{"product_id":"catheter-based-tricuspid-valve-repair-improves-survival-and-reduces-hospitalizations-in-severe-heart-valve-leakage","title":"Catheter-Based Tricuspid Valve Repair Improves Survival and Reduces Hospitalizations in Severe Heart Valve Leakage","description":"\u003cp\u003eIn a randomized trial, 360 patients had symptomatic severe tricuspid regurgitation. This is a leaky heart valve on the right side of the heart. Transcatheter tricuspid-valve repair plus medical therapy was clearly superior to medical therapy alone. Transcatheter tricuspid-valve repair is a catheter-based procedure to fix the valve without open surgery. The win ratio for the first primary end point — a combined measure of death, heart-failure hospitalization, and quality-of-life improvement at 1 year — was 2.42 (95% CI, 1.76 to 3.33; P\u0026lt;0.001). At 3 years, 52.4% of patients in the repair group were alive and free from heart-failure hospitalization, compared with only 21.0% in the medical-therapy group (hazard ratio, 0.40; 95% CI, 0.29 to 0.55; P\u0026lt;0.001). Major adverse events within 30 days occurred in 14 patients (5.9%) in the repair group.\u003c\/p\u003e\n\n\u003ch1\u003eCatheter-Based Tricuspid Valve Repair Improves Survival and Reduces Hospitalizations in Severe Heart Valve Leakage\u003c\/h1\u003e\n\n\u003ch2\u003eTable of Contents\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\u003ca href=\"#ddn-key-points\"\u003eKey Points\u003c\/a\u003e\u003c\/li\u003e\n\n\u003cli\u003e\u003ca href=\"#background\"\u003eBackground: Why This Research Matters\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#methods\"\u003eHow the Study Was Conducted\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#population\"\u003eWho Participated in the Study\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#procedure\"\u003eWhat the Procedure Involved\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#results\"\u003eKey Findings: What the Study Showed\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#safety\"\u003eSafety and Side Effects\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#implications\"\u003eWhat This Means for Patients\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#limitations\"\u003eLimitations of the Study\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#recommendations\"\u003eRecommendations and Next Steps\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#ddn-faq\"\u003eFrequently Asked Questions\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#source\"\u003eSource Information\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003c!-- ddn:keypoints:start --\u003e\n\u003ch2 id=\"ddn-key-points\"\u003eKey Points\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eIn a trial of 360 patients with symptomatic severe tricuspid regurgitation, transcatheter valve repair plus medical therapy was superior to medical therapy alone.\u003c\/li\u003e\n\u003cli\u003eAt 3 years, 52.4% of the repair group were alive and free from heart-failure hospitalization, compared with 21.0% of the medical-therapy group.\u003c\/li\u003e\n\u003cli\u003eThe win ratio for the combined measure of death, heart-failure hospitalization, and quality-of-life improvement at 1 year was 2.42.\u003c\/li\u003e\n\u003cli\u003eMajor adverse events within 30 days occurred in 14 patients (5.9%) in the repair group; one death occurred 17 days after the procedure.\u003c\/li\u003e\n\u003cli\u003eThe number needed to treat to prevent one death or heart-failure hospitalization in 1 year was 4.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c!-- ddn:keypoints:end --\u003e\n\n\n\u003ch2 id=\"background\"\u003eBackground: Why This Research Matters\u003c\/h2\u003e\n\n\u003cp\u003eTricuspid regurgitation is linked to increased illness and death. In tricuspid regurgitation, the tricuspid valve on the right side of the heart does not close properly. This allows blood to leak backward. Treatment options using medication alone have been limited. Isolated tricuspid-valve surgery (open-heart surgery to repair or replace just this valve) is rarely performed because the surgical risk is high.\u003c\/p\u003e\n\n\u003cp\u003eTranscatheter tricuspid-valve interventions (catheter-based procedures that repair the valve through a vein without open surgery) have emerged as an alternative to surgery. Among these, tricuspid edge-to-edge repair is the most widely adopted technique. It is associated with high procedural success and a favorable safety profile.\u003c\/p\u003e\n\n\u003cp\u003eBefore this study, two randomized controlled trials had compared transcatheter tricuspid-valve repair with medical therapy alone. Both showed improvements in quality of life. However, neither trial showed clear reductions in heart-failure hospitalization or death at 1 year. A more recent analysis suggested that 2-year outcome data might show reductions in heart-failure hospitalization. But the low number of events in both trials limited the ability to determine the true benefits of transcatheter valve repair.