Multicenter study of the safety and effectiveness of intracranial aneurysm treatment with the p64MW-HPC flow modulation device.

BACKGROUND AND PURPOSE: The new p64 flow diverter with hydrophilic polymer coating (HPC) was designed to reduce thrombogenicity. To date, it is unclear how antithrombogenic surface modifications affect neoendothelialization and thrombus formation in patients with unruptured intracranial aneurysms. The purpose of this study was to evaluate the safety and effectiveness of the p64MW-HPC in the treatment of unruptured aneurysms of small to giant size and of both the anterior and posterior circulation. MATERIALS AND METHODS: Between March 2020 and October 2022 all patients with unruptured intracranial aneurysms treated with the p64MW-HPC were included at five neurovascular centers. Demographic data, aneurysm characteristics, antiplatelet therapy, procedural complications, and clinical and angiographic outcomes were recorded. RESULTS: A total of 100 patients with 100 unruptured intracranial aneurysms met the inclusion criteria. Eighty-three aneurysms were classified as saccular, 12 aneurysms were fusiform, 4 aneurysms dissecting, and 1 aneurysm was blister-like. Dual antiplatelet therapy with Clopidogrel and Aspirin was given in 68 cases, and with Ticagrelor and Aspirin in 24 cases. Technical issues with deployment were encountered in 14 cases (torsion (n = 3), foreshortening (n = 8), and incomplete opening (n = 3)). Ischemic stroke occurred in a total of seven cases. In one patient a wire perforation and subsequent severe ICH occurred. Complete aneurysm occlusion at angiographic follow-up (mean time = 7 months) was seen in 73% and adequate occlusion in 93%. CONCLUSION: This study is the largest multicenter study to date documenting the safety and effectiveness of the new antithrombogenic p64MW-HPC in the treatment of unruptured intracranial aneurysms of the anterior and posterior circulation.

Flow Diversion for ICA Aneurysms with Compressive Neuro-Ophthalmologic Symptoms: Predictors of Morbidity, Mortality, and Incomplete Aneurysm Occlusion.

BACKGROUND AND PURPOSE: Flow diversion is an effective treatment for aneurysms of the ICA with compression-related neuro-ophthalmologic symptoms, especially when treatment is initiated early after symptom onset and aneurysm occlusion is complete. However, non-negligible complication rates have been reported. Our aim was to identify risk factors for morbidity/mortality and incomplete aneurysm occlusion. MATERIALS AND METHODS: We performed a secondary analysis of a previous publication, which included all patients treated with flow diversion for an unruptured aneurysm of the ICA with compression-related symptoms. RESULTS: Fifty-four patients with 54 aneurysms (48 women, 88.9%; mean age, 59.2 [SD, 15.9] years; range, 21-86 years) treated with flow diversion were included. We observed morbidity and mortality rates of 7.4% and 3.7%. Increasing age (OR per decade, 3.2; 95% CI, 1.23-8.49; P = .02) and dual-antiplatelet therapy with ticagrelor (OR, 13.9; 95% CI, 1.16-165.97; P = .04) were significantly associated with morbidity/mortality. After a median follow-up of 13.3 [SD, 10.5] months, the rates of complete aneurysm occlusion, neck remnant, and aneurysm remnant were 74%, 14%, and 12%. Incomplete occlusion at follow-up was less frequently observed in aneurysms treated with additional coil embolization (OR, 0.1; 95% CI, 0.01-0.86; P = .04). CONCLUSIONS: Although a promising treatment for compressive ICA aneurysms, flow diversion carries a relevant risk for complications and incomplete aneurysm occlusion. Our results may help identify patients in which flow diversion may not be the ideal treatment method. Additional coil embolization increased the likelihood of complete aneurysm occlusion at follow-up.

Use of antibiotics and the prevalence of antibiotic-associated diarrhoea in patients with spinal cord injuries: an international, multi-centre study.

