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Andre A. Wakim, Jennifer B. Mattar, Margaret Lambert, and Francisco A. Ponce

OBJECTIVE

Deep brain stimulation (DBS) is an elective procedure that can dramatically enhance quality of life. Because DBS is not considered lifesaving, it is important that providers produce consistently good outcomes, and one factor they usually consider is patient age. While older age may be a relative contraindication for some elective surgeries, the progressive nature of movement disorders treated with DBS may suggest that older patients stand to benefit substantially from surgery. To better understand the risks of treating patients of advanced age with DBS, this study compares perioperative complication rates in patients ≥ 75 to those < 75 years old.

METHODS

Patients undergoing DBS surgery for various indications by a single surgeon (May 2013–July 2019) were stratified into elderly (age ≥ 75 years) and younger (age < 75 years) cohorts. The risks of common perioperative complications and various outcome measures were compared between the two age groups using risk ratios (RRs) and 95% confidence intervals (CIs).

RESULTS

A total of 861 patients were available for analysis: 179 (21%) were ≥ 75 years old and 682 (79%) were < 75 years old (p < 0.001). Patients ≥ 75 years old, compared with those < 75 years old, did not have significantly different RRs (95% CIs) of seizure (RR 0.4, 95% CI 0.1–3.3), cerebrovascular accident (RR 1.9, 95% CI 0.4–10.3), readmission within 90 days of discharge (RR 1.22, 95% CI 0.8–1.8), explantation due to infection (RR 2.5, 95% CI 0.4–15.1), or surgical revision (for lead, RR 2.5, 95% CI 0.4–15.1; for internal pulse generator, RR 3.8, 95% CI 0.2–61.7). Although the risk of postoperative intracranial bleeding was higher in the elderly group (6.1%) than in the younger group (3.1%), this difference was not statistically significant (p = 0.06). However, patients ≥ 75 years old did have significantly increased risk of altered mental status (RR 2.5, 95% CI 1.6–4.0), experiencing more than a 1-night stay (RR 1.7, 95% CI 1.4–2.0), and urinary retention (RR 2.3, 95% CI 1.2–4.2; p = 0.009).

CONCLUSIONS

Although elderly patients had higher risks of certain outcome measures than younger patients, this study showed that elderly patients undergoing DBS for movement disorders did not have an increased risk of more serious complications, such as intracranial hemorrhage, infection, or readmission. Advanced age alone should not be considered a contraindication for DBS.

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Nikolas R. Monteferrante, Brian G. Wilhelmi, Margaret Lambert, and Francisco A. Ponce

OBJECTIVE

Deep brain stimulation (DBS) is a well-established therapy for treating neurological movement disorders. Some patients who have received DBS therapy have noticed significant weight gain. Further investigation into correlations between patient characteristics and weight gain following DBS device implantation, which the authors here have done, will provide physicians with useful clinical information.

METHODS

The authors performed a retrospective study of patients with Parkinson’s disease (PD) and essential tremor (ET) who had received DBS therapy in the period from 2012 to 2017. Patient weights had been recorded preoperatively and at 3, 6, and 12 months postoperatively. These data were used to compare patient characteristics, including diagnosis, body mass index (BMI), sex, levodopa equivalent dose (LED), and change in Unified Parkinson’s Disease Rating Scale (UPDRS) score. For PD patients, a quantile multivariate regression analysis was used to examine whether significant correlations existed between several of these patient characteristics, as well as age and weight gain following implantation.

RESULTS

PD patients had gained a significant amount of weight at 3 months (mean [SE] 2.66 [0.428] kg, p < 0.001), 6 months (3.64 [0.492] kg, p < 0.001), and 12 months (4.18 [0.540] kg, p < 0.001) after DBS placement. Patients who had undergone subthalamic nucleus (STN) DBS device placement gained, on average, more weight than the patients with globus pallidus internus (GPi) placement at both 6 months (mean 2.558 [1.020] kg, p = 0.01) and 12 months (2.358 [1.130] kg, p = 0.04). BMI in the STN cohort was greater than that in the GPi cohort at 6 months (mean difference [SE] 2.60 [1.127] kg/m2, p = 0.02) and at 12 months (2.36 [1.112] kg/m2, p = 0.04). A reduction in LED was negatively correlated with weight change at 6 months (r = −0.33, p < 0.001) and 12 months (r = −0.41, p < 0.001). There was no weight gain correlated with DBS therapy for ET.