\u003c\/p\u003e\n\n\u003cp\u003eBecause of these uncertainties, the effect of transcatheter tricuspid-valve repair in patients at increased risk for heart-failure events remained unclear. The TRIC-I-HF trial was designed to answer this question directly. It tested whether transcatheter tricuspid-valve repair plus medical therapy would result in a lower risk of death and hospitalization for heart failure than medical therapy alone. The study enrolled patients with severe tricuspid regurgitation who were at increased risk for future heart-failure events.\u003c\/p\u003e\n\n\u003ch2 id=\"methods\"\u003eHow the Study Was Conducted\u003c\/h2\u003e\n\n\u003cp\u003eTRIC-I-HF was an investigator-initiated, prospective, multicenter, open-label, randomized, controlled strategy trial. \"Investigator-initiated\" means the doctors and researchers who designed the study were not employees of a device company. \"Open-label\" means both patients and doctors knew which treatment was given. \"Randomized\" means patients were assigned to treatment groups by chance, like flipping a coin.\u003c\/p\u003e\n\n\u003cp\u003eThe trial was conducted at 29 high-volume heart-valve centers in Germany. Participating centers had substantial experience in transcatheter tricuspid-valve repair. On average, each center had performed 176±163 procedures before the trial began.\u003c\/p\u003e\n\n\u003cp\u003eThe trial was conducted in accordance with the principles of the Declaration of Helsinki (an international set of ethical standards for medical research). All participants provided written informed consent. The trial was approved by the responsible ethics committees.\u003c\/p\u003e\n\n\u003cp\u003ePatients were randomly assigned in a 2:1 ratio to one of two groups:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eTricuspid-repair group:\u003c\/strong\u003e transcatheter tricuspid-valve repair plus medical therapy\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMedical-therapy group:\u003c\/strong\u003e medical therapy alone\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eRandomization was conducted in permuted blocks. This means patients were assigned in small groups to keep the two treatment arms balanced. The assignment was stratified according to trial site and severity of tricuspid regurgitation. Stratification ensures that each group has a similar mix of patients from each hospital and with each severity level.\u003c\/p\u003e\n\n\u003cp\u003eTranscatheter valve repair was recommended to be performed within 14 days after randomization. Clinical follow-up in both groups was conducted at 1 month and 12 months. After that, annual visits continued up to 3 years, with a window of ±6 weeks. For this analysis, follow-up was completed, with the last randomly assigned patient reaching the 12-month follow-up visit.\u003c\/p\u003e\n\n\u003cp\u003ePatient selection and enrollment were at the discretion of the local heart team. There was no need for approval by a central eligibility committee or screening for baseline medical treatment. To be eligible, patients had to have at least severe tricuspid regurgitation on a five-grade scale (mild, moderate, severe, massive, and torrential). This had to persist despite medical therapy including diuretic therapy adjusted to the individual optimal dose for at least 30 days.\u003c\/p\u003e\n\n\u003cp\u003ePatients were considered to be at advanced risk for future heart-failure events if they met either of two criteria. The first criterion was a history of decompensation (worsening of heart failure requiring treatment) in the previous 12 months. The second criterion was the presence of a cardiorenal or cardiohepatic syndrome. In these patients with heart failure, cardiorenal syndrome was defined as chronic kidney disease. Chronic kidney disease was defined as an estimated glomerular filtration rate below 60 ml per minute per 1.73 m² of body-surface area. The estimated glomerular filtration rate is a measure of kidney function. Cardiohepatic syndrome was defined by elevated levels of at least two of three laboratory markers of cholestasis (a condition where bile flow is blocked): bilirubin, alkaline phosphatase, and γ-glutamyltransferase.\u003c\/p\u003e\n\n\u003cp\u003eThe presence of advanced risk of future heart-failure events was added to the protocol as an additional inclusion criterion in July 2023. All patients underwent preprocedural right heart catheterization (a procedure that measures pressures inside the heart chambers) to allow comprehensive hemodynamic characterization and selection based on previously identified cutoff values.