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Biosense Webster
Clinical Evidence
Biosense Webster is committed to the dissemination of scientific evidence in peer-reviewed journals. We are proud of our track record of publishing cutting-edge clinical research that fuels the development of devices, which provide novel alternatives for the treatment of complex heart arrhythmias.
The PRECEPT Prospective, Multicenter, Nonrandomized Study
Persistent atrial fibrillation ablation with contact Force-Sensing catheter: The prospective multicenter PRECEPT trial
Mansour M, et al. JACC Clin Electrophysiol. 2020;6(8):958-969.
PRECEPT evaluated the safety/effectiveness of persistent atrial fibrillation ablation with contact force-sensing THERMOCOOL SMARTTOUCH® SF Catheter and CARTO VISITAG™ Module using a tailored PVI-only/PVI+ approach. 80% of patients experienced clinical success at 15 months.
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.
156596-201021