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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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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.
Predictors of Left Ventricular Outflow Tract Obstruction After Transcatheter Mitral Valve Replacement in Severe Mitral Annular Calcification: An Analysis of the Transcatheter Mitral Valve Replacement in Mitral Annular Calcification Global Registry
Sabbagh, Abdallah El , Al‐Hijji, Mohammed , Wang, Dee Dee , Eleid, Mackram F. , Ureña, Marina , Himbert, Dominique , Chakravarty, Tarun , Fang, Hao , Zahr, Firas , Dvir, Danny , Sardar, Muhammad , Cheema, Asim N. , Alnasser, Sami , Iyer, Vijay , Kaddissi, Georges, Webb, John G. , Makkar, Raj , Vahanian, Alec , Rihal, Charanjit S. , Eleid, Mackram F , Nejjari, Mohammed , Dvir, Danny , Rihal, Charanjit, Guerrero, Mayra E , Al-Hijji, Mohammed A , Wang, Dee Dee , Holzhey, David Michael , Pershad, Ashish , Nejjari, Mohammed , O’Neill, William W. , Rihal, Charanjit S. , Guerrero, Mayra
Circulation: Cardiovascular Interventions | October 19, 2021 | Volume: 14 | Issue: 10 | Pages: No page available
10.1161/circinterventions.121.010854
Background: Several studies have evaluated preprocedural imaging predictors of left ventricular outflow tract obstruction (LVOTO) after transcatheter mitral valve replacement. The patient cohorts in these studies were heterogeneous and included patients with transcatheter mitral valve replacement in failed bioprostheses, annuloplasty rings, and severe mitral annular calcification (MAC). The goal of this study was to evaluate predictors of LVOTO specific to patients undergoing valve-in-MAC. Methods: This study included patients with severe MAC who underwent valve-in-MAC and had optimal quality preprocedural multidetector row computed tomography scans eligible for retrospective analysis. Baseline demographic, echocardiographic, and procedural data on these patients were collected. multidetector row computed tomography parameters were analyzed for association with LVOTO, defined as increase in mean LVOT gradient by ≥10 mm Hg with accompanying hemodynamic instability. Results: Seventy-one patients with optimal preprocedural computed tomography scans were included in this study (mean age, 72.5±13.5 years), 9 of which developed LVOTO (all female). Baseline mean LVOT area, neo-LVOT area (145.3 versus 270.9 mm 2 ; P =0.006), indexed neo-LVOT area (90.1 versus 157.4; P =0.05), and virtual transcatheter heart valve to septum distance (3.1 versus 6.9 mm; P =0.002) were lower in the LVOTO group. Expected % LVOT area reduction was higher in the latter group (58.3 versus 42.7%; P =0.008). In the univariable analysis, the baseline mean LVOT area, neo-LVOT area, indexed neo-LVOT area, and valve to septum distance were all significantly associated with LVOTO. Conclusions: The systolic mean LVOT area, neo-LVOT area, indexed neo-LVOT, expected percentage LVOT area reduction, and the valve to septum distance were associated with LVOTO after valve-in-MAC.