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eCrossover from medical therapy to transcatheter tricuspid-valve repair\u003c\/strong\u003e was permitted only if all of the following criteria were met:\u003c\/p\u003e\n\n\u003col\u003e\n\u003cli\u003eAt least 30 days had elapsed since randomization\u003c\/li\u003e\n\u003cli\u003eA heart-failure decompensation had resulted in hospitalization\u003c\/li\u003e\n\u003cli\u003eIntravenous diuretic therapy was administered during that hospitalization\u003c\/li\u003e\n\u003c\/ol\u003e\n\n\u003cp\u003eAccordingly, crossover was allowed only after a patient had had a primary end-point event. Any subsequent hospitalization for the crossover procedure was not counted as an additional end-point event.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eStatistical analysis:\u003c\/strong\u003e For the first primary end point, researchers calculated that a sample size of 224 patients in the tricuspid-repair group and 112 patients in the medical-therapy group (a total of 336 patients) would provide 85% power. This calculation assumed a win ratio of 1.818 and a significance level of 5% for a two-sided test. It also assumed that the proportion of wins would be 0.4, the proportion of losses would be 0.22, and the proportion of ties would be 0.38. For the second coprimary end point, researchers assumed an incidence of 45% in the medical-therapy group and 30% in the tricuspid-repair group. Assuming a two-sided significance level of 5%, a power of 90%, and a 2:1 randomization ratio, they calculated that 324 patients would be required. To account for anticipated dropouts, the target sample size was increased to 360 patients.\u003c\/p\u003e\n\n\u003cp\u003eAll analyses were conducted according to the intention-to-treat principle in the full analysis population, which included all patients who underwent randomization. The two primary end points were tested in a hierarchical manner in a closed testing procedure. This means the second primary end point was tested only if the first one showed a significant difference. The first primary end point was evaluated by means of the Finkelstein–Schoenfeld method and summarized as a win ratio with corresponding 95% confidence intervals. If the difference in the win-ratio analysis was significant, the second coprimary end point would be analyzed. The second coprimary end point would be analyzed with the use of a two-sided log-rank test. The two-sided log-rank test would compare event-free survival between trial groups. Kaplan–Meier methods and stratified Cox proportional-hazards models were used to estimate event-free survival and hazard ratios with 95% confidence intervals. Both tests were two-sided at a significance level of 0.05 and stratified according to the severity of tricuspid regurgitation for the main analysis. There were no interim efficacy analyses. No adjustments for multiplicity were performed for secondary end points.\u003c\/p\u003e\n\n\u003ch2 id=\"population\"\u003eWho Participated in the Study\u003c\/h2\u003e\n\n\u003cp\u003eFrom March 2022 through June 2025, a total of 360 patients underwent randomization. Of these, 237 patients were assigned to the tricuspid-repair group and 123 patients to the medical-therapy group.\u003c\/p\u003e\n\n\u003cp\u003eThe mean (±SD) age of the patients was 80.3±6.4 years, with a range of 53 to 92 years. Women made up 56.4% of the participants. Baseline characteristics were well balanced between the two groups. The trial population reflected patients at increased risk for future heart-failure events.\u003c\/p\u003e\n\n\u003cp\u003eKey baseline characteristics included:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e75.0%\u003c\/strong\u003e had New York Heart Association (NYHA) class III or IV heart failure (moderate to severe limitation of physical activity due to heart failure symptoms)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e55.0%\u003c\/strong\u003e had been hospitalized for heart failure in the previous year\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e81.7%\u003c\/strong\u003e had cardiorenal syndrome (kidney dysfunction related to heart failure)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e46.2%\u003c\/strong\u003e had cardiohepatic syndrome (liver dysfunction related to heart failure)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e92.0%\u003c\/strong\u003e in the repair group and \u003cstrong\u003e97.6%\u003c\/strong\u003e in the medical-therapy group had atrial fibrillation or flutter (irregular heart rhythms)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e25.3%\u003c\/strong\u003e in the repair group and \u003cstrong\u003e26.0%\u003c\/strong\u003e in the medical-therapy group had diabetes mellitus\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e79.3%\u003c\/strong\u003e in the repair group and \u003cstrong\u003e82.1%\u003c\/strong\u003e in the medical-therapy group had arterial hypertension (high blood pressure)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e46.4%\u003c\/strong\u003e in the repair group and \u003cstrong\u003e55.3%\u003c\/strong\u003e in the medical-therapy group had coronary artery disease\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eAt baseline, tricuspid regurgitation was graded as severe in 50.8% of patients, massive in 34.2%, and torrential in 10.3%. The mean left ventricular ejection fraction (a measure of how well the left side of the heart pumps) was 54.3±8.6%.