CONCLUSIONS

PD patients experienced a significant change in weight over time after DBS therapy, whereas ET patients did not. PD patients with an STN target site experienced greater weight gain, on average, than those with a GPi target site. Furthermore, there was a significant increase in BMI at 6 and 12 months in patients with an STN target compared to that in patients with a GPi target. PD patients whose LED was reduced after DBS gained more weight at 6 and 12 months after surgery than the patients whose LED was kept at the same level or increased.

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David S. Xu and Francisco A. Ponce

OBJECTIVE

The aim of this article is to review the authors’ and published experience with deep brain stimulation (DBS) therapy for the treatment of patients with Alzheimer’s disease (AD) and Parkinson’s disease dementia (PDD).

METHODS

Two targets are current topics of investigation in the treatment of AD and PDD, the fornix and the nucleus basalis of Meynert. The authors reviewed the current published clinical experience with attention to patient selection, biological rationale of therapy, anatomical targeting, and clinical results and adverse events.

RESULTS

A total of 7 clinical studies treating 57 AD patients and 7 PDD patients have been reported. Serious adverse events were reported in 6 (9%) patients; none resulted in death or disability. Most studies were case reports or Phase 1/2 investigations and were not designed to assess treatment efficacy. Isolated patient experiences demonstrating improved clinical response after DBS have been reported, but no significant or consistent cognitive benefits associated with DBS treatment could be identified across larger patient populations.

CONCLUSIONS

PDD and AD are complex clinical entities, with investigation of DBS intervention still in an early phase. Recently published studies demonstrate acceptable surgical safety. For future studies to have adequate power to detect meaningful clinical changes, further refinement is needed in patient selection, metrics of clinical response, and optimal stimulation parameters.

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Francisco A. Ponce, Kelly D. Foote, and Andres M. Lozano

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James J. Zhou, Tsinsue Chen, S. Harrison Farber, Andrew G. Shetter, and Francisco A. Ponce

OBJECTIVE

The field of deep brain stimulation (DBS) for epilepsy has grown tremendously since its inception in the 1970s and 1980s. The goal of this review is to identify and evaluate all studies published on the topic of open-loop DBS for epilepsy over the past decade (2008 to present).

METHODS

A PubMed search was conducted to identify all articles reporting clinical outcomes of open-loop DBS for the treatment of epilepsy published since January 1, 2008. The following composite search terms were used: (“epilepsy” [MeSH] OR “seizures” [MeSH] OR “kindling, neurologic” [MeSH] OR epilep* OR seizure* OR convuls*) AND (“deep brain stimulation” [MeSH] OR “deep brain stimulation” OR “DBS”) OR (“electric stimulation therapy” [MeSH] OR “electric stimulation therapy” OR “implantable neurostimulators” [MeSH]).

RESULTS

The authors identified 41 studies that met the criteria for inclusion. The anterior nucleus of the thalamus, centromedian nucleus of the thalamus, and hippocampus were the most frequently evaluated targets. Among the 41 articles, 19 reported on stimulation of the anterior nucleus of the thalamus, 6 evaluated stimulation of the centromedian nucleus of the thalamus, and 9 evaluated stimulation of the hippocampus. The remaining 7 articles reported on the evaluation of alternative DBS targets, including the posterior hypothalamus, subthalamic nucleus, ventral intermediate nucleus of the thalamus, nucleus accumbens, caudal zone incerta, mammillothalamic tract, and fornix. The authors evaluated each study for overall epilepsy response rates as well as adverse events and other significant, nonepilepsy outcomes.

CONCLUSIONS

Level I evidence supports the safety and efficacy of stimulating the anterior nucleus of the thalamus and the hippocampus for the treatment of medically refractory epilepsy. Level III and IV evidence supports stimulation of other targets for epilepsy. Ongoing research into the efficacy, adverse effects, and mechanisms of open-loop DBS continues to expand the knowledge supporting the use of these treatment modalities in patients with refractory epilepsy.

