TY - JOUR
T1 - Transfemoral tricuspid valve replacement and one-year outcomes
T2 - the TRISCEND study
AU - TRISCEND study investigators
AU - Kodali, Susheel
AU - Hahn, Rebecca T.
AU - Makkar, Raj
AU - Makar, Moody
AU - Davidson, Charles J.
AU - Puthumana, Jyothy J.
AU - Zahr, Firas
AU - Chadderdon, Scott
AU - Fam, Neil
AU - Ong, Geraldine
AU - Yadav, Pradeep
AU - Thourani, Vinod
AU - Vannan, Mani A.
AU - O’Neill, William W.
AU - Wang, Dee Dee
AU - Tchétché, Didier
AU - Dumonteil, Nicolas
AU - Bonfils, Laurent
AU - Lepage, Laurent
AU - Smith, Robert
AU - Grayburn, Paul A.
AU - Sharma, Rahul P.
AU - Haeffele, Christiane
AU - Babaliaros, Vasilis
AU - Gleason, Patrick T.
AU - Elmariah, Sammy
AU - Inglessis-Azuaje, Ignacio
AU - Passeri, Jonathan
AU - Herrmann, Howard C.
AU - Silvestry, Frank E.
AU - Lim, Scott
AU - Fowler, Dale
AU - Webb, John G.
AU - Moss, Robert
AU - Modine, Thomas
AU - Lafitte, Stephane
AU - Latib, Azeem
AU - Ho, Edwin
AU - Goldberg, Ythan
AU - Shah, Pinak
AU - Nyman, Charles
AU - Rodés-Cabau, Josep
AU - Bédard, Elisabeth
AU - Brugger, Nicolas
AU - Sannino, Anna
AU - Mack, Michael J.
AU - Leon, Martin B.
AU - Windecker, Stephan
N1 - Publisher Copyright:
© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved.
PY - 2023/12/7
Y1 - 2023/12/7
N2 - 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.
AB - 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.
KW - EVOQUE
KW - TTVR
KW - Transcatheter tricuspid valve replacement
KW - Tricuspid regurgitation
UR - http://www.scopus.com/inward/record.url?scp=85179135603&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85179135603&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehad667
DO - 10.1093/eurheartj/ehad667
M3 - Article
C2 - 37930776
AN - SCOPUS:85179135603
SN - 0195-668X
VL - 44
SP - 4862
EP - 4873
JO - European heart journal
JF - European heart journal
IS - 46
ER -