STS/ACC TVT Registry: Cerebral embolic protection and TAVR outcomes
Reported from the TCT Congress 2020
At TCT Connect 2020, David J. Cohen (Kansas City, Missouri, USA) presented results from an analysis of the TVT registry focusing on impact of Cerebral Embolic Protection (CEP) on TAVR outcomes. Nicolas Dumonteil provides a summary of the key messages.
This was an observational study that included all consecutive patients of the TVT registry treated by TF TAVR during 2018 and 2019, encompassing all prosthesis, bicuspid valves, aortic valve in valve procedures. CEP device used was the Sentinel (Boston Scientific), currently the only CEP system approved for commercial use in the USA. Only emergent procedures, non TF access, concomitant mitral procedures, and low volume sites were excluded, resulting in a cohort of 123 186 patients.
The methodology
In a pre-specified primary instrumental variable analysis, 12 409 patients undergoing TF TAVR with CEP were compared to 110 777 patients without CEP. Baseline characteristics were well balanced except bicuspid aortic valves that were more frequent in the CEP group, and dialysis patients less frequent. Primary endpoint was in-hospital stroke (hospital-reported, centrally adjudicated, no routine independent neurological assessment). No significant reduction in in-hospital stroke was noticed in the CEP group (1,39 % vs 1,54 % in non CEP group, Adjusted RR 0.90 (95 % CI 0.68-1.13; P=0.41)).
In a secondary propensity-weighted analysis, patients undergoing TF TAVR with CEP experienced significantly less in-hospital stroke (1.30 % vs 1.58 %, Adjusted RR 0.82 (95 % CI 0.69-0.97; P=0.02)), as well as less in-hospital death or stroke, 30-day death and 30-day stroke.
This study allowed to show on a large sample of patients that the use of CEP was safe, without any significant excess of vascular complications, major bleeding or device failure.
What do these results add to our knowledge and how can they influence our practice?
Stroke occurs in 2-5 % of the TAVR procedures, irrespective of centre volume, operatorʼs experience, and is probably the most devastating TAVR complication. As it is mostly embolic during the procedure, rationale for CEP is strong.
To date, CEP has only been tested in small randomized control trials using brain imaging (MRI) endpoints, underpowered to reveal clinical benefit.
Both the confidence interval for the primary analysis of this study and the secondary analysis suggest a possible modest reduction in stroke with the use of CEP (~ 20 % relative risk reduction, Number Needed to Treat ~ 300 for disabling stroke).
Although results of the primary analysis were consistent across all subgroups, there are signals generating hypothesis that CEP during TAVR for bicuspid patients and aortic valve in valve procedures could be clinically beneficial.
We agree with D. Cohen statement that this supports clinical equipoise and, as CEP appears not to be harmful, encourage to keep-on testing whether CEP provides significant clinical benefit (stroke reduction, neurocognitive decline prevention) for all patients undergoing TAVR, or maybe in some higher-risk subgroups.
No comments yet!