Procedural results and 30-day clinical events analysis following Edwards transcatheter aortic valve implantation in 48 consecutive patients: initial experience.

Background: Transcatheter aortic valve implantation (TAVI) is a rapidly evolving strategy for therapy of aortic stenosis. We presented the procedural results and analyzed the death causes of 30-day mortality and clinical events in patients who underwent TAVI with Edwards prosthetic valves in University Hospital of Caen, France.

Methods: The patients with severe aortic stenosis but at high surgical risk or inoperable were considered as candidates for TAVI. Forty-eight patients undergoing TAVI from July 2010 to September 2011 were enrolled in this registry. The Edwards prosthetic valves were solely used in this clinical trial.

Results: Overall 48 patients underwent TAVI, 28 of which accepted TAVI by trans-femoral (TF) approaches, 20 by trans-apical approaches (TA). The aortic valve area (AVA) was (0.70 ± 0.23) cm(2), left ventricular ejection fraction (LVEF) was (57.4 ± 17.6)%, Log EuroSCORE was (19.2 ± 15.8)%, mean gradient was (47.0 ± 16.6) mmHg. There were no significant differences between TF and TA groups in all these baseline parameters. Device success rate was 95.8%, and procedural success rate was 93.7% in total. Procedural mortality was 6.7% (3/48): two deaths in TA group (10%), and one death in TF group (3.6%). Forty-six Edwards valves were implanted: 10 Edwards Sapien and 36 Edwards XT. Procedure-related complications included cardiac tamponade in 2 cases (4.2%), acute myocardial infarction (AMI) in 1 case (2.1%), permanent pacemaker implantation in 1 case (2.1%), life-threatening and major bleeding in 3 cases; access site related major complication in 1 case, AKI stage 3 in 3 cases (6.3%), minor stroke in 1 case (2.1%). Thirty-day survival rate was 89.6%. There were 5 deaths in total (10.4%): 4 in TA group (20%) and 1 in TF group (3.6%).

Conclusion: The procedural success rate and 30-day mortality were acceptable in these high risk patients with Edwards prosthetic valves in the first 48 TAVI.