Neuromodulation Society of the United Kingdom and Ireland

NSUKI is the voice of Neuromodulation in the UK and Ireland

Encourage 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.

Webinar -Sham Controlled Studies in SCS Video (recorded 23 Nov. 2020)

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)

Guidance for Competencies for Spinal Cord Stimulation

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,
Dr S Love-Jones, Prof J Fitzgerald

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.  

COVID-19 is an infectious disease caused by a newly discovered coronavirus. Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment.  Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness2.

NHS hospitals have been told to suspend all non-urgent elective surgery for at least three months from 15 April to help the service deal with the COVID-19 pandemic3. This will impact the population served by Neuromodulators in the UK. This practice recommendation is aimed at managing the neuromodulation devices during the pandemic.

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.

Clinicians should judge each case on its own merit, the below are general recommendations and should not be seen as guidelines:

1.    Avoid insertion of any new ITDD except for highly selected cancer pain cases where the benefit is considered to outweigh the risk of acquiring a COVID-19 pneumonia.
2.    ITDD replacements are urgent procedures that need to be carried out in a timely manner to prevent drug withdrawal.
3.    ITDD replacements require in person meeting with patients although the consenting discussion can be done remotely and documented in the patient’s notes in line with the GMC guidance7.
4.    Physicians may elect to replace ITDD early in the pandemic or delay the replacement until the end of summer if the device end of life allows it.
5.    The timing of ITDD device replacement should be discussed and agreed with patients in light of the changing situation. The option and consequences of non-replacement of the ITDD and therapy discontinuation should be discussed.
6.    In few highly selected cases the physician may consider oral substitution to be an appropriate replacement for the ITDD infusion for the duration of the pandemic. This should be considered in discussion with the patient and only in cases where abrupt drug withdrawal is not known to cause life threatening reactions.
7.    For other ITDD troubleshooting use telemedicine where possible to resolve issues except in cases were the presenting symptoms suggest malfunction of a component of the ITDD system with threatening or actual symptoms of drug withdrawal, where face to face contact is necessary.
8.    The ITDD caring team should make every effort to track their patients through the pandemic. In the event of a patient being admitted to intensive care contact should be made with the responsible consultant and discussion around the need for and timing of ITDD refill initiated.
9.    ITDD refills necessitate an in-person meeting with the patient to enable device programming. These can be carried out in hospital or in cases at the patient’s residence.  
10.    ITDD refills are intimate procedures that require the operator to come within a distance of less than 1 meter from the patient in order to refill and program the device. PHE guidance on personal protective equipment use should be followed8.
11.    Where feasible the patient should be laid flat for an ITDD refill, in order to maximise the distance between them and the operator. A preliminary temperature check as well as a check on symptoms of COVID-19 is advisable before embarking on the procedure.
12.    ITDD refills need to be carried out in a timely manner to prevent abrupt drug withdrawal, a number of strategies can be utilised to mitigate the risk of exposure to COVID infection associated with repeated hospital attendances, these include:
a.    Where feasible and in discussion with patients, clinicians may elect to use a higher drug concentration for the duration of the pandemic. This should reduce the frequency of ITDD refills. There is no evidence of worsening of symptoms of pain or spasticity from use of higher concentration9,10. The risk of development of an intrathecal granuloma needs to be balanced against the risk of COVID infection particularly in the elderly and vulnerable populations.
b.    Ziconotide therapy cessation is not associated with withdrawal symptoms11. In cases of ziconotide only infusions, clinicians may consider not refilling the ITDD for the duration of the pandemic, patients should be warned that the ITDD device will alarm regularly for the foreseeable future.
c.    Opioid only ITDD infusions may, after discussion with patients and their GP, be substituted with oral equivalent. This should only be considered in vulnerable individuals since opioid equivalence is not an exact science and withdrawal symptoms are more likely to occur than not.
d.    Where abrupt intrathecal opioid discontinuation has been agreed there will be a need for careful remote daily follow up of the patient to allow for timely management of withdrawal symptoms and adjustment of oral opioid dosage. Patients should be advised that their ITDD will alarm intermittently.
e.    Routine oral substitution of baclofen or clonidine is not advised due to potential for life threatening withdrawal effects.
f.    Where hospital ITDD refills are considered to be too risky and therapy discontinuation not an option, home refills should be considered in order to reduce the exposure of vulnerable or immunosuppressed individuals to the hospital environment.
g.    In suspected or symptomatic patients, consider the possibility of delaying the refill if low reservoir alarm date allows until the patient has served a self-isolation period recommended.
h.    Where an ITDD refill delay is not possible in a symptomatic or confirmed COVID-19 positive patients, proceed to refill the ITDD in a nominated part of the hospital for COVID-19 positive procedures and using necessary PPE as per PHE guidance12.

