BACKGROUND:The effect of transcatheter tricuspid-valve repair on clinical outcomes, including death and hospitalization for heart failure, in patients with severe tricuspid regurgitation remains uncertain. METHODS:We randomly assigned patients with symptomatic severe tricuspid regurgitation and an increased risk of future heart-failure events in a 2:1 ratio to tricuspid-valve repair plus medical therapy (tricuspid-repair group) or medical therapy alone (medical-therapy group). The first primary end point was a hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 1 year, assessed by win ratio. If the between-group difference was significant, a second primary end point would be tested: a composite of death from any cause or hospitalization for heart failure through 3 years. RESULTS:A total of 360 patients underwent randomization (237 patients were assigned to the tricuspid-repair group and 123 to the medical-therapy group). The mean (±SD) age of the patients was 80.3±6.4 years, and 56.4% were women. The win ratio for the first primary end point was 2.42 (95% confidence interval [CI], 1.76 to 3.33; P<0.001), favoring tricuspid-valve repair. The Kaplan-Meier estimate for freedom from death from any cause or hospitalization for heart failure (second primary end point) through 3 years was 52.4% (95% CI, 43.2 to 63.6) in the tricuspid-repair group and 21.0% (95% CI, 12.7 to 34.6) in the medical-therapy group (hazard ratio for death from any cause or hospitalization for heart failure, 0.40; 95% CI, 0.29 to 0.55; P<0.001). Major adverse events within 30 days occurred in 14 patients (5.9%) in the tricuspid-repair group. CONCLUSIONS:Among patients with symptomatic severe tricuspid regurgitation, transcatheter tricuspid-valve repair plus medical therapy was superior to medical therapy alone with respect to a hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 1 year and was also associated with a lower risk of a composite of death from any cause or hospitalization for heart failure through 3 years. (Funded by the German Center for Cardiovascular Research and others; TRIC-I-HF ClinicalTrials.gov number, NCT04634266.).

Background:In patients with primary mitral regurgitation (MR) (PMR), advanced symptoms classified as New York Heart Association (NYHA) class IV are typically driven by valve deterioration. Transcatheter edge-to-edge repair (mitral valve transcatheter edge-to-edge repair [M-TEER]) reliably achieves effective reduction of mitral regurgitation in high-risk patients. However, whether or not preprocedural NYHA class IV continues to predict outcomes after successful MR reduction remains unclear. Methods:The Outcomes of Patients tReated wIth Mitral Transcatheter Edge-to-edge Repair for Primary Mitral Regurgitation Registry includes PMR patients undergoing M-TEER at 27 international sites between 2009 and 2023. Clinical outcomes were compared between patients in NYHA class IV and those in NYHA class II/III. Results:A total of 2528 patients were included (median age 82 years [interquartile range (IQR) 76-85], 45.9% female), and 19.7% presented in NYHA class IV. Baseline left ventricular ejection fraction and right ventricular function did not differ significantly between groups. Procedural success (residual MR ≤ 1+: 66.7% vs. 64.6%, p = 0.55) and 2-year rehospitalization rates (17.9% vs. 20.4%, log-rank p = 0.78) were comparable. In contrast, 2-year all-cause mortality was higher in NYHA class IV patients (31.8% vs. 21.1%, log-rank p < 0.0001). Multivariable Cox regression confirmed preprocedural NYHA class IV as an independent predictor of mortality (hazard ratio [HR] 1.75; 95% CI 1.32-2.31; p < 0.001). Conclusions:In PMR, preprocedural NYHA class IV remains an independent predictor of all-cause mortality after effective MR reduction with M-TEER, despite comparable postprocedural results.

