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

TP1是KFO311临床和转化研究的中心项目，并组织前瞻性患者登记和生物材料收集。在KFO311的第一个资助期，我们将现有的临床登记处转移到KFO311登记处，并建立了一个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/或体外膜氧合（ECMO）的患者以及>90例携带左心室辅助装置（LVAD）的患者。一些出版物来自该注册表，例如关于使用Impella泵卸载左心室，以及ECMO支持肺栓塞患者的手术治疗。我们在试点研究中考察了肺动脉高压和右心衰竭患者（ORION-PH）和LVAD植入后患者（ORION-LVAD）口服补铁的情况。我们将80例扩张型心肌病患者纳入DETECT-ID登记，并在心内膜活检中测量铁含量。此外，我们建立了VAD患者传动系统感染的新评分。tp1在下一个资助期的目标是：继续推行TP1作为中央临床项目。2)。数据库/生物材料库的扩展，包括持续的30天和1年随访，特别是系列心脏材料（VAD/HTx）的收集。3)。开发用于预测（前）终末期心肺衰竭患者短期和长期预后的评分。4)。临床（试点）研究：终止口服补铁的ORION-PH和ORION-LVAD研究。与detect - id注册表的TP2一起，现在对骨骼肌进行平行活检，以确定骨骼肌与心肌和循环铁参数相比缺铁。此外，使用压力-容量记录导管系统，我们希望在植入支持系统前后对更深度的急性和晚期心力衰竭患者进行表征，以改善治疗管理。通过使用Cardio-Mems系统连续测量LVAD患者的PA压力，我们计划进一步优化LVAD设置。德国RVAD植入的前瞻性多中心注册（约50例/年）将被纳入KFO311注册。在复苏过程中接受va - ecmo的患者将进行系统随访，以优化治疗策略，并确定生存和神经预后的预测因素。在随机的危险-休克研究中，研究了Impella泵在心肌梗死后心源性休克患者中的作用（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的分析。

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.