At present, we are well aware of the rise in mortality caused by severe tricuspid regurgitation (TR). Medical and surgical treatments have turned out to be suboptimal. Hence, endovascular intervention presents as an alternative therapeutic strategy with promising results.
The aim of this multicenter, prospective study was to assess the safety and efficacy of the PASCAL transcatheter tricuspid valve repair system.
Primary end point was a composite of major cardiovascular events (MACE) at 30 days. Patients were followed up at 6 months, one, and five years. MACE included cardiovascular death, AMI, stroke, need of dialysis, severe bleeding, access site complications and device related intervention.
It included 65 patients, mean age 77, mostly women (55%). STS score was 7.7%. Most patients were in functional class III/IV, 89% presented atrial fibrillation, 68% CABG or mitral valve replacement history and 14% had permanent pacemaker.
Implantation success rate was 91%, while procedural success was 88%. The number of devices needed per patient was mostly 1 (46%) followed by 2 (41%).
Read also: EuroPCR 2022 | The MITRA TUNE Registry.
After one year, 86% presented moderate TR or lower. Functional class also improved.
Primary end point resulted 3.1% at 30 days and 16.9% at 1 year. Cardiovascular mortality was 3.1% and 7.7% respectively. There was 56% reduction in rehospitalization for cardiac failure.
Conclusion
At 1 year, transcatheter tricuspid valve repair with PASCAL was shown safe and effective. There was significant reduction of TR, with improved functional class and quality of life. This study is still ongoing.
Dr. Andrés Rodríguez
Member of the Editorial Board of SOLACI.org.
Original Title: Transcatheter tricuspid valve repair: CLASP TR study one year results.
Reference: Rebecca Hahn et al. EUROPCR.
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