Key result
PASCAL and MitraClip XTR achieve ~92% procedural success for severe TR with comparable short-term complications.
Why the study?
Novel device developments enable edge-to-edge repair of severe tricuspid regurgitation, prompting a comparison of acute and short-term outcomes between the MitraClip XTR and PASCAL systems.
Does the PASCAL system compared to the MitraClip XTR system improve procedural success and short-term outcomes in patients with severe tricuspid regurgitation?
Cohort (n=120)
Does the PASCAL system compared to the MitraClip XTR system improve procedural success and short-term outcomes in patients with severe tricuspid regurgitation?
Absolute Event Rate: 92% vs 92%
Both the PASCAL and MitraClip XTR systems are highly efficacious for treating severe tricuspid regurgitation, yielding comparable procedural success and short-term clinical improvement.
Comparable procedural success with PASCAL and XTR in severe TR; leaves open whether randomized trials confirm long-term equivalence.
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
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Löw et al. (2021) conducted a cohort in Severe tricuspid regurgitation (n=120). MitraClip XTR vs. PASCAL system was evaluated on Procedural success (TR ≤ 2). Edge-to-edge repair using the MitraClip XTR or PASCAL system achieved procedural success in 92% of patients with severe tricuspid regurgitation, with comparable short-term complication rates.