Novel Stabilization Catheter for His Pacing Lead Implant

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.