The 2-year outcomes of the transcatheter mitral valve repair system PASCAL have shown high survival and low rehospitalization rates, and durable reduction of mitral valve regurgitation.
These results were provided by the CLASP trial, presented during the EuroPCR scientific sessions and simultaneously published in JACC: Cardiovascular Interventions.
The PASCAL system (Edwards) has been authorized for research protocols only in the US.
At present, patients are being enrolled to the CLASP IID/IIF, set to test the PASCAL against the MitraClip in patients with both functional and degenerative MR.
If it lives up to its promise, the PASCAL is likely to be authorized by the FDA for use in the clinical arena.
There are several differences between devices: one is the ability to treat one leaflet after the other, or in tandem. 4th generation MitraClips will offer the same characteristic.
Read also: Very Short Dual Antiplatelet Therapy after Complex PCI.
The CLASP trial included 124 patients with significant mitral valve regurgitation (≥ 3+) and functional class II to IV who made good candidates for edge-to-edge repair.
69% of the population had functional mitral valve regurgitation and 60% were in functional class III-IV. Outcomes at 30 days and one year were presented at TCT 2020 and simultaneously published in JACC: Cardiovascular Interventions.
The new outcomes were presented at the EuroPCR; 48 patients that completed the 2 year follow up with 72% survival rate in the functional group and 94% in the degenerative group. 78% of patients presented mitral regurgitation ≤1+, which was accompanied by improved end diastolic volume and functional class.
Original Title: Durable reduction of mitral regurgitation after 2 years: another ace up the TMVR sleeve.
Reference: Georg Goliasch et al. JACC Cardiovasc Interv. 2021 May 7;S1936-8798(21)00822-0. Online ahead of print. doi: 10.1016/j.jcin.2021.04.047. Presentado simultáneamente en el EuroPCR.
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