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Third-generation transcatheter heart valve improves on deficiencies of earlier valves
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A third-generation transcatheter heart valve addresses issues with earlier valves and was associated with improved ease of use, accuracy of positioning and paravalvular sealing, according to a new report.
Researchers conducted a study to evaluate whether transcatheter aortic valve replacement with the third-generation Sapien 3 device (Edwards Lifesciences) is a viable alternative to high- or intermediate-risk surgery for patients with severe aortic stenosis.
“The Sapien 3 transcatheter valve incorporates features designed to address the well-known deficiencies of TAVR. An ultra–low-profile delivery system facilitates safe, controlled and accurate implantation and an external seal minimizes paravalvular regurgitation,” researchers wrote.
The study included 150 patients with severe aortic stenosis and multiple comorbidities (mean age, 83 years; mean Society of Thoracic Surgeons score, 7.4%; mean logistic EuroSCORE, 21.6%). Patients were enrolled at 16 centers in Canada and Europe.
The researchers evaluated clinical and echocardiographic outcomes at baseline, post-procedure and 30 days. Of note, new sizing recommendations for the device were developed while the study was underway.
A transfemoral approach was utilized in 64% of patients, whereas a transapical or direct aortic approach was used in the others.
Results at 30 days indicated that 96.4% of patients had no or mild paravalvular regurgitation and 3.5% had moderate regurgitation. No severe regurgitation was reported.
Transfemoral access was associated with a mortality rate of 2.1% and a disabling stroke rate of 0%. This approach also was associated with fully percutaneous access and closure in 95.8% of patients. Nontransfemoral alternative access was associated with a mortality rate of 11.6% and a disabling stroke rate of 5.6%.
“The low-profile delivery system permits safe and fully percutaneous arterial access in the majority of patients. The low rates of mortality, stroke, vascular complications and paravalvular regurgitation achieved with transfemoral access are among the lowest reported to date and support further evaluation of this new device as an alternative to surgery in intermediate-risk patients,” the researchers concluded.
Disclosure: The researchers report financial relationships with several device and pharmaceutical companies, including Edwards Lifesciences.
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