\u003c\/p\u003e\n\n\u003cp\u003eMedical therapy for right heart failure included:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003eLoop diuretics (water pills) in 94.2% of patients, with a median daily dose of 80 mg\u003c\/li\u003e\n\u003cli\u003eSodium–glucose cotransporter 2 inhibitors (a class of medication that helps the heart and kidneys) in 52.2%\u003c\/li\u003e\n\u003cli\u003eMineralocorticoid receptor antagonists (medications that block a hormone that worsens heart failure) in 43.1%\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eThe median EuroSCORE II score was 4.3 (interquartile range, 2.9 to 6.2) in the repair group. The median EuroSCORE II score was 4.2 (interquartile range, 2.8 to 7.9) in the medical-therapy group. EuroSCORE II is a measure of predicted risk of death after cardiac surgery, ranging from 1 to 100%, with higher scores indicating greater risk. The median TRI-SCORE was 4.0 (interquartile range, 3.0 to 6.0) in the repair group. The median TRI-SCORE was 5.0 (interquartile range, 4.0 to 6.0) in the medical-therapy group. TRI-SCORE is a measure of risk after isolated tricuspid-valve surgery, ranging from 0 to 12, with higher scores indicating greater risk.\u003c\/p\u003e\n\n\u003cp\u003eThe median N-terminal pro–B-type natriuretic peptide (NT-proBNP) was 2022 pg\/ml (interquartile range, 1229 to 3283) in the repair group. The median NT-proBNP was 2076 pg\/ml (interquartile range, 1195 to 4066) in the medical-therapy group. NT-proBNP is a blood marker of heart failure severity. The mean Kansas City Cardiomyopathy Questionnaire (KCCQ) score was 51.9±22.3 in the repair group. The mean KCCQ score was 52.4±23.5 in the medical-therapy group. The KCCQ score is a measure of quality of life, ranging from 0 to 100, with higher scores indicating better health status. The mean 6-minute walk distance was 240.1±128.4 meters in the repair group and 233.4±117.8 meters in the medical-therapy group.\u003c\/p\u003e\n\n\u003ch2 id=\"procedure\"\u003eWhat the Procedure Involved\u003c\/h2\u003e\n\n\u003cp\u003eAmong the 231 patients who underwent transcatheter tricuspid therapy, the specific procedures were:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e227 patients (98.3%)\u003c\/strong\u003e were scheduled to undergo transcatheter edge-to-edge repair (a technique that clips the valve leaflets together to reduce leakage)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e3 patients (1.3%)\u003c\/strong\u003e underwent transcatheter annuloplasty (a technique that reshapes the valve ring)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e1 patient (0.4%)\u003c\/strong\u003e underwent transcatheter tricuspid-valve replacement (a deviation from the trial protocol)\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eThe local heart-valve team selected from devices that had received a European Certificate of Conformity (known as the CE mark) for transcatheter tricuspid-valve repair. The choice was based on what was suitable for the individual patient. The commercially available CE-marked devices included the PASCAL system and the Cardioband system (both from Edwards Lifesciences) and the TriClip system (from Abbott Cardiovascular).\u003c\/p\u003e\n\n\u003cp\u003eOf those undergoing edge-to-edge repair, 149 patients (65.6%) received the PASCAL system and 75 patients (33.0%) received the TriClip system. At least one device was implanted in all these patients. The number of devices implanted was one in 28.6% of patients, two in 62.1%, and three or more in 9.4%.\u003c\/p\u003e\n\n\u003ch2 id=\"results\"\u003eKey Findings: What the Study Showed\u003c\/h2\u003e\n\n\u003cp\u003eFollow-up was completed in 93.5% of eligible patients at 1 year, 58.3% at 2 years, and 20.5% at 3 years. The mean follow-up interval was 594±323 days in the tricuspid-repair group and 567±351 days in the medical-therapy group.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eFirst primary end point:\u003c\/strong\u003e The first primary end point was a hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 12 months. Quality-of-life improvement was assessed using the KCCQ, with a clinically meaningful improvement defined as an increase of at least 15 points.