ORLANDO -- When palliative surgery is not possible, percutaneous aortic valve replacement may be an option for high risk patients, researchers reported here.
ORLANDO, May 14 -- When palliative surgery is not possible, percutaneous aortic valve replacement with an investigational device may be an option for high risk patients, researchers reported here.
In a report describing the North American experience with the valve, the device demonstrated safety and efficacy comparable to surgery for severe, symptomatic aortic stenosis, according to findings reported at the Society of Cardiovascular Angiography and Interventions meeting.
At one-month post procedure, there were hemodynamic and functional improvements in 11 patients, said Anita Asgar, M.D., of the Institut Cardiologie de Montreal, in Montreal.
The 30-day post procedure the mean aortic valve area was 1.4cm2, the mean left ejection fraction was 56%, and New York Heart Association (NYHA) clinical class improved by one grade (all P<0.01), she said.
But periprocedural mortality was 18% and overall mortality was 35%, which she said was comparable to the surgical mortality seen in patients with severe aortic stenosis.
The series included 22 patients of whom 18 were surgical turn-downs and four were patients who refused surgery, she said. The average age of the patients was 84.
Dr. Asgar said that "by far the most important clinical message of our study is that this procedure requires a dedicated, multi-disciplinary approach."
In this series that team required general anesthesia, surgical peripheral arterial access and either femoral vein-femoral artery cardiopulmonary bypass or left atrial-to-femoral artery percutaneous ventricular assist device (PVAD, TandemHeart Cardiac Assist, Inc.).
Aortic balloon valvuloplasty was performed first, then retrograde CoreValve PAVR.
The post-replacement aortic bioprosthetic valve area was more than 1.2cm2 and paravalvular regurgitation was less than or equal to Grade 2 in all cases.
The first 11 patients underwent valve placement with a 21 Fr Generation II system and the second 11 had the procedure done with the 18 Fr Generation III system, she said. The valve consists of a self-expandable procine bioprosthesis within a nitinol frame.
One man died following a periprocedural stroke. Seven more patients died post discharge from non-procedure-related events. Dr. Asgar said autopsy confirmed valve function.
Although the procedure is feasible, Dr. Asgar noted that it is technically challenging and may sometimes require that percutaneous transluminal angioplasty and/or percutaneous coronary interventions be done at the same time.