000 03653nam a22005177a 4500
008 220221s20222022 xxu||||| |||| 00| 0 eng d
024 _a10.1016/j.hrthm.2022.01.021 [doi]
024 _aS1547-5271(22)00036-4 [pii]
040 _aOvid MEDLINE(R)
099 _a35066177
245 _aPreclinical safety and electrical performance of novel atrial leadless pacemaker with dual-helix fixation.
251 _aHeart Rhythm. 19(5):776-781, 2022 May.
252 _aHeart Rhythm. 19(5):776-781, 2022 May.
252 _zHeart Rhythm. 2022 Jan 20
253 _aHeart rhythm
260 _c2022
260 _fFY2022
260 _p2022 Jan 20
265 _sppublish
266 _d2022-02-21
268 _aHeart Rhythm. 2022 Jan 20
501 _aAvailable online through MWHC library: 2004 - present
520 _aBACKGROUND: Complications associated with transvenous pacemakers, specifically those involving the lead or subcutaneous pocket, may be avoided with leadless pacemakers (LPs). The safety and efficacy of single-chamber right ventricular LPs have been demonstrated, but their right atrium (RA) use poses new design constraints.
520 _aCONCLUSION: The novel atrial LP demonstrated successful implantation, with acceptable electrical performance, mechanical stability, and safety in a 12-week preclinical study. Copyright (c) 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.
520 _aMETHODS: A new LP was designed with a dual-helix fixation mechanism specific to the RA anatomy. A 12-week preclinical ovine study was conducted to evaluate implant success, electrical performance, mechanical stability, and safety in vivo, with supporting benchtop measurements to quantify the mechanical forces needed for device retrieval and dislodgment.
520 _aOBJECTIVES: The purpose of this study was to evaluate the implant success, electrical performance, and safety of a novel RA LP design in benchtop and preclinical studies.
520 _aRESULTS: LPs were successfully implanted in all 10 ovine subjects with no complications. The pacing capture threshold improved significantly over time from implant to week 12 (1.1 +/- 0.7 V vs 0.4 +/- 0.2 V, P = .008). Sensing amplitudes and pacing impedances were stable from implant to week 12 (4.8 +/- 1.8 mV vs 6.0 +/- 1.9 mV, P = .160; and 393 +/- 77 OMEGA vs 398 +/- 65 OMEGA, P = .922, respectively). Gross pathology and microscopic histology revealed no adverse interactions and no evidence of device dislodgment or clinically significant myocardial perforation. Benchtop ex vivo porcine atrial tissue measurements revealed greater pull forces required to dislodge the LP vs transvenous active fixation lead (0.42 +/- 0.18 lbf vs 0.29 +/- 0.08 lbf, P = .020), and greater rotational forces required for deliberate extraction (0.28 +/- 0.04 lbf vs 0.14 +/- 0.07 lbf, P <.001).
546 _aEnglish
650 _a*Lipopolysaccharides
650 _a*Pacemaker, Artificial
650 _aAnimals
650 _aCardiac Pacing, Artificial
650 _aEquipment Design
650 _aHeart Atria
650 _aHumans
650 _aProstheses and Implants
650 _aSheep
650 _aSwine
650 _aTreatment Outcome
651 _aMedStar Heart & Vascular Institute
657 _aJournal Article
700 _aEldadah, Zayd A
790 _aBadie N, Banker RS, Breeman K, Cantillon DJ, Doshi R, Eldadah Z, Knops RE, Ligon D, Nee P, Neuzil P, Rashtian M, Rippy MK, Victorine K
856 _uhttps://dx.doi.org/10.1016/j.hrthm.2022.01.021
_zhttps://dx.doi.org/10.1016/j.hrthm.2022.01.021
942 _cART
_dArticle
999 _c809
_d809