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Tsinsue Chen, Zaman Mirzadeh, Kristina M. Chapple, Margaret Lambert, Holly A. Shill, Guillermo Moguel-Cobos, Alexander I. Tröster, Rohit Dhall, and Francisco A. Ponce

OBJECTIVE

Recent studies have shown similar clinical outcomes between Parkinson disease (PD) patients treated with deep brain stimulation (DBS) under general anesthesia without microelectrode recording (MER), so-called “asleep” DBS, and historical cohorts undergoing “awake” DBS with MER guidance. However, few studies include internal controls. This study aims to compare clinical outcomes after globus pallidus internus (GPi) and subthalamic nucleus (STN) DBS using awake and asleep techniques at a single institution.

METHODS

PD patients undergoing awake or asleep bilateral GPi or STN DBS were prospectively monitored. The primary outcome measure was stimulation-induced change in motor function off medication 6 months postoperatively, measured using the Unified Parkinson’s Disease Rating Scale part III (UPDRS-III). Secondary outcomes included change in quality of life, measured by the 39-item Parkinson’s Disease Questionnaire (PDQ-39), change in levodopa equivalent daily dosage (LEDD), stereotactic accuracy, stimulation parameters, and adverse events.

RESULTS

Six-month outcome data were available for 133 patients treated over 45 months (78 GPi [16 awake, 62 asleep] and 55 STN [14 awake, 41 asleep]). UPDRS-III score improvement with stimulation did not differ between awake and asleep groups for GPi (awake, 20.8 points [38.5%]; asleep, 18.8 points [37.5%]; p = 0.45) or STN (awake, 21.6 points [40.3%]; asleep, 26.1 points [48.8%]; p = 0.20) targets. The percentage improvement in PDQ-39 and LEDD was similar for awake and asleep groups for both GPi (p = 0.80 and p = 0.54, respectively) and STN cohorts (p = 0.85 and p = 0.49, respectively).

CONCLUSIONS

In PD patients, bilateral GPi and STN DBS using the asleep method resulted in motor, quality-of-life, and medication reduction outcomes that were comparable to those of the awake method.

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Tsinsue Chen, Zaman Mirzadeh, Kristina M. Chapple, Margaret Lambert, Virgilio G. H. Evidente, Guillermo Moguel-Cobos, Srivadee Oravivattanakul, Padma Mahant, and Francisco A. Ponce

OBJECTIVE

Ventral intermediate nucleus deep brain stimulation (DBS) for essential tremor is traditionally performed with intraoperative test stimulation and conscious sedation, without general anesthesia (GA). Recently, the authors reported retrospective data on 17 patients undergoing DBS after induction of GA with standardized anatomical coordinates on T1-weighted MRI sequences used for indirect targeting. Here, they compare prospectively collected data from essential tremor patients undergoing DBS both with GA and without GA (non-GA).

METHODS

Clinical outcomes were prospectively collected at baseline and 3-month follow-up for patients undergoing DBS surgery performed by a single surgeon. Stereotactic, euclidean, and radial errors of lead placement were calculated. Functional (activities of daily living), quality of life (Quality of Life in Essential Tremor [QUEST] questionnaire), and tremor severity outcomes were compared between groups.

RESULTS

Fifty-six patients underwent surgery: 16 without GA (24 electrodes) and 40 with GA (66 electrodes). The mean baseline functional scores and QUEST summary indices were not different between groups (p = 0.91 and p = 0.59, respectively). Non-GA and GA groups did not differ significantly regarding mean postoperative percentages of functional improvement (non-GA, 47.9% vs GA, 48.1%; p = 0.96) or QUEST summary indices (non-GA, 79.9% vs GA, 74.8%; p = 0.50). Accuracy was comparable between groups (mean radial error 0.9 ± 0.3 mm for non-GA and 0.9 ± 0.4 mm for GA patients) (p = 0.75). The mean euclidean error was also similar between groups (non-GA, 1.1 ± 0.6 mm vs GA, 1.2 ± 0.5 mm; p = 0.92). No patient had an intraoperative complication, and the number of postoperative complications was not different between groups (non-GA, n = 1 vs GA, n = 10; p = 0.16).

