The PASCAL IID Registry: A prospective registry for transcatheter edge-to-edge repair in prohibitive risk patients with degenerative mitral regurgitation and complex mitral valve anatomy

Reported from TCT 2022

Alex Sticchi provides his take on the PASCAL IID Registry and an initial comparison with the CLASP IID. The trial was presented by Jörg Hausleiter during TCT Congress 2022.

PASCAL System (Edwards Lifesciences) for transcatheter edge-to-edge (TEER) reported exciting results at the TCT 2022 with important studies. First, the CLASP IID randomized trial directly compared the PASCAL versus the MitraClip system, showing noninferiority.

The PASCAL IID Registry presented by Prof Hausleiter is interesting due to its future implications. This study is a prospective registry for transcatheter edge-to-edge repair in prohibitive risk patients with degenerative mitral regurgitation (DMR) and complex mitral valve anatomy.

This study represents the registry arm of the CLASP IID trial after the exclusion for anatomical criteria from the main study in the selection process due to MitraClip instruction for use and the criteria of the 2021 “Consensus Document on Non-Suitability for Transcatheter Mitral Valve Repair by Edge-to-Edge Therapy”[1].

The PASCAL IID included 98 patients with prohibitive surgical risk patients with significant symptomatic DMR (MR 3+/4+) and complex mitral valve anatomy, with a mean age of 81.8 years, 61.2% male, mean STS score of 4.6, and 69.4% presenting atrial fibrillation.

The 15.3% of patients had two criteria of anatomical complexity, and the more common criteria were the presence of at least two independent significant jets (30.1%), a mitral valve orifice area <4.0 cm2 (15.9%), bileaflet/multiscallop prolapse involvement (15.0%).

The study reported a procedural success of 92.9%, a procedural time of 111.0 minutes with a device time of 79.5 minutes. Comprehensibly, the timing of the procedure resulted as numerically higher compared to the most favourable anatomy of the CLASP IID, and the procedural success was higher in the randomized trial (table). On the other side, the mean number of clips implanted per patient was 1.6, like the 1.5 with the PASCAL system and 1.6 with the MitraClip of the CLASP IID. Similarly to the main trial, the total mean length of stay was 1 day.

In terms of safety, the rate of major adverse events was 11.2%, driven by 7.1% of severe bleeding, including major, extensive, life-threatening or fatal bleeding, according to the MVARC criteria. It is possible that the complexity of the valve is reflected in the higher clinical risk and challenging vascular access causing an increase in bleedings compared to the CLASP IID PASCAL arm. The survival rate was similar in both studies.

Regarding procedure efficacy, the follow-up at 6 months showed 92.4% of patients with MR ≤ 2+ and 56.1% with MR ≤ 1+. If the residual MR grade is not so far from the CLASP IID for the MR ≤ 2+, it is considerably distant considering the group with MR ≤ 1+ (table).

Finally, regarding symptom improvement, the rate of patients in NYHA class II/II moved from 31.6% to 84.2% (p<0.001). A comparable favourable result was reported in the improvement of the Kansas City Cardiomyopathy Questionnaire (mean points from 57 to 72 points; p<0.001).

In conclusion, PASCAL IID showed beneficial outcomes in terms of safety and efficacy in prohibitive risk DMR patients with complex mitral valve anatomy. This study opens to a further expansion of treatment options using TEER.

References

Lim DS, Herrmann HC, Grayburn P, Koulogiannis K, Ailawadi G, Williams M, Ng VG, Chau KH, Sorajja P, Smith RL, Guerrero M, Daniels D, Granada JF, Mack MJ, Leon MB, McCarthy P. Consensus Document on Non-Suitability for Transcatheter Mitral Valve Repair by Edge-to-Edge Therapy. New Pub Elsevier. 2021;5:227–33.

Also read the analysis of CLASP IID with an interview of Scott Lim and Konstantinos P. Koulogiannis