BACKGROUND:The evolving landscape of mitral valve transcatheter edge-to-edge repair (M-TEER) for mitral regurgitation (MR) has seen continuous advancements, driving improvements in therapeutic efficacy. Particularly in primary MR (PMR), contemporary device iterations of M-TEER offer technical advantages for improved management of complex anatomies. However, data on temporal trends in M-TEER for PMR are limited. AIMS:The primary objective of our study was to analyse temporal trends in the safety, efficacy, and stability of M-TEER treatment. METHODS:The PRIME-MR registry, a retrospective multicentre study, enrolled consecutive patients undergoing M-TEER for PMR at 27 centres in Europe and North America. M-TEER procedures were categorised into four time periods (2009-2013, 2014-2016, 2017-2019, and 2020-2023), to align with major device updates. RESULTS:The analysis included 3,082 consecutive patients (median age 82 years [interquartile range 76.0-85.0], 45.1% female). Patients treated were highly symptomatic (New York Heart Association [NYHA] Class ≥III in 80.4%). Patient characteristics showed a decline in symptomatic severity (NYHA Class ≥III 85.9% in 2009-2013 vs 71.8% in 2020-2023), accompanied by lower mean Society of Thoracic Surgeons scores (5.6% [2009-2013] vs 4.6% [2020-2023]; p for trend<0.0001), and less severe MR. Over time, complication rates decreased (procedures with complications: 42.4% [2009-2013] vs 23.1% [2020-2023]; p for trend<0.0001), whereas technical efficacy increased (residual MR ≤1+: 54.0% [2009-2013] vs 68.4% [2020-2023]; p for trend<0.001). There was an increased occurrence of stable results without any deterioration at one-year follow-up (63.6% [2009-2013] vs 74.4% [2020-2023]; p for trend=0.03). CONCLUSIONS:Findings from the PRIME-MR registry highlight substantial reductions in residual MR severity and complication rates over time in PMR patients undergoing M-TEER.

AIMS:Transcatheter mitral valve replacement (TMVR) with the Tendyne Mitral Valve System is a treatment option for patients with severe symptomatic mitral regurgitation (MR) unsuitable for conventional mitral valve surgery or transcatheter edge-to-edge repair (TEER). This study sought to evaluate the safety and effectiveness of TMVR through 5-year follow-up. METHODS AND RESULTS:The Tendyne Expanded Clinical Study is a prospective, single-arm, multicentre study that enrolled patients between November 2014 and June 2020. The study enrolled 191 patients (mean age 74.1 ± 8.0 years, 62.8% male, 70.2% New York Heart Association Class (NYHA) class III/IV, 88.5% secondary MR), of whom 186 (97.4%) underwent TMVR with Tendyne. MR grade decreased from ≥3+ in 99.5% patients at baseline to grade ≤1+ in 95.3% at 5 years. In those patients surviving to 5 years (n = 49), durable symptomatic improvement was evidenced by 73.5% patients being in NYHA class I/II at 5 years. The Kansas City Cardiomyopathy Questionnaire overall summary score increased from 48.5 ± 22.5 points at baseline to 67.6 ± 21.5 points at 5 years. Serious adverse events that occurred through 5 years included life-threatening bleeding (11.5%), fatal bleeding (2.6%), renal insufficiency/failure (28.8%), endocarditis (7.3%), device thrombosis (5.8%), and new onset atrial fibrillation (13.1%). No structural device degeneration or device embolism occurred through 5 years. CONCLUSIONS:The Tendyne TMVR was effective at achieving immediate and sustainable elimination of MR, which was associated with symptomatic improvement and absence of structural valve degeneration in a high-risk cohort over 5 years. These findings support TMVR with the Tendyne System as an alternative for patients with appropriate mitral valve anatomy and symptomatic secondary MR unsuitable for mitral surgery or TEER.

