Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study
Authors: Kodali Susheel , Hahn Rebecca T , Makkar Raj , Makar Moody , Davidson Charles J , Puthumana Jyothy J , Zahr Firas , Chadderdon Scott , Fam Neil , Ong Geraldine , Yadav Pradeep , Thourani Vinod , Vannan Mani A , O’Neill William W , Wang Dee Dee , Tchétché Didier , Dumonteil Nicolas , Bonfils Laurent , Lepage Laurent , Smith Robert , Grayburn Paul A , Sharma Rahul P , Haeffele Christiane , Babaliaros Vasilis , Gleason Patrick T , Elmariah Sammy , Inglessis-Azuaje Ignacio , Passeri Jonathan , Herrmann Howard C , Silvestry Frank E , Lim Scott , Fowler Dale , Webb John G , Moss Robert , Modine Thomas , Lafitte Stephane , Latib Azeem , Ho Edwin , Goldberg Ythan , Shah Pinak , Nyman Charles , Rodés-Cabau Josep , Bédard Elisabeth , Brugger Nicolas , Sannino Anna , Mack Michael J , Leon Martin B , Windecker Stephan ,   the TRISCEND study investigators, 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 
Published: November 2023

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 &lt; .001), with increases in stroke volume (10.5 ± 16.8 mL, P &lt; .001) and cardiac output (0.6 ± 1.2 L/min, P &lt; .001). New York Heart Association class I or II was achieved in 93.3% (P &lt; .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P &lt; .001), and six-minute walk distance increased by 56.2 m (P &lt; .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.