Performance and safety of 3D intracardiac echocardiography
The prospective, non-randomized, multi-center, observational study*** into the safety and performance of Philips 3D Intracardiac Echocardiography Catheter (ICE) – VeriSight Pro – was led by Dr. Mohamad Alkhouli at Mayo Clinic School of Medicine. The study was based on a cohort of 155 patients evaluated for a range of percutaneous cardiac intervention procedures, including left atrial appendage occlusion (LAAO), cardiac ablation, heart valve replacement, and patent foramen ovale (PFO) as well as atrial septal defect (ASD) ‘hole-in-the-heart’ repair procedures.
Compared to TEE, which involves passing an ultrasound transducer deep into the patient’s esophagus, an ICE catheter has a tip-mounted ultrasound transducer that can be routed to the heart via the patient’s blood vessels and a small incision in the skin. For the majority of patients, ICE is considerably more comfortable than TEE and requires less sedation or anesthesia, improving patient safety and experience and reducing the number of operating room staff required during a procedure.
During the study, patients were followed until discharge or 48 hours after their procedure, with safety demonstrated by the fact that no periprocedural device-related adverse events were reported. Philips VeriSight Pro 3D ICE demonstrated acceptable or better image quality compared to TEE or competitive ICE technology in over 95% of the procedures. VeriSight Pro 3D ICE was considered to be an acceptable or better surrogate to TEE 89.7% of the time.
All three clinical studies are part of more than 110 ongoing clinical studies that support Philips image-guided therapy solutions with clinical evidence. For ten consecutive years, Philips has been recognized as a top innovator in the Clarivate Top 100 Global Innovator list.
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*Supported by a research grant from Philips. Philips had no role in the design of the study or conduct of the analysis.
**In the Secemsky study, the Hazard Ratio of 0.96 implies that patients undergoing PCI using angiography and IVI imaging during PCI have a 4% lower risk of dying during the following year than patients undergoing PCI using angiography alone.
***Philips sponsored and developed the Philips Intracardiac Echocardiograhy (ICE) Clinical Registry, NCT 04950192
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