Original title: Trends in outcome after transfemoral transcatheter aortic valve implantation. Pooled-RotterdAm-Milano-Toulouse In Collaboration Plus (PRAGMATICPlus) initiative. Reference: Nicolas M. Van Mieghem et al. Am Heart J 2012;0:1-10. Article in press.
Since its introduction in 2002, Transfemoral Transcatheter Aortic Valve Implantation (TAVI) has turned into a viable and safe strategy to treat patients with severe acute stenosis and high surgical risk, which paved its way into the European guidelines for valvulopathy treatment.
Better devices and better experience should produce better outcomes. However, this has not yet been demonstrated. 944 consecutive patients were enrolled in 3 thirds according to procedure date. Baseline characteristics of all 3 cohorts were balanced using a multivariate logistic regression model, which brought 642 patients to final analysis. Valve Academic Research Consortium (VARC) definitions were used to determine the technical and clinical end points.
Medtronic CoreValve System (Medtronic Inc., Minneapolis, MN) was used in 56.2% of the population and Edwards SAPIEN on the remaining population. Comparing the oldest cohort to the last one, there was significant reduction in vascular complications (15% vs. 7.9%; p=0.023), life threatening bleeding (17.8% vs. 7.9%; p=0.003) and major bleeding (22.4% vs. 12.1%; p=0.007). In the multivariate analysis the last cohort also presented less global mortality at 30 days (OR 0.35, 95% CI 0.12-0.96).
There were no differences in periprocedural infarction, neurological events, definite pacemaker requirements, neurological events or death for cardiac cause. Survival at 12 months was 79% for the oldest cohort, 85% for the second and 86% for the most recent one (p=0.016).
Conclusion
The larger experience and the improved devices resulted in improved safety and greater survival at 12 months in patients with severe aortic stenosis with high surgical risk that received a TAVI
Editorial Comment:
Probably we have not yet reached a plateau, since the larger the experience in pioneer centers, the more TAVI programs are opened throughout the world, and the better the devices we get. The implications of the above information are of outmost importance since, for example, translated into figures, this represents a 47% reduction of the relative risk of vascular complications.
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