News | EP Lab | August 05, 2021| By Dave Fornell, Editor

First-in-Human Experience With Novel 4D ICE Catheter For Catheter Ablation and LAA Closure Procedures

HRS 2021 late-breaking study shows utility of 3D/4D intracardiac echo image guidance for EP procedures

An example from the study of the Biosense Webster NuVision 3D/4D ICE imaging capability showing the left atrial appendage (LAA) visualization on 3D ICE. The system allows the user to place a false lighting source to be placed in different positions to change the lighting and shadows to better visualize the anatomy.

An example from the study of the Biosense Webster NuVision 3D/4D ICE imaging capability showing the left atrial appendage (LAA) visualization on 3D ICE. The system allows the user to place a false lighting source to be placed in different positions to change the lighting and shadows to better visualize the anatomy. 

August 5, 2021 —  A prospective, non-randomized, multicenter, first-in-human clinical study found good diagnostic and procedural guidance value using a new 3D/4D intracardiac echo (ICE) imaging catheter in radio frequency and cryo-ablation procedures, and left atrial appendage (LAA) occlusion procedures. The study of the new Biosense Webster NuVision ICE catheter was presented at the 2021 Heart Rhythm Society (HRS) meeting. 

The catheter effectively guided transeptal puncture in all attempts, and image quality and catheter performance were rated by operators as very good in 82% of patients, explained lead author Vivek Y. Reddy, M.D., director, cardiac arrhythmia service, Icahn School of Medicine at Mount Sinai, New York. Overall, he said the 4D ICE catheter is a safe and effective visualization tool to guide a variety of electrophysiology procedures with multiplanar imaging.

The novel 4D ICE catheter is capable of real-time volumetric imaging with a 90° x 90° field of view, both 2D and 4D Color Doppler flow ability, independent distal tip rotation and penetration depth up to ~15 cm. The catheter was designed to allow multiplanar visualization of target cardiac structures with facile, minimal catheter manipulation. 

"Our data support a growing shift in the electrophysiology field toward multiplanar imaging catheters that can offer operators a clearer look at a patient's heart and enhance their field of view when performing life-saving procedures," Reddy explained. "For patients, this technology provides the most comprehensive look at their heart, helping to ensure their physician can provide optimal outcomes."

3D/4D ICE is a New Imaging Technology

For years, 2D ICE has been a standard imaging technology in the electrophysiology (EP) and cath labs, because it enables light sedation compared to full sedation required for use of transesophageal echo (TEE). However, until now it has been limited to only 2-D imaging, while TEE has offered live 3D/4D imaging, so it was easier in understand the anatomy being imaged. This new version of ICE offers live 3D/4D imaging using the Biosense Webster NuVision Ultrasound Catheter that operates using GE Healthcare Vivid Ultra Edition ultrasound systems. 

Philips in 2021 also released the new VeriSight Pro ICE catheter, which offers superior 2-D and 3-D live image guidance for EP and structural heart procedures, which recently saw first use in the United States at Mayo Clinic and Northwestern Medicine.

Biosense Webster 4D Ice First-in-Human Study

The study was conducted by 9 operators at 2 European clinical sites. The 10 French catheter was introduced into the right atrium (RA) via femoral vein access, and imaging was performed from the RA, coronary sinus, or directly from within the left atrium, after manipulating the catheter through a transeptal puncture hole dilated with a 12 French sheath (n=2). Primary and secondary safety endpoints were absence of: i) unanticipated AEs or procedure/device related AEs, and ii) all device or procedure-related AEs. 

Primary and secondary performance endpoints were ability to provide adequate imaging for procedural completion. Secondary performance endpoint was positive user questionnaire responses of 2D/3D images. 

In 28 patients (age 59±15 yrs, 25% F), the 4D ICE catheter was used to guide either LAA closure (n=2: one each - Watchman-FLX and Amulet) or catheter ablation of AF (cryoballoon, n=8; RFA, n=12) or other arrhythmias (PVC / VT / SVT / WPW; n=6). All safety and performance endpoints were met in all patients. 

Reddy said the next steps are to gather further data on reproducible image acquisition, safety outcomes, and hospital resource utilization will be collected. 

The study researchers included Vivek Y. Reddy, M.D., Icahn School of Medicine at Mount Sinai, New York; Petr Neuzil M.D., Na Homolce Hospital, Prague, Czech Republic; Shephal K. Doshi, M.D., Pacific Heart Institute, Santa Monica, Cailf; Brett Gidney, M.D., Santa Barbara Cottage Hospital, Santa Barbara, Calif.;  Andrea Natale, M.D., and Amin Al Ahmad, M.D., St. David’s Medical Center, Austin, Texas; Miguel Valderrabano, M.D., Ph.D., Houston Methodist Medical Center, Houston, Texas; Gediminas Rackauskas, M.D., Ph.D., and Audrius Aidietis, M.D., Ph.D. Centre for Cardiology and Angiology, Department of Cardiovascular Diseases, Vilnius University, Lithuania.

