Key result
Percutaneous implantation of a micropacemaker into the pericardial space was successfully achieved in a pig model, demonstrating feasibility without entering the vascular space.
A novel percutaneous micropacemaker system can be successfully implanted into the pericardial space in a porcine model, offering a potential future alternative to transvenous pacemakers.
Preclinical feasibility supports human translation studies; leaves open safety, efficacy, and clinical utility.
BACKGROUND: Permanent cardiac pacemakers require invasive procedures with complications often related to long pacemaker leads. We are developing a percutaneous pacemaker for implantation of an entire pacing system into the pericardial space. METHODS: Percutaneous micropacemaker implantations were performed in 6 pigs (27.4-34.1 kg) using subxyphoid access to the pericardial space. Modifications in the implantation methods and hardware were made after each experiment as the insertion method was optimized. In the first 5 animals, nonfunctional pacemaker devices were studied. In the final animal, a functional pacemaker was implanted. RESULTS: Successful placement of the entire nonfunctional pacing system into the pericardial space was demonstrated in 2 of the first 5 animals, and successful implantation and capture was achieved using a functional system in the last animal. A sheath was developed that allows retractable features to secure positioning within the pericardial space. In addition, a miniaturized camera with fiberoptic illumination allowed visualization of the implantation site before electrode insertion into myocardium. All animals studied during follow-up survived without symptoms after the initial postoperative period. CONCLUSIONS: A novel micropacemaker system allows cardiac pacing without entering the vascular space or surgical exposure of the heart. This pericardial pacemaker system may be an option for a large number of patients currently requiring transvenous pacemakers but is particularly relevant for patients with restricted vascular access, young children, or those with congenital heart disease who require epicardial access.
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Bar‐Cohen et al. (2018) studied Cardiac pacing requirement (n=6). Percutaneous micropacemaker implantation into the pericardial space was evaluated on Successful placement and capture. Percutaneous implantation of a micropacemaker into the pericardial space was successfully achieved in a pig model, demonstrating feasibility without entering the vascular space.
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