Minimally Invasive Percutaneous Epicardial Placement of a Prototype Miniature Pacemaker with Leadlet under Direct Visualization: A Feasibility Study in an Infant Porcine Model

Rohan N Kumthekar, Justin D Opfermann, Paige Mass, Bradley C Clark, Jeffrey P Moak, Elizabeth D Sherwin, Teresa Whitman, Mark Marshall, Charles I Berul
Heart Rhythm: the Official Journal of the Heart Rhythm Society 2019 February 28

BACKGROUND: Pacemaker implantation in infants is limited to epicardial lead placement and an abdominal generator pocket. We propose a minimally invasive solution using a prototype miniature pacemaker with a steroid-eluting leadlet that can affix against the epicardium under thoracoscopy.

OBJECTIVES: To evaluate the safety and feasibility of acute implantation of a prototype miniature pacemaker in an infant porcine model.

ANIMALS AND METHODS: A self-anchoring two-channel access port was inserted into a 1 cm incision left of the subxiphoid space. A rigid thoracoscope with variable viewing angle was inserted through the main channel to visualize the heart under insufflation. An 18-gauge needle through the second channel accessed the pericardial space, which was secured with a 7-French sheath. The leadlet was affixed against the epicardium using a distal helical side-biting electrode. The sheath, thoracoscope and port were removed, and the pacemaker was tucked into the incision. Ventricular sensing, lead impedances, and capture thresholds were measured.

RESULTS: Twelve piglets (weight 4.8 ± 1.9 kg) had successful device implantation. Median time from incision to leadlet fixation was 21 (IQR 18 - 31) minutes. Median lead impedance was 510 (IQR 495 - 620) ohms. Median R-wave amplitude was 5.7 (IQR 4.2 - 7.0) mV. Median capture threshold was 1.63 (IQR 1.32 - 2.97) at 0.4 ms pulse width and 1.50 (IQR 1.16 - 2.38) V at 1.0 ms pulse width. There were no complications.

CONCLUSION: Minimally invasive epicardial placement of a prototype miniature pacemaker under thoracoscopy was safe and avoided open-chest surgery and creation of an abdominal generator pocket.

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