Department of Surgery, University of Texas Medical Branch, Galveston, TX.
John Sealy School of Medicine, University of Texas Medical Branch, Galveston, TX.
J Vasc Surg Venous Lymphat Disord. 2024 Nov;12(6):101958. doi: 10.1016/j.jvsv.2024.101958. Epub 2024 Aug 5.
Thrombolytic therapy has been a mainstay of treatment for massive or submassive pulmonary embolism (PE), a common and highly morbid pathology. New percutaneous mechanical thrombectomy (PMT) devices have recently become widely available and have been used increasingly for the treatment of acute PE, but evidence demonstrating its efficacy over standard catheter-directed lytic protocol remains limited.
Using TriNetX Data Network, a global federated database of >250 million patients, we conducted a retrospective cohort study of patients from January 2017 to August 2023 with a diagnosis of PE, treated with either PMT or catheter-directed thrombolysis (CDT). Eligible patients were 1:1 propensity score-matched for preoperative covariates including demographics and comorbidities. We calculated and compared the 30-day outcomes of all-cause mortality, bleeding complications (blood transfusion, gastrointestinal bleed, and intracranial hemorrhage), diagnosis of acute respiratory failure (RF), myocardial infarction (MI), and pulmonary hypertension (PH) using odds ratios (OR) with 95% confidence intervals (CIs). Also, the 5-year outcomes of all-cause mortality, a composite outcome of chronic PH (chronic PE, chronic cor pulmonale, chronic thromboembolic PH), right heart failure (RHF), RF, and emergency department visits, were compared using hazard ratios (HRs) with 95% CIs.
We identified 2978 patients treated with PMT and 1137 patients treated with CDT. After matching, we compared 1102 patients in each cohort. For 30-day outcomes, all-cause mortality, acute RF, and blood transfusion were similar between the two groups. However, compared with CDT, PMT was associated with a better safety profile, including lower bleeding risk for both ICH (OR, 0.46; 95% CI, 0.24-0.890) and gastrointestinal bleed (OR, 0.42; 95% CI, 0.28-0.63). PMT also demonstrated better immediate functional outcomes, with less PH (OR, 0.53; 95% CI, 0.41-0.68) and MI (OR, 0.54; 95% CI, 0.41-0.76). At 5 years, the all-cause mortality and RF for both procedures were similar, but PMT was associated with lower rates of chronic PH (HR, 0.70; 95% CI, 0.55-0.90), RHF (HR 0.49; 95% CI, 0.37-0.65), and emergency department visits (348 for PMT vs 426 for CDT; P < .01).
In patients undergoing catheter-based therapy for PE, PMT has an improved procedural safety profile vs CDT and results in significantly fewer 30-day postoperative complications, with fewer bleeding events, and is also associated with fewer periprocedural MIs and less acute PH. Perhaps, more important, PMT also demonstrated improved long-term outcomes with significantly fewer chronic PH and RHF diagnoses with fewer emergency department visits.
溶栓治疗一直是治疗大面积或次大面积肺栓塞（PE）的主要方法，PE 是一种常见且高度致命的病理。最近，新的经皮机械血栓切除术（PMT）设备已广泛应用，并越来越多地用于治疗急性 PE，但仍缺乏证明其疗效优于标准导管引导溶栓方案的证据。
利用 TriNetX 数据网络（一个包含>2.5 亿患者的全球联邦数据库），我们对 2017 年 1 月至 2023 年 8 月期间患有 PE 并接受 PMT 或导管引导溶栓（CDT）治疗的患者进行了回顾性队列研究。符合条件的患者根据术前协变量（包括人口统计学和合并症）进行 1:1 倾向评分匹配。我们使用比值比（OR）和 95%置信区间（CI）计算并比较了所有原因死亡率、出血并发症（输血、胃肠道出血和颅内出血）、急性呼吸衰竭（RF）、心肌梗死（MI）和肺动脉高压（PH）的 30 天结局。还使用 95%CI 的风险比（HR）比较了所有原因死亡率、慢性 PH（慢性 PE、慢性肺心病、慢性血栓栓塞性 PH）、右心衰竭（RHF）、RF 和急诊就诊的复合结局的 5 年结局。
我们确定了 2978 例接受 PMT 治疗的患者和 1137 例接受 CDT 治疗的患者。匹配后，我们比较了每个队列中的 1102 例患者。在 30 天结局方面，两组的所有原因死亡率、急性 RF 和输血情况相似。然而，与 CDT 相比，PMT 具有更好的安全性，包括较低的 ICH（OR，0.46；95%CI，0.24-0.890）和胃肠道出血（OR，0.42；95%CI，0.28-0.63）风险。PMT 还显示出更好的即时功能结局，较低的 PH（OR，0.53；95%CI，0.41-0.68）和 MI（OR，0.54；95%CI，0.41-0.76）发生率。在 5 年时，两种治疗方法的所有原因死亡率和 RF 相似，但 PMT 与较低的慢性 PH（HR，0.70；95%CI，0.55-0.90）、RHF（HR 0.49；95%CI，0.37-0.65）和急诊就诊（PMT 为 348 例，CDT 为 426 例；P<0.01）发生率相关。
在接受基于导管的 PE 治疗的患者中，PMT 与 CDT 相比具有更好的手术安全性，术后 30 天并发症更少，出血事件更少，围手术期 MI 发生率也更低，急性 PH 发生率更低。也许更重要的是，PMT 还显示出改善的长期结局，慢性 PH 和 RHF 诊断的发生率更低，急诊就诊的次数也更少。
