Intrathecal Drug Delivery Systems (IDDS): The Implantable Systems Performance Registry (ISPR)

Peter E Konrad, John M Huffman, Lisa M Stearns, Robert J Plunkett, Eric J Grigsby, E K Stromberg, Mollie P Roediger, Michelle D Wells, Todd W Weaver, Peter E Konrad, John M Huffman, Lisa M Stearns, Robert J Plunkett, Eric J Grigsby, E K Stromberg, Mollie P Roediger, Michelle D Wells, Todd W Weaver

Abstract

Objectives: The ISPR was initially created to monitor the product performance of Medtronic implanted intrathecal drug infusion and spinal cord systems available in the United States.

Materials and methods: Data were collected from 50 representative sites implanting and following patients with intrathecal drug delivery systems across the United States between August 7, 2003 and January 31, 2014. Device performance over time was estimated using life table survival methods.

Results: Of the 6093 patients enrolled in the ISPR, 3405 (55.9%) were female and 2675 (43.9%) were male, and 13 (0.2%) did not provide gender data. The average age at enrollment was 52.9 years (SD =17.6 years) and average follow-up time was 29.6 months. Currently, the estimates of device survival from pump-related events exceed 90% for all pump models across the applicable follow-up time points. The majority of product performance events were catheter-related. At 5 years of follow-up, all applicable catheter models, with the exception of revised not as designed or grafted not as designed catheters, had greater than 81% survival from catheter-related events.

Conclusions: The ISPR is designed to serve as an ongoing source of system and device-related information with a focus on "real-world" safety and product performance. ISPR data continue to be used to guide future product development efforts aimed at improving product reliability and quality.

Keywords: intrathecal drug delivery; neuromodulation; pain; registry; spasticity.

© 2016 The Authors. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals, Inc. on behalf of International Neuromodulation Society.

Figures

Figure 1
Figure 1
Events by category.
Figure 2
Figure 2
Pump survival from pump events.
Figure 3
Figure 3
Catheter survival from catheter events.

References

    1. Food and Drug Administration . Development and use of risk minimization action plans. 2005. . Accessed September 12, 2014.
    1. Food and Drug Administration . Establishing pregnancy exposure registries. . Accessed September 9, 2014.
    1. Gliklich RE, Dreyer NA. Registries for evaluating patient outcomes: a user's guide Rockville, MD: Agency for Healthcare Research and Quality, 2007.
    1. Gliklich RE, Dreyer NA. Registries for evaluating patient outcomes: a user's guide, 2nd ed Rockville, MD: Agency for Healthcare Research and Quality, 2010.
    1. Gliklich RE, Dreyer NA. Registries for evaluating patient outcomes: a user's guide, 3rd ed Rockville, MD: Agency for Healthcare Research and Quality, 2014.
    1. Food and Drug Administration , Center for Device and Radiologic Health (CDRH). Strengthening our national system for medical device postmarket surveillance September, 2012. . Accessed September 12, 2014.
    1. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) . Use of patient registries: results of the ISPOR patient registry special interest. . Accessed September 8, 2014.
    1. Howlader N, Noone AM, Krapcho M et al. SEER cancer statistics review, 1975‐2011. Bethesda, MD: National Cancer Institute; . Updated November 2013. Published April 2014.
    1. Miller R. TAVR registry data triggers expansion of FDA‐approved indication. The Gray Sheet. . Accessed September 1, 2014
    1. Fröbert O, Lagerqvist B, Olivecrona G et al. Thrombus aspiration during ST‐segment elevation myocardial infarction. N Engl J Med 2013;369:1587–1597.
    1. Lauer MS, D'Agostino RB. The randomized registry trial – the next disruptive technology in clinical research? N Engl J Med 2013;369:1579–1581.
    1. Hamza M, Doleys D, Wells M et al. Prospective study of 3‐year follow‐up of low dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med 2012;13:1304–1313.
    1. Deer T, Chapple I, Classen A et al. Intrathecal drug delivery for treatment of chronic low back pain: report from the National Outcomes Registry for Low Back Pain. Pain Med 2004;5:6–13.
    1. Smith TJ, Staats PS, Deer T et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug‐related toxicity, and survival. J Clin Oncol 2002;20:4040–4049.
    1. Roberts LJ, Finch PM, Goucke CR, Price LM. Outcome of intrathecal opioids in chronic non‐cancer pain. Eur J Pain 2001;5:353–361.
    1. Saulino M, Guillemette S, Leier J, Hinnenthal J. Medical cost impact of intrathecal baclofen therapy for severe spasticity. Neuromodulation 2015;18:141–149. doi:
    1. Guillemette S, Witzke S, Leier J, Hinnenthal J, Prager JP. Medical cost impact of intrathecal drug delivery for noncancer pain. Pain Med 2013;14:504–515.
    1. Hatheway JA, Caraway D, David G et al. Systemic opioid elimination after implantation of an intrathecal drug delivery system significantly reduced health‐care expenditures. Neuromodulation 2015;18:207–213. doi:
    1. Deer T, Skaribas I, Nelson C et al. Interim results from the partnership for advancement in neuromodulation pain registry. Neuromodulation 2014;17:656–664. doi:
    1. Prager J, Deer T, Levy R et al. Best practices for intrathecal drug delivery for pain. Neuromodulation 2014;17:354–372. doi:
    1. Sasaki J, Weaver TW, Sun M, Shen L. The safety of cervical spinal cord stimulation: lead‐related product performance events reported in a prospective registry. Poster presented at the 16th Annual Meeting of the North American Neuromodulation Society Meeting; December 2012; Las Vegas, NV.
    1. Winer J, Hargens L, Weaver T, Stoker V. ISPR: a registry‐based approach to measuring complications for ITB therapy. Poster presented at the 55th Annual Meeting of the Congress of Neurological Surgeons; October 2005; Boston, MA.
    1. Stearns LJ, Hargens L, Stoker V, Weaver TW. ISPR: a web‐based implantable systems performance registry. Poster presented at the 21st Annual Meeting of the American Academy of Pain Medicine; February 2005; Palm Springs, CA.
    1. Broste SK, Kim JS. Extension of life‐table methodology to allow for left‐censoring in survival studies of pacing devices followed by commercial monitoring services. Pacing Clin Electrophysiol 1987;10:853–861.
    1. Medtronic Neuromodulation Product Performance Report. . Accessed August 28, 2015.
    1. Medtronic Medical Device Safety Notification . Use of unapproved drugs with the 554 SynchroMed implantable infusion pump November 2012. . Accessed September 10, 2016.
    1. Follett K, Burchiel K, Deer T et al. Prevention of intrathecal drug delivery catheter‐related complications. Neuromodulation 2003;6:32–41. doi: .
    1. Rothman K. Modern epidemiology. Boston, MA: Little, Brown, and Company, 1986.
    1. Gallagher RM. Editorial. Intrathecal drug delivery for chronic back pain: better science for clinical innovation. Pain Med 2004;5:1–3.
    1. Krumholz HM, Ross JS, Gross CP et al. A historic moment for open science: the Yale University Open Data Access project and medtronic. Ann Intern Med 2013;158:910–911.
    1. Rumsfeld JS, Peterson ED. Achieving meaningful device surveillance: from reaction to proaction. JAMA 2010;304:2065–2066.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren