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Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients
Deeb, G. 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Scott, McDaniel, Sharon S., Pack, Angelina, White, Wendi, Young, Travis S. , Burgess, Pam, Pu, Min , Upadhya, Bharathi , Applegate, Robert J., Kon, Neal D., Arnan, Martinson, Baghshomali, Sanam, Bishop, L. R., Bradbury, Edward, Gandhi, Sanjay , Kincaid, Edward H., Lefkowitz, David , Lisle, Benjamin, Batteria, Melissa, Rerisi, Elizabeth, Stepinowski, Kimberly, Senicola, Tanya, Goncalves, John, Schubach, Scott , Schwartz, Richard, Antaky, Karin, Christiansen, C, Marzo, Kevin , Michel, Kathleen, Varghese, Princy , Wirkowski, Elizieta, Lévesque, Linda E. , Cleman, Michael , Forrest, John K. , Hashim, Sabet, Mangi, Abeel A. , Amin, Hardick, Darr, Umer, Dewar, Michael, Faheem, Osman, Geirsson, Arnar , Kaleel, Abdel Salam, Kaple, Ryan , Lansky, Alexandra, Grory, Brian Mac, Pfau, Steven , Schindler, Joseph , Yuh, David D., Serruys, Patrick W , Limaye, Kaustubh , Windecker, Stephan , Reardon, Michael J , Bode, Felix J , Mieghem, Nicolas M. Van , Søndergaard, Lars , Olsen, Peter Skov , Crestanello, Juan A. , George, Isaac , Serruys, Patrick W. , Williams, Mathew , Adams, David , Investigators, SURTAVI Trial, Meyer, Karen, Roberts, Dana, Sorajja, Paul , Flavin, Thomas, Gössl, Mario , Mooney, Michael R , Pendleton, Kristin, Fry, Robert, Heine, Carl, Tran, Tin, Bremer, Karen, Pieter, Jan, Verbiest, Henk, Waller, Deborah, Ahmed, Arshad , Allaqaband, Suhail Q. , Werner, Paul , Bessette, Lynn, Klein, Jason, Brady, Kevin, Chung, Steven, Franz, Douglas, Pershad, Ashish , Porter, Charlotte, Craig, John, Elijovich, Lucas , Wolf, Bradley, Wright, Lance, Roberts, Brad, Henry, Carl, Laham, Roger J. , Burke, David, Chui, Angus Shing Fung , Liu, David M. , Nathan, Senthil, Pinto, Duane S. , Searls, D. Eric, Fisher, Susan, Lim, D. Scott , Ng, Ken, Bates, Michael, Grey, William, Rose, Geoffrey, Scherer, Markus, Martin, Jerry, Cheng, Wen, Kar, Saibal , Mody, Cyrus, Ramzy, Danny , Sohn, Jeanie, Hahn, Rebecca T , Contreras, Jose Gutierrez, Kummer, Benjamin R. , Miller, Eliza C. , Nazif, Tamim , Qureshi, Abid, Rostanski, Sara , Willey, Joshua , Yaghi, Shadi , Rosenbloom, Michael, Schell, Wendy, Huang, Hong , Ali, Omar, Henry, Scott, Bleiziffer, Sabine , Hengstenberg, Christian , Brenner, Susanne, Kasel, Albert Markus , Kreuzpointner, Robert , Poppert, Holger , Seifert, Christian, Voß, Bernhard , Cowhig, Dahlia, Newbold, Stephanie, Velazquez, Eric J. , Harrison, J. Kevin, Hughes, George Chad , Ali, Yasmin, Gokhale, Sankalp , Hendry, Robert, Hernandez, Christian, Klein, Michael, Kolls, Brad J. , Maldonado, Andres M. 