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Towards unambiguous reporting of complications related to deep brain stimulation surgery: A retrospective single-center analysis and systematic review of the literature

BACKGROUND AND OBJECTIVE: To determine rates of adverse events (AEs) related to deep brain stimulation (DBS) surgery or implanted devices from a large series from a single institution. Sound comparisons with the literature require the definition of unambiguous categories, since there is no consensus...

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Autores principales: Engel, Katja, Huckhagel, Torge, Gulberti, Alessandro, Pötter-Nerger, Monika, Vettorazzi, Eik, Hidding, Ute, Choe, Chi-un, Zittel, Simone, Braaß, Hanna, Ludewig, Peter, Schaper, Miriam, Krajewski, Kara, Oehlwein, Christian, Mittmann, Katrin, Engel, Andreas K., Gerloff, Christian, Westphal, Manfred, Moll, Christian K. E., Buhmann, Carsten, Köppen, Johannes A., Hamel, Wolfgang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6071984/
https://www.ncbi.nlm.nih.gov/pubmed/30071021
http://dx.doi.org/10.1371/journal.pone.0198529
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author Engel, Katja
Huckhagel, Torge
Gulberti, Alessandro
Pötter-Nerger, Monika
Vettorazzi, Eik
Hidding, Ute
Choe, Chi-un
Zittel, Simone
Braaß, Hanna
Ludewig, Peter
Schaper, Miriam
Krajewski, Kara
Oehlwein, Christian
Mittmann, Katrin
Engel, Andreas K.
Gerloff, Christian
Westphal, Manfred
Moll, Christian K. E.
Buhmann, Carsten
Köppen, Johannes A.
Hamel, Wolfgang
author_facet Engel, Katja
Huckhagel, Torge
Gulberti, Alessandro
Pötter-Nerger, Monika
Vettorazzi, Eik
Hidding, Ute
Choe, Chi-un
Zittel, Simone
Braaß, Hanna
Ludewig, Peter
Schaper, Miriam
Krajewski, Kara
Oehlwein, Christian
Mittmann, Katrin
Engel, Andreas K.
Gerloff, Christian
Westphal, Manfred
Moll, Christian K. E.
Buhmann, Carsten
Köppen, Johannes A.
Hamel, Wolfgang
author_sort Engel, Katja
collection PubMed
description BACKGROUND AND OBJECTIVE: To determine rates of adverse events (AEs) related to deep brain stimulation (DBS) surgery or implanted devices from a large series from a single institution. Sound comparisons with the literature require the definition of unambiguous categories, since there is no consensus on the reporting of such AEs. PATIENTS AND METHODS: 123 consecutive patients (median age 63 yrs; female 45.5%) treated with DBS in the subthalamic nucleus (78 patients), ventrolateral thalamus (24), internal pallidum (20), and centre médian-parafascicular nucleus (1) were analyzed retrospectively. Both mean and median follow-up time was 4.7 years (578 patient-years). AEs were assessed according to three unambiguous categories: (i) hemorrhages including other intracranial complications because these might lead to neurological deficits or death, (ii) infections and similar AEs necessitating the explantation of hardware components as this results in the interruption of DBS therapy, and (iii) lead revisions for various reasons since this involves an additional intracranial procedure. For a systematic review of the literature AE rates were calculated based on primary data presented in 103 publications. Heterogeneity between studies was assessed with the I(2) statistic and analyzed further by a random effects meta-regression. Publication bias was analyzed with funnel plots. RESULTS: Surgery- or hardware-related AEs (23) affected 18 of 123 patients (14.6%) and resolved without permanent sequelae in all instances. In 2 patients (1.6%), small hemorrhages in the striatum were associated with transient neurological deficits. In 4 patients (3.3%; 0.7% per patient-year) impulse generators were removed due to infection. In 2 patients electrodes were revised (1.6%; 0.3% per patient-year). There was no lead migration or surgical revision because of lead misplacement. Age was not statistically significant different (p>0.05) between patients affected by AEs or not. AE rates did not decline over time and similar incidences were found among all patients (423) implanted with DBS systems at our institution until December 2016. A systematic literature review revealed that exact AE rates could not be determined from many studies, which could not be attributed to study designs. Average rates for intracranial complications were 3.8% among studies (per-study analysis) and 3.4% for pooled analysis of patients from different studies (per-patient analysis). Annual hardware removal rates were 3.6 and 2.4% for per-study and per-patient analysis, respectively, and lead revision rates were 4.1 and 2.6%, respectively. There was significant heterogeneity between studies (I(2) ranged between 77% and 91% for the three categories; p< 0.0001). For hardware removal heterogeneity (I(2) = 87.4%) was reduced by taking study size (p< 0.0001) and publication year (p< 0.01) into account, although a significant degree of heterogeneity remained (I(2) = 80.0%; p< 0.0001). Based on comparisons with health care-related databases there appears to be publication bias with lower rates for hardware-related AEs in published patient cohorts. CONCLUSIONS: The proposed categories are suited for an unequivocal assessment of AEs even in a retrospective manner and useful for benchmarking. AE rates in the present cohorts from our institution compare favorable with the literature.
