Conventional single-chamber pacemakers versus transcatheter pacing systems in a "real world" cohort of patients : A comparative prospective single-center study
Copyright © 2021 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. All rights reserved..
PURPOSE: Despite the developments in conventional transvenous pacemakers (VVI-PM), the procedure is still associated with significant complications. Although there are no prospective clinical trials that compared VVI-PM with transcatheter pacemaker systems (TPS).
METHODS: This is a prospective, observational, single-center study that included all patients with an indication for a single-chamber pacemaker implant within a 4-year period. All clinical, ECG and echocardiographic characteristics at implant, electrical parameters, associated complications and mortality were analyzed. A Cox survival model and a Bayesian cohort analysis were performed for differences in complication rates between groups.
RESULTS: There were 443 patients included (198 TPS and 245 VVI-PM). The mean age was 81.5 years (TPS group, 79.2 ± 6.6 years; VVI-PM group, 83.5 ± 8.9 years). There was a male predominance in TPS group (123, 62.1% vs. 67, 27.3%; p < 0.001). The presence of systolic dysfunction and renal insufficiency were more frequent in VVI-PM group than in TPS patients. Mean follow-up was 22.3 ± 15.9 months. In a multivariable paired data the TPS group presented fewer complications than VVI-PM group (HR = 0.39 [0.15-0.98], p-value 0.013), but major complications were not different (6, 3% vs 14, 5.6% respectively, p = 0.1761). There was no difference in the mortality rate between the groups. The TPS group had less risk than VVI-PM group to have a complication, with a 96% of probability.
CONCLUSIONS: TPS patients had a lower overall complication rate than VVI-PM patients including matched-pair samples using a Bayesian analysis. These results confirm the safety profile of TPS in clinical practice.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:21 |
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| Enthalten in: |
Indian pacing and electrophysiology journal - 21(2021), 2 vom: 15. März, Seite 89-94 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Martinez-Sande, Jose Luis [VerfasserIn] |
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| Links: |
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| Themen: |
Complications |
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| Anmerkungen: |
Date Revised 18.03.2021 published: Print-Electronic Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1016/j.ipej.2020.12.004 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM319816818 |
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| 100 | 1 | |a Martinez-Sande, Jose Luis |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Conventional single-chamber pacemakers versus transcatheter pacing systems in a "real world" cohort of patients |b A comparative prospective single-center study |
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| 500 | |a Date Revised 18.03.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a Copyright © 2021 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. All rights reserved. | ||
| 520 | |a PURPOSE: Despite the developments in conventional transvenous pacemakers (VVI-PM), the procedure is still associated with significant complications. Although there are no prospective clinical trials that compared VVI-PM with transcatheter pacemaker systems (TPS) | ||
| 520 | |a METHODS: This is a prospective, observational, single-center study that included all patients with an indication for a single-chamber pacemaker implant within a 4-year period. All clinical, ECG and echocardiographic characteristics at implant, electrical parameters, associated complications and mortality were analyzed. A Cox survival model and a Bayesian cohort analysis were performed for differences in complication rates between groups | ||
| 520 | |a RESULTS: There were 443 patients included (198 TPS and 245 VVI-PM). The mean age was 81.5 years (TPS group, 79.2 ± 6.6 years; VVI-PM group, 83.5 ± 8.9 years). There was a male predominance in TPS group (123, 62.1% vs. 67, 27.3%; p < 0.001). The presence of systolic dysfunction and renal insufficiency were more frequent in VVI-PM group than in TPS patients. Mean follow-up was 22.3 ± 15.9 months. In a multivariable paired data the TPS group presented fewer complications than VVI-PM group (HR = 0.39 [0.15-0.98], p-value 0.013), but major complications were not different (6, 3% vs 14, 5.6% respectively, p = 0.1761). There was no difference in the mortality rate between the groups. The TPS group had less risk than VVI-PM group to have a complication, with a 96% of probability | ||
| 520 | |a CONCLUSIONS: TPS patients had a lower overall complication rate than VVI-PM patients including matched-pair samples using a Bayesian analysis. These results confirm the safety profile of TPS in clinical practice | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Complications | |
| 650 | 4 | |a Leadless | |
| 650 | 4 | |a Transcatheter pacemaker | |
| 650 | 4 | |a Transvenous | |
| 700 | 1 | |a Garcia-Seara, Javier |e verfasserin |4 aut | |
| 700 | 1 | |a Gonzalez-Melchor, Laila |e verfasserin |4 aut | |
| 700 | 1 | |a Rodriguez-Mañero, Moises |e verfasserin |4 aut | |
| 700 | 1 | |a Baluja, Aurora |e verfasserin |4 aut | |
| 700 | 1 | |a Fernandez-Lopez, Xesus Alberte |e verfasserin |4 aut | |
| 700 | 1 | |a Gonzalez Juanatey, Jose Ramon |e verfasserin |4 aut | |
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