An unexpectedly high rate of revisions and removals in deep brain stimulation surgery: Analysis of multiple databases

Abstract

Introduction Deep brain stimulation (DBS) is an established therapy for movement disorders, and is under active investigation for other neurologic and psychiatric indications. While many studies describe outcomes and complications related to stimulation therapies, the majority of these are from large academic centers, and results may differ from those in general neurosurgical practice. Methods Using data from both the Centers for Medicare and Medicaid Services (CMS) and the National Surgical Quality Improvement Program (NSQIP), we identified all DBS procedures related to primary placement, revision, or removal of intracranial electrodes. Cases of cortical stimulation and stimulation for epilepsy were excluded. Results Over 28,000 cases of DBS electrode placement, revision, and removal were identified during the years 2004–2013. In the Medicare dataset, 15.2% and of these procedures were for intracranial electrode revision or removal, compared to 34.0% in the NSQIP dataset. In NSQIP, significant predictors of revision and removal were decreased age (odds ratio (OR) of 0.96; 95% CI: 0.94, 0.98) and higher ASA classification (OR 2.41; 95% CI: 1.22, 4.75). Up to 48.5% of revisions may have been due to improper targeting or lack of therapeutic effect. Conclusion Data from multiple North American databases suggest that intracranial neurostimulation therapies have a rate of revision and removal higher than previously reported, between 15.2 and 34.0%. While there are many limitations to registry-based studies, there is a clear need to better track and understand the true prevalence and nature of such failures as they occur in the wider surgical community.

Long-Term Stability of Short Circuits in Deep Brain Stimulation

“…Among the remainder device complications and infections were the main reasons. The device complications could not be specified in this study . Our own data demonstrate a high and yet underestimated incidence of short circuits as an important technical dysfunction, which may have contributed to the high revision rate.…”

“…Thus, the detection of a short circuit needs careful evaluation and follow‐up but does not necessitate surgical revision in all patients. These considerations are of particular interest since a recent analysis of multiple North American databases revealed an unexpectedly high rate of revisions and removals in DBS surgery between 15 and 34% . The reasons for revisions/removals could not be identified in detail but suggested improper targeting or lack of therapeutic effect in up to half of the cases.…”

Surgical management of adverse events associated with deep brain stimulation: A single-center experience

“…1,24 It should, however, be noted that a recent study of a large national registry including over 28,000 cases revealed that the incidence of revisions and removals of DBS electrodes was greater than 15%, which the authors considered might be due to improper targeting or lack of therapeutic effect. 25 In addition, a recent study showed that complication rates could be reduced with sophistication of surgical techniques. 6,14 These reports may have addressed the importance of the subspecialty training prior to opening a DBS practice.…”

Letter: Systematic Stereotactic Error Reduction Using a Calibration Technique in Single-Brain-Pass and Multitrack Deep Brain Stimulations

“…A recent US study reported an exceedingly high rate of lead relocation due to suboptimal placement in up to 16% of DBS procedures. 4 In other words, up to 1 in 6 DBS procedures are revision operations, performed to rectify a targeting error that could have been avoided or immediately rectified during the initial procedure. This finding underscores the importance of obtaining routine postoperative stereotactic CT or MR imaging, irrespective of any clinical or neurophysiological observations made during surgery.…”