Right Ventricular Contraction Patterns in Patients Undergoing Transcatheter Tricuspid Valve Repair for Severe Tricuspid Regurgitation

ObjectivesThis study investigated patterns of right ventricular (RV) contraction by using cardiac magnetic resonance (CMR) imaging in patients undergoing transcatheter tricuspid valve repair (TTVR).BackgroundThe role of RV function in patients with severe tricuspid regurgitation undergoing TTVR is poorly understood.MethodsGlobal RV dysfunction was defined as CMR-derived RV ejection fraction (RVEF) ≤45% and longitudinal RV dysfunction was defined as tricuspid annular plane systolic excursion (TAPSE) <17 mm on echocardiography. Patients were stratified into 3 types of RV contraction: type I, TAPSE ≥17 and RVEF >45%; type II, TAPSE <17 and RVEF >45%; and type III, TAPSE <17 and RVEF ≤45%. CMR feature tracking was performed to assess longitudinal and circumferential RV strain. The primary outcome was a composite of all-cause mortality or first heart failure hospitalization.ResultsOf 79 patients (median age 79 years, 51% female), 18 (23%) presented with global and 40 (51%) presented with longitudinal RV dysfunction. The composite outcome occurred in 22 patients (median follow-up 362 days). Global RV dysfunction but not longitudinal RV dysfunction (hazard ratio: 6.62; 95% confidence interval: 2.77-15.77; and hazard ratio: 1.30; 95% confidence interval: 0.55-3.08, respectively) was associated with the composite outcome. Compared with type I RV contraction, patients with type II RV contraction exhibited increased circumferential strain, with a preservation of RVEF despite diminished longitudinal strain. Patients with type III RV contraction exhibited both diminished longitudinal and circumferential strain, resulting in an impaired RVEF. Patients with type III RV contraction showed the worst survival (P < 0.001).ConclusionsGlobal RV dysfunction is a predictor of outcomes among TTVR patients. Tricuspid regurgitation patients can be stratified into 3 types of RV contraction, in which a loss of longitudinal function can be compensated by increasing circumferential function, preserving RVEF and favorable outcomes.     

Early Multinational Experience of Transcatheter Tricuspid Valve Replacement for Treating Severe Tricuspid Regurgitation

ObjectivesThe aim of this registry was to evaluate the feasibility and safety of transcatheter tricuspid valve implantation (TTVI) in patients with extreme surgical risk.BackgroundIsolated tricuspid regurgitation (TR) surgery is associated with high in-hospital mortality.MethodsThirty consecutive patients (mean age 75 ± 10 years; 56% women) from 10 institutions, with symptomatic functional TR, had institutional and notified body approval for compassionate use of the GATE TTVI system. Baseline, discharge, and 30-day follow-up echocardiographic data and procedural, in-hospital, and follow-up clinical outcomes were collected.ResultsAt baseline, all patients had multiple comorbidities, severe or greater TR, and reduced baseline right ventricular function. Technical success was achieved in 26 of 30 patients (87%). Device malpositioning occurred in 4 patients, with conversion to open heart surgery in 2 (5%). Of those who received the device, 100% had reductions in TR of ≥1, and 75% experienced reductions of ≥2 grades, resulting in 18 of 24 of patients (76%) with mild or less TR at discharge. All patients had mild or less central TR. There was continued improvement in TR grade between discharge and 30 days in 15 of 19 patients (79%). In-hospital mortality was 10%. At mean follow-up of 127 ± 82 days, 4 patients (13%) had died. Of patients alive at follow-up, 62% were in New York Heart Association functional class I or II, with no late device-related adverse events.ConclusionsCompassionate treatment of severe, symptomatic functional TR using a first-generation TTVI device is associated with significant reduction in TR and improvement in functional status with acceptable in-hospital mortality. Further studies are needed to determine the appropriate patient population and long-term outcomes with TTVI therapy.     

