Neuromodulation Society of the United Kingdom and IrelandNSUKI is the voice of Neuromodulation in the UK and IrelandEncourage your fellow implanters to join NSUKI to increase the volume of that voice. Membership includes membership of INS and subscription to the journal Neuromodolation: Technology at the Neural Interface. The journal is fully indexed in Medline and Index Medicus. Respondents sought by 30 November 2021 for University of Liverpool survey on neurostimulation: https://delphimanager.liv.ac.uk/ineurostim/Delphi Webinar - Resumption of Services in the UK, What We Learnt From the 1st Wave of COVID Video (recorded 11 Nov. 2020) Trial-STIM RCT Webinar Video (recorded 27 August 2020) Recommendations for the Management of Implanted Neurostimulation & Intrathecal Drug Delivery Devices During the COVID-19 Pandemic* Prof S Eldabe, Dr G Baranidharan, Dr A Gulve, Dr S Thomson, Dr J Hughes, Mr G Vajramani, Mr C Patel, Neuromodulation therapies defined as “the alteration of nerve activity through targeted delivery of a stimulus, such as electrical stimulation or chemical agents, to specific neurological sites in the body” are utilised in the treatment of a diverse range of medical conditions. These therapies require the placement of a long-term implant in most patients with a requirement for long term management1. Guidance on Intrathecal Drug Delivery Devices (ITDD)Background: ITDD is utilised in the management of pain and spasticity, therefore drugs or drug combinations infused by ITDD vary considerably between individual patients. While some may cause sudden severe and life-threatening withdrawal reactions other are known to cause no withdrawal effects4. Abrupt interruption of intrathecal baclofen has in cases, resulted catastrophic multi-organ failure5 while abrupt withdrawal of intrathecal clonidine has resulted in hypertensive crisis and cardiomyopathy6. Guidance on Neurostimulation DevicesRecommendations * For guidance relating to DBS systems please see the BSSFN statement at https://www.bssfn.org/covid-19 Guidance on Resumption of Neuromodulation during the COVID-19 Recovery Phase IntroductionCoronavirus disease 2019 is caused by SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). The virus is transmitted either through airborne droplets (e.g. coughing, sneezing or even respiration) or less commonly through direct contact (e.g. via contact with a surface, including medical equipment such as a pulse oximeter or nasal cannula, containing the virus). The mean incubation period is between 4 and 7 days (range 2 days to > 2 weeks) [19, 20]. The virus is shed from the nasopharynx for a median of 20 (range 8-37) days after illness onset [21]. Although individuals are most infectious when they are at the peak of their symptoms, the virus can still be transmitted person-to-person in individuals who are asymptomatic or have subclinical symptoms, which is most likely to occur in individuals living together or in close physical contact; this scenario accounts for a majority of cases. Based on the latest data, there appears to be little risk that brief contact with an asymptomatic carrier of the virus, such as that which occurs during a pain medicine encounter, confers any appreciable risk of becoming infected. Early efforts were geared towards social distancing and decreasing the transmission of the virus. The NHS is now entering a COVID-19 recovery phase, with some non COVID services resuming. Planning for the recovery phase will depend on the ongoing impact of COVID-19 locally and the resources that are available. The demands on local capacity for neuromodulation work and restoration of pain services in this transitional phase will vary greatly across the United Kingdom. The situation will remain highly fluid as the emergence of new cases of COVID-19 is monitored. The coronavirus pandemic has changed the way we have worked and will continue to change the way we offer services to improve patient care. In addition, there are new logistical challenges and evolving processes to ensure safe service delivery from patients and staff perspectives. Factors to consider when resuming neuromodulation services1. Local COVID-19 situation a. It is likely that geographical differences in infection rates will occur. The decision to resume implant surgery should take into consideration the demand on healthcare resources including personal protection equipment, and risk to staff and patients in your region. 2. Prioritising Procedures Category 2 & 3 patients: Replacement of intrathecal pumps, replacement of pulse generators, revision procedures, treatment of cancer pain and intractable neuropathic pain should be prioritised. Local pain services may wish to prioritise the resumption of lower risk patients first. Interventions that do not fall within the categorisation should be assessed on an individual basis and a collaborative approach should be taken with other clinicians to guide prioritisation. It is important that the reasons for decision making in difficult cases are carefully documented, with at least two clinicians involved in the decision making process. 