Aims Mitral valve transcatheter edge-to-edge repair (TEER) has been established as a suitable alternative to mitral valve surgery in patients with severe mitral regurgitation (MR) and high surgical risk. The PASCAL system represents a novel device, potentially augmenting the toolkit for TEER. The aim of this study was to assess and compare short and 1 year safety and efficacy of the PASCAL and MitraClip systems for TEER. Methods and results Procedural, short, and 1 year outcomes of a 1:2 propensity-matched cohort including 41 PASCAL and 82 MitraClip cases were investigated. Matching was based on clinical, laboratory, echocardiographic, and functional characteristics. The primary endpoints assessed were procedural success [as defined by the Mitral Valve Academy Research Consortium (MVARC)], residual MR, functional class, and a composite endpoint comprising death, heart failure hospitalization, and mitral valve re-intervention. We found for the PASCAL and the matched MitraClip cohort no significant differences in MVARC defined technical (90.2% vs. 95.1%, P = 0.44), device (90.2% vs. 89.0%, P = 1.0), or procedural (87.8% vs. 80.5%, P = 0.45) success rates. Accordingly, the overall MR reduction and improvement in New York Heart Association (NYHA) class were comparable (1 year follow-up: MR ≤ 2 95% vs. 93.6%, P = 1.0; NYHA ≤ 2 57.1% vs. 66.7%, P = 0.59). The composite outcome revealed no statistically significant difference between both devices (1 year follow-up: 31.7% vs. 37.8%, P = 0.55). Interestingly, we found at both short and 1 year follow-up a significantly higher rate of patients with none or trace MR in the PASCAL-treated cohort (short follow-up: 17.9% vs. 0%, P = 0.0081; 1 year follow-up: 25% vs. 0%, P = 0.0016). Conversely, the rate of aborted device implantations due to an elevated transmitral gradient was higher in PASCAL interventions (9.8% vs. 1.2%, P = 0.04). Conclusions Transcatheter edge-to-edge repair using the PASCAL or MitraClip device results in favourable and comparable outcomes regarding safety, efficacy, and clinical improvement after 1 year.
AimsWe investigated short and mid-term safety and efficacy of the PASCAL system for percutaneous mitral valve repair (PMVr) in severe mitral regurgitation (MR) in an all-comer population. Methods and resultsIn the first consecutive 41 patients undergoing PMVr using the PASCAL system in our centre, procedural success and safety were assessed. Efficacy in improving MR and functional class were evaluated. Median patient age was 74 years, 58.5% were male patients, and median European System for Cardiac Operative Risk Evaluation Score II was 5.1%. All patients suffered from severe MR with 59% functional MR, 29% degenerative MR, and 12% of mixed aetiology MR. The technical success rate was 90%, limited by four cases where PASCAL implantation was aborted due to a prohibitive mitral gradient. On average, 1.16 PASCAL devices per patient were implanted. All patients successfully implanted with a PAS-CAL device were discharged with MR grade ≤ 2 and 79% with MR grade ≤ 1. Mean follow-up was 8.7 ± 4.9 months. Ninety-seven per cent of patients remained at MR ≤ 2 at follow-up, which translated into a significantly improved New York Heart Association functional class as well as a significant reduction of systolic pulmonary artery pressure and brain natriuretic peptide levels. The procedure-related rate for major adverse events was 3%. Neither early nor late single-leaflet detachment was found. In one patient, air embolism occurred, resulting in modification of the PASCAL instructions for use. Conclusions Percutaneous mitral valve repair using PASCAL in a real-world, all-comer population was feasible and safe, resulting in a significant mid-term reduction of MR with persistent clinical improvement.
Funding Acknowledgements Type of funding sources: None. OnBehalf Mitral vAlve prolapse and disjunction by cardiac maGnetIC resonance (MA-GIC) registry Backgroung Mitral valve prolapse (MVP) is 2-3% prevalent in the general population with good prognosis. However, some patients develop complex ventricular arrhythmias (CVAs), sudden cardiac death (SCD), or severe mitral regurgitation (MR). Previous studies suggested that bi-leaflet involvement, mitral annulus disjunction (MAD), and myocardial fibrosis (MF) are associated with adverse outcome. Notwithstanding, these findings were limited to autopsic series or single-centre studies involving highly selected patients. Moreover, MF has been scantly investigated as predictor of clinical outcome. Purpose To investigate the prognostic significance of MF in an international multicentre study of MVP patients studied by cardiovascular magnetic resonance (CMR) with late gadolinium enhancement (LGE). Methods From October 2007 to June 2020 patients undergoing LGE-CMR were screened in 14 European centres. Inclusion criteria were: i) age > 18 years; ii) full clinical history and cardiac rhythm monitoring at baseline; iii) MVP (leaflet displacement ≥ 2 mm beyond the annulus). Exclusion criteria were: i) ischemic heart disease; ii) primary cardiomyopathy; iii) inflammatory heart disease; iv) congenital heart diseases; v) moderate-to-severe valvular heart disease. CVAs at the study outset was defined as one of the following: i) ventricular ectopic beats >10000/24h; ii) ≥ 1 episode of non-sustained ventricular tachycardia (VT); iii) sustained VT; iv) aborted SCD. Primary end-point was a composite of SCD, unexplained syncope, and mitral valve repair/replacement. Secondary end-point was a composite of SCD and unexplained syncope. Results Four-hundred-fifty-eight MVP patients were eventually included (46 ± 16 years old, 51% males) of whom 68% had MAD. LGE was detected in 103 (22%) of subjects with mid-wall pattern (46%) in left ventricular (LV) lateral wall (66%) as the most prevalent feature. At baseline, 37% of LGE-positive patients vs. 18% of LGE-negative individuals had CVAs (P < 0.001). SVT and/or aborted SCD were more prevalent in LGE-positive than in LGE-negative patients (9% vs 2%, P < 0.001). By multivariable Cox-regression analysis, LGE presence or extent were strong independent predictors of the primary (HR = 4.02, P = 0.003 and HR = 4.76 per 10% increase, P = 0.032, respectively) and secondary (HR = 5.39, P = 0.008 and HR = 8.78 per 10% increase, P = 0.012, respectively) endpoints after correction for major confounders including LV volumes, left atrial size and MAD presence. Conlusion Myocardial fibrosis by LGE is the strongest independent predictor of clinical outcome in MVP. In contrast, MAD per se does not harbinger worse prognosis.
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