Health Status After Transcatheter Tricuspid Valve Repair in Patients With Functional Tricuspid Regurgitation

ObjectivesThe aim of this study was to investigate changes in quality of life (QoL) after transcatheter tricuspid valve repair (TTVR) for tricuspid regurgitation (TR).BackgroundTTVR provides feasible and durable efficacy in reducing TR, but its clinical benefits on QoL still remain unclear.MethodsIn 115 subjects undergoing TTVR for severe functional TR, QoL was evaluated using the 36-Item Short Form Health Survey (SF-36) and the Minnesota Living With Heart Failure Questionnaire (MLHFQ). All-cause mortality, heart failure (HF) rehospitalization, and a composite endpoint of all-cause mortality, HF rehospitalization, and repeat TTVR were recorded as clinical events.ResultsSuccessful device implantation was achieved in 110 patients (96%). Moderate or less TR at discharge was achieved in 95 patients (83%). Mean SF-36 physical component summary (PCS) score improved from 34 ± 9 to 37 ± 9 points (+3 points; 95% CI: 1-5 points; P = 0.001), mean SF-36 mental component summary score improved from 49 ± 9 to 51 ± 10 points (+2 points; 95% CI: 0-4 points; P = 0.017), and mean MLHFQ score decreased from 29 ± 14 to 20 ± 15 points (−8 points; 95% CI: −11 to −5 points; P < 0.001). Baseline PCS, moderate or less TR at discharge, and baseline massive or torrential TR were associated with 1-month change in PCS score (P < 0.05). Change in PCS score after 1 month predicted HF rehospitalization after TTVR (adjusted HR: 0.74 [95% CI: 0.60-0.92] per 5-point increase in PCS score; P = 0.008).ConclusionsThis study demonstrates that TTVR provides improvement in QoL in patients with relevant TR. TR reduction to a moderate or less grade was associated with improvement of SF-36 and MLHFQ scores. Further, global QoL was associated with clinical outcomes and might serve as a future outcome surrogate following TTVR.     

Multicenter Experience With the Transcatheter Leaflet Repair System for Symptomatic Tricuspid Regurgitation

BackgroundTranscatheter treatment techniques for tricuspid regurgitation (TR) have evolved in recent years, with leaflet repair being the most commonly used, but thus far evidence on the PASCAL and PASCAL Ace system is based mainly on compassionate use data.ObjectivesThis is the first report on commercial use in a multicenter study with a large patient cohort investigating the safety and efficacy of the PASCAL and PASCAL Ace system in the treatment of TR.MethodsIn a retrospective, multicenter, observational setting, data from all consecutive patients undergoing leaflet repair for TR at 8 centers was collected, including a centralized analysis of echocardiographic data.ResultsA total of 235 high-risk patients (mean age 78 ± 8 years, 49% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality score 8.6% ± 6.8%) were included. TR was functional in 87% of patients and graded severe or higher in 91%. TR was successfully reduced to moderate or less in 78% of patients (P < 0.001). Procedural success was 78% (n = 153). At the latest available follow-up (median 173 days), TR reduction was sustained (78% with TR moderate or less; P < 0.001), and echocardiography showed indications of right ventricular remodeling (mean right ventricular end-diastolic diameter 56 ± 9 mm vs 53 ± 9 mm; P < 0.001). Patients’ symptoms diminished significantly (63% were in New York Heart Association functional class I or II at follow-up; P < 0.001). In a device-specific analysis, the PASCAL and PASCAL Ace showed no difference in TR reduction (postprocedural TR moderate or less in 77% vs 78%; P = 0.82).ConclusionsIn early clinical experience, the PASCAL (Ace) leaflet repair system has high technical and procedural success rates with efficient TR reduction and significant clinical and echocardiographic improvement at follow-up.     

