Original title: Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis. Reference: David H. Adams et al. N Engl J Med. 2014 Mar 29. [Epub ahead of print].
Transcatheter Aortic valve replacement (TAVR) with balloon expandable valve showed survival improvement in inoperable patients and was similar to surgery inoperable high-risk patients. An alternative to the above device is the self-expandable nitinol prosthesis with a tri-leaflet porcine pericardial valve (Core Valve, Medtronic) which showed to reduce mortality and greater stroke versus best medical therapy in inoperable patients. This study was designed to evaluate the safety and efficacy of trans catheter replacement prosthesis Core Valve compared to surgical replacement in high-risk patients.
It was considered a surgical high-risk if 2 surgeons and one interventional cardiologist estimated the risk of death at 30 days after surgery of ≥15 %, but the combination of death and irreversible complication was less than 50%. Risk estimation included the STS PROM score calculation (Society of Thoracic Surgeons Predicted Risk of Mortality) which reached 7.4 % on average. 995 patients were evaluated at 45 U.S. centers; finally, 795 were included and randomized from which 390 received the CoreValve (323 by iliofemoral access and 67 by other access) and 357 received conventional surgeries. The rate of death from any cause at one year (primary end point) was lower for CoreValve than for surgery (14.2 % versus 19.1 %), representing an absolute risk reduction of 4.9 % ( p < 0.001 for noninferiority and P = 0.04 for superiority). A combination of cardiovascular and cerebrovascular events per year was also significantly lower with TAVR (20.4 % versus 27.3 %, P = 0.03). Considering only the strokes to 30 days, the rate was 4.9 % for CoreValve and 6.2% for surgery (p = 0.46), at one year rate reached 8.8 % and 12.6 % respectively (p = 0.10). Major vascular complications and the need for pacemaker were more frequent with TAVR, for surgery bleeding, acute renal failure and new atrial fibrillation were more common. Paravalvular aortic regurgitation was significantly higher in the TAVR group in all time cuts.
Conclusion
This study compared the trans catheter aortic valve replacement with self- expandable CoreValve versus surgical replacement in patients with symptomatic severe aortic stenosis and increased surgical risk considering a significant reduction in all-cause mortality at one year with the trans catheter replacement.
Editorial comment
The survival benefit was consistent across all nine subgroups pre-specified by protocol. Beyond calculated STS score, in this study evaluation was very important by a multidisciplinary team that took into account many other factors not measured in the STS or other scores available. Most (76.2%) patients with moderate / severe failure at discharge evolved with mild or no failure after a year.
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