The primary outcome of stroke at 72 hours or before discharge occurred in 34 of 1501 patients with CEP and 43 of 1499 patients without (2.3% vs 2.9%; difference, -0.6 percentage points [95% CI, –1.7 to 0.5 percentage points]; P = .30). There were 8 disabling strokes with the debris capture device versus 20 with unprotected TAVR (0.5% versus 1.3%; difference, -0.8 percentage points [95% CI, –1.5 to –0.1 percentage points]; P = 0.02). The number needed to treat to prevent an additional disabling stroke was 125, Samir Kapadia, MD, Cleveland Clinic, Ohio, reported in a late session at Transcatheter Cardiovascular Therapeutics (TCT) 2022. “Remember these patients are 70 to 80 years old, they’re trying to enjoy life at the end of their years and they’re looking for a good quality of life … so if you can prevent even one disabling stroke, it’s very important,” he said. at theheart.org | Medscape Cardiology. Specifically, subgroup analyzes were unable to identify patients in whom overall stroke rates would be preferentially lower with vaccine protection. “If you’re going to say, okay, which patients are we going to use Sentinel based on this particular study, we didn’t find a specific high-risk group,” he said. Nevertheless, Kapadia concluded his presentation by saying that as a clinician, not a physician, “CEP with the Sentinel device should be considered for all patients undergoing TAVR to reduce disabling strokes.” The long-awaited results were published simultaneously in the New England Journal of Medicine. Although PROTECTED TAVR is a negative trial, “a disabling stroke rate of less than 1% is still an important finding” that will resonate with patients, Kendra Grubb, MD, surgical director of the Structural Heart & Valve Center, Emory University, Atlanta, Georgia, commented on theheart.org | Medscape Cardiology. “Strokes are absolutely devastating for our patients and, especially if you look at the age demographic of this study, patients over 70, for many of them having a stroke and having to live with a stroke is worse than death,” he said. . In terms of changing practice, Grubb said centers that use CEPs will likely justify their practice by reducing stroke inactivation, while centers that don’t use CEPs will point to the lost primary endpoint. “We don’t have clearly defined patient populations that will benefit, so it just supports what we’re already doing.” About 2% to 3% of patients have a stroke after TAVR, but whether the use of CEP has a clinically significant effect is unclear. Sentinel was approved by the US Food and Drug Administration in June 2017 based on data from the SENTINEL IDE trial that showed the device captured debris in 99% of patients and a trend toward a lower volume of new brain lesions. However, Medicare does not fully reimburse for use of the device, and US registry data show that CEP was used in just 13% of TAVR procedures at the end of 2019.
existing beliefs
PROTECTED TAVR randomly assigned 3000 patients (mean age, 78.9 years) in a 1:1 ratio to undergo TAVR with or without Sentinel CEP (Boston Scientific) at 51 centers in North America, Europe, and Australia. Patients were evaluated before and after by a neurologist and events were independently adjudicated.
