Percutaneous implantation of the CoreValve aortic valve prosthesis in patients at high risk or rejected for surgical valve replacement: Clinical evaluation and feasibility of the procedure in the first 30 patients in the AMC-UvA

Objective. To report the feasibility, safety and efficacy of percutaneous aortic valve implantation (PAVI) with the CoreValve self-expanding aortic valve bioprosthesis in elderly patients with aortic valve stenosis who are rejected for surgery or have a high surgical risk.Methods. PAVI using the CoreValve ReValving System was performed under general anaesthesia in 30 high-risk (surgical) patients with a symptomatic severe aortic valve stenosis.Results. The patients had a mean age of 80.5+/-7.7 years, a mean aortic valve area of 0.71+/-0.19 cm(2), a peak transvalvular aortic gradient of 79+/-25 mmHg, as measured with echo Doppler, a logistic EuroSCORE of 15+/-10% and a Society of Thoracic Surgeons (STS) score of 5.2+/-2.9%. Device success was achieved in all patients and acute procedural success in 27 patients (90%). In the surviving patients, there was in a reduction of the peak aortic pressure gradient from 76+/-24 mmHg to 22+/-7 mmHg (n=24, p <0.00001) 30 days after successful device implantation. At 30 days, major adverse cardiovascular and cerebral events had occurred in seven patients (23%). This included mortality in six patients (20%), of which one death was cardiovascular. The other five non-cardiovascular deaths involved two patients who died of an exacerbation of severe pre-existent pulmonary disease and three of infectious complications.Conclusions. Percutaneous aortic valve implantation was successfully performed in our centre in highrisk patients, with a 30-day mortality of 20%. When successful, marked haemodynamic improvement and relief of symptoms was achieved. (Neth Heart J 2010;18:18-24.)