The safety issues and hardware-related complications of deep brain stimulation therapy: a single-center retrospective analysis of 478 patients with Parkinson&amp;rsquo;s disease

Zhang, Jing; Wang, Tao; Zhang, Chencheng; Zeljic, Kristina; Zhan, Siyan; Sun, Bomin; Li, Dianyou

doi:10.2147/cia.s130882

Cited by 27 publications

(19 citation statements)

References 28 publications

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“…RC-IPG implantation was also not associated with increased risk of complication compared with prior reports of DBS complication rates with standard IPGs. 1,2,5,7,26,30 While some centers elect to implant 2 IPGs for bilateral stimulation, we typically use 1 IPG capable of bilateral stimulation. This holds true for both standard and rechargeable IPGs.…”

Section: Discussionmentioning

confidence: 99%

Reduced long-term cost and increased patient satisfaction with rechargeable implantable pulse generators for deep brain stimulation

Hitti¹,

Vaughan²,

Ramayya³

et al. 2019

Journal of Neurosurgery

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OBJECTIVEDeep brain stimulation (DBS) has revolutionized the treatment of neurological disease, but its therapeutic efficacy is limited by the lifetime of the implantable pulse generator (IPG) batteries. At the end of the battery life, IPG replacement surgery is required. New IPGs with rechargeable batteries (RC-IPGs) have recently been introduced and allow for decreased reoperation rates for IPG replacements. The authors aimed to examine the merits and limitations of these devices.METHODSThe authors reviewed the medical records of patients who underwent DBS implantation at their institution. RC-IPGs were placed either during initial DBS implantation or during an IPG change. A cost analysis was performed that compared RC-IPGs with standard IPGs, and telephone patient surveys were conducted to assess patient satisfaction.RESULTSThe authors identified 206 consecutive patients from 2011 to 2016 who underwent RC-IPG placement (mean age 61 years; 67 women, 33%). Parkinson’s disease was the most common indication for DBS (n = 144, 70%), followed by essential tremor (n = 41, 20%), dystonia (n = 13, 6%), depression (n = 5, 2%), multiple sclerosis tremor (n = 2, 1%), and epilepsy (n = 1, 0.5%). DBS leads were typically placed bilaterally (n = 192, 93%) and targeted the subthalamic nucleus (n = 136, 66%), ventral intermediate nucleus of the thalamus (n = 43, 21%), internal globus pallidus (n = 21, 10%), ventral striatum (n = 5, 2%), or anterior nucleus of the thalamus (n = 1, 0.5%). RC-IPGs were inserted at initial DBS implantation in 123 patients (60%), while 83 patients (40%) were converted to RC-IPGs during an IPG replacement surgery. The authors found that RC-IPG implantation resulted in $60,900 of cost savings over the course of 9 years. Furthermore, patient satisfaction was high with RC-IPG implantation. Overall, 87.3% of patients who responded to the survey were satisfied with their device, and only 6.7% found the rechargeable component difficult to use. In patients who were switched from a standard IPG to RC-IPG, the majority who responded (70.3%) preferred the rechargeable IPG.CONCLUSIONSRC-IPGs can provide DBS patients with long-term therapeutic benefit while minimizing the need for battery replacement surgery. The authors have implanted rechargeable stimulators in 206 patients undergoing DBS surgery, and here they demonstrate the cost-effectiveness and high patient satisfaction associated with this procedure.

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Section: Discussionmentioning

confidence: 99%

Reduced long-term cost and increased patient satisfaction with rechargeable implantable pulse generators for deep brain stimulation

Hitti¹,

Vaughan²,

Ramayya³

et al. 2019

Journal of Neurosurgery

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“…Deep brain stimulation surgery has been utilized for the treatment of medically intractable movement disorders for more than two decades. Various clinical series have shown that it is a safe procedure with low rates of complications and adverse events, particularly in the experienced large-volume centers [ 8 – 10 ]. Here, we investigated occurrences and risk factors of surgical and hardware-related complications of DBS surgery performed by a single primary surgeon in a single center.…”

Section: Discussionmentioning

confidence: 99%

“…Only a fraction of these patients had intractable infection or inflammation that made removal of hardware components (mostly extension and IPG) inevitable. With the advent of new technologies, better surgical techniques, and prevention strategies [ 10 , 34 , 35 ], the rates of such serious wound complications have diminished considerably. Also, alternative medical and surgical strategies have been used to tackle these complications once occurred [ 36 , 37 ].…”

