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Eberhard Grube1, Jean Laborde2, Ulrich Gerckens1, Lutz Buellesfeld1, Stein Iversen1
1Heart Center Siegburg, Siegburg, Germany2Clinique Pasteur, Toulouse, France
Background and Method: Percutaneous aortic valve replacement is a new promising technology for patients with significant aortic valve stenosis (AS) and high risk for surgery.
In 2002, Cribier et al. performed the first human implantations of balloon-expandable aortic valve prostheses in patients with aortic valve stenosis inoperable due to severe co-morbidities. This percutaneous heart valve was based on a 14mm long stent that contained the valve composed of three bovine pericardial leaflets. Initial reports on the outcome demonstrated promising results on safety and feasibility of this new technique. However, the experiences are still limited, restricted to end-stage inoperable patients and the optimal technique is yet unknown.
We present now the first report on a human implantation of a new alternative technique using the self-expanding CoreValve aortic valve prosthesis implanted via a retrograde approach.
The CoreValve aortic valve prosthesis consists of a commercialized bioprosthetic valve made of bovine pericardial tissue, which is mounted and sutured in a self-expanding nitinol stent. The prosthetic frame (stent) is manufactured by laser cutting of a nitinol metal tube with a length of 50mm. The lower part has a high radial force to push aside the calcified leaflets and avoid recoil, the middle part is constrained to avoid coronaries and carries the valve, whereas the upper part expands for fixation in the ascending aorta and axes the system. The actual valve inner diameter is 21-22mm. The valve is delivered via a 25 french catheter, which houses the stent in the distal part. For stent deployment, the retrograde approach is used via the common iliac artery as access site (after surgical cut-down). The procedure is presently performed in general anesthesia with TEE guidance and femoro-femoral cardiac assistance as a requirement for safety reasons.
Clinical, hemodynamic, and echocardiographic outcomes are assessed serially during the procedure. Echocardiographic follow-up to 30 days after prosthesis implantation is performed to evaluate the short-term outcome.
Results: The prosthesis was successfully deployed within the diseased native aortic valve in 10 of 12 patients, one patient died due to ventricular rupture prior to device implantation, one patient was converted to surgery due to unsuccessful device placement. 2D and doppler echo immediately after device deployment showed a significant reduction in transaortic mean pressure gradient from 45.7 +/- 25.2mmHg to 10.5+/-5.1mmHg. In the in-hospital follow-up, 5 patients died, 4 procedure-related with myocardial perforation (1), crush-syndrome (1) and multi-organe failure (2), and 1 patient non-procedure related due to lung cancer. All patients developed temporary thrombocytopenia, that was persistent if antiplatelet medication was not given. Patients with clopidogrel and ASS showed restoration of normal platelet counts after 4-8 days. The 5 patients with uneventful in-hospital follow-up were discharged with significant improvement of the clinical status. The 14 day follow-up was uneventful in all 5 patients.
Conclusion: This first experience with a self-expanding aortic valve prosthesis using the retrograde approach confirms the concept with a promising acute device success rate and immediate improvements of the hemodynamic status. The safety profile is currently under evaluation.
