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

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.

Keywords: ambulation; atrial fibrillation ablation; early discharge; hemostasis; perclose; percutaneous closure; proglide; prostyle; same day discharge; suture mediate closure; vascular closure.

Figure 1

Time to hemostasis between groups over time. Results are presented as box plots and are a comparison of time to hemostasis between the manual compression (MC) and suture mediated closure (SMC) treatment arms, stratified by the patients in the first and second half of the study. While hemostasis times remain stable in the MC group, they are notably shorter in the SMC group during the second half of the study, demonstrating a learning curve for the technique. Circles represent outliers.

Figure 2

Time to hemostasis by treatment group stratified by number of access sites. Results are presented as box plots and are a comparison of time to hemostasis between the suture mediated closure (SMC) and manual compression (MC) treatment arms, stratified by the number of access sites per patient (ranging from 2 to 4). SMC results in shorter times to hemostasis with differences most pronounced in patients with fewer access sites. Exploratory p Values (Mann−Whitney U): 2‐points of access (n = 36), p < 0.001; 3‐points of access (n = 52), p = 0.002; 4‐points of access (n = 19), p = 0.379. Open circles represent outliers, and asterisks “*” represent extreme outliers.

Figure 3

Time to hemostasis between suture mediated closure (SMC) and manual compression (MC) with a Figure of eight suture. Results are presented as box plots and are a comparison of time to hemostasis between the SMC and manual compression with a figure of eight suture (MC + Fo8) SMC results in shorter times to hemostasis (p = 0.001). Open circles represent outliers, and asterisks “*” represent extreme outliers. Fo8, figure‐of‐eight suture.