Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study
Author:
Kodali Susheel1, Hahn Rebecca T1, Makkar Raj2ORCID, Makar Moody2, Davidson Charles J3, Puthumana Jyothy J3, Zahr Firas4ORCID, Chadderdon Scott4, Fam Neil5, Ong Geraldine5, Yadav Pradeep6, Thourani Vinod6, Vannan Mani A6, O’Neill William W7, Wang Dee Dee7, Tchétché Didier8, Dumonteil Nicolas8, Bonfils Laurent8, Lepage Laurent8, Smith Robert9, Grayburn Paul A910, Sharma Rahul P11, Haeffele Christiane11ORCID, Babaliaros Vasilis12, Gleason Patrick T12, Elmariah Sammy1314, Inglessis-Azuaje Ignacio13, Passeri Jonathan13, Herrmann Howard C15, Silvestry Frank E15ORCID, Lim Scott16, Fowler Dale16, Webb John G17, Moss Robert17, Modine Thomas1819, Lafitte Stephane18, Latib Azeem20, Ho Edwin20, Goldberg Ythan2021, Shah Pinak22, Nyman Charles22, Rodés-Cabau Josep23, Bédard Elisabeth23, Brugger Nicolas24, Sannino Anna10, Mack Michael J9, Leon Martin B1, Windecker Stephan24ORCID, Makkar Raj, Chakravarty Tarun, Joseph Jubin, Nakamura Mamoo, Oakley Luke, Cheng Wen, Makar Moody, Singh Siddharth, Friedman John D, Chang David H, Hamilton Michele A, Singh Siddharth, Davidson Charles J, Davidson Laura, Pham Duc Thinh, Malaisrie S Chris, Puthumana Jyothy, Narang Akhil, Avery Ryan, Ghafourian Kambiz, Zahr Firas, Song Howard, Chadderdon Scott, Fuss Christina, Steiner Johannes, Kodali Susheel, Ng Vivian, Vahl Torsten, George Isaac, Hahn Rebecca T, Khalique Omar, Pulerwitz Todd, Masoumi Amirali, Fam Neil, Alnasser Sami, Peterson Mark, Bisleri Gianluigi, Ong Geraldine, Deva Djeven, Moe Gordon, Yadav Pradeep, Rajagopal Vivek, Thourani Vinod, Kauten James, Vannan Mani, Mobasseri Sara, Sayegh Hassan, Dinsfriend William, Rangarajan Vibhav, Blanco Raul, Flueckiger Peter, Mathew Roshin, Polsani Venkateshwar, DeMoss Benjamin, Krishnamoorthy Arun, Singh Rajeev, O'Neill William W, Frisoli Tiberio, O'Neill Brian, Villablanca Pedro, Alnajjar Raed, Apostolou Dimitrios, Wang Dee Dee, Lee James, Eng Marvin, Tchétché Didier, Dumonteil Nicolas, Berthoumieu Pierre, Bonfils Laurent, Lepage Laurent, Fondard Olivier, Colombier Daniel, Cassagneau Romain, Szerlip Molly, Smith Robert, Grayburn Paul, Wang Zuyue, Gopal Ambarish, Afzal Aasim, Sharma Rahul, Lee David, Boyd Jack, MacArthur John, Haeffele Christiane, Liang David, Tuzovic Mirela, Fleischmann Dominik, Krishnam Mayil, Jimenez Shirin, Babaliaros Vasilis, Byku Isida, Devireddy Chandan, Greenbaum Adam, Hanzel George, Grubb Kendra, Guyton Robert, Paone Gaetano, Xie Joe, Gleason Patrick, Gupta Divya, Windecker Stephan, Praz Fabien, Pilgrim Thomas, Samin Daryoush, Reineke David, Brugger Nicolas, Praz Fabien, Gräni Christoph, Hunziker Lukas, Ruberti Andrea, Bartkowiak Joanna, Elmariah Sammy, Inglessis-Azuaje Ignacio, Patel Nilay, Sakhuja Rahul, Jassar Arminder, Langer Nathaniel, Passeri Johnathan, Yucel Evin, Dal-Bianco Jacob, Ghoshhajra Brian, Hedgire Sandeep, Ton Khue, Herrmann Howard, Fiorilli Paul, Desai Nimesh, Szeto Wilson, Silvestry Frank, Chen Tiffany, Ziadi Maria, Ortega-Legaspi Juan, Lim David Scott, Sodhi Nishtha, Ailawadi Gorav, Yarboro Leora, Villines Todd, Salerno Michael, Fowler Dale, Freeman Martha, Mazimba Sula, Webb John, Boone Robert, Ye Jian, Moss Robert, Murphy Darra, Toma Mustafa, Leroux Lionel, Modine Thomas, Labrousse Louis, Lafitte Stephane, Bouchat Marine, Malvy Julien, Cochet Hubert, Ternacle Julien, Latib Azeem, Scotti Andrea, Chau Mei, Ho Edwin, Goldberg Ythan, Slipczuk Leandro, Chavez Patricia, Jorde Ulrich, Murthy Sandhya, Shah Pinak, Kaneko Tsuyoshi, Nyman Charles, Shook Douglas, Sun Yee-Ping, Steigner Michael, Stewart Garrick, Rodés-Cabau Josep, Farjat Pasos Julio, Berenguer Jorge Nuche, Mesnier Jules, Panagides Vassili, Dagenais François, Bédard Elisabeth, Beaudoin Jonathan, Salaun Erwan, Labbé Benoît M, Lévesque Marie-Hélène, Albert Gabriella, Bernier Mathieu, O'Connor Kim,
Affiliation:
1. Division of Cardiology, Columbia University Irving Medical Center , 161 Fort Washington Avenue , NewYork, NY 10032, USA 2. Cedars-Sinai Medical Center , Los Angeles, CA , USA 3. Northwestern University Feinberg School of Medicine , Chicago, IL , USA 4. Oregon Health & Science University , Portland, OR , USA 5. St. Michael’s Hospital , Toronto, ON , Canada 6. Marcus Heart Valve Center, Piedmont Heart Institute , Atlanta, GA , USA 7. Henry Ford Hospital , Detroit, MI , USA 8. Clinique Pasteur Toulouse , Toulouse , France 9. Baylor Scott & White: The Heart Hospital Plano , Dallas, TX , USA 10. Baylor Scott and White Research Institute Cardiac Imaging Core Laboratory , Plano, TX , USA 11. Stanford University , Stanford, CA , USA 12. Emory University , Atlanta, GA , USA 13. Massachusetts General Hospital , Boston, MA , USA 14. University of California San Francisco , San Francisco, CA , USA 15. University of Pennsylvania , Philadelphia, PA , USA 16. University of Virginia , Charlottesville, VA , USA 17. St. Paul's Hospital , Vancouver, BC , Canada 18. Hôpital Haut Lévêque , Pessac , France 19. Bordeaux University Hospital , Bordeaux , France 20. Montefiore Medical Center, Albert Einstein College of Medicine , The Bronx, NY , USA 21. Lenox Hill Hospital , New York, NY, USA 22. Brigham and Women’s Hospital , Boston, MA , USA 23. Quebec Heart & Lung Institute, Laval University , Quebec City, QC , Canada 24. Bern University Hospital (Inselspital) , Bern , Switzerland
Abstract
Abstract
Background and Aims
For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes.
Methods
The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year.
Results
Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III–IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure.
Conclusions
In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490.
Funder
Edwards Lifesciences
Publisher
Oxford University Press (OUP)
Subject
Cardiology and Cardiovascular Medicine
Cited by
42 articles.
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