Biosense Webster – Clinical Evidence

Clinical Evidence

Biosense Webster, Inc. 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 alternatives for the treatment of complex heart conditions.

Doctor looking at ultrasound

Atrial Fibrillation Ablation With a Spring Sensor-irrigated Contact Force Sensing Catheter Compared With Other Ablation Catheters: Systematic Literature Review And Meta-analysis

Macle L, Frame D, Gache LM, Monir G, Pollak SJ, Boo LM. BMJ Open 2019;9(6):e023775.

target

Objective

Atrial fibrillation technology comparison

THEMOCOOL SMARTTOUCH® Catheter versus other ablation technologies: Clinical effectiveness, procedure efficiency, and safety

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Methodology

  • Systematic literature review and meta-analysis 

  • 14,054 studies screened 

  • 34 studies included 

  • 5004 atrial fibrillation patients 

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Results

THEMOCOOL SMARTTOUCH® CATHETER ablation is associated with:

  • Approximately 1.5 increased odds - freedom from recurrent atrial arrhythmia at 12-months
  • Similar safety profile
  • 9.0% procedure time decrease and 18.7% fluoroscopy time decrease

The Industrialization Of Ablation: A Highly Standardized and Reproducible Workflow for Radiofrequency Ablation of Atrial Fibrillation

De Potter T, Hunter TD, Boo LM, et al. J Interv Card Electrophysiol. 2019 Oct 17. doi: 10.1007/s10840-019-00622-y [Epub ahead of print].

target

Objective

Standardization of AF ablation workflow 

THERMOCOOL SMARTTOUCH© CATHETER and VISITAG SURPOINT™: Efficiency and effectiveness evaluation 

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Methodology

  • Large retrospective real-world cohort study
  • 605 paroxysmal atrial fibrillation patients
  • 182 persistent atrial fibrillation patients
  • Standardized VISITAG SURPOINT™ settings for PVI: anterior 550, posterior 400
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Results

THERMOCOOL SMARTTOUCH© CATHETER with VISITAG SURPOINT™ atrial fibrillation ablation:

  • 86% and 74% freedom from recurrent atrial arrhythmia at 12-months for paroxysmal and persistent atrial fibrillation, respectively
  • 0 cases of stroke, cardiac tamponade or death
  • Short procedure time and low fluoroscopy exposure

Gains in Paroxysmal Atrial Fibrillation Ablation Using a Standardized Workflow to Optimize Contact Force Technologies

Osorio J, Hunter TD, Bubien RS, Rajendra A, Arciniegas J, Morales G. J Atr Fibrillation. 2018;11(4):2097.

target

Objective

Standardized paroxysmal atrial fibrillation ablation workflow 

THERMOCOOL SMARTTOUCH© with CARTO VISITAG™ Module versus prior technologies: Procedural efficiency and long-term clinical outcomes 

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Methodology

  • Retrospective real-world cohort study 

  • THERMOCOOL™ SF Catheter - 32 patients 

  • THERMOCOOL SMARTTOUCH© Catheter with standardized CARTO VISITAG™ Module - 232 patients 

  • Cryoballoon ablation - 59 patients 

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Results

THERMOCOOL SMARTTOUCH© CATHETER with VISITAG™ Module atrial fibrillation ablation:

  • Shortest procedure/fluoroscopy times and lowest radiation exposure
  • Similar safety profile
  • Lowest repeat procedure rate

Additional Clinical Evidence

  • 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

  • Chinitz LA, Melby DP, Marchlinski FE, et al. Safety and efficiency of porous-tip contact-force catheter for drug-refractory symptomatic paroxysmal atrial fibrillation ablation: results from the SMART SF trial. Europace. 2018;20(FI_3):f392-f400

  • De Potter T, Van Herendael H, Balasubramaniam R. 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.  

  • Marchlinski FE, Haffajee C, Beshai JF, 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

  • 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.  

  • Natale A, Reddy VY, Monir G, 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):647-656

  • 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

 

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