Reuters Health – 04/02/2021 – Ongoing research suggests it is feasible to use the PASCAL transcatheter valve-repair system to treat patients with severe symptomatic tricuspid regurgitation (TR).
The condition is increasingly prevalent and reduces both survival and quality of life, said Dr. Susheel Kodali of Columbia University Medical Center in New York City.
“Surgery for tricuspid regurgitation remains a highly morbid surgery with significant mortality risk,” he told Reuters Health by email. “There is no approved transcatheter therapy for TR, but several devices including PASCAL have shown promise in early studies in reducing TR and improving clinical symptoms with a much less morbid procedure than surgery.”
In a new paper in the Journal of the American College of Cardiology, Dr. Kodali and his colleagues report 30-day results from 34 enrolled patients. Their average age was 76 years, 88% had atrial fibrillation/flutter and 94% had systemic hypertension. Other comorbidities included pulmonary hypertension, renal insufficiency and diabetes.
The device was successfully implanted in all 29 patients in whom implantation was attempted. Procedural and clinical success could not be assessed in four patients due to unreadable or missing transesophageal echocardiography.
Eighty-five percent of patients had at least a one-grade reduction in TR, and 70% had at least a two-grade reduction. There were significant improvements in New York Heart Association functional status and other measures.
The composite major adverse event rate at 30 days was 5.9%. There was no cardiovascular mortality and there were no re-interventions.
Altogether, say the researchers, use of the repair system resulted in significant improvement in functional status and exercise capacity. Moreover, “the consistent reduction in TR, with right ventricular remodeling and increased forward stroke volume and annular dimensions, was associated with a consistent improvement in quality-of-life measures.”
In an accompanying editorial, Dr. Anita W. Asgar of Montreal Heart Institute, in Quebec, Canada, observes that “transcatheter technologies have demonstrated safety and feasibility, but what remains is likely the most difficult: knowing who, when, and how to treat to achieve the clinical benefit that we are searching for. The solution will be found in thoughtfully designed clinical trials that are powered to give us the answers we need.”
The study was funded by Edwards Lifesciences, which makes the PASCAL system. Dr. Kodali has ties to the company as do other authors, some of whom are employees.
SOURCE: https://bit.ly/3aaTGQw and https://bit.ly/2MdNBL2 The Journal of the American College of Cardiology, online January 25, 2021.
By David Douglas
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