The Centera transcatheter heart valve (THV) shows promise in addressing the “Achilles’ heel” of transcatheter aortic valve replacement (TAVR), according to Luis Nombela-Franco, MD, PhD, who wrote an editorial about the device’s pivotal study published in the Journal of the American College of Cardiology.
The study analyzed the self-expanding nitinol valve’s safety and efficacy in 203 patients across 23 centers in Europe, Australia and New Zealand. All patients—mean age 82.7; 67.5 percent female—had severe aortic stenosis and were considered to be at high surgical risk.
At 30 days of follow-up, rates of permanent pacemaker implantation (4.5 percent) and moderate or worse paravalvular leak (0.6 percent) were lower than those observed in previous devices, Nombela-Franco noted.
“Although TAVR has demonstrated similar or even lower rates of mortality, stroke, major bleeding, acute kidney injury, and new-onset atrial fibrillation compared to surgery, PVL (paravalvular leak) and PPI (permanent pacemaker implantation) have been considered the Achilles’ heel of TAVR,” he wrote. “Some of the key mechanistic factors in these two complications may be inversely related, and improving one factor may jeopardize the other.”
But this device, developed by Edwards Lifesciences—which funded the study—demonstrates potential to solve this conundrum and put TAVR on par with surgery in these areas.
“The novel motorized delivery system of the Centera valve seems to give extraordinary stability to the implantation process, demonstrated by the low rate (3.5 percent) of resheathing,” Nombela-Franco wrote. “An accurate position within the annulus is a key factor for both the low PPI and PVL rates.”
Lead researcher Hermann Reichenspurner, MD, PhD, and colleagues noted the following procedural and 30-day outcomes in 198 patients (five of the original 203 were unable to have the valves implanted, with two dying from complications):
- 1 percent of patients died.
- 4 percent suffered a stroke, while 2.5 percent experienced disabling stroke.
- New-onset atrial fibrillation occurred in 8 percent of patients.
- Device success was 96.4 percent.
- Average procedural time was 67 minutes and average fluoroscopy time was 17.9 minutes.
- Effective orifice areas widened from 0.71 to 1.88 square centimeters, while mean aortic transvalvular gradient dropped from 40.5 to 7.2 millimeters of mercury.
- The proportion of patients with New York Heart Association functional class of III or IV decreased from 68.2 percent at baseline to 7 percent.
- Clinical quality-of-life improvements were noted, including increased distance in a six-minute walking test.
“The data indicate that this self-expanding THV is associated with a stable deployment mechanism, high device success, and a low need for recapture and repositioning,” Reichenspurner and colleagues wrote. “Significant improvements in hemodynamic and clinical functional assessments were shown. In comparison with other commercially available (self-expanding) TAVR systems, the low rate of new PPM implantation and the low incidence of more than mild PVL are notable.”
In addition to having a small sample size and a short follow-up, the study lacked an alternative arm for randomized comparison. Also, Nombela-Franco pointed out baseline echocardiographic data are missing, “impairing our understanding of the potential risk of PPI in these study patients.”
But regardless of the baseline risk levels, the PPI rate remains low, Nombela-Franco wrote.