Repositionable Valves Found Safe, Effective in Two Trials

MIAMI BEACH, FLA.—A fully repositionable/retrievable percutaneous valve achieved 97% freedom from all-cause mortality and 100% freedom from CV mortality at 30 days in patients with severe aortic stenosis, according to results of the DISCOVER CE mark study.

The prospective, multicenter clinical trial was designed to evaluate the 18F Direct Flow transcatheter aortic valve (Direct Flow Medical) in 33 older patients. Results of the trial were presented at TCT 2012.

The combined safety endpoint at 30 days, according to VARC definitions, occurred in 9% of patients.

The Direct Flow valve was implanted successfully in all patients, with good procedural results (see Figure).

Repo Valves“The valve provides hemodynamic stability during implantation; allows for controlled positioning, repositioning and safe retrieval; and virtually eliminates aortic regurgitation,” Joachim Schofer, MD, of Hamburg University Cardiovascular Center, Hamburg, Germany, said.

Core lab hemodynamics by echocardiography revealed that mean gradient decreased from 46 mm Hg before the procedure to 13.6 mm Hg at discharge to 12.9 mm Hg at 30 days. Aortic regurgitation (AR) measurements on core lab echocardiography revealed that 75% of patients had either no AR or trace AR. Angiographic core lab data showed the same, Schofer said.

Seventy-five percent of patients experienced improvement of 1 NYHA class or more.

The Direct Flow system features a nonmetallic valve design on a flexible 18F delivery system. It was designed to minimize AR and allows assessment and optimization of hemodynamics before final detachment at a stage when the valve is fully deployed and functional.

Fifty-two percent of valves implanted were 27 mm (>24 mm to 26.5 mm annulus) and 48% were 25 mm (19 mm to 24 mm annulus). The smallest diameter of the femoral arteries accessed was 5.2 mm.

Outcomes with a fully resheathable valve

Ganesh Manoharan, MBBCh, MD, from Royal Victoria Hospital, Belfast, United Kingdom, presented acute results and 1-year outcomes from a prospective, multicenter evaluation of the 23-mm Portico transcatheter aortic valve and transfemoral delivery system (St. Jude Medical).

The study included 11 older patients (one withdrew consent) from the Canadian first-in-human experience and 10 from the European first-in-human clinical study (all women).

At 1 year, there were no reported deaths, major strokes or MIs and no patients required a new pacemaker. Five patients in the Canadian cohort had follow-up data at 1 year; no major vascular complications developed during follow-up. Serious adverse events observed were not related to the device or procedure, Manoharan said. NYHA class also improved and was maintained out to 1 year.

Both cohorts experienced improvements in echo data gradients, both mean and peak, from baseline and changes observed from baseline to 30 days were sustained at 1 year. Improvements in aortic valve area and effective orifice area were also sustained.

Only mild AR was reported at 1-year follow-up.

“These early, encouraging results suggest that TAVR with the Portico valve is feasible and safe,” Manoharan said.

The self-expanding valve is made of bovine and porcine pericardial tissue. It was designed to be fully resheathable, repositionable and retrievable and to increase control and placement accuracy during valve deployment. The valve is implanted transfemorally without need for rapid pacing.

Disclosures
  • Dr. Manoharan reports consulting fees/honoraria from Guided Delivery Systems, Medtronic CardioVascular and St. Jude Medical.
  • Dr. Schofer reports consulting fees/honoraria from Direct Flow Medical.

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