BACKGROUND:The impact of proportionality to heart valve regurgitation has been widely investigated in mitral regurgitation, helping to better characterize the best candidates for therapies. However, it has never been studied in tricuspid regurgitation (TR). The aim of the present study is to investigate the impact of the proportionality of TR on outcomes. METHODS:Patients undergoing tricuspid transcatheter edge-to-edge repair were selected from the TRIVALVE registry (International Multisite Transcatheter Tricuspid Valve Therapies Registry). Patients were divided according to the ratio between effective regurgitant orifice area (EROA) and right ventricular (RV) end diastolic diameter (RVEDD) into tertiles: patients with low EROA/RVEDD (RV, dominant); intermediate EROA/RVEDD (RV and TR, RV-TR, codominant), and high EROA/RVEDD (TR, dominant). The primary outcome was all-cause mortality. Median follow-up was 9.7 months (4.2-12.0). RESULTS:A total of 204 patients were included in the present study: 67 for the RV dominant, 68 for the RV-TR codominant, and 69 for the TR dominant group. The 3 groups presented different baseline characteristics. Survival analysis among the 3 groups showed a trend towards worse prognosis for the RV-dominant group, as compared with the RV-TR codominant and TR dominant groups. CONCLUSIONS:The conceptual framework of proportionality is applicable to TR with EROA/RVEDD, defining a higher risk RV-dominant phenotype with a trend towards worse survival after tricuspid transcatheter edge-to-edge repair.

BACKGROUND:Studies on mitral transcatheter edge-to-edge repair for atrial functional mitral regurgitation (AFMR) and ventricular functional mitral regurgitation (VFMR) are limited. METHODS:We report 1-year outcomes of mitral transcatheter edge-to-edge repair for AFMR and VFMR using the PASCAL transcatheter valve repair system in the MiCLASP multicenter European postmarket clinical follow-up study (REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04430075). RESULTS:Analysis included 295 patients with functional mitral regurgitation (75.5±9.93 years old, 59.3% male) from the first 600 enrolled in the MiCLASP study, with AFMR in 17.6% (52) and VFMR in 82.4% (243). Patients with AFMR were older (79.7±6.67 versus 74.6±10.30 years), majority female (75.0% versus 33.3%), and had higher rates of hypertension (98.1% versus 82.3%) and atrial fibrillation (82.7% versus 60.1%) than patients with VFMR (all P<0.05). Patients with VFMR had higher NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels (3350.0 [1720.0-6564.0] versus 1562.0 [790.0-2286.0]; P<0.001) and more severe mitral regurgitation (≥3+) at baseline (71.9% versus 46.2%; P<0.001). Procedural success was high (AFMR, 96.2%; VFMR, 97.1%; P=0.661), and patients with AFMR had shorter procedure duration (73.5 versus 85.5 minutes; P=0.044). One-year Kaplan-Meier estimate of freedom from all-cause mortality or heart failure hospitalizations was 79.3% in AFMR and 70.9% in VFMR (P=0.267). Both AFMR and VFMR groups demonstrated significant mitral regurgitation reduction (mitral regurgitation ≤1+, 93.1% and 81.3%), low mean transmitral gradients (3.5 and 3.1 mm Hg), significant proportional reductions in left ventricular end-diastolic volume (-12.9% and -16.4%) and left atrial volume (-9.6% and -10.9%), high proportions at New York Heart Association class I/II (76.5% and 64.6%), and significant increases in Kansas City Cardiomyopathy Questionnaire Overall Summary score (+18.0 and +11.6 points), respectively (all P<0.05 from baseline). CONCLUSIONS:One-year MiCLASP results support the safety of mitral transcatheter edge-to-edge repair with the PASCAL system in both AFMR and VFMR, with comparable echocardiographic, functional, and quality-of-life changes, despite baseline differences in clinical presentation.

