University of Kansas Medical Center, Kansas City, KS, USA.
University Clinic Schleswig-Holstein, Lubeck, Germany.
Ann Otol Rhinol Laryngol. 2021 May;130(5):467-474. doi: 10.1177/0003489420958733. Epub 2020 Sep 13.
An increasing number of facilities offer Upper Airway Stimulation (UAS) with varying levels of experience. The goal was to quantify whether a surgical learning curve exists in operative or sleep outcomes in UAS.
International multi-center retrospective review of the ADHERE registry, a prospective international multi-center study collecting UAS outcomes. ADHERE registry centers with at least 20 implants and outcomes data through at least 6-month follow-up were reviewed. Cases were divided into two groups based on implant order (the first 10 or second 10 consecutive implants at a given site). Group differences were assessed using Mann-Whitney U-tests, Chi-squared tests, or Fisher's Exact tests, as appropriate. A Mann-Kendall trend test was used to detect if there was a monotonic trend in operative time. Sleep outcome equivalence between experience groups was assessed using the two one-sided tests approach.
Thirteen facilities met inclusion criteria, contributing 260 patients. Complication rates did not significantly differ between groups ( = .808). Operative time exhibited a significant downward trend ( < .001), with the median operative time dropping from 150 minutes for the first 10 implants to 134 minutes for the subsequent 10 implants. The decrease in AHI from baseline to 12-month follow-up was equivalent between the first and second ten (22.8 vs 21.2 events/hour, respectively, < .001). Similarly, the first and second ten groups had equivalent ESS decreases at 6 months (2.0 vs 2.0, respectively, < .001). ESS outcomes remained equivalent for those with data through 12-months.
Across the centers' first 20 implants, an approximately 11% reduction operative time was identified, however, no learning curve effect was seen for 6-month or 12-month AHI or ESS over the first twenty implants. Ongoing monitoring through the ADHERE registry will help measure the impact of evolving provider and patient specific characteristics as the number of implant centers increases.
越来越多的机构提供不同经验水平的上气道刺激（UAS）。本研究旨在定量评估 UAS 手术或睡眠结果是否存在手术学习曲线。
对 ADHERE 注册中心进行国际多中心回顾性研究，该注册中心是一项前瞻性国际多中心研究，收集 UAS 结果。对至少有 20 例植入物且有至少 6 个月随访结果的 ADHERE 注册中心进行了回顾性分析。根据植入物顺序（特定部位的前 10 例或后 10 例连续植入物）将病例分为两组。使用 Mann-Whitney U 检验、卡方检验或 Fisher 精确检验评估组间差异，视情况而定。采用 Mann-Kendall 趋势检验检测手术时间是否存在单调趋势。使用双侧单边检验方法评估经验组之间的睡眠结果等效性。
13 个中心符合纳入标准，共纳入 260 例患者。两组并发症发生率无显著差异（ = .808）。手术时间呈显著下降趋势（ < .001），前 10 例植入物的中位手术时间从 150 分钟降至后 10 例植入物的 134 分钟。从基线到 12 个月随访时，AHI 的降低在第 1 和第 10 组之间等效（分别为 22.8 与 21.2 事件/小时， < .001）。同样，两组在 6 个月时 ESS 降低也等效（分别为 2.0 与 2.0， < .001）。对于有 12 个月数据的患者，ESS 结果仍等效。
在中心的前 20 例植入物中，发现手术时间约缩短 11%，但在前 20 例植入物中，6 个月或 12 个月的 AHI 或 ESS 并未出现学习曲线效应。通过 ADHERE 注册中心持续监测，将有助于衡量随着植入中心数量的增加，不断变化的提供者和患者特定特征的影响。
