Citations 8
Three-Year Outcomes Following TAVR in Younger (
Modine, Thomas , Tchétché, Didier , Mieghem, Nicolas M. Van , Deeb, G. Michael , Chetcuti, Stanley, Yakubov, Steven J. , Sorajja, Paul , Gada, Hemal, Mumtaz, Mubashir , Ramlawi, Basel , Bajwa, Tanvir , Crouch, John , Teirstein, Paul S., Kleiman, Neal S. , Iskander, Ayman, Chu, Michael , Sudre, Arnaud , Huang, Jian, Popma, Jeffrey J. , Forrest, John K. , Van Mieghem, Nicolas M , Bagur, Rodrigo , Chu, Michael W A , Berthoumieu, Pierre , Sudre, Arnaud , Adrichem, Rik , Ito, Saki , Forrest, John K , Modine, Thomas , Sorajja, Paul , Bagur, Rodrigo , Ito, Saki , Huang, Jian Qun , Reardon, Michael J.
Circulation: Cardiovascular Interventions | October 18, 2024 | Volume: 17 | Issue: 11 | Pages: No page available
10.1161/circinterventions.124.014018
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery. METHODS: The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years. RESULTS: In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery ( P =0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; P =0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; P <0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, P =0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients ( P <0.001) and lower rates of severe prosthesis-patient mismatch ( P <0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation. CONCLUSIONS: Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR. REGISTRATION: URL: https://clinicaltrials.gov ; Unique identifier: NCT02701283.
Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk
O’Hair, Daniel, Yakubov, Steven J. , Oh, Jae K. , Deeb, G. Michael, Bajwa, Tanvir , Kleiman, Neal S. , Chetcuti, Stanley, Gada, Hemal, Mumtaz, Mubashir , Heiser, John, Merhi, William , Petrossian, George , Robinson, N. Bryce , Tang, Gilbert H.L. , Rovin, Joshua D. , Little, Stephen H. , Jain, Renuka , Verdoliva, Sarah , Hanson, Tim, Li, Shuzhen , Popma, Jeffrey J. , Reardon, Michael J. , Ito, Saki , Reardon, Michael J , Grubb, Kendra J , Deeb, G. Michael , Mieghem, Nicolas M. Van , Adams, David , Søndergaard, Lars , Hanson, Tim
JAMA Cardiology | December 14, 2022 | Volume: 8 | Issue: 2 | Pages: 111
ImportanceThe frequency and clinical importance of structural valve deterioration (SVD) in patients undergoing self-expanding transcatheter aortic valve implantation (TAVI) or surgery is poorly understood.ObjectiveTo evaluate the 5-year incidence, clinical outcomes, and predictors of hemodynamic SVD in patients undergoing self-expanding TAVI or surgery.Design, Setting, and ParticipantsThis post hoc analysis pooled data from the CoreValve US High Risk Pivotal (n = 615) and SURTAVI (n = 1484) randomized clinical trials (RCTs); it was supplemented by the CoreValve Extreme Risk Pivotal trial (n = 485) and CoreValve Continued Access Study (n = 2178). Patients with severe aortic valve stenosis deemed to be at intermediate or increased risk of 30-day surgical mortality were included. Data were collected from December 2010 to June 2016, and data were analyzed from December 2021 to October 2022.InterventionsPatients were randomized to self-expanding TAVI or surgery in the RCTs or underwent self-expanding TAVI for clinical indications in the nonrandomized studies.Main Outcomes and MeasuresThe primary end point was the incidence of SVD through 5 years (from the RCTs). Factors associated with SVD and its association with clinical outcomes were evaluated for the pooled RCT and non-RCT population. SVD was defined as (1) an increase in mean gradient of 10 mm Hg or greater from