Results from EPD’s DURABLE-I clinical trial, whose principal investigator is Professor Evgeny A Pokushalov, were presented for the first time at the 2017 AF Symposium by Professor Karl-Heinz Kuck, Head of the Department of Cardiology at the Asklepios Klinik in Hamburg, Germany.
The presentation, “DURABLE-I Study: Real-time gap detection during AF ablation using dielectric sensing”, was given during the Friday afternoon session “Mapping and Ablation of Atrial Fibrillation I: Lesion Formation and Durability in AF Ablation”, moderated by Professor Douglas Packer.
“One of the biggest challenges today in isolating the pulmonary vein to create local lesions is reducing the number of gaps remaining after a successful and well validated ablation,” said Professor Kuck. “Recent studies have demonstrated that recurrences of AF post-PVI (pulmonary vein isolation) ablation are mostly attributed to a low rate of durability. In these studies, gaps were demonstrated in up to 70% of patients followed up two to three months post best practice ablations.”
EPD’s D700 dielectric sensing intra-cardiac system addresses this challenge by providing electrode-tissue contact quality, real-time lesion assessment and gap detection, for improved procedure efficacy and efficiency. The DURABLE-I, a single center, non-randomized study, performed at the Meshalkin State Research Institute of Circulation Pathology in Novosibirsk, Russia, included 20 paroxysmal AF patients and was designed to prospectively assess the D700 System’s gap detection accuracy.
A panoramic real-time visualization of η (ETA) during an index procedure from the DURABLE-I trial highlights a gap (red line) in the left atrial appendage (LAA) ridge that was correctly identified by EPD D700 yet undiagnosed by either electrical isolation test or adenosine infusion. Click here to watch the video.
All patients underwent conservative CARTO3-guided PVI procedures with the ThermoCool SmartTouch irrigated ablation catheter which measured contact-force. EPD’s D700 system was used to measure transmurality, contiguity, and permanency of ablation points and the ablation lines. PVI isolation was achieved in all patients and validated using electrical isolation and pharmacological tests. All patients returned for a repeated EP study, by the same operator, one month post-ablation. The spatial locations of the gaps at the follow-up procedure were compared to the locations of gaps identified by the D700 system at the time of the index (initial) procedure.
Analysis of the results indicates that, despite the state-of-the-art performance of the ablation procedure and strict electrical and pharmacological validation testing, 70% of the trial patients had gaps one month after the first procedure. EPD’s D700 correctly detected gaps in real time during the index ablation procedure in 7 out of the 14 patients.
“We are very excited about these results,” said Dr. Yitzhack Schwartz, Chief Medical Director at EP Dynamics Research. “In this case, an operator leveraging our real-time gap detection technology and treating these identified gaps before edema formation could have potentially reached durable isolation in 13 out of 20 patients (65%) instead of 6 patients (30%), thus significantly improving the efficacy of the procedure.”
About atrial fibrillation
Atrial fibrillation (AF) is an abnormal heart rhythm which is characterized by irregular and rapid beating. As the most common arrhythmia, it affects about 3% of the population in North America and Europe and is the second leading cause of stroke.
About EP Dynamics
EP Dynamics (EPD), a member of the Hobart Group companies, is dedicated to improving the efficacy and efficiency of minimally invasive catheter-based procedures performed to treat cardiac arrhythmias. EPD is developing a proprietary dielectric-based platform that enables the measurement of the permanency, transmurality and continuity of cardiac AF ablation lesions, thereby significantly improving the efficacy of AF ablation. The platform also provides an estimated ablation depth, reports catheter contact quality and gives an accurate 3D localization of EP catheters. For more information, please visit www.epd-medical.com.
About Hobart Group
The Hobart Group develops and commercializes medical technologies which target top healthcare markets with significant unmet needs. Its growing portfolio of companies covers the areas of cardiology, diabetes, oncology, neurology and rehabilitation. Together, Hobart Group companies have over 200 scientists, engineers, regulatory and business experts across four continents, benefitting from clinical expertise and extensive regulatory and international market knowledge across Europe, the USA and Asia. For more information, visit www.Hobart-Group.com.