein, Ricardo Bello, William Jakobleff, Mario Garcia, Cynthia Taub, Daniel Spevak, Roger Swayze, Nadia Sookraj, Louis P. Perrault, Arsène-Joseph Basmadjian, Denis Bouchard, Michel Carrier, Raymond Cartier, Michel Pellerin, Jean François Tanguay, Ismail El-Hamamsy, André Denault, Philippe Demers, Sophie Robichaud Jonathan Lacharité, Keith A. Horvath, Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Margaret Iraola, Ann Greenberg, Chittoor Sai-Sudhakar, Ayseha Hasan, Asia McDavid, Bradley Kinn, Pierre Pagé, Carole Sirois, David Latter, Howard Leong-Poi, Daniel Bonneau, Lee Errett, Mark D. Peterson, Subodh Verma, Randi Feder-Elituv, Gideon Cohen, Campbell Joyner, Stephen E. Fremes, Fuad Moussa, George Christakis, Reena Karkhanis, Terry Yau, Michael Farkouh, Anna Woo, Robert James Cusimano, Tirone David, Christopher Feindel, Lisa Garrard, Suzanne Fredericks, Amelia Mociornita, Jonathan Choy, Steven Meyer, Emily Kuurstra, James S. Gammie, Cindi A. Young, Dana Beach, Robert Villanueva, Pavan Atluri, Y. Joseph Woo, Mary Lou Mayer, Michael Bowdish, Vaughn A. Starnes, David Shavalle, Ray Matthews, Shadi Javadifar, Linda Romar, Irving L. Kron, Karen Johnston, John M. Dent, John Kern, Jessica Keim, Sandra Burks, Kim Gahring, David A. Bull, Dennis O. Dixon, Mark Haigney, Richard Holubkov, Alice Jacobs, Frank Miller, John M. Murkin, John Spertus, Andrew S. Wechsler, Frank Sellke, Robert Byington, Neal Dickert, John S. Ikonomidis, David O. Williams, Clyde W. Yancy, James C. Fang, Nadia Giannetti, Wayne Richenbacher, Vivek Rao, Karen L. Furie, Rachel Miller, Sean Pinney, William C. Roberts, Mary N. Walsh, Judy Hung, Xin Zeng, Niamh Kilcullen, David Hung, Stephen J. Keteyian, Clinton A. Brawner, Heather Aldred, Jeffrey Browndyke, and Yanne Toulgoat-Dubois

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Myocardial Ischemia, 030204 cardiovascular system & hematology, Risk Assessment, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Risk Factors, Mitral valve, Humans, Medicine, Prospective Studies, Adverse effect, Aged, Mitral regurgitation, business.industry, Mitral Valve Insufficiency, Odds ratio, Middle Aged, medicine.disease, Patient Discharge, Confidence interval, 3. Good health, Cardiac surgery, Surgery, Treatment Outcome, medicine.anatomical_structure, 030228 respiratory system, Heart failure, Quality of Life, Female, Cardiology and Cardiovascular Medicine, business
Abstract

To determine the frequency and risk factors for non-home discharge (NHD) and its association with clinical outcomes and quality of life (QOL) at 1 year following cardiac surgery in patients with ischemic mitral regurgitation (IMR).Discharge disposition was evaluated in 552 patients enrolled in trials of severe or moderate IMR. Patient and in-hospital factors associated with NHD were identified using logistic regression. Subsequently, association of NHD with 1-year mortality, serious adverse events (SAEs), and QOL was assessed.NHD was observed in 30% (154/522) with 25% (n = 71/289) in moderate and 36% (n = 83/233) in patients with severe IMR (unadjusted P = .006), a difference not significant after including age (5-year change: adjusted odds ratio [adjOR], 1.52; 95% confidence interval [CI], 1.35-1.72; P .001), diabetes (adjOR, 1.94; 95% CI, 1.27-2.94; P = .002), and previous heart failure (adjOR, 1.64; 95% CI, 1.06-2.52; P = .03). Odds of NHD were increased for patients with postoperative SAEs (adjOR, 1.85; 95% CI, 1.19-2.86; P = .01) but not based on type of cardiac surgery. Greater rates of death and SAEs were observed in NHD patients at 1 year: adjusted hazard ratio, 4.29 (95% CI, 2.14-8.59; P .001) and adjusted rate ratio, 1.45 (95% CI, 1.03-2.02; P = .03), respectively. QOL did not differ significantly between groups.NHD is common following surgery for IMR, influenced by older age, diabetes, previous heart failure, and postoperative SAEs. These patients may be at greater risk of death and subsequent SAEs after discharge. Discussion of NHD with patients may have important implications for decision-making and guiding expectations following cardiac surgery.

Published
2021

7. Cost-Effectiveness of CABG plus Mitral-Valve Repair vs CABG Alone for Moderate Ischemic Mitral Regurgitation

Author

Bart S. Ferket, Vinod H. Thourani, Pierre Voisine, Samuel F. Hohmann, Helena L. Chang, Peter K. Smith, Robert E. Michler, Gorav Ailawadi, Louis P. Perrault, Marissa A. Miller, Karen O'Sullivan, Stephanie L. Mick, Emilia Bagiella, Michael A. Acker, Ellen Moquete, Judy W. Hung, Jessica R. Overbey, Anuradha Lala, Margaret Iraola, James S. Gammie, Annetine C. Gelijns, Patrick T. O'Gara, Alan J. Moskowitz, Wendy C. Taddei-Peters, Dennis Buxton, Ron Caulder, Nancy L. Geller, David Gordon, Neal O. Jeffries, Albert Lee, Claudia S. Moy, Ilana Kogan Gombos, Jennifer Ralph, Richard Weisel, Timothy J. Gardner, Eric A. Rose, Michael K. Parides, Deborah D. Ascheim, Helena Chang, Melissa Chase, Yingchun Chen, Seth Goldfarb, Lopa Gupta, Katherine Kirkwood, Edlira Dobrev, Ron Levitan, Jessica Overbey, Milerva Santos, Michael Weglinski, Paula Williams, Carrie Wood, Xia Ye, Sten Lyager Nielsen, Henrik Wiggers, Henning Malgaard, Michael Mack, Tracine Adame, Natalie Settele, Jenny Adams, William Ryan, Robert L. Smith, Paul Grayburn, Frederick Y. Chen, Anju Nohria, Lawrence Cohn, Prem Shekar, Sary Aranki, Gregory Couper, Michael Davidson, R. Morton Bolman, Anne Burgess, Debra Conboy, Nicolas Noiseux, Louis-Mathieu Stevens, Ignacio Prieto, Fadi Basile, Joannie Dionne, Julie Fecteau, Eugene H. Blackstone, A. Marc Gillinov, Pamela Lackner, Leoma Berroteran, Diana Dolney, Suzanne Fleming, Roberta Palumbo, Christine Whitman, Kathy Sankovic, Denise Kosty Sweeney, Gregory Pattakos, Pamela A. Clarke, Michael Argenziano, Mathew Williams, Lyn Goldsmith, Craig R. Smith, Yoshifumi Naka, Allan Stewart, Allan Schwartz, Daniel Bell, Danielle Van Patten, Sowmya Sreekanth, John H. Alexander, Carmelo A. Milano, Donald D. Glower, Joseph P. Mathew, J. Kevin Harrison, Stacey Welsh, Mark F. Berry, Cyrus J. Parsa, Betty C. Tong, Judson B. Williams, T. Bruce Ferguson, Alan P. Kypson, Evelio Rodriguez, Malissa Harris, Brenda Akers, Allison O'Neal, John D. Puskas, Robert Guyton, Jefferson Baer, Kim Baio, Alexis A. Neill, Mario Senechal, François Dagenais, Kim O'Connor, Gladys Dussault, Tatiana Ballivian, Suzanne Keilani, Alan M. Speir, Patrick Magee, Niv Ad, Sally Keyte, Minh Dang, Mark Slaughter, Marsha Headlee, Heather Moody, Naresh Solankhi, Emma Birks, Mark A. Groh, Leslie E. Shell, Stephanie A. Shepard, Benjamin H. Trichon, Tracy Nanney, Lynne C. Hampton, David A. D'Alessandro, Joseph J. DeRose, Daniel J. Goldstein, Ricardo Bello, William Jakobleff, Mario Garcia, Cynthia Taub, Daniel Spevak, Roger Swayze, Arsène-Joseph Basmadjian, Denis Bouchard, Michel Carrier, Raymond Cartier, Michel Pellerin, Jean François Tanguay, Ismail El-Hamamsy, André Denault, Philippe Demers, Sophie Robichaud, Keith A. Horvath, Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Ann Greenberg, Chittoor Sai-Sudhakar, Ayseha Hasan, Asia McDavid, Bradley Kinn, Pierre Pagé, Carole Sirois, David Latter, Howard Leong-Poi, Daniel Bonneau, Lee Errett, Mark D. Peterson, Subodh Verma, Randi Feder-Elituv, Gideon Cohen, Campbell Joyner, Stephen E. Fremes, Fuad Moussa, George Christakis, Reena Karkhanis, Terry Yau, Michael Farkouh, Anna Woo, Robert James Cusimano, Tirone David, Christopher Feindel, Lisa Garrard, Suzanne Fredericks, Amelia Mociornita, John C. Mullen, Jonathan Choy, Steven Meyer, Emily Kuurstra, Cindi A. Young, Dana Beach, Pavan Atluri, Y. Joseph Woo, Mary Lou Mayer, Michael Bowdish, Vaughn A. Starnes, David Shavalle, Ray Matthews, Shadi Javadifar, Linda Romar, Irving L. Kron, Karen Johnston, John M. Dent, John Kern, Jessica Keim, Sandra Burks, Kim Gahring, David A. Bull, Patrice Desvigne-Nickens, Dennis O. Dixon, Mark Haigney, Richard Holubkov, Alice Jacobs, Frank Miller, John M. Murkin, John Spertus, Andrew S. Wechsler, Frank Sellke, Cheryl L. McDonald, Robert Byington, Neal Dickert, John S. Ikonomidis, David O. Williams, Clyde W. Yancy, James C. Fang, Nadia Giannetti, Wayne Richenbacher, Vivek Rao, Karen L. Furie, Rachel Miller, Sean Pinney, William C. Roberts, Mary N. Walsh, Stephen J. Keteyian, Clinton A. Brawner, Heather Aldred, Judy Hung, Xin Zeng, Jeffrey Browndyke, and Yanne Toulgoat-Dubois

