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
Division of Cardiology, Section of Electrophysiology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.
Department of Medicine, Division of Cardiology, Section of Electrophysiology and Pacing, Emory University School of Medicine, Atlanta, Georgia, USA.
J Cardiovasc Electrophysiol. 2024 Dec;35(12):2372-2381. doi: 10.1111/jce.16440. Epub 2024 Oct 8.
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.
评估心房颤动（AF）消融术后缝线介导的经皮闭合术（SMC）与手动压迫（MC）相比的成本和效率。SMC已被证明在减少AF消融术后的止血时间和卧床休息时间方面是有效的。迄今为止，尚未有比较这两种技术直接和间接成本的随机数据报道。
我们进行了一项1:1随机试验，比较AF消融术后SMC与MC。主要终点已在之前发表。然而，收集了与间接成本相关的次要终点，包括并发症发生率、医院利用情况（即出院延迟、额外的患者就诊、护理利用）、疼痛、患者报告的结果，以及与AF消融相关的直接护理成本。我们还对主要终点进行了二次分析，以评估学习曲线，并进行亚组分析，比较不同穿刺部位数量的疗效，并与采用8字缝合法（Fo8）的MC组进行比较，后者可能会影响手术的相对效率。
总共107例患者被随机分组并纳入研究：SMC组53例，MC组54例。在SMC组中，研究组的前半部分和后半部分之间观察到学习曲线（p = 0.037），而MC组没有这种差异。在考虑穿刺部位数量后，SMC组的止血时间仍然较短（p = 0.002）。与Fo8组（n = 37）相比，SMC组的止血时间仍然较短（p = 0.001）。在计划当天出院的患者中，MC组的延迟更多（31.5%对11.3%，p = 0.0144）。SMC组和MC组出院时（p = 0.243）和30天时（p = 1.00）的主要和次要并发症发生率相似，护理利用、自我报告的疼痛以及患者报告的总体结果也相似。MC组和SMC组与手术相关的总体护理成本相似（56533.65美元[45699.47美元，66987.64美元]对57050.44美元[47251.40美元，66426.34美元]，p = 0.601）。
已证明SMC可缩短AF消融术后的止血时间和下床活动时间，并有助于更早地当天出院，且不会增加直接或间接成本。
