Functional and hemodynamic result with the PASCAL Ace percutaneous mitral valve repair: A single-center experience.

OBJECTIVES: The PASCAL device is a transcatheter edge-to-edge repair system (TEER) for treatment of mitral regurgitation (MR). The PASCAL Ace as a newer version of the PASCAL device consists of a thinner profile without a spacer. The aim of the study was to examine the functional and hemodynamic outcome after TEER with the PASCAL Ace device in a real-world cohort. METHODS: Between September 2020 and August 2021, all consecutive patients with MR 3+/4+ treated percutaneously with PASCAL Ace were included in this study. Primary endpoints included successful device implantation, device success, improvement of exercise capacity, quality of life, and a composite of all-cause mortality, non-fatal stroke, myocardial infarction, new need for renal replacement therapy or severe bleeding at 30 days and 5 month. RESULTS: 49/66 patients had a functional etiology. Overall success rate was 98.5%. At follow-up, 84.7% of the patients had MR grade ≤ 1. TEER was associated with an improvement of LV ejection fraction (45% to 53%, p = 0.048). 86.5% were in NYHA class I or II. 6-minute-walking distance improved by 79m (p = 0.009). Kansas City Cardiomyopathy Questionnaire (KCCQ) improved by 19 points (p = 0.012). NT-proBNP levels decreased from 4832 to 2137 pg/dl (p = 0.003). Mean pulmonary capillary wedge pressures improved from 21 to 15mmHg (p = 0.001). At 5 month, a total of 3 patients died, none of cardiovascular cause. CONCLUSION: PASCAL Ace is safe and effective in treating MR, resulting in a sustained MR reduction, a reverse cardiac remodelling, improvement of exercise capacity, quality of life, NT-proBNP levels and hemodynamics at follow-up.

Impact of Rhythm vs. Rate Control in Atrial Fibrillation on the Long-Term Outcome of Patients Undergoing Transcatheter Edge-to-Edge Mitral Valve Repair.

Atrial fibrillation (AF) is a highly prevalent comorbidity in patients with severe mitral valve regurgitation (MR) undergoing transcatheter mitral valve repair (TMVR) and has been shown to significantly worsen their outcome. However, data on the impact of AF treatment strategy in this rapidly growing cohort of patients is unknown. In a multicenter, observational cohort study, 542 consecutive patients undergoing TMVR were enrolled, and subsequently, comprehensive survival analyses according to AF status and therapy were performed using propensity score matching and Cox regression. In the analyzed cohort, 373 (73.3%) of the TMVR patients had concomitant AF. Of these patients, 212 (59%) were on rate control therapy and 161 (41%) were on rhythm control therapy. At 3 years, significantly reduced cumulative survival was observed for patients on rhythm compared to patients on rate control (46.7% (75/161) vs. 56.5% (91/161), p = 0.032). Amiodarone was used to a substantial extent for rhythm control and found to be an independent mortality predictor (Hazard Ratio 1.5, 95%CI 1.1-2.1, p = 0.04). The adverse outcome of concomitant AF in TMVR patients was confirmed (AF: 47.3% (126/266) vs. non-AF: 58.3% (78/133), p = 0.047). Rhythm control achieved almost exclusively pharmacologically is associated with an adverse outcome compared to the rate control of AF in TMVR. This raises awareness of the importance of AF and its treatment, as this seems to be a promising key point for improving the prognosis of TMVR patients.

Functional and hemodynamic results after transcatheter mitral valve leaflet repair with the PASCAL device depending on etiology in a real-world cohort.

BACKGROUND: The PASCAL system (Edwards Lifescience, Irvine, CA, USA) is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of our study was to examine the functional and hemodynamic outcome after repair of functional (FMR) and degenerative mitral regurgitation (DMR) using the PASCAL system in a real-world setting. METHODS: A total 92 consecutive patients with symptomatic MR 3+/4+ were treated in our institute using the PASCAL device. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days and 7 months. RESULTS: 68.5% had a functional and 31.5% a degenerative etiology. Overall success rate was achieved in 97.8% patients (98.4% FMR, 96.6% DMR). At follow-up, 85.7% of the patients (89.2% FMR, 78.3% DMR) had MR grade ≤ 1. 96.4% (97.4% FMR, 94.4% DMR) were in New York Heart Association class I or II. Six-minute walking distance improved by 96 m (92 m FMR, 106 m DMR), Kansas City Cardiomyopathy Questionnaire improved by 19 points (19 points FMR, 19 points DMR). Pro-B-type natriuretic peptide (proBNP) levels decreased from 4673 to 2179 pg/dl (5239-2018 pg/ml FMR, 3418-2530 pg/ml DMR) and mean pulmonary capillary wedge pressure from 21 to 16 mmHg (21-17 mmHg FMR, 19-13 mmHg DMR). At 30 days, there was 1 cardiovascular death (1.2%) with DMR. At 1 year, Kaplan-Meier survival was 86% (86% FMR, 86% DMR). CONCLUSIONS: Severe MR can successfully and safely be treated with the PASCAL device regardless of etiologies. This interventional approach resulted in a sustained MR reduction, improvement in exercise capacity, quality of life, proBNP levels, and hemodynamics in FMR and DMR at follow-up.

Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device.

AIMS: To examine the functional and hemodynamic mid-term outcome at 5 months of mitral regurgitation (MR) reduction using the PASCAL repair system. METHODS AND RESULTS: Between July 2019 and February 2020 31 consecutive patients with MR 3 +/4 + (mean age 77.5 years, all in New York Heart Association (NYHA) class III-IV, STS score 9.1 ± 7.4) underwent MR reduction in our institute using the PASCAL device. 61.3% had a functional, 29.0% a degenerative, and 9.7% a mixed etiology. Successful implantation was achieved in 30/31 (96.8%) patients. 27/31 patients (87.1%) completed 5-month follow-up with clinical, echocardiographic, laboratory and hemodynamic assessment. At 5 months, 70.4% of the patients had MR grade ≤ 1 (p < 0.001). 85.2% were in NYHA class I or II (p < 0.001). Six-minute walk distance improved by 145 m (p = 0.010), Kansas City cardiomyopathy questionnaire and European quality of life 5 dimensions questionnaire (EQ5D) improved by 31 (p < 0.001) and 9 points (p = 0.001), respectively. Mean pulmonary capillary wedge pressure decreased significantly from 22.1 ± 9 mmHg to 17.3 ± 8 mmHg (p = 0.041) and right atrial pressure from 10.3 ± 6 mmHg to 8.0 ± 6 mmHg (p = 0.013) from baseline to 5 months. In addition, propensity score matching showed that PASCAL and MitraClip procedures resulted in equally hemodynamic and functional improvement. CONCLUSION: MR reduction of severe MR with the PASCAL device is feasible and safe regardless of etiologies. Mid-term follow-up at 5 months showed a sustained MR reduction, improvement of exercise capacity, quality of life, proBNP levels and hemodynamics regarding pulmonary capillary wedge pressure and right atrial pressure.

Concomitant transapical mitral valvuloplasty and CentriMag assist device placement: in a "no-option" patient.

Left ventricular assist devices and percutaneous valve interventions have radically changed the treatment of advanced heart disease and minimized surgical morbidity in patients with end-stage heart failure who would not survive conventional surgery. We describe a successful approach to the simultaneous placement of a percutaneous left ventricular assist device and mitral valvuloplasty in a decompensated patient with end-stage ischemic cardiomyopathy, severe peripheral arterial disease, porcelain aorta, and severe mitral and aortic disease.