AIMS:To assess the association between right heart failure (RHF) and mortality in patients with severe tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention (TTVI), and to determine whether clinical RHF status reduces the survival benefit of successful versus failed TTVI. METHODS AND RESULTS:The TriValve International Registry (Transcatheter Tricuspid Valve Therapies) is a multicenter registry collecting data of patients with symptomatic, severe or greater TR undergoing TTVI. The population was stratified according to RHF status defined by the following clinical criteria: history of previous hospitalization for RHF (<1 year) OR presence of signs of RHF (jugular venous distension, ascites, peripheral oedema) OR high dose diuretic (≥125 mg/day of furosemide or equivalent). The outcome of interest was 1-year all-cause death. Among 639 patients included in the TriValve registry, 498 had complete data regarding RHF status. Overall, 54 (10.8 %) patients had no criteria for RHF, 133 (26.7 %) patients fulfilled 1 criterion, 240 (48.2 %) 2 criteria and 71 (14.3 %) 3 criteria. At a median follow-up of 216 days (IQR 49-372 days), cumulative incidence of all-cause death was higher in patients with 2 or 3 RHF criteria versus those with no or 1 RHF criterion (adjusted HR 2.91-95 % CI 1.46-5.83, P = 0.002). However, RHF status did not influence the association between procedural success and all-cause death at 1-year follow-up (p for interaction 0.857). CONCLUSIONS:In a large real-world population undergoing TTVI for severe TR, the presence of at least 2 RHF clinical criteria was independently associated with an increased risk of 1-year mortality. Procedural success was associated with a lower risk of mortality regardless of RHF status.

Interventional closure of symptomatic paravalvular leaks (PVL) after valve replacement has developed to an attractive treatment option for patients at high operative risk. However, prospective and long-term data are sparse. We analysed data from a multicentre prospective registry on interventional PVL closure. 41 patients with symptomatic PVL were included in the plug registry at nine German hospitals from 2014 until 2020. In total 50 interventions with 67 plug implantations were recorded, 46.3

BACKGROUND:Current clinical guidelines do not recommend mitral transcatheter edge-to-edge repair (M-TEER) for patients with moderate functional mitral regurgitation (FMR), and the implications of M-TEER in this population are not well documented. AIMS:We aimed to assess M-TEER outcomes in patients with symptomatic moderate FMR compared to those with FMR ≥3+ who were treated with the PASCAL system in the MiCLASP study. METHODS:Patients were stratified by baseline FMR grade (2+ or ≥3+). The echocardiographic core laboratory-assessed mitral regurgitation (MR) reduction, clinical events committee-adjudicated major adverse events (MAE) rate and functional and quality-of-life outcomes were evaluated up to 1 year after M-TEER. RESULTS:Of the 544 (FMR=322; degenerative MR=163; mixed/other=59) enrolled patients, 101 had baseline FMR 2+ and 197 FMR ≥3+. Both groups achieved significant MR reduction at discharge, which was sustained up to 1 year, with 89.8% of patients achieving MR ≤1+ in the FMR 2+ group and 77.8% in the FMR ≥3+ group (all p<0.001 vs baseline). At 1 year, significant improvements (all p<0.001 vs baseline) in functional capacity (New York Heart Association Class I/II: 67.1% FMR 2+; 70.1% FMR ≥3+) and quality of life (change in the Kansas City Cardiomyopathy Questionnaire overall score: +13.9 points FMR 2+; +13.9 points FMR ≥3+) were achieved in both groups, with high survival (90.0% FMR 2+; 84.2% FMR ≥3+; p=0.176) and low MAE rates (13.9% FMR 2+; 18.3% FMR ≥3+; p=0.413). CONCLUSIONS:In the MiCLASP study, patients with moderate FMR experienced significant MR reduction at 1 year, resulting in clinical and symptomatic benefits comparable to those with ≥moderate-severe FMR, suggesting that select patients with symptomatic moderate FMR can benefit from M-TEER.