Impact of Massive or Torrential Tricuspid Regurgitation in Patients Undergoing Transcatheter Tricuspid Valve Intervention

ObjectivesThe aim of this study was to assess the clinical outcome of baseline massive or torrential tricuspid regurgitation (TR) after transcatheter tricuspid valve intervention (TTVI).BackgroundThe use of TTVI to treat symptomatic severe TR has been increasing rapidly, but little is known regarding the impact of massive or torrential TR beyond severe TR.MethodsThe study population comprised 333 patients with significant symptomatic TR from the TriValve Registry who underwent TTVI. Mid-term outcomes after TTVI were assessed according to the presence of massive or torrential TR, defined as vena contracta width ≥14 mm. Procedural success was defined as patient survival after successful device implantation and delivery system retrieval, with residual TR ≤2+. The primary endpoint comprised survival rate and freedom from rehospitalization for heart failure, survival rate, and rehospitalization at 1 year.ResultsBaseline massive or torrential TR and severe TR were observed in 154 patients (46.2%) and 179 patients (53.8%), respectively. Patients with massive or torrential TR had a higher prevalence of ascites than those with severe TR (27.3% vs. 20.4%, respectively; p = 0.15) and demonstrated a similar procedural success rate (83.2% vs. 77.3%, respectively; p = 0.21). The incidence of peri-procedural adverse events was low, with no significant between-group differences. Freedom from the composite endpoint was significantly lower in patients with massive or torrential TR than in those with severe TR, which was significantly associated with an increased risk for 1-year death of any cause or rehospitalization for heart failure (adjusted hazard ratio: 1.91; 95% confidence interval: 1.10 to 3.34; p = 0.022). Freedom from the composite endpoint was significantly higher in patients with massive or torrential TR when procedural success was achieved (69.9% vs. 54.2%, p = 0.048).ConclusionsBaseline massive or torrential TR is associated with an increased risk for all-cause mortality and rehospitalization for heart failure 1 year after TTVI. Procedural success is related to better outcomes, even in the presence of baseline massive or torrential TR. (International Multisite Transcatheter Tricuspid Valve Therapies Registry [TriValve]; NCT03416166)     

Clinical Outcomes Following Isolated Transcatheter Tricuspid Valve Repair: A Meta-Analysis and Meta-Regression Study

ObjectivesThe aim of this study was to assess the pooled clinical and echocardiographic outcomes of different isolated transcatheter tricuspid valve repair (ITTVR) strategies for significant (moderate or greater) tricuspid regurgitation (TR).BackgroundSignificant TR is a common valvular heart disease worldwide.MethodsPublished research was systematically searched for studies evaluating the efficacy and safety of ITTVR for significant TR in adults. The primary outcomes were improvement in New York Heart Association (NYHA) functional class and 6-minute walking distance and the presence of severe or greater TR at the last available follow-up of each individual study. Random-effect meta-analysis was performed comparing outcomes before and after ITTVR.ResultsFourteen studies with 771 patients were included. The mean age was 77 ± 8 years, and the mean European System for Cardiac Operative Risk Evaluation II score was 6.8% ± 5.4%. At a weighted mean follow-up of 212 days, 209 patients (35%) were in NYHA functional class III or IV compared with 586 patients (84%) at baseline (risk ratio: 0.23; 95% CI: 0.13-0.40; P < 0.001). Six-minute walking distance significantly improved from 237 ± 113 m to 294 ± 105 m (mean difference +50 m; 95% CI: +34 to +66 m; P < 0.001). One hundred forty-seven patients (24%) showed severe or greater TR after ITTVR compared with 616 (96%) at baseline (risk ratio: 0.29; 95% CI: 0.20-0.42; P < 0.001).ConclusionsPatients undergoing ITTVR for significant TR experienced significant improvements in NYHA functional status and 6-minute walking distance and a significant reduction in TR severity at mid-term follow-up.     

