Implantable cardioverter defibrillators - Translating evidence from randomized clinical trials to routine clinical practice
J.B. (Hans) van Rees
Promotores: Prof. dr. M.J. Schalij, Prof. dr. J.J. Bax
30 januari 2014
Guidelines for ICD implantation are primarily based on data of randomized clinical trials and the current thesis evaluates the effects of these guidelines on routine clinical practice. As demonstrated earlier ICD treatment is superior to medical therapy in the prevention of sudden cardiac death in a selected population. However, patients included in the clinical trials have different characteristics than patients in the real world because of the strict inclusion criteria used in the trials. Inevitably, this leads to disparities between the studied population and routine clinical practice and can affect the established survival benefit of ICD therapy. Consequently, it is necessary to assess ICD patients outside the setting of a clinical trial and compare the findings with data of randomized clinical trials. This thesis comprised several studies about ICD patients in routine clinical practice and assessed several aspects of primary and secondary prevention ICD patients including long-term follow-up, safety and risk stratification. Also, ICD patients were identified who do not benefit from ICD therapy and a risk model for death without appropriate ICD therapy was created.
Intramyocardial bone marrow cell injection: Clinical and functional effects in ischemic heart disease
Jan van Ramshorst
Promotor: prof. dr. M.J. Schalij, copromotor: prof. dr. D.E. Atsma
2 april 2014
Coronary artery disease is a major cause of mortality and morbidity in the western world. Despite successive revascularization procedures, a large number of patients ends up with end-stage coronary artery disease, not amenable for conventional revascularization. These patients often have stress-inducible myocardial ischemia, resulting in disabling complaints of angina, refractory to medical treatment. Intramyocardial bone marrow cell injection is currently under investigation as a new therapeutic option for these patients. This treatment aims to improve myocardial perfusion and contractile function (and decrease anginal complaints) through administration of bone marrow cells into ischemic myocardium.
In the current thesis, the use of intramyocardial bone marrow cell injection for the treatment of chronic myocardial ischemia is evaluated several studies. First, the results of a randomized, placebo controlled, double-blinded trial are described, demonstrating that bone marrow cell injection is associated with a reduction in angina complaints, improved myocardial perfusion and increased left ventricular function. Furthermore, the effects of intramyocardial bone marrow cell injection were further explored by evaluating changes in diastolic function, cardiac innervation, and left ventricular synchronicity. In addition, the long term effects of bone marrow cell injection are described.