Sensing in Sacral Neuromodulation: A Feasibility Study in Subjects With Urinary Incontinence and Retention.

OBJECTIVES: Sacral neuromodulation (SNM) therapy standard of care relies on visual-motor responses and patient-reported sensory responses in deciding optimized lead placement and programming. Automatic detection of stimulation responses could offer a simple, consistent indicator for optimizing SNM. The purpose of this study was to measure and characterize sacral evoked responses (SERs) resulting from sacral nerve stimulation using a commercial, tined SNM lead. MATERIALS AND METHODS: A custom external research system with stimulation and sensing hardware was connected to the percutaneous extension of an implanted lead during a staged (tined lead) evaluation for SNM. The system collected SER recordings across a range of prespecified stimulation settings (electrode configuration combinations for bipolar stimulation and bipolar sensing) during intraoperative and postoperative sessions in 21 subjects with overactive bladder (OAB) and nonobstructive urinary retention (NOUR). Motor and sensory thresholds were collected during the same sessions. RESULTS: SERs were detected in all 21 subjects. SER morphology (number of peaks, magnitude, and timing) varied across electrode configurations within and across subjects. Among subjects and electrode configurations tested, recordings contained SERs at motor threshold and/or sensory threshold in 75% to 80% of subjects. CONCLUSIONS: This study confirmed that implanted SNM leads can be used to directly record SERs elicited by stimulation in subjects with OAB and NOUR. SERs were readily detectable at typical SNM stimulation settings and procedural time points. Using these SERs as possible objective measures of SNM response has the capability to automate patient-specific SNM therapy, potentially providing consistent lead placement, programming, and/or closed-loop therapy.

Vulnerability and fragility risk indices for non-renewable resources.

Protected areas are tasked with mitigating impacts to a wide range of invaluable resources. These resources are often subject to a variety of potential natural and anthropogenic impacts that require monitoring efforts and management actions to minimize the degradation of these resources. However, due to insufficient funding and staff, managers often have to prioritize efforts, leaving some resources at higher risk to impact. Attempts to address this issue have resulted in numerous qualitative and semi-quantitative frameworks for prioritization based on resource vulnerability. Here, we add to those methods by modifying an internationally standardized vulnerability framework, quantify both resource vulnerability, susceptibility to human disturbance, and fragility, susceptibility to natural disturbance. This modified framework quantifies impacts through a six-step process: identifying the resource and management objectives, identifying exposure and sensitivity indicators, define scoring criteria for each indicator, collect and compile data, calculate indices, and prioritize sites for mitigations. We applied this methodology to two resource types in Grand Canyon National Park (GRCA): caves and fossil sites. Three hundred sixty-five cave sites and 127 fossil sites in GRCA were used for this analysis. The majority of cave and fossil sites scored moderate to low vulnerability (0-6 out of 10 points) and moderate to low fragility for fossils. The percentage of sites that fell in the high-priority range was 5.5% for fossils and 21.9% for caves. These results are consistent with the known state of these resources and the results present a tool for managers to utilize to prioritize monitoring and management needs.

Rationale and design of an implant procedure and pivotal study to evaluate safety and effectiveness of Medtronic's tibial neuromodulation device.

Percutaneous tibial neuromodulation is a medical guideline recommended therapy for treating symptoms of overactive bladder. Stimulation is delivered to the tibial nerve via a thin needle placed percutaneously for 30 min once a week for 12-weeks, and monthly thereafter. Studies have shown that this therapy can effectively relieve symptoms of overactive bladder; however, the frequent office visits present a barrier to patients and can impact therapy effectiveness. To mitigate the burden of frequent clinic visits, small implantable devices are being developed to deliver tibial neuromodulation. These devices are implanted during a single minimally invasive procedure and deliver stimulation intermittently, similar to percutaneous tibial neuromodulation. Here, we describe the implant procedure and design of a pivotal study evaluating the safety and effectiveness for an implantable tibial neuromodulation device. The Evaluation of Implantable Tibial Neuromodulation (TITAN 2) pivotal study is a prospective, multicenter, investigational device exemption study being conducted at up to 30 sites in the United States and enrolling subjects with symptoms of overactive bladder.

Neurodevelopmental outcomes for high-risk neonates in a low-resource setting.

Worldwide, most neonates who survive prematurity and serious illness reside in low-resource settings where developmental outcome data and follow-up care are limited. This study aimed to assess in Fiji, a low-resource Pacific setting, prevalence and risk factors for moderate to severe neurodevelopmental impairment (NDI) in early childhood among high-risk neonates compared with controls. Retrospective cohort study comparing long-term outcomes for high-risk neonatal intensive care unit patients (n=149) compared with matched term, normal birth weight neonates (n=147) discharged from Colonial War Memorial Hospital between November 2008 and April 2010. NDI was defined as one or more of cerebral palsy, moderate to severe hearing or visual impairment, or global developmental delay using Bayley Scales of Infant and Toddler Development Third Edition (ie, score <70 in ≥1 of cognitive, language or motor domains). At median (IQR) age 36.1 (28.3, 38.0) months, prevalence of moderate to severe NDI % (95% CI, n) in high-risk and control groups was 12 (5 to 17, n=13) and 5 (2 to 12, n=5), respectively, an increased risk ratio (95% CI) of 2.7 (0.8 to 8.9). Median gestational age (weeks (median, IQR)) in the high-risk group was 37.5 (34-40) weeks. Among high-risk neonates, gestational age, birth weight, asphyxia, meningitis and/or respiratory distress were significantly associated with risk of NDI. Prevalence of NDI was high among this predominantly term high-risk neonatal cohort compared with controls. Results, including identified risk factors, inform efforts to strengthen quality of care and models of follow-up for high-risk neonates in this low-resource setting.

