The PASCAL Transcatheter Valve Repair System has continued to perform well as a tool for treating tricuspid regurgitation (TR), according to new findings published in the Journal of the American College of Cardiology.
The solution, manufactured by Edwards Lifesciences, gained CE mark approval in 2020 and is available in Europe. In the United States, it is not yet available to the public.
For this latest analysis, researchers explored 30-day data from the ongoing CLASP TR Early Feasibility Study. The team emphasized the importance of studying TR, describing it as “an increasingly prevalent valve disorder seen with aging populations.”
“Contemporary natural history and outcomes studies have consistently shown that greater TR severity is associated with increased mortality when most patients do not undergo surgical repair,” wrote lead author Susheel K. Kodali, MD, of Columbia University Medical Center in New York City, and colleagues. “Currently, there are no Class I indications for surgical repair of isolated TR, and medical therapy is limited to diuretic agents and symptom management. Given its high prevalence, adverse prognosis, symptom burden, and direct association with progressive right heart failure, TR represents an important unmet treatment need.”
The study included 34 patients with a mean age of 76 years old. Patients were treated at one of seven U.S. investigational sites from February to October 2019, and each individual was specifically determined to be an appropriate candidate for transcatheter tricuspid repair by their doctors.
While 53% of patients were women, 79.4% were in New York Heart Association (NYHA) functional class III or IV. Common comorbidities among study participants included atrial fibrillation/flutter (88.2%) systemic hypertension (94.1%), pulmonary hypertension (67.6%), renal insufficiency (44.1%) and diabetes (11.8%). Also, 47.1% of patients had prior hospitalizations for heart failure-related issues.
Overall, the authors found, the PASCAL repair system has been working as it was intended. Five study participants, it should be noted, ultimately did not have a device implanted. The mean length of stay was 2.5 days.
After 30 days, 85% of patients that received an implant experienced a TR severity reduction of at least one grade. The major adverse event rate was 5.9%, and no patients experienced cardiovascular death, stroke, myocardial infarction, renal complications or reintervention. Also, 89% of patients saw improvements in their NYHA functional class.
“At 30 days, this repair system resulted in significant functional status, exercise capacity, and quality-of-life improvements,” the researchers concluded, though they did note that their study included a “relatively small number of patients.”
Read the full study here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.