AIMS:The prognostic value of N-terminal pro-B-type natriuretic peptide (NT-proBNP) in patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) for primary mitral regurgitation (PMR) is unclear. This study assessed the association between NT-proBNP and outcomes and explored its additive value to the Mitral Regurgitation International Database (MIDA) score. METHODS AND RESULTS:PRIME-MR, a retrospective, international, multicentre registry, includes 3083 consecutive PMR patients treated with M-TEER. This analysis focused on 1382 patients (median age 81 years, 47% female, 82% New York Heart Association [NYHA] functional class III/IV, median EuroSCORE II 4.1%) with available NT-proBNP levels and follow-up. The primary endpoint was death or heart failure hospitalization within 3 years. Median NT-proBNP level was 1991 pg/ml (T1: 578, T3: 6285), and 384 patients reached the primary endpoint (Kaplan-Meier estimate: 48.5%). Log-transformed NT-proBNP levels independently predicted the primary endpoint (adjusted hazard ratio [HR] 1.17, 95% confidence interval [CI] 1.07-1.28; p < 0.001) after adjusting for NYHA class, haemoglobin, creatinine, and atrial fibrillation. In 1041 patients with a modified MIDA score (median 9), the score was initially associated with the primary endpoint (HR 1.10, 95% CI 1.04-1.17; p = 0.002), but lost significance when adjusting for NT-proBNP levels, which remained independently predictive (adjusted HR 1.20, 95% CI 1.07-1.34; p = 0.002). CONCLUSIONS:NT-proBNP, but not the MIDA score, was independently associated with death or heart failure hospitalizations within 3 years in M-TEER-treated PMR patients. Incorporating NT-proBNP levels into clinical assessment may improve risk stratification and potentially supports earlier intervention at lower NT-proBNP levels to optimize outcomes.

BACKGROUND:Patients with tricuspid regurgitation (TR) are at high risk for morbidity and mortality, with poorer outcomes associated with increasing TR severity. Tricuspid transcatheter edge-to-edge repair (T-TEER) has emerged as a promising treatment option. AIMS:TriCLASP is a prospective, single-arm, European post-market study evaluating the safety and effectiveness of T-TEER with the PASCAL system to treat patients with ≥severe TR. METHODS:The TriCLASP study enrolled 300 patients to evaluate the safety and performance of T-TEER. Major adverse events (MAE), reduction in TR grade, and clinical, functional, and quality-of-life outcomes were assessed at 1 year. RESULTS:Enrolled patients had a mean age of 80.1 years, 52.0% were female, and 75.8% had ≥severe TR. Tricuspid regurgitation was reduced to ≤moderate in 87.7% of patients (p<0.001). The composite MAE rate was 1.7% at 30 days and 12.7% at 1 year. Kaplan-Meier estimates for survival and freedom from heart failure hospitalisation (HFH) were 88.3±1.9% and 83.2±2.3%, respectively. Annualised HFH rates decreased by 72.2% in the 12 months pre- versus post-procedure (p<0.001). Significant functional and quality-of-life improvements were observed from baseline to 1 year, including 74.5% of patients in New York Heart Association Class I/II, a 29.4-metre increase in the 6-minute walk distance, and an 8.3-point increase in the Kansas City Cardiomyopathy Questionnaire score (p<0.001). CONCLUSIONS:The 1-year results of the TriCLASP study confirm the safety and effectiveness of T-TEER with the PASCAL system in patients with ≥severe TR. Patients experienced significant TR reduction, low mortality, high freedom from HFH, and significant improvements in symptoms, functional capacity, and quality of life.

AIMS:Tricuspid regurgitation (TR) is a detrimental disease frequently diagnosed in patients with right-sided heart failure (HF). While transcatheter tricuspid valve interventions (TTVI) effectively reduce TR and improve quality of life (QoL) in earlier stages of the disease, their effect on reducing HF hospitalizations (HFH) and improving survival remains unclear. METHODS:TRIC-I-HF-DZHK24 (NCT04634266) is an investigator-initiated, prospective, randomized, open-label, multicentre strategy trial. Approximately 360 patients with severe TR and manifest right-sided HF will be enrolled. In contrast to previous trials, subjects with increased risk for HFH will be selected as facilitated by specific inclusion criteria: HFH in the previous year, or presence of cardio-renal syndrome, or evidence for cardio-hepatic syndrome. Subjects will be randomized 2:1 to TTVI and optimal medical therapy (OMT) or continuation of OMT alone. All CE-marked transcatheter repair devices including tricuspid transcatheter edge-to-edge repair (T-TEER) or transcatheter tricuspid annuloplasty can be used for TTVI. The participating 29 study sites are highly experienced and treated a mean of 176 patients in 4.5 years with T-TEER before study activation. The primary outcome will be assessed at 1 year. First, a composite of all-cause mortality, HFH, and QoL improvement will be tested hierarchically. If positive, the combination of hard clinical endpoints including all-cause mortality and HFH will be tested. Patients will be followed for a total of 3 years. The safety outcome comprises complications of TTVI, life-threatening bleeding and death. CONCLUSIONS:The TRIC-I-HF-DZHK24 trial will define the role of TTVI in patients with severe TR and right-sided HF.

BACKGROUND Mitral transcatheter edge -to -edge repair (M-TEER) is a guideline -recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post -market setting have not been established. OBJECTIVES The authors report 30 -day and 1 -year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post -market clinical follow-up study. METHODS Patients with symptomatic, clinically significant MR were prospectively enrolled. The primary safety endpoint was clinical events committee -adjudicated 30 -day composite major adverse event rate and the primary effectiveness endpoint was echocardiographic core laboratory -assessed MR severity at discharge compared with baseline. Clinical, echocardiographic, functional, and quality -of -life outcomes were assessed at 1 year. RESULTS A total of 544 patients were enrolled (59% functional MR, 30% degenerative MR). The 30 -day composite major adverse event rate was 6.8%. MR reduction was signi ficant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR <= 2+ and 82.6% MR <= 1+ (all P < 0.001 vs baseline). One-year Kaplan -Meier estimate for survival was 87.3%, and freedom from heart failure hospitalization was 84.3%. Signi ficant functional and quality -of -life improvements were observed at 1 year, including 71.6% in NYHA functional class I/II, 14.4 -point increase in Kansas City Cardiomyopathy Questionnaire score, and 24.2-m improvement in 6 -minute walk distance (all P < 0.001 vs baseline). CONCLUSIONS One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post -market setting. Results demonstrate high survival and freedom from heart failure hospitalization, signi ficant and sustained MR reduction, and improvements in symptoms, functional capacity, and quality of life. (J Am Coll Cardiol Intv 2024;17:890 -903) (c) 2024 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

BACKGROUND:The safety profile of transcatheter tricuspid valve (TTV) repair techniques is well established, but residual tricuspid regurgitation (TR) remains a concern. OBJECTIVES:The authors sought to assess the impact of residual TR severity post-TTV repair on survival. METHODS:We evaluated the survival rate at 2 years of 613 patients with severe isolated functional TR who underwent TTV repair in TRIGISTRY according to the severity of residual TR at discharge using a 3-grade (mild, moderate, and severe) or 4-grade scheme (mild, mild to moderate, moderate to severe, and severe). RESULTS:Residual TR was none/mild in 33%, moderate in 52%, and severe in 15%. The 2-year adjusted survival rates significantly differed between the 3 groups (85%, 70%, and 44%, respectively; restricted mean survival time [RMST]: P = 0.0001). When the 319 patients with moderate residual TR were subdivided into mild to moderate (n = 201, 33%) and moderate to severe (n = 118, 19%), the adjusted survival rate was also significantly different between groups (85%, 80%, 55%, and 44%, respectively; RMST: P = 0.001). Survival was significantly lower in patients with moderate to severe residual TR compared to patients with mild to moderate residual TR (P = 0.006). No difference in survival rates was observed between patients with no/mild and mild to moderate residual TR (P = 0.67) or between patients with moderate to severe and severe residual TR (P = 0.96). CONCLUSIONS:The moderate residual TR group was heterogeneous and encompassed patients with markedly different clinical outcomes. Refining TR grade classification with a more granular 4-grade scheme improved outcome prediction. Our results highlight the importance of achieving a mild to moderate or lower residual TR grade during TTV repair, which could define a successful intervention.

