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Resheathable TAVR system shows promise in symptomatic severe aortic stenosis
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A novel transcatheter aortic valve replacement system demonstrates safety and efficacy in the treatment of high-risk patients with symptomatic severe aortic stenosis, enabling safe repositioning and position optimization, according to recent findings.
In the prospective, single-arm, multicenter study, researchers evaluated 100 patients (mean age, 84.1 years; 95% women, median Society of Thoracic Surgeons Predicted Risk of Mortality score, 5.6) at high surgical risk with NYHA class II or greater severe aortic stenosis.
Participants underwent transfemoral TAVR with the 18F system (Portico, St. Jude Medical), using either a 23-mm (n = 50) or 25-mm valve (n = 50). Participants were seen for follow-up at 30, 90 and 180 days, and at 1 year. Valve Academic Research Consortium definitions were used to categorize adverse events, which were adjudicated by an independent events committee. Patients were assessed through echocardiography and underwent neurological evaluation at baseline, post-TAVR, 30 days and 1 year.
The primary endpoint was 30-day all-cause mortality.
Implantation successful
Ganesh Manoharan, MD, of the Royal Victoria Hospital in Belfast, United Kingdom, and colleagues found that the TAVR system achieved an overall device success rate (defined as successful access, delivery and deployment of one valve) of 92.5%.
At 30 days, the rate of mortality was 2.9% (n = 3). Two deaths were from CV causes and one patient died from hospital-acquired pneumonia.
The 30-day rate of disabling stroke was 2.9%, with two strokes occurring within 24 hours and one occurring 24 days after TAVR.
The 30-day rate of major vascular complications was 5.9%.
In the 24 patients (23.8%) for whom the valve was resheathed to optimize positioning, all procedures were successful, according to the researchers. Four patients required a second valve.
The majority of patients experienced improvements in symptoms after undergoing TAVR with the transfemoral delivery system. Improvement by at least one NYHA class was achieved in 75.3%, and improvement by at least two NYHA classes was achieved in 25.9% of patients, according to the researchers. An improvement in 6-minute walk distance was also seen, increasing from 174 m at baseline to 195.7 m at 30 days.
Serious paravalvular leak low
At 30 days, the rate of no or trace paravalvular leak was 30.4%; the rate of mild paravalvular leak was 65.8%; and the rate of moderate paravalvular leak was 3.8%. An improvement was seen in mean gradient across the aortic valve (from 45.3 mm Hg to 8.9 mm Hg; P < .0001) and valve area increased after TAVR (from 0.6 cm2 to 1.7 cm2; P < .0001), the researchers wrote.
Implantation of a permanent pacemaker was required in 9.8% of patients. No statistical difference was observed in the depth of implant between patients who required a permanent pacemaker post-TAVR with the transfemoral delivery system and those who did not.
“This study demonstrates that the 23 and 25 mm Portico valves are safe and efficacious at treating high-risk symptomatic patients with severe aortic stenosis,” Manoharan and colleagues wrote. “The overall mortality and stroke rates at 30 days were low at 2.9% each. Although the study size is small, the 30-day mortality results appear favorable when compared with early-generation and newer-generation [TAVR] devices.” – by Jennifer Byrne
Disclosure: The study was funded by St. Jude Medical. Manoharan reports receiving consultant fees and honoraria from Boston Scientific, Medtronic and St. Jude Medical. Please see the full study for a list of the other researchers’ relevant financial disclosures.
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