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Multicenter Evaluation of a Next-Generation Balloon Expandable Transcatheter Aortic Heart Valve | Journal Scan
Study Questions:
What are the outcomes with a third-generation SAPIEN 3 transcatheter valve as compared to high- or intermediate-risk surgery for severe aortic stenosis?
Methods:
This prospective study enrolled 150 patients at 16 sites in Europe and Canada. Clinical and echocardiographic outcomes were assessed at baseline, post-procedure, and 30 days. New sizing recommendations were developed during the course of the study.
Results:
Patients were 83.6 ± 5.0 years old, with multiple comorbidities reflected by a Society of Thoracic Surgeons score of 7.4% ± 4.5% and logistic EuroSCORE of 21.6 ± 12.3%. A transfemoral approach was chosen in 64.0% and alternative access (transapical/direct aortic) in the remainder. At 30 days, paravalvular regurgitation was none to mild in 96.4% and moderate in 3.5%. No patient had severe regurgitation. Transfemoral implantation was associated with low mortality (2.1%), no disabling stroke (0.0%), and fully percutaneous access and closure in 95.8%. Non-transfemoral alternative access was associated with higher rates of mortality (11.6%) and stroke (5.6%).
Conclusions:
The authors concluded that this third-generation device addresses major deficiencies of earlier valves in terms of ease of use, accuracy of positioning, and paravalvular sealing.
Perspective:
This study reports that the third-generation SAPIEN 3 transcatheter valve addresses major deficiencies of earlier transcatheter valves in terms of ease of use, accuracy of positioning, and paravalvular sealing. The low-profile delivery system appears to permit 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 may support further evaluation of this new device as an alternative to surgery in intermediate-risk patients.
Keywords: Aortic Valve Stenosis, Canada, Comorbidity, Echocardiography, Heart Valve Prosthesis, Heart Valve Prosthesis, Europe, Heart Valves, Stroke
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