\u003c\/p\u003e\n\n\u003cp\u003eFor this first primary hierarchical end point at 1 year after randomization, 16,909 wins were observed in the tricuspid-repair group and 6,966 wins in the medical-therapy group, with 5,276 ties. This corresponded to a \u003cstrong\u003ewin ratio of 2.42\u003c\/strong\u003e (95% confidence interval [CI], 1.76 to 3.33; P\u0026lt;0.001) in favor of tricuspid repair. A win ratio of 2.42 means that patients in the repair group were more than twice as likely to have a better outcome than patients in the medical-therapy group. The result was statistically highly significant (P\u0026lt;0.001), meaning there is less than a 0.1% chance this finding was due to random chance.\u003c\/p\u003e\n\n\u003cp\u003eThe interventional strategy showed consistently more wins across all components of the primary end point:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eDeath from any cause:\u003c\/strong\u003e 4,366 wins in the repair group vs. 3,166 wins in the medical-therapy group\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eHospitalization for heart failure:\u003c\/strong\u003e 9,280 wins vs. 2,871 wins\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eImprovement of at least 15 points in the KCCQ score:\u003c\/strong\u003e 3,263 wins vs. 929 wins\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003e\u003cstrong\u003eSecond primary end point:\u003c\/strong\u003e Because the win-ratio analysis showed a significant difference, the second primary end point was analyzed. This was a composite of death from any cause or hospitalization for heart failure, assessed in a time-to-event analysis at a minimum follow-up of 12 months.\u003c\/p\u003e\n\n\u003cp\u003eKaplan–Meier estimates for event-free survival (the percentage of patients alive and free from heart-failure hospitalization) were:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eAt 1 year:\u003c\/strong\u003e 73.9% in the tricuspid-repair group vs. 48.4% in the medical-therapy group\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAt 3 years:\u003c\/strong\u003e 52.4% (95% CI, 43.2 to 63.6) in the tricuspid-repair group vs. 21.0% (95% CI, 12.7 to 34.6) in the medical-therapy group\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eThis corresponded to a \u003cstrong\u003ehazard ratio of 0.40\u003c\/strong\u003e (95% CI, 0.29 to 0.55; P\u0026lt;0.001). A hazard ratio of 0.40 means that patients in the repair group had a 60% lower risk of death or heart-failure hospitalization compared with the medical-therapy group. This result was also statistically highly significant.\u003c\/p\u003e\n\n\u003cp\u003eIn a post hoc analysis (an analysis performed after the study was completed), the number needed to treat to prevent one death or hospitalization for heart failure with tricuspid-valve repair in 1 year was \u003cstrong\u003e4\u003c\/strong\u003e (95% CI, 3 to 6). This means that for every 4 patients treated with tricuspid-valve repair, one death or heart-failure hospitalization was prevented within 1 year.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eIndividual components of the primary end point:\u003c\/strong\u003e\u003c\/p\u003e\n\n\u003cp\u003eFor death from any cause, the Kaplan–Meier estimates for survival were:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eAt 1 year:\u003c\/strong\u003e 86.5% in the tricuspid-repair group vs. 82.5% in the medical-therapy group\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAt 3 years:\u003c\/strong\u003e 72.3% in the tricuspid-repair group vs. 53.9% in the medical-therapy group (hazard ratio, 0.62; 95% CI, 0.40 to 0.96)\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eFor hospitalization for heart failure, the estimated percentage of patients who were alive and free from hospitalization was:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eAt 1 year:\u003c\/strong\u003e 79.6% in the tricuspid-repair group vs. 51.3% in the medical-therapy group (hazard ratio, 0.35; 95% CI, 0.25 to 0.50)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAt 3 years:\u003c\/strong\u003e 62.4% in the tricuspid-repair group vs. 31.0% in the medical-therapy group (hazard ratio, 0.35; 95% CI, 0.25 to 0.51)\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eTricuspid repair was also associated with a lower cumulative incidence of hospitalization for heart failure when researchers accounted for the competing risk of death. There was no evidence of a violation of the proportional-hazards assumption (a statistical assumption that the treatment effect remains constant over time).