Citations 5
Real-World Outcomes of Transcatheter Tricuspid Valve Replacement
Makkar, R R, Gupta, A, O’Neill, Brian P., Lalani, Christina , Sharma, Rahul P., Yadav, Pradeep, Frisoli, Tiberio M., Thourani, Vinod, Eleid, Mackram F., Lee, James, Babaliaros, Vasilis C., Haeffele, Christiane , Bajwa, Tanvir , Flueckiger, Peter, Cubeddu, Robert J., Davidson, Laura J., Padang, Ratnasari , Spinetto, Pedro Villablanca, Narang, Akhil , Williams, Mathew, Gleason, Patrick, Tang, Gilbert H. L., Khera, Sahil , Vavalle, John P., Byku, Isida , Depta, Jeremiah P., Garcia, Santiago, Kapadia, Samir, Zajarías, Alan , Chanin, Jake, Kodali, Susheel K., Herrmann, Howard C., Morse, M. Andrew, Petrossian, George , Sivak, Joseph A. , Hahn, Rebecca T., Song, Yang, Leon, M.B., Yeh, Robert W., Davidson, C, Haeffele, Christiane , Makkar, Raj , Gupta, Aakriti , O’Neill, Brian Patrick , Sharma, Rahul P., Yadav, Pradeep , Frisoli, Tiberio , Thourani, Vinod H. , Makar, Moody M. , Eleid, Mackram F. , Lee, James, Babaliaros, Vasilis , Flueckiger, Peter B. , Davidson, Laura J., Allaqaband, Suhail Q. , Williams, Mathew R., Gleason, Patrick T. , Tang, Gilbert H.L. , Vavalle, John P. , Depta, Jeremiah P , Garcia, Santiago A. , Kapadia, Samir , Kodali, Susheel , Herrmann, Howard C. , Morse, M. Andrew M. , Hahn, Rebecca T , Song, Yang, Yeh, Robert W. , Davidson, Charles J.
JAMA | April 13, 2026 | Volume: 335 | Issue: 18 | Pages: 1606
Importance Transcatheter tricuspid valve replacement (TTVR) demonstrated superior outcomes over medical therapy in patients with severe tricuspid regurgitation (TR) in the Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device II (TRISCEND II) randomized clinical trial, and received regulatory approval in the US in 2024. Contemporary real-world data on its effectiveness and safety remain limited. Objective To evaluate 30-day clinical, echocardiographic, and health status outcomes of TTVR in real-world use. Design, Setting, and Population Retrospective cohort study of all consecutive patients who underwent TTVR in the US from February 2024 through March 2025 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Patients had symptomatic, severe TR despite optimal medical therapy and TTVR was deemed appropriate by a heart team. Statistical analysis was conducted from September 2025 to February 2026. Exposure Device-enabled TTVR. Main Outcomes and Measures Thirty-day event rates (all-cause death, stroke, bleeding, new cardiac implantable electronic device [CIED] implantation, heart failure hospitalizations), TR reduction, and changes in health status (New York Heart Association [NYHA] functional class and Kansas City Cardiomyopathy Questionnaire Overall Summary [KCCQ-OS] score) are reported. Subgroup analyses examined the impact of baseline CIED status on outcomes. Results Among 1034 attempted procedures at 82 centers (mean [SD] age, 77.1 [10.6] years; 69.1% female; 73.2% NYHA functional class III/IV), a valve was successfully implanted in 1017 patients (98.4%). Mild or less TR was achieved in 98.4% of patients post procedure and in 97.7% at 30 days. At 30 days, all-cause mortality was 3.1%; stroke, 0.2%; bleeding, 7.9%; new CIED, 15.9% in CIED-naive patients; and heart failure hospitalization, 3.1%. There were significant improvements in NYHA functional class (class I/II, 82.7%; P < .001) and mean KCCQ-OS score (22.4 points; P < .001) from baseline to 30 days. There were no significant differences in 30-day mortality ( P = .47), heart failure hospitalization ( P > .99), and functional outcomes ( P = .55) when patients were stratified by baseline CIED status. Conclusions and Relevance Early US real-world experience with TTVR confirms safety and effectiveness in patients with severe TR. Thirty-day outcomes are consistent with the TRISCEND II pivotal trial, demonstrating acceptable safety, near-complete TR elimination, and significant health status improvements in an older, comorbid population. Rates of new CIED implantation and bleeding were lower than randomized clinical trial experience.
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 < .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
Lifetime Management of Aortic Stenosis: Transcatheter Versus Surgical Treatment for Young and Low-Risk Patients
Russo, Giulio , Tang, Gilbert H.L. , Sangiorgi, Giuseppe , Enriquez‐Sarano, Maurice , Maisano, Francesco , Pedicino, Daniela , Enriquez-Sarano, Maurice , Russo, Giulio , Maisano, Francesco , Taramasso, Maurizio
Circulation: Cardiovascular Interventions | November 15, 2022 | Volume: 15 | Issue: 11 | Pages: 915-927
10.1161/circinterventions.122.012388
Transcatheter aortic valve replacement is now indicated across all risk categories of patients with symptomatic severe aortic stenosis and has been proposed as first line option for the majority of patients >74 years old. However, median age of patients enrolled in the transcatheter aortic valve replacement low-risk trials is 74 years and transcatheter aortic valve replacement has never been systematically investigated in young low risk patients. Although the long-term data in surgical aortic valve replacement in young patients (age <75) are well known, such data remain lacking in transcatheter aortic valve replacement. In the absence of clear guideline recommendations in patients with challenging anatomies (eg, hostile calcium, bicuspid), it is important to know the potential advantages and disadvantages of each treatment and to consider how they might integrate with each other in the lifetime management of such patients. In this review, we discuss current outstanding issues on the management of severe aortic stenosis from a lifetime management perspective, particularly in terms of initial intervention and future reinterventions.
Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients
Deeb, G. 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Franch, Pushkar, Illya, Robin, Tonya, Shaheen, Devin, Sin, Danielle, Taylor, Zachary , Tovar, Joseph, Daele, Jessie Van, Vidal, Samantha, Yung, Lau Yan, Jilaihawi, Hasanian, Fara, Michael , Ischida, Koto, Loulmet, Didier F., Siller, K, Staniloae, Cezar , Torres, José, Zhang, Cen , Hartlev, Christie, Huffman, Andrew, Kellum, Annie, Liptrot, Roderick, Ryan, James , Lilly, Scott , Rushing, Gregory , Grose, Noah, Lee, Vivien , Mazzaferri, Ernest L. , Mutgi, Smil, O’Neil, Susan, Perchuk, Alex, Sai‐Sudhakar, Chittoor, Slivka, Andrew , Hanes, Stacie, Banowetz, Michael, Dautenhahn, David, Mehl, Brad, Bodenhamer, Robert Mark, Ghani, Mohammad , Raikar, Goya V., Tahirkheli, Naeem , Wasemiller, Wayne, Amoroso, Elisa M , Holt, Shelley, Tucker, Claire , Martin, Randolph P., Kauten, James, Rajagopal, Vivek , Awad, Eric, Brown, W. Morris, Gott, J. 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V., Lauterborn, Marjo, John, Henriette , Parthier, Sonja, Schaprian, Katja, Twelker, K., Nickenig, Georg, Welz, Armin, Bode, Felix J. , Fuchs, Ângela, Mellert, F, Petzold, Gabor C. , Sedaghat, Alex, Sinning, Jan‐Malte, Werner, Nikos , Bang, Helle, Brodersen, Bente Birgitte, Christensen, Pernille Roed, Eriksen, Elsebet, Groth, Susanne , Larsen, Mie Christa Jensen, Johansen, Mette Ellegaard, Lilleør, Thomas Nikolaj Bang, Larsen, Lisette Lund, Preis, Anne-Cathrine, Rieck-Broberg, Jeanette, Ihlemann, Nikolaj , Noerager, Betina, Steinbrüchel, Daniel A., Arendrup, Henrik, Franzen, Olaf, Hansen, Klaus, Højgaard, Joan , Holme, Susanne, Kjøeller, Morten, Lund, J. 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. 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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. 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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.
Surgical and Transcatheter Mitral Valve Replacement in Mitral Annular Calcification: A Systematic Review
Alexis, Sophia L. , Malik, Aaqib H. , El‐Eshmawi, Ahmed, George, Isaac , Sengupta, Aditya , Kodali, Susheel , Hahn, Rebecca T. , Khalique, Omar , Zaid, Syed , Bapat, Vinayak , Leon, Martin B. , Tang, Gilbert H.L. , Hahn, Rebecca T , Guerrero, Mayra , Adams, David
Journal of the American Heart Association | March 17, 2021 | Volume: 10 | Issue: 7 | Pages: No page available
Abstract Mitral annular calcification with mitral valve disease is a challenging problem that could necessitate surgical mitral valve replacement (SMVR). Transcatheter mitral valve replacement (TMVR) is emerging as a feasible alternative in high‐risk patients with appropriate anatomy. PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched from inception to December 25, 2019 for studies discussing SMVR or TMVR in patients with mitral annular calcification; 27 of 1539 articles were selected for final review. TMVR was used in 15 studies. Relevant data were available on 82 patients who underwent hybrid transatrial TMVR, and 354 patients who underwent transapical or transseptal TMVR. Outcomes on SMVR were generally reported as small case series (447 patients from 11 studies); however, 1 large study recently reported outcomes in 9551 patients. Patients who underwent TMVR had a shorter median follow‐up of 9 to 12 months (range, in‐hospital‒19 months) compared with patients with SMVR (54 months; range, in‐hospital‒120 months). Overall, those undergoing TMVR were older and had higher Society of Thoracic Surgeons risk scores. SMVR showed a wide range of early (0%–27%; median 6.3%) and long‐term mortality (0%–65%; median at 1 year, 15.8%; 5 years, 38.8%, 10 years, 62.4%). The median in‐hospital, 30‐day, and 1‐year mortality rates were 16.7%, 22.7%, and 43%, respectively, for transseptal/transapical TMVR, and 9.5%, 20.0%, and 40%, respectively, for transatrial TMVR. Mitral annular calcification is a complex disease and TMVR, with a versatile option of transatrial approach in patients with challenging anatomy, offers a promising alternative to SMVR in high‐risk patients. However, further studies are needed to improve technology, patient selection, operative expertise, and long‐term outcomes.