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.     

Insufficient Mitral Leaflet Remodeling in Relation to Annular Dilation and Risk of Residual Mitral Regurgitation After MitraClip Implantation

ObjectivesThe purpose of this study was to determine whether the mitral valve (MV) total leaflet area (TLA)-to-mitral annular area (MAA) (TLA/MAA) ratio measured using 3-dimensional (3D) transesophageal echocardiography (TEE) was associated with residual mitral regurgitation (MR) after MitraClip implantation in patients with secondary MR.BackgroundThe factors influencing the results of MitraClip implantation for secondary MR are controversial. This study hypothesized that insufficient remodeling of the mitral leaflets relative to the annular dilation may be associated with significant MR after MitraClip implantation.MethodsThis study included patients with secondary MR treated with MitraClips. Using 3D TEE dataset, the TLA in diastole and MAA in systole were measured with dedicated software.ResultsIn a total cohort of 119 patients (mean age 74 ± 9 years; 61% male), significant residual MR (≥2+) was present in 43 patients (36%). In patients with significant residual MR, MAA was greater than in patients without residual MR (10.7 ± 2.4 cm² vs. 9.0 ± 2.1 cm²; p < 0.001) whereas no significant difference was observed in TLA (12.2 ± 2.6 cm² vs. 12.0 ± 2.9 cm²; p = 0.836). TLA/MAA ratio was lower in patients with significant residual MR as compared to their counterparts (1.14 ± 0.15 vs. 1.34 ± 0.16; p < 0.001), suggesting insufficient leaflet remodeling relative to annular dilation. On receiver-operating characteristic curve analysis, the TLA/MAA ratio had better discriminative power to identify patients who will have significant residual MR compared to MAA alone (area under the curve [AUC]: 0.830 vs. 0.723; p = 0.049).ConclusionsIn patients with secondary MR, insufficient mitral leaflet remodeling relative to the annulus dilation, as reflected by a lower TLA/MAA ratio, is associated with significant residual MR after MitraClip implantation.     

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.     

Electrosurgical Detachment of MitraClips From the Anterior Mitral Leaflet Prior to Transcatheter Mitral Valve Implantation

ObjectivesThe aim of this study was to test the hypothesis that transcatheter electrosurgery might allow intentional detachment of previously placed MitraClip(s) from the anterior leaflet to recreate a single mitral orifice for transcatheter mitral valve implantation (TMVI), leaving the retained MitraClip(s) securely fastened to the posterior leaflet and without interfering with the mitral bioprosthesis.BackgroundPatients with severe mitral regurgitation or stenosis despite edge-to-edge mitral repair with the MitraClip typically have few therapeutic options because the resultant double orifice precludes TMVI. Transcatheter electrosurgery may allow detachment of failed MitraClip(s) from the anterior leaflet to recreate a single orifice for TMVI.MethodsThis was a single-center, 5-patient, consecutive, retrospective observational cohort. Patients underwent transcatheter electrosurgical laceration and stabilization of failed MitraClip(s) to recreate a single orifice, leaving the MitraClip(s) securely fastened to the posterior leaflet. Subsequently, patients underwent TMVI with an investigational device, the Tendyne mitral bioprosthesis, on a compassionate basis. Patients were followed up to 30 days.ResultsMitraClip detachment from the anterior leaflet and Tendyne implantation were successful in all patients. All patients survived to discharge. All patients were discharged with grade 0 central mitral regurgitation. Two patients had moderate perivalvular mitral regurgitation that did not require reintervention. During the follow-up period of 30 days, there were no deaths, cases of valve dysfunction, or reintervention. There was no evidence of erosion or bioprosthetic valve dysfunction attributable to the retained MitraClip(s) still attached to the posterior leaflet.ConclusionsTranscatheter electrosurgical detachment of failed MitraClips from the anterior leaflet followed by TMVI is technically feasible and safe at 30 days. Longer term study is needed to determine the clinical benefit of this approach and new algorithms for TMVI sizing following electrosurgical laceration and stabilization of a failed MitraClip to avoid perivalvular leak.     

