Division of Cardiology, Children's National Health System, Washington, District of Columbia.
Sheikh Zayed Institute for Pediatric Surgical Innovation, Washington, District of Columbia.
Heart Rhythm. 2019 Aug;16(8):1261-1267. doi: 10.1016/j.hrthm.2019.02.033. Epub 2019 Mar 1.
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.
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.
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.
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.
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.
婴儿心脏起搏器的植入仅限于心外膜导联和腹部发生器袋。我们提出了一种微创解决方案，使用带有类固醇洗脱导联的原型微型起搏器，该起搏器可在胸腔镜下固定在心外膜上。
本研究旨在评估在婴儿猪模型中急性植入原型微型起搏器的安全性和可行性。
在剑突下空间左侧插入一个自锚定的 2 通道接入端口。通过主通道插入一个具有可变视角的刚性胸腔镜，在充气下观察心脏。通过第二个通道的 18-G 针进入心包腔，并使用 7-F 鞘固定。导联通过远端螺旋侧咬电极固定在心外膜上。取出鞘、胸腔镜和端口，将起搏器塞进切口。测量心室感知、导联阻抗和捕获阈值。
12 头小猪（体重 4.8±1.9kg）成功植入了设备。从切口到导联固定的中位数时间为 21 分钟（四分位距[IQR]18-31 分钟）。导联阻抗中位数为 510Ω（IQR 495-620Ω）。R 波振幅中位数为 5.7mV（IQR 4.2-7.0mV）。脉宽为 0.4ms 时捕获阈值中位数为 1.63V（IQR 1.32-2.97V），脉宽为 1.0ms 时捕获阈值中位数为 1.50V（IQR 1.16-2.38V）。无并发症。
胸腔镜下心外膜微创放置原型微型起搏器是安全的，避免了开胸手术和腹部发生器袋的创建。
