Andrea Scotti

Outcome after percutaneous edge-to-edge mitral repair for functional and degenerative mitral regurgitation: a systematic review and meta-analysis

Objectives Differences in terms of safety and efficacy of percutaneous edge-to-edge mitral repair between patients with functional and degenerative mitral regurgitation (MR) are not well established. We performed a systematic review and meta-analysis to clarify these differences. Methods PubMed, EMBASE, Google scholar database and international meeting abstracts were searched for all studies about MitraClip. Studies with <25 patients or where 1-year results were not delineated between MR aetiology were excluded. This study is registered with PROSPERO. Results A total of nine studies investigating the mid-term outcome of percutaneous edge-to-edge repair in patients with functional versus degenerative MR were included in the meta-analysis (n=2615). At 1 year, there were not significant differences among groups in terms of patients with MR grade≤2 (719/1304 vs 295/504; 58% vs 54%; risk ratio (RR) 1.12; 95% CI: 0.86 to 1.47; p=0.40), while there was a significantly lower rate of mitral valve re-intervention in patients with functional MR compared with those with degenerative MR (77/1770 vs 80/818; 4% vs 10%; RR 0.60; 95% CI: 0.38 to 0.97; p=0.04). One-year mortality rate was 16% (408/2498) and similar among groups (RR 1.26; 95% CI: 0.90 to 1.77; p=0.18). Functional MR group showed significantly higher percentage of patients in New York Heart Association class III/IV (234/1480 vs 49/583; 16% vs 8%; p<0.01) and re-hospitalisation for heart failure (137/605 vs 31/220; 23% vs 14%; p=0.03). No differences were found in terms of single leaflet device attachment (25/969 vs 20/464; 3% vs 4%; p=0.81) and device embolisation (no events reported in both groups) at 1 year. Conclusions This meta-analysis suggests that percutaneous edge-to-edge repair is likely to be an efficacious and safe option in patients with both functional and degenerative MR. Large, randomised studies are ongoing and awaited to fully assess the clinical impact of the procedure in these two different MR aetiologies.

Impact and evolution of right ventricular dysfunction after successful MitraClip implantation in patients with functional mitral regurgitation

Background Right ventricular dysfunction (RVdysf) is a predictor of poor outcome in patients with heart failure and valvular disease. The aim of this study was to evaluate the evolution and the impact of RVdysf in patients with moderate–severe functional mitral regurgitation (FMR) successfully treated with MitraClip. Methods and results From October 2008 to July 2014, 60 consecutive high surgical risk FMR patients were evaluated and stratified into two groups: RVdysf group (TAPSE < 16 mm and/or S′TDI < 10 cm/s, 21 patients) and No-RVdysf group (38 patients). The overall mean age of patients was 73 ± 8 (83% male). Ischemic FMR etiology was present in 67%. Mean LVEF was 30 ± 10%. Overall mean time follow-up was 565 ± 310 days. The only significant difference between the two groups was a greater prevalence of stroke, ICD and use of aldosterone antagonist in RVdysf group. Acute procedural success was achieved in 90% of patients. At 6-month echo-matched analysis significant RV function improvement was observed in patients with baseline RVdysf (TAPSE 15 ± 3.0 vs. 19 ± 4.5, p = 0.007; S′TDI 7 ± 1.2 vs. 11 ± 2.8, p < 0.0001; baseline vs. 6-month, respectively). The mean improvement in the 6-min walking test was significant in both groups (120 and 143 m, RVdysf and No-RVdysf groups, respectively). At Kaplan–Meier analysis, the presence of RVdysf did not affect the outcome in terms of freedom from composite efficacy endpoint. Conclusions This study shows that successful MitraClip implantation in patients with FMR and concomitant right ventricular dysfunction yields significant improvement of RV function at mid-term follow-up. Further data on larger population will be required to confirm our observations.