Subjects
Male, Mitral Valve Annuloplasty, Time Factors, Cost effectiveness, medicine.medical_treatment, Cost-Benefit Analysis, Coronary Artery Disease, 030204 cardiovascular system & hematology, 0302 clinical medicine, Risk Factors, Mitral valve, Multicenter Studies as Topic, Hospital Costs, Coronary Artery Bypass, health care economics and organizations, Randomized Controlled Trials as Topic, Heart Valve Prosthesis Implantation, Mortality rate, Hazard ratio, Mitral Valve Insufficiency, Middle Aged, 3. Good health, Models, Economic, Treatment Outcome, medicine.anatomical_structure, Cardiology, Mitral Valve, Female, Quality-Adjusted Life Years, Cardiology and Cardiovascular Medicine, Incremental cost-effectiveness ratio, Artery, Pulmonary and Respiratory Medicine, Canada, medicine.medical_specialty, Article, 03 medical and health sciences, Internal medicine, medicine, Humans, Computer Simulation, Cardiac Surgical Procedures, Aged, Mitral regurgitation, Mitral valve repair, business.industry, 030228 respiratory system, Quality of Life, Surgery, business
Abstract

Objective The Cardiothoracic Surgical Trials Network reported that left ventricular reverse remodeling at 2 years did not differ between patients with moderate ischemic mitral regurgitation randomized to coronary artery bypass grafting plus mitral valve repair (n = 150) or coronary artery bypass grafting alone (n = 151). To address health resource use implications, we compared costs and quality-adjusted survival. Methods We used individual patient data from the Cardiothoracic Surgical Trials Network trial on survival, hospitalizations, quality of life, and US hospitalization costs to estimate cumulative costs and quality-adjusted life years. A microsimulation model was developed to extrapolate to 10 years. Bootstrap and deterministic sensitivity analyses were performed to address uncertainty. Results In-hospital costs were $59,745 for coronary artery bypass grafting plus mitral valve repair versus $51,326 for coronary artery bypass grafting alone (difference $8419; 95% uncertainty interval, 2259-18,757). Two-year costs were $81,263 versus $67,341 (difference 13,922 [2370 to 28,888]), and quality-adjusted life years were 1.35 versus 1.30 (difference 0.05; −0.04 to 0.14), resulting in an incremental cost-effectiveness ratio of $308,343/quality-adjusted life year for coronary artery bypass grafting plus mitral valve repair. At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [−3866 to 56,826]) and quality-adjusted life years showed no difference (−0.92 to 0.87), with 5.08 versus 5.08. The likelihood that coronary artery bypass grafting plus mitral valve repair would be considered cost-effective at 10 years based on a cost-effectiveness threshold of $100K/quality-adjusted life year did not exceed 37%. Only when this procedure reduces the death rate by a relative 5% will the incremental cost-effectiveness ratio fall below $100K/quality-adjusted life year. Conclusions: The addition of mitral valve repair to coronary artery bypass grafting for patients with moderate ischemic mitral regurgitation is unlikely to be cost-effective. Only if late mortality benefits can be demonstrated will it meet commonly used cost-effectiveness criteria.

Published
2019

8. Pacemaker Implantation After Mitral Valve Surgery With Atrial Fibrillation Ablation

Author

Joseph J. DeRose, Donna M. Mancini, Helena L. Chang, Michael Argenziano, François Dagenais, Gorav Ailawadi, Louis P. Perrault, Michael K. Parides, Wendy C. Taddei-Peters, Michael J. Mack, Donald D. Glower, Babatunde A. Yerokun, Pavan Atluri, John C. Mullen, John D. Puskas, Karen O’Sullivan, Nancy M. Sledz, Hugo Tremblay, Ellen Moquete, Bart S. Ferket, Alan J. Moskowitz, Alexander Iribarne, Annetine C. Gelijns, Patrick T. O’Gara, Eugene H. Blackstone, A. Marc Gillinov, Marissa A. Miller, Dennis Buxton, Amy Connolly, Nancy L. Geller, David Gordon, Neal O. Jeffries, Albert Lee, Claudia S. Moy, Ilana Kogan Gombos, Jennifer Ralph, Richard Weisel, Timothy J. Gardner, Eric A. Rose, Deborah D. Ascheim, Emilia Bagiella, Helena Chang, Melissa Chase, Edlira Dobrev, Seth Goldfarb, Lopa Gupta, Katherine Kirkwood, Ron Levitan, Jessica Overbey, Milerva Santos, Michael Weglinski, Paula Williams, Carrie Wood, Xia Ye, Michael Mack, Tracine Adame, Natalie Settele, Jenny Adams, William Ryan, Robert L. Smith, Paul Grayburn, Frederick Y. Chen, Anju Nohria, Lawrence Cohn, Prem Shekar, Sary Aranki, Gregory Couper, Michael Davidson, R. Morton Bolman, Anne Burgess, Debra Conboy, Ray Blackwell, Roger Kerzner, Michael Banbury, Andrea M. Squire, Bruce Lytle, Tomislav Mihaljevic, Pamela Lackner, Leoma Berroteran, Diana Dolney, Suzanne Fleming, Roberta Palumbo, Christine Whitman, Kathy Sankovic, Denise Kosty Sweeney, Gregory Pattakos, Mathew Williams, Lyn Goldsmith, Craig R. Smith, Yoshifumi Naka, Allan Stewart, Allan Schwartz, Daniel Bell, Danielle Van Patten, Sowmya Sreekanth, Peter K. Smith, John H. Alexander, Carmelo A. Milano, Joseph P. Mathew, J. Kevin Harrison, Stacey Welsh, T. Bruce Ferguson, Alan P. Kypson, Evelio Rodriguez, Malissa Harris, Brenda Akers, Allison O'Neal, Vinod H. Thourani, Robert Guyton, Jefferson Baer, Kim Baio, Alexis A. Neill, Pierre Voisine, Mario Senechal, Kim O’Connor, Gladys Dussault, Tatiana Ballivian, Suzanne Keilani, Robert E. Michler, David A. D'Alessandro, Daniel J. Goldstein, Ricardo Bello, William Jakobleff, Mario Garcia, Cynthia Taub, Daniel Spevack, Roger Swayze, Nadia Sookraj, Arsène-Joseph Basmadjian, Denis Bouchard, Michel Carrier, Raymond Cartier, Michel Pellerin, Jean François Tanguay, Ismael El-Hamamsy, André Denault, Jonathan Lacharité, Sophie Robichaud, David H. Adams, Robin Varghese, Yael Mandel-Portnoy, Keith A. Horvath, Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Margaret Iraola, Ann Greenberg, Chittoor Sai-Sudhakar, Ayseha Hasan, Asia McDavid, Bradley Kinn, Jonathan Choy, Steven Meyer, Emily Kuurstra, James S. Gammie, Christopher R. DeFilippi, Dino T. Gaetani, Cindi A. Young, Dana Beach, Julia Collins, Steven F. Bolling, Francis D. Pagani, Cathie Bloem, Michael A. Acker, Y. Joseph Woo, Mary Lou Mayer, Joseph E. Bavaria, Wilson Y. Szeto, Kenneth Margulies, Martin Keane, Helene Glassberg, Dinesh Jagasia, James Kirkpatrick, Irving L. Kron, Karen Johnston, John M. Dent, John Kern, Jessica Keim, Sandra Burks, Kim Gahring, Abeel Mangi, Joseph Akar, David Yuh, Lynn Wilson, David A. Bull, Patrice Desvigne-Nickens, Dennis O. Dixon, Mark Haigney, Richard Holubkov, Alice Jacobs, Frank Miller, John M. Murkin, John Spertus, Andrew S. Wechsler, Frank Sellke, Cheryl L. McDonald, Robert Byington, Neal Dickert, John S. Ikonomidis, David O. Williams, Clyde W. Yancy, John M. Canty, James C. Fang, Nadia Giannetti, Wayne Richenbacher, Vivek Rao, Karen L. Furie, Rachel Miller, Sean Pinney, William C. Roberts, Mary N. Walsh, Judy Hung, Xin Zeng, Jean-Philippe Couderc, Dan Balda, Wayne Bowen, Mauri Wilson, and Anne Schering

