Northside Hospital Heart Institute successfully completed its first left-sided intracardiac thrombectomy using the Emboliner Embolic Protection Catheter, a protection device under a one-time emergency use authorization, marking a major advancement in the hospital’s structural heart and interventional cardiology capabilities.
The device manufacturer authorized emergency use of the device, which has completed its clinical trial phase and is currently under FDA review. This procedure marked the first use of the device at Northside Hospital Gwinnett and the state of Georgia, and the first use outside of a completed clinical trial site in the United States.
With less than 24 hours’ notice, Northside leaders and teams across the system mobilized to ensure the procedure could proceed. Northside leaders and teams across the system mobilized to ensure the procedure could proceed safely and in compliance with federal regulatory guidelines.
The patient was admitted to Northside Gwinnett with a large ischemic stroke after recently undergoing a transcatheter mitral valve replacement at another facility. Advanced intracardiac imaging identified a large mass attached to a septal occluder device, raising concern for thrombus and possible infection.
Due to significant comorbidities, the patient was not a candidate for open-heart surgery and was referred to the Structural Heart Team for a high-risk intracardiac thrombectomy.
“This patient was critically ill, and the complexity of the procedure required close collaboration and careful planning,” said Dr. Rahil Rafeedheen, interventional cardiologist with the Northside Hospital Heart Institute.
The team used the Emboliner®, which provides whole-body embolic protection by capturing debris in the ascending aorta before it can reach vital organs. Unlike currently FDA-approved devices that provide cerebral protection only, this device offers systemic protection during high-risk intracardiac procedures.
The procedure was completed successfully. Pathology confirmed thrombus, and cultures identified Serratia, validating the team’s treatment approach. The patient was extubated postoperatively, recovered well, and is currently awaiting discharge to cardiac rehabilitation.
The case involved collaboration among interventional and structural cardiology, cardiac anesthesiology, cardiac surgery, general cardiology, hospital administration, IRB’s legal counsel, and the clinical research team.
“This complex case was an exceptional example of teamwork and assembling resources across the system to ensure the patient received timely and excellent care,” said Dr. Michele Voeltz, Northside Hospital Heart Institute interventional cardiologist. “This case is merely the beginning of the amazing things we can accomplish at Northside.”
This case highlights the continued growth of Northside Hospital Heart Institute and Northside Gwinnett’s ability to deliver advanced cardiac care close to home.
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