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Perceval S Sutureless Valve for Aortic Valve Replacement: A Review of the Clinical Effectiveness, Safety, and Cost-Effectiveness

Last updated: January 29, 2015
Project Number: RC0625-000
Product Line: Rapid Response
Research Type: Devices and Systems
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the clinical effectiveness and safety of the Perceval S sutureless valve for patients requiring aortic valve replacement?
  2. What is the cost-effectiveness of the Perceval S sutureless valve for patients requiring aortic valve replacement?

Key Message

Based on preliminary results from single-arm studies and small non-randomized comparisons with alternative methods for valve replacement, sutureless valve implantation has a high initial success rate, with low rates of in-hospital death, strokes, endocarditis, and renal failure. Rates of paravalvular regurgitation and heart arrhythmias leading to pacemaker implantation are raised compared to standard surgical valve implantation. However, long-term evidence on valve stability, durability, and safety are lacking, and criteria for selecting the best procedure for patients who are also potential candidates for conventional surgery or TAVI.