Section: Discussionmentioning

confidence: 99%

“…As in all surgical operations, this procedure is not without complications and problems. In addition to operative complications, inherent to the technique are hardware- and stimulation-related adverse events, which have increasingly been recognized in the literature as the experience has exponentially grown in the past years [ 6 – 10 ]. Here, we present our experience with 181 patients undergoing DBS placement and discuss strategies to minimize complications and adverse events in the light of this contemporary series and others in the literature.…”

Section: Introductionmentioning

confidence: 99%

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Experience Reduces Surgical and Hardware-Related Complications of Deep Brain Stimulation Surgery: A Single-Center Study of 181 Patients Operated in Six Years

Sorar

Hanalıoğlu

Koçer³

et al. 2018

Parkinson's Disease

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Objective Deep brain stimulation (DBS) surgery has increasingly been performed for the treatment of movement disorders and is associated with a wide array of complications. We aimed to present our experience and discuss strategies to minimize adverse events in light of this contemporary series and others in the literature. Methods A retrospective chart review was conducted to collect data on age, sex, indication, operation date, surgical technique, and perioperative and late complications. Results A total of 181 patients (113 males, 68 females) underwent DBS implantation surgery (359 leads) in the past six years. Indications and targets were as follows: Parkinson's disease (STN) (n=159), dystonia (GPi) (n=13), and essential tremor (Vim) (n=9). Mean age was 55.2 ± 11.7 (range 9–74) years. Mean follow-up duration was 3.4 ± 1.6 years. No mortality or permanent morbidity was observed. Major perioperative complications were confusion (6.6%), intracerebral hemorrhage (2.2%), stroke (1.1%), and seizures (1.1%). Long-term adverse events included wound (7.2%), mostly infection, and hardware-related (5.5%) complications. Among several factors, only surgical experience was found to be related with overall complication rates (early period: 31% versus late period: 10%; p=0.001). Conclusion The rates of both early and late complications of DBS surgery are acceptably low and decrease significantly with cumulative experience.

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“…In a retrospective analysis of data from a single medical center on DBS on PD patients, conducted by Shanghai Jiao Tong University, 41 cases of deaths were reported during the 16 years of follow-ups after implantation. [166] Among these lethal cases, only 2 were due to intracranial hemorrhage, making up 0.4% of the total. Additionally, 22 (4.6%) cases of nonlethal, biological complications related to the probe material were reported, of which 11 (2%) were cases of immune rejection and 9 (1.8%) were cases of infection.…”

Section: Relevant Clinical Results Related To Mechanical and Biologicmentioning

confidence: 99%

The Future of Neuroimplantable Devices: A Materials Science and Regulatory Perspective

2019

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The past two decades have seen unprecedented progress in the development of novel materials, form factors, and functionalities in neuroimplantable technologies, including electrocorticography (ECoG) systems, multielectrode arrays (MEAs), Stentrode, and deep brain probes. The key considerations for the development of such devices intended for acute implantation and chronic use, from the perspective of biocompatible hybrid materials incorporation, conformable device design, implantation procedures, and mechanical and biological risk factors, are highlighted. These topics are connected with the role that the U.S. Food and Drug Administration (FDA) plays in its regulation of neuroimplantable technologies based on the above parameters. Existing neuroimplantable devices and efforts to improve their materials and implantation protocols are first discussed in detail. The effects of device implantation with regards to biocompatibility and brain heterogeneity are then explored. Topics examined include brain‐specific risk factors, such as bacterial infection, tissue scarring, inflammation, and vasculature damage, as well as efforts to manage these dangers through emerging hybrid, bioelectronic device architectures. The current challenges of gaining clinical approval by the FDA—in particular, with regards to biological, mechanical, and materials risk factors—are summarized. The available regulatory pathways to accelerate next‐generation neuroimplantable devices to market are then discussed.

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The safety issues and hardware-related complications of deep brain stimulation therapy: a single-center retrospective analysis of 478 patients with Parkinson’s disease

Cited by 27 publications

References 28 publications

Reduced long-term cost and increased patient satisfaction with rechargeable implantable pulse generators for deep brain stimulation

Reduced long-term cost and increased patient satisfaction with rechargeable implantable pulse generators for deep brain stimulation

Experience Reduces Surgical and Hardware-Related Complications of Deep Brain Stimulation Surgery: A Single-Center Study of 181 Patients Operated in Six Years

The Future of Neuroimplantable Devices: A Materials Science and Regulatory Perspective

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