Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact

2006 ◽  
Vol 5 (3) ◽  
pp. 191-203 ◽  
Author(s):  
Krishna Kumar ◽  
Jefferson R. Wilson ◽  
Rod S. Taylor ◽  
Shivani Gupta
Keyword(s):  
Spinal Cord ◽  
Adverse Events ◽  
Success Rate ◽  
Spinal Cord Stimulation ◽  
Time Course ◽  
Healthcare Resource ◽  
Unit Cost ◽  
Healthcare Budget ◽  
The Cost

Object The long-term success of spinal cord stimulation is impeded by the high incidence of adverse events. The cost of complications to the healthcare budget is influenced by the time course needed to reverse the effect, and by the type of corrective measures required. Understanding the mechanism of complications and reducing them can improve the overall success rate and the cost factor. Methods The authors performed a retrospective analysis of data obtained in 160 patients treated during a 10-year period. For each category of complication, the level of healthcare resource use was assessed for each case and a unit cost was applied. The total cost of each complication was determined by summing across healthcare resource headings. All cost calculations were performed in Canadian dollars at 2005 prices. To understand the mechanics of various hardware-related complications and how to avoid them, the authors have utilized the results of bench tests conducted at Medtronic, Inc. Fifty-one adverse events occurred in 42 of the 160 patients. The complications were classified as either hardware related (39 events) or biological (12 events). The mean cost of complications during the 10-year study period was $7092 (range $130–$22,406). Conclusions Complications not only disrupt the effect of pain control but also pose an added expense to the already high cost of therapy. It is possible to reduce the complication rate, and thus improve the long-term success rate, by following the suggestions made in this paper, which are supported by the biomechanics of the human body and the implanted material.

Financial impact of spinal cord stimulation on the healthcare budget: a comparative analysis of costs in Canada and the United States

2009 ◽  
Vol 10 (6) ◽  
pp. 564-573 ◽  
Author(s):  
Krishna Kumar ◽  
Sharon Bishop
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Unit Cost ◽  
The United States ◽  
Maintenance Cost ◽  
Healthcare Budget ◽  
The Us ◽  
Initial Implantation ◽  
The Individual ◽  
The Cost

Object Many institutions with spinal cord stimulation (SCS) programs fail to realize that besides the initial implantation cost, budgetary allocation must be made to address annual maintenance costs as well as complications as they arise. Complications remain the major contributing factor to the overall expense of SCS. The authors present a formula that, when applied, provides a realistic representation of the actual costs necessary to implant and maintain SCS systems in Canada and the US. Methods The authors performed a retrospective analysis of 197 cases involving SCS (161 implanted and 36 failed trial stimulations) between 1995 and 2006. The cost of patient workup, initial implantation, annual maintenance, and resources necessary to resolve complications were assessed for each case and a unit cost applied. The total cost allocated for each case was determined by summing across healthcare resource headings. Using the same parameters, the unit cost was calculated in both Canadian (CAD) and US dollars (USD) at 2007 prices. Results The cost of implanting a SCS system in Canada is $21,595 (CAD), in US Medicare $32,882 (USD), and in US Blue Cross Blue Shield (BCBS) $57,896 (USD). The annual maintenance cost of an uncomplicated case in Canada is $3539 (CAD), in US Medicare $5071 (USD), and in BCBS $7277 (USD). The mean cost of a complication was $5191 in Canada (range $136–18,837 [CAD]). In comparison, in the US the figures were $9649 (range $381–28,495) for Medicare and $21,390 (range $573–54,547) for BCBS (both USD). Using these calculations a formula was derived as follows: the annual maintenance cost (a) was added to the average annual cost per complication per patient implanted (b); the sum was then divided by the implantation cost (c); and the result was multiplied by 100 to obtain a percentage (a + b ÷ c × 100). To make this budgetary cap universally applicable, the results from the application of the formula were averaged, resulting in an 18% premium. Conclusions For budgeting purposes the institution should first calculate the initial implantation costs that then can be “grossed up” by 18% per annum. This amount of 18% should be in addition to the implantation costs for the individual institution for new patients, as well as for each actively managed patient. This resulting amount will cover the costs associated with annual maintenance and complications for every actively managed patient. As the initial cost of implantation in any country reflects their current economics, the formula provided will be applicable to all implanters and policy makers alike.