BACKGROUND: Little is known about the use of antibiotics and the extent of antibiotic-associated diarrhoea (AAD) in patients with spinal cord injuries (SCIs). AIMS: To record the use of antibiotics, establish the prevalence of AAD and Clostridium difficile infection (CDI), and assess if there was any seasonal variation in antibiotic use and incidence of AAD in patients with SCIs. METHODS: A retrospective study was conducted in six European SCI centres between October 2014 and June 2015. AAD was defined as two or more watery stools (Bristol Stool Scale type 5, 6 or 7) over 24 h. FINDINGS: In total, 1267 adults (median age 54 years, 30.7% female) with SCIs (52.7% tetraplegia, 59% complete SCI) were included in this study. Among the 215 (17%) patients on antibiotics, the top three indications for antibiotics were urinary tract infections (UTIs), infected pressure ulcers and other skin infections. Thirty-two of these 215 (14.9%) patients developed AAD and two patients out of the total study population (2/1267; 0.16%) developed CDI. AAD was more common in summer than in spring, autumn or winter (30.3% vs 3.8%, 7.4% and 16.9%, respectively; P<0.01). AAD was associated with age ≥65 years, tetraplegia, higher body mass index, hypoalbuminaemia, polypharmacy, multiple antibiotic use and high-risk antibiotic use. Summer and winter seasons and male sex were identified as independent predictors for the development of AAD. CONCLUSION: This survey found that AAD is common in patients with SCIs, and UTI is the most common cause of infection. Summer and winter seasons and male sex are unique predictors for AAD. Both AAD and UTIs are potentially preventable; therefore, further work should focus on preventing the over-use of antibiotics, and developing strategies to improve hospital infection control measures.

Use of antibiotic and prevalence of antibiotic-associated diarrhoea in-patients with spinal cord injuries: a UK national spinal injury centre experience.

BACKGROUND: This was a retrospective audit, with the aims being to (1) record the use of antibiotics; (2) establish the prevalence of antibiotic-associated diarrhoea (AAD) and Clostridium difficile-associated diarrhoea (CDAD); and (3) assess if there was any seasonal variation in antibiotic use and incidence of AAD. METHODS: The study was performed at a single spinal cord injury (SCI) centre in the UK. Data were collected using a standardised questionnaire during October 2014 to June 2015. We define AAD as two or more watery stools of type 5, 6 or 7 (Bristol stool scale) over 24 h. RESULTS: Three-hundred-and-nineteen adults (mean age: 55.9 years, 29.2% female) with SCI (58.2% tetraplegia; 43.7% complete SCI) were included. Of 70 (21.9%) patients on antibiotics, the top three indications for antibiotics were urinary-tract infections, infected pressure ulcers and other skin infections. Seventeen of 78 (21.8%) developed AAD and three of 319 (0.94%) developed CDAD. AAD was more common in the summer season than in spring, autumn and winter (47.1%, 10.0%, 10.0%, 23.8%, P=0.025). AAD was associated with older adults greater than 65 years (70.6% vs 23.8%, P=0.007). Polypharmacy and the summer season were identified as independent predictors for AAD. CONCLUSION: This survey found that AAD is common in SCI patients and may be a risk factor for a poorer outcome and increased hospital costs. A multicentre study is underway to establish the incidence and risk factors for AAD.

Is undernutrition risk associated with an adverse clinical outcome in spinal cord-injured patients admitted to a spinal centre?

BACKGROUND/OBJECTIVES: To evaluate whether undernutrition risk measured using the Spinal Nutrition Screening Tool (SNST) and the Malnutrition Universal Screening Tool (MUST) is associated with worse clinical outcomes in respect of length of in-patient hospital stay (LOS) and mortality in the 12 months after admission to a spinal cord injuries (SCIs) centre. METHODS: A multicentre, prospective, cross-sectional observational study was conducted in four UK SCI centres (SCICs). A total of 150 SCI patients (aged 18-88 years (median: 44 years), 30.7% females) were studied between July 2009 and March 2010. LOS and mortality 12 months after admission to the SCIC was monitored. Multivariate regression analysis was used to identify unique predictors of the variance of LOS. RESULTS: The patients initially undernourished or at risk of undernutrition (44.6%) had a significantly longer LOS (median (days): 129 vs 85, P=0.012) and greater 12-month mortality (% deceased: 9.2% vs 1.4%, P=0.036). In addition, serum albumin and new admission to an SCIC were identified as independent predictors for long LOS. CONCLUSION: The present study suggests that undernutrition risk, as identified by the SNST, is associated with adverse clinical outcomes. Nutritional screening should be helpful in improving clinical outcomes if it promotes more appropriate and effective nutritional intervention.

