CADTH | Evidence Driven
CADTH | Evidence Driven

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

Details

Files
Project Line:
Health Technology Review
Project Sub Line:
Summary with Critical Appraisal
Project Number:
RC0625-000

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.


Files

Perceval S Sutureless Valve for Aortic Valve Replacement: A Review of the Clinical Effectiveness, Safety, and Cost-Effectiveness Rapid Response January 29, 2015 View PDF
Last Updated : January 29, 2015