TAVI Calculation of Costs Trial

Conditions

aortic valve stenosis I35.0

Klaus Kaier, Frederike von Kampen, Hardy Baumbach, Constantin von zur Mühlen, Philip Hehn et al. (9 authors)

BMC Health Services Research2017-07-115 citations

Quality of life among elderly patients undergoing transcatheter or surgical aortic valve replacement– a model-based longitudinal data analysis

Klaus Kaier, Anja Gutmann, Hardy Baumbach, Constantin von zur Mühlen, Philip Hehn et al. (10 authors)

Health and Quality of Life Outcomes2016-07-2521 citations

10.1186/s12955-016-0512-9

In-hospital resource utilization in surgical and transcatheter aortic valve replacement

Jochen Reinöhl, Klaus Kaier, Anja Gutmann, Stefan Sorg, Constantin von zur Mühlen et al. (15 authors)

BMC Cardiovascular Disorders2015-10-227 citations

10.1186/s12872-015-0118-x

Interventions

Group 1: patients receiving catheter-assisted, minimally invasive aortic valve implantation (TAVI) Group 2: patients receiving conventional-operative aortic valve replacement (AVR) Group 3: patients

Eligibility

Sex/Gender

All

Age

75 Years to No maximum

Inclusion criteria

Inclusion criteria: Age: = 75 years Significant, symptomatic aortic stenosis is defined by: - Echocardiographic criteria: - dpmean aorta> 40 mm Hg or - vmax aorta:> 4.0 m / s or - AVA(aortic valve area): <0.8 cm2 (or AVA / BSA <0.5 cm2/m2). - symptoms: - NYHA class = II or - Angina pectoris, CCS class = II or - Cardiac syncope Informing the patient or his legal advisor on the study projects. Approval and signature of the consent form. Willingness to Contribute to the study projects. Commitment to participate in the follow-up visits by the patient.

Exclusion criteria

Exclusion criteria: Acute myocardial infarction within the past month, defined by: - STEMI or NSTEMI with CK elevation greater than twice the norm, and significant CK-MB fraction and / or significant troponin rise (WHO definition). Untreated, clinically significant coronary artery disease. Previous mechanical valve replacement and / or supply any prosthetic heart valve ring Congenital bicuspid aortic valve or mono- Non-calcifying aortic valve stenosis Combined Aortenklappenvitium with aortic valve insufficiency = grade 3 Severe mitral stenosis = grade 3 and / or miter valve insufficiency = grade 3 Sepsis or active endocarditis Hemodynamic instability, which requires inotropic or mechanical support. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. Stroke or TIA within the last 6 months. Blood value derailment, defined by: Leokozytopenie (cell count <3000/mm3), anemia (HB <9mg/dl), thrombocytopenia (counts <50.000/mm3). Hemophilia and / or coagulopathy and / or lack of consent to blood transfusions. Gastro-intestinal bleeding within the last 3 months. Known intolerance to aspirin (ASA), clopidogrel (Plavix) and / or hypersensitivity to contrast media, which can not be adequately treated. Need for emergency surgery from any cause. Limited life expectancy <12 months of non-cardiac cause.

Design outcomes

Primary

Measure	Time frame
Total mortality over an observation period of 24 month	—

Secondary

Measure	Time frame
Total cost of health services over an observation period of 24 months	—

Countries

Germany

Contacts

Public ContactJochen Reinöhl

Uniklinik Freiburg, Medzin III, Kardiologie/Angiologie

jochen.reinoehl@uniklinik-freiburg.de0761 270 34010

Outcome results

None listed