3-Year Outcomes of Transcatheter Mitral Valve Repair in Patients With Heart Failure

BackgroundIn the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, transcatheter mitral valve repair (TMVr) resulted in fewer heart failure hospitalizations (HFHs) and lower mortality at 24 months in patients with heart failure (HF) with mitral regurgitation (MR) secondary to left ventricular dysfunction compared with guideline-directed medical therapy (GDMT) alone.ObjectivesThis study determined if these benefits persisted to 36 months and if control subjects who were allowed to cross over at 24 months derived similar benefit.MethodsThis study randomized 614 patients with HF with moderate-to-severe or severe secondary MR, who remained symptomatic despite maximally tolerated GDMT, to TMVr plus GDMT versus GDMT alone. The primary effectiveness endpoint was all HFHs through 24-month follow-up. Patients have now been followed for 36 months.ResultsThe annualized rates of HFHs per patient-year were 35.5% with TMVr and 68.8% with GDMT alone (hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.37 to 0.63; p < 0.001; number needed to treat (NNT) = 3.0; 95% CI: 2.4 to 4.0). Mortality occurred in 42.8% of the device group versus 55.5% of control group (HR: 0.67; 95% CI: 0.52 to 0.85; p = 0.001; NNT = 7.9; 95% CI: 4.6 to 26.1). Patients who underwent TMVr also had sustained 3-year improvements in MR severity, quality-of-life measures, and functional capacity. Among 58 patients assigned to GDMT alone who crossed over and were treated with TMVr, the subsequent composite rate of mortality or HFH was reduced compared with those who continued on GDMT alone (adjusted HR: 0.43; 95% CI: 0.24 to 0.78; p = 0.006).ConclusionsAmong patients with HF and moderate-to-severe or severe secondary MR who remained symptomatic despite GDMT, TMVr was safe, provided a durable reduction in MR, reduced the rate of HFH, and improved survival, quality of life, and functional capacity compared with GDMT alone through 36 months. Surviving patients who crossed over to device treatment had a prognosis comparable to those originally assigned to transcatheter therapy. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation [COAPT]; NCT01626079)     

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)     

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.     

Coronary Access After TAVR-in-TAVR as Evaluated by Multidetector Computed Tomography

ObjectivesThe aim of this study was to assess coronary accessibility after transcatheter aortic valve replacement (TAVR)–in–TAVR using multidetector computed tomography.BackgroundExpanding TAVR to patients with longer life expectancy may involve more frequent bioprosthetic valve failure and need for redo TAVR. Coronary access after TAVR-in-TAVR may be challenging, particularly as the leaflets from the initial transcatheter heart valve (THV) will form a neo-skirt following TAVR-in-TAVR.MethodsIn 45 patients treated with different combinations of CoreValve and Evolut (CV/EV) THVs with supra-annular leaflet position and SAPIEN THVs with intra-annular leaflet position, post-TAVR-in-TAVR multidetector computed tomographic scans were analyzed to examine coronary accessibility.ResultsAfter TAVR-in-TAVR, the coronary arteries originated below the top of the neo-skirt in 90% of CV/EV-first cases compared with 67% of SAPIEN-first cases (p = 0.009). For these coronary arteries originating below the top of the neo-skirt, the distance between the THV and the aortic wall was <3 mm in 56% and 25% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.035). Coronary access may be further complicated by THV-THV stent frame strut misalignment in 53% of CV/EV-in-CV/EV cases. The risk for technically impossible coronary access was 27% and 10% in CV/EV-first and SAPIEN-first cases, respectively (p = 0.121). Absence of THV interference with coronary accessibility can be expected in 8% and 33% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.005).ConclusionsCoronary access after TAVR-in-TAVR may be challenging in a significant proportion of patients. THVs with intra-annular leaflet position or low commissural height and large open cells may be preferable in terms of coronary access after TAVR-in-TAVR.     

