Multicentre clinical study evaluating a novel resheathable annular functioning self-expanding transcatheter aortic valve system: safety and performance results at 30 days with the Portico system

作者：Manoharan Ganesh; Linke Axel; Moellmann Helge; Redwood Simon; Frerker Christian; Kovac Jan; Walther Thomas

来源：Eurointervention, 2016, 12(6): 768-774.

DOI：10.4244/eijv12i6a125

• aortic stenosis
• elderly
• femoral
• heart failure
• transcatheter aortic valve implantation

Aims: The aim of this study was to evaluate the safety and performance of the resheathable and reposition able St. Jude Medical Portico self-expanding transfemoral TAVI system.
Methods and results: This prospective, single-arm, multicentre study evaluated the 18 Fr Portico system with either a 23 or a 25 mm valve. Patient follow-up was at 30, 90, 180 days and one year. Results up to 30 days are presented. Adverse events were categorised by VARC definitions and adjudicated by an independent events committee. Echocardiography was evaluated by an independent laboratory and all patients underwent neurological assessment at baseline, post procedure, at 30 days and one year. The primary endpoint was all-cause mortality at 30 days. A total of 102 patients (mean age 84.1 4.8 years; 97% female; median STS score 5.6) were enrolled. The 30-day mortality, disabling stroke and major vascular complications were 2.9%, 2.9% and 5.9%, respectively. Resheathing and repositioning (23.8%) was successful in all instances. Paravalvular leak at 30 days was none/trace in 30.4%, mild in 65.8% and moderate in 3.8%. Mean gradient improved from 45.3 +/- 13.8 to 8.9 +/- 3.8 mmHg and valve area improved from 0.6 +/- 0.2 to 1.7 +/- 0.4 cm(2). Permanent pacemaker implantation was required in 9.8% of patients.
Conclusions: The novel Portico TAVI system is safe and effective at treating high-risk patients with symptomatic severe aortic stenosis, allowing safe repositioning and optimisation of device position. ClinicalTrials. gov Identifier: NCT01493284

• 出版日期2016-8