 

Related Intra-cardiac Echo Content:

Northwestern Medicine First in U.S. to Use Live 3D Intracardiac Echo for EP Procedure

Mayo Clinic First to Use Next Generation 4D ICE System to Guide Structural Heart Procedures

Trends and Advancements in Intra-cardiac Echo Imaging Systems

Intra-Cardiac Echo Aids EP Ablations, Structural Heart Procedures

Intracardiac Echo Should be More Widely Adopted to Minimize Radiation in Catheter Ablations

Conavi Medical Receives FDA Clearance for Feature Expansion on Foresight Intracardiac Echocardiography System

Find more ICE content

 

 

Related Content

A comparison of color-flow Doppler cardiac ultrasound showing blood flow, and blood speckle tracking revealing a more detailed and complex understanding of the low. It shows the formation of a vortex that may play a role in future assessments for the efficiency of flow in the heart and vessels. #ASE21 #ASE2021 #Vectorflowimaging

A comparison of color-flow Doppler cardiac ultrasound showing blood flow, and blood speckle tracking revealing a more detailed and complex understanding of the flow. It shows the formation of a vortex that may play a role in future assessments for the efficiency of flow in the heart and vessels. Image from JASE, read more.

Feature | Cardiac Imaging | August 17, 2021 | By Dave Fornell, Editor
In the past several years, a few ca...
A cardiac MRI of athletes who had COVID-19 is seven times more effective in detecting inflammation of the heart than symptom-based testing, according to a study led by researchers at The Ohio State University Wexner Medical Center and College of Medicine with 12 other Big Ten programs.

Cardiac Magnetic Resonance Imaging in Athletes With Clinical and Subclinical Myocarditis A-D, Athlete A with subclinical possible myocarditis was asymptomatic with normal electrocardiogram (ECG), echocardiogram, and high-sensitivity troponin findings. A, T2 mapping showing elevated T2 in basal-mid inferolateral wall in short axis view. B, late gadolinium enhancement (LGE) in the basal inferolateral wall in short axis view. C, Postcontrast steady state-free precession (SSFP) images showing contrast uptake in the basal-mid inferolateral wall in short axis view. D, LGE in the inferolateral wall in 3-chamber view. E-H, Athlete B with subclinical probable myocarditis was asymptomatic with normal ECG, normal echocardiogram, and elevated high-sensitivity troponin findings. E, T2 mapping showing elevated T2 in the anteroseptal wall in short axis view. F, LGE in the anteroseptal wall in 3-chamber view. G, T2 mapping showing elevated T2 in the anteroseptal wall in 3-chamber view. F, Postcontrast SSFP image showing pericardial effusion in short axis view. I-K, Athlete C with clinical myocarditis and chest pain, dyspnea, abnormal ECG, normal echocardiogram, and normal troponin findings. I, T2 mapping showing elevated T2 in the lateral wall short axis view. J, Postcontrast SSFP images showing contrast uptake in midlateral wall in short axis view. K, LGE in the epicardial midlateral wall in short axis view. L-N, Athlete D with clinical myocarditis, chest pain, abnormal ECG, echocardiogram, and troponin findings. L, T1 mapping showing elevated native T1 in midlateral wall in short axis view. M, T2 mapping showing elevated T2 in the midlateral wall in short axis view. N, LGE in the epicardial midlateral wall in short axis view. IR indicates inferior right view; IRP, inferior, right, posterior view; PLI, posterior, left, inferior view; SL, superior left view; SLA, superior, left, anterior view. Image courtesy of JAMA Cardiol. Published online May 27, 2021. doi:10.1001/jamacardio.2021.2065

News | Cardiac Imaging | June 15, 2021
June 15, 2021 — A...
Rensselaer algorithm can identify risk of cardiovascular disease using lung cancer scan #CT
News | Cardiac Imaging | June 14, 2021
June 14, 2021 — Heart disease and cancer are the ...
Women’s Heart Attack Research Program (HARP) shows combining OCT and cardiac MRI can detect the underlying cause of heart attack in women who did not have blocked arteries

The Women’s Heart Attack Research Program (HARP) study shows combining OCT and cardiac MRI can help detect the underlying cause of heart attacks in women who did not have blocked arteries.

News | Cardiac Imaging | November 17, 2020
November 17, 2020 — Diagnostic imaging techniques were able to find the underlying cause of heart attack in many wome
An example of a CT coronary artery calcium scoring exam showing how each vessel segment is scored to assess a patient's risk for a future heart attack. Example is from Philips Healthcare.

An example of a CT coronary artery calcium scoring exam showing how each vessel segment is scored to assess a patient's risk for a future heart attack. Example is from Philips Healthcare.

News | Cardiac Imaging | September 25, 2020
September 25, 2020 — A study out of University Hospitals (UH) found that removing the cost barrier for coronary arter
Rafael Rivero, M.D., Global Head of Medical Affairs at MSI, said: "The importance of MyoStrain cannot be understated because of the test's immense clinical value and ability to quantify intramyocardial dysfunction across 48 segments of the heart. In a six-heartbeat MRI scan, MyoStrain arms physicians with novel clinical information about a patient's heart health."
News | Cardiac Imaging | August 11, 2020
August 11, 2020 — Myocardial Solutions, Inc. and United Imaging, Inc.
The Mindways Solid phantom with volume of interest in the quality assurance phantom (red circles, left side). A participant's noncontrast-enhanced axial CT (right side) with volume of interest (yellow circles) in the trabecular bone compartment of three vertebrae for bone mineral density measurements. Image courtesy of Radiological Society of North America

The Mindways Solid phantom with volume of interest in the quality assurance phantom (red circles, left side). A participant's noncontrast-enhanced axial CT (right side) with volume of interest (yellow circles) in the trabecular bone compartment of three vertebrae for bone mineral density measurements. Image courtesy of Radiological Society of North America

News | Cardiac Imaging | July 15, 2020
July 15, 2020 — ...