German Multicenter Experience With a New Leaflet-Based Transcatheter Mitral Valve Repair System for Mitral Regurgitation

ObjectivesThe aim of this study was to investigate the procedural and short-term safety and efficacy of a new leaflet-based transcatheter mitral valve repair system.BackgroundThe PASCAL repair system has been recently approved for percutaneous treatment of mitral regurgitation (MR). Novel characteristics are broad paddles positioned around a central spacer and the ability for independent leaflet capture.MethodsProcedural and 30-day outcomes were investigated in the first 309 patients with symptomatic MR 3+/4+ treated with the PASCAL repair system at 10 sites. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE).ResultsAmong the 309 patients (mean age 77 ± 10 years, 42% women, mean European System for Cardiac Operative Risk Evaluation II score 5.8 ± 4.5%) included in this study, MR etiology was degenerative in 33%, functional in 52%, and mixed in 16%. Eighty-six percent of patients were in New York Heart Association functional class III or IV. The technical success rate was 96%. Of 308 patients discharged alive, MR was ≤2+ in 93.5%. At 30 days, the MAE rate was 4.1%, with an estimated all-cause mortality rate of 2.0%, and 72% of patients were in New York Heart Association functional class ≤II (p < 0.001). Rates of device success and CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) trial–defined clinical success were 81.9% and 86.9%, respectively. Single-leaflet device attachment occurred in 7 patients (2.3%).ConclusionsMitral valve repair with the PASCAL system in the early post-approval phase was effective and safe, with high procedural success rates and low rates of MAE. MR was significantly reduced, accompanied by significant improvement in functional status.     

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.     

Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes

ObjectivesThe study reports for the first time the 30-day outcomes of the first U.S. study with the Cardioband tricuspid valve reconstruction system for the treatment of functional tricuspid regurgitation (TR).BackgroundIncreasing severity of TR is associated with progressively higher morbidity and mortality; however, treatment options for isolated significant disease are limited.MethodsIn this single-arm, multicenter, prospective Food and Drug Administration–approved early feasibility study (EFS), 30 patients with severe or greater symptomatic functional TR were enrolled who were deemed candidates for transcatheter tricuspid repair with the Cardioband tricuspid system by the local heart team and multidisciplinary screening committee.ResultsThe mean patient age was 77 years, 80% were women, 97% had atrial fibrillation, 70% were in New York Heart Association functional class III to IV with mean left ventricular ejection fraction of 58%, and 27% had severe, 20% massive, and 53% torrential TR. Device success was 93% and all patients were alive at 30 days. Between baseline and 30 days, septolateral tricuspid annular diameter was reduced by 13% (p < 0.001), 85% of patients had ≥1 grade TR reduction and 44% had ≤moderate TR, 75% were in New York Heart Association functional class I to II (p < 0.001), and overall Kansas City Cardiomyopathy Questionnaire score improved by 16 points (p < 0.001).ConclusionsIn patients with severe symptomatic functional TR, this is the first study in the United States with the Cardioband tricuspid system for direct transcatheter annular reduction. This early feasibility study demonstrates high procedural feasibility with no 30-day mortality. There is significant reduction of functional TR with clinically significant improvements in functional status and quality of life. (Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study; NCT03382457)     

Imaging for Tricuspid Valve Repair and Replacement

Primary or secondary tricuspid regurgitation (TR) represents an important health care burden and challenge which has often been neglected or undertreated in the past. The expansion and reinforcement of the indications for tricuspid valve (TV) intervention in the 2017 editions of the guidelines as well as the introduction of transcatheter tricuspid valve intervention (TTVI) has considerably increased the attention of the community on the TV and the volume of TV interventions in the past years. Depending on the anatomic target, TTVI can be categorized as the following: 1) direct or indirect tricuspid restrictive annuloplasty; 2) direct (edge-to-edge repair) or indirect (coaptation device) restoration of leaflet coaptation; 3) heterotopic tricuspid valve implantation; and 4) transcatheter tricuspid valve replacement. Multimodality imaging has crucial role for the following: 1) patient selection for TTVI and procedure planning; 2) guiding and monitoring the procedure; and 3) assessing and following over time the results of the procedure. The key points for pre-procedural imaging are: 1) accurate quantitation of TR severity; 2) proper identification of the mechanism(s) responsible for the TR; and 3) quantitation of RV dysfunction and pulmonary arterial hypertension. This imaging work-up is essential to select the right type of intervention for the right patient and TV. Transesophageal echocardiography and fluoroscopy imaging is also key for guiding the TTVI procedures and fusion between these 2 modalities may further enhance the quality of procedure guiding.     

