Thorac Cardiovasc Surg 2013; 61 - OP109
DOI: 10.1055/s-0032-1332348

One year experience with the JenaValve Transapical Aortic Valve Implantation System – combined data from the two premarket studies

AJ Rastan 1, H Treede 2, M Ferrari 3, HR Figulla 3, S Ensminger 4, J Kempfert 5, FW Mohr 5
  • 1Herz-Kreislauf-Zentrum Rotenburg, Herz- und Gefäßchirurgie, Leipzig, Germany
  • 2Universitäres Herzzentrum Hamburg/Eppendorf, Klinik für Herz- und Gefäßchirurgie, Hamburg, Germany
  • 3Uni Jena, Klinik für Kardiologie, Jena, Germany
  • 4Herz- und Diabeteszentrum NRW, Klinik für Herzchirurgie, Bad Oeynhausen, Germany
  • 5Herzzentrum Leipzig, Klinik für Herzchirurgie, Leipzig, Germany

Objectives: Transcatheter aortic valve implantation (TAVI) has become a well accepted option to treat high risk patient with symptomatic aortic valve stenosis. The self-expanding transapical JenaValve consists of a nitinol stent with a porcine valve prosthesis available in three different sizes. The stent is fixed in anatomical position by clipping the native aortic cusps. The procedure can be performed under beating heart conditions. The system received CE-mark 09/2011.

The aim is to report the pooled 1-year results of all pre CE-mark implantations using the JenaValve.

Methods: 79 pts. with symptomatic aortic valve stenosis (age 83.5 ± 4.0 years, logEuroScore 27.8 ± 7.3%) were included in the first-in-man (07/2009 – 04/2010) and the consecutive CE-mark study (10/2010 – 07/2011).

Results: Overall, 76 patients underwent TAVI with the JenaValve. In 69/79 (87.3%) pts. the stent-valve was successfully implanted (valve sizes 23 mm: 42%, 25 mm: 39%, 27 mm: 19%). We observed a 30-day mortality rate of 6.6% (5/76 pts) and stroke rate of 3.9%. Perioperative pacemaker implantation was necessary in 7.9%. No coronary obstructions occurred. Further 20 patients died during the first year corresponding to a 12-months survival rate of 67.1%.

Paravalvular regurgitation of grade I or less was present in 88.4% post procedure and in 92.1% at 12-months follow-up. During the first year no regurgitation >II, signs of central regurgitation or valve dysfunction were observed.

Fig. 1

After 12 months 86.9% of pts were in NYHA stage I or II.

Conclusions: Anatomically correct positioning and implantation without rapid pacing are key features of the JenaValve. However, implantation success was influenced by the learning curve and device refinements. First results of the selfexpanding JenaValve system showed promising result with respect of aortic regurgitation rate and low gradients at follow-up. Ongoing studies will further evaluate this TAVI device in high risk aortic stenosis patients.