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.     

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.     

The Prevalence and Impact of Atrial Fibrillation on 1-Year Outcomes in Patients Undergoing Transcatheter Mitral Valve Repair: Results From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry

Objectives

The aim of this study was to compare 1-year outcomes following transcatheter mitral valve (MV) repair in patients with and without atrial fibrillation (AF).

Persistence of Iatrogenic Atrial Septal Defect After Interventional Mitral Valve Repair With the MitraClip System: A Note of Caution

ObjectivesThe purpose of this study was to investigate the persistence rates of iatrogenic atrial septal defect (iASD) after interventional edge-to-edge repair with serial transesophageal echocardiography examinations and close clinical follow-up (FU).BackgroundTranscatheter mitral valve repair (TMVR) with the MitraClip system (Abbott Vascular, Abbott Park, Illinois) is a therapeutic alternative to surgery in selected high-risk patients. Clip placement requires interatrial transseptal puncture and meticulous manipulation of the steerable sheath. The persistence of iASD after MitraClip procedures and its clinical relevance is unknown.MethodsA total of 66 patients (76.7% male, mean age 77.1 ± 7.9 years) with symptomatic mitral regurgitation (MR) at prohibitive surgical risk (EuroSCORE II 10.1 ± 6.1%) underwent MitraClip procedures and completed 6 months of FU.ResultsTransesophageal echocardiography after FU showed persistent iASD in 50% of cases. Patients with iASD did not significantly differ from patients without ASD concerning baseline characteristics, New York Heart Association functional class, severity of MR, and acute procedural success rates (p > 0.05). When comparing procedural details and hemodynamic measures between groups, MitraClip procedures took longer in patients without iASD (82.4 ± 39.7 min vs. 68.9 ± 45.5 min; p = 0.05), and echocardiography after FU showed less decrease of systolic pulmonary artery pressures in the iASD group (−1.6 ± 14.1 mm Hg vs. 9.3 ± 17.4 mm Hg; p = 0.02). Clinically, patients with iASD presented more often with New York Heart Association functional classes >II after FU (57% vs. 30%; p = 0.04), showed higher levels of N-terminal pro-brain natriuretic peptide (6,667.3 ± 7,363.9 ng/dl vs. 4,835.9 ± 6,681.7 ng/dl; p = 0.05), and had less improvement in 6-min walking distances (20.8 ± 107.4 m vs. 114.6 ± 116.4 m; p = 0.001). Patients with iASD showed higher death rates during 6 months (16.6% vs. 3.3%; p = 0.05). Cox regression analysis found that only persistence of iASD (p = 0.04) was associated with 6-month survival.ConclusionsThe persistence rate of 50% iASD after MitraClip procedures is considerably high. Persistent interatrial shunting was associated with worse clinical outcomes and increased mortality. Further studies are warranted to investigate if persistent interatrial shunting is the mediator or marker of advanced disease in these patients.     

Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study

ObjectivesThe authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in the multicenter, prospective, single-arm CLASP study.BackgroundSevere MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated.MethodsEligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days.ResultsBetween June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively.ConclusionsThe PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349)     

Effects of Transcatheter Mitral Valve Repair With MitraClip on Left Ventricular and Atrial Hemodynamic Load and Myocardial Wall Stress

Aims

To evaluate the effects of MitraClip on left ventricular (LV) and left atrial (LA) myocardial wall stress as assessed with the use of N-terminal pro–B-type natriuretic peptide (NT-proBNP) and strain imaging.

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.     

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.     

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.     

Survival of Transcatheter Mitral Valve Repair Compared With Surgical and Conservative Treatment in High-Surgical-Risk Patients

