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Minimally Invasive Implantation of a Micropacemaker Into the Pericardial Space.

ABSTRACT: 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 6 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, nonfunctional pacemaker devices were studied. In the final animal, a functional pacemaker was implanted. RESULTS:Successful placement of the entire nonfunctional 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 before electrode insertion into myocardium. All animals studied during follow-up survived without symptoms after the initial postoperative period. CONCLUSIONS:A novel micropacemaker system allows cardiac pacing without entering the vascular space or 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.

SUBMITTER: Bar-Cohen Y

PROVIDER: S-EPMC6050018 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Minimally Invasive Implantation of a Micropacemaker Into the Pericardial Space.

Bar-Cohen Yaniv Y Silka Michael J MJ Hill Allison C AC Pruetz Jay D JD Chmait Ramen H RH Zhou Li L Rabin Sara M SM Norekyan Viktoria V Loeb Gerald E GE

Circulation. Arrhythmia and electrophysiology 20180701 7

<h4>Background</h4>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.<h4>Methods</h4>Percutaneous micropacemaker implantations were performed in 6 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 ...[more]

PMID: 29945929

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Project description:PurposeThe outer stent lumen can be located either deeper (in or under Tenon's layer) or more superficially in the conjunctival stroma after the transscleral XEN Glaucoma Gel Microstent (XEN-GGM; Allergan Plc., USA) implantation. The present study aimed to investigate the effect of the postoperative conjunctival implant position on surgical success and intraocular pressure (IOP) after XEN-GGM.MethodsProspective data from 66 consecutive open-angle glaucoma eyes of 54 patients were collected preoperatively and 1 and 2 weeks, and 1, 6 and 12 months postoperatively. The layer of implantation was determined in the first month postoperatively as intra- and subtenon or intraconjunctival depending on the location of the outer lumen of the stent in OCT (Visante OCT; Zeiss, Germany). Primary outcome measures were differences in relative IOP reduction at 12 months between the two groups. Further, complete and qualified surgical success, number of secondary needlings and number of IOP-lowering medications and absolute IOP were assessed.ResultsRelative IOP reduction was higher in intra- and subtenon group (n = 37/66, 56%) at week 1 (-54% versus -19%, p < 0.001), week 2 (-39% versus -21%, p = 0.02), month 1 (-42% versus -28%, p = 0.035) and month 12 (-39% versus -24%, p = 0.024). The mean absolute IOP was lower in intra- and subtenon group at week 1 (10.8 [95%CI, 8.8-14.1] versus 16.6 [95%CI, 14.1-19.0] mmHg, p < 0.001) and months 12 (13.9 [95%CI, 12.4-15.4] versus 16.7 [95%CI, 14.6-18.8] mmHg, p = 0.041). At month 6, a lower burden for IOP-lowering medication was shown for the intra- and subtenon group (0.2 ± 0.5 versus 1.0 ± 1.1, p = 0.034). The mean number of secondary needlings, which were done in 47/66 (71%) of the eyes, was lower in the intra- and subtenon group in the first year (1.9 ± 1.7 versus 1.2 ± 1.2, p = 0.03). Qualified surgical success was higher in the intra- and subtenon group (90% versus 61%, p = 0.01) after 1 year.ConclusionThe present study demonstrates a higher efficacy achieved with lower secondary needling rates in deeper implant positions in conjunctiva after XEN-GGM.

Dataset Information

Minimally Invasive Implantation of a Micropacemaker Into the Pericardial Space.

Publications

Minimally Invasive Implantation of a Micropacemaker Into the Pericardial Space.

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