discharge or at 30 days to last echocardiography with a final mean gradient of 20 mm Hg or greater or (2) new-onset moderate or severe intraprosthetic aortic regurgitation or an increase of 1 grade or more.ResultsOf 4762 included patients, 2605 (54.7%) were male, and the mean (SD) age was 82.1 (7.4) years. A total of 2099 RCT patients, including 1128 who received TAVI and 971 who received surgery, and 2663 non-RCT patients who received TAVI were included. The cumulative incidence of SVD treating death as a competing risk was lower in patients undergoing TAVI than surgery (TAVI, 2.20%; surgery, 4.38%; hazard ratio [HR], 0.46; 95% CI, 0.27-0.78; P = .004). This lower risk was most pronounced in patients with smaller annuli (23 mm diameter or smaller; TAVI, 1.32%; surgery, 5.84%; HR, 0.21; 95% CI, 0.06-0.73; P = .02). SVD was associated with increased 5-year all-cause mortality (HR, 2.03; 95% CI, 1.46-2.82; P &lt; .001), cardiovascular mortality (HR, 1.86; 95% CI, 1.20-2.90; P = .006), and valve disease or worsening heart failure hospitalizations (HR, 2.17; 95% CI, 1.23-3.84; P = .008). Predictors of SVD were developed from multivariate analysis.Conclusions and RelevanceThis study found a lower rate of SVD in patients undergoing self-expanding TAVI vs surgery at 5 years. Doppler echocardiography was a valuable tool to detect SVD, which was associated with worse clinical outcomes.Trial RegistrationClinicalTrials.gov Identifiers: NCT01240902, NCT01586910, and NCT01531374
Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients
Deeb, G. 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O., Perko, Mario J. , Sander, Kåre, Smerup, Morten , Thiis, Jens J., Thyregod, Hans Gustav Hørsted , Monnin, Kathryn, Popelas, Lori, Slyman, Martha, Grewal, Kanny, Matros, Todd, Watson, Daniel, Arshi, Arash, Blossom, Geoffrey B., Chapekis, Anthony T., Duff, Steven B., Hicks, William, Holland, Stephanie , Kander, Nathan H., Lyons, Jefferson M., Mejilla, Jennifer, Reese, Brenda, Sanchez, Carlos E. , Vora, Nirav , Erwin, Sheila, Hall, Jamie , Hayes, Natalie, Miller, Margie, Main, Michael L., Allen, Keith B. , Aggarwal, Sanjeev, Borkon, Michael, Boutwell, Christine, Davis, James R. , Grantham, Aaron, Magalski, Anthony, Olds, Karin, Buchanan, Tiffany, Daniel, Misty, Estrada, Katrina, Hollen, Matthew, Lazarsfeld-Jensen, Ann , Kennen, Jada, Bechis, Mary, Rubenson, David, Teirstein, Paul, Ahmad, Daniel, Atri, Prashant , Azarbal, Farnaz, Brewster, Scot, Brown, Christopher , Foley, T. Raymond , Groves, Elliott M. , Kalafut, Mary, Levisman, Jeffrey, Mellinger, Douglas, Odunukan, Olufunso W. , Ong, Daniel, Oyama, Jared, Panguluri, Praveen, Raney, Aidan A., Rao, Suraj, Schultz, Jason, Sharma, Alok , Stinis, Curtiss, Thompson, C. Bradley , Wadia, Subeer , Walsh, Joseph, White, Jeremy , Purrington, Elizabeth, Zulick, Chelle, Murillo, Jaime , Mahoney, Paul, Newton, Joseph, Rich, Jeffrey, Bagameri, Gabor, Dimeling, George, Jordan, Grace, Mistry, Neville F., Philpott, Jonathan M. , Sirak, John, Sourbeer, Sarah, Talreja, Deepak, Zweifler, Richard M., Helm, Elizabeth, Postema, Karen, Over, Elizabeth Van, Chilton, Dale, Mitchell, Lou, Berkompas, Duane , Fanning, Justin, Khan, Muhib , Sang, Stephane Leung Wai , Omran, Kaskar, Patzelt, Lawrence H., Thoits, Timothy , Vijayappa, Madhu, Kasle, Margie, Trautman, Leigh, Dash, Rajiv, Fischbein, Michael P. , Fearon, William F. , George, Paul V., Speight, Martina K., Tai, Waimai Amy, Albersen, Inke, Bras, Rebecca Gornelda, Feirabend, Conny, Helwig-Vernooij, Johanna Catharina, Kranen, Gerda, Oostveen, Manfred, Rost, Ilona, Deutekom, Inge