A closer look at world’s first TAVR patient treated with new cerebral embolic protection device
A new cerebral embolic protection device (CEPD) that covers three vessels at once is safe to use during transcatheter aortic valve replacement (TAVR), according to new first-in-human data now published in JACC: Case Reports.[1]
While the first use of this device was previously announced, this is the first time a full analysis of the team's experience has been made available in an industry journal.
The EnCompass F2 device from Nevada-based EnCompass Technologies includes a self-expanding, cylindrical nitinol frame and an electrospun filter. It is deployed through the patient’s TAVR transfemoral access site. When deployed it covers the brachiocephalic artery, left common carotid artery and left subclavian artery. The delivery system and sheath are then removed, and deployment can take less than two minutes.
Prior CEPD technologies, including the Sentinal system from Boston Scientific, have been developed to catch debris during TAVR procedures and help reduce the patient’s stroke risk. However, these technologies have failed to consistently demonstrate the ability to improve long-term patient outcomes.
“The failure of existing CEPDs to reduce stroke in clinical trials may be attributable to insufficient sample size, varying degrees of stroke risk in enrolled subjects, inexperienced operators, or, importantly, ineffective CEPD,” wrote first author Isaac George, MD, a cardiothoracic surgeon and structural heart specialist with New York-Presbyterian Hospital, and colleagues. “As such, there remains an unmet clinical need for a safe and efficacious CEPD for widespread use in TAVR.”
Reviewing first-in-human data
George et al. detailed their first-in-human experience with this technology. The patient in question was a 70-year-old man with severe aortic stenosis and a medical history of hypertension, hyperlipidemia, nonobstructive coronary artery disease and peripheral artery disease. He had previously received a right common femoral artery stent.
The patient received a 26-mm Sapien 3 transcatheter heart valve from Edwards Lifesciences. The stent from an earlier procedure made left transfemoral artery access the preferred treatment approach.
There were no procedural complications during the patient’s TAVR. After 30 days, meanwhile, there was no evidence that the patient had experienced a stroke or any other adverse cardiac and cerebrovascular outcomes.
“This case also demonstrates the feasibility of performing CEPD for TAVR with access by a single femoral artery only,” the authors wrote.
The group also emphasized that EnCompass F2 device could potentially make the use of a CEPD suitable for a larger number of patients, “particularly those with significant vascular disease.”
More research already underway
The EnCompass F2 device has not received U.S. Food and Drug Administration approval. Clinical trials are currently underway to track the safety and effectiveness of this technology in more patients.
EnCompass Technologies did fund this first-in-human study. Also, George and senior author Tamim M. Nazif, MD, an interventional cardiologist with New York-Presbyterian Hospital, have worked as consultants for EnCompass Technologies.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.