Long-Term Results of a Novel, Externally-Powered, Spinal Cord Stimulator for Chronic Pain (AUS nPower study)

Introduction: A novel spinal cord stimulation (SCS) system with a battery-free micro-implantable pulse generator (mIPG;Nalu Medical, Inc. CA, USA) is available for the treatment of intractable chronic pain. The system utilizes an external power source that bi-directionally communicates with the mIPG (∼1.5 cc volume). Methods: A prospective, multi-center clinical study was initiated to confirm the safety and performance of this novel system, in the treatment of trunk and limb intractable chronic pain. Specifically, subjects with leg(s) and/or back pain, meeting eligibility criteria were recruited and consented into the study. Subjects underwent a SCS trial utilizing a menu of therapy options, including tonic and the novel pulsed stimulation pattern (PSP) therapy. Eligible subjects received the permanent implant and were followed-up for up to 12-months from activation. Due to global COVID-19 restrictions, subjects were moved into a long-term follow-up (LTFU) phase, with study visits planned every 6-months, for an additional 2-years from their last visit. This reports on the long-term clinical and functional (depression, activities of daily living, overall change in quality of life) outcomes. The study was approved by an independent Ethics Committee and conducted in compliance with local regulations. Results: Twenty-five (25) intractable chronic back and/or leg pain subjects, using the PSP therapy, passed a screening and trial phase with ≥50% pain reduction in leg(s) and/or back and moved into the long-term implant phase of the study. Of these 25 subjects, 13 subjects have currently completed an average of 22-months follow-up;the average pain reduction was 73% (n=12) in the leg and 64% (n=11) in the back, from baseline to this time point. The responder rate (≥50% pain relief) was 92% in the leg (11/12) and 64% (7/11) in the back. In addition, all subjects wore the external power source via an adhesive clip and rated both its average comfort and ease of use as <1 on an 11-point scale (0=Very Comfortable, 10=Very Uncomfortable;0=Very Easy, 10=Very Difficult). The average percent improvement on the Beck’s Depression Inventory (BDI) was 40% (n=13) from screening to 22-months;the average improvement in Oswestry Disability Index (ODI) was 34% (n=13) at this time point. Sixty-nine percent (69%;9/13) of subjects indicated “very much improved” on the Patient Global Impression of Change. Conclusion: These results continue to demonstrate the favorable performance of this novel, battery-free, externally-powered micro-implantable SCS through 22-months post implantation. Further investigation is warranted to confirm these preliminary findings. Disclosure: Paul Verrills, FAFMM GDMM (Hons) MM (Pain Medicine) FIPP AMA: Abbott: Consulting Fee: Self, Abbott: Speakers Bureau: Self, Nalu: Ownership Interest - Future Stock Options: Self, Nalu: Contracted Research: Self, Nevro: Contracted Research: Self, Saluda: Contracted Research: Self, Nalu: Speakers Bureau: Self, Biotronik: Consulting Fee: Self, Presidio: Contracted Research: Self, John Salmon, MBBS: None, Dan Bates, MBBS: None, James Yu, MD: None, Bruce Mitchell, MD: None, Neels Du Toit, MBChB: None, Matthew Green, MD: None, Murray Taverner, MBBS: None, Vahid Mohabbati, MD: None, Peter Staats, MBA,MD: Saluda Medical: Consulting Fee: Self, Grunenthal: Royalty:, Medtronic: Fees for Non-CME/CE Services (e.g. advisor):, electroCore: Employee:, SPR therapeutics: Ownership Interest:, Nalu: Fees for Non-CME/CE Services (e.g. advisor):, Gary Heit, MD, PhD: Nalu Medical Inc: Consultant: Self, Robert Levy, MD, PhD: Nalu: Ownership Interest:, Saluda: Ownership Interest:, James Makous, PhD: Nalu Medical: Consulting Fee:, Nalu Medical: Ownership Interest:

Maternal and neonatal outcomes of COVID-19 in a high-risk pregnant cohort with and without HIV.