Baseline Functional Capacity and Transcatheter Mitral Valve Repair in Heart Failure With Secondary Mitral Regurgitation

ObjectivesThe aim of this study was to determine the prognostic utility of baseline functional status and its impact on the outcomes of transcatheter mitral valve repair (TMVr) in patients with heart failure (HF) with secondary mitral regurgitation (SMR).BackgroundThe COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial demonstrated that TMVr with the MitraClip in patients with HF with moderate to severe or severe SMR improved health-related quality of life. The clinical utility of a baseline assessment of functional status for evaluating prognosis and identifying candidates likely to derive a robust benefit from TMVr has not been previously studied in patients with HF with SMR.MethodsThe COAPT study was a multicenter, randomized, controlled, parallel-group, open-label trial of TMVr with the MitraClip plus guideline-directed medical therapy (GDMT) versus GDMT alone in patients with HF, left ventricular ejection fraction 20% to 50%, and moderate to severe or severe SMR. Baseline functional status was assessed by 6-min walk distance (6MWD).ResultsPatients with 6MWD less than the median (240 m) were older, were more likely to be female, and had more comorbidities. After multivariate modeling, age (p = 0.005), baseline hemoglobin (p = 0.007), and New York Heart Association functional class III/IV symptoms (p < 0.0001) were independent clinical predictors of 6MWD. Patients with 6MWD <240 m versus ≥240 m had a higher unadjusted and adjusted rate of the 2-year composite of all-cause death or HF hospitalization (64.4% vs. 48.6%; adjusted hazard ratio: 1.53; 95% confidence interval: 1.19 to 1.98; p = 0.001). However, there was no interaction between baseline 6MWD and the relative effectiveness of TMVr plus GDMT versus GDMT alone with respect to the composite endpoint (p = 0.633).ConclusionsBaseline assessment of functional capacity by 6MWD was a powerful discriminator of prognosis in patients with HF with SMR. TMVr with the MitraClip provided substantial improvements in clinical outcomes for this population irrespective of baseline functional capacity.     

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.     

Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients

BackgroundSevere symptomatic degenerative mitral regurgitation (DMR) has a poor prognosis in the absence of treatment, and new transcatheter options are emerging.ObjectivesThe CLASP IID (Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial) randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared with the MitraClip system in patients with significant symptomatic DMR. This report presents the primary safety and effectiveness endpoints for the trial.MethodsPatients with 3+ or 4+ DMR at prohibitive surgical risk were assessed by a central screening committee and randomized 2:1 (PASCAL:MitraClip). Study oversight also included an echocardiography core laboratory and a clinical events committee. The primary safety endpoint was the composite major adverse event rate at 30 days. The primary effectiveness endpoint was the proportion of patients with mitral regurgitation (MR) ≤2+ at 6 months.ResultsA prespecified interim analysis in 180 patients demonstrated noninferiority of the PASCAL system vs the MitraClip system for the primary safety and effectiveness endpoints of major adverse event rate (3.4% vs 4.8%) and MR ≤2+ (96.5% vs 96.8%), respectively. Functional and quality-of-life outcomes significantly improved in both groups (P < 0.05). The proportion of patients with MR ≤1+ was durable in the PASCAL group from discharge to 6 months (PASCAL, 87.2% and 83.7% [P = 0.317 vs discharge]; MitraClip, 88.5% and 71.2% [P = 0.003 vs discharge]).ConclusionsThe CLASP IID trial demonstrated safety and effectiveness of the PASCAL system and met noninferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic DMR.     

Impact of Myocardial Scar on Prognostic Implication of Secondary Mitral Regurgitation in Heart Failure

