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Self-expanding valve exhibits similar safety, efficacy profile as other TAVR devices
Short-term results from a post-market, multicenter registry of the Acurate TA transcatheter aortic valve demonstrate a safety and efficacy profile that is comparable to other previously approved transcatheter aortic valve replacement devices, researchers reported in the European Journal of Cardio-Thoracic Surgery.
The researchers evaluated the Acurate TA transcatheter aortic valve (Symetis) in the first 250 patients who underwent implantation at 17 centers in Argentina, Germany, Italy and Switzerland. The all-comers population was older (mean age, 80 years), had a mean aortic gradient of 43.2 ± 17.4 mm Hg, mean Society of Thoracic Surgeons risk score of 8 ± 5.9% and mean EuroSCORE of 22.3 ± 12.7%. Ninety-three percent of the cohort presented with NYHA class III/IV HF. Each patient in the registry was treated within a multidisciplinary heart team.
Results demonstrated a procedural success rate of 98%. There were two valve-in-valve procedures performed and three cases of conversion to conventional surgery.
At 30 days, the mortality rate was 6.8%, the stroke rate was 2.8% and the mean transvalvular gradient was 12.4 ± 5.8 mm Hg.
Post-implant echocardiography results showed that 2.3% of patients had a relevant paravalvular leak (moderate 2+); results showed none/trace or a 1+ leak in all other patients.
Ten percent of patients required new pacemaker implantation. Eighty-five percent of patients presented improved to NYHA class I/II HF at follow-up.
“These ‘real-world’ data highlight an excellent functional outcome, especially in regard to a low rate of relevant paravalvular leak,” the investigators wrote.
The Acurate TA transcatheter aortic valve is designed for transapical implantation. The device is composed of a self-expanding nitinol stent covered by an anti-paravalvular leak skirt. It has received CE mark approval for use in Europe.
Disclosure: The researchers report no relevant financial disclosures.