Minimally invasive percutaneous pericardial ICD placement in an infant piglet model: Head-to-head comparison with an open surgical thoracotomy approach

Clark, Bradley C.; Davis, Tanya D.; Ahmed, Magdy M El-Sayed; McCarter, Robert; Ishibashi, Nobuyuki; Jordan, Christopher P.; Kane, Timothy D.; Kim, Peter C.W.; Krieger, Axel; Nath, Dilip S.; Opfermann, Justin D.; Berul, Charles I.

doi:10.1016/j.hrthm.2015.12.015

Cited by 13 publications

(11 citation statements)

References 18 publications

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“…We have previously demonstrated the safety and feasibility of percutaneous pericardial ICD lead placement in a piglet model under direct visualization; this procedure was performed with a subxiphoid approach and necessitated an additional lateral thoracoscopic incision . The percutaneous pericardial method showed comparable ability to defibrillate the heart and similar measures of lead stability during a 2‐week survival period compared with an open surgical epicardial approach.…”

Section: Discussionmentioning

confidence: 99%

“…A 7F‐25 cm tear‐away sheath (Classic Sheath, Merit Medical, South Jordan, UT, USA) with dilator is inserted over the wire and sheath access is obtained. A modified side‐biting ICD lead (Medtronic, Minneapolis, MN, USA) is inserted through the sheath and into the pericardial space; this is the identical lead used in our prior minimally invasive procedures with the addition of a steroid‐eluting tip. Side‐biting active fixation is performed onto the epicardial surface of the ventricle; prior to fixation, we ensured adequate visualization of the fixation site to avoid injury to coronary vasculature.…”

Section: Methodsmentioning

confidence: 99%

“…Our group has initially demonstrated the ability to perform minimally invasive pacemaker placement through a subxiphoid approach and lateral thoracoscopic visualization . Subsequently, we demonstrated the safety and feasibility of the minimally invasive method of ICD lead placement as compared to an open surgical epicardial approach; lead stability, ventricular pacing thresholds and ability to successfully defibrillate the heart over a 2‐week survival period were similar between the open surgical and minimally invasive approaches . The development of a novel delivery tool that incorporates visualization and needle access allows for the procedure to be performed with a single 1 cm subxiphoid incision.…”

Section: Introductionmentioning

confidence: 99%

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

Clark

Opfermann

Davis

et al. 2017

Cardiovasc electrophysiol

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Clark

Opfermann

Davis

et al. 2017

Cardiovasc electrophysiol

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“…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

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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.

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“…While epicardial lead placement originally required open surgical techniques for implantation, less invasive methods have become increasingly attractive and include subxiphoid pericardial windows and more recently percutaneous implantation(19–21). Furthermore, a recent report highlighted experience with a thoracoscopic method in a piglet model(22). …”

Section: Discussionmentioning

confidence: 99%

A Novel Defibrillation Tool

Killu

Naksuk

Stárek

et al. 2017

JACC: Clinical Electrophysiology

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Introduction Epicardial defibrillation systems currently require surgical access. We aimed to develop a percutaneous defibrillation system with partially-insulated epicardial coils to focus electrical energy on the myocardium and prevent or minimize extra-cardiac stimulation. Methods We tested 2 prototypes created for percutaneous introduction into the pericardial space via a steerable sheath. This included a partially-insulated defibrillation coil and a defibrillation mesh with a urethane balloon acting as an insulator to the face of the mesh not in contact with the epicardium. The average energy associated with a chance of successful defibrillation 75% of the time (ED75) was calculated for each experiment. Results Of 16 animal experiments, 3 pig experiments had malfunctioning mesh prototypes such that results were unreliable; these were excluded. Therefore, 13 animal experiments were analyzed - 6 canines (29.8±4.0kg); 7 pigs (41.1±4.4kg). The overall ED75 was 12.8±6.7J (10.9±9.1J for canines; 14.4±3.9J in pigs [P=0.37]). The lowest ED75 obtained in canines was 2.5J while in pigs it was 9.5J. The lowest energy resulting in successful defibrillation was 2J in canines and 5J in pigs. There was no evidence of coronary vessel injury or trauma to extra-pericardial structures. Conclusion Percutaneous, epicardial defibrillation using a partially insulated coil is feasible and appears to be associated with low defibrillation thresholds. Focusing insulation may limit extra-cardiac stimulation and potentially lower energy requirements for efficient defibrillation.

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Minimally invasive percutaneous pericardial ICD placement in an infant piglet model: Head-to-head comparison with an open surgical thoracotomy approach

Cited by 13 publications

References 18 publications

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

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

Minimally Invasive Implantation of a Micropacemaker Into the Pericardial Space

A Novel Defibrillation Tool

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