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Neil, Mirsattari, Seyed M. , Young, Bryan, Dajani, Khaled Z. , Darki, Amir , Schwartz, Jeffrey, Howe-Clayton, Desirae L., Bruce, Charles J. , Freeman, William D. , Nkomo, Vuyisile T. , Pislaru, Sorin V. , Alkhouli, Mohamad , Maor, Elad , Panaich, Sidakpal , Peterson, Angela, Raphael, Claire E. , Sanon, Saurabh , Scharf, Eugene , Lapierre, Serge, Piazza, Nicolo, Rooij, Frank van, Barnes, Caroline, Griffin, Sandra, Goldstein, Steven A. , Marcus, Rachel, Widell, Jared K., Lowery, Robert, Klein, Marc, Jacoby, Michael, Purpura, Jenelle, Cohen, Barry, English, Karen, Généreux, Philippe , Slater, James N. , Turner, Joanne, Montgomery, Susan, Barry, Michael J. , Navas, Jorge, Patel, Vijay S , Arora, Ajay K., Stone, Lisa, Turner, Nancy, Singh, Julie, Chan, Grace, DeOrchis, Vincent S., Esposito, Rick, Han, Michael David , Kaplan, Barry, Palazzo, Robert, Wright, Paul, Houanche, Pascale, Morales, Vanessa, Taylor, Zachary, Sarić, Muhamed , Galloway, Aubrey C. , Attubato, Michael , Grossi, Eugene A. , Jones, Danielle, Orsinelli, David A. , Ryan, James Michael, Ryan, Thomas A. , Kılıç, Ahmet , O'Neil, Susan, Cheatham, John P. , Mehl, Brad, Ghani, Mohammad, Randolph, John F. , Williams, John Paul , Tucker, Claire, Dean, David A. , Gott, John, Russell, Christopher, Vannan, Mani A. , Butler, Kim, Spangler, Jessica, Maini, Brijeshwar , Mumtaz, Mubashir, Aneja, Parul, Shah, Jagdish, Gebhardt, Linda, Jones, Ursula, John, Henriette, Fuchs, Angela, Sedaghat, Alexander , Vasa‐Nicotera, Mariuca , Groth, Susanne, Kristensen, Line, Rosenberg, Tine , Møller, Jacob Eifer , Andersen, Henrik, Bieliauskas, Gintautas , Carranza, Christian Lildal , Backer, Ole De , Hansen, Klaus, Lund, Jens, Richards, David A. , Hicks, William, Hayes, Natalie, King, Dana, Chhatriwalla, Adnan K , Cohen, David Jonathan , Jensen, Ann, Bechis, Mary Z., Hu, Stephen, Tyner, Jeffrey W. , BREWSTER, SCOT A., Hanna, Nicholas, Patel, Aalok P. , Thompson, Caleb, Walsh, Joseph, Cohen, Daniel, Jordan, Grace, Helm, Elizabeth, Rai, Vivek, Liang, David H. , Miller, D. Craig , Yeung, Alan C. , Rost, Ilona, Heijmen, Robin H. , Ten Berg, Jurrien , Bosschaert, Mike A.R., Berke, Andrew, Reynolds, Rebecca M. , Sharma, Rakesh , Stuart, Amanda, Chandrasekaran, Venkatachalam, Herbert, Natalie, Batra, Sanjay, Cullis, Paul, Martin, James G. , Burkert, Mary Lynn, Wheatley, Jessica, Ball, Michael, Robison, Robert, Fremes, Stephen E. , Elbaz‐Greener, Gabby , Feld, Yair , Wijeysundera, Harindra C. , Beck, Pamela, Nelson, Ana, Malek, Ali R. , Pan, Hao , Ramos, Angelica, Brinkman, William T. , Gopal, Ambarish, Szerlip, Molly , Jacobs, Amber, Ludwig, Sheryl, Underwood, Carol, Faza, Nadeen Nader , Atkins, Marvin D. , Bledsoe, Don, Chiu, David, Goel, Sachin S. , Gray, Tiffany, Lin, Chun, White, Shannon, Wong, Richmond, Lau, Jeffrey, Nakamura, Dean, Gallagher, Lauren, Siki, Mary A. , Herrmann, Howard C. , Desai, Nimesh D. , Messé, Steven R. , Price, Raymond, Quinn, Colin, Vallabhajosyula, Prashanth , Wu, Libo, Horlick, Eric , Silver, Frank, Beyersdorf, Friedhelm , Neumann, Franz‐Josef , Siepe, Matthias , Thoma, Martin, Hager, Christine, Stader, Michael, Stämpfli, Simon F. , Falk, Volkmar , Maisano, Francesco , Holubec, Tomáš , Wegener, Susanne , Atkinson, Rachel, Costa, Marco , García, Carlos , Jadhav, Vikram, Le, Scott, Miller, Benjamin F. , Deo, Salil V. , Anderson, Jennifer , Page, Susie, Freeman, Jon, Alfonso, Carlos, Panos, Anthony L. , Romano, José G. , Adelman, Eric E. , Kim, Karen C. , McDermott, Margaret, Pace, Robert, Ramchandren, Sindhu , Wang, Michael, Zahuranec, Darin B. , Ruel, Marc , Glover, Chris, Cavalcante, João