Surgical risk was evenly distributed in both groups, with approximately one-third of patients each at extreme/high, intermediate, and low risk. The mean CHA2DS2-VASC score was 4.2. The device was delivered in 99.4% of patients attempted, without significant complications. At 72 hours or at discharge, there was no difference between the Sentinel group and the control group in all-cause mortality (8 vs 4), the safety composite of all-cause mortality and stroke (41 vs 45), or the acute kidney damage (8 vs 7); There was one vascular complication related to the CEP access point. Nondisabling strokes were reported in 1.5% of controls and 1.7% of CEP patients (P = 0.67). As expected, most disabling strokes were ischemic (17 vs. 6), with few symptomatic hemorrhagic strokes (3 vs. 2). Most strokes were perioperative and detected within the first day, Kapadia noted. Among the controls, 12 strokes were in uncomplicated TAVR cases and in areas that would have been protected if the Sentinel had been used. One of the 8 disabling strokes in the CEP group occurred in a protected vessel in an uncomplicated TAVR. Panelist Steven R. Messe, MD, professor of neurology at the Hospital of University of Pennsylvania, Philadelphia, who worked on PROTECTED TAVR, also said that preexisting behaviors will affect how the results affect practice, but that “reducing disabling strokes is a holy grail in neurology.” That said, the number needed to treat 125 is “somewhat high and I think that’s important and considering the cost, given that it’s clearly safe,” he added. Panelist Anita Asgar, MD, an interventional cardiologist at the Institut de Cardiologie de Montreal, Quebec, Canada, said her institution only occasionally uses the device and expressed disappointment that the trial did not provide guidance on who would benefit from the device. . “For us, cost is going to be a huge issue.” Adding to the discussion, David J. a P value of 0.02. “So our confidence in that 125 is quite large and may even include zero or infinity,” he said. “A lot of implications for practice will really depend on people’s quasi-emotional or Bayesian interpretation of this finding, believe it or not.” Cohen highlighted the subgroup analyses, saying, “I’ve said for a long time, and I think this trial reinforces it, that there are only two right ways to use embolization in TAVR: for everyone or for no one. It doesn’t work, and I think this test showed that very well.” Alexandra Lansky, MD, professor of medicine in cardiology at Yale School of Medicine, New Haven, Connecticut, had a somewhat different interpretation of the findings. “Yes, you missed your primary endpoint, but it’s a 20% reduction in terms of the relative benefit of your treatment, and when you look at disabling stroke, which is a component of the primary endpoint, you’re looking at a 60% reduction in stroke disability episode, which is extremely important in terms of prognosis, implications for patients, etc.,” he said. “I completely agree with your ramifications; this is not something we can completely ignore.” Lansky questioned whether the researchers took stroke severity into account, given the competing 30-day mortality risk of disabling strokes, and pointed out that US centers appeared to have lower rates of stroke overall and inactivation, despite striking consistency among the various subgroups. . Kapadia responded that National Institutes of Health Stroke Scale scores were significantly higher in disabling strokes, but that they found no competing risk for 30-day mortality. He said they could not explain the US results, but “this is an important thing to investigate further”. In an accompanying article, John D. Carroll, MD, University of Colorado, Denver, and Jeffrey L. Saver, MD, David Geffen School of Medicine, University of California Los Angeles, say the trial “deals a serious blow” to hope that the Sentinel device would have a definitive effect on TAVR-related strokes. “The ‘smoking gun’ of captured debris was not associated with high-quality evidence of stroke prevention,” Carroll writes. “The safety of the device and its potential effect on disabling strokes provide a glimmer of hope, but the concern remains that CEP, approved and marketed based on surrogate outcomes, may not actually provide a clear and unequivocal clinical avail”. Professor Bernard Prendergast, MD, St. Thomas’ Hospital and Cleveland Clinic London, United Kingdom, commenting during the panel discussion that the data will not be sufficient to convince the National Health Service to reimburse the use of the Sentinel device, but that further information will be released by the ongoing British Heart Foundation PROTECT-TAVI trial, which is testing the device in 7000 patients, and a mandatory meta-analysis with data from PROTECTED TAVR. When participants were asked if they would use the device for a loved one undergoing TAVR, a show of hands revealed that all but one, Asgar, said they would — a similar number to when approval was first discussed device. The study was funded by Boston Scientific. Kapadia reports grant/research support from Boston Scientific and stock, shareholder, equity with Anteris and Navigate. Study chair Martin Leon, MD, founded TCT and the Cardiovascular Research Foundation. Grubb is a consultant to Boston Scientific, Medtronic, Edwards Lifesciences, Abbott, and Gore. Grubb reports consulting fee/honoraria/speaker’s bureau participation with Boston Scientific, Ancora Heart, WL Gore & Associates, OpSens, HLT, Edwards Lifesciences, Medtronic, and Abbott Vascular. Messe exhibitions sponsor support/research contracts with WL Gore & Associates and Terumo Medical and consulting fee/fee/speakers bureau participation with Boston…