Subjects
Male, medicine.medical_specialty, Randomization, medicine.medical_treatment, Heart Valve Diseases, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Risk Factors, Internal medicine, Atrial Fibrillation, medicine, Humans, 030212 general & internal medicine, Heart Atria, Cardiac Surgical Procedures, Aged, business.industry, valvular heart disease, Hazard ratio, Cardiac Pacing, Artificial, Atrial fibrillation, Middle Aged, medicine.disease, Ablation, Confidence interval, Cardiac surgery, Pulmonary Veins, Cardiology, Catheter Ablation, Mitral Valve, Female, Cardiology and Cardiovascular Medicine, business
Abstract

Background The incidence of permanent pacemaker (PPM) implantation is higher following mitral valve surgery (MVS) with ablation for atrial fibrillation (AF) compared with MVS alone. Objectives This study identified risk factors and outcomes associated with PPM implantation in a randomized trial that evaluated ablation for AF in patients who underwent MVS. Methods A total of 243 patients with AF and without previous PPM placement were randomly assigned to MVS alone (n = 117) or MVS + ablation (n = 126). Patients in the ablation group were further randomized to pulmonary vein isolation (PVI) (n = 62) or the biatrial maze procedure (n = 64). Using competing risk models, this study examined the association among PPM and baseline and operative risk factors, and the effect of PPM on time to discharge, readmissions, and 1-year mortality. Results Thirty-five patients received a PPM within the first year (14.4%), 29 (83%) underwent implantation during the index hospitalization. The frequency of PPM implantation was 7.7% in patients randomized to MVS alone, 16.1% in MVS + PVI, and 25% in MVS + biatrial maze. The indications for PPM were similar among patients who underwent MVS with and without ablation. Ablation, multivalve surgery, and New York Heart Association functional (NYHA) functional class III/IV were independent risk factors for PPM implantation. Length of stay post-surgery was longer in patients who received PPMs, but it was not significant when adjusted for randomization assignment (MVS vs. ablation) and age (hazard ratio [HR]: 0.81; 95% confidence interval [CI]: 0.61 to 1.08; p = 0.14). PPM implantation did not increase 30-day readmission rate (HR: 1.43; 95% CI: 0.50 to 4.05; p = 0.50). The need for PPM was associated with a higher risk of 1-year mortality (HR: 3.21; 95% CI: 1.01 to 10.17; p = 0.05) after adjustment for randomization assignment, age, and NYHA functional class. Conclusions AF ablation, multivalve surgery, and NYHA functional class III/IV were associated with an increased risk for permanent pacing. PPM implantation following MVS was associated with a significant increase in 1-year mortality. (Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery; NCT00903370)

Published
2019

9. Two-Year Outcomes of Surgical Treatment of Severe Ischemic Mitral Regurgitation

Author

Eric A. Rose, Peter K. Smith, Michael Argenziano, Annetine C. Gelijns, Helena L. Chang, Sandra G. Burks, Louis P. Perrault, François Dagenais, Gorav Ailawadi, Marissa A. Miller, Judy Hung, Ellen Moquete, Patrick T. O'Gara, Robert E. Michler, Vinod H. Thourani, Ismail El-Hamamsy, Neal Jeffries, Lopa N. Gupta, Richard D. Weisel, Carmelo A. Milano, Jessica Overbey, Pierre Voisine, A. Marc Gillinov, John D. Puskas, Wendy C. Taddei-Peters, Joseph J. DeRose, Michael K. Parides, Michael A. Acker, Emilia Bagiella, Pavan Atluri, James S. Gammie, and Alan J. Moskowitz

Subjects
Reoperation, medicine.medical_specialty, Heart Ventricles, 030204 cardiovascular system & hematology, Ventricular Function, Left, Article, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Recurrence, law, Internal medicine, Mitral valve, Humans, Medicine, Treatment Failure, cardiovascular diseases, 030212 general & internal medicine, Myocardial infarction, Stroke, Heart Failure, Heart Valve Prosthesis Implantation, Mitral regurgitation, Ventricular Remodeling, business.industry, Mitral Valve Insufficiency, General Medicine, medicine.disease, Surgery, Hospitalization, medicine.anatomical_structure, Heart failure, Concomitant, Quality of Life, Cardiology, Mitral Valve, Myocardial infarction complications, business
Abstract

In a randomized trial comparing mitral-valve repair with mitral-valve replacement in patients with severe ischemic mitral regurgitation, we found no significant difference in the left ventricular end-systolic volume index (LVESVI), survival, or adverse events at 1 year after surgery. However, patients in the repair group had significantly more recurrences of moderate or severe mitral regurgitation. We now report the 2-year outcomes of this trial.We randomly assigned 251 patients to mitral-valve repair or replacement. Patients were followed for 2 years, and clinical and echocardiographic outcomes were assessed.Among surviving patients, the mean (±SD) 2-year LVESVI was 52.6±27.7 ml per square meter of body-surface area with mitral-valve repair and 60.6±39.0 ml per square meter with mitral-valve replacement (mean changes from baseline, -9.0 ml per square meter and -6.5 ml per square meter, respectively). Two-year mortality was 19.0% in the repair group and 23.2% in the replacement group (hazard ratio in the repair group, 0.79; 95% confidence interval, 0.46 to 1.35; P=0.39). The rank-based assessment of LVESVI at 2 years (incorporating deaths) showed no significant between-group difference (z score=-1.32, P=0.19). The rate of recurrence of moderate or severe mitral regurgitation over 2 years was higher in the repair group than in the replacement group (58.8% vs. 3.8%, P0.001). There were no significant between-group differences in rates of serious adverse events and overall readmissions, but patients in the repair group had more serious adverse events related to heart failure (P=0.05) and cardiovascular readmissions (P=0.01). On the Minnesota Living with Heart Failure questionnaire, there was a trend toward greater improvement in the replacement group (P=0.07).In patients undergoing mitral-valve repair or replacement for severe ischemic mitral regurgitation, we observed no significant between-group difference in left ventricular reverse remodeling or survival at 2 years. Mitral regurgitation recurred more frequently in the repair group, resulting in more heart-failure-related adverse events and cardiovascular admissions. (Funded by the National Institutes of Health and Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00807040.).

