Leaflet Configuration and Residual Tricuspid Regurgitation After Transcatheter Edge-to-Edge Tricuspid Repair

ObjectivesThis study aimed to assess the anatomical leaflet variation and investigate its impact on the procedural outcome in patients undergoing transcatheter edge-to-edge tricuspid repair.BackgroundTricuspid regurgitation (TR) is associated with a poor prognosis.MethodsThe study participants were consecutive patients who underwent transcatheter edge-to-edge tricuspid repair with the MitraClip, TriClip, or PASCAL systems from June 2015 to July 2020 at the Bonn Heart Center. The tricuspid leaflet morphologies were imaged using 2-dimensional and 3-dimensional transesophageal echocardiography. The severity of TR was assessed according to the 5-grade scheme. The primary endpoint was residual TR ≥3+ within 30 days.ResultsOf the 145 study participants, 103 (71.1%) participants were categorized as the 3-leaflet configuration, while 42 (28.9%) were categorized as the 4-leaflet configuration. Successful device implantation was achieved in 136 (93.8%) patients, with no statistical difference between the 3-leaflet and 4-leaflet configuration groups. However, compared with patients with a 3-leaflet configuration, patients with 4-leaflet configuration more frequently had residual TR ≥3+ (18.4% vs 38.1%; P = 0.018). In the multivariable model, the 4-leaflet configuration was associated with an increased risk of residual TR ≥3+ (odds ratio: 2.65; 95% CI 1.15-6.10; P = 0.022), independent of baseline TR grade, coaptation gap width, and TR jet location. After 1-year follow-up, compared with patients with residual TR <3+, patients with residual TR ≥3+ had a significantly higher incidence of the composite of all-cause mortality or heart failure hospitalization (27.7% vs 56.1%; P = 0.016).ConclusionsA 4-leaflet configuration of the tricuspid valve is observed in approximately one-third of patients undergoing transcatheter edge-to-edge tricuspid repair, which is associated with an increased risk of residual TR after the procedure.     

Mitral Valve Surgery After Transcatheter Edge-to-Edge Repair: Mid-Term Outcomes From the CUTTING-EDGE International Registry

ObjectivesThe aim of this study was to determine clinical and echocardiographic characteristics, mechanisms of failure, and outcomes of mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER).BackgroundAlthough >100,000 mitral TEER procedures have been performed worldwide, longitudinal data on MV surgery after TEER are lacking.MethodsData from the multicenter, international CUTTING-EDGE registry were retrospectively analyzed. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 9.0 months (interquartile range [IQR]: 1.2-25.7 months) after MV surgery, and follow-up was 96.1% complete at 30 days and 81.1% complete at 1 year.ResultsFrom July 2009 to July 2020, 332 patients across 34 centers underwent MV surgery after TEER. The mean age was 73.8 ± 10.1 years, median Society of Thoracic Surgeons risk for MV repair at initial TEER was 4.0 (IQR: 2.3-7.3), and primary/mixed and secondary mitral regurgitation were present in 59.0% and 38.5%, respectively. The median interval from TEER to surgery was 3.5 months (IQR: 0.5-11.9 months), with overall median Society of Thoracic Surgeons risk of 4.8% for MV replacement (IQR: 2.8%-8.4%). The primary indication for surgery was recurrent mitral regurgitation (33.5%), and MV replacement and concomitant tricuspid surgery were performed in 92.5% and 42.2% of patients, respectively. The 30-day and 1-year mortality rates were 16.6% and 31.3%, respectively. On Kaplan-Meier analysis, the actuarial estimates of mortality were 24.1% at 1 year and 31.7% at 3 years after MV surgery.ConclusionsIn this first report of the CUTTING-EDGE registry, the mortality and morbidity risks of MV surgery after TEER were not negligible, and only <10% of patients underwent MV repair. These registry data provide valuable insights for further research to improve these outcomes.     

