PASCAL in Tricuspid Regurgitation with Encouraging Results

Courtesy of Dr. Carlos Fava.

Tricuspid regurgitation (TR) is associated with higher mortality and morbidity, and it most frequently has a functional cause.

Furthermore, it has been proven that tricuspid surgery has mortality rates between 8% and 20%. On the other hand, it has been verified that, in the case of left-sided disease affecting the tricuspid valve, treating both pathologies improves the prognosis.

It has also been proven that, when patients receiving MitraClip for the mitral valve also have severe tricuspid disease and are treated with the device, their prognosis improves.

This study included 28 patients with TR and high risk for surgery who underwent treatment with the PASCAL repair system (Edwards Lifesciences, Irvine, California).

Read also: More Evidence on Tricuspid Valve Repair.

Their mean age was 78 years, over half of the patients were women, and their New York Heart Association (NYHA) functional class was III in 25 cases and IV in the remaining 3. Their aetiology was functional in 23 cases, degenerative in 2 cases, and mixed in the other 3. The Society of Thoracic Surgeons (STS) mortality score was 4.6% and the EuroSCORE II was 6.2%. TR was 5+ in 12 patients, 4+ in 9 patients, and 3+ in 9. The ejection fraction was 58%, the tricuspid annular diameter was 49.5 mm, and the coaptation gap was 6.9 mm.

Procedural success was 86%, with 1.4 implanted devices/patient; there were no complications during the procedure.

At 30 days, 2 patients had died (7.1%). Almost 90% of patients were in NYHA functional class I-II and had experienced significant improvement in relation with the six-min walk distance test. TR presence was ≤2 in 85% of patients, and there was evidence of favorable right ventricular remodeling.

Conclusion

This analysis is the first experience evaluating the PASCAL system in tricuspid regurgitation, and it demonstrated high procedural success, acceptable safety, and clinical improvement. Studies with longer follow-up are needed to confirm these initial encouraging results.

Courtesy of Dr. Carlos Fava.

Original Title: Compassionate Use of the PASCAL Transcatheter Valve Repair System for Severe Tricuspid Regurgitation A Multicenter, Observational, First-in-Human Experience.

Reference: Neil P. Fam. (J Am Coll Cardiol Intv 2019; 12:2488–95).

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