ObjectivesThe objective of the present study was to use cardiovascular magnetic resonance (CMR) to examine the natural history of secondary MR severity and the implication of left ventricular (LV) scar on its prognostic significance.BackgroundThere is a need for further understanding of the prognostic implication of secondary mitral regurgitation (MR) given the heterogeneous findings of the 2 recent randomized trials on percutaneous mitral intervention in patients with secondary MR.MethodsPatients with heart failure were enrolled into a prospective observational registry between 2008 and 2019. Outcomes were a composite of all-cause death, heart transplantation, or LV assist device implantation at follow-up. CMR was used to quantify the mitral regurgitation volume and mitral regurgitation fraction (MRF) along with scar burden utilizing late gadolinium enhancement. Patients were categorized into 4 subgroups based on presence and tertiles of scar extent: no scar, limited scar (scar burden 1% to 4%), intermediate scar (scar burden 5% to 20%), and extensive scar (scar burden >20%).ResultsAmong patients (n = 441) included in the study (age 59 ± 14 years, 43% with ischemic etiology), 85 (19%) experienced an adverse event. MRF ≥30% was associated with increased risk of events among the study group (hazard ratio: 1.74; 95% confidence interval: 1.10 to 2.76; p = 0.02). When stratified by presence or absence of scar, MRF ≥30% was associated with events only among patients with scar (hazard ratio: 1.67; 95% confidence interval: 1.02 to 2.76; p = 0.04) but not among patients without scar. On further classification of patients with scar, the prognostic significance of secondary MR was observed primarily among patients with intermediate scar burden.ConclusionsThe natural history of secondary MR is complex, and outcomes are affected by severity of MR and vary depending upon the extent of scar. (DeBakey Cardiovascular Magnetic Resonance Study [DEBAKEY-CMR]; NCT04281823)     

Reparación mitral transcatéter según la etiología de la insuficiencia mitral: datos de la vida real procedentes del registro español de MitraClip

Introduction and objectivesTranscatheter mitral valve repair (TMVR) with MitraClip is a therapeutic option for high surgical risk patients with severe mitral regurgitation (MR). The main objective of this study was to analyze differences in outcomes in patients with severe MR according to the cause of MR.MethodsObservational, multicenter, and prospective study with consecutive patient inclusion. The primary endpoint was the combination of all-cause mortality and new readmissions due to heart failure after 1 year. We compared clinical and procedural characteristics and the event rate for each MR group. We performed a multivariate analysis to identify predictive variables for the primary endpoint.ResultsA total of 558 patients were included: 364 (65.2%) with functional etiology, 111 (19.9%) degenerative and 83 (14.9%) mixed. The mean age was 72.8 ± 11.1 years and 70.3% of the sample were men. There were 95 (17%) events in the overall sample. No significant differences were found in the 3 groups in the number of primary outcome events: 11 (11.3%) in degenerative MR, 71 (21.3%) in functional MR, and 13 (18.1%) in mixed MR (P = .101). Independent predictors were functional class (P = .029), previous surgical revascularization (P = .031), EuroSCORE II (P = .003), diabetes mellitus (P = .037), and left ventricular ejection fraction (P = .015).ConclusionsThis study confirms the safety and efficacy of TMVR with MitraClip irrespective of MR etiology in real-life data and shows the main factors related to prognosis during the first year of follow up.     

Mitral Valve Transcatheter Edge-to-Edge Repair Using MitraClip or PASCAL: A Multicenter Propensity Score–Matched Comparison

BackgroundSince its introduction in 2003, Abbott’s MitraClip (MC) has become the most established catheter-based treatment for mitral regurgitation (MR). Recent approval of Edwards Lifescience’s PASCAL device has extended the field of TEER.ObjectivesThe aim of this retrospective multicenter study was to compare the PASCAL and MC regarding procedural results and short- and long-term outcomes after mitral valve transcatheter edge-to-edge repair (TEER).MethodsData from 3 high-volume centers were analyzed. The primary endpoint was residual MR at discharge. Secondary endpoints were technical success, MR reduction, and 30-day mortality. After 1 year, all-cause mortality and residual MR were reported.ResultsA total of 412 patients (216 MC, 196 PASCAL) treated between 2018 and 2020 were included. A total of 184 patients (92 in each treatment group) remained after propensity score matching. The rate of baseline MR ≥3 was 98.9% in both groups (P = 1.00). Both TEER systems achieved equally high technical success rates (97.8%; P = 1.00), resulting in residual MR ≤1 in 69.6% vs 77.1% of patients (P = 0.24) and MR reduction by ≥2 grades in 83.7% vs 92.4% of patients (P = 0.13) using the MC and PASCAL, respectively. Thirty-day mortality was 1.1% in both cohorts (P = 0.98), and 1-year follow-up showed similar MR reductions (residual MR ≤1, 78.0% with MC vs 82.3% with PASCAL; P = 0.70) and comparable all-cause mortality (14.1% with MC vs 6.5% with PASCAL; P = 0.14). In multivariate regression analysis, Society of Thoracic Surgeons score independently correlated with an optimal result (MR ≤1), while device choice did not show a significant impact.ConclusionsIn this retrospective multicenter study, the established MC and the novel PASCAL mitral valve TEER systems were safe and offered excellent performance with comparable short- and long-term outcomes.     

