000 | 03653nam a22005177a 4500 | ||
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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 |
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942 |
_cART _dArticle |
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999 |
_c809 _d809 |