Optimization of transient and permanent cardiopulmonary support in patients with heart and lung failure

TP 1是KFO 311临床和预防研究的中心项目，组织前瞻性患者登记和生物材料收集。在KFO 311的第一个资助期内，我们将现有的临床注册中心转移到KFO 311注册中心，并建立了基于服务器的数据库和生物材料库。自2017年以来，我们纳入了>250例使用Impella泵和/或体外膜肺氧合（ECMO）的患者以及> 90例携带左心室辅助装置（LVAD）的患者。几篇文献来源于登记研究，例如关于Impella泵的左心室去负荷和ECMO支持下肺栓塞患者的手术治疗。我们在初步研究中检查了肺动脉高压和右心衰竭患者（ORION-PH）和LVAD植入后患者（ORION-LVAD）的口服补铁。我们将80例扩张型心肌病患者纳入DETECT-ID登记研究，并测量肌内膜活检组织中的铁含量。此外，我们还建立了VAD患者传动系感染的新评分。TP 1在下一个资助期的目标是：1.继续TP 1作为中心临床项目。2.）的情况。扩展数据库/生物材料库，包括一致的30天和1年随访，收集特别是系列心脏材料（VAD/HTx）。3.）第三章预测终末期（前）心力衰竭和肺衰竭患者短期和长期预后的评分的发展4.）临床（初步）研究：终止口服补铁的ORION-PH和ORION-LVAD研究。与TP 2一起继续DETECT-ID登记研究，现在进行骨骼肌平行活检，以确定骨骼肌与心肌和循环铁参数相比的铁缺乏。此外，使用压力-容积-记录导管系统，我们希望更深入地描述急性和终末前心力衰竭患者在植入支持系统前后的特征，以改善治疗管理。我们计划通过连续测量LVAD患者的PA压力来进一步优化LVAD设置。RVAD治疗的前瞻性德国多中心登记研究（约。50例患者/年）将纳入KFO 311登记研究。在复苏期间接受VA-ECMO的患者将被系统地随访，以优化治疗策略，并确定生存和神经结局的预测因素。在研究Impella泵在心肌梗死后心源性休克患者中的随机Danger-休克-研究中（主要终点死亡率，由Abiomed支持），我们将对机械卸载的效率进行额外分析。

TP1 is the central project of the KFO311 for clinical and translationalresearch and organizes the prospective patient registry and thecollection of biomaterials. In the first funding period of the KFO311 wetransferred the existing clinical registries into a KFO311 registry, andestablished a server based data bank and biomaterial bank. Since2017 we included >250 patients with Impella pump and/orextracorporeal membrane oxygenation (ECMO) as well as >90patients carrying a left ventricular assist device (LVAD). Severalpublications originated from the registry, eg regarding left ventricularunloading by Impella pump, and surgical treatment of patients withpulmonary embolism supported by ECMO. We examine oral ironsupplementation in patients with pulmonary hypertension and rightheart failure (ORION-PH) and in patients after LVAD implantation(ORION-LVAD) in pilot studies. We included 80 patients with dilatedcardiomyopathy into the DETECT-ID registry and measured ironcontent in endomyocardial biopsies. In addition, we established anovel score for driveline infections in VAD patients. The goals of TP1in the next funding period are: 1.) Continuation of TP1 as centralclinical project. 2.) Extension of the data bank/biomaterial bankincluding consistent 30-day and 1-year follow-ups, collectionespecially of serial heart material (VAD/HTx). 3.) Development ofscores for the prediction of short-term and long-term outcomes ofpatients with (pre-)terminal heart and lung failure. 4.) Clinical (pilot)studies: Termination of the ORION-PH and ORION-LVAD studies onoral iron supplementation. Continuation together with TP2 of theDETECT-ID registry now with parallel biopsies of skeletal muscle forthe determination iron deficiency in the skeletal muscle compared tothe myocardium and to circulating iron parameters. Furthermore,using a pressure-volume-recording-catheter system we want tocharacterize in more depth patients with acute and preterminal heartfailure before and after implantation of support systems to enable animproved therapeutic management. With continuous measurementsof PA pressures in LVAD patients using the Cardio-Mems system weplan to optimize further LVAD settings. The prospective Germanmulticenter registry of RVAD implantations (ca. 50 patients/year) willbe included into the KFO311 registry. Patients who receive VA-ECMOduring resuscitation will be followed systematically to optimizetreatment strategies, and identify predictors of survival and neurological outcomes. In the randomized DanGer-Shock-Studyinvestigating Impella pump in patients with cardiogenic shock aftermyocardial infarction (primary endpoint mortality, supported byAbiomed), we will perform additional analyses of the efficiency ofmechanical unloading.