PASCAL‐based mitral valve repair in an all‐comer population: acute and mid‐term clinical results

Abstract

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.

One‐year results following PASCAL‐based or MitraClip‐based mitral valve transcatheter edge‐to‐edge repair

“…Success rates are mainly in line with previously published studies and differences well attributable to the advanced state of disease in this cohort. 8,[11][12][13][14][15][16][17][18]31,33,34 Interestingly, aborted implantations due to elevated MPG were significantly more frequent in the PASCAL group (P = 0.0419), although MV area was significantly larger in this patient cohort (P = 0.0378) and baseline MPG did not differ between groups. This might represent a limitation of the broader PASCAL implant compared with the slenderer NTR and XTR.…”

“…[11][12][13] To date, only limited information regarding the use of this novel TEER device has been reported and especially midterm and long-term real-world data are scarce. [11][12][13][14][15][16][17][18] Thus, in the present study, we investigated PASCAL therapy in comparison with MitraClip therapy in a propensity-matched analysis regarding feasibility, safety, and efficacy.…”

Outcomes of patients undergoing edge‐to‐edge mitral valve repair with the Edwards PASCAL transcatheter valve repair system under conscious sedation

“…Also, the CLASP IID trial comparing M‐TEER outcomes with the PASCAL system and Mitra Clip demonstrated safety, effectiveness, and non‐inferiority to the Mitra Clip in patients with symptomatic degenerative DM and at prohibitive risk of mitral valve surgery 8 . The device success and safety were also evaluated in a cohort of all‐comers with severe symptomatic MR resulting in low early and midterm major adverse event rates, significant early and midterm reduction of MR, and persistent clinical improvement according to New York Heart Association (NYHA) functional class 4–6,9 . Moreover, the 3‐year outcomes from CLASP study revealed positive and long‐lasting outcomes of PASCAL system to treat patients with clinically significant MR demonstrating high survival, reduced heart failure (HF) hospitalization, and sustained MR reduction 10 …”

“…8 The device success and safety were also evaluated in a cohort of all-comers with severe symptomatic MR resulting in low early and midterm major adverse event rates, significant early and midterm reduction of MR, and persistent clinical improvement according to New York Heart Association (NYHA) functional class. [4][5][6]9 Moreover, the 3-year outcomes from CLASP study revealed positive and long-lasting outcomes of PASCAL system to treat patients with clinically significant MR demonstrating high survival, reduced heart failure (HF) hospitalization, and sustained MR reduction. 10 Traditionally, most TEER procedures have been performed under general anesthesia (GA).…”