New TAVR system yields positive 30-day outcomes

Transcatheter aortic valve replacement with a low-profile, self-expanding nitinol valve was effective and associated with a low rate of mortality and adverse events at 30 days, according to data from the CENTERA-2 pivotal study.

Researchers studied safety and efficacy of the valve (Centera, Edwards Lifesciences) in 203 patients with severe symptomatic aortic stenosis and increased surgical risk. TAVR procedures with the novel valve were performed from March 2015 to July 2016 at 23 centers in Australia, Europe and New Zealand.

The primary endpoint — all-cause mortality at 30 days — was 1%. Most cases of death were related to CV causes. Also at 30 days, cumulative event rates were 4% for any stroke, 2.5% for disabling stroke, 1.5% for MI, 4.9% for life-threatening bleeding, 14.4% for major bleeding, 3.5% for acute kidney injury, 8% for new-onset atrial fibrillation and 0.5% for valve embolism.

Device success was 96.4% at 30 days, according to data published in the Journal of the American College of Cardiology.

In other findings, the proportion of patients with NYHA functional class III/IV was 68.2% at baseline. At 30 days after TAVR with the valve, just 7% of patients were classified as III/IV. Improvements in quality of life were also observed.

The researchers also reported significant improvements over 30 days in hemodynamic outcomes, including mean aortic transvalvular gradient (decrease from 40.5 mm Hg to 7.2 mm Hg; P < .001) and effective orifice area (increase from 0.71 cm² to 1.88 cm²; P < .001), according to the findings.

Overall, 0.6% of patients had paravalvular aortic regurgitation classified as moderate or higher at 30 days.

New permanent pacemaker implantation was required in 4.5% of patients who received the valve (4.9% for patients at risk), according to the findings.

“In comparison with other commercially available [self-expanding] TAVR systems, the low rate of new [permanent pacemaker] implantation and the low incidence of more than mild [paravalvular leak] are notable,” Hermann Reichenspurner, MD, from the department of cardiovascular surgery at University Heart Center, Hamburg, Germany, and colleagues wrote.

The researchers discussed several potential explanations for the low rate of permanent pacemaker implantation, including the low frame height of the valve (18 mm to 23 mm vs. 52 mm to 55 mm with CoreValve/Evolut R [Medtronic] and 49 mm to 53 mm with Portico [St. Jude Medical]) and minimal protrusion into the left ventricular outflow tract.

The valve is made of bovine pericardial tissue, is 14F compatible and utilizes a motorized delivery system to allow for ease of repositionability. The researchers noted that the valve “may also overcome some limitations associated with established [self-expanding transcatheter heart valves].’

The valve comes in sizes 23 mm, 26 mm and 29 mm. Most patients in this study implanted with the valve received the 26-mm size. The transfemoral route was used the implant the valve, and the majority of patients received conscious sedation for the procedure. The mean age of patients enrolled in the pivotal study was 83 years and 67% were women.

Previously reported data from Binder and colleagues demonstrated feasibility of TAVR with the valve in 15 patients implanted via femoral or axillary arterial percutaneous access.

The new data were presented at EuroPCR in May.

“The results show adequate early clinical safety and performance outcomes in this high-surgical-risk patient cohort. The rates of mortality, stroke, [permanent pacemaker] implantation, vascular complications and paravalvular regurgitation are low and have to be confirmed with longer follow-up periods and in larger patient groups,” the researchers concluded. – by Katie Kalvaitis

References:

Binder RK, et al. JACC Cardiovasc Interv. 2013;doi:10.1016/j.jcin.2013.01.129.

Reichenspurner H, et al. J Am Coll Cardiol. 2017;doi:10.1016/j.jacc.2017.10.060.

Disclosures: the CENTERA THV trial is sponsored by Edwards Lifesciences. Reichenspurner reports he has received speaker support and travel honoraria from Edwards Lifesciences and has served as a consultant to HeartWare/Medtronic. Please see the full study for all other authors’ relevant financial disclosures.