Cerebral protection device reduces brain lesions

Organisation: Position: Deadline Date: Location:

In transcatheter aortic valve implantation, the use of a cerebral filter reduced the number and volume of brain lesions, according to a University of Lepzig study.

Among patients with severe aortic stenosis (narrowing of the aortic valve) undergoing transcatheter aortic valve implantation, the use of a cerebral protection device (a filter that captures debris [tissue and plaque] dislodged during the procedure) reduced the number and volume of brain lesions, according to a new study.

Although the clinical outcomes of transcatheter aortic valve implantation (TAVI; replacement of the aortic valve, delivered via a blood vessel with a catheter) have improved considerably during the last decade, stroke, which is associated with a 3-fold increase in mortality following TAVI, remains an important concern. Adding to this concern is the observation that ischemic lesions are found in as many as 80% of TAVI patients. Numerous devices have been developed to protect the brain from injury caused by embolic debris during TAVI, although clear evidence of the efficacy of any embolic protection device in TAVI is still missing.

Dr Axel Linke, of the University of Leipzig, Germany, and colleagues randomly assigned 100 higher-risk patients with severe aortic stenosis to undergo TAVI with a cerebral protection device (n = 50; filter group) or without a cerebral protection device (n = 50; control group). Brain magnetic resonance imaging (MRI) was performed at study entry, 2 days, and 7 days after TAVI.

The researchers found that the number of new brain lesions 2 days after TAVI was lower in the filter group (4) than in the control group (10). New lesion volume after TAVI was lower in the filter group (242 mm3) vs in the control group (527 mm3).

Regarding adverse events, 1 patient in the control group died prior to the 30-day visit. Life-threatening haemorrhages occurred in 1 patient in the filter group and 1 in the control group. Major vascular complications occurred in 5 patients in the filter group and 6 patients in the control group. One patient in the filter group and 5 in the control group had acute kidney injury, and 3 patients in the filter group had a thoracotomy (surgical incision into the chest wall).

“Larger studies are needed to assess the effect of cerebral protection device use on neurological and cognitive function after TAVI and to devise methods that will provide more complete coverage of the brain to prevent new lesions,” the authors write.

Abstract
Importance: Stroke remains a major predictor of mortality after transcatheter aortic valve implantation (TAVI). Cerebral protection devices might reduce brain injury as determined by diffusion-weighted magnetic resonance imaging (DWMRI).
Objective: To determine the effect of a cerebral protection device on the number and volume of cerebral lesions in patients undergoing TAVI.
Design, Setting, and Participants: Investigator-initiated, single center, blinded, randomized clinical trial in higher-risk patients with severe aortic stenosis undergoing TAVI at the University of Leipzig Heart Center. Brain MRI was performed at baseline, 2 days, and 7 days after TAVI. Between April 2013 and June 2014, patients were randomly assigned to undergo TAVI with a cerebral protection device (filter group) or without a cerebral protection device (control group). The last 1-month follow-up occurred in July 2014.
Interventions: TAVI with or without a cerebral protection device (filter system).
Main Outcomes and Measures: The primary end point was the numerical difference in new positive postprocedure DWMRI brain lesions at 2 days after TAVI in potentially protected territories. The first hierarchical secondary outcome was the difference in volume of new lesions after TAVI in potentially protected territories.
Results: Among the 100 enrolled patients, mean (SD) age was 80.0 (5.1) years in the filter group (n = 50) and 79.1 (4.1) years in the control group (n = 50), and the mean (SD) procedural risk scores (logistic EuroScores) were 16.4% (10.0%) in the filter group and 14.5% (8.7%) in the control group. For the primary end point, the number of new lesions was lower in the filter group, 4.00 (interquartile range [IQR], 3.00-7.25) vs 10.00 (IQR, 6.75-17.00) in the control group (difference, 5.00 [IQR, 2.00-8.00]; P < .001). For the first hierarchical secondary end point, new lesion volume after TAVI was lower in the filter group (242 mm3 [95% CI, 159-353]) vs in the control group (527 mm3 [95% CI, 364-830]) (difference, 234 mm3 [95% CI, 91-406]; P = .001). Considering adverse events, 1 patient in the control group died prior to the 30-day visit. Life-threatening hemorrhages occurred in 1 patient in the filter group and 1 in the control group. Major vascular complications occurred in 5 patients in the filter group and 6 patients in the control group. One patient in the filter group and 5 in the control group had acute kidney injury, and 3 patients in the filter group had a thoracotomy.
Conclusions and Relevance: Among patients with severe aortic stenosis undergoing TAVI, the use of a cerebral protection device reduced the frequency of ischemic cerebral lesions in potentially protected regions. Larger studies are needed to assess the effect of cerebral protection device use on neurological and cognitive function after TAVI and to devise methods that will provide more complete coverage of the brain to prevent new lesions.

Authors
Stephan Haussig; Norman Mangner; Michael G Dwyer; Lukas Lehmkuh; Christian Lücke; Felix Woitek; David M Holzhey; Friedrich W Mohr; Matthias Gutberlet; Robert Zivadinov; Gerhard Schuler; Axel Linke

JAMA material
JAMA Surgery abstract
JAMA Surgery editorial


Receive Medical Brief's free weekly e-newsletter



Related Posts

Thank you for subscribing to MedicalBrief


MedicalBrief is Africa’s premier medical news and research weekly newsletter. MedicalBrief is published every Thursday and delivered free of charge by email to over 33 000 health professionals.

Please consider completing the form below. The information you supply is optional and will only be used to compile a demographic profile of our subscribers. Your personal details will never be shared with a third party.


Thank you for taking the time to complete the form.