CONCLUSIONS

DBS performed with the patient under GA to treat essential tremor is as safe and effective as traditional DBS surgery with intraoperative test stimulation while the patient is under conscious sedation without GA.

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Tsinsue Chen, Zaman Mirzadeh, Kristina Chapple, Margaret Lambert, and Francisco A. Ponce

OBJECTIVE

As the number of deep brain stimulation (DBS) procedures performed under general anesthesia (“asleep” DBS) increases, it is more important to assess the rates of adverse events, inpatient lengths of stay (LOS), and 30-day readmission rates in patients undergoing these procedures compared with those in patients undergoing traditional “awake” DBS without general anesthesia.

METHODS

All patients in an institutional database who had undergone awake or asleep DBS procedures performed by a single surgeon between August 2011 and August 2014 were reviewed. Adverse events, inpatient LOS, and 30-day readmissions were analyzed.

RESULTS

A total of 490 electrodes were placed in 284 patients, of whom 126 (44.4%) underwent awake surgery and 158 (55.6%) underwent asleep surgery. The most frequent overall complication for the cohort was postoperative mental status change (13 patients [4.6%]), followed by hemorrhage (4 patients [1.4%]), seizure (4 patients [1.4%]), and hardware-related infection (3 patients [1.1%]). Mean LOS for all 284 patients was 1.19 ± 1.29 days (awake: 1.06 ± 0.46 days; asleep: 1.30 ± 1.67 days; p = 0.08). Overall, the 30-day readmission rate was 1.4% (1 awake patient, 3 asleep patients). There were no significant differences in complications, LOS, and 30-day readmissions between awake and asleep groups.

CONCLUSIONS

Both awake and asleep DBS can be performed safely with low complication rates. The authors found no significant differences between the 2 procedure groups in adverse events, inpatient LOS, and 30-day readmission rates.

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Francisco A. Ponce, Wael F. Asaad, Kelly D. Foote, William S. Anderson, G. Rees Cosgrove, Gordon H. Baltuch, Kara Beasley, Donald E. Reymers, Esther S. Oh, Steven D. Targum, Gwenn S. Smith, Constantine G. Lyketsos, and Andres M. Lozano

OBJECT

This report describes the stereotactic technique, hospitalization, and 90-day perioperative safety of bilateral deep brain stimulation (DBS) of the fornix in patients who underwent DBS for the treatment of mild, probable Alzheimer's disease (AD).

METHODS

The ADvance Trial is a multicenter, 12-month, double-blind, randomized, controlled feasibility study being conducted to evaluate the safety, efficacy, and tolerability of DBS of the fornix in patients with mild, probable AD. Intraoperative and perioperative data were collected prospectively. All patients underwent postoperative MRI. Stereotactic analyses were performed in a blinded fashion by a single surgeon. Adverse events (AEs) were reported to an independent clinical events committee and adjudicated to determine the relationship between the AE and the study procedure.

RESULTS

Between June 6, 2012, and April 28, 2014, a total of 42 patients with mild, probable AD were treated with bilateral fornix DBS (mean age 68.2 ± 7.8 years; range 48.0–79.7 years; 23 men and 19 women). The mean planned target coordinates were x = 5.2 ± 1.0 mm (range 3.0–7.9 mm), y = 9.6 ± 0.9 mm (range 8.0–11.6 mm), z = −7.5 ± 1.2 mm (range −5.4 to −10.0 mm), and the mean postoperative stereotactic radial error on MRI was 1.5 ± 1.0 mm (range 0.2–4.0 mm). The mean length of hospitalization was 1.4 ± 0.8 days. Twenty-six (61.9%) patients experienced 64 AEs related to the study procedure, of which 7 were serious AEs experienced by 5 patients (11.9%). Four (9.5%) patients required return to surgery: 2 patients for explantation due to infection, 1 patient for lead repositioning, and 1 patient for chronic subdural hematoma. No patients experienced neurological deficits as a result of the study, and no deaths were reported.

CONCLUSIONS

Accurate targeting of DBS to the fornix without direct injury to it is feasible across surgeons and treatment centers. At 90 days after surgery, bilateral fornix DBS was well tolerated by patients with mild, probable AD.

Clinical trial registration no.: NCT01608061 (clinicaltrials.gov)