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Progress Elusive for Post-TAVR Stroke Rate

The incidence of stroke post-transcatheter aortic valve replacement (TAVR) remained constant over the first 5 years it was clinically offered in the U.S., the TVT Registry showed.

The 30-day rate of stroke was constant as it did not rise or fall in the large femoral access cohort (P=0.47 for trend) or among all the patients (P=0.22 for trend) who underwent TAVR over the 5 year period, reported Samir Kapadia, MD, of the Cleveland Clinic, and colleagues in JAMA.

The rate of stroke was 2.3% and 0.4% for transient ischemic attacks (TIA) in the 30 days following TAVR, the investigators found, calling the findings “a framework for future efforts to reduce post-TAVR stroke rates.”

These rates in a predominantly high- or extreme-risk population were lower than expected from the pivotal trials, which had 30-day stroke rates of 3.4% to 6.7%, noted Steven Messé, MD, of the University of Pennsylvania in Philadelphia, and Gorav Ailawadi, MD, of the University of Virginia in Charlottesville, in an accompanying editorial.

However, the registry likely underestimated strokes for a number of reasons, they suggested.

As to the stability of the rates across a period when progressively lower-risk patients were being treated, better devices were coming along, and centers were gaining experience, the editorialists noted that “the continual expansion of TVT with new inexperienced sites, less experienced proceduralists, or both may have offset this benefit overall.”

Stephen Bailey, MD, of Allegheny Health Network in Pittsburgh, who was not involved in the study, also saw a note of caution in the findings, considering that other clinical trials from the same time period have shown an improvement in various clinical outcomes after TAVR.

“I think that will be a bit of a surprise to most in the field, because the stroke rate has been going to lower levels in clinical trials, and I think we all would have thought that as the procedure has become much more common and procedural volume has gone up, that we have done better and that we were doing better in terms of this outcome,” Bailey told MedPage Today.

Notably, other data showed that the median time for any stroke event was 2.0 days following TAVR, with 68.4% of patients who had a stroke within 3 days and 48.9% within 1 day, the researchers wrote.

The majority of strokes and TIA happened within the first few days following TAVR, indicating that the issues are procedure related, noted William Zoghbi, MD, of the Houston Methodist DeBakey Heart & Vascular Center in Texas, who was not involved in the study.

“To me, it brings about an area that needs further investigation with some randomization of the trials to look at each one of these possible factors” — the procedure itself, the catheters, the aortic valve, the aorta and its structure, the device, and other coexisting conditions like atrial fibrillation, Zoghbi told MedPage Today.

So far, embolic filter-protected transcatheter aortic valve replacement has shown only favorable signals without definitive trial evidence showing that sequestering embolic debris actually reduces events like death and stroke.

Kapadia’s group evaluated 101,430 patients who underwent TAVR from November 9, 2011 through May 31, 2017 at 521 hospitals using the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies (TVT) Registry. Among them, 47.1% were women, and the median age was 83.

The analysis included both femoral- and nonfemoral-access TAVR. The 30-day stroke risk didn’t vary by oral anticoagulant or dual antiplatelet therapy prescription at hospital discharge in either group.

The rate of 30-day mortality was significantly lower among patients without a stroke than with one (3.7% vs 16.7%; P<0.001).

Limitations of the study included its retrospective design, voluntary site-reported data on neurologic events, and no requirement for regular neuroimaging of asymptomatic patients or neurologic evaluation following TAVR.

Kapadia reported no disclosures.

Messé disclosed relationships with Yale University Cardiovascular Research Group, W.L. Gore and Associates, and Claret Medical.

Ailawadi disclosed relationships with Admedus, Edwards Lifesciences, Abbott, and Medtronic.

Zoghbi reported no disclosures.

1969-12-31T19:00:00-0500

last updated

Source: MedicalNewsToday.com