MARC details
| 000 -LEADER |
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| fixed length control field |
03653nam a22005177a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
220221s20222022 xxu||||| |||| 00| 0 eng d |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
10.1016/j.hrthm.2022.01.021 [doi] |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
S1547-5271(22)00036-4 [pii] |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
35066177 |
| 245 ## - TITLE STATEMENT |
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| Title |
Preclinical safety and electrical performance of novel atrial leadless pacemaker with dual-helix fixation. |
| 251 ## - Source |
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| Source |
Heart Rhythm. 19(5):776-781, 2022 May. |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
Heart Rhythm. 19(5):776-781, 2022 May. |
| 252 ## - Abbreviated Source |
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| Former abbreviated source |
Heart Rhythm. 2022 Jan 20 |
| 253 ## - Journal Name |
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| Journal name |
Heart rhythm |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2022 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2022 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Publication date |
2022 Jan 20 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
ppublish |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2022-02-21 |
| 268 ## - Previous citation |
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| -- |
Heart Rhythm. 2022 Jan 20 |
| 501 ## - WITH NOTE |
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| Local holdings |
Available online through MWHC library: 2004 - present |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
BACKGROUND: 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 ## - SUMMARY, ETC. |
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| Abstract |
CONCLUSION: 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 ## - SUMMARY, ETC. |
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| Abstract |
METHODS: 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 ## - SUMMARY, ETC. |
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| Abstract |
OBJECTIVES: 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 ## - SUMMARY, ETC. |
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| Abstract |
RESULTS: 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 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Lipopolysaccharides |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Pacemaker, Artificial |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Animals |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Cardiac Pacing, Artificial |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Equipment Design |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Heart Atria |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Humans |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Prostheses and Implants |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Sheep |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Swine |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Treatment Outcome |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Heart & Vascular Institute |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Eldadah, Zayd A |
| 790 ## - Authors |
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| All authors |
Badie 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 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1016/j.hrthm.2022.01.021">https://dx.doi.org/10.1016/j.hrthm.2022.01.021</a> |
| Public note |
https://dx.doi.org/10.1016/j.hrthm.2022.01.021 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Article |
