Richter Manuel J, Ewert Ralf, Warnke Christian, Gall Henning, Classen Simon, Grimminger Friedrich, Mayer Eckhard, Seeger Werner, Ghofrani Hossein-Ardeschir
Department of Pneumology, Kerckhoff Heart and Thoracic Center, Bad Nauheim, Germany.
Department of Internal Medicine, German Center for Lung Research (DZL), Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center, 35385, Giessen, Germany.
Clin Res Cardiol. 2017 Mar;106(3):174-182. doi: 10.1007/s00392-016-1037-2. Epub 2016 Sep 26.
In patients with severe pulmonary arterial hypertension, subcutaneous or catheter-based intravenous application of prostanoids carries a risk of local side effects or systemic infections, which limits their use and acceptance. Recently, a fully implantable pump for continuous application of intravenous treprostinil was approved in Germany. However, surgery is a major risk for patients with severe pulmonary arterial hypertension. The purpose of this study was to investigate the safety of a fully implantable pump inserted under local or general anesthesia in patients with severe pulmonary hypertension.
All patients with pulmonary hypertension undergoing pump implantation for the continuous application of intravenous treprostinil were included from two German centers. Surgery was performed under local or general anesthesia according to the protocol of the recruiting center. Intra-operative safety and in-hospital complications were analyzed for the two different implantation regimens.
In total, 51 patients were included. No major intra-operative complications were recorded. During the observation period, two patients died of progressive right heart failure, and two patients required treatment in the intensive care unit for acute right heart decompensation and respiratory failure. In total, major complications occurred in 8 out of 51 patients.
Our observational study provides preliminary evidence supporting the procedural safety of a fully implantable pump inserted under local or general anesthesia for patients with severe pulmonary hypertension. The observation of major complications in a subset of patients requires extensive pre- and post-operative assessments. Future trials are required to provide further evidence for the long-term safety and efficacy of the pump using this approach.
在重度肺动脉高压患者中，皮下或经导管静脉应用前列环素存在局部副作用或全身感染风险，这限制了它们的使用和接受度。最近，一种用于持续静脉输注曲前列尼尔的完全植入式泵在德国获得批准。然而，手术对重度肺动脉高压患者来说是一项重大风险。本研究的目的是调查在局部或全身麻醉下为重度肺动脉高压患者植入完全植入式泵的安全性。
纳入来自德国两个中心的所有因持续静脉输注曲前列尼尔而接受泵植入的肺动脉高压患者。根据招募中心的方案，手术在局部或全身麻醉下进行。分析了两种不同植入方案的术中安全性和住院期间并发症。
共纳入51例患者。未记录到重大术中并发症。在观察期内，2例患者死于进行性右心衰竭，2例患者因急性右心失代偿和呼吸衰竭在重症监护病房接受治疗。51例患者中共有8例发生重大并发症。
我们的观察性研究提供了初步证据，支持在局部或全身麻醉下为重度肺动脉高压患者植入完全植入式泵的手术安全性。对部分患者重大并发症的观察需要进行广泛的术前和术后评估。需要进一步的试验来为使用这种方法植入泵的长期安全性和有效性提供更多证据。
