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ICE Meta-Analysis
The Use of Intracardiac Echocardiography (ICE) Catheters in Endocardial Ablation of Cardiac Arrhythmia: Meta-Analysis of Efficiency, Effectiveness, and Safety Outcomes
Goya M, et al. J Cardiovasc Electrophysiol. 2020;31(3):664-673.
A systematic literature review and meta-analysis of 19 studies compared outcomes of cardiac arrythmia ablations performed with and without the use of ICE.
Use of ICE was associated with a significant:
- 6.95 mean reduction in fluoroscopy time
- 15.2 mean reduction in procedure time
- Reduction in fluoroscopy dose

Cardiac Perforation With Catheter Ablation
Predictors of Cardiac Perforation With Catheter Ablation of Atrial Fibrillation
Friedman DJ, et al. JACC Clin Electrophysiol. 2020;6(6):636-645.
This retrospective, observational cohort study identified factors associated with cardiac perforation occurrence during catheter ablation for atrial fibrillation.
Cardiac perforation predictors:
- 1.3× greater odds of perforation for female sex
- 1.4× greater odds of perforation for obesity
- 4.9× lower odds of perforation with use of ICE
- 0.1× lower odds of perforation with prior cardiac surgery

SMART SF Study
Safety and Efficiency of Porous-Tip Contact-Force Catheter for Drug-Refractory Symptomatic Paroxysmal Atrial Fibrillation Ablation: Results From the SMART SF Trial
Chinitz LA, et al. Europace. 2018;20(Fl_3):f392-f400.
Long-Term Safety and Effectiveness of Paroxysmal Atrial Fibrillation Ablation Using a Porous Tip Contact Force-Sensing Catheter From the SMART SF Trial
Natale A, et al. J Interv Card Electrophysiol. 2020 May 27. doi: 10.1007/s10840-020-00780-4. Online ahead of print.
The multicenter, nonrandomized SMART SF evaluated the safety and efficiency of the THERMOCOOL SMARTTOUCH® SF Catheter with CARTO VISITAG™ Module for symptomatic, drug refractory paroxysmal atrial fibrillation.
SMART SF study outcomes:
- 96.2% acute procedural effectiveness
- 2.5% primary adverse event rate
- 74.9% freedom from recurrence at 12-months

Atrioesophageal Fistula Safety
Comparing Rates of Atrioesophageal Fistula With Contact Force-Sensing and Non-Contact Force-Sensing Catheters: Analysis of Post-Market Safety Surveillance Data
Calkins H, et al. J Interv Card Electrophysiol. 2020;59(1):49-55.
A retrospective data analysis determined atrioesophageal fistula rates associated with the use of contact force-sensing and non-contact force-sensing catheters.
Retrospective analysis outcomes:
- Contact force-sensing catheters were used 2 to 5 times more frequently in left atrial procedures
- Atrioesophageal fistula rates: 0.006% for contact force-sensing catheters versus 0.005% for non-contact force-sensing catheters
- Atrioesophageal fistula events are associated with the use of high power, high force, and long radiofrequency duration
Additional Clinical Evidence
- Field ME, Gold MR, Reynolds MR, et al. Real-world outcomes of ventricular tachycardia catheter ablation with versus without intracardiac echocardiography. J Cardiovasc Electrophysiol. 2020;31(2):417-422.
- Field ME, Goldstein L, Lee SHY, et al. Intracardiac echocardiography use and outcomes after catheter ablation of ventricular tachycardia. J Comp Eff Res. 2020;9(5):375-385.
- Macle L, Frame D, Gache LM, et al. Atrial fibrillation ablation with a spring sensor-irrigated contact force-sensing catheter compared with other ablation catheters: Systematic literature review and meta-analysis. BMJ Open 2019;9(6):e023775.
- Pollak SJ, Goldstein L, Daskiran M, Kalsekar I, Khanna R. Economic impact of atrial fibrillation ablation with radiofrequency contact force catheter versus cryoballoon catheter. J Comp Eff Res. 2019;8(4):251-264.
- Osorio J, Imhoff RJ, Mallow PJ, et al. Cost minimization analysis of catheter ablation for paroxysmal atrial fibrillation by catheter technology. J Comp Eff Res. 2019;8(4):241-249.
- Friedman DJ, Pokorney SD, Khanna R, et al. Catheter ablation of atrial fibrillation with and without on-site cardiothoracic surgery. J Am Coll Cardiol. 2019;73(19):2487-2489.
- Zei PC, Hunter TD, Gache LM, O'Riordan G, Baykaner T, Brodt CR. Low-fluoroscopy atrial fibrillation ablation with contact force and ultrasound technologies: A learning curve. Pragmat Obs Res. 2019;10:1-7.
- De Potter T, Van Herendael H, Balasubramaniam R, et al. Safety and long-term effectiveness of paroxysmal atrial fibrillation ablation with a contact force-sensing catheter: Real-world experience from a prospective, multicentre observational cohort registry. Europace. 2018;20(FI_3):f410-f418.
- Jarman JWE, Hussain W, Wong T, et al. Resource use and clinical outcomes in patients with atrial fibrillation with ablation versus antiarrhythmic drug treatment. BMC Cardiovasc Disord. 2018;18(1):211.
- Reddy VY, Pollak S, Lindsay BD, et al. Relationship between catheter stability and 12-month success after pulmonary vein isolation: a subanalysis of the SMART-AF Trial. JACC Clin Electrophysiol. 2016;2(6):691-699.
- Marchlinski FE, Haffajee CI, Beshai JF, Dickfeld T-ML, Gonzalez MD, Hsia HH, et al. Long-term success of irrigated radiofrequency catheter ablation of sustained ventricular tachycardia: Post-approval THERMOCOOL VT trial. J Am Coll Cardiol. 2016;67(6):674-683.
- Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, et al. Paroxysmal AF catheter ablation with a contact force-sensing catheter: Results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014;64(7):647-56.
- Oza SR, Hunter TD, Biviano AB, et al. Acute safety of an open-irrigated ablation catheter with 56-hole porous tip for radiofrequency ablation of paroxysmal atrial fibrillation: analysis from 2 observational registry studies. J Cardiovasc Electrophysiol. 2014;25(8):852-858.
- Waldo AL, Wilber DJ, Marchlinski FE, et al. Safety of the open-irrigated ablation catheter for radiofrequency ablation: safety analysis from six clinical studies. Pacing Clin Electrophysiol. 2012;35(9):1081-1089.
- Wilber DJ, Pappone C, Neuzil P, et al. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: A randomized controlled trial. JAMA. 2010;303(4):333-340.
- Stevenson WG, Wilber DJ, Natale A, et al. Irrigated radiofrequency catheter ablation guided by electroanatomic mapping for recurrent ventricular tachycardia after myocardial infarction: The multicenter Thermocool Ventricular Tachycardia Ablation trial. Circulation. 2008;118(25):2773-2782.
In the US, THERMOCOOL® Navigation Catheters are indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® 3 Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter).
The THERMOCOOL SMARTOUCH® SF Catheter is indicated for drug refractory recurrent symptomatic persistent atrial fibrillation (AF) (continuous AF >7 days but <1 year), refractory or intolerant to at least 1 Class I or III AAD, when used with the CARTO® 3 System.
The CARTO VISITAG™ Module provides access to data collected during the application of RF energy. The data does not indicate the effectiveness of RF energy application. CARTO VISITAG™ Module settings are user defined based on the user’s clinical experience and medical judgment. Biosense Webster, Inc. does not recommend any settings for the CARTO VISITAG™ Module.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions. Caution: US law restricts this device to sale by or on the order of a physician.
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