BOSTON. Transcatheter aortic valve replacement (TAVR) in patients with small aortic rings had better hemodynamic outcomes with a self-expandable valve than with a balloon-expandable valve, suggesting better clinical outcomes as well, in the France-TAVI registry.
The mean gradient was significantly lower with the self-expanding Medtronic CoreValve Evolut Pro or R devices at the end of the procedure and at 30 days and 1 year compared with the Edwards Sapien 3 balloon-expandable valves, with differences from 3.98 to 5.12 mm. Hg (all P<0.001).
The indexed effective orifice area was also greater with the self-expanding valves at 1 year (1.11 vs. 0.9 cm).two/ metertwoP<0.001), Walid Ben-Ali, MD, PhD, of the Montreal Heart Institute, reported at the Transcatheter Cardiovascular Therapeutics (TCT) meeting hosted by the Cardiovascular Research Foundation.
The significantly lower rate of moderate or severe patient-prosthesis discrepancy (PPM) at 1 year with self-expanding valves (11.3% vs. 29.4% and 3.0% vs. 8.5%, respectively) was associated with the mortality. Obtaining a balloon-expandable valve predicted a 2.94-fold increased likelihood of moderate-to-severe PPM overall.
Severe PPD at 1 year predicted a 2-fold increased risk of all-cause death at 3 years, regardless of comorbidities in matched patients in the cohort (P=0.04).
“So here we see that there is an impact at 3 years,” Ben-Ali said at a TCT news conference. However, he stated that for “clinical impact, we have to wait for a randomized trial to have a definitive conclusion” due to the study’s retrospective design and shorter follow-up due to 30% data loss at 5 years. .
the FRANCE-TAVI Registration was the first large, national, integrative study to compare the two platforms in TAVR patients with small aortic rings.
The registry included 47,494 patients who received TAVR, among whom 19,204 had a small aortic annulus, defined as less than 23 mm in diameter, and an indexed effective orifice area of less than 12 mm/mtwo on computed tomography.
The analysis focused on the 1,195 patients who received an Evolut R, Pro, or Sapien 3 device, but results were similar in a matched cohort of 928 patients.
Although this is a fairly large cohort, Ben-Ali reiterated that “we have a lot of limitations in the study design: it’s retrospective, 5% missing data, multiple imputation. Let’s wait for the SMART trial to come to a definitive conclusion.”
the Randomized Small Rings for Evolut or Sapien Assay (SMART) is enrolling 700 patients to answer the same question in a more rigorous way.
Ben-Ali said that as his group enrolls patients in SMART, “I see my patients treated with balloon expandable [devices]the best has gradients of 17 mm Hg and the worst of the self-expanding group has 9 mm Hg.”
News conference panelist Robert J. Cubeddu, MD, of the Naples Heart Institute in Florida, agreed that it reflects clinical impressions, though he cautioned that the registry findings were not adjudicated by the central laboratory.
“I’m cautiously comfortable with the findings of this,” added panelist Michael Young, MD, of Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire. “In our practice, we’re thinking about this very carefully. Our surgeons are actually very aggressive when they take patients for SAVR, surgical valve replacement, very aggressive about doing root enlargements in the hope that really small rings will get prosthetic valves.” larger surgical procedures…In our own practice, we lean toward supra-annular [self-expanding] designed for patients.
And such biases could influence which patients get which device in a way that undermines registry data, if coronary artery disease patients are more likely to get a Sapien device to preserve access, for example, suggested the panelist from the session Susheel K. Kodali, MD, of Columbia University Irving Medical Center in New York City. He urged “real caution” in interpreting the findings.
While these patients feel better with lower gradients after TAVR, Young added, “we just don’t know, one, the durability and, two, the clinical outcomes at the end.”
The lifetime management perspective is important, he said. “That goes into the narrative in choosing TAVR versus SAVR at this point. Typically, if the ring is small, we’re also looking at the sinuses, so to speak, so in the next 5 to 10 years your coronary options will be limited.
While PPM may not be as important in very old patients, it is in younger patients, said session panelist Bernard Prendergast, MD, of St. Thomas Hospital and the Cleveland Clinic in London.
These data are a call to the industry to think about patients with small rings as it moves toward fourth- and fifth-generation devices, he said.
Ben-Ali disclosed relationships with Edwards Lifesciences, Medtronic and Fonds de Recherche Santé du Québec.
Prendergast disclosed relationships with Edwards Lifesciences, Abbott Vascular and Medtronic.
Cubeddu did not disclose any relationship with the industry.
Young disclosed a relationship with Medtronic.