A second prosthesis as a procedural rescue option in trans-apical aortic valve implantation

Objective: Trans-apical aortic valve implantation (TA-AVI) using the Edwards SAPIEN (TM) prosthesis has evolved to a routine procedure for selected high-risk elderly patients. In rare cases, misplacement of the SAPIEN (TM) valve (too low a position), dysfunction of the leaflets or perforation of the interventricular septum (ventricular septal defect, VSD) occurs and requires immediate implantation of a second prosthesis within the first one. Results of this 'bailout' maneuver have not been reported yet. Methods: Of 305 TA-AVI procedures, 15 patients required a second prosthesis due to dysfunctional leaflets (n = 6), low position (n = 7), or VSD (n = 2). Mean age was 82.5 +/- 1.3 years, mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 45.5 +/- 5.4, and Society of Thoracic Surgeons (STS) Score was 13.5 +/- 1.5. Results: All second SAPIEN (TM) valves could be implanted successfully within the first one. The second prosthesis solved leaflet dysfunction, sealed the VSD (lower position of the second prosthesis), or corrected the initial misplacement (higher position of the second prosthesis) in all patients. Within 30 days, four patients died (low cardiac output n = 3, all with preoperative ejection fraction (EF) < 35%; intestinal ischemia n = 1). Intra-operative echocardiogram and angiogram revealed mild paravalvular leak in three and none/trace in 12 patients. Transvalvular gradients were low despite the implantation of the second valve (P(max)/mean 13.7 +/- 4.3/6.4 +/- 2.0). Conclusion: Placement of a second SAPIEN (TM) valve is a valuable 'bailout' technique in case of VSD, dysfunctional leaflets, or too low placement of the first prosthesis. The technique leads to an excellent functional result with low transvalvular gradients. The simple, straight, tubular stent design of the SAPIEN (TM) prosthesis may be the ideal design for such valve-in-valve procedures. (C) 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B. V. All rights reserved.