Klinische und hämodynamische Effekte einer Transkatheter Mitralklappenrekonstruktion mit dem PASCAL©-System bei Patient:innen mit hochgradiger Mitralklappeninsuffizienz in Abhängigkeit von der Ätiologie der Insuffizienz
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Philipps-Universität Marburg
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Abstract
The chronic MR is the second most common valvular disease in Europe and western countries. According to etiology, there are two different forms of MR: primary or degenerative mitral regurgitation (DMR) and secondary or functional mitral regurgitation (FMR). Both forms (FMR and DMR) can interfere with each other in the chronic course. As a result, a special form of MR with mixed etiology may develop in some cases. The chronic severe MR induces a progressive pulmonary hypertension in addition to a secondary tricuspid regurgitation, which in turn increases the pressure and volume overload on the right heart. The MR mortality could reach 10%/year in symptomatic patients with structural cardiac changes and other risk factors. Furthermore, both MR-mortality and hospitalisation increase significantly in older patients.
Due to prohibitive perioperative risk, conventional surgery as gold standard treatment for patients with severe MR is being differed by cardiac surgeons in about 50% of elderly patients with concomitant diseases. In the past two decades, transcatheter mitral valve therapy has become a valuable and established treatment option in those patients. Since then, there have been further developments for percutaneous mitral valve repair due to the inherent, dynamic and three-dimensional anatomical complexity of the mitral valve with different mechanisms of regurgitation. Among currently 5 different CE-certified catheter and hybrid techniques with corresponding systems for the treatment of MR, without conventional cardiac surgery, TEER „transcatheter edge to edge repair“ is the most widely used technology. TEER is adapting the free edges of anterior and posterior mitral valve leaflets by grasping them with a clipping device.
The MitraClip system (Abbott Vascular Evalve inc. Menlo Park, CA, USA) is the most widely used technology for percutaneous mitral valve leaflet repair. With the PASCAL system (Edwards Lifescience, Irvine, CA, USA), another new transcatheter valve repair system has been approved in 2019 for interventional treatment of MR. Both Systems MitraClip and PASCAL are implanted via transfemoral venous access with transseptal punction, and allow an independent grasping of anterior and posterior leaflet in order to ensure sufficient grasping of each leaflet in challenging anatomies.
The recent guidelines ESC/EACTS 2021 and ACC/AHA 2020 gave the TEER procedure for FMR an upgraded IIa recommendation. This upgrade was the result of the two randomised controlled trials MITRA-FR and COAPT, published in 2018. The TEER procedure also received IIa recommendation in the latest ACC/AHA and IIb recommendation in ESC/EASCT guidelines for the treatment of severe DMR with a prohibitive operational risk.
Because of their unique design, both PASCAL implant systems appear to be applicable in patients with complex morphological features beyond the EVEREST criteria and challenging complex anatomies in real world setting. First promising results have been reported in the prospective CLASP study treating patients with functional or degenerative MR (FMR/DMR). However, it is still unknown whether functional or degenerative etiologies can be equally treated with the PASCAL repair system in everyday clinical practice. Therefore, the aim of our study was to assess the hemodynamic effects, procedural and clinical outcome after TEER intervention of functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR) using the PASCAL - and PASCAL ace repair system in a real world setting.
Methods and results
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. 68.5% patients had a functional and 31.5% patients had 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. Altogether, 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).
Discussion
The analysis included patients with challenging complex pathologies of the mitral valve beyond the EVEREST criteria, representing the diversity in everyday care. It was striking that the number of patients with MR>2 in FMR group decreased over time. In contrast, in the DMR group more patients developed a MR>2 at follow-up and were nearly twice as much as in the FMR group. As a result of reduced volume overload of the left ventricle after PASCAL Implantation, there was a significant decrease in the end-diastolic LV diameter in FMR and DMR. A new finding was that MR reduction using the PASCAL repair system resulted in a significant decrease of the PCWPmean and PAPmean in the overall population at follow-up. These favorable effects could be observed in FMR as well as in DMR. Our results showed also a significant improvement in the functional capacity and in the quality of life, irrespective of the underlying MR-etiology. The limitations of our small, non-randomized and non-blinded retrospective single center study must be taken in account when interpreting the results.
Conclusions
Transcatheter mitral valve repair using the PASCAL-device was feasible and safe in reducing MR severity in patients with at least MR grade 3 +, irrespective of the underlying etiology in a real-world setting. In addition, we showed a sustained MR reduction with a consecutive improvement in clinical outcome and quality of life at follow-up. Moreover, successful MR reduction promoted an improvement of hemodynamics regarding PCWPmean and PAPmean after PASCAL -implantation in both etiologies. In FMR as well as DMR, MR reduction led to a reverse cardiac remodelling. The results of the ongoing prospective, multicenter and randomized CLASP IID/IIF pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the PASCAL system compared to MitraClip in patients with FMR and DMR are still awaited. Meanwhile, an interim analysis of the CLASP IID trial was published in September 2022, in patients with DMR and prohibitive surgical risk, PASCAL system met non-inferiority endpoints to the MitraClip system, in addition it has shown a better rate of sustained MR reduction at follow-up.
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Dates
Created: 2023Issued: 2023-11-15Updated: 2023-11-15
Faculty
Medizin
Publisher
Philipps-Universität Marburg
Language
ger
Data types
DoctoralThesis
Keywords
mitral valveMitralklappeKatheterinterventioncatheter interventionMIMitralinsuffizienzHerzinsuffizienzDMRmitral regurgitationTEERheart failurePASCALmitral valve repairMitralregurgitationFMR
DDC-Numbers
610
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Shalla, Alaa: Klinische und hämodynamische Effekte einer Transkatheter Mitralklappenrekonstruktion mit dem PASCAL©-System bei Patient:innen mit hochgradiger Mitralklappeninsuffizienz in Abhängigkeit von der Ätiologie der Insuffizienz. : Philipps-Universität Marburg 2023-11-15. DOI: https://doi.org/10.17192/z2023.0573.