Spinal Cord Stimulation in Treatment of Chronic Benign Pain: Challenges in Treatment Planning and Present Status, a 22-Year Experience

Neurosurgery ◽  
2006 ◽  
Vol 58 (3) ◽  
pp. 481-496 ◽  
Author(s):  
Krishna Kumar ◽  
Gary Hunter ◽  
Denny Demeria
Keyword(s):  
Quality Of Life ◽  
Spinal Cord ◽  
Pain Relief ◽  
Success Rate ◽  
Spinal Cord Stimulation ◽  
Pain Clinic ◽  
Axial Component

Abstract OBJECTIVE: To present an in-depth analysis of clinical predictors of outcome including age, sex, etiology of pain, type of electrodes used, duration of pain, duration of treatment, development of tolerance, employment status, activities of daily living, psychological status, and quality of life. Suggestions for treatment of low back pain with a predominant axial component are addressed. We analyzed the complications and proposed remedial measures to improve the effectiveness of this modality. METHODS: Study group consists of 410 patients (252 men, 58 women) with a mean age of 54 years and a mean follow-up period of 97.6 months. All patients were gated through a multidisciplinary pain clinic. The study was conducted over 22 years. RESULTS: The early success rate was 80% (328 patients), whereas the long-term success rate of internalized patients was 74.1% (243 patients) after the mean follow-up period of 97.6 months. Hardware-related complications included displaced or fractured electrodes, infection, and hardware malfunction. Etiologies demonstrating efficacy included failed back syndrome, peripheral vascular disease, angina pain, complex regional pain syndrome I and II, peripheral neuropathy, lower limb pain caused by multiple sclerosis. Age, sex, laterality of pain or number of surgeries before implant did not play a role in predicting outcome. The percentage of pain relief was inversely related to the time interval between pain onset and time of implantation. Radicular pain with axial component responded better to dual Pisces electrode or Specify-Lead implantation. CONCLUSION: Spinal cord stimulation can provide significant long-term pain relief with improved quality of life and employment. Results of this study will be effective in better defining prognostic factors and reducing complications leading to higher success rates with spinal cord stimulation.

Time-course of treatment-emergent adverse events in a long-term safety study of lisdexamfetamine dimesylate in children and adolescents with ADHD

2016 ◽  
Vol 33 (S1) ◽  
pp. S132-S132
Author(s):  
I. Hernández Otero ◽  
T. Banaschewski ◽  
P. Nagy ◽  
C.A. Soutullo ◽  
A. Zuddas ◽  
...  
Keyword(s):  
Adverse Events ◽  
Children And Adolescents ◽  
Time Course ◽  
Open Label ◽  
Lisdexamfetamine Dimesylate ◽  
Safety Population ◽  
First Onset ◽  
Stimulant Medications ◽  
Competing Interest

IntroductionThe long-term safety and efficacy of lisdexamfetamine dimesylate (LDX) in children and adolescents with attention deficit/hyperactivity disorder (ADHD) was evaluated in a European 2-year, open-label study (SPD489-404).ObjectiveTo evaluate the time-course of treatment-emergent adverse events (TEAEs) in SPD489-404.MethodsParticipants aged 6–17 years received open-label LDX (30, 50 or 70 mg/day) for 104 weeks (4 weeks dose-optimization; 100 weeks dose-maintenance).ResultsAll enrolled participants (n = 314) were included in the safety population and 191 (60.8%) completed the study. TEAEs occurred in 282 (89.8%) participants; most were mild or moderate. TEAEs considered by the investigators as related to LDX were reported by 232 (73.9%) participants with the following reported for ≥ 10% of participants: decreased appetite (49.4%), weight decreased (18.2%), insomnia (13.1%). TEAEs leading to discontinuation and serious TEAEs occurred in 39 (12.4%) and 28 (8.9%) participants, respectively. The median (range) time to first onset and duration, respectively, of TEAEs identified by the sponsor as being of special interest were: insomnia (insomnia, initial insomnia, middle insomnia, terminal insomnia), 17.0 (1–729) and 42.8 (1–739) days; weight decreased, 29.0 (1–677) and 225.0 (26–724) days; decreased appetite, 13.5 (1–653) and 169.0 (1–749) days; headache, 22.0 (1–718) and 2.0 (1–729) days. Reports of insomnia, weight decreased, decreased appetite and headache were highest in the first 4–12 weeks.ConclusionsTEAEs associated with long-term LDX treatment were characteristic of stimulant medications, with the greatest incidence observed during the first 4–12 weeks.Disclosure of interestThe authors have not supplied their declaration of competing interest.