3. Reducing the risk to patients All appropriate and available non-invasive treatments should be explored and discussed with the patients, before neuromodulation is considered. A robust MDT assessment as per NICE guidance TA159 on Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin should be undertaken prior to implant surgery. Where possible telemedicine should be used to reduce face to face consultation. In order to minimise visits to hospital for patients, consider proceeding directly to a definitive procedure such as full implant with on table trial rather than first performing trial procedure. The risks and benefits of this should be discussed. Services should follow local policy on the routine testing of patients for coronavirus prior to elective procedures and develop guidance on post-procedural isolation. Patients must understand their risks are greater if they are in an ‘at risk’ group [3], and very high risk patients should only undergo procedures with appropriate MDT support with a minimum of two clinician involvement. The turnaround time between the patients is going to be longer to allow social distancing for patients and staff, and the cleaning procedures after each case. Appropriate time should be allocated for this to avoid cancellations on the day of surgery and wasted visit to hospital for the patient. As far as possible, post-operative wound monitoring, activation of the therapy and any other troubleshooting should be performed via telemedicine. 4. Reducing risk to staff Patients having active symptoms of COVID-19 infection should have their procedure deferred unless there is an overriding clinical priority. Appropriate PPE must be available and social distancing protocols to be maintained except during actively imparting essential clinical care or monitoring. Where possible deep sedation or general anaesthesia requiring the potential need for airway support and subsequent aerosol generation should be avoided [11]. The turnaround time between the patients is going to be longer to allow social distancing for patients and staff, and the cleaning procedures after each case. Appropriate time should be allocated for this to avoid cancellations on the day of surgery. Minimum number of staff essential for surgery should be allowed in the operating theatres. 5. Reducing risk to industry partners Appropriate PPE as per local guidelines must be available and social distancing protocols to be maintained except during actively imparting essential clinical care or monitoring. To minimise your stay in operating theatres, you should only enter theatre for critical steps required during the procedure and leave the theatre as soon this is finished. Where possible remote programming and training of the patients to use devices should be undertaken. Post-implant programming visits should be kept to minimum. Where possible attendance of personnel from multiple companies during a single operating day should be avoided. 6. Consent It is recognised that face to face appointments to discuss the risks and benefits of treatment may not be in the best interests of patients and staff. However, it is important that the same principles of consent are followed, whether patient are spoken to on the telephone or by video call or in person. Face to face appointment for signing consent form can take place when patients attend the hospital for COVID testing. It is vital that patients understand the additional risks of attending hospital, and having surgery during the COVID-19 pandemic. Written patient information on the additional risks of surgery during the COVID-19 pandemic should be available to patients to aid the consent process. You may wish to use information and consent for patients undergoing implant surgery during the coronavirus pandemic developed by NSUKI. The guidance in the General Medical Council (GMC) publication ‘Consent: patients and doctors making decisions together’ must be followed [12]. It is vital that the person discussing the risks of a procedure with the patient is not only familiar with the risks/benefit of the procedure but also remains current on the risks and mortality from COVID-19. Example Template (Adapted from BASS Consent SARS-CoV-2) Information for Patients Undergoing Implant Surgery During the Coronavirus Pandemic Your Surgeon / Pain Physician has recommended spinal cord stimulator / deep brain stimulator / Intrathecal Pump Implant for the treatment of your pain. They should have discussed with you all the options including non-operative treatments and the risks / benefits of delaying implant surgery. In addition to the usual risks and benefits of the surgery, it is important that you are made aware of specific risks during the coronavirus (COVID-19) pandemic and certain precautions you need to take before and after your surgery as recommended by your medical team. You will come in contact with members of staff who could unknowingly be carrying coronavirus. Equally you could be infected but not yet showing symptoms. Most hospitals will ask you to self-isolate and undergo COVID test you prior to planned surgery and postpone surgery if you test positive. There may be circumstances where the clinical urgency of your condition means that surgery will be offered despite your infection status not being known. There are reports stating that if you have an operation with coronavirus in your system (even without symptoms) there is a significant risk that you could end up being ill with coronavirus and may need intensive care treatment. There is even a significant risk of death if this happens. Even if you do not have the coronavirus in your system you still have above risk but it is thought to be less. However, because you are in a hospital environment, your risk of catching coronavirus may increase. We are learning about the coronavirus all the time. There may be some risks that we are not aware of yet that may also affect your outcome from surgery. In light of the information above, if you decide to delay treatment your consultant will discuss alternative options at this time. If you decide to go ahead, we require you to sign this form indicating that you have read it, understood it and have no further questions. I confirm I have read the information above, I understood it and I have no further questions.
