- Department / Institute
- Department for Vascular Surgery
- Subject area
- Aorta, Endovascular Aortic surgery
- Name of supervisor
- Prof. Dr. Nikolaos Tsilimparis, Jan Stana PhD
- Number of open positions
- Project title
- RESCOUT TEVAR REGISTRY, Reduction of Systemic Cardiac Output in TEVAR
- Language requirements
- Fluency in English
- Academic requirements
- 4-year Bachelor's plus Master's degree; preferably clinical experience in vascular surgery
- Study model
- Full doctoral study model or sandwich model
Study rationale: High systolic blood pressure, pulsatile motion and the so called “windsock effect” of the aorta are factors that must be considered when it comes to deployment of stent grafts, especially in the ascending aorta. These forcescan cause distal migration of the stent-graft and therefore increase the risk of unintended coverage of aortic branches and unsuccessful treatment of theunderlying pathology. Currently available options for cardiac output reduction such as “Partial right inflow occlusion” or “Rapid right ventricular pacing” require additional vascular access and material. Therefore, they may hold certain risks. A modified Valsalva manoeuvre called “MuVIT-Munich Valsalva Implantation Technique” may be a suitable alternative. To compare the methods mentioned above and to acquire data on the physiological changes during cardiac output reduction a multicentre study should be performed.
Study objectives: To evaluate the outcome of different methods for cardiac output reduction in patients undergoing TEVAR, by analysing and comparing a comparative endpoint consisting of Technical and Procedural success for each method.
Study design and plan: An International multicenter, retrospective and prospective cohort studyconducted as a descriptive register study. Vital parameters and data routinely acquired and measured before, during and after endovascular surgical procedures will be collected, analysed, and compared. The patients data will be pseudonymized. If patients who are eligible for the study are not able to give consent because of the severity of their disease, or do not survive the required treatment their data will be anonymized.
Study participants inclusion criteria: 1.) Age ≥ 18 years 2.) All patients with pathologies of the thoracic aorta that require endovascular treatment.
Procedures: a.) TEVAR (thoracic endovascular aortic repair) b.) bTEVAR (branched thoracic endovascular aortic repair) c.) fTEVAR (fenestrated thoracic endovascular aortic repair)
Exclusion criteria: 1) Pregnancy or breastfeeding period 2.) Life expectancy ≤ 1 year 3.) Lack of compliance regarding follow up examinations 4.) Presence of lung fistulae or bullae or high risk for pneumothorax 5.) Unstable coronary artery disease 6.) Presence of open foramen ovale 7.) High-grade aortic stenosis 8.) Poor pump function 9.) Uncontrolled arrhythmias
Outcome: Collecting information on the factors, that influence the outcome. Haemodynamic data: collecting information on preoperative haemodynamic data; Reintervention: Aortic related reintervention; Mortality: At 6 and 12 months follow up Endoleaks; Other complications: device delivery or vascular access complications
Data analysis: 202 Patients in total; 101 assigned to an intervention arm (MuVIT); 101 assigned to a control arm/ standard care (Rapid Ventricular Pacing, Partial right inflow occlusion)