Health Economics & Market Access

Retrospective Database Studies

Health Economics & Market Access

Retrospective Database Studies

Using large real-world evidence databases, Biosense Webster, Inc. is generating outcomes research that advances our understanding of the treatment of heart rhythm disorders and improve patient care.

Dementia Study Snapshot

Risk of Dementia in AFib Patients Receiving Catheter Ablation vs. Anti-Arrhythmic Drugs

Comparative risk of dementia among patients with atrial fibrillation treated with catheter ablation versus anti-arrhythmic drugs
Zeitler et al. AHJ (2022)

This goal of this collaborative study sponsored by Biosense Webster, Inc. was to determine the risk of dementia in patients treated for atrial fibrillation with catheter ablation (CA) versus anti-arrhythmic drugs (AAD).

Compared to AADs, CA was associated with a lower risk of dementia by:

  • 41% overall 
  • 45% in males
  • 40% in females 

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Incident atrial fibrillation healthcare utilization and costs

Healthcare Utilization and Costs Associated with Incident AFib

Healthcare utilization and costs associated with a diagnosis of incident atrial fibrillation
Abhishek et al. Heart Rhythm O2 (2022). 
 
This study published in Heart Rhythm O2 compares the cost of care for AFib patients compared to non-AFib patients to demonstrate the burden and incremental cost of care that AFib imposes on healthcare systems.
 
Patients with incident AFib had higher 12-month healthcare utilization in comparison to patients without AFib:

  • 23% Higher risk of all-cause ER visits
  • 77% Higher risk of all-cause inpatient visits

Total healthcare costs per year were $27,896 higher among AFib patients versus non-AFib patients.

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summary of ICE vs. No ICE Study Snapshot

Outcomes in Patients Undergoing Catheter Ablation with or without ICE

Differences in Outcomes Among Patients with Atrial Fibrillation Undergoing Catheter Ablation with Versus without Intracardiac Echocardiography
Pimentel et al. J Cardiovasc Electrophysiol. 2022

This retrospective cohort study investigated the complications and healthcare utilization between patients undergoing catheter ablation (CA) for atrial fibrillation (AFib) with versus without the use of  intracardiac echocardiography (ICE).

At the 12-month follow-up, patients undergoing a CA procedure for AFib with ICE had a:

  • 50% lower risk of complications
  • 36% lower risk of repeat ablation

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Snapshot of study. The box on the left highlights the study methods used and contains a group icon representing the study patients. The boxes on the top and bottom right highlight the results comparing the very early cohort to the early cohort and very early cohort to the late cohort, respectively. They both contain a physician icon representing outpatient visit outcomes, a clipboard representing office visit outcomes, and an icon of a person holding their heart representing electrical cardioversion outcome

Very Early Referral to AF Catheter Ablation Reduces Healthcare Utilization

Very early versus early referral for ablation among young patients for newly diagnosed paroxysmal atrial fibrillation
D’Angelo, R., et al. PACE. 2022; 45(3), 348-356

This retrospective, observational cohort study examined the differences in healthcare utilization between young patients with paroxysmal atrial fibrillation (AF) undergoing ablation treatment within 6 months (very early cohort), 6 to 12 months (early cohort), or 12 to 24 months (late cohort) post-diagnosis.

This study found that:

  • Patients in the very early cohort had a 14% lower risk of AF-related outpatient visits in comparison to patients in the early cohort 
  • Patients in the very early cohort had a 5% lower risk of AF-related office visits in comparison to patients in the early cohort 
  • Patients in the very early cohort had a 26% lower risk of electrical cardioversions in comparison to patients in the early cohort 

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Same Day Discharge After AF Ablation in the U.S.

Same Day Discharge After AF Ablation in the U.S.

Same‐day discharge after catheter ablation in patients with atrial fibrillation in a large nationwide administrative claims database
Field et al. J Cardiovasc Electrophysiol 32.9 (2021): 2432-2440. 

Using a nationwide administrative claims database, this retrospective study examined outcome differences between same-day discharge vs. overnight stay after AF ablation in the U.S. This study found: 

  • No significant difference between same-day discharge and overnight stay in terms of efficacy and 30-day post-procedural  
  • No significant differences in secondary outcomes such as repeat ablation, inpatient admission and cardioversion. 

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Summary of AF Ablation Healthcare Utilization Study

Healthcare Utilization Before and After AF Catheter Ablation

Catheter Ablation and Healthcare Utilization and Cost Among Patients with Paroxysmal versus Persistent Atrial Fibrillation
Friedman, Daniel J., 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 (PsAF) atrial fibrillation.

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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Summary of Contact Force Porous Tip vs. Cryoballoon Study

Contact Force Porous Tip vs. Cryoballoon

Real-World Economic and Clinical Outcomes in Catheter Ablation of Atrial Fibrillation: Contact Force Porous Tip Catheter versus Second Generation Cryoballoon Catheter
Costea et al. BMJ open 2020, 10(8), e035499.

A retrospective, observational cohort study that examined clinical and economic outcomes differences between AF patients ablated with the THERMOCOOL SMARTTOUCH® SF Catheter compared to the Arctic Front™ Advance Cryoballoon.

Compared to Arctic Front™ Advance Cryoballoon, patients treated with THERMOCOOL SMARTTOUCH® SF Catheter were associated with:

  • 17% lower total index ablation costs
  • 27% lower total supply costs
  • 54% fewer 4-6 month cardiovascular related inpatient admissions

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Summary of ICE Meta-analysis

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 minute mean reduction in fluoroscopy time
  • 15.2 minute mean reduction in procedure time
  • Reduction in fluoroscopy dose

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Summary of Cardiac Perforation and Ablation study

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

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Summary of ICE in VT ablation study

Use of ICE in VT Ablation

Real-world Outcomes of Ventricular Tachycardia Catheter Ablation with Versus Without Intracardiac Echocardiography
Field ME, et al. J Cardiovasc Electrophysiol. 2020;31(2), 417-422.

This retrospective, observational cohort study sought to assess the differences in outcomes between ventricular tachycardia (VT) patients undergoing catheter ablation with versus without the use of intracardiac echocardiography (ICE).

As compared to the non-ICE cohort, at 12-month follow-up, the ICE cohort was associated with:

  • 24% lower odds of VT-related readmission
  • 30% lower odds of repeat VT ablation

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Summary of catheter ablation and on-site surgery study

Catheter Ablation and On-site Cardiothoracic Surgery

Catheter Ablation of Atrial Fibrillation with and Without On-Site Cardiothoracic Surgery
Friedman, Daniel J et al. J Am Coll Cardiol. 2019;73(19), 2487-2489

A retrospective, non-randomized database study investigated the relationship between the presence or absence of on-site cardiothoracic surgery (CTS) units, with 30-day outcomes after atrial fibrillation (AF) catheter ablation.

Study findings:

  • There was no significant difference between the presence or absence of CTS units and rates of cardiac perforation, CTS, re-hospitalization, and death after AF catheter ablation.

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The THERMOCOOL SMARTTOUCH® SF Catheter is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (AF) and for drug refractory recurrent symptomatic persistent 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.

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