Key result
Percutaneous aortic valve replacement with the 21F CoreValve significantly increased mean aortic valve area (from 0.56 to 1.3 cm2, P<0.001) and LVEF (from 49% to 56%, P<0.001) in high-risk patients.
Why the study?
Does percutaneous aortic valve replacement with the 21F CoreValve system improve aortic valve area and LVEF in high-risk patients with severe aortic stenosis?
Observational (n=11)
Does percutaneous aortic valve replacement with the 21F CoreValve system improve aortic valve area and LVEF in high-risk patients with severe aortic stenosis?
Absolute Event Rate: 1.3% vs 0.56%
p-value: p=< 0.001
PAVR with the 21F CoreValve system significantly improves aortic valve area and LVEF in high-risk patients with severe aortic stenosis, though mortality remains high in this population.
Feasibility of PAVR shown in high-risk nonsurgical AS; leaves open safety and efficacy for larger prospective trials.
AIMS: Percutaneous aortic valve replacement (PAVR) is an emerging therapy for nonsurgical patients with severe aortic stenosis (AS). We investigated whether novel therapeutic approaches may facilitate AVR outcomes for high-risk patients. METHODS AND RESULTS: Eleven patients [n = 6 (54%) men] aged 82 +/- 10 years underwent PAVR after being refused for open surgery. The mean+/-SD AV area and left ventricular ejection fraction (LVEF) of these patients was 0.56 +/- 0.19 cm(2) and 49 +/- 17%, respectively, with severe functional limitation (NYHA class III (n = 8) and IV (n = 3)). One patient underwent PAVR combined with simultaneous percutaneous coronary intervention (PCI). Two male patients needed left iliac artery angioplasty. A percutaneous ventricular assist device (PVAD) was used in the most recent case. Compared with pre-PAVR, mean AV area (1.3 +/- 0.4 cm(2); P < 0.001) and LVEF (56 +/- 11%; P < 0.001) increased. One man had a peri-procedural stroke and died 5 days post-PAVR. Four other patients died within 4 months of hospital discharge. The median duration of survival of the survivors was 305 (range 249-431) days. CONCLUSIONS: Novel percutaneous techniques facilitate CoreValve PAVR (21 Fr.). Future lower profile devices (e.g. 18 Fr. Generation III CoreValve) should permit inclusion of a broader spectrum of high-risk patients. PAVR may evolve toward a full percutaneous approach.
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Berry et al. (2007) conducted an observational in Severe aortic stenosis (n=11). Percutaneous aortic valve replacement (PAVR) with the 21F CoreValve Revalving System vs. Pre-PAVR baseline was evaluated on Aortic valve (AV) area (cm2) (p=< 0.001). Percutaneous aortic valve replacement with the 21F CoreValve significantly increased mean aortic valve area (from 0.56 to 1.3 cm2, P<0.001) and LVEF (from 49% to 56%, P<0.001) in high-risk patients.
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