Costs, efficiency, and patient‐reported outcomes associated with suture‐mediated percutaneous closure for atrial fibrillation ablation: Secondary analysis of a randomized clinical trial

Introduction To evaluate the cost and efficiency of suture‐mediated percutaneous closure (SMC) compared to manual compression (MC) after atrial fibrillation (AF) ablation. SMC has been demonstrated to be efficacious in reducing hemostasis and bedrest times after AF ablation. To date, randomized data...

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Published inJournal of cardiovascular electrophysiology Vol. 35; no. 12; pp. 2372 - 2381
Main Authors Kiani, Soroosh, Eggebeen, Joel, Al‐Gibbawi, Mounir, Smith, Paige, Preiser, Thomas, Kundu, Suprateek, Zheng, Ziduo, Bhatia, Neal K., Shah, Anand D., Westerman, Stacy B., De Lurgio, David B., Tompkins, Christine M., Patel, Anshul M., El‐Chami, Mikhael F., Merchant, Faisal M., Lloyd, Michael S.
Format Journal Article
LanguageEnglish
Published United States Wiley Subscription Services, Inc 01.12.2024
John Wiley and Sons Inc
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Abstract Introduction To evaluate the cost and efficiency of suture‐mediated percutaneous closure (SMC) compared to manual compression (MC) after atrial fibrillation (AF) ablation. SMC has been demonstrated to be efficacious in reducing hemostasis and bedrest times after AF ablation. To date, randomized data comparing the direct and indirect cost between the two techniques have not been described. Methods We conducted a 1:1 randomized trial comparing SMC to MC following AF ablation. The primary endpoints have been previously published. However, secondary endpoints pertinent to indirect cost including complication rates, hospital utilization (i.e., delays in discharge, additional patient encounters, nursing utilization), pain, patient reported outcomes, as well as the direct costs of care associated with AF ablation were collected. We also performed secondary analysis of the primary endpoint to evaluate for a learning curve, and subgroups analysis comparing efficacy across different numbers of access sites and compared to those in the MC group with a figure‐of‐eight suture (Fo8), that could potentially have impacted the relative efficiency of the procedure. Results A total of 107 patients were randomized and included: 53 in the SMC group and 54 in MC. A learning curve was observed in the SMC group between the first and second half of the study group (p = 0.037), with no such difference in the MC group. After accounting for the number of access sites, time to hemostasis remained shorter in the SMC Group (p = 0.002). Compared to those in the Fo8 arm (n = 37), the time to hemostasis remained shorter in the SMC group (p = 0.001). Among those planned for same‐day discharge, there were more delays in the MC group (31.5% vs. 11.3%, p = 0.0144). Rates of major and minor complications were similar between SMC and MC groups at discharge (p = 0.243) and 30 days (p = 1.00), as were nursing utilization, self‐reported pain, and overall patient reported outcomes. The overall cost of care related to the procedure was similar between the MC and SMC groups ($56 533.65 [$45 699.47, $66 987.64] vs. $57 050.44 [$47 251.40, $66 426.34], p = 0.601). Conclusion SMC has been shown to decrease time to hemostasis and ambulation and facilitate earlier same‐day discharge after AF ablation without an increase in direct or indirect costs.
