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Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients
Deeb, G. 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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 < .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.
Positron Emission Tomography Imaging With [ 18 F]flortaucipir and Postmortem Assessment of Alzheimer Disease Neuropathologic Changes
Fleisher, Adam , Pontecorvo, Michael J. , Devous, Michael D. , Arora, Anupa, Truocchio, Stephen P., Aldea, Patricia, Flitter, Matthew, Locascio, Tricia, Devine, Marybeth, Siderowf, Andrew , Beach, Thomas G. , Montine, Thomas J. , Curtis, Craig, Perrin, Allison, Salloway, Stephen , Daniel, Misty, Wellman, Charles, Joshi, Abhinay D., Irwin, David J. , Lowe, Val J. , Ikonomović, Miloš D. , Masdeu, Joseph C. , Harris, Thomas S., Navitsky, Michael, Southekal, Sudeepti , Mintun, Mark A., Investigators, A16 Study, Irwin, David J , Lu, Ming‐Chi , Serrano, Geidy E. , Seeley, William W. , Masdeu, Joseph C , Kennedy, Ian Andrew , Investigators, A16 Study
JAMA Neurology | April 27, 2020 | Volume: 77 | Issue: 7 | Pages: 829
Importance Positron emission tomography (PET) may increase the diagnostic accuracy and confirm the underlying neuropathologic changes of Alzheimer disease (AD). Objective To determine the accuracy of antemortem [ 18 F]flortaucipir PET images for predicting the presence of AD-type tau pathology at autopsy. Design, Setting, and Participants This diagnostic study (A16 primary cohort) was conducted from October 2015 to June 2018 at 28 study sites (27 in US sites and 1 in Australia). Individuals with a terminal illness who were older than 50 years and had a projected life expectancy of less than 6 months were enrolled. All participants underwent [ 18 F]flortaucipir PET imaging, and scans were interpreted by 5 independent nuclear medicine physicians or radiologists. Supplemental autopsy [ 18 F]flortaucipir images and pathological samples were also collected from 16 historically collected cases. A second study (FR01 validation study) was conducted from March 26 to April 26, 2019, in which 5 new readers assessed the original PET images for comparison to autopsy. Main Outcomes and Measures [ 18 F]flortaucipir PET images were visually assessed and compared with immunohistochemical tau pathology. An AD tau pattern of flortaucipir retention was assessed for correspondence with a postmortem B3-level (Braak stage V or VI) pathological pattern of tau accumulation and to the presence of amyloid-β plaques sufficient to meet the criteria for high levels of AD neuropathological change. Success was defined as having at least 3 of the 5 readers above the lower bounds of the 95% CI for both sensitivity and specificity of 50% or greater. Results A total of 156 patients were enrolled in the A16 study and underwent [ 18 F]flortaucipir PET imaging. Of these, 73 died during the study, and valid autopsies were performed for 67 of these patients. Three autopsies were evaluated as test cases and removed from the primary cohort (n = 64). Of the 64 primary cohort patients, 34 (53%) were women and 62 (97%) were white; mean (SD) age was 82.5 (9.6) years; and 49 (77%) had dementia, 1 (2%) had mild cognitive impairment, and 14 (22%) had normal cognition. Prespecified success criteria were met for the A16 primary cohort. The flortaucipir PET scans predicted a B3 level of tau pathology, with sensitivity ranging from 92.3% (95% CI, 79.7%-97.3%) to 100.0% (95% CI, 91.0%-100.0%) and specificity ranging from 52.0% (95% CI, 33.5%-70.0%) to 92.0% (95% CI, 75.0%-97.8%). A high level of AD neuropathological change was predicted with sensitivity of 94.7% (95% CI, 82.7%-98.5%) to 100.0% (95% CI, 90.8%-100.0%) and specificity of 50.0% (95% CI, 32.1%-67.9%) to 92.3% (95% CI, 75.9%-97.9%). The FR01 validation study also met prespecified success criteria. Addition of the supplemental autopsy data set and 3 test cases, which comprised a total of 82 patients and autopsies for both the A16 and FR01 studies, resulted in improved specificity and comparable overall accuracy. Among the 156 enrolled participants, 14 (9%) experienced at least 1 treatment-emergent adverse event. Conclusions and Relevance This study’s findings suggest that PET imaging with [ 18 F]flortaucipir could be used to identify the density and distribution of AD-type tau pathology and the presence of high levels of AD neuropathological change, supporting a neuropathological diagnosis of AD.