Abstract Body: Background
Functional impairments following stroke remain a significant therapeutic challenge. Vivistim, FDA-approved since 2021, has shown consistent results, providing 2-3 more improvement in arm and hand function compared to intensive rehabilitation alone. At Atlantic Health System, 25 patients underwent Vivistim implantation and received Paired VNS rehabilitation.
Methods
A multidisciplinary team at AHS identified, educated, and implanted Vivistim in 25 post-acute stroke patients with moderate-to-severe motor impairments in the arm and hand. Post-implantation, patients were referred to one of 11 sites. Regular follow-ups were conducted by the implanting team to monitor side effects, safety and efficacy of this novel intervention.
Results
All 25 patients successfully underwent outpatient implantation, with no reported infections at the implant sites. One patient developed a hematoma that resolved without intervention. Another required device explantation approximately 410 days post-therapy due to tingling sensations near the implant site likely unrelated to the device. This patient maintained a 25-point improvement on the Fugl-Meyer Assessment-Upper Extremity (FMA-UE) despite explantation, indicating sustained benefits. Of the 25, 22 completed the therapy protocol. The remaining three discontinued therapy due to unrelated complications: one experienced two grand mal seizures linked to changes in seizure medication, another sustained an arm injury from a fall, and the third developed double vision, impairing her ability to drive. Patient ages ranged from 40 to 80 years (mean 62.6), with time to implantation post-stroke ranging from 1 to 11 years (mean 3.6). The interval from implantation to therapy initiation varied from 8 to 32 days (mean 15.3). The baseline FMA-UE score averaged 33 (range 19-56), with an average post-therapy score of 43 (range 24-63), for a mean improvement of 9.53 points. Notably, the patient with the longest follow-up (22 months) showed continued progress, reducing her 9-Hole Peg Test time by 61.42 seconds over her assessment 6 months prior.
Conclusion
This case series represents the largest cohort reported to date from a single implanting site in a real-world setting. Vivistim was implanted safely, with no infections or surgical complications. Patients showed positive responses to Paired VNS despite an average of 3.6 years post-stroke, supporting the efficacy of this innovative treatment in the chronic stroke population.