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


( Last Updated : January 29, 2015)
Project Line:
Health Technology Review
Project Sub Line:
Summary with Critical Appraisal
Project Number:
RC0625-000

Details


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.