Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.

Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov).

Long-Term Efficacy of a Novel Spinal Cord Stimulation Clinical Workflow Using Kilohertz Stimulation: Twelve-Month Results From the Vectors Study.

BACKGROUND AND OBJECTIVES: Multiple variables play a role in spinal cord stimulation (SCS) treatment outcomes, including patient anatomy, pain pattern, lead location, stimulation parameters, and so on. A wide range of stimulation parameters are considered safe and on-label, and as a result a growing number of new frequencies and frequency-combinations are being incorporated into standard practice. A standardized approach to therapy delivery may provide more consistent outcomes for more patients. The Vectors study evaluated whether there is significant sustained improvement in pain and functional outcomes when therapy is delivered using a standardized approach. MATERIALS AND METHODS: Vectors, a post-market, single-arm study evaluated the safety and efficacy of SCS with an implantable neurostimulator starting with 1 kHz stimulation, targeting the T9-T10 disc space following paresthesia mapping. Subjects with chronic intractable low back and leg pain (visual analogue scale [VAS] ≥ 50 mm) were enrolled. The primary endpoint was change in overall pain (VAS) at the three-month visit compared to baseline. Subjects were followed through 12 months. Secondary endpoints included changes in low back and leg pain, quality of life (European Quality of Life - Five Dimensions, EQ-5D-5L), disability (Oswestry Disability Index, ODI), individual subject goals, and subject satisfaction. RESULTS: There was a significant reduction in overall pain (VAS; 45.4 mm) through the three-month visit, which was sustained through 12 months. At 12 months, 79% of subjects had ≥50% improvement in at least one pain domain (overall, lowback or leg) with 85% of subjects reporting therapy satisfaction. There was a decrease in disability and an improvement in quality of life with 70% of subjects achieving a personal activity goal by the three-month visit. CONCLUSIONS: Long-term pain relief and improvement in quality of life and function were achieved when following a standardized workflow. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT03345472.

Use of broad-spectrum antibiotics and the development of irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS) is a functional bowel disorder with an estimated prevalence of 9% to 22% in the United States. It is responsible for 28% of gastroenterology visits, with associated health care costs of $8 billion annually. Yet, IBS etiology is the subject of much debate. OBJECTIVES: Our study examines a possible relationship between IBS and exposure to broad-spectrum antibiotics. It is known that antibiotics alter the colonic flora; we hypothesize that this can create the manifestations seen in IBS patients. METHODS: Following approval by the Gundersen Clinic, Ltd Human Subjects Committee/IRB, the medical records of adults who were started on a broad-spectrum antibiotic at Gundersen Lutheran Health System between January 1, 2008, and December 31, 2008, were reviewed retrospectively. From this population, we identified those who developed IBS within 12 months and compared their demographic and clinical characteristics with the characteristics of those who did not. RESULTS: Of the 26,107 adult patients exposed to broad-spectrum antibiotics during the study period, 115 received an IBS diagnosis within 12 months. Most were women (84%; n = 97), and they had a higher prevalence of associated comorbidities than those who did not develop IBS. Patients indicated for macrolide or tetracycline use had a higher proportion of IBS development within 12 months; indication for tetracycline use maintained significance even after controlling for sex and comorbid conditions (odds ratio; 1.48; P = .046). CONCLUSION: Use of broad-spectrum antibiotics--particularly macrolides or tetracyclines--may be associated with IBS development. To date, we know of no other study that has associated these antibiotics with IBS development. Further studies are necessary.