Outcomes After Transcatheter Edge-to-Edge Mitral Valve Repair According to Mitral Regurgitation Etiology and Cardiac Remodeling

BackgroundTranscatheter edge-to-edge repair (TEER) has been increasingly used for selected patients with mitral regurgitation (MR), but limited data are available regarding clinical outcomes in patients with varied etiology and mechanism of MR.ObjectivesThe aim of this study was to evaluate the outcomes of TEER according to etiology and left ventricular (LV) and left atrial remodeling.MethodsConsecutive patients who underwent TEER between 2007 and 2020 were included in the analysis. Among patients with functional MR (FMR), those with predominant LV remodeling were classified as having ventricular FMR (v-FMR), whereas those without LV remodeling but predominant left atrial remodeling were classified as having atrial FMR (a-FMR). The primary outcome was a composite of all-cause mortality and heart failure hospitalization at 2 years and was compared among patients with degenerative MR (DMR), a-FMR, and v-FMR.ResultsA total of 1,044 patients (11% with a-FMR, 48% with v-FMR, and 41% with DMR) with a mean Society of Thoracic Surgeons score of 8.6 ± 7.8 underwent TEER. Patients with a-FMR had higher rates of atrial fibrillation and severe tricuspid regurgitation with larger left and right atria, whereas patients with v-FMR had lower LV ejection fractions with larger LV dimensions. Residual MR more than moderate at discharge was not significantly different among the 3 groups (5.2% vs 3.2% vs 2.6%; P = 0.37). Compared with patients with DMR, 2-year event rates of the primary outcome were significantly higher in patients with a-FMR and v-FMR (21.6% vs 31.5% vs 42.3%; log-rank P < 0.001).ConclusionsDespite excellent procedural outcomes, patients with a-FMR and v-FMR had worse clinical outcomes compared with those with DMR.     

Transcatheter Edge-to-Edge Repair for Treatment of Tricuspid Regurgitation

BackgroundTricuspid regurgitation (TR) is a frequent disease with a progressive increase in mortality as disease severity increases. Transcatheter therapies for treatment of TR may offer a safe and effective alternative to surgery in this high-risk population.ObjectivesThe purpose of this report was to study the 1-year outcomes with the TriClip transcatheter tricuspid valve repair system, including repair durability, clinical benefit and safety.MethodsThe TRILUMINATE trial (n = 85) is an international, prospective, single arm, multicenter study investigating safety and performance of the TriClip Tricuspid Valve Repair System in patients with moderate or greater TR. Echocardiographic assessment was performed by a core laboratory.ResultsAt 1 year, TR was reduced to moderate or less in 71% of subjects compared with 8% at baseline (p < 0.0001). Patients experienced significant clinical improvements in New York Heart Association (NYHA) functional class I/II (31% to 83%, p < 0.0001), 6-minute walk test (272.3 ± 15.6 to 303.2 ± 15.6 meters, p = 0.0023) and Kansas City Cardiomyopathy Questionnaire (KCCQ) score (improvement of 20 ± 2.61 points, p < 0.0001). Significant reverse right ventricular remodeling was observed in terms of size and function. The overall major adverse event rate and all-cause mortality were both 7.1% at 1 year.ConclusionTranscatheter tricuspid valve repair using the TriClip device was found to be safe and effective in patients with moderate or greater TR. The repair itself was durable at reducing TR at 1 year and was associated with a sustained and marked clinical benefit with low mortality after 1 year in a fragile population that was at high surgical risk. (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR; NCT03227757)     

Prognostic Value of Increased Mitral Valve Gradient After Transcatheter Edge-to-Edge Repair for Primary Mitral Regurgitation

ObjectivesThis study sought to evaluate the prognostic value of an increased mean mitral valve pressure gradient (MVG) in patients with primary mitral regurgitation (MR) after transcatheter edge-to-edge repair (TEER).BackgroundConflicting data exist regarding impact of increased mean MVG on outcomes after TEER.MethodsThis study included 419 patients with primary MR (mean age 80.6 ± 10.4 years; 40.6% female) who underwent TEER. Patients were divided into quartiles (Qs) based on discharge echocardiographic mean MVG. Primary outcome was the composite endpoint of all-cause mortality and heart failure hospitalization. Secondary outcomes included all-cause mortality and the secondary composite endpoint of all-cause mortality, heart failure hospitalization, and mitral valve reintervention.ResultsThe median number of MitraClips used was 2 per patient. MR reduction ≤moderate was achieved in 407 (97.1%) patients. Mean MVG was 1.9 ± 0.3 mm Hg, 3.0 ± 0.1 mm Hg, 4.0 ± 0.1 mm Hg, and 6.0 ± 1.2 mm Hg in Q1, Q2, Q3, and Q4, respectively. There was no significant differences across quartiles in the primary outcome (15.4%, 19.6%, 22.0%, and 21.9% in Q1-Q4, respectively; P = 0.63), all-cause mortality (15.9% vs 18.6% vs 19.4% vs 17.1%, respectively; P = 0.91), and the secondary composite endpoint at 2 years (33.3% vs 29.5% vs 22.0% vs 31.6%, respectively; P = 0.37). After multivariate adjustment for baseline clinical and procedural variables, the mean MVG in Q4 compared with Q1 to Q3 was not independently associated with the primary outcome (HR: 1.22; 95% CI: 0.82-1.83; P = 0.33), all-cause mortality, and the secondary composite endpoint.ConclusionsIncreased mean MVG was not independently associated with adverse events after TEER in patients with primary MR.     