Validation of the spinal nutrition screening tool (SNST) in patients with spinal cord injuries (SCI): result from a multicentre study.

BACKGROUND/OBJECTIVES: A disease-specific nutrition screening tool (NST): the spinal nutrition screening tool (SNST) has been developed for use in patients with spinal cord injury (SCI) but its reliability and agreement with other published tools requires investigation. The aims of this study were to assess the prevalence of malnutrition risk in SCI patients and to confirm the diagnostic accuracy of the SNST. SUBJECTS/METHODS: Patients' baseline clinical data, anthropometric measurements and NST scores were assessed. The validity of the SNST was assessed by (i) comparing with a full dietetic assessment (criterion validity); (ii) comparison with a generic NST: malnutrition universal screening tool (MUST) (concurrent validity); and (iii) completion of an additional SNST to assess inter- and intra-rater reliability. Agreement was assessed using Cohen's κ-statistics. RESULTS: Using the SNST, the prevalence of malnutrition risk ranged from 22 to 64% on admission to four SCI centres. The SNST had substantial agreement with MUST (κ: 0.723, 95% confidence interval (CI): 0.607-0.839) and dietitian assessment (κ: 0.567, 95% CI: 0.434-0.699). The SNST had a moderate to substantial reliability (inter-rater reliability: κ: 0.5, 95% CI: 0.2-0.8; intra-rater reliability: κ: 0.64, 95% CI: 0.486-0.802). When compared with dietetic assessment, the SNST had a numerically lower specificity (76.1% vs 80.4%) and similar agreement to MUST (κ: 0.57 vs 0.58) but SNST showed a numerically higher sensitivity (85.7% vs 80.4%) and a numerically higher negative predictive value (92% vs 89.2%) than MUST. CONCLUSIONS: This study shows that malnutrition is common in SCI patients. The SNST is an acceptable (valid and reliable) NST and may be a useful alternative to MUST in identifying SCI patients at risk of malnutrition.

Resolution of SPAM following cordectomy: implications for understanding pathophysiology.

STUDY DESIGN: Case report. OBJECTIVE: To describe the clinical benefit of a spinal cordectomy with the aim of limiting neurological deterioration related to the development of a subacute posttraumatic ascending myelopathy (SPAM) supporting previously described mechanism for SPAM formation. SETTING: National Spinal Injuries Centre, Stoke Mandeville Hospital, UK. METHOD AND RESULTS: A 38-year old patient presented 6 months after spinal cord injury substantial neurological deterioration expanding from the initial T4-injury level through C4. Magnetic resonance imaging revealed intra-medullary haemorrhage at the site of injury and subsequent-ascending cord oedema. A cordectomy was performed leading to neurological stabilisation and complete resolution of SPAM. CONCLUSION: Cordectomy can be an effective intervention in case of rapid progressive neurological deterioration.

A low-dose radioisotope procedure for assessment of subcutaneous drug delivery systems used for slow intrathecal infusion of antispasmodic agents.

STUDY DESIGN: Retrospective single centre study. OBJECTIVES: To evaluate a low-dose radioisotope imaging procedure for assessment of implanted intrathecal drug delivery and to compare the radiation dose and diagnostic value of these studies with other reported studies using higher administered radiation dose. SETTING: National Spinal Injuries Centre, Stoke Mandeville Hospital, UK. METHOD: A total of 11 spinally injured patients with subcutaneous drug delivery systems and uncontrolled spasm were investigated for catheter failure using a low-dose radioisotope procedure with an administered dose of radioactivity of 40 MBq Technetium-99m. RESULTS: Loss of catheter patency was demonstrated in six patients, enabling identification of the site of blockage. Catheter patency and subsequent perfusion of CSF (ie normal result) was demonstrated in five patients. Radiation effective dose was estimated at 1.3 mSv per patient study, with a low associated risk of deleterious effect of one in 13,000. CONCLUSION: Radioisotope investigation using a reduced administered dose of 40 MBq Technetium-99m DTPA, formulated according to a strict radiopharmaceutical protocol, provides a safe test for assessment of intrathecal drug delivery systems.