L. , Sultan, Ibrahim , Campbell, David, Giurgiutiu, Dan‐Victor , Gulati, Deepak, Hawkes, Christine, Henry, Lisa, Jadhav, Ashutosh P. , Klein, Bradley, Rangaraju, Srikant , Rocha, Marcelo, Streib, Christopher , Walker, Greg, Ball, Stephen, Goel, Kashish , Ahmad, Rashid, Hermann, Lisa, Hoff, Steven, Kirshner, Howard S. , Baer, Judy, Liang, Grace, Heidenreich, Paul A. , McDaniel, Sharon, Young, Travis, Burgess, Pam, Pu, Min, Bishop, Laura, Gandhi, Sanjay, Lefkowitz, David, Rerisi, Elizabeth , Christiansen, Colleen, Misra, Ajay, Varghese, Princy, Levesque, Linda, Sugeng, Lissa , Dewar, Michael, Greer, David M. , Grory, Brian Mac, Thompson, Craig, Youn, Teddy, Yun, James J
JAMA Cardiology | August 24, 2022 | Volume: 7 | Issue: 10 | Pages: 1000
Importance In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.
Transcatheter interventions in adults with congenital heart disease: Surveys from the Society for Cardiovascular Angiography and Interventions to identify current patterns of care and perception on training requirements
Wadia, Subeer , Accavitti, Michael J., Kenny, Damien , Hijazi, Ziyad M. , Jones, Thomas K. , McElhinney, Doff B. , Kavinsky, Clifford J. , Wadia, Subeer K , Cabalka, Allison K. , Morgan, Gareth John , McElhinney, Doff B
Catheterization and Cardiovascular Interventions | May 11, 2017 | Volume: 90 | Issue: 3 | Pages: 418-424
Abstract Background Interventional catheterization is central to the care of Adults with Congenital Heart Disease (ACHD). Current standards for care provision and training in ACHD intervention are lacking. We sought to examine trends in current practice and training among interventionalists. Methods We analyzed the results of two separate international surveys in June 2016. One was sent to all active members from the Society of Cardiovascular Angiography and Interventions (SCAI) who self‐identified Structural Heart Disease or Congenital Heart Disease as a practice area. The second survey was conducted through the Pediatric Interventional Early Career Society (PICES) aimed at pediatric and adult congenital interventionalists in their first seven years after training. The total survey sample sizes were 1,535 and 112, respectively. Results Response rates for the SCAI and PICES surveys were 15% (237/1,535) and 75% (84/112), respectively. Most respondents (74%) worked at institutions with pediatric and adult facilities in proximity (major medical centers). While 75% of SCAI respondents believed complex transcatheter procedures should be performed by ACHD‐trained interventionalists or multidisciplinary teams, only 32% reported such care is being provided at the present time. Most pediatric and adult cardiologists surveyed (73%) do not believe current interventional fellowships provide adequate training for proficiency in ACHD interventions. Conclusions ACHD management remains underdeveloped in relative terms, particularly in the United States. Significant gaps in interventional standards of practice and future training needs were recognized by this study. Our survey should serve as an impetus to establish training guidelines for physicians who seek to perform ACHD interventions.