Abstract 3790: Balloon Expandable Aortic Valve implantation: initial 50 patients in Canada
Objectives: Balloon expandable aortic valves [BEAV] have been implanted in Vancouver, BC since Jan. 2005 for severe, symptomatic aortic stenosis in patients at high risk for sternotomy and cardiopulmonary bypass surgery. We describe our experience with the first 50 patients.
Background: The Cribier-Edwards BEAV [Edwards Lifesciences Inc.] is a stainless steel stent with equine pericardial leaflets and a fabric cuff. Potential patients were reviewed by a team of cardiologists and cardiac surgeons to gain consensus that surgical risk was excessive and BEAV insertion appropriate.
Methods: Femoral artery access was used in 43 patients. In 7 patients with severe femoral or aortic disease left ventricular (LV) apical access was used through a mini thoracotomy. A 22 or 24 French sheath was introduced into the femoral artery or LV apex. Rapid ventricular burst pacing was used to reduce cardiac output and motion during deployment.
Results: Mean age was 81±8 [62–94y]. Valve implantation was successful in 86% of patients. Unsuccessful cases were due to inability to cross the aortic valve (3) or iliac artery (1), delivery catheter failure (1) and malposition (2). Aortic valve area increased from 0.6±0.2cm2 to 1.8±0.4cm2, p<0.001. In patients with moderate to severe MR, 57% improved at least one grade (p<0.003). Left ventricular ejection fraction improved significantly from 60%±15% IQR to 65%±7.5% IQR, p<0.001. Improvements were maintained at 1 month. No late structural valve deterioration has been seen with the longest follow up being 14 months Paravalvular aortic regurgitation was common but generally mild. Hemolysis was not observed. Peri-procedural stroke occurred in 1 patient (2%) with no long term sequellae. At baseline 90% were NYHA class 3 or 4; by 1 month 84% improved by 1 or more class (p < 0.001). Predicted 30 day surgical mortality by logistic Euroscore was 27%±16%. Despite additional comorbidities not accounted for by this estimate actual 30 day mortality was 12%, with 30 day mortality falling from 16% in the initial 25 patients to 8% in the final 25 patients (p=0.39).
Conclusion: BEAV implantation is feasible in patients at high risk for surgery with severe aortic stenosis. Outcomes are favorable and continue to improve.