SELECT-AV: Self-Expandable Valves Show Non-Inferiority to Balloon-Expandable in TAVR
Key Insights
A randomized trial, SELECT-AV, compared self-expandable (SE) and balloon-expandable (BE) valves in transcatheter aortic valve (search) replacement (TAVR).
The study demonstrated non-inferiority of SE valves compared to BE valves regarding a composite endpoint of all-cause mortality, stroke (search), or rehospitalization at one year.
General anesthesia was found to be non-inferior to local anesthesia in patients undergoing TAVR, indicating flexibility in anesthesia management.
The SELECT-AV trial, a 2x2 randomized study, has provided valuable insights into the comparative effectiveness of self-expandable (SE) and balloon-expandable (BE) valves in patients undergoing transcatheter aortic valve (search) replacement (TAVR). The trial also examined the impact of general versus local anesthesia on patient outcomes.
The study's primary objective was to determine whether SE valves were non-inferior to BE valves with respect to a composite endpoint of all-cause mortality, stroke (search), or rehospitalization at one year. The results indicated that SE valves met the criteria for non-inferiority, suggesting they are a viable alternative to BE valves in TAVR procedures. This finding provides clinicians with more options when selecting the most appropriate valve type for individual patients.
In addition to valve type, the trial investigated the effect of anesthesia type on patient outcomes. Patients were randomized to receive either general or local anesthesia during the TAVR procedure. The study found that general anesthesia was non-inferior to local anesthesia for the same composite endpoint, indicating that the choice of anesthesia does not significantly impact patient outcomes. This offers greater flexibility in anesthesia management during TAVR procedures.
The SELECT-AV trial's findings contribute to the growing body of evidence supporting the safety and efficacy of TAVR. The demonstration of non-inferiority for both SE valves and general anesthesia provides clinicians with valuable information to optimize patient care and procedural approaches. Further research may explore specific patient subgroups that may benefit more from one valve type or anesthesia approach over another.