Key result
The PeriPath device met all clinical mechanical requirements and was preferred over commercial access tools for minimally invasive pericardial access in a preliminary simulator study.
Why the study?
When vascular anatomy precludes transvenous cardiac lead placement, open chest surgery is often required; a minimally invasive tool under direct visualization could reduce tissue damage, pain, recovery time, and fluoroscopy needs.
The PeriPath device demonstrates adequate mechanical properties and functionality for minimally invasive pericardial access and lead implantation in preclinical testing.
Supports device development for pericardial access; leaves open human safety and efficacy pending clinical trials.
Small vasculature, venous obstruction, or congenital anomalies can preclude transvenous access to the heart, often resulting in open chest surgery to implant cardiac therapy leads for pacing, defibrillation, or cardiac resynchronization. A minimally invasive approach under direct visualization could reduce tissue damage, minimize pain, shorten recovery time, and obviate the need for fluoroscopy. Therefore, PeriPath was designed as a single-use, low-cost pericardial access tool based on clinical requirements. Its mechanical design aids in safe placement of conductive leads to the pericardium using a modified Seldinger technique. The crossed working channels provide an optimal view of the surgical field under direct visualization. Finite element analysis (FEA) confirms that the device is likely not to fail under clinical working conditions. Mechanical testing demonstrates that the tensile strength of its components is sufficient for use, with minimal risk of fracture. The PeriPath procedure is also compatible with common lead implantation tools and can be readily adopted by interventional cardiologists and electrophysiologists, allowing for widespread implementation. Prior animal work and a physician preliminary validation study suggest that PeriPath functions effectively for minimally invasive lead implantation procedures.
No takes yet. Share an insight, caveat, or question.
Contento et al. (2022) studied Pericardial access (n=3). PeriPath device vs. Commercial access tools was evaluated on Mechanical performance and usability. The PeriPath device met all clinical mechanical requirements and was preferred over commercial access tools for minimally invasive pericardial access in a preliminary simulator study.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: