Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study

Abstract

Use of the first-generation TriGuard EDD during TAVR is safe, and device performance was successful in 80% of cases during the highest embolic-risk portions of the TAVR procedure. The potential of the TriGuard EDD to reduce total cerebral ischaemic burden merits further randomised investigation.

Cognitive Outcomes After Transcatheter Aortic Valve Implantation: A Metaanalysis

“…In studies with multiple TAVI intervention groups, groups were combined for the overall analysis . For studies that did not report means and standard deviations of cognitive scores, the values were extracted from graphs or calculated (from medians, interquartile ranges, or confidence intervals (CIs)) using the Cochrane Handbook for Systematic Reviews of Interventions guidelines…”

Transcatheter Aortic Valve Replacement and Stroke

“…Several different devices have been developed and are part of clinical testing programs, with mixed results thus far. [15][16][17] In a histopathologic analysis, Mieghem et al 18 demonstrated that ≈75% of embolic protection devices retrieved after TAVR contained embolic debris. The significance of silent cerebral embolism on prognosis, however, remains uncertain.…”

Transcatheter aortic valve replacement: Are we ready to expand the use?

“…Concomitant mitral regurgitation is a frequent comorbid condition to SAS that usually tends to decrease after TAVR, but in some cases it does not occur and can also be a strong predictor of early (odds ratio [OR]: 1.49, 95% CI: 1.12-2.00; p = = 0.004; heterogeneity test = 0.006) and late (OR: 1.44, 95% CI: 1.23-1.68; p < 0.001; heterogeneity test = 0.019) post-procedural mortality, which is higher in those patients who also have low left ventricular ejection fraction and low gradient: 11.5% vs. 38.1%; adjusted hazard ratio: 3.27; 95% CI: 1.31-8.15; p = 0.011 and adjusted hazard ratio: 4.62; p = 0.005 [18,19]. Moreover, patients with SAS and mitral regurgitation included in the PART-NER trial had a higher mortality rate at follow-up with isolated SAVR in comparison with TAVR without mitral valve repair or replacement [28].…”

“…In our series of CoreValve cases without pre-dilation (n = 165), we have an any stroke rate of 2.4% (1.2% major stroke). Additionally, some studies using cerebral protection devices and subrogate endpoints showed promising findings regarding less micro-and macro-embolization when cerebral protection was used [17][18][19][20].…”