Impact of Mitral Regurgitation Severity and Left Ventricular Remodeling on Outcome After MitraClip Implantation: Results From the Mitra-FR Trial

ObjectivesThis study aimed to identify a subset of patients based on echocardiographic parameters who might have benefited from transcatheter correction using the MitraClip system in the MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) trial.BackgroundIt has been suggested that differences in the degree of mitral regurgitation (MR) and left ventricular (LV) remodeling may explain the conflicting results between the MITRA-FR and the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trials.MethodsIn a post hoc analysis, we evaluated the interaction between the intervention and subsets of patients defined based on MR severity (effective regurgitant orifice [ERO], regurgitant volume [RVOL] and regurgitant fraction [RF]), LV remodeling (end-diastolic and end-systolic diameters and volumes) and combination of these parameters with respect to the composite of death from any cause or unplanned hospitalization for heart failure at 24 months.ResultsWe observed a neutral impact of the intervention in subsets with the highest MR degree (ERO ≥30 mm², RVOL ≥45 ml or RF ≥50%) as in patients with milder MR degree. The same was seen in subsets with the milder LV remodeling using either diastolic or systolic diameters or volumes. When parameters of MR severity and LV remodeling were combined, there was still no benefit of the intervention including in the subset of patients with an ERO/end-diastolic volume ratio ≥ 0.15 despite similar ERO and LV end-diastolic volume compared with COAPT patients.ConclusionsIn the MITRA-FR trial, we could not identify a subset of patients defined based on the degree of the regurgitation, LV remodeling or on their combination, including those deemed as having disproportionate MR, that might have benefited from transcatheter correction using the MitraClip system. (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation [MITRA-FR]; NCT01920698)     

Early Outcomes of 2 Mitral Valve Transcatheter Leaflet Approximation Devices: A Propensity Score–Matched Multicenter Comparison

BackgroundIn addition to the edge-to-edge MitraClip repair system, the edge-to-spacer PASCAL repair system was approved for percutaneous treatment of severe mitral regurgitation (MR). Comparative data are lacking.ObjectivesThe aim of this study was to compare procedural and short-term safety and efficacy of 2 leaflet-based transcatheter mitral valve repair systems.MethodsProcedural and 30-day outcomes were investigated in a propensity score–matched cohort of 307 PASCAL and 307 MitraClip patients at 10 sites. Matching criteria included sex, age, left ventricular ejection fraction, New York Heart Association functional class, MR etiology, left ventricular end-diastolic diameter, left atrial volume index, and vena contracta width. The 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).ResultsTechnical success was 97.0% in the PASCAL group and 98.0% in the MitraClip group (P = 0.624). MR ≤2+ at discharge was comparable in both groups (PASCAL: 93.8% vs MitraClip: 92.4%; P = 0.527), with more patients exhibiting MR ≤1+ in the PASCAL group (70.5% vs 56.6%; P < 0.001). The postprocedural mean gradient was significantly higher in the MitraClip group (3.3 ± 1.5 mm Hg vs 3.9 ± 1.7 mm Hg; P < 0.001). At 30 days, all-cause mortality and MAE rates were similar (mortality: 1.7% vs 3.3%; P = 0.299; MAE: 3.9% vs 5.2%; P = 0.562).ConclusionsIn this first large propensity score–matched comparison, procedural success rates and MAE did not differ significantly between patients treated with the PASCAL or MitraClip valve repair system. Procedural results with less than moderate MR and no elevated transmitral gradient were more common in the PASCAL group, which might have an impact on long-term outcome.     

