Natural history of neuromodulation devices and therapies: a patient-centered survival analysis

Abstract

OBJECTIVEDespite rapid development and expansion of neuromodulation technologies, knowledge about device and/or therapy durability remains limited. The aim of this study was to evaluate the long-term rate of hardware and therapeutic failure of implanted devices for several neuromodulation therapies.METHODSThe authors performed a retrospective analysis of patients’ device and therapy survival data (Kaplan-Meier survival analysis) for deep brain stimulation (DBS), vagus nerve stimulation (VNS), and spinal cord stimulation (SCS) at a single institution (years 1994–2015).RESULTSDuring the study period, 450 patients underwent DBS, 383 VNS, and 128 SCS. For DBS, the 5- and 10-year initial device survival was 87% and 73%, respectively, and therapy survival was 96% and 91%, respectively. For VNS, the 5- and 10-year initial device survival was 90% and 70%, respectively, and therapy survival was 99% and 97%, respectively. For SCS, the 5- and 10-year initial device survival was 50% and 34%, respectively, and therapy survival was 74% and 56%, respectively. The average initial device survival for DBS, VNS, and SCS was 14 years, 14 years, and 8 years while mean therapy survival was 18 years, 18 years, and 12.5 years, respectively.CONCLUSIONSThe authors report, for the first time, comparative device and therapy survival rates out to 15 years for large cohorts of DBS, VNS, and SCS patients. Their results demonstrate higher device and therapy survival rates for DBS and VNS than for SCS. Hardware failures were more common among SCS patients, which may have played a role in the discontinuation of therapy. Higher therapy survival than device survival across all modalities indicates continued therapeutic benefit beyond initial device failures, which is important to emphasize when counseling patients.

Neurostimulation in the patient with chronic pain: forecasting the future with data from the present – data-driven analysis or just dreams?

“…The rate of explants is one of the most important concerns, in the analysis of suitability of implanted candidates. In a study by Patel et al ,5 the main reason for the removal of the hardware was the lack of effectiveness of the stimulation (81%), and in the study from Teton et al ,6 the percentage of patients still using SCS therapy decreases by almost 15% every 5 years. In this sense, Goudman et al 2 suggested that the individual goals of patients and their level of satisfaction regarding compliance might significantly affect the SCS therapy and its outcome.…”

Methods and system for recording human physiological signals from implantable leads during spinal cord stimulation

“…Stimulation of the spinal cord has long been used to effectively treat lower back pain (1) and complex regional pain syndrome (CRPS) (2). One of the challenges faced during spinal cord stimulation (SCS) therapy is loss of chronic efficacy of the treatment (3). Underlying reasons for this change of therapy may include device failure, lead migration, habituation of SCS treatment, etc (3)(4)(5).…”

“…One of the challenges faced during spinal cord stimulation (SCS) therapy is loss of chronic efficacy of the treatment (3). Underlying reasons for this change of therapy may include device failure, lead migration, habituation of SCS treatment, etc (3)(4)(5). Finding a control signal that can provide necessary notification or even adjustment to treatment is necessary for long-term SCS therapy and user experience improvement.…”

Trends in spinal cord stimulation utilization: change, growth and implications for the future

“…Similarly, private insurance companies have also tightened up their local coverage determination policies and preauthorization processes and in some cases have continued to label some devices as investigational to deny coverage. In addition, recent studies comparing the long-term outcomes and durability of treatment effect between SCS and other neuromodulation techniques to treat Parkinson’s disease or provide vagal stimulation have brought the value of SCS into question for other reasons 5. As SCS treatment continues to grow for chronic pain conditions, it is important to evaluate its use, identify trends and examine the implications of growth in cost and utilization and potential changes in access as a result.…”