Table 1.
Study Exit Reasons.
| Exit reason | Adult patients | Pediatric patients | Total** |
|---|---|---|---|
| Adverse event or device event | 2 (0.2%) | 2 (0.7%) | 4 (0.3%) |
| Therapy discontinued | 70 (7.6%) | 54 (19.6%) | 124 (10.3%) |
| Death | 131 (14.1%) | 47 (17.0%) | 178 (14.8%)* |
| Eligibility criteria not met† | 11 (1.2%) | 0 (0.0%) | 11 (0.9%) |
| Patient withdrawal of consent | 19 (2.1%) | 7 (2.5%) | 26 (2.2%) |
| Withdrawal of patient by physician‡ | 16 (1.7%) | 20 (7.2%) | 36 (3.0%) |
| Other | 6 (0.6%) | 1 (0.4%) | 7 (0.6%) |
| Final status unknown: Follow‐up terminated | |||
| Lost to follow‐up | 54 (5.8%) | 11 (4.0%) | 65 (5.4%) |
| Patient care transferred§ | 282 (30.5%) | 65 (23.6%) | 347 (28.9%) |
| Patient no longer available for follow‐up | 43 (4.6%) | 4 (1.4%) | 47 (3.9%) |
| Site closure¶ | 292 (31.5%) | 65 (23.6%) | 357 (29.7%) |
| Total | 926 | 276 | 1202 |
Reason for study exit was reported as death for 178 patients, 169 of which were reported as unrelated to the device. Patient indications for device implants in those who died were multiple sclerosis: 51; cerebral palsy: 41; spinal cord injury: 22; stroke: 10; traumatic brain injury: 6; the remainder (39) were in patients with other/unknown primary intrathecal baclofen indication. Two deaths involved pump pocket infections in immunocompromised patients, which are not classified as device related: one patient treated with ITB for traumatic brain injury‐related spasticity experienced a pump pocket infection within one month of implantation that progressed to sepsis and resulted in death; the second patient, being treated for CP‐related spasticity, experienced pump pocket erosion and an MSSA‐positive infection two years postimplantation that resulted in death. Relationship to device/therapy was “unknown” in an additional seven patients: four multiple sclerosis and three cerebral palsy.
Includes situations such as consented/enrolled before implant but pump implant not completed.
Includes situations such as patient turned 18+ and transferred to adult care clinic.
Transfer of care for enrolled patients is typical for pediatric patients transitioning to adult care and in cases of patient relocation.
Over the 15‐year span for ISPR/PSR a total of 53 sites enrolled patients implanted for the treatment of spasticity with 27 active sites through October 2017. Site closure takes place primarily due to principal investigator retirement or relocation.
Twenty‐five percent of these patients were enrolled with a replacement pump.