Ventricular Tachycardia (VT) is a major public health problem associated with the majority of the 300,000 cases of sudden cardiac death in the United States each year. The best current therapy for VT involves drugs to reduce VT episodes plus implantation of a cardiac defibrilator (ICD) that prolongs life by terminating episodes of VT. Permanent cessation of VT can be achieved by ablation of the origin site(s) and exit pathway(s) of the arrhythmia. Despite the advantages of this technique, its adoption has been limited because it is currently appropriate only for the few patients with hemodynamically stable VT. This project will create a disruptive, less expensive, more effective, and safer system for minimally invasive identification and ablation of critical VT sites. It will combine the HeartLander (HL) epicardial walker with a non-invasive mapping technology and a flexible, needle-based, radio frequency ablation technique. In prior work we have demonstrated that these technologies can be integrated into a unified system and have also eliminated major technical risks of the technologies. In this Fast Track SBIR application, we propose to complete the integration of the technologies and then verify the efficacy of the system in a Yorkshire swine pig model of VT. Upon successful completion, we will be ready to advance to the clinic a simpler, safer, more reliable and less expensive approach to effectively treating the 500,000 annual cases of ventricular tachycardia. We will also have built the hardware and computation infrastructure to support additional mapping methodologies that will enable the treatment of complex multi-focal arrhythmias.
Public Health Relevance Statement: Project Narrative Ventricular Tachycardia (VT) causes 300,000 deaths in the United States each year, but existing treatments have significant drawbacks (e.g., implantable cardioverter-defibrillators do not prevent VT but only stop the arrhythmia with a painful shock). At present, it is only possible permanently treat VT, the origination and/or reentrance of the improper electrical signal(s) easily and reliably for a small percentage of the VT-affected population. We propose to leverage prior work, merge four well-understood but highly innovative NIH-funded technologies, provide large animal proof-of-concept for a therapy that will expand the number of VT patients who can receive this permanent cessation technique while significantly reducing the cost and increasing the safety of VT ablation therapy, and build a platform for an on-going expansion of techniques to permanently treat a range of arrhythmias.
Project Terms: Ablation; Adoption; Adverse effects; Affect; Algorithms; Animals; Anti-Arrhythmia Agents; Area; Arrhythmia; base; Blood Vessels; Cardiac; Cessation of life; Chronic; Clinic; commercialization; Complex; computer infrastructure; cost; Death, Sudden, Cardiac; design; Distress; Doppler Ultrasound; Electrodes; Eligibility Determination; experimental study; Failure; Family suidae; Film; flexibility; Funding; Heart; hemodynamics; Hour; Imagery; Implantable Defibrillators; implantation; improved; in vivo; innovation; innovative technologies; Lesion; Life; Maps; Methodology; miniaturize; minimally invasive; Modeling; Morphology; Myocardial; Myocardial Infarction; Myocardium; Navigation System; Needles; novel; Operative Surgical Procedures; Pain; Pathway interactions; Patient-Focused Outcomes; Patients; Pattern; Pericardial body location; Pharmaceutical Preparations; Phase; Physiological; Population; Process; Public Health; Radiofrequency Interstitial Ablation; Recurrence; reduce symptoms; Risk; Safety; Saline; sensor; Shock; Signal Transduction; Site; Small Business Innovation Research Grant; System; Techniques; Technology; Testing; Therapeutic; Thinness; Tissues; tool; Ultrasonography; United States; United States National Institutes of Health; Ventricular Tachycardia; Walkers; Work
