NEW YORK (Reuters Health) – The results of a study at the German Heart Center in Munich suggest that transcatheter aortic valve implantation can lead to clinically relevant improvements in patients who are poor candidates for open surgery.

For a growing number of patients with aortic stenosis, advanced age and comorbidity make open surgery a risky undertaking, Dr. Sabine Bleiziffer and co-researchers note in the April 3rd issue of Deutsches Arzteblatt International. For these patients, valve implantation via catheter, which is performed on the beating heart, offers a new therapeutic alternative.

The procedure involves positioning of a stent-mounted valve in the aortic annulus. The authors note that two such devices are available, both of which cost ten to twenty time more than a conventional aortic valve prostheses.

The present study included 152 high-risk patients who underwent catheter-based aortic valve implantation from June 2007 to September 2008. Vascular access was transfemoral in 121 cases, transapical in 26, and through other sites in 5 cases.

By 30 days, 11.8% of the subjects had died. While this may seem high, mortality with open surgery in high-risk patients is typically around 24%.

The most common post-treatment complication, seen in 20% of patients, was third-degree atrioventricular block requiring pacemaker implantation, followed by vascular complications in 16%, and cerebrovascular events in 5%.

At 6-month follow-up, marked clinical improvements were noted in the study group and the implanted valves showed good hemodynamic function, the report indicates.

Specifically, before the procedure, 97% of the patients were in NYHA stage III or IV; at 6 months, 83% were in stage I or II.

The authors note that randomized and observational studies are now underway that will help clarify the indications for catheter-based aortic valve implantation.

Reference:
Dtsch Arztebl Int 2009;106:235-241.