Feasibility of Goal-Directed Fluid Therapy in Patients with Transcatheter Aortic Valve Replacement - An Ambispective Analysis.

"Conflict of interest: RFT, MN, GBF, HD, and KS have nothing to declare. MS received financial activities from Edwards Lifesciences, Medtronic, the Getinge Group, FERRER, AMOMED, Orion Pharma, Grünenthal, Fisher&Peykel, BTG, and Ratiopharm. ST received institutional research grant & honoraria for lectures/workshops by Orionpharma and Edwards and honoraria for lectures by Amomed outside this work. MH received payment from Edwards Lifesciences and AMOMED due to lecturing activities."

"No financial support. Conflict of interest: RFT, MN, GBF, HD, and KS have nothing to declare. MS received financial activities from Edwards Lifesciences, Medtronic, the Getinge Group, FERRER, AMOMED, Orion Pharma, Grünenthal, Fisher&Peykel, BTG, and Ratiopharm. ST received institutional research grant & honoraria for lectures/workshops by Orionpharma and Edwards and honoraria for lectures by Amomed outside this work. MH received payment from Edwards Lifesciences and AMOMED due to lecturing activities."

"Patients in the intervention group were originally consecutive participants in a two-arm pilot study in intraoperative thermal management using a noninvasive warming system in minimally invasive heart valve replacement. As GDFT was also applied in the study, data were also analyzed regarding hemodynamic optimization in TAVR. Therefore, in this ambispective substudy, patients in the prospective intervention group with GDFT were compared with a retrospective control group before the hemodynamic optimization protocol was implemented. Inclusion criteria were age ≥ 18 years, elective TAVR in general anesthesia, and no participation in another interventional study. Exclusion criteria were lack of ability to consent study participation, pregnant or nursing patients, emergency procedures, preinterventional decubitus, tissue and/or extremity ischemia, peripheral arterial occlusive disease grade IV, atrial fibrillation or other severe heart rhythm disorders which impeded usage of uncalibrated pulse contour analysis because of its insufficient validity in these disorders, and necessity of usage of intra-aortic balloon pump. All procedures performed in studies involving humans were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. The study was approved by the local ethics committee at Charité - Universitätsmedizin Berlin (EA 1/142/10) and registered at ClinicalTrials.gov (NCT01176110). Informed written consent was obtained from all study patients in the intervention group. Data from patients in the retrospective control group before GDFT implementation were collected anonymously, therefore informed written consent was waived. The study was performed at the Charité - Universitätsmedizin Berlin, Campus Charité Mitte. Our study adheres to CONSORT guidelines."