Published
2016

10. Cost-Effectiveness of Mitral Valve Repair Versus Replacement for Severe Ischemic Mitral Regurgitation

Author

Annetine C. Gelijns, James S. Gammie, Robert E. Michler, Alan J. Moskowitz, Lopa Gupta, Judy Hung, Ellen Moquete, A. Marc Gillinov, Denis Bouchard, Samuel F. Hohmann, Peter K. Smith, Gorav Ailawadi, John C. Mullen, Bart S. Ferket, Michael K. Parides, Anuradha Lala, Patrick T. O'Gara, Helena L. Chang, Pierre Voisine, Michael A. Acker, Emilia Bagiella, Robert L. Smith, David O. Meltzer, Eric A. Rose, Marissa A. Miller, Michael J. Mack, and Vinod H. Thourani

Subjects
medicine.medical_specialty, Mitral valve repair, Ischemic mitral regurgitation, business.industry, Cost effectiveness, medicine.medical_treatment, 030204 cardiovascular system & hematology, law.invention, Quality-adjusted life year, 03 medical and health sciences, 0302 clinical medicine, medicine.anatomical_structure, Randomized controlled trial, law, Internal medicine, Mitral valve, medicine, Cardiology, 030212 general & internal medicine, Cardiology and Cardiovascular Medicine, business
Abstract

Background: The CTSN (Cardiothoracic Surgical Trials Network) recently reported no difference in left ventricular end-systolic volume index or in survival at 2 years between patients with severe ischemic mitral regurgitation (MR) randomized to mitral valve repair or replacement. However, replacement provided more durable correction of MR and fewer cardiovascular readmissions. Yet, cost-effectiveness outcomes have not been addressed. Methods and Results: We conducted a cost-effectiveness analysis of the surgical treatment of ischemic MR based on the CTSN trial (n=126 for repair; n=125 for replacement). Patient-level data on readmissions, survival, quality-of-life, and US hospital costs were used to estimate costs and quality-adjusted life years per patient over the trial duration and a 10-year time horizon. We performed microsimulation for extrapolation of outcomes beyond the 2 years of trial data. Bootstrap and deterministic sensitivity analyses were done to address parameter uncertainty. In-hospital cost estimates were $78 216 for replacement versus $72 761 for repair (difference: $5455; 95% uncertainty interval [UI]: −7784–21 193) while 2-year costs were $97 427 versus $96 261 (difference: $1166; 95% UI: −16 253–17 172), respectively. Quality-adjusted life years at 2 years were 1.18 for replacement versus 1.23 for repair (difference: −0.05; 95% UI: −0.17 to 0.07). Over 5 and 10 years, the benefits of reduction in cardiovascular readmission rates with replacement increased, and survival minimally improved compared with repair. At 5 years, cumulative costs and quality-adjusted life years showed no difference on average, but by 10 years, there was a small, uncertain benefit for replacement: $118 023 versus $119 837 (difference: −$1814; 95% UI: −27 144 to 22 602) and quality-adjusted life years: 4.06 versus 3.97 (difference: 0.09; 95% UI: −0.87 to 1.08). After 10 years, the incremental cost-effectiveness of replacement continued to improve. Conclusions: Our cost-effectiveness analysis predicts potential savings in cost and gains in quality-adjusted survival at 10 years when mitral valve replacement is compared with repair for severe ischemic MR. These projected benefits, however, were small and subject to variability. Efforts to further delineate predictors of long-term outcomes in patients with severe ischemic MR are needed to optimize surgical decisions for individual patients, which should yield more cost-effective care. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00807040.

Published
2018

11. Secondary Surgical Site Infection after Coronary Artery Bypass Grafting: A Multi-Institutional Prospective Cohort Study

Author

Brian C. Gulack, Katherine A. Kirkwood, Wei Shi, Peter K. Smith, John H. Alexander, Sandra G. Burks, Annetine C. Gelijns, Vinod H. Thourani, Daniel Bell, Ann Greenberg, Seth D. Goldfarb, Mary Lou Mayer, Michael E. Bowdish, Marissa A. Miller, Wendy C. Taddei-Peters, Dennis Buxton, Ron Caulder, Nancy L. Geller, David Gordon, Neal O. Jeffries, Albert Lee, Claudia S. Moy, Ilana Kogan Gombos, Jennifer Ralph, Timothy J. Gardner, Patrick T. O'Gara, Michael K. Parides, Deborah D. Ascheim, Alan J. Moskowitz, Ellen Moquete, Eric A. Rose, Melissa Chase, Yingchun Chen, Rosemarie Gagliardi, Lopa Gupta, Edlira Kumbarce, Ron Levitan, Karen O'Sullivan, Milerva Santos, Alan Weinberg, Paula Williams, Carrie Wood, Xia Ye, Eugene H. Blackstone, A. Marc Gillinov, Pamela Lackner, Leoma Berroteran, Diana Dolney, Suzanne Fleming, Roberta Palumbo, Christine Whitman, Kathy Sankovic, Denise Kosty Sweeney, Gregory Pattakos, Pamela A. Clarke, Michael Argenziano, Mathew Williams, Lyn Goldsmith, Craig R. Smith, Yoshifumi Naka, Allan Stewart, Allan Schwartz, Danielle Van Patten, Stacey Welsh, Carmelo A. Milano, Donald D. Glower, Joseph P. Mathew, J. Kevin Harrison, Mark F. Berry, Cyrus J. Parsa, Betty C. Tong, Judson B. Williams, T. Bruce Ferguson, Alan P. Kypson, Evelio Rodriguez, Malissa Harris, Brenda Akers, Allison O'Neal, John D. Puskas, Robert Guyton, Jefferson Baer, Kim Baio, Alexis A. Neill, Robert E. Michler, David A. D'Alessandro, Joseph J. DeRose, Daniel J. Goldstein, Ricardo Bello, William Jakobleff, Mario Garcia, Cynthia Taub, Daniel Spevak, Roger Swayze, Louis P. Perrault, Arsène-Joseph Basmadjian, Denis Bouchard, Michel Carrier, Raymond Cartier, Michel Pellerin, Jean François Tanguay, Ismael El-Hamamsy, André Denault, Jonathan Lacharité, Sophie Robichaud, Keith A. Horvath, Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Margaret Iraola, Michael A. Acker, Y. Joseph Woo, Irving L. Kron, Gorav Ailawadi, Karen Johnston, John M. Dent, John Kern, Jessica Keim Sandra Burks, Kim Gahring, David A. Bull, Patrice Desvigne-Nickens, Dennis O. Dixon, Mark Haigney, Richard Holubkov, Alice Jacobs, Frank Miller, John M. Murkin, John Spertus, Andrew S. Wechsler, Frank Sellke, Cheryl L. McDonald, Robert Byington, Neal Dickert, John S. Ikonomidis, David O. Williams, Clyde W. Yancy, James C. Fang, Wayne Richenbacher, Vivek Rao, Karen L. Furie, Rachel Miller, Sean Pinney, William C. Roberts, Shirish Huprikar, and Marilyn Levi

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Time Factors, 030204 cardiovascular system & hematology, Patient Readmission, Risk Assessment, Article, Body Mass Index, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Interquartile range, medicine, Humans, Surgical Wound Infection, Saphenous Vein, Prospective Studies, 030212 general & internal medicine, Coronary Artery Bypass, Prospective cohort study, Aged, Groin, business.industry, Incidence, Hazard ratio, Length of Stay, Middle Aged, United States, Confidence interval, Anti-Bacterial Agents, Surgery, Treatment Outcome, Editorial, surgical procedures, operative, medicine.anatomical_structure, Tissue and Organ Harvesting, Female, Erythrocyte Transfusion, Cardiology and Cardiovascular Medicine, business, Complication, Body mass index, Artery
Abstract

OBJECTIVE: To analyze patient risk factors and processes of care associated with secondary surgical site infection (SSI) after coronary artery bypass grafting (CABG). METHODS: Data were collected prospectively between February and October 2010 for consenting adult patients undergoing CABG with saphenous vein graft (SVG) conduits. Patients who developed a deep or superficial SSI of the leg or groin within 65 days of CABG were compared to those who did not develop a secondary SSI. RESULTS: Among 2,174 patients identified, 65 (3.0%) developed a secondary SSI. Median time to diagnosis was 16 days (interquartile range [IQR]: 11 - 29) with the majority (86%) diagnosed after discharge. Gram-positive bacteria were most common. Readmission was more common in patients with a secondary SSI (34% vs 17%, p < 0.01). After adjustment, an open SVG harvest approach was associated with an increased risk of secondary SSI (adjusted hazard ratio [HR]: 2.12, 95% confidence interval [CI]: 1.28, 3.48). Increased body mass index (BMI) (adjusted HR: 1.08, 95% CI: 1.04, 1.12) and packed red blood cell (PRBC) transfusions (adjusted HR: 1.13, 95% CI: 1.05, 1.22) were associated with a higher risk of secondary SSI. Antibiotic type, antibiotic duration, and post-operative hyperglycemia were not associated with risk of secondary SSI. CONCLUSIONS: Secondary SSI following CABG continues to be an important source of morbidity. This serious complication often occurs after discharge and is associated with open SVG harvesting, larger BMI, and blood transfusions. Patients with a secondary SSI have longer lengths of stay and are readmitted more frequently.