1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study

ObjectivesThe authors report the CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) expanded experience, 1-year outcomes, and analysis by functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR).BackgroundThe 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically significant mitral regurgitation (MR) have been previously reported.MethodsEligible patients had symptomatic MR ≥3+, were receiving optimal medical therapy, and were deemed candidates for transcatheter mitral repair by the local heart team. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days. Follow-up was continued to 1 year.ResultsOne hundred nine patients were treated (67% FMR, 33% DMR); the mean age was 75.5 years, and 57% were in New York Heart Association functional class III or IV. At 30 days, there was 1 cardiovascular death (0.9%), MR ≤1+ was achieved in 80% of patients (77% FMR, 86% DMR) and MR ≤2+ in 96% (96% FMR, 97% DMR), 88% of patients were in New York Heart Association functional class I or II, 6-min walk distance had improved by 28 m, and Kansas City Cardiomyopathy Questionnaire score had improved by 16 points (p < 0.001 for all). At 1 year, Kaplan-Meier survival was 92% (89% FMR 96% DMR) with 88% freedom from heart failure hospitalization (80% FMR, 100% DMR), MR was ≤1+ in 82% of patients (79% FMR, 86% DMR) and ≤2+ in 100% of patients, 88% of patients were in New York Heart Association functional class I or II, and Kansas City Cardiomyopathy Questionnaire score had improved by 14 points (p < 0.001 for all).ConclusionsThe PASCAL transcatheter valve repair system demonstrated a low complication rate and high survival, with robust sustained MR reduction accompanied by significant improvements in functional status and quality of life at 1 year. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study [CLASP]; NCT03170349)     

Impact of Right Ventricular Dysfunction on Outcomes After Transcatheter Edge-to-Edge Repair for Secondary Mitral Regurgitation

ObjectivesThis study sought to assess the impact of right ventricular dysfunction (RVD) as defined by impaired right ventricular-to-pulmonary artery (RV-PA) coupling, on survival after edge-to-edge transcatheter mitral valve repair (TMVR) for severe secondary mitral regurgitation (SMR).BackgroundConflicting data exist regarding the benefit of TMVR in severe SMR. A possible explanation could be differences in RVD.MethodsUsing data from the EuroSMR (European Registry on Outcomes in Secondary Mitral Regurgitation) registry, this study compared the characteristics and outcomes of SMR patients undergoing TMVR, according to their RV-PA coupling, assessed by tricuspid annular plane systolic excursion-to-systolic pulmonary artery pressure (TAPSE/sPAP) ratio.ResultsOverall, 817 patients with severe SMR and available RV-PA coupling assessment underwent TMVR in the participating centers. RVD was present in 211 patients (25.8% with a TAPSE/sPAP ratio <0.274 mm/mm Hg). Although all patients demonstrated significant improvement in their New York Heart Association (NYHA) functional class, there was a trend toward a lower rate of NYHA functional class I or II among patients with RVD (56.5% vs. 65.5%, respectively; p = 0.086) after TMVR. Survival rates at 1 and 2 years were lower among patients with RVD (70.2% vs. 84.0%, respectively; p < 0.001; and 53.4% vs. 73.1%, respectively; p < 0.001). On multivariate analysis, a reduced TAPSE/sPAP ratio was a strong predictor of mortality (odds ratio: 1.62; 95% confidence interval: 1.14 to 2.31; p = 0.007).ConclusionsRVD, as shown by impairment of RV-PA coupling, is a major predictor of adverse outcome in patients undergoing TMVR for severe SMR. The often neglected functional and anatomic RV parameters should be systematically assessed when planning TMVR procedures for patients with severe SMR.     

Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results

ObjectivesThe TRISCEND study (Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy after Replacement of Tricuspid Valve with Transcatheter Device) is evaluating the safety and performance of transfemoral transcatheter tricuspid valve replacement in patients with clinically significant tricuspid regurgitation (TR) and elevated surgical risk.BackgroundTranscatheter valve replacement could lead to a paradigm shift in treating TR and improving patient quality of life.MethodsIn the prospective, single-arm, multicenter TRISCEND study, patients with symptomatic moderate or greater TR, despite medical therapy, underwent percutaneous transcatheter tricuspid valve replacement with the EVOQUE system. A composite rate of major adverse events, echocardiographic parameters, and clinical, functional, and quality-of-life measures were assessed at 30 days.ResultsFifty-six patients (mean age of 79.3 years, 76.8% female, 91.1% TR severe or greater, 91.1% atrial fibrillation, and 87.5% New York Heart Association functional class III or IV) were treated. At 30 days, TR was reduced to mild or less in 98%. The composite major adverse events rate was 26.8% at 30 days caused by 1 cardiovascular death in a patient with a failed procedure, 2 reinterventions after device embolization, 1 major access site or vascular complication, and 15 severe bleeds, of which none were life-threatening or fatal. No myocardial infarction, stroke, renal failure, major cardiac structural complications, or device-related pulmonary embolism were observed. New York Heart Association significantly improved to functional class I or II (78.8%; P < 0.001), 6-minute walk distance improved 49.8 m (P < 0.001), and Kansas City Cardiomyopathy Questionnaire score improved 19 points (P < 0.001).ConclusionsEarly experience with the transfemoral EVOQUE system in patients with clinically significant TR demonstrated technical feasibility, acceptable safety, TR reduction, and symptomatic improvement at 30 days. The TRISCEND II randomized trial (NCT04482062) is underway.     

Functional and Echocardiographic Improvement After Transcatheter Repair for Tricuspid Regurgitation: A Systematic Review and Pooled Analysis

ObjectivesThe aim of this study was to assess the feasibility, efficacy, and clinical outcomes of transcatheter repair of tricuspid regurgitation (TR) in a pooled analysis of interventional studies.BackgroundNew percutaneous devices are available to treat severe TR, but the evidence is sparse and limited to smaller cohorts.MethodsSeveral electronic databases were searched for interventional studies involving percutaneous repair of TR. Devices used were the Cardioband, FORMA, MitraClip, PASCAL, and Trialign. Outcomes included in the final analysis were successful implantation, residual severe TR, post-procedural New York Heart Association (NYHA) functional class III or IV, 6-min walk distance, and echocardiographic parameters. Subgroup and meta-regression analysis were performed to further explore residual heterogeneity.ResultsSeven studies and 454 patients undergoing transcatheter tricuspid valve repair were included in the pooled analysis; 95% of patients had at least severe TR, and 91% were in NYHA functional class III or IV. Successful implantation was achieved in 86% of patients. At the longest follow-up available (weighted mean 265 days), 9% had died. Compared with baseline, a significantly lower proportion of patients had at least severe TR (relative risk: 0.38; 95% confidence interval: 0.20 to 0.70; p = 0.004) and were in NYHA functional class III or IV (relative risk: 0.23; 95% confidence interval: 0.20 to 0.30; p < 0.001). Patients also experienced increases in 6-min walk distance (mean difference +64.6 m; p < 0.001) and significant reductions in tricuspid valve annular diameter (mean difference −3 mm; p < 0.001), while left and right ventricular function did not change significantly.ConclusionsA strategy of transcatheter repair for severe TR appears to be feasible, effective, and associated with improved clinical outcomes at mid-term follow-up.     

Impact of Residual Mitral Regurgitation on Survival After Transcatheter Edge-to-Edge Repair for Secondary Mitral Regurgitation

ObjectivesThe aim of this study was to assess the impact of residual mitral regurgitation (resMR) on mortality with respect to left ventricular dilatation (LV-Dil) or right ventricular dysfunction (RV-Dys) in patients with secondary mitral regurgitation (SMR) who underwent mitral valve transcatheter edge-to-edge repair (TEER).BackgroundThe presence of LV-Dil and RV-Dys correlates with advanced stages of heart failure in SMR patients, which may impact the outcome after TEER.MethodsSMR patients in a European multicenter registry were evaluated. Investigated outcomes were 2-year all-cause mortality and improvement in New York Heart Association functional class with respect to MR reduction, LV-Dil (defined as LV end-diastolic volume ≥159 ml), and RV-Dys (defined as tricuspid annular plane systolic excursion-to-systolic pulmonary artery pressure ratio of <0.274 mm/mm Hg).ResultsAmong 809 included patients, resMR ≤1+ was achieved in 546 (67%) patients. Overall estimated 2-year mortality rate was 32%. Post-procedural resMR was significantly associated with mortality (p = 0.031). Although the improvement in New York Heart Association functional class persisted regardless of either LV-Dil or RV-Dys, the beneficial treatment effect of resMR ≤1+ on 2-year mortality was observed only in patients without LV-Dil and RV-Dys (hazard ratio: 1.75; 95% confidence interval: 1.03 to 3.00).ConclusionsAchieving optimal MR reduction by TEER is associated with improved survival in SMR patients, especially if the progress in heart failure is not too advanced. In SMR patients with advanced stages of heart failure, as evidenced by LV-Dil or RV-Dys, the treatment effect of TEER on symptomatic improvement is maintained, but the survival benefit appears to be reduced.     

