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Self-expandable TAVR system yields low stroke rates
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A self-expandable transcatheter aortic valve replacement system was associated with low early and late stroke rates in high-risk patients with aortic stenosis, according to findings from the ADVANCE study.
The researchers presented data from 996 patients who underwent TAVR with a self-expandable system (CoreValve, Medtronic) at 44 centers in Colombia, Europe and Israel (mean age, 81.1 years; 51% female). They assessed incidence of clinically relevant neurological events, including stroke and a composite of stroke and transient ischemic attack, occurring 0 to 1 days (periprocedural), 2 to 30 days (early) and 31 to 730 days (late) after TAVR.
Strokes occurred in 1.4% of patients during the first day after TAVR, and increased to 3% at 30 days and 5.6% at 2 years. During the early period, there were 14 strokes and two TIAs. Sixteen strokes and one TIA occurred during the early period, and 21 patients had strokes and 13 patients had TIAs during the late period.
The researchers observed no significant predictive factors for periprocedural stroke or transient ischemic attack. Multivariable analysis indicated that acute kidney injury predicted incidence of early stroke (HR = 4.32; 95% CI, 1.19-15.64), as did major vascular complication (HR = 3.12; 95% CI, 1.04-9.31) and female gender (HR = 0.26; 95% CI, 0.07-0.92 for men vs. women).
A history of atrial fibrillation predicted early incidence of the combined stroke/TIA endpoint (HR = 3.02; 95% CI, 1.12-8.17), along with major vascular complications (HR = 3.99; 95% CI, 1.41-11.34). CABG was the only factor found to be significantly predictive of late stroke (HR = 3.26; 95% CI, 1.38-7.67), and was a borderline significant predictor of the combined endpoint of late stroke/TIA (HR = 1.96; 95% CI, 0.97-3.95).
The researchers observed no influence of access site on rates of stroke or TIA.
In an accompanying editorial, Vinod H. Thourani, MD, Lillian Tsai, AB, and Hannah Jensen, MD, PhD, all of Emory University School of Medicine, wrote that the current data set comes at “an intriguing time.”
“In the quickly developing arena of TAVR, we must also remember that even a year can make a difference, because not only do devices and technology evolve, patient selection by TAVR centers becomes more refined, and alternative TAVR access routes are identified and used with increasing safety and feasibility,” they wrote. “It will also be extremely interesting to learn how embolic protection devices influence neurological outcomes.”
They added that early clinical data have been promising results for self-expandable devices. “With three different embolic protection devices already in the clinical phase, we should expect results from larger trials soon,” they wrote. “However, neurological challenges still form a significant portion of morbidity and mortality after TAVR and [surgical] AVR, and their more subtle forms will go undetected if not specifically sought. Future studies, like the evolution of TAVR itself, must maintain a continuous, stringent drive to identify, prevent, and treat neurological dysfunction in this susceptible and often vulnerable patient population.”
Disclosure: Medtronic supported the study. The researchers report associations with a number of device and pharmaceutical companies. Please see the full study for a list of all other authors’ relevant financial disclosures. Thourani reports serving on the advisory boards for Abbott Medical, Boston Scientific, Edwards Lifesciences and St. Jude Medical and receiving research support from Direct Flow Medical, Edwards Lifesciences, Medtronic, Sorin Medical and St. Jude Medical.
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