Improved early diagnosis of thrombosis in Left Ventricular Assist Device (LVAD) using accelerometer
a) Aim of the study
Implantable left ventricular assist devices (LVAD) are increasingly used for treatment of advanced heart failure, both as a bridge to heart transplantation, and as destination therapy due to lack of organs. Lifelong treatment with LVAD poses high risk for serious complications such pump thrombosis which is a medical emergency that prompts immediate diagnosis and treatment. The diagnosis is however indirect and cumbersome, and routine methods are insensitive. We have recently demonstrated that a small accelerometer attached to housing of the pump can detect pump thrombosis with much higher sensitivity and sensitivity than routine methods. The sensor can easily be integrated to existing heart pumps and paves the way for a new generation of heart pumps with an automated system for detection of complications and monitoring of effect of treatments. In a porcine model we aim 1) to investigate correlation between accelerometer signal and thrombus size/location, 2) to test the method in monitoring of treatments (anticoagulation/lysis of thrombus), 3) to develop automated signal algorithms for continuous surveillance.
b) Harmfulness of the animals
General anesthesia (total intravenous anestesia) and surgery will be performed by the same standards as in patients. All pigs will be euthanized the same day after the protocol is completed, and thus the animals will not suffer.
c) Scientific impact and value for society.
The scientific impact of the results is high as the technology has potential for reducing morbidity and mortality in a growing and very sick patient population. The results have great value for future patients and their relatives and society. The method also can reduce costs related to advance heart failure treatment.
d) Number of animals
We will use 15 pigs (90 kg) as the pig heart has great similarities to the human heart. Sample size calculation is based on data from previous studies.
e) How we meet the requirements for replacement, reduction and refinement
Replacement, reduction and refinement are ensured by the following : 1) the research group consists of highly skilled experts with long experience in animal research, 2) anesthesia and surgery will be performed by the same standards as in patients, 3) we need to test to test the accelerometer in a beating heart model before clinical use. This makes in-vitro models unsuitable. 4) the number of animals included in the study is based on sample size calculation and kept as low as possible.
5) Antiarrhythmic drugs will be given to reduce risk of ventricular fibrillation.
Implantable left ventricular assist devices (LVAD) are increasingly used for treatment of advanced heart failure, both as a bridge to heart transplantation, and as destination therapy due to lack of organs. Lifelong treatment with LVAD poses high risk for serious complications such pump thrombosis which is a medical emergency that prompts immediate diagnosis and treatment. The diagnosis is however indirect and cumbersome, and routine methods are insensitive. We have recently demonstrated that a small accelerometer attached to housing of the pump can detect pump thrombosis with much higher sensitivity and sensitivity than routine methods. The sensor can easily be integrated to existing heart pumps and paves the way for a new generation of heart pumps with an automated system for detection of complications and monitoring of effect of treatments. In a porcine model we aim 1) to investigate correlation between accelerometer signal and thrombus size/location, 2) to test the method in monitoring of treatments (anticoagulation/lysis of thrombus), 3) to develop automated signal algorithms for continuous surveillance.
b) Harmfulness of the animals
General anesthesia (total intravenous anestesia) and surgery will be performed by the same standards as in patients. All pigs will be euthanized the same day after the protocol is completed, and thus the animals will not suffer.
c) Scientific impact and value for society.
The scientific impact of the results is high as the technology has potential for reducing morbidity and mortality in a growing and very sick patient population. The results have great value for future patients and their relatives and society. The method also can reduce costs related to advance heart failure treatment.
d) Number of animals
We will use 15 pigs (90 kg) as the pig heart has great similarities to the human heart. Sample size calculation is based on data from previous studies.
e) How we meet the requirements for replacement, reduction and refinement
Replacement, reduction and refinement are ensured by the following : 1) the research group consists of highly skilled experts with long experience in animal research, 2) anesthesia and surgery will be performed by the same standards as in patients, 3) we need to test to test the accelerometer in a beating heart model before clinical use. This makes in-vitro models unsuitable. 4) the number of animals included in the study is based on sample size calculation and kept as low as possible.
5) Antiarrhythmic drugs will be given to reduce risk of ventricular fibrillation.