Transcatheter Edge-to-Edge Repair for Atrial Secondary Mitral Regurgitation

BackgroundAtrial secondary mitral regurgitation (ASMR) is a subtype of SMR that has a poor prognosis, and thus far, evidence of the therapeutic options for the management of ASMR is limited.ObjectivesThis study aimed to investigate the effectiveness of transcatheter edge-to-edge repair (TEER) for ASMR.MethodsThe study retrospectively analyzed consecutive patients who underwent MitraClip at the Heart Center Bonn. ASMR was defined as cases that met all of the following criteria: 1) normal mitral leaflets without organic disorder; 2) left ventricular ejection fraction >50%; and 3) absence of LV enlargement and segmental abnormality. The primary outcome measure was MR reduction to ≤1+, and its predictors were explored in a logistic regression analysis.ResultsAmong 415 patients with SMR, 118 patients met the criteria for ASMR (mean age 80 ± 8 years, 39.8% male). The technical success rate was 94.1%, and MR reduction to ≤1+ after TEER was achieved in 94 (79.7%) patients with ASMR. The in-hospital mortality rate was 2.5%. In multivariable logistic analysis, a large left atrial volume index and low leaflet-to-annulus index were associated with a lower incidence of MR reduction to ≤1+ after TEER for ASMR. In addition, the use of a newer generation of the MitraClip systems (NTR/XTR or G4 systems) was associated with a higher incidence of MR reduction to ≤1+.ConclusionsTEER is a safe and feasible therapeutic option for patients with ASMR. Assessments of left atrial volume index and leaflet-to-annulus index may assist with patient selection for TEER in patients with ASMR.     

Outcomes of TTVI in Patients With Pacemaker or Defibrillator Leads: Data From the TriValve Registry

ObjectivesThe interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear.BackgroundFeasibility of TTVI in presence of a CIED lead has never been proven on a large basis.MethodsThe study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed.ResultsPre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm² vs. 0.6 ± 0.3 cm²; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30).ConclusionsTTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead.     

Long-Term Outcomes of Patients With Elevated Mitral Valve Pressure Gradient After Mitral Valve Edge-to-Edge Repair

ObjectivesThe aim of this study was to investigate the adverse impact of elevated postprocedural mitral valve pressure gradient (MPG) on outcome in a real-world population of patients with severe mitral regurgitation (MR) who underwent transcatheter mitral valve edge-to-edge repair (TEER).BackgroundTEER has become a routine treatment alternative for patients with severe MR at high surgical risk. The consequences of elevated MPG after TEER have been subject to controversial debates.MethodsAll consecutive patients undergoing TEER for either severe degenerative MR (DMR) or functional MR (FMR) at a high-volume center between September 2008 and January 2020 were prospectively included and followed periodically. Postprocedural MPG by discharge transthoracic echocardiography was considered elevated at ≥5 mm Hg. The primary combined endpoint was death or heart failure rehospitalization after 5 years.ResultsA total of 713 patients undergoing TEER (DMR, n = 265; FMR, n = 445) were included. Elevated postprocedural MPG was present in 37.0% of those with DMR (n = 98) and 22.0% of those with FMR (n = 98). In contrast to patients with FMR, 6-minute walk distance did not improve in patients with DMR with elevated MPG. Kaplan-Meier analyses did not demonstrate significant differences for the primary endpoint in patients with DMR (low vs elevated MPG, 67.3% vs 74.4%; P = 0.06) and those with FMR (78.6% vs 74.8%; P = 0.54). After adjustment, elevated MPG was an independent predictor of the primary endpoint in patients with DMR (HR: 1.59; 95% CI: 1.03-2.45; P = 0.034) but not in those with FMR (HR: 0.87; 95% CI: 0.63-1.22; P = 0.43).ConclusionsElevated postprocedural MPG is an independent predictor of adverse clinical and functional outcomes in patients with DMR but not in those with FMR     

Effect of Mitral Valve Gradient After MitraClip on Outcomes in Secondary Mitral Regurgitation: Results From the COAPT Trial

ObjectivesThe authors sought to evaluate the association between mean mitral valve gradient (MVG) and clinical outcomes among patients who underwent MitraClip treatment for secondary mitral regurgitation (SMR) in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial.BackgroundIn the COAPT trial, patients with heart failure (HF) and severe SMR who remained symptomatic despite guideline-directed medical therapy had marked 2-year reductions in mortality and HF hospitalizations after treatment with MitraClip.MethodsMitraClip-treated patients were divided into quartiles (Q) based on discharge echocardiographic MVG (n = 250). Endpoints including all-cause mortality, HF hospitalization, and health status measures at 2 years were compared between quartiles.ResultsMean MVG after MitraClip was 2.1 ± 0.4 mm Hg, 3.0 ± 0.2 mm Hg, 4.2 ± 0.5 mm Hg, and 7.2 ± 2.0 mm Hg in Q1 (n = 63), Q2 (n = 61), Q3 (n = 62), and Q4 (n = 64), respectively. There was no difference across quartiles in the 2-year composite endpoint of all-cause mortality or HF hospitalization (43.2%, 49.2%, 40.6%, and 40.9%, respectively; p = 0.80), nor in improvements in New York Heart Association functional class, Kansas City Cardiomyopathy Questionnaire score, or 6-min walk time. Results were similar after adjustment for baseline clinical and echocardiographic characteristics, post-procedure MR grade, and number of clips (all-cause mortality or HF hospitalization Q4 [44.6%] vs. Q1 to Q3 [40.3%]; adjusted hazard ratio: 1.23, 95% confidence interval: 0.60 to 2.51; p = 0.57).ConclusionsAmong HF patients with severe SMR, higher MVGs on discharge did not adversely affect clinical outcomes following MitraClip. These findings suggest that in select patients with HF and SMR otherwise meeting the COAPT inclusion criteria, the benefits of MR reduction may outweigh the effects of mild-to-moderate mitral stenosis after MitraClip.     

2-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study

ObjectivesThis study reports 2-year outcomes from the multicenter, prospective, single-arm CLASP study with functional mitral regurgitation (FMR) and degenerative MR (DMR) analysis.BackgroundTranscatheter repair is a favorable option to treat MR. Long-term prognostic impact of the PASCAL transcatheter valve repair system in patients with clinically significant MR remains to be established.MethodsPatients had clinically significant MR ≥3+ as evaluated by the echocardiographic core laboratory and were deemed candidates for transcatheter repair by the heart team. Assessments were performed by clinical events committee to 1 year (site-reported thereafter) and core laboratory to 2 years.ResultsA total of 124 patients (69% FMR, 31% DMR) were enrolled with a mean age of 75 years, 56% were male, 60% were New York Heart Association functional class III to IVa, and 100% had MR ≥3+. At 2 years, Kaplan-Meier estimates showed 80% survival (72% FMR, 94% DMR) and 84% freedom from heart failure (HF) hospitalization (78% FMR, 97% DMR), with 85% reduction in annualized HF hospitalization rate (81% FMR, 98% DMR). MR ≤1+ was achieved in 78% of patients (84% FMR, 71% DMR) and MR ≤2+ was achieved in 97% (95% FMR, 100% DMR) (all p < 0.001). Left ventricular end-diastolic volume decreased by 33 ml (p < 0.001); 93% of patients were in New York Heart Association functional class I to II (p < 0.001).ConclusionsThe PASCAL repair system demonstrated sustained favorable outcomes at 2 years in FMR and DMR patients. Results showed high survival and freedom from HF rehospitalization rates with a significantly reduced annualized HF hospitalization rate. Durable MR reduction was achieved with evidence of left ventricular reverse remodeling and significant improvement in functional status. The CLASP IID/IIF randomized pivotal trial is ongoing.     

