SAN DIEGO — Patients who underwent transfemoral transcatheter aortic valve replacement with one of two next-generation transcatheter heart valves had high device success, improved 30-day clinical outcomes and acceptable rates of paravalvular aortic regurgitation, according to data from the NEOPRO registry presented at TCT 2018.
The different design features of both valves (Acurate Neo, Symetis/Boston Scientific; Evolut Pro, Medtronic) contributed to minor differences in clinical outcomes and procedural characteristics, researchers said during a press conference.
“Both of these devices are in clinical use in Europe, and right now, there are no available randomized data comparing these two,” Azeem Latib, MD, FESC, FACC, of the San Raffaele Scientific Institute in Milan, said during the press conference.
Researchers analyzed data from 1,551 patients who were treated at 24 centers between 2012 and March 2018. Patients were treated with Acurate Neo (n = 1,263; mean age, 82 years; 35% men) or Evolut Pro (n = 288; mean age, 82 years; 36% men).
“They are both self-expanding valves, both with a supra-annular design, both with pericardial leaflets and they both have and external sealing skirt to reduce paravalvular leak,” Latib said during the press conference. “The Evolut Pro is repositionable and retrievable up to 80%. … They require different sheath sizes and the radial strength is also different with the lower radial strength in the Acurate valve compared to Evolut Pro.”
The primary endpoint was Valve Academic Research Consortium (VARC)-2 device success. Secondary outcomes of interest included VARC-2 procedural outcomes, predischarge echocardiographic outcomes and 30-day clinical outcomes.
As this study was nonrandomized, there were many differences in baseline characteristics, which led the researchers to perform a propensity-matched group analysis with 251 patients in each group (mean age in both groups, 81 years; 34% men in both groups), as well as performing adjustment of the overall cohort by propensity score quintiles, researchers said during the press conference.
“Interesting to note that in the Evolut group, there was certainly more severe calcification, so physicians were choosing this valve in more severe patients,” Latib said.
The primary outcome occurred in 92% of patients in the Acurate Neo group and 90.7% in the Evolut Pro group (P = .539). In the propensity score-matched population, the primary outcome was seen in 90.6% of patients treated with Acurate Neo and 91.6% of those treated with Evolut Pro (P = .751).
Moderate to severe paravalvular aortic regurgitation was similar in the Acurate Neo and Evolut Pro groups (5.2% vs. 5.7%, respectively; P = .659), while the rate was numerically higher in the Acurate Neo group in the propensity score-matched population (7.3% vs. 5.7%; P = .584).
In the overall cohort, compared with the Evolut Pro group, patients in the Acurate Neo group had more bleeding events (14.9% vs. 8.5%, P = .004) and vascular complications (17.1% vs. 11.6%; P = .025), which may be related to the different sheath size, Latib said during the press conference. The differences were not significant in the propensity score-matched population.
The rate of new pacemaker implantation was lower in patients treated with Acurate Neo vs. Evolut Pro (8.8% vs. 13.2%; P = .045).
“When we matched [patients], differences as far as pacemaker rates disappeared,” Latib said. – by Darlene Dobkowski
Latib A, et al. Late-Breaking Clinical Science 3. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.
Disclosure: Latib reports he received grant/research support and consultant fees/honoraria from Abbott Vascular, Acist Medical, Amaranth Medical, Cardiovalve, ICS, InnovHeart, Keystone Heart, Medtronic, Millipede, Mitralign, Nuvera, Philips and Supira.