Improved Outcomes with Self-Expanding TAVR System

By Will Boggs MD

NEW YORK (Reuters Health) - The new CENTERA transcatheter aortic valve appears to be safe and effective, yielding low mortality, significantly improved hemodynamics, and a low rate of adverse events.

Transcatheter aortic valve replacement (TAVR) is increasingly used instead of surgical aortic valve replacement (SAVR) for patients with prohibitive and high or intermediate risk. TAVR has, however, been associated with such shortcomings as more frequent need for second valve implantation, higher rates of paravalvular leak (PVL), and more frequent need for permanent pacemaker (PPM) implantation.

The CENTERA system features a low-profile delivery catheter, a contoured self-expanding nitinol valve frame with bovine pericardial tissue leaflets, and a motorized delivery system for stable valve deployment and repositionability.

Dr. Hermann Reichenspurner from University Heart Center, Hamburg, Germany, and colleagues report 30-day results with the CENTERA system in 203 patients with severe symptomatic aortic stenosis and estimated high surgical risk. The findings were published online December 18 in the Journal of the American College of Cardiology.

The valve was successfully implanted in 198 patients (97.5%), including two whose periprocedural complications resulted in death. The valve required recapture and repositioning in 3.5% of cases, none of which led to ventricular or aortic injury.

All-cause mortality at 30 days was 1.0%, compared with an expected mortality of 16%.

Device success at 30 days was 96.4%, and event rates were low: stroke, 4.0%; disabling stroke, 2.5%; myocardial infarction, 1.5%: life-threatening bleeding, 4.9%; acute kidney injury, 3.5%; valve embolization, 0.5%; and new-onset atrial fibrillation, 8.0%.

Only 4.5% of patients required a new PPM, and most patients had none/trace (61.9%) or mild (37.5%) PVL. PVL was moderate in 0.6% of patients, and none experienced severe aortic regurgitation or a significant PVL.

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

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“These excellent results are extremely promising for potential TAVR candidates,” writes Dr. Luis Nombela-Franco from Hospital Clinico San Carlos, Madrid, Spain, in a related editorial. “Although we must be cautious in the absence of direct randomized comparisons and larger series, it seems that this valve could overcome previous weaknesses of THV and compete against surgery in terms of the permanent pacemaker implantation (PPI) and PVL rates.”

“If we are able to reduce significant PVL and PPI rates to 1% and 5%, respectively, this valve would represent a major step forward in the TAVR horizon with clinical improvement for our patients,” he said.

Dr. Anthony A. Bavry from University of Florida, Gainesville, who recently reviewed the development of self-expanding transcatheter aortic valves, told Reuters Health by email, "For a self-expandable transcatheter aortic valve, the low rate of significant aortic regurgitation and need for permanent pacemaker are quite remarkable.”

“This device utilizes a motorized delivery system which could make for more precise deployment than the currently available self-expandable valve,” he said.

“Although further study with longer follow-up is needed, the performance of this device appears to be quite good and may join our armamentarium of treatment options for aortic stenosis,” Dr. Bavry said. “In the United States, only two TAVR devices are currently available. Enhanced devices will inevitably come to the market, which will help to improve procedural outcomes.”

Dr. Reichenspurner did not respond to a request for comment.

Edwards Lifesciences, maker of the CENTERA system, sponsored the trial and had various relationships with most of the study authors, as well as with Dr. Nombela-Franco.

SOURCES: https://bit.ly/2CH4Rhn and https://bit.ly/2kMPkVL

J Am Coll Cardiol 2017.

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