BACKGROUND: The impact of SARS-CoV-2 infection in pregnant women living with HIV (PLHIV) has not been described previously. OBJECTIVES: To describe the clinical presentation and outcomes of a cohort of women with high-risk pregnancies with confirmed COVID-19 to determine whether risk factors for disease severity and adverse outcomes of COVID-19 differed in pregnant women without HIV compared with PLHIV. METHODS: We prospectively enrolled pregnant women with COVID-19 attending the high-risk obstetric service at Tygerberg Hospital, Cape Town, South Africa, from 1 May to 31 July 2020, with follow-up until 31 October 2020. Women were considered high risk if they required specialist care for maternal, neonatal and/or anaesthetic conditions. Common maternal or obstetric conditions included hypertensive disorders, morbid obesity (body mass index (BMI) ≥40 kg/m2) and diabetes. Information on demographics, clinical features, and maternal and neonatal outcomes was collected and compared for PLHIV v. pregnant women without HIV. RESULTS: One hundred women (72 without HIV and 28 PLHIV) with high-risk pregnancies had laboratory-confirmed COVID-19. Among the 28 PLHIV, the median (interquartile range) CD4 count was 441 (317 - 603) cells/µL, and 19/26 (73%) were virologically suppressed. COVID-19 was diagnosed predominantly in the third trimester (81%). Obesity (BMI ≥30 in n=61/81; 75%) and hypertensive disorders were frequent comorbidities. Of the 100 women, 40% developed severe or critical COVID-19, 15% required intensive care unit admission and 6% needed invasive ventilation. Eight women died, 1 from advanced HIV disease complicated by bacteraemia and urosepsis. The crude maternal mortality rate was substantially higher in women with COVID-19 compared with all other deliveries at our institution during this period (8/91 (9%) v. 7/4 058 (0.2%); p<0.001). Neonatal outcomes were favourable. No significant differences in COVID-19 risk factors, disease severity, and maternal/neonatal outcome were noted for PLHIV v. those without HIV. CONCLUSIONS: In this cohort of high-risk pregnant women, the impact of COVID-19 was severe, significantly increasing maternal mortality risk compared with baseline rates. Virally suppressed HIV infection was not associated with worse COVID-19 outcomes in pregnancy.

COVID-19 infection in high-risk south african pregnancies with and without HIV

Background: Data from Africa reporting the outcomes of COVID-19 infection in pregnancy are limited, particularly for women with high-risk pregnancies (hypertension, diabetes and obesity) and pregnant women living with HIV (PLHIV). We describe the clinical features, maternal and birth outcomes of COVID-19 high-risk pregnancies at a South African tertiary care referral hospital with a 24% antenatal HIV prevalence. Methods: We prospectively collected data from COVID-19 infected pregnant women attending the high-risk obstetric service at Tygerberg Hospital, Cape Town, between 1 May 2020 and 31 July 2020, and documented pregnancy and birth outcomes until 30 October 2020. Laboratory testing for SARS-CoV-2 infection was performed only in symptomatic pregnant women. Descriptive analysis was performed for all COVID-19 infected women with high-risk pregnancies;demographic and outcome variables were compared for PLHIV versus pregnant women without HIV. Results: One hundred pregnant women (72 without HIV and 28 PLHIV) had laboratory-confirmed COVID-19 infection (Table 1). Obesity, hypertensive disorders and gestational diabetes were frequent comorbidities. Among 28 PLHIV, the majority received antiretroviral treatment 27 (96%);median CD4 count was 441 (14-838) cell/mm3 for 21 (75%) and 19 (73%) were virologically suppressed. COVID-19 infection was diagnosed predominantly in the 3rd trimester (81%);50% of women delivered within 2 weeks of infection onset. Forty women developed pneumonia;13 developed adult respiratory distress syndrome (ARDS) and 6 required invasive ventilation. Eight women died, 7 from ARDS and 1 from advanced HIV disease with bacteraemia. Pregnancy outcomes included 91 live births (including 5 sets of twins), 5 stillbirths, 4 miscarriages, 2 mothers who died with the fetus in situ and 1 medical termination of pregnancy. Birth outcomes for 2 women were unknown. Outcome for the 91 liveborn neonates were good except for one who died from complications related to perinatal asphyxia. No significant differences for COVID-19 infection impact and outcome were noted for PLHIV versus those without HIV. Conclusion: In this cohort of high-risk pregnant women with COVID-19 infection, no clinical differences in outcome attributable to HIV-infection were noted, however the majority of PLHIV were virally suppressed. The impact of COVID-19 infection in pregnancy was severe (40% complicated by pneumonia;8% crude mortality rate);neonatal outcomes were favourable.