Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30-day results.

BACKGROUND: Severe tricuspid regurgitation (TR) is independently associated with increased morbidity and mortality. Percutaneous transcatheter approaches may offer an alternative for patients not amenable to surgery. METHODS: TriCLASP is a prospective, single-arm, multicenter European post-market clinical follow-up study (NCT04614402) to evaluate the safety and performance of the PASCAL system (Edwards Lifesciences) in patients with severe or greater TR. At 30 days, a composite of major adverse events (MAEs) adjudicated by a clinical events committee, echocardiographic parameters adjudicated by core laboratory, and clinical, functional, and quality-of-life measures were evaluated. RESULTS: Mean age of the 74 enrolled patients was 80.3 years, with 58.1% female, 90.5% systemic hypertension, and 77.0% in New York Heart Association (NYHA) class III/IV. Mean Society for Thoracic Surgeons score (MV repair) was 9.0%. TR severity was significantly reduced at discharge (p < 0.001) and sustained at 30 days (p < 0.001), and 90.0% of patients achieved ≤moderate TR. The composite MAE rate at 30 days was 3.0%, including 4 events in 2 patients: cardiovascular mortality 1.5%, stroke 1.5%, renal complications requiring unplanned dialysis or renal replacement therapy 1.5%, and severe bleeding 1.5%. There were no nonelective tricuspid valve reinterventions, major access site and vascular complications, major cardiac structural complications, or device embolizations. NYHA class I/II was achieved in 55.8%, 6-minute walk distance improved by 38.2 m (p < 0.001), and Kansas City cardiomyopathy questionnaire scores improved by 13.4 points (p < 0.001). CONCLUSION: Experience with the PASCAL transcatheter valve repair system in a European post-market setting confirms favorable safety and effectiveness at 30 days. TR significantly reduced, and clinical, functional, and quality-of-life outcomes significantly improved. This study is ongoing. Clinical Trial Registration: The study is ongoing and registered on ClinicalTrials.gov as NCT04614402. The current analysis is an interim report.

[Cardioband®: Where do we stand, who are suitable patients?] / Cardioband®: Wo stehen wir, was sind geeignete Patienten?

Functional mitral regurgitation (FMR) is characterized by a dilatation of the mitral valve annulus resulting in an insufficient adaptation of the anterior and posterior mitral valve leaflets and/or severe tethering of the leaflets due to dilatation of the left ventricle. The Cardioband® system was introduced in 2015 and is a catheter-based direct mitral valve annuloplasty procedure for treatment of FMR. In the European CE approval study 60 patients with moderate or severe FMR were analyzed per protocol. There were no device or procedure-related deaths. The technical success rate of the procedure, defined as successful implantation and tightening was 97%. At 1 year, the overall survival and survival free of hospital readmission for heart failure were 87% and 66%, respectively. Currently, various interventional treatment procedures are available, such as the edge-to-edge technique as well as direct and indirect annuloplasty. In summary, patients with FMR as a result of a dilatation of the mitral valve annulus appear to be suitable for direct annuloplasty with the Cardioband® system.