16-LB: Long-Term 10 kHz Spinal Cord Stimulation in Painful Diabetic Neuropathy: A Randomized Controlled Trial

Diabetes ◽  
2021 ◽  
Vol 70 (Supplement 1) ◽  
pp. 16-LB
Author(s):  
ERIKA PETERSEN ◽  
JAMES SCOWCROFT ◽  
ELIZABETH S. BROOKS ◽  
JUDITH L. WHITE ◽  
KASRA AMIRDELFAN ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Randomized Controlled Trial ◽  
Diabetic Neuropathy ◽  
Spinal Cord Stimulation ◽  
Controlled Trial ◽  
Painful Diabetic Neuropathy ◽  
Randomized Controlled

scholarly journals Magnetic Resonance Imaging of the Lumbar Spine in a Patient with a Spinal Cord Stimulator

2013 ◽  
Vol 3;16 (3;5) ◽  
pp. E295-E300
Author(s):  
Thomas T. Simopoulos
Keyword(s):  
Magnetic Resonance Imaging ◽  
Spinal Cord ◽  
Case Report ◽  
Lumbar Spine ◽  
Magnetic Resonance ◽  
Adverse Events ◽  
Spinal Cord Stimulation ◽  
Spinal Cord Stimulator ◽  
Resonance Imaging ◽  
Lumbar Mri

Background: The use of magnetic resonance imaging (MRI) is continuously escalating for the evaluation of patients with persistent pain following lumbar spine surgery (LSS). Spinal cord stimulation (SCS) therapy is being clinically applied much more commonly for the management of chronic pain following LSS. There is an increased probability that these 2 incompatible modalities may be accidentally used in the same patient. Objectives: The purpose of this case report is to: (1) summarize a case in which a patient with a thoracic spinal cord stimulator underwent a diagnostic lumbar MRI, (2) describe the 3 magnetic fields used to generate images and their interactions with SCS devices, and (3) summarize the present literature. Study design: Case report. Setting: University hospital. Results: Aside from mild heat sensations in the generator/pocket site and very low intensity shocking sensations in the back while in the MRI scanner, the patient emerged from the study with no clinically detected adverse events. Subsequent activation of the SCS device would result in a brief intense shocking sensation. This persisted whenever the device was activated and required Implantable Pulse Generator (IPG) replacement. Electrical analysis revealed that some of the output circuitry switches, which regulate IPG stimulation and capacitor charge balancing, were damaged, most likely by MRI radiofrequency injected current. Limitations: Single case of a patient with a thoracic SCS having a lumbar MRI study. Conclusion: This case demonstrates the lack of compatibility of lumbar MRI and the Precision SCS system as well as one of the possible patient adverse events that can occur when patients are exposed to MRI outside of the approved device labeling. Key words: Spinal cord stimulation devices, magnetic resonance imaging

scholarly journals Long-term quality of life improvement for chronic intractable back and leg pain patients using spinal cord stimulation: 12-month results from the SENZA-RCT

2018 ◽  
Vol 27 (8) ◽  
pp. 2035-2044 ◽  
Author(s):  
Kasra Amirdelfan ◽  
Cong Yu ◽  
Matthew W. Doust ◽  
Bradford E. Gliner ◽  
Donna M. Morgan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Leg Pain ◽  
Life Improvement ◽  
Pain Patients
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