Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.
J Am Coll Cardiol. 2023 Jun 20;81(24):2328-2340. doi: 10.1016/j.jacc.2023.04.017. Epub 2023 May 18.
The incidence and clinical impact of lead-related venous obstruction (LRVO) among patients with cardiovascular implantable electronic devices (CIEDs) is poorly defined.
The objectives of this study were to determine the incidence of symptomatic LRVO after CIED implant; describe patterns in CIED extraction and revascularization; and quantify LRVO-related health care utilization based on each type of intervention.
LRVO status was defined among Medicare beneficiaries after CIED implant from October 1, 2015, to December 31, 2020. Cumulative incidence functions of LRVO were estimated by Fine-Gray methods. LRVO predictors were identified using Cox regression. Incidence rates for LRVO-related health care visits were calculated with Poisson models.
Among 649,524 patients who underwent CIED implant, 28,214 developed LRVO, with 5.0% cumulative incidence at maximum follow-up of 5.2 years. Independent predictors of LRVO included CIEDs with >1 lead (HR: 1.09; 95% CI: 1.07-1.15), chronic kidney disease (HR: 1.17; 95% CI: 1.14-1.20), and malignancies (HR: 1.23; 95% CI: 1.20-1.27). Most patients with LRVO (85.2%) were managed conservatively. Among 4,186 (14.8%) patients undergoing intervention, 74.0% underwent CIED extraction and 26.0% percutaneous revascularization. Notably, 90% of the patients did not receive another CIED after extraction, with low use (2.2%) of leadless pacemakers. In adjusted models, extraction was associated with significant reductions in LRVO-related health care utilization (adjusted rate ratio: 0.58; 95% CI: 0.52-0.66) compared with conservative management.
In a large nationwide sample, the incidence of LRVO was substantial, affecting 1 of every 20 patients with CIEDs. Device extraction was the most common intervention and was associated with long-term reduction in recurrent health care utilization.
心血管植入式电子设备(CIEDs)患者中与铅相关的静脉阻塞(LRVO)的发生率和临床影响尚不清楚。
本研究旨在确定 CIED 植入后症状性 LRVO 的发生率;描述 CIED 取出和血运重建的模式;并根据每种干预方式量化 LRVO 相关的医疗保健利用情况。
在 2015 年 10 月 1 日至 2020 年 12 月 31 日期间,在 Medicare 受益人群中确定 CIED 植入后的 LRVO 状态。使用 Fine-Gray 方法估计 LRVO 的累积发生率函数。使用 Cox 回归识别 LRVO 的预测因素。使用泊松模型计算 LRVO 相关医疗保健就诊的发病率。
在接受 CIED 植入的 649524 名患者中,有 28214 例发生 LRVO,在最长 5.2 年的随访中,LRVO 的累积发生率为 5.0%。LRVO 的独立预测因素包括具有>1 个导联的 CIED(HR:1.09;95%CI:1.07-1.15)、慢性肾脏病(HR:1.17;95%CI:1.14-1.20)和恶性肿瘤(HR:1.23;95%CI:1.20-1.27)。大多数 LRVO 患者(85.2%)接受了保守治疗。在 4186 名(14.8%)接受干预的患者中,74.0%行 CIED 取出,26.0%行经皮血运重建。值得注意的是,90%的患者在取出后未再植入另一台 CIED,仅有低比例(2.2%)的患者使用无导线起搏器。在调整后的模型中,与保守治疗相比,提取与 LRVO 相关的医疗保健利用率显著降低(调整后的比率比:0.58;95%CI:0.52-0.66)。
在一项大型全国性样本中,LRVO 的发生率相当高,每 20 例 CIED 患者中就有 1 例发生 LRVO。设备提取是最常见的干预措施,与长期减少复发的医疗保健利用率有关。