Clin Res Cardiol 96: Suppl 1 (2007)

V55 - Experiences with the percutaneous Cribier-Edwards heart valve in severe calcified aortic stenosis
S. Sack1, P. Kahlert1, S. Khandanpour1, C. Naber1, S. Philipp2, I. Kordish1, E. Kottenberg-Assenmacher3, M. Kamler4, J. Peters3, HG. Jakob4, R. Erbel1
1Klinik für Kardiologie, Westdeutsches Herzzentrum, Universitätsklinikum Essen, Essen; 2Universität Duisburg-Essen, Westdeutsches Herzzentrum Essen, Essen; 3Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen, Essen; 4Klinik für Thorax- und Kardiovaskuläre Chirurgie, Universitätsklinikum Essen, Essen;
Background: Valve replacement in calcified aortic stenosis of elderly people with reduced LV function and comorbidities is associated with a high perioperative mortality. Balloon aortic valvuloplasty (BAV) has been introduced 20 years ago, but the method was left due to short lasting of results. A new technique is the percutaneous valve deployment of the Edwards Cribier valve mounted on a balloon catheter. We report of our initial clinical experiences in 11 patients.
Methods: Percutaneous heart valve (PHV) was performed in local anaesthesia with light sedation (n=7) or under general anaesthesia (n=4). In two patients, the antegrade approach with transseptal puncture of the interatrial septum was used; in eight patients valve was introduced by retrograde approach via femoral artery. In all cases, balloon aortic valvuloplasty was done prior to valve deployment. The Cribier-Edwards heart valve (23 or 26 mm) was mounted on a Z-MED balloon catheter (22 or 25 mm, 3 cm) and crimped fitting to 22 or 24F, respectively. After BAV, the 22 of 24 F sheath was introduced percutaneously in the femoral artery. For the retrograde approach a steerable Flexcatheter was used which enabled the advancemnet through the aortic arch by steering the catheter and avoiding stress on the aortic wall. During positioning of the PHV, rapid pacing was conducted to reduce transvalvular blood flow and avoid dislocation of the valve while exposed. Angiograms of the aortic root were performed before and after the procedure. In 4 patients, the arterial puncture size were occluded with percutaneous closing devices, in 6 patients surgical cut down with suture of the artery was performed.
Results: In 11 patients (7 males, 4 females, mean age 79 ± 4 years), PHV was performed. All patients were no candidates for surgery due to high operative risk analysed by EuroSCORE (32±14%) and valve replacement was refused. PHV could successfully implanted in all patients, no dislocation of the valve occurred. Valve orifice increased dramatically from 0.78 ± 0.28 cm2 to 2.65 ± 0.97 cm2. Pressure gradient dropped significantly form 45 ± 22 mm Hg (peak-to-peak) or 34 ± 16 mm Hg (mean) to 2.8 ± 1.8 mm Hg (peak-to-peak) or 2 ± 1.7 mm Hg (mean). Immediately after implant, two patients demonstrated low cardiac output and mechanical and drug support was needed. Both patients showed an impaired LV function with an EF < 25% prior to the implant. One of the two patients died while cardiac support failed and electromechanical uncoupling occurred. The other patient resolved but cardiac arrest occurred one day later during hemodialysis due to chronic renal failure. Resuscitation was successful again, but two days later cardiac arrest occurred again and was unresolved. In one patient, VF occurred after valve implant which could be terminated by external defibrillation. One patient developed a complete heart block and required a permanent pacemaker. Nine patients (82%) were discharged from hospital.
Summary: In elderly patients with severe aortic stenosis and no possibility for valve replacement, PHV implantation is a new and promising method to deploy a valve in aortic position. Hemodynamic and clinical results are very convincing. Perioperative mortality is high in patients with severly depressed left ventricular function.