Short-Term Clinical Outcomes of Transcatheter Tricuspid Valve Repair With the Third-Generation MitraClip XTR System

ObjectivesThe aim of this study was to assess 30-day outcomes of transcatheter edge-to-edge repair with the MitraClip XTR for significant tricuspid regurgitation (TR), relative to baseline coaptation gap sizes (CGS).BackgroundTranscatheter edge-to-edge repair using the MitraClip NT for patients with significant TR is safe and efficacious; the utility of the MitraClip XTR is unknown.MethodsPatients with significant, symptomatic TR treated at a single site between April 2018 and December 2019, with consent and with complete data, were included (n = 50). Baseline and 30-day echocardiograms were assessed by an echocardiography core laboratory. Patients were divided into 3 subgroups on the basis of site-assessed CGS: subgroup I (< 7 mm), subgroup II (7 to 10 mm), and subgroup III (>10 mm).ResultsTechnical success of the MitraClip XTR implantation was 100% (88% in the septal-anterior position) using a median of 2 clips (interquartile range: 1 to 2). At 30 days, single-leaflet detachment was noted in 3 patients (6%), with no instances of device embolization. TR was reduced by 1 grade in subgroup I and by 2 grades in subgroups II and III. New York Heart Association functional class was reduced by 1 class in all 3 subgroups. The 6-min walk distance increased in subgroup I (+115 m; p = 0.014) and subgroup II (+31.5 m; p = 0.028) but not subgroup III (+50 m; p = 0.999). A CGS of ≤8.4 mm was predictive of a reduction to moderate or less TR.ConclusionsMitraClip XTR implantation is a safe, effective treatment for a wider range of CGS in patients with symptomatic, significant TR than prior device iterations. All patients showed improvement in New York Heart Association functional class, and those with CGS <10 mm also experienced improved functional capacity.     

1-Year Outcomes of Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study

BackgroundTricuspid regurgitation (TR) is prevalent and undertreated, with mortality and morbidity increasing with TR severity. Given poor outcomes with medical therapy and high in-hospital mortality for isolated tricuspid valve surgery, emerging transcatheter repair devices offer a promising alternative.ObjectivesThe Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility study (NCT03382457) evaluates the treatment of functional TR via annular reduction with the Cardioband Tricuspid Valve Reconstruction System (Edwards Lifesciences).MethodsPatients with ≥ moderate functional TR were eligible for this prospective, single-arm multicenter study. At 1 year, patients were evaluated for echocardiographic parameters, clinical and quality-of-life measures, and major adverse events.ResultsThe 37 patients enrolled had a mean age of 78 years; 76% were female; and they had ≥ severe functional (97.3%) or mixed (2.7%) TR, atrial flutter/fibrillation (97%), and New York Heart Association functional class III/IV (65%). At 1 year, 73.0% achieved ≤ moderate TR (P < 0.0001), and 73.1% had ≥2 grade reductions. Echocardiography showed significant reductions in the tricuspid annulus diameter (P < 0.0001), mean vena contracta (P < 0.0001), proximal isovelocity surface area effective regurgitant orifice area (P < 0.0001), right ventricular end-diastolic diameter (P < 0.0001), and inferior vena contracta (P = 0.0006). New York Heart Association functional class improved significantly (P < 0.0001), with 92.3% achieving class I/II, and Kansas City Cardiomyopathy Questionnaire scores improved by 19.0 points (P < 0.0001). One-year cardiovascular mortality was 8.1%, reinterventions were necessary in 5.4%, major access site complications occurred in 8.1%, and severe bleeding was noted in 35.1% of patients. Kaplan-Meier estimates of survival and freedom from heart failure rehospitalization were 85.9% and 88.7%, respectively.ConclusionsOne-year experience using the Cardioband system for tricuspid valve repair shows high survival and low rehospitalization rates with durable outcomes in TR reduction and echocardiographic, clinical, and quality-of-life outcomes.     

