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Acute and Short-term Results of MitraClip XTR vs. PASCAL Transcatheter Valve Repair System for Edge-to-Edge Repair of Severe Tricuspid Regurgitation

ABSTRACT Background Novel device developments enable the edge-to-edge treatment of inoperable patients with severe tricuspid regurgitation (TR) and large coaptation gaps. We compared the acute and short-term results of patients treated with the MitraClip XTR vs. PASCAL system. Methods We retrospectively analyzed 120 patients (72 pts. MitraClip XTR, 48 pts. PASCAL) treated for isolated severe TR on a compassionate-use basis. Results Mean patient age was 77 ± 8 years and the LaPar risk score was 6.7 ± 1.7%. Patients in the PASCAL group had a larger coaptation gap and a trend to more severe TR. Procedural success (TR ≤ 2) was achieved in 92% of patients in each group (XTR group: 66/72, PASCAL group: 44/48). Thirty-day follow-up was available in 94% of patients. Two patients in the PASCAL group and one patient in the MitraClip XTR group died within 30-days of the procedure. Device complications were observed in 15.3% of patients in the XTR group and in 10.4% of patients in the PASCAL group. There was a trend for a more pronounced reduction of vena contracta width in the PASCAL group compared to the XTR group. Tricuspid repair was associated with a comparable improvement in New York Heart Association (NYHA) functional class and 6-minute walking distance in both groups. Conclusion The PASCAL and the MitraClip XTR system appeared to be highly efficacious in treating patients with severe TR with a comparable rate of device complications in both groups but a trend for a more pronounced reduction of vena contracta width in the PASCAL group. Abbreviations CABG: Coronary artery bypass graft, EROA: Effective regurgitant orifice area; ICD: Implantable cardioverter-defibrillator, LVEF: Left ventricular ejection fraction. MACCE: Major adverse cardiac and cerebrovascular events; MLHFQ: Minnesota Living With Heart Failure Questionnaire; MR: Mitral regurgitation; NYHA: New York Heart Association; RV/RA gradient: Right ventricular/right atrial gradient. SLDA: Single leaflet device attachment; STVR: Surgical tricuspid valve repair; TR: Tricuspid regurgitation