Two-year cardiac mortality after MitraClip treatment of functional mitral regurgitation in ischemic and non-ischemic dilated cardiomyopathy

BACKGROUND MitraClip implantation has evolved as a new tool for treatment of inoperable or high-risk patients with severe functional mitral regurgitation (FMR) due to dilated cardiomyopathy (DCM). Limited data are available regarding MitraClip outcomes comparing patients with ischemic and non-ischemic DCM. METHODS From 2008 to 2016, 314 patients received MitraClip for FMR at four institutions: Brescia, Zurich and Milan. Patients were stratified according to MR aetiology in non-ischemic FMR (n = 99) and ischemic FMR (n = 215). Preoperative risk factors, operative variables and outcomes up to 2-year were evaluated. A multivariable Cox Proportional Hazards survival model with covariate adjustments was used to assess the relationship between FMR aetiology and 2-year cardiac mortality. RESULTS As expected, patients with ischemic FMR had significantly more risk factors and comorbidities. Overall procedural success rate was 80% and in-hospital cardiac mortality was 3% without significant differences between aetiology. Two-year overall (25% vs. 19%, p = 0.574) and cardiac (18% vs. 16%, p = 0.990) mortality rates were comparable. No differences were detected in terms of re-hospitalization rates (32%), LVAD implantation (4.5%) and mitral valve surgery (1%). LVEF ≤ 25%, LVEDV > 216 ml, NT-proBNP ≥ 10.000 pg/ml and AF were the strongest baseline predictors of 2-year cardiac mortality. Greater improvements of 6MWT and NYHA functional class were observed in patients with non-ischemic FMR. CONCLUSIONS The ischemic or non-ischemic aetiology of DCM did not affect in-hospital and 2-year cardiac mortality after MitraClip in patients with FMR. In case of unfavorable baseline clinical condition, the indication for MitraClip should be carefully weighed in favour of conservative medical therapy alone or left ventricular assist device.

Observed versus predicted mortality after MitraClip treatment in patients with symptomatic heart failure and significant functional mitral regurgitation: Observed versus predicted mortality after MitraClip treatment in patients with symptomatic heart failure and significant functional mitral regurgitati

mitral regurgitation (FMR) that takes place as a result of a ‘ventricular secondary’ mechanism, due to dilatation and spherical remodelling of the left ventricle.1 In HF patients, the presence of severe FMR is associated with HF symptoms, increased hospitalization rates and worse long-term prognosis despite optimal medical therapy (OMT).2 Transcatheter edge-to-edge mitral valve repair using the MitraClip device (Abbott Vascular, Santa Clara, CA, USA) has evolved as a new tool for treatment of high-risk or inoperable patients with FMR. Several studies based on real-world registries (ACCESS-EU, TRAMI, EVEREST II HRR and REALISM HR) showed how MitraClip is a safe treatment that could induce improvement in symptoms, favourable left ventricular remodelling, and reduced HF hospitalizations in high-risk patients with severe mitral regurgitation (MR). Despite these evidences, it is still unclear how surgical or percutaneous interventions on FMR may change long-term survival of HF patients. Therefore, we retrospectively evaluated a consecutive series of HF patients (n= 238) with significant (3+ moderate and 4+ severe) ischaemic (n= 167) and non-ischaemic (n= 71) FMR treated with MitraClip, between October 2008 and April 2017, at San Raffaele Hospital of Milan (n=133), at Spedali Civili of Brescia (n= 59), and at University Heart Center of Zurich (n= 46), to compare the observed all-cause mortality with that predicted by the 3C-HF, MAGGIC and SHFM scores, three well-validated scoring systems used to predict the probability of survival in patients with HF.3–5 All included patients had symptomatic systolic chronic HF [New York Heart Association (NYHA) class III–IV] despite OMT (including cardiac resynchronization therapy). The 3C-HF, MAGGIC and SHFM scores were calculated for each patient on the date of the MitraClip implantation. The observed overall survival was obtained using Kaplan–Meier analysis. Observed and predicted survivals were compared at the 1-, 2-, 3and 5-year time-point after MitraClip implantation using 2x2 matrix and χ2 test. Procedural success was observed in 89.5% of patients (Mitral Valve Academic Research Consortium definition). In-hospital death occurred in 7 patients (3%) due to cardiac causes (n= 6) and pneumonia (n= 1). After discharge, we observed 89 deaths over a median (range) follow-up of 655 (739–912) days, 68 of them were cardiac. Data on patients (n= 44) who were lost to follow-up were censored at the time of the last contact. The latter may have led us to underestimate the observed mortality. The observed overall survival was consistent with that predicted by SHFM (1-year: 79% observed vs. 80% predicted, Δ=1%, P= 0.785; 2-year: 66% observed vs. 67% predicted, Δ=1%, P= 0.815; 5year: 41% observed vs. 40% predicted, Δ=1%, P= 0.822), higher than that predicted by MAGGIC (1-year: 79% observed vs. 73% predicted, Δ= 6%, P= 0.124; 3-year: 55% observed vs. 48% predicted, Δ= 7%, P= 0.125) and significantly higher than that