Cardiopulmonary Hemodynamic Profile Predicts Mortality After Transcatheter Tricuspid Valve Repair in Chronic Heart Failure

ObjectivesThis study was designed to assess hemodynamic changes in response to transcatheter tricuspid valve edge-to-edge repair (TTVR) and to identify hemodynamic predictors associated with mortality.BackgroundSevere tricuspid regurgitation (TR) is associated with high mortality. TTVR effectively alleviates heart failure symptoms, but comprehensive hemodynamic characterization of patients undergoing TTVR is currently lacking.MethodsThis international, multicenter study included 236 patients undergoing TTVR. Data from clinical assessment, echocardiography, intraprocedural right heart catheterization, and noninvasive cardiac output measurement were analyzed. Hemodynamic predictors for mortality were identified using linear Cox regression analysis and were used for stratification of patients with subsequent analysis of survival time.ResultsPatients (median age 78 years, 53% women) were symptomatic (89% in New York Heart Association functional class III or IV) because of severe TR (grade ≥3+ in 100%). TTVR significantly reduced TR at discharge (grade ≥3+ in 16%; p < 0.001), with a corresponding 19% reduction of the right atrial v wave (21 mm Hg vs. 16 mm Hg; p < 0.001) and an improvement in cardiac output (from 3.5 to 4.0 l/min; p < 0.01). Invasive mean pulmonary artery pressure, transpulmonary gradient, pulmonary vascular resistance, and right ventricular stroke work were significant predictors of 1-year mortality (p < 0.05 for all). Hemodynamic stratification by mean pulmonary artery pressure and transpulmonary gradient best predicted 1-year survival (p < 0.001). Although patients with pre-capillary dominant pulmonary hypertension showed an unfavorable prognosis (1-year survival 38%), patients without or with post-capillary pulmonary hypertension had favorable outcome (1-year survival 92% or 78%, respectively).ConclusionsInvasive assessment of cardiopulmonary hemodynamic status predicts survival after TTVR. Invasive hemodynamic characterization may help identify patients profiting most from TTVR.     

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.     

Transcatheter Edge-to-Edge Mitral Valve Repair With the MitraClip G4 System

ObjectivesThe primary objective of this study was to evaluate the effectiveness of the MitraClip G4 in the reduction of mitral regurgitation (MR).BackgroundThe next-generation MitraClip G4 system was recently introduced for the treatment of MR in the United States.MethodsThe study included consecutive patients undergoing transcatheter mitral edge-to-edge repair for MR with the MitraClip G4. The key outcome was the proportion of patients with MR reduction to ≤2+ at 30 days.ResultsFifty-nine patients (median age 77 years, 62.7% men) were treated with the MitraClip G4. Reduction of MR to ≤2+ was achieved in 57 patients (96.6%) during the procedure, 58 patients (98.3%) at discharge, and 57 patients (96.6%) by 30 days. The median number of MitraClips used per patient was 2 (interquartile range: 1 to 3). Wide clips (NTW/XTW) were used in 82.7% of patients. The XTW clip was used most frequently as the first clip in patients with degenerative MR (65.4%) and the NTW clip in those with secondary MR (72.7%). The independent grasping mechanism was used in 49.2% of patients.ConclusionsUse of the MitraClip G4 system was associated with excellent reduction in MR to ≤2+ in 96.6% of patients at 30 days. The availability of multiple MitraClip G4 sizes, especially the wide clips, and the ability to independently grasp leaflets are the likely contributors to MR reduction.     