\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eSecondary end points:\u003c\/strong\u003e The severity of tricuspid regurgitation at 30 days was moderate or less in 135 of 192 patients (70.3%) in the tricuspid-repair group, compared with 29 of 98 patients (29.6%) in the medical-therapy group. The corresponding percentages for mild tricuspid regurgitation or less at 1 year were 56.3% in the repair group and 19.2% in the medical-therapy group.\u003c\/p\u003e\n\n\u003cp\u003eTricuspid repair was associated with substantial improvement in NYHA functional class at 1 year. NYHA class I or II heart failure was reported in 138 of 187 patients (73.8%) in the tricuspid-repair group. NYHA class I or II heart failure was reported in 49 of 86 patients (57.0%) in the medical-therapy group. NYHA class I or II heart failure means no or mild limitation of physical activity.\u003c\/p\u003e\n\n\u003cp\u003eThe mean change in the KCCQ score from baseline to 1-year follow-up was 11.2±21.9 points (95% CI, 8.0 to 14.5) in the tricuspid-repair group and 4.3±24.9 points (95% CI, −1.1 to 9.6) in the medical-therapy group.\u003c\/p\u003e\n\n\u003ch2 id=\"safety\"\u003eSafety and Side Effects\u003c\/h2\u003e\n\n\u003cp\u003eMajor adverse events occurred in 14 patients (5.9%) within 30 days after tricuspid transcatheter-valve repair. One death occurred 17 days after the procedure.\u003c\/p\u003e\n\n\u003cp\u003eIn total, 48 patients crossed over from the medical-therapy group to receive transcatheter tricuspid-valve repair. Crossover was permitted only after a primary end-point event involving hospitalization for severe heart failure that required intravenous diuretic therapy. In 28 of 48 crossovers (58%), the valve-repair procedure was performed during the hospitalization that constituted the primary end-point event. The remaining crossover procedures were performed during subsequent hospitalizations.\u003c\/p\u003e\n\n\u003ch2 id=\"implications\"\u003eWhat This Means for Patients\u003c\/h2\u003e\n\n\u003cp\u003eThis trial provides strong evidence that transcatheter tricuspid-valve repair plus medical therapy is superior to medical therapy alone. This is in patients with symptomatic severe tricuspid regurgitation. These patients are at increased risk for heart-failure events. The benefits were consistent across multiple measures.\u003c\/p\u003e\n\n\u003cp\u003eThe findings showed that the interventional strategy was superior with respect to:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003eA hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 1 year\u003c\/li\u003e\n\u003cli\u003eA lower risk of the composite of death from any cause or hospitalization for heart failure through 3 years\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eThe number needed to treat of 4 is particularly striking. It means that for every 4 patients treated with transcatheter tricuspid-valve repair, one death or heart-failure hospitalization was prevented within 1 year. This is a strong treatment effect for a condition that previously had limited options.\u003c\/p\u003e\n\n\u003cp\u003eThe procedure also led to meaningful improvements in valve function. At 30 days, 70.3% of patients in the repair group had moderate or less tricuspid regurgitation, compared with 29.6% in the medical-therapy group. By 1 year, 56.3% of repair-group patients had mild or less regurgitation, compared with 19.2% in the medical-therapy group.\u003c\/p\u003e\n\n\u003cp\u003ePatients in the repair group also reported better quality of life. The mean KCCQ score improved by 11.2 points in the repair group, compared with 4.3 points in the medical-therapy group. The KCCQ is a questionnaire that measures how heart failure affects daily life, including symptoms, physical limitations, and social function.\u003c\/p\u003e\n\n\u003cp\u003eMore patients in the repair group improved to NYHA class I or II heart failure (73.8% vs. 57.0%). This means they experienced no or mild limitation of physical activity, compared with more significant limitations before treatment.\u003c\/p\u003e\n\n\u003ch2 id=\"limitations\"\u003eLimitations of the Study\u003c\/h2\u003e\n\n\u003cp\u003eThe trial had several limitations that patients and doctors should consider.\u003c\/p\u003e\n\n\u003cp\u003eFirst, the trial was open-label, meaning both patients and doctors knew which treatment was given. This could potentially influence how patients reported their symptoms and quality of life. However, the hard outcomes of death and hospitalization are less likely to be affected by this knowledge.\u003c\/p\u003e\n\n\u003cp\u003eSecond, follow-up was completed in only 20.5% of eligible patients at 3 years. This means the 3-year results are based on a smaller number of patients than the 1-year results. The long-term benefits beyond 3 years remain unknown.