Published
2017

12. Surgical Ablation of Atrial Fibrillation during Mitral-Valve Surgery

Author

Jean-Philippe Couderc, Timothy J. Gardner, John D. Puskas, Joseph J. DeRose, Eugene H. Blackstone, Alan J. Moskowitz, Wendy C. Taddei-Peters, Marissa A. Miller, Helena L. Chang, John C. Mullen, Eric A. Rose, Gorav Ailawadi, Robert E. Michler, Annetine C. Gelijns, Robin Varghese, Nancy L. Geller, Keith A. Horvath, Michael Argenziano, Deborah D. Ascheim, Patrick T. O'Gara, Denis Bouchard, Michael J. Mack, A. Marc Gillinov, Peter K. Smith, Steven F. Bolling, Emilia Bagiella, Paula Williams, Pierre Voisine, Ellen Moquete, Michael K. Parides, and Michael A. Acker

Subjects
medicine.medical_specialty, medicine.diagnostic_test, business.industry, medicine.medical_treatment, Hazard ratio, Atrial fibrillation, Catheter ablation, General Medicine, medicine.disease, Ablation, Surgery, medicine.anatomical_structure, Internal medicine, Mitral valve, Ambulatory, medicine, Cardiology, Adverse effect, business, Electrocardiography
Abstract

More patients in the ablation group than in the control group were free from atrial fibrillation at both 6 and 12 months (63.2% vs. 29.4%, P

Published
2015

13. Functional impairments for outcomes in a randomized trial of unruptured brain AVMs

Author

Richard B. Libman, Michael K. Parides, Ellen Moquete, Alan J. Moskowitz, Charlotte Cordonnier, Joachim Berkefeld, Catharina J.M. Klijn, Xavier Barreau, Marco Antonio Stefani, Kirsty Harkness, Andreas Hartmann, Alessandra Biondi, Ruediger von Kummer, Eric Vicaut, Jessica Overbey, Jay P. Mohr, Emmanuel Houdart, Christian Stapf, Claudia S. Moy, Helen Kim, John Pile-Spellman, Unité de Recherche Clinique Saint-Louis Lariboisère Fernand Widal, Clinique Saint-Louis Lariboisère Fernand Widal, Troubles cognitifs dégénératifs et vasculaires - U 1171 (TCDV), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Universitätsklinikum Frankfurt, University Medical Center [Utrecht], Department of Neuroradiology (X.B.), CHU Bordeaux, CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, Calvez, Ghislaine, Movement Disorder (MD), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)

Subjects
Male, [SDV]Life Sciences [q-bio], Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, Postoperative Complications, 0302 clinical medicine, Randomized controlled trial, Interquartile range, Modified Rankin Scale, law, Stroke, ComputingMilieux_MISCELLANEOUS, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Rehabilitation, Hazard ratio, Arteriovenous malformation, Middle Aged, Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3], Embolization, Therapeutic, [SDV] Life Sciences [q-bio], Treatment Outcome, Cognitive Sciences, Female, Therapeutic, Psychology, Adult, Intracranial Arteriovenous Malformations, medicine.medical_specialty, Adolescent, Clinical Trials and Supportive Activities, Clinical Sciences, Article, Embolization, Young Adult, 03 medical and health sciences, Physical medicine and rehabilitation, Clinical Research, medicine, Journal Article, Humans, Retrospective Studies, Neurology & Neurosurgery, Neurosciences, Retrospective cohort study, medicine.disease, Confidence interval, Brain Disorders, Surgery, International ARUBA Investigators, Neurology (clinical), 030217 neurology & neurosurgery, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Follow-Up Studies
Abstract

Objective:To investigate the effects of medical vs interventional management on functional outcome in A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA).Methods:We used the initial results of a nonblinded, randomized, controlled, parallel-group trial involving adults ≥18 years of age with an unruptured brain arteriovenous malformation (AVM) to compare the effects of medical management (MM) with or without interventional therapy (IT) on functional impairment, defined by a primary outcome of death or symptomatic stroke causing modified Rankin Scale (mRS) score ≥2. ARUBA closed recruitment on April 15, 2013.Results:After a median of 33.3 months of follow-up (interquartile range 16.3–49.8 months), of the 223 enrolled in the trial, those in the MM arm were less likely to experience primary outcomes with an mRS score ≥2 than those who underwent IT. The results applied for both those as randomized (MM n = 109 vs IT n = 114) (hazard ratio [HR] 0.25, 95% confidence interval [CI] 0.11–0.57, p = 0.001) and as treated (MM n = 125 vs IT n = 98) (HR 0.10, 95% CI 0.04–0.28, p < 0.001). Functional impairment for the outcomes showed no significant difference by Spetzler-Martin grade for MM but was more frequent with increasing grades for IT (p < 0.001).Conclusion:Death or stroke with functional impairment in ARUBA after a median follow-up of 33 months was significantly lower for those in the MM arm both as randomized and as treated compared with those with IT. Functional severity of outcomes was lower in the MM arm, regardless of Spetzler-Martin grades.ClinicalTrials.gov identifier:NCT00389181.Classification of evidence:This study provides Class II evidence that for adults with unruptured brain AVMs, interventional management compared to MM increases the risk of disability and death over ≈3 years.

Published
2017

14. Readmissions After Cardiac Surgery: Experience of the National Institutes of Health/Canadian Institutes of Health Research Cardiothoracic Surgical Trials Network

Author

Emilia Bagiella, Alan J. Moskowitz, Stacey Welsh, John D. Puskas, Alexander Iribarne, Sandra G. Burks, John H. Alexander, Kim T. Baio, Edlira Dobrev, Mandy Murphy, Patrick T. O'Gara, Michael A. Acker, Mary Lou Mayer, Alexis A. Neill, Wendy C. Taddei-Peters, T. Bruce Ferguson, Helena Chang, Louis P. Perrault, Joseph J. DeRose, A. Marc Gillinov, Karen C. Johnston, and Ellen Moquete

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, business.industry, Proportional hazards model, Volume overload, medicine.disease, Surgery, Cardiac surgery, medicine.anatomical_structure, Diabetes mellitus, Emergency medicine, medicine, Cardiology and Cardiovascular Medicine, business, Prospective cohort study, Management practices, Cohort study, Artery
Abstract

Background Readmissions are a common problem in cardiac surgery. The goal of this study was to examine the frequency, timing, and associated risk factors for readmission after cardiac operations. Methods A 10-center cohort study prospectively enrolled 5,158 adult cardiac surgical patients (5,059 included in analysis) to assess risk factors for infection after cardiac operations. Data were also collected on all-cause readmissions occurring within 65 days after the operation. Major outcomes included the readmission rate stratified by procedure type, cause of readmission, length of readmission stay, and discharge disposition after readmission. Multivariable Cox regression was used to determine risk factors for time to first readmission. Results The overall rate of readmission was 18.7% (number of readmissions, 945). When stratified by the most common procedure type, readmission rates were isolated coronary artery bypass grafting, 14.9% (n = 248); isolated valve, 18.3% (n = 337); and coronary artery bypass grafting plus valve, 25.0% (n = 169). The three most common causes of first readmission within 30 days were infection (17.1% [n = 115]), arrhythmia (17.1% [n = 115]), and volume overload (13.5% [n = 91]). More first readmissions occurred within 30 days (80.6% [n = 672]) than after 30 days (19.4% [n = 162]), and 50% of patients were readmitted within 22 days from the index operation. The median length of stay during the first readmission was 5 days. Discharge in 15.8% of readmitted patients (n = 128) was to a location other than home. Baseline patient characteristics associated with readmission included female gender, diabetes mellitus on medication, chronic obstructive pulmonary disease, elevated creatinine, lower hemoglobin, and longer operation time. More complex surgical procedures were associated with an increased risk of readmission compared with the coronary artery bypass grafting group. Conclusions Nearly 1 of 5 patients who undergo cardiac operations require readmission, an outcome with significant health and economic implications. Management practices to avert in-hospital infections, reduce postoperative arrhythmias, and avoid volume overload offer important targets for quality improvement.