ObjectivesThe goal of this study was to compare survival between transcatheter mitral valve (MV) repair using MitraClip system (Abbott Vascular, Santa Clara, California), MV-surgery, and conservative treatment in high-surgical-risk patients symptomatic with severe mitral valve regurgitation (MR).BackgroundUp to 50% of patients with symptomatic severe MR are denied for surgery due to high perioperative risk. Transcatheter MV repair might be an alternative.MethodsConsecutive patients (n = 139) treated with transcatheter MV repair were included. Comparator surgically (n = 53) and conservatively (n = 59) treated patients were identified retrospectively. Surgical risk was based on the logistic European System for Cardiac Operative Risk Evaluation (log EuroSCORE) or the presence of relevant risk factors, as judged by the heart team.ResultsThe log EuroSCORE was higher in the transcatheter MV repair group (23.9 ± 16.1%) than in the surgically (14.2 ± 8.9%) and conservatively (18.7 ± 13.2%, p < 0.0001) treated patients. Left ventricular ejection fraction was higher in surgical patients (43.9 ± 14.4%, p = 0.003), with similar values for the transcatheter MV repair (36.8 ± 15.3%) and conservatively treated (34.5 ± 16.5%) groups. After 1 year of follow-up, the transcatheter MV repair and surgery groups showed similar survival rates (85.8% and 85.2%, respectively), whereas 67.7% of conservatively treated patients survived. The same trend was observed after the second and third years. After weighting for propensity score and controlling for risk factors, both the transcatheter MV repair (hazard ratio [HR]: 0.41, 95% confidence interval [CI]: 0.22 to 0.78, p = 0.006) and surgical (HR: 0.52, 95% CI: 0.30 to 0.88, p = 0.014) groups showed better survival than the conservatively treated group. The transcatheter MV repair and surgical groups did not differ (HR: 1.25, 95% CI: 0.72 to 2.16, p = 0.430).ConclusionsDespite a higher log EuroSCORE, high-surgical-risk patients with symptomatic severe MR treated with transcatheter MV repair show similar survival rates compared with surgically treated patients, with both displaying survival benefit compared with conservative treatment.     

(Meta)‐Analysis of Safety and Efficacy Following Edge‐to‐Edge Mitral Valve Repair Using the MitraClip System

Objectives

The authors investigated safety and efficacy of the MitraClip‐System (MCS) using a systematic analysis.

Background

The safety and efficacy of the MCS continues to be debated, and randomized trials are still lacking.

Method

A systematic literature search was conducted using common medical and scientific databases. The following kinds of data were obtained: at baseline, 30 days, 6 and 12 month post‐procedure. For safety and efficacy mortality‐rate (survival), mitral regurgitation <2+ (MR), adverse event rate (AE), NYHA class and reoperation‐rate were documented. A meta‐analysis with quantitative summary was performed.

Results

Twenty‐six studies including 3821 patient's who were treated with MCS, were analyzed. Weighted mean age was 73.9 ± 2.3 years and LogEuroScore was 25.2 ± 6.0%. Post‐procedural MR<2+ was achieved in 86.4% and 66.3% of the patients were in NYHA class I/II within 30 days, AE‐rate was 18.3%, mortality‐rate was 2.8% and reoperation‐rate was 3.5%. Freedom from MR>3 + ?4 was 80.2% (80.1%), from NYHA III/IV was 78.6% (66.1%) and freedom from death was 82.6% (87.8%) and from reoperation 95.6% (88.6%) at 6 and 12 month.

Conclusion

Based on the analysis of the current literature treatment with MCS is associated with good short‐term success and low mortality. MCS is safe and effective for patients with limited surgical options. The results are comparable with open mitral valve repair (oMVR) but patients are markedly older and have a higer risk profile than patients who undergo oMVR. Prospective randomized controlled trials are warranted to determine potential AEs, device durability and long‐term follow‐up. (J Interven Cardiol 2015;28:69–75)

     

Outcomes After Current Transcatheter Tricuspid Valve Intervention: Mid-Term Results From the International TriValve Registry

Objectives

A large, prospective international registry was developed to evaluate the initial clinical applications of transcatheter tricuspid valve intervention (TTVI) with different devices.

Insights From the Early Experience of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry

The current system for postmarket surveillance of medical devices in the United States is limited. To help change this paradigm for transcatheter valve therapies (TVTs), starting with transcatheter aortic valve replacement, the Society of Thoracic Surgeons and the American College of Cardiology partnered to form the TVT Registry program in close collaboration with the U.S. Food and Drug Administration and the Center for Medicare and Medicaid Services. The goal of the TVT Registry is to measure and improve quality of care and patient outcomes in clinical practice and to have a pivotal role in the scientific evidence and surveillance for medical devices. Challenges were faced in the early experience of the registry included developing multistakeholder partnerships, data collection requirements, and the use of the registry for pre- and post-market device evaluations. In addressing these challenges, the TVT Registry demonstrates that it is feasible for professional societies to assume a pivotal role in pre- and/or post-market studies, leveraging a clinical registry infrastructure. Sharing the TVT Registry experience may help other professional societies and stakeholders better anticipate and plan for these challenges.