Novel therapeutic aspects of percutaneous aortic valve replacement with the 21F CoreValve Revalving System.

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.