Towards improved clinical and physiological assessments of recovery in spinal cord injury: a clinical initiative.

Clinical practice and scientific research may soon lead to treatments designed to repair spinal cord injury. Repair is likely to be partial in the first trials, extending only one or two segments below the original injury. Furthermore, treatments that are becoming available are likely to be applied to the thoracic spinal cord to minimise loss of function resulting from damage to surviving connections. These provisos have prompted research into the improvement of clinical and physiological tests designed (1) to determine the level and density of a spinal cord injury, (2) to provide reliable monitoring of recovery over one or two spinal cord segments, and (3) to provide indices of function provided by thoracic spinal root innervation, presently largely ignored in assessment of spinal cord injury. This article reviews progress of the Clinical Initiative, sponsored by the International Spinal Research Trust, to advance the clinical and physiological tests of sensory, motor and autonomic function needed to achieve these aims.

The inter rater reliability of the original and of the modified Ashworth scale for the assessment of spasticity in patients with spinal cord injury.

Thirty patients with spinal cord injury (SCI) were randomly selected to participate in this study which evaluated the inter rater reliability of the original and of the modified Ashworth scale for the assessment of spasticity in the lower limbs. A doctor and a physiotherapist rated the muscle tone of hip adductors, hip extensors, hip flexors and ankle plantarflexors according to the original and to the modified Ashworth scale. The results were analyzed using a Cohen's Kappa statistical test and showed varying levels of reliability for different muscle groups and limbs. Kappa values ranged between 0.21 and 0.61 (mean 0.37). The original scale was slightly more reliable than was the modified scale. However, this difference was not significant (P > 0.05), and was not consistent between the two limbs and between different muscle groups. It was concluded that the Ashworth scale is of limited use in the assessment of spasticity in the lower limb of patients with SCI. Further work is required to establish a standardised speed of muscle stretching during the test, or to find more appropriate grades and descriptions of spasticity for this patient group. The effects of training of the raters in the use of the scales also warrants further investigation.

Intrathecal baclofen--a multicentre clinical comparison of the Medtronics Programmable, Cordis Secor and Constant Infusion Infusaid drug delivery systems.

A retrospective review was carried out of 34 consecutive traumatic spinal cord damaged patients who have had the Medtronics Programmable, Cordis Secor or Constant Infusion Infusaid intrathecal baclofen drug delivery systems inserted between July 1987 and 1992. The results indicate that whilst this treatment has many benefits there is a significant risk of complications, some potentially fatal. It should only be provided by a skilled and experienced team. The Medtronics Programmable pump is an excellent pump. It is of particular benefit where the therapeutic window is small or fine-tuning required. The Constant Infusion Infusaid is adequate if less precise control and continuous infusion is sufficient. It is of particular benefit in financially disadvantaged countries. The Cordis Secor device is helpful when unpredictable intermittent relief of spasticity is required but is otherwise limited by its complication rate.

A comparison of the chest radiograph and computerised tomography in assessing lung changes in acute spinal injuries--an assessment of their prevalence and the accuracy of the chest X-ray compared with CT in their assessment.

Lung function in patients following an acute spinal injury is frequently much more compromised than may be expected from the level of injury and the chest radiograph appearance. Experimental evidence in anaesthetised patients and subsequently our own experience with patients with acute spinal injuries suggested that in paralysed patients lung changes were frequent and that in many spinal patients large pleural effusions and lung consolidation could be present without the usual associated chest radiograph changes being recognised. This study was performed to assess the prevalence of chest pathology and the sensitivity of the chest radiograph in portraying it. Sixty patients (50 males, 10 females, 31 cervical, 29 thoracic or thoracolumbar; 15 incomplete, 45 complete; ages 17-66, mode 22 years) with spinal injuries from a variety of causes were assessed with a supine chest radiograph and three computerised tomography axial cuts at standardised locations through the thorax. The chest radiograph agreed with the computerised tomography in only 12 patients (six normal, six abnormal). The chest radiograph suggested that there were 19 normals but computerised tomography only showed 12. In a total of 35 patients, the chest radiograph significantly underestimated the degree of change and in 13 the chest radiograph suggested greater pathology than was shown on computerised tomography. Thirteen of the 20 patients with cervical lesions but no chest trauma had lung changes.(ABSTRACT TRUNCATED AT 250 WORDS)

Psychological and emotional effects of the use of oral baclofen: a preliminary study.

