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Severe tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed. In this international, multicenter trial, we randomly assigned 400 patients with severe symptomatic tricuspid regurgitation in a 2:1 ratio to undergo either transcatheter tricuspid-valve replacement and medical therapy (valve-replacement group) or medical therapy alone (control group). The hierarchical composite primary outcome was death from any cause, implantation of a right ventricular assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 m on the 6-minute walk distance. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy. A total of 267 patients were assigned to the valve-replacement group and 133 to the control group. At 1 year, the win ratio favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001). In comparisons of patient pairs, those in the valve-replacement group had more wins than the control group with respect to death from any cause (14.8% vs. 12.5%), postindex tricuspid-valve intervention (3.2% vs. 0.6%), and improvement in the KCCQ-OS score (23.1% vs. 6.0%), NYHA class (10.2% vs. 0.8%), and 6-minute walk distance (1.1% vs. 0.9%). The valve-replacement group had fewer wins than the control group with respect to the annualized rate of hospitalization for heart failure (9.7% vs. 10.0%). Severe bleeding occurred in 15.4% of the valve-replacement group and in 5.3% of the control group (P = 0.003); new permanent pacemakers were implanted in 17.4% and 2.3%, respectively (P<0.001). For patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life. (Funded by Edwards Lifesciences; TRISCEND II ClinicalTrials.gov number, NCT04482062.).

A randomized trial that enrolled patients with severe aortic stenosis at low or intermediate surgical risk showed that transcatheter aortic-valve implantation was noninferior to surgical aortic-valve replacement at 1 year.

A previous analysis in this trial showed that among patients with severe, symptomatic aortic stenosis who were at low surgical risk, the rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR) than with surgical aortic-valve replacement. Longer-term outcomes are unknown. We randomly assigned patients with severe, symptomatic aortic stenosis and low surgical risk to undergo either TAVR or surgery. The first primary end point was a composite of death, stroke, or rehospitalization related to the valve, the procedure, or heart failure. The second primary end point was a hierarchical composite that included death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, and health-status outcomes were assessed through 5 years. A total of 1000 patients underwent randomization: 503 patients were assigned to undergo TAVR, and 497 to undergo surgery. A component of the first primary end point occurred in 111 of 496 patients in the TAVR group and in 117 of 454 patients in the surgery group (Kaplan-Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, -4.3 percentage points; 95% confidence interval [CI], -9.9 to 1.3; P = 0.07). The win ratio for the second primary end point was 1.17 (95% CI, 0.90 to 1.51; P = 0.25). The Kaplan-Meier estimates for the components of the first primary end point were as follows: death, 10.0% in the TAVR group and 8.2% in the surgery group; stroke, 5.8% and 6.4%, respectively; and rehospitalization, 13.7% and 17.4%. The hemodynamic performance of the valve, assessed according to the mean (±SD) valve gradient, was 12.8±6.5 mm Hg in the TAVR group and 11.7±5.6 mm Hg in the surgery group. Bioprosthetic-valve failure occurred in 3.3% of the patients in the TAVR group and in 3.8% of those in the surgery group. Among low-risk patients with severe, symptomatic aortic stenosis who underwent TAVR or surgery, there was no significant between-group difference in the two primary composite outcomes. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).

In a randomized trial, 1468 patients with severe aortic stenosis who were at low risk for death with surgery were assigned to either transcatheter aortic-valve replacement with a self-expanding valve or surgical aortic-valve replacement. At 2 years, TAVR was noninferior to surgery with respect to death or disabling stroke.

In a randomized trial, 1000 patients with severe aortic stenosis who were at low risk for death with surgery were assigned to undergo transcatheter aortic-valve replacement with a balloon-expandable valve or surgical aortic-valve replacement. At 1 year, the rate of death, stroke, or rehospitalization was significantly lower in the TAVR group.

Among patients with heart failure and secondary mitral regurgitation, transcatheter mitral-valve repair resulted in a lower rate of hospitalization for heart failure and lower mortality than medical therapy alone. The goal for freedom from device-related complications was exceeded.

In a randomized trial, patients with tricuspid regurgitation who were treated with transcatheter edge-to-edge repair had more favorable clinical outcomes at 1 year than did patients who received medical therapy.

Tricuspid valve repair, particularly with annuloplasty rings, is increasingly recognized as an effective treatment. PM-AR-T is a semi-rigid annuloplasty ring based on a nickel-titanium alloy which has made progress in animal models, however, studies on PM-AR-T's performance in patients with tricuspid regurgitation (TR) are lacking. This study aimed to compare the efficacy and safety of the PM-AR-T with the Edwards MC3 ring for the TR treatment. A non-inferiority, randomized controlled trial was conducted in 20 centers across China, enrolling patients with tricuspid valve disease requiring surgical repair. Patients were randomized to receive either PM-AR-T or Edwards MC3 ring. The primary endpoint was the success rate of valve repair at 6 months. A total of 164 patients underwent valve annuloplasty, 83 and 81 in the PM-AR-T and Edwards MC3 groups. Valve repair success rates were 92.8% and 93.8% in the PM-AR-T and Edwards MC3 groups, demonstrating non-inferiority with a difference of -1.1% (95% confidence interval [CI]: -9.5 to 7.4), which was less than the pre-specified non-inferiority margin of -10%. No significant intergroup differences were found in valve regurgitation, echocardiographic parameters, and New York Heart Association (NYHA) functional classification at any postoperative time point. At 12 months, the proportions of patients without regurgitation were comparable, 30.4% and 27.8% in the PM-AR-T and Edwards MC3 groups (P = 0.705). Improvement to NYHA functional class I status was detected in 46.2% and 45.6% of the two groups by 12 months (P = 0.893). Both rings exhibited comparable safety profiles, with no device-related serious adverse events, cardiovascular deaths, major bleeding events, severe structural damage, infective endocarditis, or thromboembolic events. The PM-AR-T tricuspid valve semi-rigid ring is effective in improving TR, demonstrating non-inferiority to the Edwards MC3 ring, with a favorable safety profile. Clinical Trial Registration: This study was registered at Chinese Clinical Trial Registry (ChiCTR2100043007).

In a randomized trial involving more than 2000 patients, transcatheter aortic-valve replacement was noninferior to surgical replacement in the primary end point of death from any cause or disabling stroke at 2 years. Transcatheter aortic-valve replacement (TAVR) is a new therapy for patients with severe aortic stenosis who are not candidates for surgery 1 , 2 or who are at high risk for complications due to surgery. 3 , 4 The acceptance of the use of TAVR in high-risk patients was based on evidence from clinical trials 5 , 6 that used early-generation TAVR devices; these procedures were associated with considerable procedure-related complications. 7 – 9 Recently, increased operator experience and enhanced transcatheter valve systems have led to a worldwide trend to use TAVR in patients who are at low or intermediate risk. 10 – 12 This trend has been evaluated in small . . .

Transcatheter repair of secondary mitral regurgitation was associated with a lower rate of hospitalization for heart failure and lower all-cause mortality than medical therapy at 5 years of follow-up.