van, Weelden, Atie van, Heijmen, Robin, Bosschaert, Mike Arnoud Ramon, Kroon, Thomas L. de, Hilkens, P.H.E. , Mast, Eliza G., Rensing, B. J. W. M., Schonewille, W.J., Akker, Alberta Nelina van den, Haag, Elizabeth, Jennings, Joan, Krug, Patricia, Santiago, Lyn, Seth, Sonika , Dimsuyu, Nellia, Mihalatos, Dennis, Petrossian, George , Robinson, N. Bryce , Bercow, Neil, Berke, Andrew E. , Deutsch, Ezra, Stevens, Perry, Brown, Sue, Jardim, Victor Dos Santos, Radford, Nicole, Sookhoo, Venessa, Kyereme, Kojo, Punzalan, Rachel, Sculeany, Bogdan, Brecker, Stephen , Jahangiri, Marjan , Alassa, Aiman, Chandrasekaran, Venkatachalam, Clarke, Brian , Dowling, Cameron , Moynihan, Barry, Roy, David, Sarsam, Mazin A.I., Bess, Renee, Henkel, Megan, Cohen, Gerald M., Davis, Thomas, Aboukasm, Amer, LaLonde, Thomas , Yamasaki, Hiroshi , Burkert, Marylynn, Kingma, Barbara, Wheatley, Jessica, Segar, Douglas S., Heimansohn, David, Hermiller, James, Ball, Michael, Elsner, Gregory, Hanan, Scott A., Moainie, Sina L. , Nukes, Theodore, Reibold, Patrick, Robison, Robert, Salerno, Christopher T. , Sampson, Andrew, Walts, Peter A., Wandel, Emily, Li, Mary , Sarker, Sulagna, Ahmed, Shaheeda, Radhakrishnan, Sam, Arbel, Yaron , Christakis, George T., Cohen, Gideon, Czarnecki, Andrew , Hopyan, Julia, Komatsu, Ikki , McCraig, Kathleen, Shuvy, Menashe, Toma, Jonathan, Vincenzo, Basile, Wheeler, Cindi, Wolff, Rafael , Beck, Pamela J., Cabral, Donna J., DaCosta, Christine, Hudson, Laura, Pastie, Michelle, Abrahams, Nicole, Altamar, Ingrid, Buitrago, Mike, Cassman, Gabrielle, Leibovici, Zvi, Nelson, Ana, Recchia, Kelly, Robbins, Gillian, Studor, Kelly, Bethea, Brian, Beyer, Erik, Evans, Sharron, Goodis, Caleene, Mueller‐Kronast, Nils , Pantoja, Claudia, Wells, Channing, Youngblood, Colten, Snelus, Patricia, Gopal, Deepika, Jackson, Kristie, Brown, David L. , Ryan, William H. , Gopal, Ambarish, Harrington, Katherine, Mack, Michael J. , Nosnik, Pedro, Potluri, Srinivasa , Smith, Robert L. , Szerlip, Molly, Blaylock, Candice, Brinegar, Patricia, Canter, Laura, Green, LaShawna, Green, Lisa , Hazen, Pamela, Jacobs, Amber, Khan, Saba , Ludwig, Sheryl, Mata, Mary, Moore, Tammara, Underwood, Carol , Little, Stephen H. , Nagueh, Sherif F. , Albright, Kimberly, Barker, Colin M. , Bledsoe, Donald, Chiu, David, Gray, Tiffany , Imperial-Aubin, Delmar, Lin, Chun C., Moye, Stacy, Ramchandani, Mahesh, Ramlawi, Basel , Reul, Ross M. , Reyes, Manuel, Scheinin, Scott , Volpi, John , Ballmoos, Moritz Wyler von, Blackburn, Beth, Hart, Chari Y. T., Whitacker, Pearl, Lau, Jeffrey, Spies, Christian , Badawi, Ramy A., Graner, Sarah, Nakamura, Dean, Plank, Benjamin, Salem, Rony, Seto, Todd B. , Valenta, Douglas, Cruz, Amber, Gallagher, Lauren T. , Schuck, Laura, Weeks, Andre, Fishman, Lise, Schwarz, Teresa, Bavaria, Joseph E. , Anwaruddin, Saif , Giri, Jay , Khella, Sami, Li, Robert, McGarvery, Michael, Price, R A, Szeto, Wilson Y. , Sun, Yang , Wu, Libo , Tsang, Wendy , Thavendiranathan, Dinesh, Feindel, Chris, Casaubon, Leanne K. , Cusimano, Robert J. , Campo, Martín del , Osten, Mark , Höwisch-Pengel, Rita, Lechner, Gabriele, Steiger, Barbara, Allgeier, Martin, Jander, Nikolaus , Büttner, Heinz Joachim, Comberg, Thomas, Diab, Nawras , Gick, Michael, Günkel, Ludwig, Pingpoh, Clarence , Rothe, H. Jürgen, Thoma, Martin , Winker, Thomas, Häger, Christine , Sänger, Ulrike, Stader, Michael, Biaggi, Patric , Gruner, Christiane, Binder, Ronald K. , Corti, Roberto , Holy, Erik W. , Grünenfelder, Jürg , Maier, Willibald, Nietlispach, Fabian, Atkinson, Rachel , Davis, Angela , Hall, Suzanne, Mangene, Samantha, Mazzurco, Stacey, Hoit, Brian D. , Musarra, Raymond, Markowitz, Alan , Asi, Khaled, Attizzani, Guilherme F. , Chuang, Dennis Y. , Elgudin, Yakov , Le, Scott T., Serkin, Zakhar, Shams, Tanzila, Sila, Cathy, Simon, Daniel I. , Bezerra, Hiram G. , Greening, Kyle, Karson, Jodi, Page, Susie, Shawgo, Tilitha, Freeman, Jon C., Mulhern, Kevin, Nath, Jayant , Tadros, Peter, Zorn, George L., Hockstad, Eric, Lechtenberg, Colleen, Muehlebach, Gregory, Rippee, Michael , Rosterman, Lee , Sundararajan, Jayashree, Wang, Yunxia , Wiley, Mark, Atapattu, Suresh, Kall, Christian Marin y, Lowery, Maureen H., Marchena, Eduardo de , Salerno, Tomás A. , Carillo, Roger, Ferreira, Alexandre , Williams, Donald, Bhatt, Shradha, Migda, Erin M., Oakley, Jessica, Warshal, Wendy, Wilcock, Sandra, Booher, Anna M., LaBounty, Troy , Boyle, Mary Jo, Geml, Rachel, Grossman, Paul , Guerin, Danielle, Hodges, Kelley, Lammers, Deborah, Menees, Daniel, Patel, Himanshu J. , Prager, Richard L. , Romano, Matthew, Stamper, Angela, Wang, Michael, Ziarkiewicz, Melanie, Charlebois, Cheryl, Chilton, Colleen, Labinaz, Marino , Lam, Khanh, Masters, Roy G., Steffenhagen, Nikolai, Enlow-Germovsek, Melissa, Konopka, Kristin, McGargle, Rachel, Travis, Melissa, Anderson, Kathy, Crock, Fred, Edelman, Kathy, Katz, William E. , Aghaebrahim, Amin Nima, Al-Bayai, Alhamza, Bonaccorsi, Christina, Gulati, Deepak , Henry, Lisa, Kenmuir, Cynthia L. , Klein, Bradley G., Kliner, Dustin , Limaye, Kaustubh , Nanduri, Sunanda, Navid, Forozan, Patel, Pratit , Rocha, Marcelo Borges , Schindler, John , Shoirah, Hazem , Tadi, Prasanna , Tememe, Danoushka, Totoraitis, Ruta, Walker, Greg , Ziayee, Habibullah, Caufield, Lori, Yeager, Carol, Forbes, Jennifer , Schwart, Karl Q., Knight, Peter A. , Ling, Frederick, Benesch, Curtis, Bogachan, Sahin, Hicks, George L., Kelly, Adam G. , Narins, Craig R. , Stuver, Thomas, Adams, Kathy, Blair-Anton, Lynn, Haynes, Mary Lou, Watts, Carol, Baker, Michael , Mendes, Lisa A., Kaiser, Clayton A., Robbins, Mark, Zhao, David , Ahmad, Rashid, Crenshaw, Marshall, Fredi, Joseph L., Hermann, Lisa, Hoff, Steven J. , Levack, Melissa M., Mittal, Shilpi , O’Duffy, Anne E, Petracek, Michael R., Baer, Judy, Liang, Grace , Nguyen, Son , Nguyen, Patricia K. , Burdon, Thomas A., Giacomini, John C., Yong, Celina M. , Buchbinder, Maurice , Fann, James I. , Kilgore, Shannon M., Mitchell, R. 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. Pineda, Price, Andrew James , Sherwood, Matthew W. , Swisher, Christa B. , Wang, Andrew , Lamm, Janet, Schroeder, Ryan, De, Ajanta, Charles, Elizabeth, Wheeler, Lauren, Merlino, John , Greene, James, Harrison, Amy, Leshnower, Bradley G. , Miller, Jeffrey S. , Nahab, Fadi B , Stewart, James, Kappetein, A. Pieter , Bekkers, Jos A. , Jaegere, Peter Paul de, Koudstaal, Peter J. , Henderson, Amy, Schneider, David J. , Tischler, Marc, Ittleman, Frank P., Coyle, David, Ehle, Gregory L., El-Haddad, Mohamed, Falduto, Catherine, Gorman, Mark, Seecheran, Naveen Anand , Burgess, Brian, Cummings, Christopher, Holland, Neil, Long, Doug, Barton, Sally, Mariscalco, Giovanni , Reid, Lori, Reilly, Susan, Seshiah, Puvi , Azemi, Talhat, Brown, Robert, Hammond, Jonathan , Underhill, David J., Escobar, Jose, Solanki, Ashish, Cooper, Raymond, Wang, Dee Dee , Greenbaum, Adam B. , Guerrero, Mayra , Cosme, Carlos De La Cruz, Muñoz-García, Antonio J. , Torres, Marta, Hera, Jesús M. de la , Tassa, Cesar Morís de la, Fernández, Pablo Avanzas, Fernández, Lorena Benavente, Valle, Raquel Del, Arnold, Marcel , Beyeler, Morin , Capek, Lukas, Corpataux, Noé , Göldlin, Martina B., Lanz, Jonas , Praz, Fabien , Spirito, Alessandro , Stortecky, Stefan , Allen, Meredith, Gonzales, Michael, Whisenant, Brian K. , Citro, Kathleen, Fisher, Michele, Shah, Ashish S. , Bui, Anh, Watanabe, Colin, Pfeffer, Thomas A , Bäck, Magnus , Rück, Andreas , Palma, Rodney De , Anderson, Michelle, Limaye, Sameer, Farhi, Anita, Ricketts, Melissa, Mandel, Steven, Chu, Michael , Bagur, Rodrigo , Gofton, Teneille , McKenzie, F. 