Transcatheter Mitral Valve Repair in Patients With Atrial Functional Mitral Regurgitation

BackgroundAmong patients with severe functional mitral regurgitation (FMR), atrial functional mitral regurgitation (aFMR) represents an underrecognized entity. Data regarding outcomes after mitral valve transcatheter edge-to-edge repair (M-TEER) in aFMR remain scarce.ObjectivesThe objective of this study was to analyze the outcome of aFMR patients undergoing M-TEER.MethodsUsing patients from the international EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry undergoing M-TEER for FMR, the authors analyzed baseline characteristics and 2-year outcomes in aFMR in comparison to non-aFMR and ventricular FMR. Additionally, the impact of right ventricular dysfunction (RVD) (defined as right ventricular to pulmonary artery uncoupling) on outcome after M-TEER was assessed.ResultsAmong 1,608 FMR patients treated by M-TEER, 126 (7.8%) were categorized as aFMR. All 126 aFMR patients had preserved left ventricular function without regional wall motion abnormalities, left arterial dilatation and Carpentier leaflet motion type I. Procedural success (defined as mitral regurgitation ≤2+ at discharge) was 87.2% (P < 0.001) and New York Heart Association (NYHA) functional class significantly improved during follow-up (NYHA functional class III/IV: 86.5% at baseline to 36.6% at follow-up; P < 0.001). The estimated 2-year survival rate in aFMR patients was 70.4%. Two-year survival did not differ significantly between aFMR, non-aFMR, and ventricular FMR. Besides NYHA functional class IV, RVD was identified as a strong independent predictor for 2-year survival (HR: 2.82 [95% CI: 1.24-6.45]; P = 0.014).ConclusionsaFMR is a frequent cause of FMR and can be effectively treated with M-TEER to improve symptoms at follow-up. Advanced heart failure symptoms and RVD were identified as important risk factors for survival in aFMR patients.     

Acute Kidney Injury Following Tricuspid Transcatheter Edge-to-Edge Repair

BackgroundLittle is known about the incidence and clinical relevance of postprocedural acute kidney injury (AKI) in patients undergoing transcatheter edge-to-edge repair (TEER) for tricuspid regurgitation (TR).ObjectivesThe aim of this study was to investigate the prognostic impact of postprocedural AKI following TEER for TR.MethodsTwo hundred sixty-eight patients who underwent TEER for TR at 2 centers were retrospectively analyzed. Postprocedural AKI was defined as an increase in serum creatinine of ≥0.3 mg/dL within 48 hours or ≥50% within 7 days after the procedure compared with baseline. The association between AKI and the composite outcome, consisting of all-cause mortality and rehospitalization for heart failure within 1 year after the procedure, was determined.ResultsThe mean age of the patients was 79.0 ± 6.8 years, and 43.3% were men. Postprocedural AKI occurred in 42 patients (15.7%). Age, male sex, an estimated glomerular filtration rate of <60 mL/min/1.73 m², and absence of procedural success were associated with the occurrence of AKI. Patients with AKI had a higher incidence of in-hospital mortality than those without AKI (9.5% vs 0.9%; P = 0.006). Moreover, AKI was associated with the incidence of the composite outcome within 1 year after TEER for TR (adjusted HR: 2.39; 95% CI: 1.45-3.94; P = 0.001).ConclusionsPostprocedural AKI occurred in 15.7% of patients undergoing TEER for TR, despite the absence of iodinated contrast agents, which was associated with worse clinical outcomes. These findings highlight the clinical impact of AKI following TEER for TR and should help in identifying patients at high risk for AKI.     

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.     

