The use of the biodesign innovation process to identify an unmet clinical need in heart failure with preserved ejection fraction

Heart failure, also known as congestive heart failure, is a disorder that occurs when the heart cannot pump enough blood to meet the requirements from the body. Heart Failure with Preserved Ejection Fraction (HFpEF) is a classification of heart failure where the left ventricular ejection fraction is greater than or equal to 50%. Half of all heart failure cases are HFpEF with 32 million people living with HFpEF worldwide. HFpEF has a complex aetiology and pathophysiology as well as poor outcomes with a 5-year mortality of up to 75%. While the treatment landscape is constantly evolving, the heterogeneous nature of this population makes standardising treatment with medication extremely difficult in HFpEF patients. There are limited specific drug therapies available for the treatment of HFpEF and no device-based therapy has yet been approved for the management of HFpEF. This thesis outlines how the phases of the Biodesign Process were deployed to identify an unmet clinical need in HFpEF. The three phases of the Biodesign Process are Identify, Invent, and Implement. Through the Identify Phase, 880 need statement were created by the cardiology team. These 880 need statements were narrowed down to the top 3 need statements through detailed validation and research. The HFpEF need was chosen to be the topic of further research due to personal preference. An insight into the relationship between epicardial adipose tissue (EAT) and HFpEF was crucial to the Invent Phase of the Biodesign Process. The insight discovered was that increased EAT is associated with the development, progression, and prognosis of HFpEF. This thesis hypothesises that reducing EAT back to a healthy level in a subset of HFpEF patients will provide an acute and chronic outcome to the symptoms of HFpEF patients. In the Concept Generation stage of the Invent Phase, a brainstorming session was conducted. This session led to the development of Concept 1 and Concept 2. Through further validation with key stakeholders, Concept 1 was chosen to have the best chance of success. Concept 1 involves intravascular access to the chambers of the heart where a high intensity focused ultrasound (HIFU) will be deployed to denature EAT on the other side of the myocardium. A relevant haemodynamic parameter will be monitored to measure the effect of the acute reduction of EAT. The selected concept showed no major failing points in terms of IP, reimbursement, or the regulatory pathway. In conclusion, the Biodesign Process enabled the identification of an unmet clinical need in HFpEF. The Biodesign Process led to the development of a proposed solution direction with no major failing points. HFpEF patients are an underserved population with no approved alternative devices for the treatment of the condition. This solution has the potential to have a significant impact on the lives of HFpEF patients.

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University of Galway

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Attribution-NonCommercial-NoDerivatives 4.0 International

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University of Galway Theses (Research Masters Theses)