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 &lt; .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P &lt; .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 &lt; .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 Aortic Valve Replacement in Low-risk Patients With Bicuspid Aortic Valve Stenosis
Forrest, John K. , Ramlawi, Basel , Deeb, G. Michael , Zahr, Firas , Song, Howard K. , Kleiman, Neal S. , Chetcuti, Stanley, Mangi, Abeel A. , Skiles, Jeffrey, Huang, Jian, Popma, Jeffrey J. , Reardon, Michael J. , Reardon, Michael J , Michelena, Héctor I. , Huang, Jian Qun
JAMA Cardiology | October 7, 2020 | Volume: No volume available | Issue: No issue available | Pages: No page available
Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Prior Coronary Artery Bypass Grafting
Khera, Sahil , Villablanca, Pedro , Taub, Cynthia C. , Kleiman, Neal S. , Weisz, Giora, Inglessis, Ignacio, Rihal, Charanjit S. , García, Mario J. , Bhatt, Deepak L. , Gupta, Tanush, Kolte, Dhaval, Kalra, Ankur , Elmariah, Sammy, Bhatt, Deepak L , Gupta, Tanush , Kolte, Dhaval , Goel, Kashish , Aronow, Herbert D. , Abbott, J. Dawn , Fonarow, Gregg C. , Elmariah, Sammy , Rihal, Charanjit S.
Circulation: Cardiovascular Interventions | April 11, 2018 | Volume: 11 | Issue: 4 | Pages: No page available
10.1161/circinterventions.117.006179
Background— A significant proportion of patients requiring aortic valve replacement (AVR) have undergone prior coronary artery bypass grafting (CABG). Reoperative heart surgery is associated with increased risk. Data on relative utilization and comparative outcomes of transcatheter (TAVR) versus surgical AVR (SAVR) in patients with prior CABG are limited. Methods and Results— We queried the 2012 to 2014 National Inpatient Sample databases to identify isolated AVR hospitalizations in adults with prior CABG. In-hospital outcomes of TAVR versus SAVR were compared using propensity-matched analysis. Of 147 395 AVRs, 15 055 (10.2%) were in patients with prior CABG. The number of TAVRs in patients with prior CABG increased from 1615 in 2012 to 4400 in 2014, whereas the number of SAVRs decreased from 2285 to 1895 ( P trend <0.001). There were 3880 records in each group in the matched cohort. Compared with SAVR, TAVR was associated with similar in-hospital mortality (2.3% versus 2.4%; P =0.71) but lower incidence of myocardial infarction (1.5% versus 3.4%; P <0.001), stroke (1.4% versus 2.7%; P <0.001), bleeding complications (10.6% versus 24.6%; P <0.001), and acute kidney injury (16.2% versus 19.3%; P <0.001). Requirement for prior permanent pacemaker was higher in the TAVR cohort, whereas the incidence of vascular complications and acute kidney injury requiring dialysis was similar in the 2 groups. Average length of stay was shorter in patients undergoing TAVR. Conclusions— TAVR is being increasingly used as the preferred modality of AVR in patients with prior CABG. Compared with SAVR, TAVR is associated with similar in-hospital mortality but lower rates of in-hospital complications in this important subset of patients.
