Abstract

Background: The Portico TM nitinol based self-expanding transcatheter aortic valve implantation (TAVI) system has the capability of being fully repositioned and retrieved in situ. This study investigates the feasibility and performance of Portico TM valve in subjects with severe symptomatic aortic stenosis up to 6 months post procedure. Hypothesis: The Portico TM system is safe and feasible in the treatment of patients with severe aortic stenosis. Methods: TAVI with the Portico TM system was performed in 83 subjects with severe AS using transfemoral (n=78), subclavian (n=4) and transaortic (n=1) access. Valve sizes included 23mm (n=5), 25mm (n=12), 27mm (n=31) and 29mm (n=35). Transthoracic echocardiography (TTE) was conducted pre and post-procedure and at 1mth and 6months in outpatient clinical follow-ups to evaluate aortic valve (AV) gradients and paravalvular regurgitation. Major stroke, vascular complications and mortality were also assessed in this cohort. Results: The mean age was 82±9yrs, with mean STS score of 5.0% and mean Euroscore II of 5.7%. The mean AV gradient improved significantly from baseline 47±17mmHg to 11±6 mmHg at 1mth and this decrease was sustained at 6 months post procedure; p<0.0001. There were no cases of severe paravalvular regurgitation by TTE at 6 months. The 30-day mortality was 1.2% (n=1) and 6 months mortality was 6.0% (n=5). Two patients (2.4%) had post procedure stroke and both were treated with intravenous thrombolysis with improvement in their symptoms, one patient (1.2%) had major vascular complications requiring vascular intervention and 10 patients (12%) required permanent pacemaker implantation. With regards to patients with impaired LV function, 12 patients (14.4%) had an EF < 55% prior to the TAVI procedure. In this group, there was a 15% improvement in EF at 6 months. Furthermore, 89% of all subjects improved at least one NYHA class at 30 days post procedure and 84% of the subjects improved at least one NYHA class at 6 months follow up. Conclusion: From our single center experience, the repositionable transcatheter Portico TM valve is feasible, safe and promising in the management of severe symptomatic aortic stenosis.

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