Early single center experience with cerebral embolic protection in high-risk cardiac surgery
Isaac George1,2, Mateusz Kachel3,4, Maximilian Reisinger3
1Division of Cardiac, Thoracic and Vascular Surgery, New York-Presbyterian Hospital, Columbia University Medical Center, NYP 177 Ft. Washington Avenue Garden North, Floor 7, New York, NY, 10032, USA. ig2006@cumc.columbia.edu.
Insights
Cerebral embolic protection (CEP) devices are feasible and safe for high-risk cardiac surgery. These devices captured debris and showed no significant neurological deficits, suggesting improved outcomes.
Area of Science:
- Cardiovascular Surgery
- Neurology
- Medical Devices
Background:
- Perioperative stroke is a significant risk in cardiac surgery.
- Cerebral embolic protection (CEP) devices are emerging tools to mitigate this risk.
- Limited studies exist on CEP device use in high-risk cardiac surgery.
Purpose of the Study:
- To analyze the feasibility, safety, and efficacy of using the Sentinel CEP device.
- To evaluate CEP device performance in high-risk cardiac surgery patients.
Main Methods:
- Ten high-risk patients with valvular heart disease or failed bioprosthesis underwent open-heart surgery.
- The Sentinel CEP device was used during all procedures.
- Device deployment, recapture, and any complications were recorded.
Main Results:
- The Sentinel CEP device was successfully deployed and recaptured in all cases.
- No Sentinel-related complications occurred, and significant calcium debris was captured.
- No major neurological deficits (NIHSS > 5) were observed; however, other postprocedural complications occurred in nine patients.
Conclusions:
- The Sentinel CEP device is feasible and safe for high-risk cardiac surgery.
- CEP devices may reduce periprocedural embolic events and improve outcomes, especially in high-risk subsets.
Abstract:
Cerebral embolic protection (CEP) devices may be a tool to mitigate the perioperative stroke risk in cardiac surgery. However, studies are limited. The aim of this study was to analyze the feasibility, safety, and efficacy of CEP use in high-risk cardiac surgery. Ten high-risk surgical candidates with native valvular heart disease (mainly mitral with severe MAC) or failed bioprosthesis were consecutively enrolled between March 2023 and April 2024. All participants underwent open-heart surgery with use of Sentinel CEP. The CEP device was successfully deployed and recaptured in all cases without any Sentinel-related complications reported. Clearly visible, large deposits of calcium debris were captured. No significant neurological deficits (above mild neurological dysfunction; NIHSS > 5) were reported in any of the patients. Nine patients suffered postprocedural complications ranging from new-onset left bundle branch block to cardiogenic shock. One individual gradually deteriorated and ultimately died. Importantly, her neurological status remained intact throughout the course of the hospitalization. All other patients were discharged in good standing. The current study extends the early experience demonstrating the feasibility and safety of Sentinel CEP in high-risk cardiac surgery. Particularly in the highest-risk patient sub-sets CEP devices may offer advantages reducing the risk of periprocedural episodes and improving outcomes.