AbstractList IntroductionTo evaluate the cost and efficiency of suture‐mediated percutaneous closure (SMC) compared to manual compression (MC) after atrial fibrillation (AF) ablation.SMC has been demonstrated to be efficacious in reducing hemostasis and bedrest times after AF ablation. To date, randomized data comparing the direct and indirect cost between the two techniques have not been described.MethodsWe conducted a 1:1 randomized trial comparing SMC to MC following AF ablation. The primary endpoints have been previously published. However, secondary endpoints pertinent to indirect cost including complication rates, hospital utilization (i.e., delays in discharge, additional patient encounters, nursing utilization), pain, patient reported outcomes, as well as the direct costs of care associated with AF ablation were collected. We also performed secondary analysis of the primary endpoint to evaluate for a learning curve, and subgroups analysis comparing efficacy across different numbers of access sites and compared to those in the MC group with a figure‐of‐eight suture (Fo8), that could potentially have impacted the relative efficiency of the procedure.ResultsA total of 107 patients were randomized and included: 53 in the SMC group and 54 in MC. A learning curve was observed in the SMC group between the first and second half of the study group (p = 0.037), with no such difference in the MC group. After accounting for the number of access sites, time to hemostasis remained shorter in the SMC Group (p = 0.002). Compared to those in the Fo8 arm (n = 37), the time to hemostasis remained shorter in the SMC group (p = 0.001). Among those planned for same‐day discharge, there were more delays in the MC group (31.5% vs. 11.3%, p = 0.0144). Rates of major and minor complications were similar between SMC and MC groups at discharge (p = 0.243) and 30 days (p = 1.00), as were nursing utilization, self‐reported pain, and overall patient reported outcomes. The overall cost of care related to the procedure was similar between the MC and SMC groups ($56 533.65 [$45 699.47, $66 987.64] vs. $57 050.44 [$47 251.40, $66 426.34], p = 0.601).ConclusionSMC has been shown to decrease time to hemostasis and ambulation and facilitate earlier same‐day discharge after AF ablation without an increase in direct or indirect costs.
To evaluate the cost and efficiency of suture-mediated percutaneous closure (SMC) compared to manual compression (MC) after atrial fibrillation (AF) ablation. SMC has been demonstrated to be efficacious in reducing hemostasis and bedrest times after AF ablation. To date, randomized data comparing the direct and indirect cost between the two techniques have not been described.INTRODUCTIONTo evaluate the cost and efficiency of suture-mediated percutaneous closure (SMC) compared to manual compression (MC) after atrial fibrillation (AF) ablation. SMC has been demonstrated to be efficacious in reducing hemostasis and bedrest times after AF ablation. To date, randomized data comparing the direct and indirect cost between the two techniques have not been described.We conducted a 1:1 randomized trial comparing SMC to MC following AF ablation. The primary endpoints have been previously published. However, secondary endpoints pertinent to indirect cost including complication rates, hospital utilization (i.e., delays in discharge, additional patient encounters, nursing utilization), pain, patient reported outcomes, as well as the direct costs of care associated with AF ablation were collected. We also performed secondary analysis of the primary endpoint to evaluate for a learning curve, and subgroups analysis comparing efficacy across different numbers of access sites and compared to those in the MC group with a figure-of-eight suture (Fo8), that could potentially have impacted the relative efficiency of the procedure.METHODSWe conducted a 1:1 randomized trial comparing SMC to MC following AF ablation. The primary endpoints have been previously published. However, secondary endpoints pertinent to indirect cost including complication rates, hospital utilization (i.e., delays in discharge, additional patient encounters, nursing utilization), pain, patient reported outcomes, as well as the direct costs of care associated with AF ablation were collected. We also performed secondary analysis of the primary endpoint to evaluate for a learning curve, and subgroups analysis comparing efficacy across different numbers of access sites and compared to those in the MC group with a figure-of-eight suture (Fo8), that could potentially have impacted the relative efficiency of the procedure.A total of 107 patients were randomized and included: 53 in the SMC group and 54 in MC. A learning curve was observed in the SMC group between the first and second half of the study group (p = 0.037), with no such difference in the MC group. After accounting for the number of access sites, time to hemostasis remained shorter in the SMC Group (p = 0.002). Compared to those in the Fo8 arm (n = 37), the time to hemostasis remained shorter in the SMC group (p = 0.001). Among those planned for same-day discharge, there were more delays in the MC group (31.5% vs. 11.3%, p = 0.0144). Rates of major and minor complications were similar between SMC and MC groups at discharge (p = 0.243) and 30 days (p = 1.00), as were nursing utilization, self-reported pain, and overall patient reported outcomes. The overall cost of care related to the procedure was similar between the MC and SMC groups ($56 533.65 [$45 699.47, $66 987.64] vs. $57 050.44 [$47 251.40, $66 426.34], p = 0.601).RESULTSA total of 107 patients were randomized and included: 53 in the SMC group and 54 in MC. A learning curve was observed in the SMC group between the first and second half of the study group (p = 0.037), with no such difference in the MC group. After accounting for the number of access sites, time to hemostasis remained shorter in the SMC Group (p = 0.002). Compared to those in the Fo8 arm (n = 37), the time to hemostasis remained shorter in the SMC group (p = 0.001). Among those planned for same-day discharge, there were more delays in the MC group (31.5% vs. 11.3%, p = 0.0144). Rates of major and minor complications were similar between SMC and MC groups at discharge (p = 0.243) and 30 days (p = 1.00), as were nursing utilization, self-reported pain, and overall patient reported outcomes. The overall cost of care related to the procedure was similar between the MC and SMC groups ($56 533.65 [$45 699.47, $66 987.64] vs. $57 050.44 [$47 251.40, $66 426.34], p = 0.601).SMC has been shown to decrease time to hemostasis and ambulation and facilitate earlier same-day discharge after AF ablation without an increase in direct or indirect costs.CONCLUSIONSMC has been shown to decrease time to hemostasis and ambulation and facilitate earlier same-day discharge after AF ablation without an increase in direct or indirect costs.