Guidance on Neurostimulation Devices

Recommendations

1.    Avoid insertion of any new neurostimulation devices during the mitigation and delay phase of the pandemic both in NHS and Private hospital settings.
2.    All in person contact is minimised. For most neurostimulation devices troubleshooting use telemedicine where possible to resolve issues. For example, postoperative wound reviews, stimulation and re-charging technique, drug queries can be resolved by videoconference, or email or text messages.
3.    Implant infections can cause sepsis and neuraxial infections. These are medical emergencies and should be treated promptly at appropriate centre as per the centre’s standard operating procedure.
4.    Loss of neurostimulator function (e.g. pain relief) due to lead migration, lead fracture, and implantable pulse generator battery depletion is not a reason to surgically revise the neurostimulator until planned elective surgery is re-introduced.
5.    Personalised alternative methods of symptom control should be discussed with each patient until till such time that elective surgery is considered safe. Psychological support should be offered where needed.

References:

1.    https://www.neuromodulation.com/learn-more
2.    https://www.who.int/health-topics/coronavirus/coronavirus#tab=tab_1
3.    Iacobucci Gareth. Covid-19: all non-urgent elective surgery is suspended for at least three months in England BMJ 2020; 368:m1106
4.    Deer TR, Pope JE, Hayek SM, et al. The Polyanalgesic Consensus Conference (PACC): Recommendations for Intrathecal Drug Delivery: Guidance for Improving Safety and Mitigating Risks. Neuromodulation. Feb 2017;20(2):155-176.
5.    Coffey RJ, Edgar TS, Francisco GE, Graziani V, Meythaler JM, Ridgely PM, et al. Abrupt withdrawal from intrathecal baclofen: recognition and management of a potentially life-threatening syndrome. Arch Phys Med Rehabil. 2002;83(6):735-41.
6.    Lee HM, Ruggoo V, Graudins A. Intrathecal Clonidine Pump Failure Causing Acute Withdrawal Syndrome With 'Stress-Induced' Cardiomyopathy. Journal of medical toxicology : official journal of the American College of Medical Toxicology. 2016;12(1):134-8.
7.    https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/consent
8.    https://www.gov.uk/government/publications/covid-19-personal-protective-equipment-use-for-non-aerosol-generating-procedures
9.    Perruchoud C, Eldabe S, Durrer A, et al. Effects of Flow Rate Modifications on Reported Analgesia and Quality of Life in Chronic Pain Patients Treated with Continuous Intrathecal Drug Therapy. Pain Med. Apr 4 2011;12(4):571-576
10.    van der Plas AA, Marinus J, Eldabe S, Buchser E, van Hilten JJ. The lack of efficacy of different infusion rates of intrathecal baclofen in complex regional pain syndrome: a randomized, double-blind, crossover study. Pain Med. Mar 2011;12(3):459-465.
11.    Wermeling D, Drass M, Ellis D, et al. Pharmacokinetics and pharmacodynamics of intrathecal ziconotide in chronic pain patients. Journal of Clinical Pharmacology. JUN 2003;43(6):624-636.
12.    https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/877658/Quick_guide_to_donning_doffing_standard_PPE_health_and_social_care_poster__.pdf

* 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 

Introduction

Coronavirus 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.

NHS hospitals were told to suspend all non-urgent elective surgery for at least three months from 15 April to help the service deal with the COVID-19 pandemic. This has significantly affected patient population suffering from severe neuropathic pain served by Neuromodulators in the UK. NSUKI produced practice recommendation on managing the neuromodulation devices during the pandemic.

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 services

1. 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.

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

1. Very High Risk. Defined as:

                                               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.

1. High Risk. Defined as:

                                               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).

1. Low Risk: All other patients