Minimally Invasive Implantation of a Micropacemaker Into the Pericardial Space

Abstract

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 six 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, non-functional pacemaker devices were studied. In the final animal, a functional pacemaker was implanted. Results Successful placement of the entire non-functional 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 prior to electrode insertion into myocardium. All animals studied during follow-up survived without symptoms after the initial post-operative period. Conclusions A novel micropacemaker system allows cardiac pacing without entering the vascular space nor 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.

Percutaneous epicardial pacing in infants using direct visualization: A feasibility animal study

“…Bar‐Cohen et al used a percutaneous technique to implant a micropacemaker into adult pigs. However, this technique required an 18‐French delivery system and the use of dye and fluoroscopy, rather than direct visualization, and was only successful in 3 out of 6 animals 32 . The novel thoracoscopic approach described in this manuscript is a significant improvement over current techniques because it is truly percutaneous without surgical incisions, allows for direct visualization of pericardial access and lead placement, only requires a single puncture instead of multiple incisions or multiple ports, and is applicable to infants as well as older children.…”

Prenatal diagnosis and management of congenital complete heart block

“…The micropacemaker was first validated in adult rabbits hearts (Loeb et al, ) and then optimized through trials in pregnant ewes with successful capture in the final four sheep fetuses (Bar‐Cohen et al, ). A somewhat larger version of the fetal micropacemaker has been further adapted for pediatric use and successfully deployed into the pericardial space via the subxiphoid approach in an adult pig model (Bar‐Cohen et al, ). In the near future, such minimally invasive pericardial pacing could offer a definitive treatment for CHB in both fetus and infant and might offer another pacing option for pediatric and adult patient populations for whom a conventional pacemaker or intraventricular leadless pacemaker is not an option.…”

Assessing the Blockage of Toxicity of Stereolithographically 3D-Printed Parts Coated with Parylene C

“…Parylene C exhibits excellent properties for medical applications, such as low water absorption, high dielectric constant, low coefficient of friction, and moderate elongation at break [12]. It has been successfully used as a protective coating on medical metals and metal alloys, such as gold, platinum [15][16][17], medical-grade stainless steel (SS 316L) [18][19][20], and magnesium alloys (AZ31, WE43, AZ9) [21], and ceramics such as Si3N4 [17] and Al2O3 [22]. In this study, the toxicity of the SLA printed petri dish was blocked by coating the printed parts with parylene C. The toxicity of parylene C coated petri dish was assessed compared with the uncoated groups through zebrafish acute toxicity test.…”