Feature | September 06, 2013| Steven L. Higgins, M.D., FHRS

Integrating Fluoroscopy Into 3-D Mapping Reduces Radiation During Catheter Ablation

New technology to help reduce X-ray dose during long EP procedures

Carto 3, Biosense Webster, CartoUnivu

Figure 1. The Carto 3 System generates real-time 3-D maps and allows visualization of catheters in the cardiac anatomy during catheter ablation procedures.

Figure 2. The CartoUnivu module integrates a static fluoroscopic image with a 3-D map generated from the Carto 3 System, enabling a seamless view of the cardiac structures.

Nationwide data show that although only about 12 percent of X-ray exams are for interventional cardiology or electrophysiology (EP) procedures, nearly 50 percent of a patient’s lifetime radiation exposure comes from the cardiovascular labs. In an effort to reduce this level of patient radiation exposure, Scripps Prebys Cardiovascular Institute, part of Scripps Memorial Hospital and Scripps Green Hospital, evaluated Biosense Webster’s CartoUnivu module for the Carto 3 System (Figure 1) before it was made commercially available earlier this year. Researchers looked for its potential benefits in reducing radiation exposure to patients and clinical staff. 
 
Methods
The CartoUnivu module provides for fixed fluoroscopic images or cines to be transferred to the 3-D electro-anatomic mapping system. The module allows for real-time visualization of intracardiac catheters against a background of a stored fluoroscopic image (Figure 2). Typically, multiple fluoroscopic images (three to eight) are acquired at different angulations and stored. Once transferred, the fluoro image is integrated into the 3-D map view, allowing the user to create an electo-anatomical map on top of the captured fluoroscopic image or looping cine. Not only does this proved fluoroscopic images for reference, our electrophysiologists consistently commented that it diminished the interest in confirming catheter location with additional fluoroscopy.
 
Researchers performed a retrospective evaluation of the impact of this new technology on radiation usage. We reviewed our first 31 CartoUnivu cases from two EP laboratories and compared the procedure and fluoroscopy times to 96 procedures for six months using traditional mapping and fluoroscopy methods, matched by operator (total of eight). The 137 patients included in the study were referred for either pulmonary vein isolation (PVI) procedures for atrial fibrillation (18 study, 51 controls), cavotricuspid isthmus block for atrial flutter (8 study, 33 controls), supraventricular tachycardia ablation, either atrioventricular nodal reentrant tachycardia (AVNRT) or Wolff–Parkinson–White syndrome (WPW) (six study, 23 controls) or ventricular tachycardia (VT) (three study, six controls). The study was approved by the Scripps Institutional Review Board; all data was de-identified for confidentiality.
 
Results
Cumulative for all procedures, researchers found that the average procedure duration for the CartoUnivu module assisted studies was 254±31 minutes versus 267±85 for the retrospective control group (p=NS). However, the average fluoroscopy times for the CartoUnivu studies were 22±19 minutes versus 60±27 minutes for the comparison group (p<.0001). The fluoroscopy dosage was 1,453 cGy/cm² for the CartoUnivu module versus 3,593 cGy/cm² in controls (p<.0001). The average reduction in fluoroscopy time was 64 percent and dosage 60 percent with the CartoUnivu approach.
 
The retrospective comparison has limitations as the new focus on reduced radiation usage impacted physician behavior with the new CartoUnivu module. Nevertheless, once mastered, the learning curve inherent with the new system would suggest an opportunity to further diminish radiation usage. Researchers evaluated the findings by operator and procedure. Every operator (n=8) has lower radiation usage with the CartoUnivu module. The radiation reduction was observed in all ablation procedures, though it was more pronounced in the complex cases (PVI and VT).
 
Conclusion
In a non-randomized retrospective review, researchers found a statistically significant 64 percent reduction in fluoroscopy times and 60 percent in dosages (p<.0001) for EP ablation procedures utilizing the CartoUnivu module fluoroscopic integration system as compared to traditional fluoroscopy supplemented with similar 3-D mapping. The availability of a fluoroscopic image to be stored and superimposed into the 3-D electro-anatomic mapping system resulted in less need for fluoroscopic confirmation of landmarks and catheter positions. They predict that this CartoUnivu module will reduce physician dependence on fluoroscopic imaging and thus diminish radiation exposure for patients, physicians and staff. If these data are confirmed, patient safety will be positively impacted by this new technology.
 
Editor’s note: Steven L. Higgins, M.D., FHRS, chairman, department of cardiology, director of electrophysiology, Scripps Memorial Hospital, La Jolla, Calif. He is a paid consultant to Biosense Webster. The Scripps Prebys Cardiovascular Institute combines the expertise of Scripps Memorial Hospital and Scripps Green Hospital, with a skilled team of nearly 100 cardiologists. Scripps was recently designated as No. 20 in the U.S. News Top-Ranked Hospitals for cardiology and heart surgery.

Related Content

Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Technavio Projects 9 Percent Global Growth for Electrophysiology Therapeutic Devices

Image courtesy of Technavio

News | EP Lab| September 11, 2017
September 11, 2017 — According to the latest market study released by Technavio, the global...
LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

Feature | Left Atrial Appendage (LAA) Occluders| September 07, 2017
September 7, 2017 — Closure of the left atrial appendage (LAA) during heart surgery protects the brain, according to
EMANATE Trial Shows Apixaban Lowers stroke in AF Patients Undergoing Cardioversion.
News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Apixaban lowers the risk of stroke compared to warfarin in anticoagulation-naïve patients with at
CASTLE-AF Study shows Catheter Ablation of Atrial Fibrillation is First-Line Treatment for Heart Failure Patients. Biotronic Ilivia 7 ICD.

The CASTLE-AF Study shows catheter alation of AF can be used effectively to treat heart failure in patients with an implanted ICD.

News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Final results from the CASTLE-AF study show a 38 percent reduction in the composite of all-cause
Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices

Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices.

Feature | EP Lab| August 29, 2017 | Dave Fornell
August 29, 2017 — The U.S.
Real-World Analysis Compares Safety, Effectiveness of Apixaban Versus Warfarin
News | Antiplatelet and Anticoagulation Therapies| August 28, 2017
August 28, 2017 — Bristol-Myers Squibb Company and Pfizer Inc.
Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.
Feature | Cybersecurity| August 16, 2017 | Dave Fornell
There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology
Overlay Init