The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations on Bleeding and Coagulation Management in Neurostimulation Devices.

INTRODUCTION: The Neurostimulation Appropriateness Consensus Committee (NACC) was formed by the International Neuromodulation Society (INS) in 2012 to evaluate the evidence to reduce the risk of complications and improve the efficacy of neurostimulation. The first series of papers, published in 2014, focused on the general principles of appropriate practice in the surgical implantation of neurostimulation devices. The NACC was reconvened in 2014 to address specific patient care issues, including bleeding and coagulation. METHODS: The INS strives to improve patient care in an evidence-based fashion. The NACC members were appointed or recruited by the INS leadership for diverse expertise, including international clinical expertise in many areas of neurostimulation, evidence evaluation, and publication. The group developed best practices based on peer-reviewed evidence and, in the absence of specific evidence, on expert opinion. Recommendations were based on international evidence in accordance with guideline creation. CONCLUSIONS: The NACC has recommended specific measures to reduce the risk of bleeding and neurological injury secondary to impairment of coagulation in the setting of implantable neurostimulation devices in the spine, brain, and periphery.

The Neurostimulation Appropriateness Consensus Committee (NACC) Recommendations for Infection Prevention and Management.

INTRODUCTION: The use of neurostimulation for pain has been an established therapy for many decades and is a major tool in the arsenal to treat neuropathic pain syndromes. Level I evidence has recently been presented to substantiate the therapy, but this is balanced against the risk of complications of an interventional technique. METHODS: The Neurostimulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society convened an international panel of well published and diverse physicians to examine the best practices for infection mitigation and management in patients undergoing neurostimulation. The NACC recommendations are based on evidence scoring and peer-reviewed literature. Where evidence is lacking the panel added expert opinion to establish recommendations. RESULTS: The NACC has made recommendations to improve care by reducing infection and managing this complication when it occurs. These evidence-based recommendations should be considered best practices in the clinical implantation of neurostimulation devices. CONCLUSION: Adhering to established standards can improve patient care and reduce the morbidity and mortality of infectious complications in patients receiving neurostimulation.

The Neurostimulation Appropriateness Consensus Committee (NACC) Safety Guidelines for the Reduction of Severe Neurological Injury.

INTRODUCTION: Neurostimulation involves the implantation of devices to stimulate the brain, spinal cord, or peripheral or cranial nerves for the purpose of modulating the neural activity of the targeted structures to achieve specific therapeutic effects. Surgical placement of neurostimulation devices is associated with risks of neurologic injury, as well as possible sequelae from the local or systemic effects of the intervention. The goal of the Neurostimulation Appropriateness Consensus Committee (NACC) is to improve the safety of neurostimulation. METHODS: The International Neuromodulation Society (INS) is dedicated to improving neurostimulation efficacy and patient safety. Over the past two decades the INS has established a process to use best evidence to improve care. This article updates work published by the NACC in 2014. NACC authors were chosen based on nomination to the INS executive board and were selected based on publications, academic acumen, international impact, and diversity. In areas in which evidence was lacking, the NACC used expert opinion to reach consensus. RESULTS: The INS has developed recommendations that when properly utilized should improve patient safety and reduce the risk of injury and associated complications with implantable devices. CONCLUSIONS: On behalf of INS, the NACC has published recommendations intended to reduce the risk of neurological injuries and complications while implanting stimulators.

Spinal cord stimulation utilization to treat the microcirculatory vascular insufficiency and ulcers associated with scleroderma: a case report and review of the literature.

OBJECTIVE: To report a case of scleroderma with associated Raynaud's phenomenon and its successful treatment with spinal cord stimulation. To demonstrate the use of transcutaneous oxygen pressure monitoring to guide the progression from trial to implantation and to assess post-implantation microcirculatory recovery. DESIGN: Case report and literature review. PATIENT: A 51-year-old female with scleroderma, associated Raynaud's phenomenon, and a non-healing 3.7-cm lower extremity ischemic ulcer. Ankle-brachial indexes demonstrated normal macrocirculation, but transcutaneous oxygen pressures demonstrated significant microcirculatory insufficiency. INTERVENTION: Treatment was a spinal cord stimulator implantation after a successful trial. Transcutaneous oxygen pressures were interpreted during the trial and post-implantation stages. Results. Based on a 5-day trial that documented improvements in transcutaneous oxygen pressures and pain relief, the patient underwent implantation. At 4 months, the ischemic ulcer had healed. The patient had significant improvement in pain control and reduced Raynaud's phenomenon signs and symptoms. At 18 months, the patient continued to have improvement with no associated complications. A literature review demonstrated only four published reports, including a total of 18 patients, on spinal cord stimulator treatment for scleroderma and associated Raynaud's phenomenon. CONCLUSIONS: We report the healing of a greater than 3-cm ischemic ulcer in an individual with normal macrocirculation but severe microcirculatory insufficiency from scleroderma. Improvements in microcirculation correlated with wound healing. Spinal cord stimulation may be considered for select individuals with microcirculatory reserves that can be modulated with treatment.

The utilization of transcutaneous oxygen pressures to guide decision-making for spinal cord stimulation implantation for inoperable peripheral vascular disease: a report of two cases.

Spinal cord stimulation (SCS) may be helpful in treating pain and vascular insufficiency associated with inoperable peripheral vascular disease (PVD). Often decision-making regarding progression from trial to implantation is based on subjective measures. Transcutaneous oxygen pressure, a measure of microcirculation and tissue perfusion, provides information on changes that may occur in PVD patients that undergo SCS trials and may provide predictive information for patient outcomes. This article reports on 2 patients with severe PVD in which transcutaneous oxygen pressures were measured during the trial phase, guided progression to implantation, and were followed in the postoperative period. Transcutaneous oxygen pressure values continued to improve following permanent implantation. We provide a review on transcutaneous oxygen pressure monitoring, along with emphasis on the technical aspects of transcutaneous oxygen pressure monitoring and its incorporation into practice. The decision to implant a SCS should be based on not only subjective measures of improvement, but also objective measures of improvement in transcutaneous oxygen pressure. Additional research is warranted to develop transcutaneous oxygen pressure predictive indices to assist in the selection of patients for progression to permanent implantation.