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Heart Rhythm. 2019 Mar 1. pii: S1547-5271(19)30207-3. doi: 10.1016/j.hrthm.2019.02.033. [Epub ahead of print]

Minimally invasive percutaneous epicardial placement of a prototype miniature pacemaker with a leadlet under direct visualization: A feasibility study in an infant porcine model.

Author information

1
Division of Cardiology, Children's National Health System, Washington, District of Columbia.
2
Sheikh Zayed Institute for Pediatric Surgical Innovation, Washington, District of Columbia.
3
Division of Cardiology, Children's Hospital at Montefiore, Bronx, New York.
4
Division of Cardiology, Children's National Health System, Washington, District of Columbia; Department of Pediatrics, George Washington University School of Medicine, Washington, District of Columbia.
5
Medtronic, Mounds View, Minnesota.
6
Division of Cardiology, Children's National Health System, Washington, District of Columbia; Department of Pediatrics, George Washington University School of Medicine, Washington, District of Columbia. Electronic address: Cberul@childrensnational.org.

Abstract

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.

OBJECTIVE:

The purpose of this study was to evaluate the safety and feasibility of acute implantation of a prototype miniature pacemaker in an infant porcine model.

METHODS:

A self-anchoring 2-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-G needle through the second channel accessed the pericardial space, which was secured with a 7-F 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. The median time from incision to leadlet fixation was 21 minutes (interquartile range [IQR] 18-31 minutes). The median lead impedance was 510 Ω (IQR 495-620 Ω). The median R-wave amplitude was 5.7 mV (IQR 4.2-7.0 mV). The median capture threshold was 1.63 V (IQR 1.32-2.97 V) at 0.4 ms pulse width and 1.50 V (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.

KEYWORDS:

Epicardial; Minimally invasive; Pacemaker; Pediatric; Porcine; Thoracoscopy

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