Single and multicentre TAVI registries
Initial experience with transfemoral implantation of the prosthesis Edwards SAPIEN XT without previous valvuloplasty in patients with severe aortic stenosis
Aims: Balloon valvuloplasty (BV) before transcatheter aortic implantation of the prosthesis has been considered a mandatory step before valve implantation. However, BV has been associated with complications such as atrioventricular block, aortic insufficiency and stroke. We report on 10 patients with severe aortic stenosis in whom direct transfemoral implantation of the SAPIEN XT was performed.
Methods and results: From November 2011 to April 2012, 10 patients (33% of the patients treated with the Edwards SAPIEN XT during that period) were selected who met the following criteria: moderate calcification, homogeneous distribution of calcium, symmetrical opening of the valve and some degree of aortic insufficiency. The valve positioning was guided by TEE in all cases. All patients had symptomatic aortic stenosis of a native valve and were high-risk for surgery. Echocardiographic characteristics: aortic annulus diameter ranged from 17 to 24 mm (determined by TEE). Six patients had mildly calcified valves; in four patients the degree of calcification was moderate. All patients had symmetric opening of the stenotic aortic valve. Mild aortic regurgitation was present in seven patients, moderate in two and trivial in one. The native valve was crossed and the prosthetic aortic valve was properly positioned in all cases and implanted in the correct position in all cases. No patient underwent post-dilatation and only one patient had mild periprosthetic regurgitation. There were no adverse events (death, need for pacemaker, myocardial infarction or stroke). At 30 days post procedure, all patients had significant clinical improvement.
Conclusions: The direct implantation of an Edwards SAPIEN XT without prior balloon valvuloplasty in selected cases is feasible and safe. The number of patients in whom this technique is applicable and their impact on reducing complications has yet to be determined.