Outcomes in the Randomized CoreValve US Pivotal High Risk Trial in Patients With a Society of Thoracic Surgeons Risk Score of 7% or Less
Reardon, Michael J. , Kleiman, Neal S. , Yakubov, Steven J. , Coselli, Joseph S. , Deeb, G. Michael, O’Hair, Daniel, Gleason, Thomas G. , Lee, Joon Sup, Hermiller, James, Chetcuti, Stan , Heiser, John, Merhi, William , Zorn, George L., Tadros, Peter, Robinson, N. Bryce , Petrossian, George , Harrison, J. Kevin , Maini, Brijeshwar , Mumtaz, Mubashir , Conte, John V., Resar, Jon R. , Aharonian, Vicken, Oh, Jae K. , Huang, Jian, Popma, Jeffrey J. , Adams, David , Deeb, G. Michael , Hughes, George Chad , Maini, Brijeshwar , Pfeffer, Thomas A , Huang, Jian Qun , Reardon, Michael J
JAMA Cardiology | August 19, 2016 | Volume: 1 | Issue: 8 | Pages: 945
Accreditation and funding for a 24‐month advanced interventional cardiology fellowship program: A call‐to‐action for optimal training of the next generation of interventionalists
Bhatt, Deepak L. , Pinto, Duane S. , Kirtane, Ajay J. , Makkar, Raj R., Rihal, Charanjit S. , Kleiman, Neal S. , Cutlip, Donald E. , Kalra, Ankur , Kapadia, Samir , Makkar, Raj, Rihal, Charanjit S. , Bhatt, Deepak L
Catheterization and Cardiovascular Interventions | August 12, 2016 | Volume: 88 | Issue: 6 | Pages: 1010-1015
Management of Patients With Acute Coronary Syndromes in the United States by Platelet Glycoprotein IIb/IIIa Inhibition
Harrington, Robert A. , Guerci, Alan D., Ohman, E. Magnus , Kopecky, Steven L., Kleiman, Neal S. , Pacchiana, Cynthia M., Berdan, Lisa G. , Kitt, Michael M., Simoons, Maarten L. , Lincoff, A. Michael , Califf, Robert M. , Hochman, Judith S. , Pepine, Carl J. , Topol, Eric J.
Circulation | June 12, 2012 | Volume: 102 | Issue: 10 | Pages: 1093-1100
Background —A multinational, randomized, placebo-controlled trial (Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy, PURSUIT) demonstrated that the platelet glycoprotein IIb/IIIa receptor antagonist eptifibatide reduced the incidence of death or myocardial infarction among patients with acute ischemic syndromes without ST-segment elevation. Because of expected differences in practice patterns, a prospectively planned analysis of outcomes as a function of regions of the world was performed. The current study provides a detailed assessment of eptifibatide among the subgroup of patients enrolled within the United States. Methods and Results —Patients presenting with chest pain within the previous 24 hours and ischemic ECG changes or creatine kinase–MB elevation were eligible for enrollment. Of the 10 948 patients randomized worldwide, 4035 were enrolled within the United States. Patients were allocated to placebo or eptifibatide infusion for up to 72 to 96 hours. Other medical therapies and revascularization strategies were at the discretion of the treating physician. Eptifibatide reduced the rate of the primary end point of death or myocardial infarction by 30 days from 15.4% to 11.9% ( P =0.003) among patients in the United States. The treatment effect was achieved early and maintained over a period of 6 months (18.9% versus 15.2%; P =0.004). Bleeding events were more common in patients receiving eptifibatide but were predominantly associated with invasive procedures. The magnitude of clinical benefit from eptifibatide was greater among patients in the United States than elsewhere in the world. Conclusions —Platelet glycoprotein IIb/IIIa receptor blockade with eptifibatide reduces the incidence of death or myocardial infarction among patients treated for acute ischemic syndromes without ST-segment elevation within the United States.