Spasticity is a common problem following spinal cord injury. The drug of choice to control spasms is baclofen. There would appear to be no reported studies which have evaluated the psychological and emotional effect of this drug. This preliminary study investigated a number of such effects, including depression, anxiety and general mood state. First, we examined 10 subjects before and during the administration of baclofen. They were then compared to a control group of 12 subjects. A second cohort of 12 subjects taking baclofen were compared to a control group of nine subjects at a specific time after injury. Results indicated that whilst some significant differences were found, suggesting an increase in fatigue with use of baclofen, no major adverse psychological effects were noted. The implications of these results were discussed and suggestions for further research were highlighted.

Ultrasound in the early diagnosis of heterotopic ossification in patients with spinal injuries.

Heterotopic ossification (HO) is a potentially disabling complication of spinal injuries and other chronic disorders. It is of unknown aetiology and currently there is no easy or convenient diagnostic method that will allow very early confirmation of the inflammatory changes that precede osteoid and, later, true bone formation. Clinical experience, however, indicates that early treatment with radiotherapy, antiinflammatory agents or diphosphonates is needed to control the progression. This study was undertaken to assess the role of ultrasound (US) in the very early diagnosis of HO in patients with spinal injuries. US was found to be very sensitive in detecting focal soft tissue abnormalities around joints and in the muscles of these patients. If combined with a Doppler study to exclude deep venous thrombosis (DVT), and infection or tumour could be excluded clinically, US was extremely accurate in predicting the presence or absence of early HO changes within hours of the clinical manifestation. In 2 patients it successfully predicted HO in the opposite leg before clinical signs were evident. This study also provided supportive evidence of the theory of microtrauma in the aetiology of HO. As ultrasound is portable, safe, cheap, reproducible and accurate, it is the method of choice in the early diagnosis of HO. It allows early treatment to prevent the formation of osteoid and subsequent bone formation.

Complications of intrathecal baclofen delivery.

The medical records of 46 consecutive patients who have had intrathecal Baclofen drug delivery systems implanted in the National Spinal Injuries Centre, the Paddocks Hospital Spinal Unit, Princes Risborough, Lodge Moor Hospital Spinal Unit, Sheffield, the Northern Regional Spinal Injuries Unit, Hexham and The Radcliffe Infirmary, Oxford, were reviewed. Patients were contacted to describe their views on the treatment. The complications of the treatment are described. Some, such as overdose and meningitis are particularly hazardous. Others, in particular pump tubing revisions, are more of an inconvenience and time consuming for the patient and physician. If the serious risks of this valuable treatment are to be minimized and the therapy applied most effectively than a well co-ordinated team is essential, involving in particular the physician responsible for the initial assessment and follow-up of the patient and an experienced surgeon. It is recommended that only a small number of centres in the UK undertake these implants.

Intrathecal baclofen for long-term treatment of spasticity: a multi-centre study.

Twenty eight patients with severe, intractable spasticity have been treated by chronic intrathecal administration of baclofen. An implantable programmable drug-administration-device (DAD) was used with a permanent intrathecal catheter. Infusion of 50 to 800 micrograms/day of baclofen completely abolished spasticity. Follow-up was up to two years. Therapeutic effect was documented by clinical assessment of tone, spasms and reflexes and by electrophysiological recordings of mono- and polysynaptic reflex activity. Complications and untoward side-effects of the procedure were few. This procedure is recommended for spasticity of spinal origin refractory to physiotherapy and oral medication. It is a preferable alternative to ablative surgical intervention.