Can cerebral embolic protection devices reduce the incidence of stroke after surgical aortic valve replacement?
In this randomized clinical trial that included 383 patients, there was no significant difference in freedom from central nervous system infarction between suction-based extraction and a standard aortic cannula (32.0% vs 33.3%, respectively) or between intra-aortic filtration and a standard aortic cannula (25.6% vs 32.4%, respectively).
The incidence of central nervous system infarction after surgical aortic valve replacement was not altered by either of the 2 cerebral embolic protection devices.
Stroke is a major complication of surgical aortic valve replacement (SAVR).
To determine the efficacy and adverse effects of cerebral embolic protection devices in reducing ischemic central nervous system (CNS) injury during SAVR.
Design, Setting, and Participants
A randomized clinical trial of patients with calcific aortic stenosis undergoing SAVR at 18 North American centers between March 2015 and July 2016. The end of follow-up was December 2016.
Use of 1 of 2 cerebral embolic protection devices (n = 118 for suction-based extraction and n = 133 for intra-aortic filtration device) vs a standard aortic cannula (control; n = 132) at the time of SAVR.
Main Outcomes and Measures
The primary end point was freedom from clinical or radiographic CNS infarction at 7 days (± 3 days) after the procedure. Secondary end points included a composite of mortality, clinical ischemic stroke, and acute kidney injury within 30 days after surgery; delirium; mortality; serious adverse events; and neurocognition.
Among 383 randomized patients (mean age, 73.9 years; 38.4% women; 368 [96.1%] completed the trial), the rate of freedom from CNS infarction at 7 days was 32.0% with suction-based extraction vs 33.3% with control (between-group difference, −1.3%; 95% CI, −13.8% to 11.2%) and 25.6% with intra-aortic filtration vs 32.4% with control (between-group difference, −6.9%; 95% CI, −17.9% to 4.2%). The 30-day composite end point was not significantly different between suction-based extraction and control (21.4% vs 24.2%, respectively; between-group difference, −2.8% [95% CI, −13.5% to 7.9%]) nor between intra-aortic filtration and control (33.3% vs 23.7%; between-group difference, 9.7% [95% CI, −1.2% to 20.5%]). There were no significant differences in mortality (3.4% for suction-based extraction vs 1.7% for control; and 2.3% for intra-aortic filtration vs 1.5% for control) or clinical stroke (5.1% for suction-based extraction vs 5.8% for control; and 8.3% for intra-aortic filtration vs 6.1% for control). Delirium at postoperative day 7 was 6.3% for suction-based extraction vs 15.3% for control (between-group difference, −9.1%; 95% CI, −17.1% to −1.0%) and 8.1% for intra-aortic filtration vs 15.6% for control (between-group difference, −7.4%; 95% CI, −15.5% to 0.6%). Mortality and overall serious adverse events at 90 days were not significantly different across groups. Patients in the intra-aortic filtration group vs patients in the control group experienced significantly more acute kidney injury events (14 vs 4, respectively; P = .02) and cardiac arrhythmias (57 vs 30; P = .004).
Conclusions and Relevance
Among patients undergoing SAVR, cerebral embolic protection devices compared with a standard aortic cannula did not significantly reduce the risk of CNS infarction at 7 days. Potential benefits for reduction in delirium, cognition, and symptomatic stroke merit larger trials with longer follow-up.
clinicaltrials.gov Identifier: NCT02389894
eAppendix 1. Devices and their Deployment
eAppendix 2. Outcomes and Ascertainment
eAppendix 3. Statistical Information
eFigure. Relative Risk of "Large Volume" Infarcts for Each Treatment Device Compared to Control
eTable 1. Baseline and operative characteristics
eTable 2. Incidence of Clinical or Radiographic CNS Infarction at 7 Days Post procedure Assuming Various Missing Data Mechanisms
eTable 3. Unadjusted and Adjusted Odds Ratios of Clinical or Radiographic CNS Infarction at 7 Days Post procedure
eTable 4. Neurocognitive Decline at 90 Days by Domain
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