To evaluate the cost and efficiency of suture-mediated percutaneous closure (SMC) compared to manual compression (MC) after atrial fibrillation (AF) ablation. SMC has been demonstrated to be efficacious in reducing hemostasis and bedrest times after AF ablation. To date, randomized data comparing the direct and indirect cost between the two techniques have not been described. We conducted a 1:1 randomized trial comparing SMC to MC following AF ablation. The primary endpoints have been previously published. However, secondary endpoints pertinent to indirect cost including complication rates, hospital utilization (i.e., delays in discharge, additional patient encounters, nursing utilization), pain, patient reported outcomes, as well as the direct costs of care associated with AF ablation were collected. We also performed secondary analysis of the primary endpoint to evaluate for a learning curve, and subgroups analysis comparing efficacy across different numbers of access sites and compared to those in the MC group with a figure-of-eight suture (Fo8), that could potentially have impacted the relative efficiency of the procedure. A total of 107 patients were randomized and included: 53 in the SMC group and 54 in MC. A learning curve was observed in the SMC group between the first and second half of the study group (p = 0.037), with no such difference in the MC group. After accounting for the number of access sites, time to hemostasis remained shorter in the SMC Group (p = 0.002). Compared to those in the Fo8 arm (n = 37), the time to hemostasis remained shorter in the SMC group (p = 0.001). Among those planned for same-day discharge, there were more delays in the MC group (31.5% vs. 11.3%, p = 0.0144). Rates of major and minor complications were similar between SMC and MC groups at discharge (p = 0.243) and 30 days (p = 1.00), as were nursing utilization, self-reported pain, and overall patient reported outcomes. The overall cost of care related to the procedure was similar between the MC and SMC groups ($56 533.65 [$45 699.47, $66 987.64] vs. $57 050.44 [$47 251.40, $66 426.34], p = 0.601). SMC has been shown to decrease time to hemostasis and ambulation and facilitate earlier same-day discharge after AF ablation without an increase in direct or indirect costs.
Introduction To evaluate the cost and efficiency of suture‐mediated percutaneous closure (SMC) compared to manual compression (MC) after atrial fibrillation (AF) ablation. SMC has been demonstrated to be efficacious in reducing hemostasis and bedrest times after AF ablation. To date, randomized data comparing the direct and indirect cost between the two techniques have not been described. Methods We conducted a 1:1 randomized trial comparing SMC to MC following AF ablation. The primary endpoints have been previously published. However, secondary endpoints pertinent to indirect cost including complication rates, hospital utilization (i.e., delays in discharge, additional patient encounters, nursing utilization), pain, patient reported outcomes, as well as the direct costs of care associated with AF ablation were collected. We also performed secondary analysis of the primary endpoint to evaluate for a learning curve, and subgroups analysis comparing efficacy across different numbers of access sites and compared to those in the MC group with a figure‐of‐eight suture (Fo8), that could potentially have impacted the relative efficiency of the procedure. Results A total of 107 patients were randomized and included: 53 in the SMC group and 54 in MC. A learning curve was observed in the SMC group between the first and second half of the study group (p = 0.037), with no such difference in the MC group. After accounting for the number of access sites, time to hemostasis remained shorter in the SMC Group (p = 0.002). Compared to those in the Fo8 arm (n = 37), the time to hemostasis remained shorter in the SMC group (p = 0.001). Among those planned for same‐day discharge, there were more delays in the MC group (31.5% vs. 11.3%, p = 0.0144). Rates of major and minor complications were similar between SMC and MC groups at discharge (p = 0.243) and 30 days (p = 1.00), as were nursing utilization, self‐reported pain, and overall patient reported outcomes. The overall cost of care related to the procedure was similar between the MC and SMC groups ($56 533.65 [$45 699.47, $66 987.64] vs. $57 050.44 [$47 251.40, $66 426.34], p = 0.601). Conclusion SMC has been shown to decrease time to hemostasis and ambulation and facilitate earlier same‐day discharge after AF ablation without an increase in direct or indirect costs.
