February 20th, 2013
Small Study Explores Expanded Use for TAVI in Native Valve Aortic Regurgitation
As transcatheter aortic valve implantation (TAVI) gains increasing acceptance, cardiologists and surgeons are exploring additional patient populations who may benefit from the procedure. A new paper in the Journal of the American College of Cardiology provides the first look at the use of TAVI in the small but important group of patients with pure, severe native aortic valve regurgitation (NAVR) who do not have aortic stenosis.
David Roy and colleagues report on their experience with 43 NAVR patients deemed ineligible for surgery who underwent TAVI with the CoreValve (Medtronic) device at 14 centers in Europe and Israel. The high risk group had a mean age of 75, and many patients had severe comorbidities. Three-fifths of the group had degeneration of the aortic valve leaflets. The device was implanted in all but one of the patients, though 8 patients required a second valve during the procedure. One patient converted to open surgery. In 35 cases the device was implanted via transfemoral access; the remaining cases were performed via subclavian access (4), direct aortic access (3), and carotid access (1).
After the procedure 34 patients had aortic regurgitation of grade I or lower. Seven patients required a new permanent pacemaker. The VARC (Valve Academic Research Consortium) procedure success rate was 74.4%. Three out of four patients with aneurysm of the ascending aorta died within 6 months of treatment, suggesting, wrote the authors, that “TAVI is unlikely to alter the prognosis of these patients and that aneurysmal dilation should be considered a contraindication to TAVI in patients with NAVR.”
All-cause mortality was 9.3% at 30 days and 21.4% at 1 year. There were two major strokes and 8 cases of major bleeding.
The authors acknowledge that TAVI will likely be used sparingly in the NAVR population:
…although these results are encouraging for those patients who are truly ineligible for surgery, surgical valve replacement remains the gold standard for those who can undergo it, even at high risk. Furthermore, there is an increasing number of patients in whom the native aortic valve can be preserved during surgery.