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Principal Investigator: William Combs
Organization: 3DT HOLDINGS, LLC
Fiscal Year: 2024
Award: $437,461
Funding agency: National Heart Lung and Blood Institute
ABSTRACT
Heart failure (HF) is a nationwide epidemic with over 6 million afflicted patients and 600,000 new patients
diagnosed each year. Many HF patients present with left bundle branch (LBB) block morphology and mechanical
dyssynchrony which are strong predictors of cardiovascular mortality. Cardiac Resynchronization Therapy (CRT)
has emerged as a powerful treatment for HF. Approximately 30% of patients still do not improve after therapy,
however, and improvement of the responder rate to pacing therefore remains a crucial clinical challenge. His
and Left Bundle Branch (LBB) pacing have therefore recently emerged as alternatives CRT. Left bundle pacing
and LBB pacing arguably produce a physiologically normal ventricular activation pattern, by utilizing the native
His-Purkinje system. Despite the creation of specialized pacing electrodes and sheaths, successful placement
of the His lead is achieved in ~80% of cases. Initially, time consuming mapping (and significant fluoroscopic
imaging and related radiation) must be performed to accomplish the following: 1) Locate the His signal, 2) Deliver
the lead perpendicular to the myocardial tissue to reach the His, and 3) Pace to demonstrate selective His
capture with acceptable pacing capture thresholds. Hence, the overall goal of this Phase I proposal is to use a
deployable suction flute-tipped lead placement sheath to both improve mapping the His location of the heart,
and to place the lead into the His with the lead’s orthogonal orientation. Recently, we have developed a sheath
which can deploy a suction flute within the heart. We intend to refine our design and optimize it for His targeting
and stabilization. Suction will also serve as an indicator that our flute is oriented orthogonally to the endocardium.
To build on the previous successes, this work will be accomplished by the following Specific Aims: 1) Refine
flute design to incorporate electrodes, arrayed in the rim of the flute and 2) Validate the safety and
efficacy of the His lead stabilization technology in a cohort of swine (n=6) in a chronic 4-week study. The
validated novel sheath configuration will align our deployable suction flute with a high degree of freedom for
adjustment. The successful completion of this Phase I proposal will systematically address the current
challenges of His lead placement, reducing the complexity of lead placement, while also improving placement
accuracy and long-term outcomes. A subsequent Phase II SBIR will translate this technology to the clinic for
optimization of His pacing, and a reduction in non-responder rates. This technology addresses some of the
shortcomings of CRT that requires three lead placements including one in the coronary sinus which is often
difficult and may require substantial fluoroscopy time. In addition to improved outcome, there is an opportunity
to reduce the healthcare cost of the treatment of HF epidemic.
Terms: <ACE Inhibitors><Address><Anatomic Sites><Anatomic structures><Anatomy><Angiotensin I-Converting Enzyme Inhibitors><Angiotensin-Converting Enzyme Antagonists><Angiotensin-Converting Enzyme Inhibitors><Apex of the Heart><Body Tissues><Bundle Branch disorder><Bundle-Branch Block><Cardiac><Cardiovascular><Cardiovascular Body System><Cardiovascular Organ System><Cardiovascular system><Catheters><Cell Communication and Signaling><Cell Signaling><Chronic><Clinic><Clinical><Compensation><Consumption><Coronary><Coronary sinus structure><Devices><Diagnosis><Distal><Diuretics><Drugs><Electrodes><Endocardium><Ensure><Epidemic><Family suidae><Fixation><Fluoroscopy><Freedom><Goals><Health Care Costs><Health Costs><Healthcare><Healthcare Costs><Heart><Heart Muscle tissue><Heart Vascular><Heart failure><Image><Implant><Intracellular Communication and Signaling><Kininase II Antagonists><Kininase II Inhibitors><LVAD><Lead><Left><Length><Liberty><Location><Maps><Mechanical Aspiration><Mechanics><Medication><Monitor><Morphology><Myocardial tissue><Outcome><Pace Stimulators><Pacemakers><Patients><Pattern><Pb element><Pharmaceutical Preparations><Phase><Physiologic><Physiological><Pigs><Position><Positioning Attribute><Purkinje Fibers><Radiation><Reproducibility><Right Atrium><Right atrial structure><Rotation><SBIR><Safety><Signal Transduction><Signal Transduction Systems><Signaling><Small Business Innovation Research><Small Business Innovation Research Grant><Structure of purkinje fibers><Suction><Suction Drainage><Suidae><Surface><Swine><System><Technology><Time><Tissues><Translating><Treatment Cost><Variant><Variation><Ventricular><Work><biological signal transduction><cardiac failure><cardiac function><cardiac resynchronization therapy><circulatory system><cohort><coronary sinus><design><designing><drug/agent><function of the heart><health care><heart Purkinje's fiber><heart function><heavy metal Pb><heavy metal lead><hemodynamics><imaging><improved><improved outcome><left ventricular assist device><mechanic><mechanical><mortality><new technology><novel><novel technologies><pig model><piglet model><porcine><porcine model><preservation><response><sample fixation><success><suid><swine model><tool>