Towards unambiguous reporting of complications related to deep brain stimulation surgery: A retrospective single-center analysis and systematic review of the literature.
Towards unambiguous reporting of complications related to deep brain stimulation surgery: A retrospective single-center analysis and systematic review of the literature.
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DOI：
10.1371/journal.pone.0198529
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发表时间：
2018
期刊：
影响因子：
3.7
通讯作者：
Hamel W
中科院分区：
文献类型：
--
作者：
Engel K;Huckhagel T;Gulberti A;Pötter-Nerger M;Vettorazzi E;Hidding U;Choe CU;Zittel S;Braaß H;Ludewig P;Schaper M;Krajewski K;Oehlwein C;Mittmann K;Engel AK;Gerloff C;Westphal M;Moll CKE;Buhmann C;Köppen JA;Hamel W
确定来自单个机构的大型系列中与脑深部电刺激（DBS）手术或植入器械相关的不良事件（AE）发生率。与文献的合理比较需要定义明确的类别，因为对此类AE的报告尚未达成共识。回顾性分析了123例连续患者（中位年龄63岁;女性45.5%）在丘脑底核（78例）、丘脑腹外侧区（24例）、内侧苍白球（20例）和中央内侧束旁核（1例）接受DBS治疗。平均和中位随访时间均为4.7年（578患者年）。根据三个明确的类别评估AE：（i）包括其他颅内并发症在内的颅内损伤，因为这些可能导致神经功能缺损或死亡，（ii）感染和需要更换硬件组件的类似AE，因为这会导致DBS治疗中断，以及（iii）由于各种原因导致的电极导线翻修，因为这涉及额外的颅内手术。对于文献的系统性综述，根据103篇出版物中提供的主要数据计算AE发生率。研究间的异质性用I2统计量进行评估，并通过随机效应荟萃回归进行进一步分析。用漏斗图分析发表偏倚。手术或硬件相关AE（23）影响123例患者中的18例（14.6%），在所有情况下均消退，无永久性后遗症。在2例患者（1.6%）中，纹状体中的小血管与一过性神经功能缺损相关。4例患者（3.3%; 0.7%/患者年）因感染取出脉冲发生器。2例患者的电极翻修（1.6%; 0.3%/患者年）。没有电极导线移位或因电极导线错位而进行手术翻修。受AE影响或未受AE影响的患者之间的年龄差异无统计学意义（p>0.05）。不良事件发生率并未随时间推移而下降，并且在我们机构植入DBS系统的所有患者（423例）中发现了相似的发生率，直至2016年12月。一项系统性文献综述显示，许多研究无法确定确切的AE发生率，这不能归因于研究设计。研究中颅内并发症的平均发生率为3.8%（按研究分析），不同研究患者的汇总分析中为3.4%（按患者分析）。每项研究和每例患者分析的年度硬件移除率分别为3.6%和2.4%，电极导线翻修率分别为4.1%和2.6%。研究之间存在显著异质性（三个类别的I2介于77%和91%之间; p< 0.0001）。考虑到研究规模（p< 0.0001）和发表年份（p<0.01），硬件移除异质性（I2 = 87.4%）降低，尽管仍存在显著程度的异质性（I2 = 80.0%; p< 0.0001）。基于与医疗保健相关数据库的比较，似乎存在发表偏倚，已发表患者队列中硬件相关AE的发生率较低。拟定的类别适用于明确评估AE，即使是以回顾性方式，也可用于基准。本机构当前队列中的AE发生率与文献相比有利。
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. 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 I2 statistic and analyzed further by a random effects meta-regression. Publication bias was analyzed with funnel plots. 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 (I2 ranged between 77% and 91% for the three categories; p< 0.0001). For hardware removal heterogeneity (I2 = 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 (I2 = 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. 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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影响因子：
2
作者：
Chou, Yu-Cheng;Lin, Shinn-Zong;Chen, Shin-Yuan
通讯作者：
Chen, Shin-Yuan
影响因子：
29
作者：
DeLong, Michael R.;Huang, Kevin T.;Lad, Shivanand P.
通讯作者：
Lad, Shivanand P.
影响因子：
3.7
作者：
Buhmann C;Huckhagel T;Engel K;Gulberti A;Hidding U;Poetter-Nerger M;Goerendt I;Ludewig P;Braass H;Choe CU;Krajewski K;Oehlwein C;Mittmann K;Engel AK;Gerloff C;Westphal M;Köppen JA;Moll CKE;Hamel W
通讯作者：
Hamel W
影响因子：
1.1
作者：
Bhatia, Robin;Dalton, Arthur;Nandi, Dipankar
通讯作者：
Nandi, Dipankar
DOI：
10.1046/j.1460-9592.2002.t01-1-00863.x
发表时间：
2002-05-01
影响因子：
1.8
作者：
Déry, JP;Gilbert, M;Philippon, F
通讯作者：
Philippon, F