Published
2014

15. Management Practices and Major Infections After Cardiac Surgery

Author

Peter K. Smith, Annetine C. Gelijns, Michael K. Parides, Lyn Goldsmith, Michael Argenziano, Michael A. Acker, John D. Puskas, Nancy L. Geller, Alan J. Moskowitz, Louis P. Perrault, Gorav Ailawadi, Sophie Robichaud, Rachel Miller, Eric A. Rose, Emilia Bagiella, Pamela Lackner, Irving L. Kron, Patrick T. O'Gara, Robert E. Michler, Deborah D. Ascheim, Ellen Moquete, T. Bruce Ferguson, Timothy J. Gardner, Keith A. Horvath, Marissa A. Miller, and Eugene H. Blackstone

Subjects
Male, medicine.medical_specialty, risk factors, Stress hyperglycemia, Risk Factors, Internal medicine, Confidence Intervals, medicine, Humans, Surgical Wound Infection, Cardiac Surgical Procedures, Antibiotic prophylaxis, Aged, Retrospective Studies, business.industry, Incidence, Incidence (epidemiology), Hazard ratio, Disease Management, Retrospective cohort study, Antibiotic Prophylaxis, Middle Aged, medicine.disease, United States, infection, Anti-Bacterial Agents, 3. Good health, Surgery, Cardiac surgery, Treatment Outcome, Heart failure, Female, Cardiology and Cardiovascular Medicine, business, Complication, cardiac surgery, Follow-Up Studies
Abstract

BackgroundInfections are the most common noncardiac complication after cardiac surgery, but their incidence across a broad range of operations, as well as the management factors that shape infection risk, remain unknown.ObjectivesThis study sought to prospectively examine the frequency of post-operative infections and associated mortality, and modifiable management practices predictive of infections within 65 days from cardiac surgery.MethodsThis study enrolled 5,158 patients and analyzed independently adjudicated infections using a competing risk model (with death as the competing event).ResultsNearly 5% of patients experienced major infections. Baseline characteristics associated with increased infection risk included chronic lung disease (hazard ratio [HR]: 1.66; 95% confidence interval [CI]: 1.21 to 2.26), heart failure (HR: 1.47; 95% CI: 1.11 to 1.95), and longer surgery (HR: 1.31; 95% CI: 1.21 to 1.41). Practices associated with reduced infection risk included prophylaxis with second-generation cephalosporins (HR: 0.70; 95% CI: 0.52 to 0.94), whereas post-operative antibiotic duration >48 h (HR: 1.92; 95% CI: 1.28 to 2.88), stress hyperglycemia (HR: 1.32; 95% CI: 1.01 to 1.73); intubation time of 24 to 48 h (HR: 1.49; 95% CI: 1.04 to 2.14); and ventilation >48 h (HR: 2.45; 95% CI: 1.66 to 3.63) were associated with increased risk. HRs for infection were similar with either

Published
2014

16. Biatrial maze procedure versus pulmonary vein isolation for atrial fibrillation during mitral valve surgery: New analytical approaches and end points

Author

Eugene H. Blackstone, Helena L. Chang, Jeevanantham Rajeswaran, Michael K. Parides, Hemant Ishwaran, Liang Li, John Ehrlinger, Annetine C. Gelijns, Alan J. Moskowitz, Michael Argenziano, Joseph J. DeRose, Jean-Phillipe Couderc, Dan Balda, François Dagenais, Michael J. Mack, Gorav Ailawadi, Peter K. Smith, Michael A. Acker, Patrick T. O'Gara, A. Marc Gillinov, Marissa A. Miller, Wendy C. Taddei-Peters, Dennis Buxton, Amy Connolly, Nancy L. Geller, David Gordon, Neal O. Jeffries, Albert Lee, Claudia S. Moy, Ilana Kogan Gombos, Jennifer Ralph, Richard Weisel, Timothy J. Gardner, Eric A. Rose, Deborah D. Ascheim, Emilia Bagiella, Ellen Moquete, Helena Chang, Melissa Chase, Seth Goldfarb, Lopa Gupta, Katherine Kirkwood, Edlira Kumbarce, Ron Levitan, Karen O'Sullivan, Jessica Overbey, Milerva Santos, Michael Weglinski, Paula Williams, Carrie Wood, Xia Ye, Michael Mack, Tracine Adame, Natalie Settele, Jenny Adams, William Ryan, Robert L. Smith, Paul Grayburn, Frederick Y. Chen, Anju Nohria, Lawrence Cohn, Prem Shekar, Sary Aranki, Gregory Couper, Michael Davidson, R. Morton Bolman, Anne Burgess, Debra Conboy, Ray Blackwell, Roger Kerzner, Michael Banbury, Andrea M. Squire, Bruce Lytle, Tomislav Mihaljevic, Pamela Lackner, Leoma Berroteran, Diana Dolney, Suzanne Fleming, Roberta Palumbo, Christine Whitman, Kathy Sankovic, Denise Kosty Sweeney, Gregory Pattakos, Mathew Williams, Lyn Goldsmith, Craig R. Smith, Yoshifumi Naka, Allan Stewart, Allan Schwartz, Daniel Bell, Danielle Van Patten, Sowmya Sreekanth, John H. Alexander, Carmelo A. Milano, Donald D. Glower, Joseph P. Mathew, J. Kevin Harrison, Stacey Welsh, T. Bruce Ferguson, Alan P. Kypson, Evelio Rodriguez, Malissa Harris, Brenda Akers, Allison O'Neal, John D. Puskas, Vinod H. Thourani, Robert Guyton, Jefferson Baer, Kim Baio, Alexis A. Neill, Pierre Voisine, Mario Senechal, Kim O'Connor, Gladys Dussault, Tatiana Ballivian, Suzanne Keilani, Robert E. Michler, David A. D'Alessandro, Daniel J. Goldstein, Ricardo Bello, William Jakobleff, Mario Garcia, Cynthia Taub, Daniel Spevack, Roger Swayze, Nadia Sookraj, Louis P. Perrault, Arsène-Joseph Basmadjian, Denis Bouchard, Michel Carrier, Raymond Cartier, Michel Pellerin, Jean François Tanguay, Ismael El-Hamamsy, André Denault, Jonathan Lacharité, Sophie Robichaud, David H. Adams, Robin Varghese, Yael Mandel-Portnoy, Keith A. Horvath, Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Margaret Iraola, Ann Greenberg, Chittoor Sai-Sudhakar, Ayseha Hasan, Asia McDavid, Bradley Kinn, John C. Mullen, Jonathan Choy, Steven Meyer, Emily Kuurstra, James S. Gammie, Christopher R. DeFilippi, Dino T. Gaetani, Cindi A. Young, Dana Beach, Julia Collins, Steven F. Bolling, Francis D. Pagani, Cathie Bloem, Y. Joseph Woo, Mary Lou Mayer, Joseph E. Bavaria, Wilson Y. Szeto, Kenneth Margulies, Martin Keane, Helene Glassberg, Dinesh Jagasia, James Kirkpatrick, Irving L. Kron, Karen Johnston, John M. Dent, John Kern, Jessica Keim, Sandra Burks, Kim Gahring, Abeel Mangi, Joseph Akar, David Yuh, Lynn Wilson, David A. Bull, Patrice Desvigne-Nickens, Dennis O. Dixon, Mark Haigney, Richard Holubkov, Alice Jacobs, Frank Miller, John M. Murkin, John Spertus, Andrew S. Wechsler, Frank Sellke, Cheryl L. McDonald, Robert Byington, Neal Dickert, John S. Ikonomidis, David O. Williams, Clyde W. Yancy, John M. Canty, James C. Fang, Nadia Giannetti, Wayne Richenbacher, Vivek Rao, Karen L. Furie, Rachel Miller, Sean Pinney, William C. Roberts, Mary N. Walsh, Judy Hung, Xin Zeng, Jean-Philippe Couderc, Wayne Bowen, Mauri Wilson, and Anne Schering

