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

Kumthekar, Rohan N.; Opfermann, Justin D.; Mass, Paige; Clark, Bradley C.; Moak, Jeffrey P.; Sherwin, Elizabeth D.; Whitman, Teresa A.; Marshall, Mark T.; Berul, Charles I.

doi:10.1016/j.hrthm.2019.02.033

Cited by 12 publications

(20 citation statements)

References 20 publications

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“…This is a report of the chronic performance of the prototype miniature pacemaker in an infant animal model. In this study, the implantation pacing parameters and procedural times were comparable to our previously described acute results …”

Section: Discussionsupporting

confidence: 80%

“…Our group has previously established the acute feasibility and procedural safety of this minimally invasive thoracoscopic technique to implant a prototype miniature pacemaker in a piglet model . We described a single incision approach under direct visualization that does not require a thoracotomy, fluoroscopy, or abdominal generator pocket.…”

Section: Discussionmentioning

confidence: 99%

“…We have designed a prototype miniature pacemaker (Medtronic PLC, Mounds View, MN, USA) with a short leadlet that can be inserted using a minimally invasive technique . Our approach utilizes a self‐anchoring single‐incision thoracic access port with two crossed working channels called PeriPath (PeriCor LLC, Bethesda, MD, USA) that facilitates pericardial access under direct‐vision videothoracoscopy .…”

Section: Introductionmentioning

confidence: 99%

“…Our approach utilizes a self‐anchoring single‐incision thoracic access port with two crossed working channels called PeriPath (PeriCor LLC, Bethesda, MD, USA) that facilitates pericardial access under direct‐vision videothoracoscopy . We recently reported successful acute implantation of this device in 12 infant piglets, with a median procedure time of less than an hour and capture thresholds similar to generally accepted values for surgically implanted epicardial pacing leads . The objective of the present study was to evaluate the chronic performance of the prototype miniature pacemaker in an infant porcine model, focusing on infectious complications and leadlet stability.…”

Section: Introductionmentioning

confidence: 99%

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Percutaneous epicardial placement of a prototype miniature pacemaker under direct visualization: An infant porcine chronic survival study

Kumthekar

Opfermann

Mass

et al. 2019

Pacing Clinical Electrophis

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Introduction: Pacemaker implantation in infants typically consists of surgical epicardial lead placement with an abdominal generator. Here, we describe the chronic performance of our minimally invasive prototype miniature pacemaker implanted under direct visualization in an immature porcine model. Methods:Twelve piglets underwent miniature pacemaker implantation. A self-anchoring twochannel access port was inserted into a 1 cm incision in the subxiphoid space, and a thoracoscope was inserted into the main channel to visualize the thoracic cavity under insufflation. The pacemaker leadlet was inserted through a sheath via secondary channel and affixed against the epicardium using a helical side-biting electrode. The miniature pacemaker was tucked into the incision, which was sutured closed. Ventricular sensing, leadlet impedance, and capture thresholds were measured biweekly. A limited necropsy was performed after euthanasia.Results: Nine piglets were followed for a median of 78 (IQR 52-82) days and gained 6.6 ± 3.2 kg.Three animals were censored from the analysis due to complications unrelated to the procedure. Capture thresholds rose above maximal output after a median of 67 (IQR 40-69) days. At termination, there was a significant decrease in R-wave amplitude (P = .03) and rise in capture thresholds at 0.4 ms (P = .01) and 1.0 ms pulse widths (P = .02). There was no significant change in leadlet impedance (P = .74). There were no wound infections.Conclusions: There were no infections following minimally invasive implantation of our prototype miniature pacemaker. Improvements to epicardial fixation are necessary to address diminished leadlet efficacy over time. K E Y W O R D S epicardial, miniature pacemaker, minimally invasive, pediatric, porcine 1 Pacing Clin Electrophysiol. 2020;43:93-99. c

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Section: Discussionsupporting

confidence: 80%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Percutaneous epicardial placement of a prototype miniature pacemaker under direct visualization: An infant porcine chronic survival study

Kumthekar

Opfermann

Mass

et al. 2019

Pacing Clinical Electrophis

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“…As a first step, we used the Micra TPS as its endocardial use has been extensively studied. Leadless technology has the potential to be implanted with minimal invasiveness, 10 but we used an open‐chest approach in order to avoid additional technical problems in this feasibility study.…”

Section: Discussionmentioning

confidence: 99%

Epicardial implantation of a leadless pacemaker in a lamb model

Backhoff

Betz

Eildermann

et al. 2020

Pacing Clinical Electrophis

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Background Pacemaker used in small children typically consist of an abdominally placed generator and epicardially affixed leads, making such a system prone to lead dysfunction during growth. Aim of this study was to investigate the feasibility of epicardial pacing with a leadless pacemaker in a lamb model. Animals and methods Seventeen lambs underwent epicardial implantation of a Micra transcatheter pacing system (TPS) (Medtronic, Minneapolis, MN, USA) via left‐lateral thoracotomy to the left ventricle (LV) surface (n = 11/17) and to the left atrial appendage (n = 6). Ventricular devices were fixated with the tines within the pericardium, whereas the tines of the atrial devices penetrated the myocardium of the left atrial appendage. After 31 weeks, animals were sacrificed and hearts were explanted for histological analysis. Results Following implantation, median P/R amplitude was 4.25/5.5 mV while median pacing threshold was 1.1/1.9 V at 0.24 ms. After 31 weeks, median P/R amplitude was 3.3/4.2 mV. Median atrial pacing threshold was 0.5/0.24 ms. Eight of 10 ventricular pacemakers had lost capture at standard impulse width even at maximum impulse amplitude. On explantation, firm adhesion of the device to the thoracic wall and dislodgement of the electrode tip was found in those ventricular devices. Conclusions Firm fixation of the Micra electrode to the epicardial surface as applied to the atrial devices resulted in excellent electrical properties during midterm follow up. Pericardial fixation as in the ventricular devices was associated with loss of capture. Therefore, it is important to embed the tines in the myocardium and to choose an alternative implantation site allowing for safe fixation of the Micra TPS in a position perpendicular to ventricular epimyocardium.

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Chronic performance of subxiphoid minimally invasive pericardial Model 20066 pacemaker lead insertion in an infant animal model

Clark

Kumthekar

Mass

et al. 2019

J Interv Card Electrophysiol

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

Cited by 12 publications

References 20 publications

Percutaneous epicardial placement of a prototype miniature pacemaker under direct visualization: An infant porcine chronic survival study

Percutaneous epicardial placement of a prototype miniature pacemaker under direct visualization: An infant porcine chronic survival study

Epicardial implantation of a leadless pacemaker in a lamb model

Chronic performance of subxiphoid minimally invasive pericardial Model 20066 pacemaker lead insertion in an infant animal model

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