October 18, 2012
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Transcatheter valve-in-valve implants effective for degenerative bioprosthetic valves

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Study results have found that transcatheter aortic valve-in-valve implantation was clinically effective in patients with degenerated stenotic or regurgitant bioprosthetic surgical valves.

Danny Dvir, MD, and fellow researchers evaluated the clinical results of valve-in-valve (VIV) implants by examining outcomes from the ongoing Global Valve-In-Valve Registry of 38 cardiac centers that enrolled 202 patients with degenerated bioprosthetic valves (mean age, 77.7 ± 10.4 years; 52.5% men).

The valves had failed because of stenosis (42%), regurgitation (34%) or both (24%). Implanted devices included the CoreValve (Medtronic; n=124) and Sapien valve (Edwards Lifesciences; n=78).

VIV implantation succeeded 93.1% of the time. Nevertheless, initial device malposition was reported in 15.3% of cases and ostial coronary obstructions in 3.5%.

After implantation, valve maximum gradients were 28.4 ± 14.1 mm Hg and mean gradients were 15.9 ± 8.6 mm Hg. Additionally, 95% of patients had no more than +1 degree of aortic regurgitation. Thirty days after implantation, all-cause mortality was 8.4%, and 83.7% of patients achieved NYHA Class I/II.

One-year follow-up on 87 patients showed an 85.8% survival rate (95% CI, 79.9-91.6) with no difference between devices.

Despite the successes, researchers noted that they had concerns about the initial device malposition, ostial coronary obstructions and high gradients after the procedure. They predicted that VIV practice may have an effect on cardiac surgery practice that will include referral of extreme-risk patients with failed bioprostheses to VIV and possibly effect the selection of valve class during surgery (mechanical vs. biological), in favor of using bioprostheses in somewhat younger patients.

Disclosure: Dvir reports no relevant financial disclosures.