背景:球囊肺血管成形术(BPA)是手术后无法手术的慢性血栓栓塞性肺动脉高压(CTEPH)或残留/复发性肺动脉高压(PH)患者的替代疗法。这项研究的目的是评估BPA计划的短期疗效和安全性。
方法:这项前瞻性单中心研究包括2017年至2019年在CTEPH患者中进行的所有BPA课程。临床评估,包括WHO功能分类,血浆生物标志物,在基线和最后一次BPA疗程后六个月进行6分钟步行测试(6MWT)和右心导管插入术。
结果:在11名CTEPH患者中进行了57次BPA治疗(64%患有无法手术的疾病,肺血管扩张剂治疗下为82%)。9名患者完成了BPA计划和至少六个月的随访期。WHO功能类别(p=0.004)和6MWT(平均增加42m;p=0.050)显着改善,血流动力学显着改善的趋势:平均肺动脉压(mPAP)降低25%(p=0.082)和肺血管阻力(PVR)降低42%(p=0.056)。在血流动力学严重受损的患者组中(3例mPAP>40mmHg),显著降低:mPAP为51%(p=0.013),PVR为67%(p=0.050).所有患者均停止前列环素类似物和长期氧疗。25%的患者发生轻微并发症。无重大并发症或死亡。
结论:在肺血管扩张剂治疗基础上采用BPA策略可进一步改善症状,不能手术的CTEPH或术后残留/复发性PH患者的运动能力和血流动力学具有可接受的风险-收益比。
BACKGROUND: Balloon pulmonary angioplasty (BPA) is an alternative therapy in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or residual/recurrent pulmonary hypertension (PH) after surgery. The aim of this study was to assess the short-term efficacy and safety of a BPA program.
METHODS: This prospective single-center study included all BPA sessions performed in CTEPH patients between 2017 and 2019. Clinical assessment including WHO functional class, plasma biomarkers, 6-min walk test (6MWT) and right heart catheterization was performed at baseline and six months after the last BPA session.
RESULTS: A total of 57 BPA sessions were performed in 11 CTEPH patients (64% with inoperable disease, 82% under pulmonary vasodilator therapy). Nine patients completed both the BPA program and a minimum six-month follow-up period. There were significant improvements in WHO functional class (p=0.004) and 6MWT (mean increase of 42 m; p=0.050) and a trend for significant hemodynamic improvement: 25% decrease in mean pulmonary artery pressure (mPAP) (p=0.082) and 42% decrease in pulmonary vascular resistance (PVR) (p=0.056). In the group of patients with severely impaired hemodynamics (three patients with mPAP >40mmHg), the reduction was significant: 51% in mPAP (p=0.013) and 67% in PVR (p=0.050). Prostacyclin analogs and long-term oxygen therapy were withdrawn in all patients. Minor complications were recorded in 25% of patients. There were no major complications or deaths.
CONCLUSIONS: A BPA strategy on top of pulmonary vasodilator therapy further improves symptoms, exercise capacity and hemodynamics with an acceptable risk-benefit ratio in patients with inoperable CTEPH or residual/recurrent PH after surgery.