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spelling pubmed-60719842018-08-16 Towards unambiguous reporting of complications related to deep brain stimulation surgery: A retrospective single-center analysis and systematic review of the literature Engel, Katja Huckhagel, Torge Gulberti, Alessandro Pötter-Nerger, Monika Vettorazzi, Eik Hidding, Ute Choe, Chi-un Zittel, Simone Braaß, Hanna Ludewig, Peter Schaper, Miriam Krajewski, Kara Oehlwein, Christian Mittmann, Katrin Engel, Andreas K. Gerloff, Christian Westphal, Manfred Moll, Christian K. E. Buhmann, Carsten Köppen, Johannes A. Hamel, Wolfgang PLoS One Research Article BACKGROUND AND OBJECTIVE: To determine rates of adverse events (AEs) related to deep brain stimulation (DBS) surgery or implanted devices from a large series from a single institution. Sound comparisons with the literature require the definition of unambiguous categories, since there is no consensus on the reporting of such AEs. PATIENTS AND METHODS: 123 consecutive patients (median age 63 yrs; female 45.5%) treated with DBS in the subthalamic nucleus (78 patients), ventrolateral thalamus (24), internal pallidum (20), and centre médian-parafascicular nucleus (1) were analyzed retrospectively. Both mean and median follow-up time was 4.7 years (578 patient-years). AEs were assessed according to three unambiguous categories: (i) hemorrhages including other intracranial complications because these might lead to neurological deficits or death, (ii) infections and similar AEs necessitating the explantation of hardware components as this results in the interruption of DBS therapy, and (iii) lead revisions for various reasons since this involves an additional intracranial procedure. For a systematic review of the literature AE rates were calculated based on primary data presented in 103 publications. Heterogeneity between studies was assessed with the I(2) statistic and analyzed further by a random effects meta-regression. Publication bias was analyzed with funnel plots. RESULTS: Surgery- or hardware-related AEs (23) affected 18 of 123 patients (14.6%) and resolved without permanent sequelae in all instances. In 2 patients (1.6%), small hemorrhages in the striatum were associated with transient neurological deficits. In 4 patients (3.3%; 0.7% per patient-year) impulse generators were removed due to infection. In 2 patients electrodes were revised (1.6%; 0.3% per patient-year). There was no lead migration or surgical revision because of lead misplacement. Age was not statistically significant different (p>0.05) between patients affected by AEs or not. AE rates did not decline over time and similar incidences were found among all patients (423) implanted with DBS systems at our institution until December 2016. A systematic literature review revealed that exact AE rates could not be determined from many studies, which could not be attributed to study designs. Average rates for intracranial complications were 3.8% among studies (per-study analysis) and 3.4% for pooled analysis of patients from different studies (per-patient analysis). Annual hardware removal rates were 3.6 and 2.4% for per-study and per-patient analysis, respectively, and lead revision rates were 4.1 and 2.6%, respectively. There was significant heterogeneity between studies (I(2) ranged between 77% and 91% for the three categories; p< 0.0001). For hardware removal heterogeneity (I(2) = 87.4%) was reduced by taking study size (p< 0.0001) and publication year (p< 0.01) into account, although a significant degree of heterogeneity remained (I(2) = 80.0%; p< 0.0001). Based on comparisons with health care-related databases there appears to be publication bias with lower rates for hardware-related AEs in published patient cohorts. CONCLUSIONS: The proposed categories are suited for an unequivocal assessment of AEs even in a retrospective manner and useful for benchmarking. AE rates in the present cohorts from our institution compare favorable with the literature. Public Library of Science 2018-08-02 /pmc/articles/PMC6071984/ /pubmed/30071021 http://dx.doi.org/10.1371/journal.pone.0198529 Text en © 2018 Engel et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Engel, Katja
Huckhagel, Torge
Gulberti, Alessandro
Pötter-Nerger, Monika
Vettorazzi, Eik
Hidding, Ute
Choe, Chi-un
Zittel, Simone
Braaß, Hanna
Ludewig, Peter
Schaper, Miriam
Krajewski, Kara
Oehlwein, Christian
Mittmann, Katrin
Engel, Andreas K.
Gerloff, Christian
Westphal, Manfred
Moll, Christian K. E.
Buhmann, Carsten
Köppen, Johannes A.
Hamel, Wolfgang
Towards unambiguous reporting of complications related to deep brain stimulation surgery: A retrospective single-center analysis and systematic review of the literature
title Towards unambiguous reporting of complications related to deep brain stimulation surgery: A retrospective single-center analysis and systematic review of the literature
title_full Towards unambiguous reporting of complications related to deep brain stimulation surgery: A retrospective single-center analysis and systematic review of the literature
title_fullStr Towards unambiguous reporting of complications related to deep brain stimulation surgery: A retrospective single-center analysis and systematic review of the literature
title_full_unstemmed Towards unambiguous reporting of complications related to deep brain stimulation surgery: A retrospective single-center analysis and systematic review of the literature
title_short Towards unambiguous reporting of complications related to deep brain stimulation surgery: A retrospective single-center analysis and systematic review of the literature
title_sort towards unambiguous reporting of complications related to deep brain stimulation surgery: a retrospective single-center analysis and systematic review of the literature
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6071984/
https://www.ncbi.nlm.nih.gov/pubmed/30071021
http://dx.doi.org/10.1371/journal.pone.0198529
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