Trans-apical aortic valve implantation using a new self-expandable bioprosthesis: initial outcomes

Jörg Kempfert, Ardawan J. Rastan, Friedhelm Beyersdorf, Markus Schönburg, Gerhard Schuler, Stefan Sorg, Friedrich-W. Mohr, Thomas Walther
2011 European Journal of Cardio-Thoracic Surgery  
Objective: Trans-apical aortic valve implantation (TA-AVI) has evolved into a standard approach for high-risk, elderly patients using the balloon-expandable Edwards SAPIEN TM prosthesis. As an alternative device, a self-expanding sub-coronary trans-apical bioprosthesis was evaluated. Methods: The Symetis Acurate TM trans-catheter heart valve is composed of a porcine biologic valve attached to a self-expandable nitinol stent. It allows for anatomical orientation, and facilitates intuitive
more » ... ation providing tactile feedback. Three valves sizes were available to treat patients with an annular diameter between 21 and 27 mm. Results: Since November 2009, a total of 40 patients have been treated at three sites. Patient age was 82.8 AE 4 years, 60% were female, logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 21.5 AE 10.9% and Society of Thoracic Surgeons (STS) Score was 9.0 AE 4.6%. All implants were delivered successfully in the intraannular and sub-coronary position off pump. One patient was converted to conventional surgery due to coronary impingement; post-dilatation was performed in 45% of patients; and two patients required the SAPIEN TM valve in valve implantation. Echocardiographic and angiographic control revealed no/trivial aortic incompetence (AI) in 59%, mild AI in 33.3%, and moderate AI in 7.7% of the patients. Three patients died within 30 days from a non-valve-related cause (respiratory), the patient converted did not recover from right-heart failure, and one patient died on day 19 due to unclear reasons. There was one incidence of new-onset atrioventricular (AV) block requiring pacemaker implantation. Two patients suffered a stroke (one secondary and the other intraprocedural). Transvalvular gradients were maximum 29.4 AE 10.7 mmHg and mean 14.3 AE 6.8 mmHg. Conclusion: The initial clinical results indicate a relatively straightforward implantation procedure and good functional results after trans-apical implantation of the Symetis
doi:10.1016/j.ejcts.2011.01.078 pmid:21924620 fatcat:cbtk4mzv5jbnli263jst7b2biq