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.     

COAPT-Like Profile Predicts Long-Term Outcomes in Patients With Secondary Mitral Regurgitation Undergoing MitraClip Implantation

ObjectivesThe aim of this study was to evaluate whether fulfilling COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) criteria identifies patients with better outcomes after MitraClip treatment for secondary mitral regurgitation (SMR).BackgroundTo date, COAPT is the only trial showing a prognostic benefit of MitraClip implantation compared with conservative management.MethodsThree hundred four patients with SMR undergoing MitraClip placement in addition to optimal medical therapy at 3 European centers were analyzed. A COAPT-like profile was defined as absence of all the following criteria: severe left ventricular impairment, moderate to severe right ventricular dysfunction, severe tricuspid regurgitation, severe pulmonary hypertension, and hemodynamic instability. Freedom from all-cause death and from a composite endpoint (cardiovascular death and heart failure hospitalization) were evaluated at 2- and 5-year follow-up.ResultsA COAPT-like profile was observed in 65% of the population. Compared with non-COAPT-like patients, those fulfilling COAPT criteria had greater survival free from all-cause death and from the composite endpoint at both 2 year (75% vs. 55% and 67% vs. 47%; p < 0.001 for both) and 5-year (49% vs. 25% and 40% vs. 19%; p < 0.001 for both) follow-up. Among the non-COAPT-like patients, similar outcomes were observed in those fulfilling 1 or ≥1 criterion. Left ventricular impairment had a late impact on outcomes, while right ventricular impairment, pulmonary hypertension, and hemodynamic instability had early effects. COAPT-like profile was an independent predictor of long-term outcomes, as well as administration of neurohormonal antagonists, European System for Cardiac Operative Risk Evaluation II score, and previous heart failure hospitalization.ConclusionsA COAPT-like profile, including specific echocardiographic and clinical criteria, identifies patients with SMR who have a better prognosis after MitraClip implantation.     

Valve Strain Quantitation in Normal Mitral Valves and Mitral Prolapse With Variable Degrees of Regurgitation

ObjectivesThe aim of this study was to quantitate patient-specific mitral valve (MV) strain in normal valves and in patients with mitral valve prolapse with and without significant mitral regurgitation (MR) and assess the determinants of MV strain.BackgroundFew data exist on MV deformation during systole in humans. Three-dimensional echocardiography allows for dynamic MV imaging, enabling digital modeling of MV function in health and disease.MethodsThree-dimensional transesophageal echocardiography was performed in 82 patients, 32 with normal MV and 50 with mitral valve prolapse (MVP): 12 with mild mitral regurgitation or less (MVP ? MR) and 38 with moderate MR or greater (MVP + MR). Three-dimensional MV models were generated, and the peak systolic strain of MV leaflets was computed on proprietary software.ResultsLeft ventricular ejection fraction was normal in all groups. MV annular dimensions were largest in MVP + MR (annular area: 13.8 ± 0.7 cm²) and comparable in MVP ? MR (10.6 ± 1 cm²) and normal valves (10.5 ± 0.3 cm²; analysis of variance: p < 0.001). Similarly, MV leaflet areas were largest in MVP + MR, particularly the posterior leaflet (8.7 ± 0.5 cm²); intermediate in MVP ? MR (6.5 ± 0.7 cm²); and smallest in normal valves (5.5 ± 0.2 cm²; p < 0.0001). Strain was overall highest in MVP + MR and lowest in normal valves. Patients with MVP ? MR had intermediate strain values that were higher than normal valves in the posterior leaflet (p = 0.001). On multivariable analysis, after adjustment for clinical and MV geometric parameters, leaflet thickness was the only parameter that was retained as being significantly correlated with mean MV strain (r = 0.34; p = 0.008).ConclusionsMVs that exhibit prolapse have higher strain compared to normal valves, particularly in the posterior leaflet. Although higher strain is observed with worsening MR and larger valves and annuli, mitral valve leaflet thickness—and, thus, underlying MV pathology—is the most significant independent determinant of valve deformation. Future studies are needed to assess the impact of MV strain determination on clinical outcome.