BACKGROUND Current treatment recommendations for patients with heart failure and secondary mitral regurgitation include transcatheter edge-to-edge repair and mitral-valve surgery. Data from randomized trials comparing these therapies are lacking in this patient population. METHODS In this noninferiority trial conducted in Germany, patients with heart failure and secondary mitral regurgitation who continued to have symptoms despite guideline-directed medical therapy were randomly assigned, in a 1:1 ratio, to undergo either transcatheter edge-to-edge repair (intervention group) or surgical mitral-valve repair or replacement (surgery group). The primary efficacy end point was a composite of death, hospitalization for heart failure, mitral-valve reintervention, implantation of an assist device, or stroke within 1 year after the procedure. The primary safety end point was a composite of major adverse events within 30 days after the procedure. RESULTS A total of 210 patients underwent randomization. The mean (+/- SD) age of the patients was 70.5 +/- 7.9 years, 39.9% were women, and the mean left ventricular ejection fraction was 43.0 +/- 11.7%. Within 1 year, at least one of the components of the primary efficacy end point occurred in 16 of the 96 patients with available data (16.7%) in the intervention group and in 20 of the 89 with available data (22.5%) in the surgery group (estimated mean difference, -6 percentage points; 95% confidence interval [CI], -17 to 6; P<0.001 for noninferiority). A primary safety end-point event occurred in 15 of the 101 patients with available data (14.9%) in the intervention group and in 51 of the 93 patients with available data (54.8%) in the surgery group (estimated mean difference, -40 percentage points; 95% CI, -51 to -27; P<0.001). CONCLUSIONS Among patients with heart failure and secondary mitral regurgitation, transcatheter edge-to-edge repair was noninferior to mitral-valve surgery with respect to a composite of death, rehospitalization for heart failure, stroke, reintervention, or implantation of an assist device in the left ventricle at 1 year.

Background Transcatheter tricuspid valve intervention (TTVI) has been increasingly adopted in recent years for the treatment of patients with tricuspid regurgitation (TR). However, no dedicated risk stratification has been established for patients undergoing TTVI. Objectives The aim of the present study was to propose a dedicated risk score for patients affected by severe TR undergoing TTVI. Methods The score was derived from the TRIVALVE (International Multisite Transcatheter Tricuspid Valve Therapies Registry; NCT03416166) registry, according to data availability. A stepwise model approach was used on predictor variables to develop a scoring system for predicting 12-month mortality or rehospitalization using multivariable logistic regression. Internal discrimination, calibration, and validation were assessed using receiver-operating characteristic curve analysis and bootstrapping with 1,000 resamples. Results A total of 483 patients were included in the study, with an overall 12-month mortality or rehospitalization rate of 19% (n = 94). The final risk score, ranging from 0 to 4.5, included the following 5 parameters (adjusted for age and gender): 1) atrial fibrillation at baseline; 2) glomerular filtration rate <30 mL/min; 3) elevated gamma-glutamyl transferase/bilirubin levels; 4) signs of right heart failure; and 5) left ventricular ejection fraction <50%. The bias-corrected area under the receiver-operating characteristic curve was 68% (95% CI: 62%-75%). A cutoff value of 2.5 demonstrated sensitivity of 65.4% and specificity of 60.5% for the outcome. Conclusions The present study proposes a dedicated risk score for patients undergoing TTVI, providing an additional and simple tool for heart teams to select the best therapy for patients affected by severe TR.

Mitral transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post-market setting have not been established. The authors report 30-day and 1-year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post-market clinical follow-up study. Patients with symptomatic, clinically significant MR were prospectively enrolled. The primary safety endpoint was clinical events committee–adjudicated 30-day composite major adverse event rate and the primary effectiveness endpoint was echocardiographic core laboratory–assessed MR severity at discharge compared with baseline. Clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. A total of 544 patients were enrolled (59% functional MR, 30% degenerative MR). The 30-day composite major adverse event rate was 6.8%. MR reduction was significant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR ≤2+ and 82.6% MR ≤1+ (all P < 0.001 vs baseline). One-year Kaplan-Meier estimate for survival was 87.3%, and freedom from heart failure hospitalization was 84.3%. Significant functional and quality-of-life improvements were observed at 1 year, including 71.6% in NYHA functional class I/II, 14.4-point increase in Kansas City Cardiomyopathy Questionnaire score, and 24.2-m improvement in 6-minute walk distance (all P < 0.001 vs baseline). One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post-market setting. Results demonstrate high survival and freedom from heart failure hospitalization, significant and sustained MR reduction, and improvements in symptoms, functional capacity, and quality of life.