Author Preiser, Thomas
De Lurgio, David B.
El‐Chami, Mikhael F.
Zheng, Ziduo
Eggebeen, Joel
Kiani, Soroosh
Smith, Paige
Tompkins, Christine M.
Westerman, Stacy B.
Patel, Anshul M.
Lloyd, Michael S.
Shah, Anand D.
Merchant, Faisal M.
Al‐Gibbawi, Mounir
Bhatia, Neal K.
Kundu, Suprateek
AuthorAffiliation 2 Department of Medicine, Division of Cardiology, Section of Electrophysiology and Pacing Emory University School of Medicine Atlanta Georgia USA
3 Department of Biostatistics and Bioinformatics Emory University Atlanta Georgia USA
1 Division of Cardiology, Section of Electrophysiology University of Massachusetts Chan Medical School Worcester Massachusetts USA
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Issue 12
Keywords percutaneous closure
atrial fibrillation ablation
early discharge
ambulation
proglide
hemostasis
prostyle
perclose
vascular closure
same day discharge
suture mediate closure
Language English
License Attribution-NonCommercial-NoDerivs
2024 The Author(s). Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.
This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
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Notes Clinical Trials Registration
Disclosures
ClinicalTrials.gov
Dr. Kiani has served on the vascular closure advisory board for Abbott Vascular. Dr. David De Lurgio is a member of the speaker's bureau and receives research support from Cardiva Medical. Other authors: No disclosures.
NCT04180540.
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Clinical Trials Registration: ClinicalTrials.gov NCT04180540.
Disclosures Dr. Kiani has served on the vascular closure advisory board for Abbott Vascular. Dr. David De Lurgio is a member of the speaker's bureau and receives research support from Cardiva Medical. Other authors: No disclosures.
ORCID 0000-0002-3272-7234
0000-0002-8765-4028
0000-0003-4978-7177
0000-0002-0708-9330
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Snippet Introduction To evaluate the cost and efficiency of suture‐mediated percutaneous closure (SMC) compared to manual compression (MC) after atrial fibrillation...
To evaluate the cost and efficiency of suture-mediated percutaneous closure (SMC) compared to manual compression (MC) after atrial fibrillation (AF) ablation....
IntroductionTo evaluate the cost and efficiency of suture‐mediated percutaneous closure (SMC) compared to manual compression (MC) after atrial fibrillation...
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SubjectTerms Ablation
Aged
ambulation
Atrial Fibrillation - diagnosis
Atrial Fibrillation - economics
Atrial Fibrillation - physiopathology
Atrial Fibrillation - surgery
atrial fibrillation ablation
Cardiac arrhythmia
Catheter Ablation - adverse effects
Catheter Ablation - economics
Clinical outcomes
Cost-Benefit Analysis
Costs
early discharge
Efficiency
Female
Fibrillation
Hemostasis
Hemostatic Techniques - economics
Hemostatic Techniques - instrumentation
Hospital Costs
Humans
Learning curves
Male
Middle Aged
Nursing
Observational learning
Original
Pain
Patient Reported Outcome Measures
Patients
perclose
percutaneous closure
Pressure
proglide
prostyle
same day discharge
suture mediate closure
Suture Techniques - adverse effects
Suture Techniques - economics
Sutures
Time Factors
Treatment Outcome
vascular closure
Title Costs, efficiency, and patient‐reported outcomes associated with suture‐mediated percutaneous closure for atrial fibrillation ablation: Secondary analysis of a randomized clinical trial
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