The mean slope was significantly lower with Medtronic CoreValve Evolut Pro or R self-expanding devices at the end of the procedure at both 30 days and 1 year compared with Edwards Sapien 3 balloon-expanding valves, with differences of 3.98 to 5.12 mm Hg (all P <0.001). Indexed effective orifice area was also greater with self-expanding valves at 1 year (1.11 vs. 0.9 cm2/m2, P<0.001), reported Walid Ben-Ali, MD, PhD, of the Montreal Heart Institute, in Transcatheter Cardiovascular Therapeutics Meeting (TCT) hosted by the Cardiovascular Research Foundation. A significantly lower rate of moderate or severe patient-prosthetic mismatch (PPM) at 1 year with the self-expanding valves — 11.3% vs. 29.4% and 3.0% vs. 8.5%, respectively — was associated with mortality. Having an expandable balloon valve predicted a 2.94-fold greater likelihood of moderate-to-severe PPM overall. Severe PPM at 1 year predicted twice the risk of death from any cause at 3 years independent of comorbidities in matched cohort patients (P=0.04). “So here we see an impact at 3 years,” Ben-Ali noted at a TCT press 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 a 30% loss of data at 5 years. The FRANCE-TAVI registry was the first large, national, all-comer study comparing the two platforms in patients with small aortic annulus TAVR. The registry included 47,494 patients who underwent TAVR, among whom 19,204 had a small aortic annulus, defined as less than 23 mm in diameter and an effective orifice area index of less than 12 mm/m2 on computed tomography. The analysis focused on the 1,195 patients who received an Evolut R or Pro or Sapien 3 device, but results were similar in a matched cohort of 928 patients. While a fairly large cohort, Ben-Ali reiterated that “We have many limitations in the study design — it’s retrospective, 5% missing data, with multiple imputation. Let’s wait for the SMART trial to have a definitive conclusion.” The Small Annuli Randomized to Evolut or Sapien (SMART) trial is enrolling 700 patients to answer the same question in a more rigorous way. Ben-Ali said that as his team enrolls patients in SMART, “I see my patients being treated with balloon expandable [devices]the best has grades of 17 mm Hg and the worst in the self-expanding group has 9 mm Hg.” Press conference co-author Robert J. Cubeddu, MD, of the Naples Heart Institute in Florida, agreed that it reflected clinical impressions, although he cautioned that the registry’s findings were not based on laboratory findings. “I’m cautiously reassured by the findings from this,” added panelist Michael Young, MD, of Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire. “In our practice, we think about it very carefully. Our surgeons are actually very aggressive when taking patients for SAVR, surgical valve replacement, very aggressive in doing root augmentations in hopes that very small rings get larger surgical prosthetic valves. . . . .In our practice, we oscillate toward the hyper-annular [self-expanding] design for patients’. And such biases could affect which patients get which device in a way that undermines registry data, if patients with coronary heart disease might be more likely to get a Sapien device to maintain access, for example, the conference panel suggested Susheel K. Kodali, MD, of Columbia University Irving Medical Center in New York. He urged “real caution” in interpreting the findings. While these patients do better with lower slopes after TAVR, Young added, “we just don’t know, one, the durability and, two, the clinical outcomes at the end.” The lifelong stewardship perspective is important, he said. “That gets into the discussion of choosing TAVR versus SAVR at this point. Usually, if the annulus is small, we also look at the sinuses. And sometimes the sinuses will be very small as well. You’re worried about isolating the sinuses and boxing the patient in, so to speak, so in the next 5 to 10 years their coronary options will be limited.” While PPM may not be as important in very old patients, it is in younger patients, noted conference panelist Bernard Prendergast, MD, of St. Thomas’ Hospital and the Cleveland Clinic, London. These data are a call to action for the industry to think about patients with small rings as it moves toward fourth- and fifth-generation devices, he said. Revelations 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 has disclosed no industry affiliations. Young disclosed a relationship with Medtronic.
