Two studies show promising results for novel TAVR devices

PARIS — Two novel transcatheter aortic valve replacement devices demonstrated encouraging outcomes in terms of morbidity and mortality, according to findings presented here.

Joachim Schofer, MD, of the Hamburg University Cardiovascular Center in Germany, presented 12-month results of the DISCOVER trial, in which the Direct Flow Medical Valve was evaluated in patients with severe aortic stenosis. A EuroSCORE of ≥20 along with severe COPD, porcelain aorta or previous thorax irradiation were key inclusion criteria. Schofer noted that protocols also included an investigator agreement between the interventionalist and the surgeon.

Joachim Schofer

One hundred patients from 10 centers in Europe were enrolled in the prospective, multicenter, non-randomized clinical trial. “The echo and angiographic hemodynamics were core lab adjudicated,” Schofer said at a press conference.

Major stroke and all-cause mortality at 12 months served as the primary endpoint.

The 12-month freedom from mortality and stroke was 86% overall. “This is a really remarkable result,” Schofer said.

Paravalvular aortic regurgitation rates also were reported. Post-procedure,1.6% of the cohort experienced moderate regurgitation, 20.3% experienced mild regurgitation and 78.1% experienced none or trace rates. At 30 days, the rates were 1.7% for moderate, 16.7% for mild and 81.7% for no or trace regurgitation.

By 6 months, there was no moderate aortic regurgitation. Mild regurgitation occurred in 24.5% of patients and none occurred in 74.5%. By 12 months, the rates were 22.9% for mild and 71.1% for none or trace.

Thomas Walther, MD, PhD, of the Kerckhoff Heart Center, Bad Nauheim, Germany, presented 12-month all-comers registry results of the Acurate TA TAVI device. The analysis included 250 patients aged 80.9 ± 6.3, with a logistic EuroSCORE of 22.3 ± 12.7 and an STS score of 8.0 ± 5.9. “It’s an elderly population with a high-risk profile,” Walther said, adding that patients were treated at 17 different sites.

All-cause mortality rates were 6.8% at 30 days and 18.8% at 12 months, with corresponding survival rates of 93.2% at 30 days 81.2% at 12 months. Walther said that these survival rates were “pretty good for an all-comers, multicenter registry, not a selected series of patients.”

Stroke occurred in 2.8% of patients at 30 days and 4% at 12 months.

Walther added that only 3.4% of patients had a +2 paravalvular leak and 0.7% had >+2 leak at 12 months. “This may be due to the technique with the Symetis Acurate prosthesis: compressing native calcified cusps by pulling the valve into the annulus,” he said.

Walther concluded that use of the device is easy to perform and standardized, with low complication rates and excellent outcomes in high-risk patients. He added that the findings are comparable to transfemoral data in an all-comers series. – by Rob Volansky

For more information:

Walther T and Schofer J. Hot line: Trial updates and registries. Presented at: EuroPCR; May 20-23, 2014; Paris.

Disclosure: Schofer reports financial disclosures with Boston Scientific. No disclosure information was available for Walther.