Clinical Outcomes With Transcatheter Edge-to-Edge Repair in Atrial Functional MR From the EXPAND Study

BackgroundAlthough transcatheter edge-to-edge repair (TEER) has been shown to improve clinical outcomes and improve quality of life in patients with symptomatic secondary mitral regurgitation (SMR) and left ventricular dysfunction, its effect in patients with atrial SMR (aSMR) has not been well described.ObjectivesThe aim of this study was to assess the safety, echocardiographic outcomes, and clinical effectiveness of TEER for aSMR.MethodsPatients with aSMR in the prospective, observational, multicenter EXPAND (A Contemporary, Prospective, Multi-Center Study Evaluating Real-World Experience of Performance and Safety for the Next Generation of MitraClip Devices) study were identified by an echocardiography core laboratory. Follow-up occurred at discharge, 30 days, and 1 year. Key endpoints included mitral regurgitation (MR) severity, functional class, heart failure hospitalizations, mortality, and 30-day major adverse events.ResultsAmong 1,041 patients enrolled in EXPAND, 835 patients had evaluable echocardiograms at baseline. Of these, 53 patients had aSMR and 360 had ventricular SMR (vSMR). In the aSMR cohort, TEER resulted in a significant reduction in MR through 1 year (MR grade ≤2 in 100.0%), significantly increased 1-year Kansas City Cardiomyopathy Questionnaire score (+26.6 ± 30.5 points; P < 0.0001), and improved functional class from baseline, similar to the effects among patients with vSMR (MR grade ≤2 in 99.5% at 1 year, 1-year increase in Kansas City Cardiomyopathy Questionnaire score 21.23 ± 24.92 points). Major adverse events at 30 days and leaflet adverse events at 1 year were infrequent in both groups.ConclusionsIn a prospective, real-world, global registry, TEER for aSMR was associated with significant MR reduction and improvement in quality of life and functional class, similar to patients with vSMR. This suggests that TEER may provide clinical benefit in patients with atrial fibrillation with SMR in the setting of heart failure with preserved ejection fraction. (The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices; NCT03502811)     

Sex-Related Clinical Characteristics and Outcomes of Patients Undergoing Transcatheter Edge-to-Edge Repair for Secondary Mitral Regurgitation

ObjectivesThe authors sought to assess sex-based differences in characteristics and outcomes of patients undergoing transcatheter edge-to-edge mitral valve repair (TMVR) for secondary mitral regurgitation (SMR).BackgroundSubgroup analysis from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial indicated potential sex-related differences in outcomes after TMVR. The impact of sex on results after TMVR in a real-world setting is unknown.MethodsThe authors assessed clinical outcomes and echocardiographic parameters in women and men undergoing TMVR for SMR between 2008 and 2018 who were included in the large, international, multicenter real-world EuroSMR registry (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation).ResultsA total of 1,233 patients, including 445 women (36%) and 788 men (64%), were analyzed. Although women were significantly older and had fewer comorbidities than men, TMVR was equally effective in women and men (mitral regurgitation [MR] grade ≤2+ at discharge: 93.2% vs. 94.6% for women vs. men; p = 0.35). All-cause mortality at 1 year (17.9% vs. 18.9%, adjusted hazard ratio: 0.806; p = 0.46) and at 2-year follow-up (26.5% vs. 26.4%, adjusted hazard ratio: 0.757; p = 0.26) were similar in women versus men after multivariate regression analysis. Durability of MR reduction, improvement in symptoms, quality of life, and functional capacity did also not differ during follow-up.ConclusionsResults from the EuroSMR registry confirmed effective and similar MR reduction with TMVR in women and men. There were no sex-related differences in clinical outcomes up to 2 years of follow-up.     

Institutional Experience With Transcatheter Mitral Valve Repair and Clinical Outcomes: Insights From the TVT Registry

ObjectivesThe aim of this study was to examine the relation between institutional experience and procedural results of transcatheter mitral valve repair.BackgroundTranscatheter mitral valve repair for the treatment of mitral regurgitation (MR) is a complex procedure requiring navigation of the left atrium, left ventricle, and mitral valve apparatus using echocardiographic guidance.MethodsMitraClip procedures from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were stratified into tertiles on the basis of site-specific case sequence (1 to 18, 19 to 51, and 52 to 482). In-hospital outcomes of procedural success, procedural time, and procedural complications were examined. To evaluate the learning curve for the procedure, generalized linear mixed models were developed using case sequence number as a continuous variable.ResultsMitraClip procedures (n = 12,334) performed at 275 sites between November 2013 and September 2017 were analyzed. Optimal procedural success (≤1+ residual MR without mortality or need for cardiac surgery) increased across tertiles of case experience (62.0%, 65.5%, and 72.5%; p < 0.001), whereas procedural time and procedural complications decreased. Acceptable procedural success (≤2+ residual MR without death or need for cardiac surgery) also increased across tertiles of case experience, but the differences were smaller (91.2%, 91.2%; and 92.9%; p = 0.006). In the learning-curve analysis, visual inflection points for procedural time, procedural success, and procedural complications were evident after about 50 cases, with continued improvements observed up to 200 cases.ConclusionsFor transcatheter mitral valve repair with the MitraClip, increasing institutional experience was associated with improvements in procedural success, procedure time, and procedural complications. The impact of institutional experience was larger when considering the goal of achieving optimal MR reduction.     