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, business.industry, medicine.medical_treatment, Atrial fibrillation, Odds ratio, 030204 cardiovascular system & hematology, Ablation, medicine.disease, Confidence interval, 3. Good health, Confirmatory trial, Pulmonary vein, 03 medical and health sciences, 0302 clinical medicine, 030228 respiratory system, Internal medicine, medicine, Cardiology, Surgery, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Atrial tachycardia, Atrial flutter
Abstract

Objective To use novel statistical methods for analyzing the effect of lesion set on (long-standing) persistent atrial fibrillation (AF) in the Cardiothoracic Surgical Trials Network trial of surgical ablation during mitral valve surgery (MVS). Methods Two hundred sixty such patients were randomized to MVS + surgical ablation or MVS alone. Ablation was randomized between pulmonary vein isolation and biatrial maze. During 12 months postsurgery, 228 patients (88%) submitted 7949 transtelephonic monitoring (TTM) recordings, analyzed for AF, atrial flutter (AFL), or atrial tachycardia (AT). As previously reported, more ablation than MVS-alone patients were free of AF or AF/AFL at 6 and 12 months (63% vs 29%; P Results Estimated freedom from AF/AFL/AT on any transmission trended higher after biatrial maze than pulmonary vein isolation (odds ratio, 2.31; 95% confidence interval, 0.95-5.65; P = .07) 3 to 12 months postsurgery; estimated AF/AFL/AT load (ie, proportion of TTM strips recording AF/AFL/AT) was similar (odds ratio, 0.90; 95% confidence interval, 0.57-1.43; P = .6). Within 12 months, estimated prevalence of AF/AFL/AT by TTM was 58% after MVS alone, and 36% versus 23% after pulmonary vein isolation versus biatrial maze (P Conclusions Statistical modeling using TTM recordings after MVS in patients with (long-standing) persistent AF suggests that a biatrial maze is associated with lower AF/AFL/AT prevalence, but not a lower load, compared with pulmonary vein isolation. The discrepancy between AF/AFL/AT prevalence assessed at 2 time points by Holter monitoring versus weekly TTM suggests the need for a confirmatory trial, reassessment of definitions for failure after ablation, and validation of statistical methods for assessing atrial rhythms longitudinally.

Published
2019

17. Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement

Author

Emilia Bagiella, Annetine C. Gelijns, Louis P. Perrault, Gorav Ailawadi, Karen L. Furie, Steven R. Messé, Christos Davatzikos, Patrick T. O'Gara, Rachelle A. Winkle, Ellen Moquete, Alan J. Moskowitz, Peter K. Smith, Ralph F. Mangusan, Alexander Iribarne, Karen O'Sullivan, Richard D. Weisel, Jessica Overbey, Michael J. Mack, Pierre Voisine, Claudia S. Moy, Michael K. Parides, Michael A. Acker, Vinod H. Thourani, Mark A. Groh, Eric A. Rose, Robert E. Michler, Jeffrey N. Browndyke, Wendy C. Taddei-Peters, Michael E. Bowdish, Marissa A. Miller, Michel Bilello, and Neal Jeffries

Subjects
Brain Infarction, Male, medicine.medical_specialty, Infarction, 030204 cardiovascular system & hematology, Embolic Protection Devices, law.invention, 03 medical and health sciences, Postoperative Complications, 0302 clinical medicine, Aortic valve replacement, Randomized controlled trial, Risk Factors, law, medicine, Clinical endpoint, Humans, Adverse effect, Stroke, Aged, Original Investigation, Heart Valve Prosthesis Implantation, business.industry, Incidence, Acute kidney injury, Delirium, Arrhythmias, Cardiac, Aortic Valve Stenosis, General Medicine, Acute Kidney Injury, medicine.disease, Surgery, Stenosis, Treatment Outcome, Aortic Valve, Heart Valve Prosthesis, Anesthesia, Female, business, 030217 neurology & neurosurgery
Abstract

Importance Stroke is a major complication of surgical aortic valve replacement (SAVR). Objective To determine the efficacy and adverse effects of cerebral embolic protection devices in reducing ischemic central nervous system (CNS) injury during SAVR. Design, Setting, and Participants A randomized clinical trial of patients with calcific aortic stenosis undergoing SAVR at 18 North American centers between March 2015 and July 2016. The end of follow-up was December 2016. Interventions Use of 1 of 2 cerebral embolic protection devices (n = 118 for suction-based extraction and n = 133 for intra-aortic filtration device) vs a standard aortic cannula (control; n = 132) at the time of SAVR. Main Outcomes and Measures The primary end point was freedom from clinical or radiographic CNS infarction at 7 days (± 3 days) after the procedure. Secondary end points included a composite of mortality, clinical ischemic stroke, and acute kidney injury within 30 days after surgery; delirium; mortality; serious adverse events; and neurocognition. Results Among 383 randomized patients (mean age, 73.9 years; 38.4% women; 368 [96.1%] completed the trial), the rate of freedom from CNS infarction at 7 days was 32.0% with suction-based extraction vs 33.3% with control (between-group difference, −1.3%; 95% CI, −13.8% to 11.2%) and 25.6% with intra-aortic filtration vs 32.4% with control (between-group difference, −6.9%; 95% CI, −17.9% to 4.2%). The 30-day composite end point was not significantly different between suction-based extraction and control (21.4% vs 24.2%, respectively; between-group difference, −2.8% [95% CI, −13.5% to 7.9%]) nor between intra-aortic filtration and control (33.3% vs 23.7%; between-group difference, 9.7% [95% CI, −1.2% to 20.5%]). There were no significant differences in mortality (3.4% for suction-based extraction vs 1.7% for control; and 2.3% for intra-aortic filtration vs 1.5% for control) or clinical stroke (5.1% for suction-based extraction vs 5.8% for control; and 8.3% for intra-aortic filtration vs 6.1% for control). Delirium at postoperative day 7 was 6.3% for suction-based extraction vs 15.3% for control (between-group difference, −9.1%; 95% CI, −17.1% to −1.0%) and 8.1% for intra-aortic filtration vs 15.6% for control (between-group difference, −7.4%; 95% CI, −15.5% to 0.6%). Mortality and overall serious adverse events at 90 days were not significantly different across groups. Patients in the intra-aortic filtration group vs patients in the control group experienced significantly more acute kidney injury events (14 vs 4, respectively; P = .02) and cardiac arrhythmias (57 vs 30; P = .004). Conclusions and Relevance Among patients undergoing SAVR, cerebral embolic protection devices compared with a standard aortic cannula did not significantly reduce the risk of CNS infarction at 7 days. Potential benefits for reduction in delirium, cognition, and symptomatic stroke merit larger trials with longer follow-up. Trial Registration clinicaltrials.gov Identifier:NCT02389894

Published
2017

18. Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial

Author

Richard B. Libman, Kirsty Harkness, Andreas Hartmann, Alessandra Biondi, Michael K. Parides, Rüdiger von Kummer, Jessica Overbey, Eric Vicaut, Joachim Berkefeld, Ellen Moquete, Jay P. Mohr, Marco Antonio Stefani, Catharina J.M. Klijn, Xavier Barreau, Alan J. Moskowitz, Rustam Al-Shahi Salman, Emmanuel Houdart, Christian Stapf, Charlotte Cordonnier, William L. Young, Claudia S. Moy, Wanke, Isabel (Beitragende*r), Sandalcioglu, Ibrahim Esol (Beitragende*r), and Sure, Ulrich (Beitragende*r)

Subjects
Adult, Intracranial Arteriovenous Malformations, Male, Pediatrics, medicine.medical_specialty, Population, Medizin, Radiosurgery, Neurosurgical Procedures, Article, law.invention, Embolization, Young Adult, Randomized controlled trial, law, Cause of Death, Clinical endpoint, Medicine, Humans, Prospective Studies, education, Stroke, Cause of death, Aged, education.field_of_study, Intention-to-treat analysis, business.industry, Hazard ratio, General Medicine, Middle Aged, medicine.disease, Combined Modality Therapy, Embolization, Therapeutic, Treatment Outcome, Female, Neurosurgery, Therapeutic, business
Abstract