COVID-19 Risk Stratification
i. Have had an organ transplant. ii. Are having chemotherapy or antibody treatment for cancer, including immunotherapy. iii. Are having an intense course of radiotherapy (radical radiotherapy) for lung cancer. iv. Are having targeted cancer treatments that can affect the immune system (such as protein kinase inhibitors or PARP inhibitors). v. Have blood or bone marrow cancer (such as leukaemia, lymphoma or myeloma). vi. Have had a bone marrow or stem cell transplant in the past 6 months, or are still taking immunosuppressant medicine. vii. Have been told by a doctor that you have a severe lung condition (such as cystic fibrosis, severe asthma or severe COPD). viii. Have a condition that means you have a very high risk of getting infections (such as SCID or sickle cell). ix. Are taking medicine that makes you much more likely to get infections (such as high doses of steroids). x. Have a serious heart condition and you're pregnant. xi. If you're at very high risk from coronavirus, you should have received a letter from the NHS.
i. Are 70 or older. ii. Are pregnant. iii. Have a learning disability, a lung condition that's not severe (such as asthma, COPD, emphysema or bronchitis), heart disease (such as heart failure), high blood pressure (hypertension), diabetes, chronic kidney disease and/or liver disease (such as hepatitis). iv. Have a condition affecting your brain or nerves (such as Parkinson's disease, motor neurone disease, multiple sclerosis, or cerebral palsy). v. Have a problem with your spleen or have had your spleen removed. vi. Have a condition that means you have a high risk of getting infections (such as HIV, lupus or scleroderma). vii. Are taking medicine that can affect your immune system (such as low doses of steroids), viii. Are very obese (a BMI of 40 or above).
NSUKI was pleased to offer bursaries to facilitate attendance at the International Neuromodulation Society's 14th World Congress in Sydney, Australia on 25 - 30 May 2019. Each bursary was up to a maximum amount of £3000. Chapter MembershipNational Neuromodulation registry documents: 2nd Joint Congress of the European INS ChaptersThe Neuromodulation Society of the UK and Ireland 2017 Research Grant Competition ResultsThe Neuromodulation Society of the UK and Ireland invited proposals for the 2017 research grant competition. Two grants of up to £2,500 were awarded for a research proposal, which may be in any field of neuromodulation research. Applications were peer reviewed and a decision made by the Neuromodulation Society of the UK and Ireland Research Committee. The winning projects were:
The funds may be used for a variety of purposes in support of a research project (e.g. small project grant, salary support, equipment purchase, running costs or additional funding to an existing grant). Applications were open to all neuromodulation researchers in the UK and Ireland (nonmember applicants will receive membership for the duration of the grant). It is expected that the result of the research will be presented at the Annual Scientific Meeting (within two years of receipt of the award). |