\u003c\/p\u003e\n\n\u003cp\u003eThird, the trial was conducted at 29 high-volume heart-valve centers in Germany. These centers had substantial experience in transcatheter tricuspid-valve repair, with a mean of 176±163 procedures before the trial began. Results may differ at centers with less experience.\u003c\/p\u003e\n\n\u003cp\u003eFourth, the trial population was predominantly White (82.3% in the repair group and 82.1% in the medical-therapy group). Whether the results apply equally to other racial and ethnic groups is not known.\u003c\/p\u003e\n\n\u003cp\u003eFifth, no adjustments for multiplicity were performed for secondary end points. This means the confidence intervals for secondary end points should not be used to infer definitive treatment effects.\u003c\/p\u003e\n\n\u003cp\u003eSixth, the trial used a hierarchical composite end point that included quality-of-life improvement. This type of end point gives priority to death, then hospitalization, then quality of life. While this approach is increasingly used in heart failure trials, it means that improvements in quality of life can contribute to a positive result. This can happen even if death and hospitalization rates were similar. In this trial, however, the repair group showed benefits across all components.\u003c\/p\u003e\n\n\u003ch2 id=\"recommendations\"\u003eRecommendations and Next Steps\u003c\/h2\u003e\n\n\u003cp\u003eBased on the results of this trial, patients with symptomatic severe tricuspid regurgitation who are at increased risk for heart-failure events may benefit from transcatheter tricuspid-valve repair plus medical therapy. The procedure was associated with a 60% lower risk of death or heart-failure hospitalization through 3 years.\u003c\/p\u003e\n\n\u003cp\u003ePatients who are considering this procedure should discuss the following with their heart team:\u003c\/p\u003e\n\n\u003col\u003e\n\u003cli\u003eWhether they meet the criteria for severe tricuspid regurgitation despite optimal medical therapy\u003c\/li\u003e\n\u003cli\u003eWhether they have markers of increased risk for heart-failure events, such as a history of decompensation in the previous 12 months or cardiorenal or cardiohepatic syndrome\u003c\/li\u003e\n\u003cli\u003eThe risks and benefits of the procedure, including the 5.9% rate of major adverse events within 30 days\u003c\/li\u003e\n\u003cli\u003eThe expected benefits, including a number needed to treat of 4 to prevent one death or heart-failure hospitalization in 1 year\u003c\/li\u003e\n\u003cli\u003eThe availability of CE-marked devices, including the PASCAL system, the Cardioband system, and the TriClip system\u003c\/li\u003e\n\u003c\/ol\u003e\n\n\u003cp\u003eThe trial was funded by the German Center for Cardiovascular Research and others. The trial is registered on ClinicalTrials.gov with the number NCT04634266.\u003c\/p\u003e\n\n\u003cp\u003eFuture research should focus on longer-term outcomes beyond 3 years, the effectiveness of the procedure at centers with less experience, and whether the results apply to more diverse patient populations. Additionally, further studies are needed to determine which patients benefit most from transcatheter tricuspid-valve repair and which patients may do well with medical therapy alone.\u003c\/p\u003e\n\n\u003c!-- ddn:faq:start --\u003e\n\u003ch2 id=\"ddn-faq\"\u003eFrequently Asked Questions\u003c\/h2\u003e\n\u003ch3\u003eWhat is transcatheter tricuspid-valve repair?\u003c\/h3\u003e\n\u003cp\u003eIt is a catheter-based procedure to fix a leaky tricuspid valve on the right side of the heart without open surgery. In a trial of 360 patients with symptomatic severe tricuspid regurgitation, most (98.3%) had edge-to-edge repair, which clips the valve leaflets together to reduce leakage. The heart team chose among CE-marked devices suitable for each patient.\u003c\/p\u003e\n\u003ch3\u003eWho was eligible for this trial?\u003c\/h3\u003e\n\u003cp\u003ePatients had at least severe tricuspid regurgitation on a five-grade scale that persisted despite medical therapy, including diuretics adjusted to the individual optimal dose for at least 30 days. They also had to be at increased risk for future heart-failure events, meaning a history of decompensation in the previous 12 months or a cardiorenal or cardiohepatic syndrome.\u003c\/p\u003e\n\u003ch3\u003eWhat did the trial find about survival and hospitalizations?\u003c\/h3\u003e\n\u003cp\u003eIn 360 patients with symptomatic severe tricuspid regurgitation, at 3 years 52.4% of those who had valve repair plus medical therapy were alive and free from heart-failure hospitalization, compared with 21.0% who had medical therapy alone. This corresponded to a 60% lower risk of death or heart-failure hospitalization in the repair group.\u003c\/p\u003e\n\u003ch3\u003eWhat does a win ratio of 2.42 mean?