BACKGROUND Severe tricuspid regurgitation (TR) is known to be associated with poor quality of life and increased risk of death when left untreated. OBJECTIVES We sought to report the 1-year clinical outcomes of subjects treated by tricuspid transcatheter edge-to- edge repair (TEER) with the TriClip system (Abbott Cardiovascular) in a contemporary real-world setting. METHODS The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device) postapproval study is a prospective, single-arm, open-label, multicenter postmarket registry conducted at 26 sites in Europe, with central event adjudication and echocardiographic core-laboratory assessment. RESULTS Enrolled subjects (n = 511) were elderly (79 f 7 years) with significant comorbidities. A total of 88% had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III/IV. TR was reduced to moderate or less in 81% at 1 year. Significant improvements in NYHA functional class (21% to 75% I/II, P <0.0001) and Kansas City Cardiomyopathy Questionnaire (KCCQ)score (19 f 26-point improvement, P <0.0001) were observed at 1 year. Oneyear mortality was significantly lower in subjects who achieved moderate or lower TR at 30 days; however, there was no difference in mortality among subjects who achieved moderate, mild, or trace TR at 30 days. In addition to TR reduction at 30 days, baseline serum creatinine and baseline right ventricular tricuspid annular plane systolic excursion (RV TAPSE) were independently associated with mortality at 1 year (OR: 2.169; 95% CI: 1.494-3.147; P <0.0001; OR: 0.636; 95% CI: 0.415-0.974; P = 0.0375). Mortality was not associated with baseline TR grade or with center volume. CONCLUSIONS Tricuspid TEER using the TriClip system was safe and effective through 1 year for subjects with significant TR and advanced disease in a diverse real-world population. (An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device [bRIGHT]; NCT04483089) (J Am Coll Cardiol 2024;84:607-616) (c) 2024 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).

AIMS:Transcatheter tricuspid valve interventions (TTVI) are increasingly used to treat patients with significant tricuspid regurgitation (TR). The evolution of concurrent mitral regurgitation (MR) severity after TTVI is currently unknown and may be pivotal for clinical decision-making. The aim of this study was to assess the evolution of MR after TTVI and to identify predictors of MR worsening and improvement. METHODS AND RESULTS:This analysis is a substudy of the TriValve Registry, an international registry designed to collect data on TTVI. This substudy included all patients with echocardiographic data on MR evolution and excluded those with a concomitant tricuspid and mitral transcatheter valve intervention or with a history of mitral valve intervention. The co-primary outcomes were MR improvement and worsening at two timepoints: pre-discharge and 2-month follow-up. This analysis included 359 patients with severe TR, mostly (80%) treated with tricuspid transcatheter edge-to-edge repair (T-TEER). MR improvement was found in 106 (29.5%) and 99 (34%) patients, while MR worsening was observed in 34 (9.5%) and 33 (11%) patients at pre-discharge and 2-month follow-up, respectively. Annuloplasty and heterotopic replacement were associated with MR worsening. Independent predictors of MR improvement were: atrial fibrillation, T-TEER, acute procedural success, TR reduction, left ventricular end-diastolic diameter> 60 mm, and beta-blocker therapy. Patients with moderate-to-severe/severe MR following TTVI showed significantly higher death rates. CONCLUSION:MR degree variation is common after TTVI, with most cases showing improvement. Clinical and procedural characteristics may predict the MR evolution, in particular procedural success and T-TEER play key roles in MR outcomes. TTVI may be beneficial, even in the presence of functional MR.