Advanced telehealth for chronic heart failure management

Heart Failure (HF), a chronic and progressive clinical syndrome characterized by symptoms like dyspnoea, oedema, and fatigue, affects millions worldwide, leading to high rates of hospitalization and mortality. Traditional management relies on in-person diagnostics and hospital-based care, often resulting in delayed intervention and increased burden on healthcare systems. Remote monitoring (RM) via telehealth represents a pivotal shift towards proactive HF management, allowing for continuous, real-time data collection, early detection of decompensation, and prompt interventions. This thesis explores an innovative approach to HF management through the design, development and validation of a novel implantable sensor for central venous pressure (CVP) monitoring in the inferior vena cava (IVC), and compares its clinical relevance to the existing pulmonary artery pressure (PAP) sensors currently used in clinical practice. Recent clinical trials utilizing PAP monitoring technologies (e.g., CardioMEMSTM, Abbott, Atlanta, GA, United States, and CordellaTM, Endotronix Inc., Lisle, IL, United States) demonstrate the clinical benefits of RM for HF, including reduced hospitalizations and optimized therapy for high-risk patients with multiple comorbidities. However, these technologies are constrained by their invasiveness, requiring right heart catheterizations, extended procedure times, prolonged exposure to contrast media, and complex target anatomy, which limits their suitability for many patients. The IVC presents a promising alternative site for assessing congestive HF, using CVP as a potential haemodynamic marker in HF monitoring. Unlike PAP, however, the full diagnostic potential of CVP remains underexplored. This thesis addresses this gap by assessing the clinical relevance of CVP in HF diagnostics, designing an anchoring system for an implantable CVP sensor optimized for IVC placement, and evaluating its feasibility within a preclinical context. A literature review on existing RM technologies and telehealth platforms established the need for improved diagnostic capabilities for HF patients, especially for those ineligible for PAP monitoring. Key research questions included the clinical significance of CVP, benefits and limitations of IVC implantation, and practical challenges in implementing solutions that combine invasive and non-invasive monitoring. Based on these questions, research objectives focused on CVP diagnostics, sensor design, development, and validation, as well as the implementation of a telehealth platform combining both RM approaches. The first part of this thesis investigated the design and development of a CVP sensor to address unique anatomical challenges in the IVC. A novel anchoring system was engineered to ensure stable sensor positioning, prevent migration, and maintain accurate CVP measurements. Bench testing using custom-made silicone IVC model evaluated device performance under physiological conditions. Computational fluid dynamics (CFD) modelling assessed the implant’s impact on blood flow, validating safety and feasibility for in-vivo testing. An animal study involving simultaneous CVP and PAP measurements established baseline data for haemodynamic trends, with results confirming the sensor’s accuracy and reliability. This study provided foundational data to support the potential of CVP as a valuable marker for HF management and demonstrated a safe, efficient IVC implantation technique. The second part of this thesis investigated a clinical, observational telehealth study assessing outcomes in three patient cohorts over 12 months: a non-invasive group using commercial devices and a tablet for vital sign monitoring (Croga); an invasive cohort using PAP monitoring along with the same devices and a tablet; and a Control group under routine standard of care. Findings indicated that the Implant group demonstrated the highest compliance (99%) and significant improvements in functional status (P<0.001), aligning with previous studies using similar technology for PAP monitoring. The telehealth intervention successfully reduced HF hospitalizations and improved medication management, underscoring the benefits of remote monitoring in HF patients. Despite these successes, limitations such as small sample size and uneven NYHA class distribution suggests a need for larger-scale studies to validate these findings both clinically and statistically. This thesis advances HF management by introducing a CVP sensor with potential to address gaps in current RM strategies and by establishing a telehealth platform that accommodates diverse patient needs. The novel integration of CVP and PAP monitoring expands clinical insights into HF progression and treatment efficacy. Future research should focus on refining the bench methods by redesigning sensor technologies and anchoring mechanisms to optimize their placement and use within the cardiovascular system, enhance bedside monitoring by expanding the scope of RM for diverse HF populations, while assessing their long-term relevance and efficacy. The results of this thesis support a more individualised and proactive approach to HF management, offering a significant step forward in the adoption and maintenance of telehealth solutions tailored to the complex and evolving needs of HF 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 (PhD Theses)