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DOI: 10.1055/s-0030-1268938
Clinical and functional outcome after transapical aortic valve implantation using the JenaValve AVR System – results of the first-in-man study
Introduction: To evaluate feasibility, safety and valve performance of the JenaValve™ as a substitute for transcatheter aortic valve implantation (TAVI) during the first-in-man study.
Methods: The JenaValve™ AVR TAVI System allows precise placement by positioning feelers. The low profile prosthesis using a porcine valve, the self expanding Nitinol stent and the possibility of repositioning and retrieving the valve before final release provide potential advantages.
Between 07/09 and 04/2010 twelve patients were enrolled. Mean age was 86.3 years, all were female, log EuroScore was 22.4±8.5, STS score was 21.6±2.5. Anulus size was 21.4±1.2mm. In 3 patients the procedure was aborted due to Type A dissection (n=1). In two patients the valve feelers could not be completely released because of tension in the catheter system induced by the aortic arch leading to balloon expandable valve implantation. This shortcoming was solved by redesigning the catheter tip. Nine patients underwent an uneventful procedure without CPB and all of them were discharged and reached the primary 30-day endpoint. Mean procedure time was 129±73min, contrast dye exposition was 135±71ml and postdilatation was necessary in 3 pts. At discharge AV gradient were max 15.4±3.4 and mean 9.6±2.6mmHg. Only 3 pts had a trivial paravalvular leak, none needed pacemaker implantation. After follow-up of 196±126 days 2 pts. died on not valve related causes.
Conclusion: The JenaValve™ AVR System allows precise valve placement. After catheter tip redesign the procedure was safe which is reflected by a 30-day survival of all 9 patients, good valve function and no AV-block.