Age-Related Outcomes After Transcatheter Mitral Valve Repair in Patients With Heart Failure: Analysis From COAPT

ObjectivesThe aim of this study was to assess the impact of age on outcomes in patients undergoing transcatheter edge-to-edge repair (TEER) from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial.BackgroundIn the COAPT trial, TEER with the MitraClip device in patients with heart failure (HF) and moderate to severe or severe secondary mitral regurgitation (SMR) reduced the risk for HF hospitalization (HFH) and all-cause mortality compared with maximally tolerated guideline-directed medical therapy (GDMT) alone. There are limited data regarding the effectiveness of MitraClip therapy in elderly patients.MethodsPatients (n = 614) were grouped by median age at randomization (74 years) and by MitraClip treatment vs GDMT alone. The primary endpoint was the 2-year rate of death or HFH assessed by multivariable Cox regression.ResultsDeath or HFH within 2 years occurred less frequently after treatment with the MitraClip vs GDMT alone in patients <74 years of age (37.3% vs 64.5%; adjusted HR: 0.41; 95% CI: 0.29-0.59) and ≥74 years of age (51.7% vs 69.6%; adjusted HR: 0.58; 95% CI: 0.42-0.81) (P_int = 0.17). Mortality was also consistently reduced with MitraClip treatment in young and elderly patients (P_int = 0.42). In contrast, elderly patients treated with the MitraClip vs GDMT alone tended to have a lesser reduction of HFH than younger patients (P_int = 0.03). Younger and older patients had similar improvements in quality of life after treatment with the MitraClip compared with GDMT alone.ConclusionsIn the COAPT trial, MitraClip treatment of moderate to severe and severe SMR reduced the composite risk for death or HFH and improved survival and quality of life regardless of age. As such, young and elderly patients with HF and severe SMR benefit from TEER, although elderly patients may not have as great a benefit from the MitraClip device in reducing HFH.     

Changes in Right Ventricular–to–Pulmonary Artery Coupling After Transcatheter Edge-to-Edge Repair in Secondary Mitral Regurgitation

BackgroundPreprocedural right ventricular–to–pulmonary artery (RV-PA) coupling is a major predictor of outcome in patients with secondary mitral regurgitation (SMR) undergoing transcatheter edge-to-edge mitral valve repair (M-TEER). However, clinical significance of changes in RV-PA coupling after M-TEER is unknown.ObjectivesThe aim of this study was to evaluate changes in RV-PA coupling after M-TEER, their prognostic value, and predictors of improvement.MethodsThis was a retrospective observational study, including patients undergoing successful M-TEER (residual mitral regurgitation ≤2+ at discharge) for SMR at 13 European centers and with complete echocardiographic data at baseline and short-term follow-up (30-180 days). RV-PA coupling was assessed with the use of echocardiography as the ratio of tricuspid annular plane systolic excursion to pulmonary artery systolic pressure (TAPSE/PASP). All-cause death was assessed at the longest available follow-up starting from the time of the echocardiographic reassessment.ResultsAmong 501 patients included, 331 (66%) improved their TAPSE/PASP after M-TEER (responders) at short-term follow-up (median: 89 days; IQR: 43-159 days), whereas 170 (34%) did not (nonresponders). Lack of previous cardiac surgery, low postprocedural mitral mean gradient, low baseline TAPSE, high baseline PASP, and baseline tricuspid regurgitation were independently associated with TAPSE/PASP improvement after M-TEER. Compared with nonresponders, responders had lower New York Heart Association functional class and less heart failure hospitalizations at short-term follow-up. Improvement in TAPSE/PASP was independently associated with reduced risk of mortality at long-term follow-up (584 days; IQR: 191-1,243 days) (HR: 0.65 [95% CI: 0.42-0.92]; P = 0.017).ConclusionsIn patients with SMR, improvement in TAPSE/PASP after successful M-TEER is predicted by baseline clinical and echocardiographic variables and postprocedural mitral gradient, and is associated with a better outcome.