The putative clinical benefits of TAVR cerebral protection remain unproven

BOSTON – Cerebral embolization protection (CEP) again came out on top in preventing strokes after transcatheter aortic valve replacement (TAVR) even though embolism material was safely captured during the procedure, according to a large randomized trial.

In the 3000-person PROTECTED TAVR trial, the double-hot filtration system did not result in any significant reduction in periradicular strokes compared to controls without the device (2.3% vs 2.9%, s= 0.30), according to Samir Kapadia, MD, of the Cleveland Clinic.

Kapadia added that no subgroup appears to get fewer strokes from protected TAVR. “Stroke is still unexpected,” he said in a presentation. Cardiovascular treatments via catheterization (TCT) meeting hosted by the Cardiovascular Research Foundation. The results were simultaneously published in New England Journal of Medicine (NEJM).

This may be frustrating for clinicians who were hoping to narrow down their CEP candidates based on this experience. It was thought that by valve anatomy or procedural characteristics, some patients would benefit at least more than others, Robert Cupido, MD, of the Naples Heart Institute in Florida, commented at a TCT press conference.

There was some rebound in the Sentinel association with lower obstruction strokes after TAVR (0.5% vs. 1.3%, s= 0.02), with the number needed to treat to prevent disabling stroke from 125 patients.

But that’s not an end result and will need to be replicated, cautioned John Carroll, MD of the University of Colorado School of Medicine/Anschutz Campus in Aurora, and Jeffrey Safire, MD, of the David Geffen School of Medicine at UCLA, in a NEJM editorial.

Otherwise, the trial yielded no significant differences in mortality rates or the combined endpoint of stroke, TIA, or delirium. The incidence of acute kidney injury was the same as 0.5% between groups.

Protected TAVR comes after years of much younger SENTINEL . TRIALCEP succeeded in clearing pathological tissue debris in 99% of patients but failed significantly to reduce new lesion size in protected brain areas or reduce adverse cardiovascular events.

However, the FDA approved the sentinel in 2017 Assuming that catching debris before it reaches the brain should theoretically benefit patients undergoing intracardiac procedures. However, since the approval, real-world data has continued to emerge No point in stroke with the device.

CEP adoption has been variable and slow to spread. When panelists were asked how the new data would affect clinical practice at the press conference, they broke into a few chuckles.

Michael Young, M.D., of Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, said the study was “disturbing the medium-sized programs. The number needed to treat 125 is going to be a hard sell for some of those programs to use that everywhere for all of their patients.”

“A lot of that turns out to be cost and we need to be realistic about that,” Cupedo said. “In many [TAVR] Across the country, the margins for sustainability, cost and revenue are only marginal.”

He suggested that it would be interesting to see how the Centers for Medicare and Medicaid Services (CMS) interprets the results of PROTECTED TAVR.

Aftersales trial was conducted in 51 centers in North America, Europe and Australia. Investigators randomly selected TAVR candidates for the procedure with or without CEP.

Neurological examinations were performed on all patients at baseline and after TAVR. Routine neuroimaging has not been performed to identify occult cerebral infarction.

The average age of the participants was 78.9. There was a greater proportion of women in the protected group (42.0% versus 37.8% of the control group), while the surgical risks of the Society of Thoracic Surgeons were similar between groups (3.4% versus 3.3%).

Sentinel deployed successfully in 94.4% of attempts.

The primary endpoint of the trial was stroke within 72 hours after TAVR or before discharge. Carroll and Cypher caution that the count of these events may be flawed in the study.

“The lack of detection of stroke events may have occurred because neurological assessments were not always performed by experienced neurologists and because a formal interview structured to determine the presence of stroke symptoms was not used. A small amount of the increase in the number of end point events may also have occurred due to Using a non-standard approach to classify asymptomatic occult infarctions as strokes,” they wrote.

In terms of safety, only one patient experienced vascular complications at the access site, according to Kapadia.

“The device’s safety and potential impact on disabling strokes provide a glimmer of hope, but concern remains that CEP, which has been approved and marketed on the basis of alternative outcomes, may not actually provide a clear and indisputable clinical benefit,” according to Carol and Siffer.

In any case, a protected TAVR may be evidence of how mature TAVR has been since it was It was first developed in 2002.

“The fact that the study’s negative findings are partly due to the lower incidence of stroke events in the control group conveys good news—the frequency of stroke without CEP is low in contemporary practice compared to early experience with TAVR and likely due to operator experience, technical improvements to procedural equipment, and use of TAVR in patients. The most correct.”

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    Nicole Low She is a reporter at MedPage Today, where she covers cardiology news and other developments in medicine. Follow

Disclosures

PROTECTED TAVR was funded by Boston Scientific.

Kapadia revealed the relationships with Navigate and Admedus.

Carroll revealed Edwards’ relationships with Live Science and Medtronic. Saver disclosed relationships and/or support from Filterlex, Abbott, Medtronic, Bayer, Roche, Johnson & Johnson, Amgen, MIVI, Rapid Medical, Novo Nordisk and Edwards.

Cubeddu has not disclosed any ties to the industry.

Young revealed an affair with Medtronic.

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