Original title: Multicenter Evaluation of a Next-Generation Balloon-Expandable Transcatheter Aortic Valve. Reference: John Webb, et al. J Am Coll Cardiol 2014;64:2235-43

Percutaneous aortic valve replacement is starting to be a reasonable alternative in patients at intermediate risk. One hundred and fifty patients who received SAPIEN 3rd generation percutaneous aortic valve implantation were analyzed prospectively. The STS score of the population for mortality was 7.4 ± 4.5%, the EuroSCORE log 21.6 ± 12.3 and EuroSCORE 26.2 ± 5.5. Femoral access was used in 96 of patients. One different to femoral (transapical or direct aortic) at 54; this last group had significantly more moderate to severe mitral insufficiency, peripheral vascular disease, previous heart attack and EuroSCORE log score.

During the procedure, one patient (0.7%) had bad valve position requiring conversion to surgery. A 30-day, mortality was 2.1% in which it was performed by femoral access and 11.1% in those who received a different access than femoral (p = 0.03), also the risk of stroke was higher in the transaortic / apical group but did not reach statistical significance (1% versus 5.6%; p = 0.13). The need for pacemaker was 13.3%.There were no coronary blockage, device embolization or re-hospitalization. An improvement in functional class, quality of life and 6 minutes test in all patients was observed. Paravalvular regurgitation was absent in 74%, resulted mild in 22%, moderate 3.5% and in no case was severe.

Conclusion

This third generation valve has better positioning and paravalvular sealing. The mortality rate and stroke by femoral access is lower than reported and gives support as valid alternative surgery in patients at intermediate risk.

Comment

The development of new generations devices are beginning to show that it is feasible and safe to extend its indication to patients with lower risk. The femoral access, as in other studies, proves to be better, which actually translates that patients have fewer comorbidities. Surely, the development of smaller devices will reduce the need to use different approaches than femoral.

Courtesy Dr. Carlos Fava
Interventional cardiologist
Favaloro Foundation
Buenos Aires Argentina

Carlos Fava