Academic Journal
The incidence and clinical ramifications for leadless pacemaker fixation mechanism exposure on the epicardial surface
| Τίτλος: | The incidence and clinical ramifications for leadless pacemaker fixation mechanism exposure on the epicardial surface |
|---|---|
| Συγγραφείς: | Breeman, KTN, Burke, MC, Shuros, A, Soltis, B, Brisben, A, Kilvington, J, Swackhamer, B, Knops, RE, Tjong, FVY |
| Πηγή: | EP Europace ; volume 23, issue Supplement_3 ; ISSN 1099-5129 1532-2092 |
| Στοιχεία εκδότη: | Oxford University Press (OUP) |
| Έτος έκδοσης: | 2021 |
| Περιγραφή: | Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Boston Scientific and Abbott Background Leadless pacemaker (LP) fixation mechanism exposure (FE) by penetration of the epicardial surface has been described. Previously reported animal model studies showed FE for 7/10 Micra LPs, versus 4/10 CapSureFix Novus RV pacing leads (both Medtronic). However, it is unknown whether FE causes pericardial effusion or pericarditis or does not have clinical significance. Purpose To determine the incidence of FE of a novel LP in a chronic animal model and its association with acute or chronic pericardial effusion. Methods Canine subjects were implanted with novel LPs (Boston Scientific) in an ongoing study. Acute pericardial effusion was assessed by post-procedural transthoracic echocardiography (TTE). Chronic pericardial effusion was assessed by TTE 90 days after implantation and post-mortem assessed pericardial fluid colour (PFC) and volume (PFV). FE was assessed visually at necropsy. Mann-Whitney U tests and chi-squared tests were used to determine whether greater PFV, more haemorrhagic PFC or LP implantation location differed significantly between subjects with and without FE. Results Results to date are reported. Canine subjects (n = 71) were chronically implanted with LPs. Due to 14 in-vivo retrievals, data is shown of 57 subjects with LPs in situ at necropsy. Pre-deployment radiocontrast injection confirmed LP position (RV apex n = 41; RV apicoseptal n = 16), and mechanical stability and electrical testing confirmed adequate talon fixation after deployment. Necropsy after median 94 days (IQR 91-540) demonstrated FE in 11 cases (19%) (figure). No acute nor chronic pericardial effusion was seen on TTE. Mean PFV for animals with and without FE was 1.8 and 1.6 cc, respectively. FE did not show an association with PFV or colour (p= 0.53 and p = 0.83, respectively). For two animals, PFV and PFC are not available; FE was not observed in either of these cases. LP implantation ... |
| Τύπος εγγράφου: | article in journal/newspaper |
| Γλώσσα: | English |
| DOI: | 10.1093/europace/euab116.483 |
| Διαθεσιμότητα: | https://doi.org/10.1093/europace/euab116.483 http://academic.oup.com/europace/article-pdf/23/Supplement_3/euab116.483/38131874/euab116.483.pdf |
| Rights: | https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model |
| Αριθμός Καταχώρησης: | edsbas.66A4BE80 |
| Βάση Δεδομένων: | BASE |
| FullText | Text: Availability: 0 CustomLinks: – Url: https://doi.org/10.1093/europace/euab116.483# Name: EDS - BASE (ns324271) Category: fullText Text: View record from BASE |
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| Items | – Name: Title Label: Title Group: Ti Data: The incidence and clinical ramifications for leadless pacemaker fixation mechanism exposure on the epicardial surface – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Breeman%2C+KTN%22">Breeman, KTN</searchLink><br /><searchLink fieldCode="AR" term="%22Burke%2C+MC%22">Burke, MC</searchLink><br /><searchLink fieldCode="AR" term="%22Shuros%2C+A%22">Shuros, A</searchLink><br /><searchLink fieldCode="AR" term="%22Soltis%2C+B%22">Soltis, B</searchLink><br /><searchLink fieldCode="AR" term="%22Brisben%2C+A%22">Brisben, A</searchLink><br /><searchLink fieldCode="AR" term="%22Kilvington%2C+J%22">Kilvington, J</searchLink><br /><searchLink fieldCode="AR" term="%22Swackhamer%2C+B%22">Swackhamer, B</searchLink><br /><searchLink fieldCode="AR" term="%22Knops%2C+RE%22">Knops, RE</searchLink><br /><searchLink fieldCode="AR" term="%22Tjong%2C+FVY%22">Tjong, FVY</searchLink> – Name: TitleSource Label: Source Group: Src Data: EP Europace ; volume 23, issue Supplement_3 ; ISSN 1099-5129 1532-2092 – Name: Publisher Label: Publisher Information Group: PubInfo Data: Oxford University Press (OUP) – Name: DatePubCY Label: Publication Year Group: Date Data: 2021 – Name: Abstract Label: Description Group: Ab Data: Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Boston Scientific and Abbott Background Leadless pacemaker (LP) fixation mechanism exposure (FE) by penetration of the epicardial surface has been described. Previously reported animal model studies showed FE for 7/10 Micra LPs, versus 4/10 CapSureFix Novus RV pacing leads (both Medtronic). However, it is unknown whether FE causes pericardial effusion or pericarditis or does not have clinical significance. Purpose To determine the incidence of FE of a novel LP in a chronic animal model and its association with acute or chronic pericardial effusion. Methods Canine subjects were implanted with novel LPs (Boston Scientific) in an ongoing study. Acute pericardial effusion was assessed by post-procedural transthoracic echocardiography (TTE). Chronic pericardial effusion was assessed by TTE 90 days after implantation and post-mortem assessed pericardial fluid colour (PFC) and volume (PFV). FE was assessed visually at necropsy. Mann-Whitney U tests and chi-squared tests were used to determine whether greater PFV, more haemorrhagic PFC or LP implantation location differed significantly between subjects with and without FE. Results Results to date are reported. Canine subjects (n = 71) were chronically implanted with LPs. Due to 14 in-vivo retrievals, data is shown of 57 subjects with LPs in situ at necropsy. Pre-deployment radiocontrast injection confirmed LP position (RV apex n = 41; RV apicoseptal n = 16), and mechanical stability and electrical testing confirmed adequate talon fixation after deployment. Necropsy after median 94 days (IQR 91-540) demonstrated FE in 11 cases (19%) (figure). No acute nor chronic pericardial effusion was seen on TTE. Mean PFV for animals with and without FE was 1.8 and 1.6 cc, respectively. FE did not show an association with PFV or colour (p= 0.53 and p = 0.83, respectively). For two animals, PFV and PFC are not available; FE was not observed in either of these cases. LP implantation ... – Name: TypeDocument Label: Document Type Group: TypDoc Data: article in journal/newspaper – Name: Language Label: Language Group: Lang Data: English – Name: DOI Label: DOI Group: ID Data: 10.1093/europace/euab116.483 – Name: URL Label: Availability Group: URL Data: https://doi.org/10.1093/europace/euab116.483<br />http://academic.oup.com/europace/article-pdf/23/Supplement_3/euab116.483/38131874/euab116.483.pdf – Name: Copyright Label: Rights Group: Cpyrght Data: https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model – Name: AN Label: Accession Number Group: ID Data: edsbas.66A4BE80 |
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