BACKGROUND: The clinical benefit of preventive eradication of unruptured brain arteriovenous malformations remains uncertain. A Randomised trial of Unruptured Brain Arteriovenous malformations (ARUBA) aims to compare the risk of death and symptomatic stroke in patients with an unruptured brain arteriovenous malformation who are allocated to either medical management alone or medical management with interventional therapy.METHODS: Adult patients (≥18 years) with an unruptured brain arteriovenous malformation were enrolled into this trial at 39 clinical sites in nine countries. Patients were randomised (by web-based system, in a 1:1 ratio, with random permuted block design [block size 2, 4, or 6], stratified by clinical site) to medical management with interventional therapy (ie, neurosurgery, embolisation, or stereotactic radiotherapy, alone or in combination) or medical management alone (ie, pharmacological therapy for neurological symptoms as needed). Patients, clinicians, and investigators are aware of treatment assignment. The primary outcome is time to the composite endpoint of death or symptomatic stroke; the primary analysis is by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00389181.FINDINGS: Randomisation was started on April 4, 2007, and was stopped on April 15, 2013, when a data and safety monitoring board appointed by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health recommended halting randomisation because of superiority of the medical management group (log-rank Z statistic of 4·10, exceeding the prespecified stopping boundary value of 2·87). At this point, outcome data were available for 223 patients (mean follow-up 33·3 months [SD 19·7]), 114 assigned to interventional therapy and 109 to medical management. The primary endpoint had been reached by 11 (10·1%) patients in the medical management group compared with 35 (30·7%) in the interventional therapy group. The risk of death or stroke was significantly lower in the medical management group than in the interventional therapy group (hazard ratio 0·27, 95% CI 0·14-0·54). No harms were identified, other than a higher number of strokes (45 vs 12, pINTERPRETATION: The ARUBA trial showed that medical management alone is superior to medical management with interventional therapy for the prevention of death or stroke in patients with unruptured brain arteriovenous malformations followed up for 33 months. The trial is continuing its observational phase to establish whether the disparities will persist over an additional 5 years of follow-up.FUNDING: National Institutes of Health, National Institute of Neurological Disorders and Stroke.

Published
2013

19. Asymmetric versus symmetric tethering patterns in ischemic mitral regurgitation: geometric differences from three-dimensional transesophageal echocardiography

Author

Deborah D. Ascheim, Judy Hung, Linda D. Gillam, Xin Zeng, Joseph P. Mathew, James S. Gammie, Ellen Moquete, Maria Carmo P. Nunes, and John M. Dent

Subjects
Male, medicine.medical_specialty, Echocardiography, Three-Dimensional, Myocardial Ischemia, Sensitivity and Specificity, Internal medicine, Mitral valve, Image Interpretation, Computer-Assisted, Medicine, Humans, Radiology, Nuclear Medicine and imaging, cardiovascular diseases, Ventricular remodeling, End-systolic volume, Aged, Mitral regurgitation, Ejection fraction, Vena contracta, business.industry, Tethering, Mitral Valve Insufficiency, Reproducibility of Results, Anatomy, medicine.disease, Image Enhancement, medicine.anatomical_structure, cardiovascular system, Cardiology, End-diastolic volume, Mitral Valve, Female, Cardiology and Cardiovascular Medicine, business, Echocardiography, Transesophageal
Abstract

Ischemic mitral regurgitation (IMR) results from mitral leaflet tethering from left ventricular remodeling. Heterogeneity in local or global left ventricular remodeling can result in differential tethering patterns and affect mitral valve function and the degree of mitral regurgitation. The aims of this study were to compare mitral valve geometry in asymmetric and symmetric tethering patterns using three-dimensional transesophageal echocardiography and to examine the impact of tethering pattern on IMR severity.Sixty-two patients with moderate or greater IMR underwent three-dimensional transesophageal echocardiography for the assessment of mitral valve geometry. Symmetric and asymmetric tethering patterns were determined by mitral regurgitation jet direction and coaptation of the mitral leaflets. The ratio of posterior to anterior leaflet tethering angle was a measure of tethering pattern (the higher the ratio, the more asymmetric the pattern). Overall tethering degree was assessed by tenting volume (TV).Compared with the symmetric group, the asymmetric group had less annular dilatation, greater annular heights (10.3 ± 1.9 vs 8.5 ± 1.9 mm, P.01), greater ratios of posterior to anterior leaflet tethering angle (3.19 ± 0.88 vs 1.95 ± 0.46, P.01), and smaller TVs with more posterior displacement of the coaptation line. Vena contracta normalized to TV was greater in the asymmetric group (0.38 ± 0.24 vs 0.19 ± 0.13 cm/mL, P.01). Multivariate analysis showed that both ratio of posterior to anterior leaflet tethering angle (β = 0.46, P.001) and TV (β = 0.41, P = .001) were predictors of IMR severity.Differences in mitral valve geometry are observed between asymmetric and symmetric tethering patterns in IMR. IMR degree is affected by both the pattern of tethering and the total degree of tethering. For the same degree of tethering, an asymmetric pattern is associated with increased MR severity. The pattern of mitral leaflet tethering may be considered in therapeutic decision making.

Published
2013

20. Design, rationale, and initiation of the Surgical Interventions for Moderate Ischemic Mitral Regurgitation Trial: A report from the Cardiothoracic Surgical Trials Network

Author

Y. Joseph Woo, T. Bruce Ferguson, Judson B. Williams, Rebecca T. Hahn, John H. Alexander, Neal Jeffries, Eric A. Rose, Ellen Moquete, Patrick T. O'Gara, Michael K. Parides, John D. Puskas, Robert E. Michler, Deborah D. Ascheim, Peter K. Smith, John M. Dent, and Pierre Pagé

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Coronary Artery Disease, 030204 cardiovascular system & hematology, Severity of Illness Index, Article, law.invention, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Severity of illness, medicine, Humans, Prospective Studies, cardiovascular diseases, 030212 general & internal medicine, Prospective cohort study, Mitral regurgitation, Ischemic mitral regurgitation, business.industry, Mitral Valve Insufficiency, medicine.disease, 3. Good health, Surgery, Clinical trial, medicine.anatomical_structure, cardiovascular system, Cardiology, Cardiology and Cardiovascular Medicine, business, Artery
Abstract

Objective Patients with coronary artery disease complicated by moderate ischemic mitral regurgitation have demonstrably poorer outcome than do patients with coronary artery disease but without mitral regurgitation. The optimal treatment of this condition has become increasingly controversial, and a randomized trial evaluating current practices is warranted. Methods We describe the design and initial execution of the Cardiothoracic Surgical Trials Network Surgical Interventions for Moderate Ischemic Mitral Regurgitation Trial. Results This is an ongoing prospective, multicenter, randomized, controlled clinical trial designed to test the safety and efficacy of mitral repair in addition to coronary artery bypass grafting in the treatment of moderate ischemic mitral regurgitation. Conclusions The results of the Cardiothoracic Surgical Trials Network Surgical Interventions for Moderate Ischemic Mitral Regurgitation Trial will provide long-awaited information on controversial therapies for this morbid disease process.

Published
2012

21. 936-91 Is Exercise Thallium-201 Imaging Helpful in Risk Stratifying Patients with Cardiac Transplant Coronary Artery Disease?

Author

Mark L. Barr, Roxanne A. Rodney, Lynne L. Johnson, and Ellen Moquete

Subjects
medicine.medical_specialty, business.industry, chemistry.chemical_element, Disease, Exercise Thallium, medicine.disease, Sudden death, Coronary artery disease, chemistry, Spect imaging, Internal medicine, Cardiology, Medicine, Thallium, Radiology, Cardiology and Cardiovascular Medicine, business, Adverse effect, Survival analysis
Abstract

Prior studies have shown that patients with normal exercise SPECT thallium (TI) scans have a favorable prognosis despite the angiographic presence of CAD. Patients with cardiac transplant (Tx) CAD have a high incidence of adverse events including silent MI and sudden death. However given the limited availability of donor hearts. and the lower survival after the second transplant, a technique to risk stratify patients with Tx CAD would be clinically useful and cost-effective. Thirteen patients (mean post-Tx time 40 mo) with angiographic CAD underwent exercise and 4 hr redistribution SPECTTI imaging. Ten patients had epicardial (≥50% diameter reduction) and small vessel disease, two had isolated small vessel disease, and one had isolated epicardial disease. SPECT imaging revealed fixed or reversible defects in 10/13 (77%) patients, 3 patients had normal scans. There was no significant difference in mets achieved during exercise, nor in the extent of CAD between the groups. During a mean follow-up of 20 mo, 8/10 (80%) patients with positive TI scans had graft failure or death vs 0/3(0%) patients with negative TI scans (p

Published
1995

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