\u003c\/h3\u003e\n\u003cp\u003eThe win ratio compared a combined measure of death, heart-failure hospitalization, and quality-of-life improvement at 1 year. A win ratio of 2.42 means patients in the repair group were more than twice as likely to have a better outcome than those in the medical-therapy group. The result was statistically highly significant.\u003c\/p\u003e\n\u003ch3\u003eWhat are the risks of the procedure?\u003c\/h3\u003e\n\u003cp\u003eIn the trial, major adverse events within 30 days occurred in 14 of 237 patients (5.9%) in the repair group, and one death occurred 17 days after the procedure. Patients considering this procedure should discuss the risks and benefits with their heart team, including this 5.9% rate of major adverse events within 30 days.\u003c\/p\u003e\n\u003ch3\u003eWhat is the number needed to treat of 4?\u003c\/h3\u003e\n\u003cp\u003eIn a post hoc analysis, the number needed to treat to prevent one death or hospitalization for heart failure with tricuspid-valve repair in 1 year was 4. This means that for every 4 patients treated with transcatheter tricuspid-valve repair, one death or heart-failure hospitalization was prevented within 1 year.\u003c\/p\u003e\n\u003ch3\u003eWhat improvements in symptoms and quality of life were seen?\u003c\/h3\u003e\n\u003cp\u003eAt 1 year, 73.8% of patients in the repair group had NYHA class I or II heart failure, meaning no or mild limitation of physical activity, compared with 57.0% in the medical-therapy group. The mean KCCQ quality-of-life score improved by 11.2 points in the repair group versus 4.3 points with medical therapy alone.\u003c\/p\u003e\n\u003ch3\u003eWhen should a patient with symptomatic severe tricuspid regurgitation seek a second opinion about transcatheter tricuspid-valve repair?\u003c\/h3\u003e\n\u003cp\u003eA second opinion is reasonable when a patient has symptomatic severe tricuspid regurgitation despite at least 30 days of adjusted diuretic therapy, and has markers of increased heart-failure risk such as a decompensation in the previous 12 months or cardiorenal or cardiohepatic syndrome. In a randomized trial, transcatheter tricuspid-valve repair plus medical therapy was superior to medical therapy alone, with a hazard ratio of 0.40 for death or heart-failure hospitalization through 3 years and a number needed to treat of 4 at 1 year. Diagnostic Detectives Network provides independent expert second opinions.\u003c\/p\u003e\n\u003c!-- ddn:faq:end --\u003e\n\n\u003ch2 id=\"source\"\u003eSource Information\u003c\/h2\u003e\n\n\u003cp\u003e\u003cstrong\u003eOriginal article title:\u003c\/strong\u003e Tricuspid-Valve Intervention in Heart Failure\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eAuthors:\u003c\/strong\u003e Jörg Hausleiter, M.D., Thomas J. Stocker, M.D., Tobias Geisler, M.D., Philipp Lurz, M.D., Ph.D., Wolfgang Rottbauer, M.D., Edith Lubos, M.D., Niklas Schofer, M.D., Christian Frerker, M.D., Johanne Frank, M.D., Holger Thiele, M.D., Rico Osteresch, M.D., Volker Rudolph, M.D., Alexander Lauten, M.D., Erion Xhepa, M.D., Jürgen Rothe, M.D., Tienush Rassaf, M.D., Stephan Baldus, M.D., Georg Nickenig, M.D., David M. Leistner, M.D., Eike Tigges, M.D., Victoria Kehl, Ph.D., Mirjam Kessler, M.D., Tobias Kister, M.D., Tobias Ruf, M.D., Muhammed Gerçek, M.D., Meinrad Gawaz, M.D., Derk Frank, M.D., Ingo Eitel, M.D., Ralph Stephan von Bardeleben, M.D., Daniel Kalbacher, M.D., Osama Soliman, M.D., Ph.D., Michael Näbauer, M.D., and Steffen Massberg, M.D., for the TRIC-I-HF-DZHK24 Investigators\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003ePublication:\u003c\/strong\u003e The New England Journal of Medicine\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003ePublication date:\u003c\/strong\u003e August 30, 2026\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eDOI:\u003c\/strong\u003e 10.1056\/NEJMoa2606934\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eClinicalTrials.gov number:\u003c\/strong\u003e NCT04634266\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c\/strong\u003e German Center for Cardiovascular Research and others\u003c\/p\u003e\n\n\u003cp\u003e\u003cem\u003eThis patient-friendly article is based on peer-reviewed research.\u003c\/em\u003e\u003c\/p\u003e","brand":"DiagnosticDetectives.Com","offers":[{"title":"Default Title","offer_id":47807399133340,"sku":null,"price":0.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0599\/5449\/5644\/files\/ddn-medical-article-catheter-based-tricuspid-valve-repair-improves-survival-and-reduces-hospitalizations-in-severe-heart-valve-leakage-hero.png?v=1792909272","url":"https:\/\/diagnosticdetectives.com\/pt\/products\/catheter-based-tricuspid-valve-repair-improves-survival-and-reduces-hospitalizations-in-severe-heart-valve-leakage","provider":"DiagnosticDetectives.Com","version":"1.0","type":"link"}