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 in | Journal of cardiovascular electrophysiology Vol. 35; no. 12; pp. 2372 - 2381 |
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Main Authors | , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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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. |
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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 |
AuthorAffiliation_xml | – name: 1 Division of Cardiology, Section of Electrophysiology University of Massachusetts Chan Medical School Worcester Massachusetts USA – name: 3 Department of Biostatistics and Bioinformatics Emory University Atlanta Georgia USA – name: 2 Department of Medicine, Division of Cardiology, Section of Electrophysiology and Pacing Emory University School of Medicine Atlanta Georgia USA |
Author_xml | – sequence: 1 givenname: Soroosh surname: Kiani fullname: Kiani, Soroosh email: skiani@emory.edu organization: University of Massachusetts Chan Medical School – sequence: 2 givenname: Joel surname: Eggebeen fullname: Eggebeen, Joel organization: Emory University School of Medicine – sequence: 3 givenname: Mounir orcidid: 0000-0002-8765-4028 surname: Al‐Gibbawi fullname: Al‐Gibbawi, Mounir organization: Emory University School of Medicine – sequence: 4 givenname: Paige surname: Smith fullname: Smith, Paige organization: Emory University School of Medicine – sequence: 5 givenname: Thomas surname: Preiser fullname: Preiser, Thomas organization: Emory University School of Medicine – sequence: 6 givenname: Suprateek surname: Kundu fullname: Kundu, Suprateek organization: Emory University – sequence: 7 givenname: Ziduo surname: Zheng fullname: Zheng, Ziduo organization: Emory University – sequence: 8 givenname: Neal K. surname: Bhatia fullname: Bhatia, Neal K. organization: Emory University School of Medicine – sequence: 9 givenname: Anand D. surname: Shah fullname: Shah, Anand D. organization: Emory University School of Medicine – sequence: 10 givenname: Stacy B. surname: Westerman fullname: Westerman, Stacy B. organization: Emory University School of Medicine – sequence: 11 givenname: David B. orcidid: 0000-0002-3272-7234 surname: De Lurgio fullname: De Lurgio, David B. organization: Emory University School of Medicine – sequence: 12 givenname: Christine M. surname: Tompkins fullname: Tompkins, Christine M. organization: Emory University School of Medicine – sequence: 13 givenname: Anshul M. surname: Patel fullname: Patel, Anshul M. organization: Emory University School of Medicine – sequence: 14 givenname: Mikhael F. orcidid: 0000-0003-4978-7177 surname: El‐Chami fullname: El‐Chami, Mikhael F. organization: Emory University School of Medicine – sequence: 15 givenname: Faisal M. surname: Merchant fullname: Merchant, Faisal M. organization: Emory University School of Medicine – sequence: 16 givenname: Michael S. orcidid: 0000-0002-0708-9330 surname: Lloyd fullname: Lloyd, Michael S. organization: Emory University School of Medicine |
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Keywords | percutaneous closure atrial fibrillation ablation early discharge ambulation proglide hemostasis prostyle perclose vascular closure same day discharge suture mediate closure |
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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. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 ObjectType-Undefined-3 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. |
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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 |
URI | https://onlinelibrary.wiley.com/doi/abs/10.1111%2Fjce.16440 https://www.ncbi.nlm.nih.gov/pubmed/39377569 https://www.proquest.com/docview/3145509166 https://www.proquest.com/docview/3114152846 https://pubmed.ncbi.nlm.nih.gov/PMC11650525 |
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