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April 13, 2026JAMA
Real-World Outcomes of Transcatheter Tricuspid Valve Replacement
R R MakkarA GuptaBrian P. O’NeillChristina LalaniRahul P. SharmaPradeep YadavTiberio M. FrisoliVinod ThouraniMoody MakarMackram F. EleidJames LeeVasilis C. BabaliarosChristiane HaeffeleTanvir BajwaPeter FlueckigerRobert J. CubedduLaura J. DavidsonRatnasari PadangPedro Villablanca SpinettoSuhail AllaqabandAkhil NarangMathew WilliamsPhillip GleasonGilbert H. L. TangSahil KheraJohn P. VavalleIsida BykuJeremiah P. DeptaSantiago GarciaSamir KapadiaAlan ZajaríasJake ChaninSusheel K. KodaliHoward C. HerrmannM. Andrew MorseGeorge PetrossianJoseph A. SivakRebecca T. HahnYang SongM.B. LeonRobert W. YehC Davidson
Key result
Real-world TTVR provides acceptable 30-day safety, near-complete TR elimination, and fewer CIED implants than randomized trials.
Why the study?
Does Transcatheter Tricuspid Valve Replacement (TTVR) improve safety and effectiveness in real-world patients with severe TR?
Key Points
- To evaluate 30-day clinical, echocardiographic, and health status outcomes of transcatheter tricuspid valve replacement in real-world settings.
- Retrospective cohort design using a registry of patients who underwent TTVR.
- Analysis performed on consecutive patients with symptomatic severe tricuspid regurgitation from February 2024 to March 2025.
- Statistical analysis conducted from September 2025 to February 2026.
- Valve was successfully implanted in 98.4% of patients, with 98.4% achieving mild or less tricuspid regurgitation post-procedure.
- 30-day all-cause mortality was 3.1%, with improvements in NYHA class and KCCQ-OS score, indicating better health status.
- Rates of new CIED implantation and bleeding were lower than those observed in randomized trials.
Study Design
Type
Observational
Structured PICO
Does Transcatheter Tricuspid Valve Replacement (TTVR) improve safety and effectiveness in real-world patients with severe TR?
P
Population
US patients with severe tricuspid regurgitation (TR) in an older, comorbid population
I
Intervention
Transcatheter Tricuspid Valve Replacement (TTVR)
O
Outcome
Thirty-day safety, TR elimination, and health status improvements
Early real-world US data confirms the safety and effectiveness of TTVR for severe TR at 30 days, with potentially lower complication rates than seen in pivotal trials.
Discussion
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
RMRaj MakkarVP of Cardiovascular Innovation, Cedars-Sinai
“These findings show that transcatheter tricuspid valve replacement is translating well from the clinical trial setting into routine practice across the United States. In a large, older and medically complex patient population, we saw very high procedural success, near-complete elimination of tricuspid regurgitation, and rapid improvement in how patients feel and function.”
“What both of these studies provide is an extension of what we saw from the pivotal trials. We continue to see safety, we continue to see efficacy in the real world as well as with continued access in a much larger cohort of patients. I think this provides very reassuring data that the way it's being rolled out seems to be along the lines that one would've envisioned.”
“The first US real-world experience confirms the clinical and quality-of-life benefits of the Evoque system across a broad patient population treated at multiple centers.”
Implication
Affirms TTVR translatability to real-world practice; extends RCT evidence but leaves open long-term durability and hard endpoints.
Abstract
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.
Cite This Study
Makkar et al. (2026) conducted an observational in Severe tricuspid regurgitation. Transcatheter Tricuspid Valve Replacement (TTVR) was evaluated on 30-day safety, TR elimination, and health status improvements. Real-world transcatheter tricuspid valve replacement demonstrated acceptable 30-day safety, near-complete TR elimination, and lower rates of new CIED implantation compared to randomized trials.