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Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized
Michael J Mack1, Michael A Acker2, Annetine C Gelijns3
1Department of Cardiothoracic Surgery, Baylor Research Institute, Baylor Scott & White Health, Plano, Texas.
Insights
Cerebral embolic protection devices did not significantly reduce central nervous system (CNS) infarction after surgical aortic valve replacement (SAVR). Further research is needed to explore potential benefits for delirium and stroke.
Area of Science:
- Cardiovascular Surgery
- Neurology
- Medical Devices
Background:
- Stroke is a significant complication following surgical aortic valve replacement (SAVR).
- Cerebral embolic protection devices aim to mitigate central nervous system (CNS) injury during SAVR.
Purpose of the Study:
- To evaluate the efficacy and safety of cerebral embolic protection devices in reducing ischemic CNS injury during SAVR.
- To compare two types of embolic protection devices (suction-based extraction and intra-aortic filtration) against a standard aortic cannula.
Main Methods:
- A randomized clinical trial involving 383 patients undergoing SAVR at 18 North American centers.
- Patients were randomized to receive either suction-based extraction (n=118), intra-aortic filtration (n=133), or a standard aortic cannula (control, n=132).
- Primary endpoint was freedom from CNS infarction at 7 days; secondary endpoints included mortality, stroke, acute kidney injury, delirium, and neurocognition.
Main Results:
- No significant difference in freedom from CNS infarction at 7 days between embolic protection devices and the control group.
- The intra-aortic filtration group showed a higher incidence of acute kidney injury and cardiac arrhythmias compared to the control.
- A potential reduction in delirium was observed in both embolic protection device groups compared to the control.
Conclusions:
- Cerebral embolic protection devices did not significantly reduce CNS infarction in patients undergoing SAVR.
- Further investigation is warranted to explore potential benefits in reducing delirium, improving cognition, and decreasing symptomatic stroke.
- Larger trials with extended follow-up are recommended to fully assess the role of these devices.
Importance:
Stroke is a major complication of surgical aortic valve replacement (SAVR).
Objective:
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.
Interventions:
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.
Results:
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.
Trial Registration:
clinicaltrials.gov Identifier: NCT02389894.
