Clinical Evidence

Clinical Evidence

Biosense Webster, Inc. is committed to the dissemination of peer-reviewed scientific evidence. 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.

Biosense Webster, Inc. is committed to the dissemination of peer-reviewed scientific evidence. 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.

Summary image of OCTARAY™ Mapping Catheter first-in-human study

First-in-Human Experience With OCTARAY™ Mapping Catheter With TRUERef™ Technology

An early multicenter experience of the novel high-density star-shaped mapping catheter in complex arrhythmias 
J Interv Card Electrophysiol. 2022;64(1):223-232. 

First-in-human experience with OCTARAY™ Mapping Catheter with TRUERef™ Technology showed good safety profile and positive physician feedback 

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Summary image of study comparing radiofrequency and cryoballoon ablation outcomes

AF Ablation Outcomes in Patients Treated With Radiofrequency or Cryoballoon catheters

Atrial fibrillation ablation with advanced radiofrequency catheter versus second-generation cryoballoon catheter
J Comp Eff Res. 2022;11(9):659-668.

This retrospective cohort study examined costs and 12-month readmission of AF patients undergoing catheter ablation with THERMOCOOL SMARTTOUCH® SF Catheter or Arctic Front Advance™ cryoballoon catheter.

The study found that patients treated with THERMOCOOL SMARTTOUCH® SF Catheter experienced:

  • 21% lower supply cost
  • 10% lower combined procedural and readmission costs
  • 34% lower odds of 12-month AF-related inpatient readmissions

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Same-day discharge summary image

Same-Day Discharge of AF Ablation in Low-Risk Patients

Prospective implementation of a same-day discharge protocol for catheter ablation of paroxysmal atrial fibrillation.
Rajendra A, et al. J Interv Card Electrophysiol. Published online November 21, 2020. doi: 10.1007/s10840-020-00914-8.

This real-world study implemented a specific protocol to prospectively identify low-risk paroxysmal AF patients suitable for same-day discharge and a postprocedural checklist to safely execute same-day discharge after ablation facilitated by contemporary radiofrequency catheter ablation technology.

Same day discharge protocol success:

  • 93% of low-risk patients prospectively identified for same-day discharge went home after an 8-hr observation period
  • No safety differences were observed between patients going home on the same day and those staying overnight

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Healthcare utilization after catheter ablation summary image

Healthcare Utilization Before and After AF Catheter Ablation

Catheter ablation and healthcare utilization and cost among patients with paroxysmal versus persistent atrial fibrillation.
Friedman DJ, et al. Heart Rhythm O2. 2021;2(1):28-36.

This retrospective, observational cohort study examined if ablation would be associated with reductions in 12-month AF-related healthcare utilization in patients with paroxysmal (PAF) and persistent atrial fibrillation (PsAF).

The study found that after ablation there were:

  • 70%/67% fewer inpatient admissions for PAF/PsAF patients, respectively
  • 73%/62% fewer emergency department visits for PAF/PsAF patients, respectively
  • 54%/58% fewer cardioversions for PAF/PsAF patients, respectively

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SMART SF study summary image

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. Published online May 27, 2020. doi: 10.1007/s10840-020-00780-4.

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

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Atrioesophageal Fistula clinical evidence

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

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