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CENTERA: Novel transcatheter heart valve shows promise in aortic stenosis
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Patients with severe symptomatic aortic stenosis who received a novel self-expanding transcatheter heart valve had improved outcomes, according to results presented at EuroPCR.
“The Edwards Centera valve demonstrates extremely favorable early clinical safety and performance outcomes in the high surgical risk [transcatheter aortic valve replacement] population,” Didier Tchétché, MD, an interventional cardiologist at Clinique Pasteur in Toulouse, France, said in a press release. “In addition to excellent patient outcomes, the valve also offers several unique features and an innovative tissue design, all of which simplify the procedure for clinicians.”
In the CENTERA trial, researchers analyzed data from 203 patients (mean age, 83 years; 68% women) with severe aortic stenosis and NYHA class II HF or worse who were at high surgical risk. Patients received the self-expanding valve (Centera Transcatheter Heart Valve System, Edwards Lifesciences) via transfemoral access from March 2015 to July 2016 and were followed up at hospital discharge and periodically for up to 5 years.
The primary endpoint was all-cause mortality at 30 days. Key secondary endpoints included stroke or disabling stroke, new-onset atrial fibrillation, new conduction abnormalities and cardiac mortality at 30 days, 6 months and 1 year.
The 30-day mortality rate was only 1% (observed to expected ratio, 0.16). At 30 days, a small percent of patients had a disabling stroke (2.5%), MI (1.5%) and the need for a new permanent pacemaker (4.9%), according to the results.
The number of patients in NYHA classes I and II increased as classes III and IV decreased at 30 days (P < .0001). Six-minute walk distance also increased at 30 days (P = .007).
Moderate paravalvular leak occurred in 0.6% of patients, and no patients experienced severe paravalvular leak.
“The novel nitinol transcatheter Centera valve has stable deployment, high technical success and a low need for recapture and repositioning,” Tchétché said in the presentation. – by Darlene Dobkowski
Reference:
Tchétché D, et al. Transcatheter valves interventions – Session comprising selected EuroPCR 2017 late-breaking trial submissions. Presented at: EuroPCR; May 16-19, 2017; Paris.
Disclosure: The study was funded by Edwards Lifesciences. Tchétché reports consulting for Edwards Lifesciences.