CMAJ: Transcatheter valve replacement safe, but needs more research

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Minimally invasive transcatheter approaches to repair the aortic and pulmonic valves can be safe, cause less mortality and provide faster recovery times compared to previous methods. However, further clinical trials are still needed, according to a review published March 8 in the Canadian Medical Association Journal.

Michael W.A. Chu, MD, of the University of Western Ontario in London, Ontario, and colleagues wrote that the risk of surgical valve replacement for older patients with aortic stenosis is high.  Transcatheter valve replacement, however, offers patients a less invasive alternative with potentially reduced risks.

The authors said that transcatheter treatment usually cannot treat patients with asymptomatic aortic stenosis or patients with a life expectancy of less than one year. The procedure is suggested for patients with congenital, symptomatic pulmonary valve stenosis or insufficiency who have previously undergone right ventricular outflow tract reconstruction for tetralogy of Fallot.

Researchers said the approach can be completed within two hours and most patients will have a shorter recovery time—two to three weeks rather than two to three months.

The researchers reported that 30-day post procedural mortality was between 10 and 12 percent and one-year survival was approximately 80 percent. Failure rates of the procedure were reported to be between 5 and 10 percent.

“Currently, no good evidence exists to evaluate either the optimal transcatheter valve device, the optimal approach to transcatheter valve implantation, or whether or not transcatheter valve implantation prolongs survival as compared with medical therapy in these high-risk patient populations,” according to the study.

Today, three transcatheter valve devices have approval from the European Union: Edwards Lifesciences’ Sapien, Medtronic’s CoreValve and Medtronic’s Melody.

“Future development of transcatheter valves must focus on improvements in design that facilitate easy and accurate positioning, with avoidance of coronary obstruction and minimization of paravalvular leak,” the authors concluded.