Impact of Proportionality of Secondary Mitral Regurgitation on Outcome After Transcatheter Mitral Valve Repair

ObjectivesThe purpose of this paper was to evaluate the impact of proportionality of secondary mitral regurgitation (SMR) in a large real-world registry of transcatheter edge-to-edge mitral valve repair (TMVr)BackgroundDifferences in the outcomes of recent randomized trials of TMVr for SMR may be explained by the proportionality of SMR severity to left ventricular (LV) volume.MethodsThe ratio of pre-procedural effective regurgitant orifice area (EROA) to LV end-diastolic volume (LVEDV) was retrospectively assessed in patients undergoing TMVr for severe SMR between 2008 and 2019 from the EuroSMR registry. A recently proposed SMR proportionality scheme was adapted to stratify patients according to EROA/LVEDV ratio in 3 groups: MR-dominant (MD), MR-LV-co-dominant (MLCD), and LV-dominant (LD). All-cause mortality was assessed as a primary outcome, secondary heart failure (HF) outcomes included hospitalization for HF (HHF), New York Heart Association (NYHA) functional class, N-terminal pro–B-type natriuretic peptide (NT-proBNP), 6-min-walk distance, quality of life and MR grade.ResultsA total of 1,016 patients with an EROA/LVEDV ratio were followed for 22 months after TMVr. MR was reduced to grade ≤2+ in 92%, 96%, and 94% of patients (for MD, MLCD, and LD, respectively; p = 0.18). After adjustment for covariates including age, sex, diabetes, kidney function, body surface area, LV ejection fraction, and procedural MR reduction (grade ≤2+), adjusted rates of 2-year mortality in MD patients did not differ from those for MLCD patients (17% vs. 18%, respectively), whereas it was higher in LD patients (23%; p = 0.02 for comparison vs. MD+MLCD). The adjusted first HHF rate differed between groups (44% in MD, 56% in MLCD, 29% in LD; p = 0.01) as did the adjusted time for first death or HHF rate (66% in MD, 82% in MLCD, 68% in LD; p = 0.02). Improvement of NYHA functional class was seen in all groups (p < 0.001). Values for 6-min-walk distances, quality of life and NT-proBNP improved in most patients.ConclusionsMD and MLCD patients had a comparable, adjusted 2-year mortality rate after TMVr which was slightly better than that of LD patients. Patients treated with TMVr had symptomatic improvement regardless of EROA/LVEDV ratio.     

Progression of Tricuspid Regurgitation After Surgery for Ischemic Mitral Regurgitation

BackgroundWhether to repair nonsevere tricuspid regurgitation (TR) during surgery for ischemic mitral valve regurgitation (IMR) remains uncertain.ObjectivesThe goal of this study was to investigate the incidence, predictors, and clinical significance of TR progression and presence of ≥moderate TR after IMR surgery.MethodsPatients (n = 492) with untreated nonsevere TR within 2 prospectively randomized IMR trials were included. Key outcomes were TR progression (either progression by ≥2 grades, surgery for TR, or severe TR at 2 years) and presence of ≥moderate TR at 2 years.ResultsPatients’ mean age was 66 ± 10 years (67% male), and TR distribution was 60% ≤trace, 31% mild, and 9% moderate. Among 2-year survivors, TR progression occurred in 20 (6%) of 325 patients. Baseline tricuspid annular diameter (TAD) was not predictive of TR progression. At 2 years, 37 (11%) of 323 patients had ≥moderate TR. Baseline TR grade, indexed TAD, and surgical ablation for atrial fibrillation were independent predictors of ≥moderate TR. However, TAD alone had poor discrimination (area under the curve, ≤0.65). Presence of ≥moderate TR at 2 years was higher in patients with MR recurrence (20% vs. 9%; p = 0.02) and a permanent pacemaker/defibrillator (19% vs. 9%; p = 0.01). Clinical event rates (composite of ≥1 New York Heart Association functional class increase, heart failure hospitalization, mitral valve surgery, and stroke) were higher in patients with TR progression (55% vs. 23%; p = 0.003) and ≥moderate TR at 2 years (38% vs. 22%; p = 0.04).ConclusionsAfter IMR surgery, progression of unrepaired nonsevere TR is uncommon. Baseline TAD is not predictive of TR progression and is poorly discriminative of ≥moderate TR at 2 years. TR progression and presence of ≥moderate TR are associated with clinical events. (Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting [CABG] Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation, NCT00806988; Comparing the Effectiveness of Repairing Versus Replacing the Heart’s Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation, NCT00807040)