Single‐incision percutaneous pericardial ICD lead placement in a piglet model

Clark, Bradley C.; Opfermann, Justin D.; Davis, Tanya D.; Krieger, Axel; Berul, Charles I.

doi:10.1111/jce.13263

Cited by 13 publications

(18 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The major advantage of this device and approach is the lack of an abdominal generator pocket. In a previous medium‐term infant porcine study evaluating the PeriPath access port for lead placement, abdominal pocket infections were a significant complication . This prototype miniature pacemaker reduces the potential for infection because of its small size and location within the incision itself, eliminating the need for lead tunneling, additional dissection, or a second incision for an abdominal 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 . 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 .…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

Self Cite

View full text Add to dashboard Cite

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

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Self Cite

View full text Add to dashboard Cite

show abstract

“…19 Similarly, Clark et al demonstrated feasibility of implanting a defibrillator lead with a “side biting” tine through a pericardial sheath. 20,21 An additional approach towards extravascular pacing demonstrated successful ventricular capture using a substernal electrode. 22 While all of these approaches targeted extravascular lead placements, our system is the first to implant the entire pacing system (pulse generator, lead and electrode) in the epicardial space.…”

Section: Discussionmentioning

confidence: 99%

Minimally Invasive Implantation of a Micropacemaker Into the Pericardial Space

Bar‐Cohen

Silka

Hill

et al. 2018

Circ: Arrhythmia and Electrophysiology

View full text Add to dashboard Cite

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.

show abstract

“…This procedure has been described extensively in our previous work. [13][14][15][16] The experimental group (or adhesion group) underwent left thoracotomy and partial pericardiectomy followed by a 6 week recovery period to develop intrathoracic adhesions. Other studies have used similar animal models to develop adhesions by performing a partial pericardiectomy and epicardial irrigation to simulate congenital heart surgery.…”

Section: Methodsmentioning

confidence: 99%

“…13 We demonstrated the feasibility of this approach to implant both ICD leads as well as a prototype miniature pacemaker in an infant porcine model. 13,14 However, these studies were done in animals who had not previously undergone cardiac surgery, and therefore could not be fairly extrapolated to postoperative patients with CHD. The objective of this study was to demonstrate the feasibility of our minimally invasive approach in an infant porcine adhesion model to apply this technique to the population of patients with previous CHD surgery.…”

Section: Introductionmentioning

confidence: 95%

Surgical pericardial adhesions do not preclude minimally invasive epicardial pacemaker lead placement in an infant porcine model

Kumthekar

Sinha

Opfermann

et al. 2020

Cardiovasc electrophysiol

Self Cite

View full text Add to dashboard Cite

Background Pericardial adhesions in infants and small children following cardiac surgery can impede access to the epicardium. We previously described minimally invasive epicardial lead placement under direct visualization in an infant porcine model using a single subxiphoid incision. The objective of this study was to assess the acute feasibility of this approach in the presence of postoperative pericardial adhesions. Methods Adhesion group piglets underwent left thoracotomy with pericardiotomy followed by a recovery period to develop pericardial adhesions. Control group piglets did not undergo surgery. Both groups underwent minimally invasive epicardial lead placement using a 2‐channel access port (PeriPath) inserted through a 1 cm subxiphoid incision. Under direct thoracoscopic visualization, pericardial access was obtained with a 7‐French sheath, and a pacing lead was affixed against the ventricular epicardium. Sensed R‐wave amplitudes, lead impedances and capture thresholds were measured. Results Eight piglets underwent successful pericardiectomy and developed adhesions after a median recovery time of 45 days. Epicardial lead placement was successful in adhesion (9.5 ± 2.7 kg, n = 8) and control (5.6 ± 1.5 kg, n = 7) piglets. There were no acute complications. There were no significant differences in capture thresholds or sensing between groups. Procedure times in the adhesion group were longer than in controls, and while lead impedances were significantly higher in the adhesion group, all were within normal range. Conclusions Pericardial adhesions do not preclude minimally invasive placement of epicardial leads in an infant porcine model. This minimally invasive approach could potentially be applied to pediatric patients with prior cardiac surgery.

show abstract

Single‐incision percutaneous pericardial ICD lead placement in a piglet model

Abstract: Percutaneous pericardial placement of an ICD lead using our novel access tool can be safely performed through a 1 cm incision without complications.

Cited by 13 publications

References 15 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

Minimally Invasive Implantation of a Micropacemaker Into the Pericardial Space

Surgical pericardial adhesions do not preclude minimally invasive epicardial pacemaker lead placement in an infant porcine model

Contact Info

Product

Resources

About