Tricuspid Regurgitation: Edge-to-Edge Treatment with PASCAL

About 4% of the population suffers from tricuspid regurgitation (TR). This disease is associated with hard-to-manage heart failure (HF)—often requiring hospitalization—and with mortality.

ATC sobre arterias nativas o puentes venosos, ¿cuál tiene mejor pronóstico?

Surgery in this valve is not simple and has high morbidity and mortality rates due to its comorbidities.

Currently, a percutaneous strategy for its resolution is under development, but we still do not have solid evidence to know its real benefit.

The PASTE registry (PASCAL for Tricuspid Regurgitation – A European Registry) included 235 patients with TR and high risk for surgery.

The chosen devices were PASCAL and PASCAL Ace.

Mean patient age was 78 years old, and 51% of subjects were male. Ninety-two percent had atrial fibrillation, 2% had undergone tricuspid valve surgery, 11% had undergone myocardial revascularization surgery (MCRS), 7% had had aortic valve replacement, 2% had undergone renal transplantation, and 92% had impaired renal function. The functional class for most patients was III-IV, 13% had ascites, one third had an implantable cardioverter-defibrillator (ICDD), and practically all of them were on diuretic drugs.

Their Society of Thoracic Surgeons (STS) score was 8.6%.

Eighty-seven percent of the TRs were functional, 91% were severe, massive or torrential; on average, the effective regurgitant orifice was 0.65 mm; the left atrial area was 39 mm; the right ventricular end-diastolic diameter was 54 mm; the inferior vena cava diameter was 24 mm; the pulmonary artery systolic pressure was 46 mmHg and their mean pressure was 29 mmHg.

Technical success was 98%, and in 78% of patients the reduction in TR was ≤2+. The number of devices implanted per patient was 1.7: 66% were implanted at the antero-septal level, and the gradient at discharge was 2.2 mmHg. Only one patient required surgery and six experienced device disconnection from one of the leaflets. Success rate for patients with ICDD was 98%.

Mortality at 30 days was 1.6%.

At the 6-month follow-up, the rate for mortality was 12%, for rehospitalization for HF was 13%, and the average for HF hospitalization since the index procedure was 105 days.

There was a significant improvement in the functional class and the quality of life, as well as in the results of the 6-minute walk test.

In addition, there was a significant reduction in right ventricular end-diastolic diameter in the right atrium area and inferior vena cava, and a reduction in TR ≤2+ in 78% of patients.

There was no difference in the results between the PASCAL and PASCAL Ace devices.

Conclusion

In this initial experience, the PASCAL and PASCAL Ace devices had high technical and procedural success rates, with efficient reduction of tricuspid regurgitation. They also showed significant clinical and echocardiographic improvement at follow-up.