Abstract 3792: Two Years Follow-up After Percutaneous Aortic Valve Replacement with the Cribier-Edwards Bioprosthesis: Results From the Initial Feasibility Studies in France
Background: The Edwards bioprosthesis is a percutaneous heart valve (PHV) made of 3 leaflets of equine pericardium sutured in a balloon expandable stainless steel stent. From February 2004 to April 2005, end-stage aortic stenosis patients (all in NYHA functional class IV) with multiple comorbidities (Parsonnet score: 47+/-6) were included on compassionate basis in 2 consecutive studies (I-REVIVE; n=16 and RECAST: n=21) aimed at assessing the feasibility, efficacy, safety and durability of PHV implantation in the aortic position.
Methods: 37 patients were recruited after being formally declined for surgical valve replacement. PHV was implanted by the retrograde (7 patients) or the antegrade approach. Clinical and echocardiographic follow-up were assessed serially at one day, one week, one month, 3 months and every 6 months thereafter.
Results: Successful implantation was obtained in 27 patients leading to a valve area of 1.70 +/- 0.10 cm2 with transvalvular gradient of 9 +/- 2 mmHg. Paravalvular aortic regurgitation was mild to moderate in 22 and severe in 5. At one month, major adverse events were 26% including 6 death of non cardiac cause. No death was device related and PHV dysfunction was observed in no case. In spite of critical condition at the time of PHV implantation, 10 patients are currently alive with a mean follow-up of 20.8 months (16 to 32 months). All patients experienced dramatic improvement of symptoms (90% in NYHA class I or II) with return to normal life. PHV function remained unchanged in all during follow-up.
Conclusions: Our experience confirms the feasibility and efficacy of PHV in releaving aortic stenosis in compassionate patients. Close clinical and echographic follow-up already confirms the 2.5 years durability of PHV. Ongoing prospective studies with updated devices and techniques in Europe/Canada (REVIVE Trial) and in USA (REVIVAL) will further determine the place of this promising new therapeutic alternative in non operable patients with calcific AS.