JACC:肺动脉内膜切除术后残余肺动脉高压患者的肺动脉去神经支配术安全性及有效性评估

2021-11-04 刘少飞 MedSci原创

肺动脉去神经支配术 (PADN) 尚未应用于肺动脉内膜切除术 (PEA) 后残留慢性血栓栓塞性肺动脉高压 (CTEPH) 的患者。本研究将评估PEA后残留的CTEPH远期安全性及有效性。

慢性血栓栓塞性肺动脉高压 (CTEPH) 在未经治疗时通常会迅速致命,而外科肺动脉内膜切除术 (PEA) 已成为该病症的首选治疗方法。然而,即使采用最佳手术方式,PEA 后仍有 10% 至 40% 的患者残留 CTEPH。几项研究表明,残留的 CTEPH 是术后早期和第一年随访期间手术治疗后不良结果的预测因子。因此,建议对PEA后残留PH采用靶向药物治疗。然而,此类疗法的成本仍然非常高,这使得许多患者无法获得。多达 10% 的患者因服用利奥西呱而出现严重低血压,这导致二线治疗(例如西地那非、伊洛前列素)的药物治疗发生变化。肺动脉去神经支配术 (PADN) 是一种新型疗法,最初应用于特发性肺动脉 (PA) 高血压患者。研究证明了可行性、安全性以及心脏功能和运动能力的改善,尽管这些研究是非随机且涉及少量患者的研究。

本研究目的:一项前瞻性、试点、随机、假对照临床试验,以测试使用远程磁导航 (RMN) 系统对 PADN 治疗 PEA 术后残留 CTEPH 患者的疗效和安全。

研究方法:

将 50 例 PEA 后至少 6 个月内药物治疗后仍有残留 CTEPH、平均肺动脉压≥25 mm Hg 或肺血管阻力(PVR)> 400 dyn‧s‧cm-5 的右心导管检查患者随机接受治疗PADN(PADN 组;n = 25)使用远程磁导航进行消融或使用 riociguat 进行药物治疗(MED 组;n = 25)。在 MED 组中,进行了带有映射但不消融的假手术。主要终点是随机化后 12 个月的 PVR。关键次要终点包括 6 分钟步行测试。

这是第一项针对任何类型 PH 的 PADN 与药物治疗的随机研究。 与 MED 相比,应用于难治性 CTEPH 患者的 PADN 手术是安全的,并且与 PVR 和 PAP 的显着降低相关。 此外,关于 RV 功能的超声心动图数据也支持这种血流动力学改善。 此外,PADN 组的 N 端前 B 型利钠肽减少和临床改善更明显,符合预先指定的反应者标准的比例更大。此外,我们结合血流动力学和临床反应来确定对 PADN 治疗的反应者。 与基线数据相比,选择 PVR 降低 ≥150 dyn‧s‧cm−5 和 6MWT 增加 ≥20% 是任意的,但似乎对评估临床和功能状态变化是可靠的。 低血压和右心衰竭体征是随访期间住院的主要原因。

研究结论:

PEA 后 CTEPH 患者使用 PADN 是安全有效的,并且在 12 个月的随访期间显着降低了 PVR 和 PAP,同时改善了 6MWT 并减少了住院需求

 

参考文献:

Romanov A, Cherniavskiy A, Novikova N, Edemskiy A, Ponomarev D, Shabanov V, Losik D, Elesin D, Stenin I, Mikheenko I, Zhizhov R, Kretov E, Pokushalov E, Po SS, Martynyuk TV, Steinberg JS. Pulmonary Artery Denervation for Patients With Residual Pulmonary Hypertension After Pulmonary Endarterectomy. J Am Coll Cardiol. 2020 Aug 25;76(8):916-926. doi: 10.1016/j.jacc.2020.06.064. PMID: 32819465.

 

 

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    2022-02-24 hbwxf
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