Rheumatic Heart Disease-Attributable Mortality at Ages 5-69 Years in Fiji: A Five-Year, National, Population-Based Record-Linkage Cohort Study.

BACKGROUND: Rheumatic heart disease (RHD) is considered a major public health problem in developing countries, although scarce data are available to substantiate this. Here we quantify mortality from RHD in Fiji during 2008-2012 in people aged 5-69 years. METHODS AND FINDINGS: Using 1,773,999 records derived from multiple sources of routine clinical and administrative data, we used probabilistic record-linkage to define a cohort of 2,619 persons diagnosed with RHD, observed for all-cause mortality over 11,538 person-years. Using relative survival methods, we estimated there were 378 RHD-attributable deaths, almost half of which occurred before age 40 years. Using census data as the denominator, we calculated there were 9.9 deaths (95% CI 9.8-10.0) and 331 years of life-lost (YLL, 95% CI 330.4-331.5) due to RHD per 100,000 person-years, standardised to the portion of the WHO World Standard Population aged 0-69 years. Valuing life using Fiji's per-capita gross domestic product, we estimated these deaths cost United States Dollar $6,077,431 annually. Compared to vital registration data for 2011-2012, we calculated there were 1.6-times more RHD-attributable deaths than the number reported, and found our estimate of RHD mortality exceeded all but the five leading reported causes of premature death, based on collapsed underlying cause-of-death diagnoses. CONCLUSIONS: Rheumatic heart disease is a leading cause of premature death as well as an important economic burden in this setting. Age-standardised death rates are more than twice those reported in current global estimates. Linkage of routine data provides an efficient tool to better define the epidemiology of neglected diseases.

Causes of puerperal and neonatal sepsis in resource-constrained settings and advocacy for an integrated community-based postnatal approach.

BACKGROUND: Puerperal sepsis and neonatal sepsis are important causes of mortality and morbidity in low-income countries. OBJECTIVES: To help improve global guidelines on postpartum care by reviewing existing data on microbiologic causes of sepsis among mothers, newborns, and mother-newborn pairs. SEARCH STRATEGY: An extensive literature review of peer-reviewed publications from resource-constrained settings was conducted using PubMed. SELECTION CRITERIA: Primary research studies containing microbiologic data on puerperal sepsis or combined maternal and neonatal sepsis published since 1980. DATA COLLECTION AND ANALYSIS: Study characteristics and results were analyzed. Data regarding causative microorganisms were tabulated and discussed in the main text. MAIN RESULTS: Diagnostic evaluation of microorganisms causing puerperal sepsis was difficult, with few studies linking microorganisms causing infection in individual mother-newborn pairs. The most frequent microorganisms associated with puerperal sepsis were Neisseria gonorrhoeae and Chlamydia trachomatis. The most frequent microorganisms associated with neonatal sepsis were Escherichia coli, Staphylococcus aureus, and Klebsiella species. CONCLUSIONS: Management tools for community-based care of mothers with puerperal sepsis-including early detection, initiation of broad-spectrum antibiotic treatment, and timely referral-should be added to those currently in use for neonatal sepsis. Further research is required to address acceptability, feasibility, and impact of community-based presumptive treatment.

Radiation dosimetry and safety issues in the investigation of pulmonary embolism.

When considering the investigation of the patient with possible pulmonary embolism, one needs to balance the likelihood of disease and the diagnostic utility of the test against the risks associated with the investigation. Both computed tomography pulmonary angiography (CTPA) and the ventilation/perfusion (V/Q) scan involve exposure to ionizing radiation. The effect of low-level ionizing radiation remains an issue of some controversy. CTPA delivers a greater effective dose and, in particular, greater doses to breast tissue, than the V/Q scan (typically 10-70 mGy for CTPA vs <1.5 mGy for V/Q to breast). Since breast tissue is particularly radiosensitive in younger women, the V/Q study has an advantage over CTPA in this group. In the pregnant patient, fetal exposure has been raised as a concern. In fact, there is typically only low fetal exposure from either study (<1 mGy). The CTPA does deliver less fetal exposure, particularly in the first trimester, but the difference between CTPA and V/Q scan is small when compared with the difference in dose to maternal breast from the 2 investigations. The "as low as reasonably achievable" (ie, ALARA) principle favors the use of V/Q scans in young women, assuming the diagnostic power of the 2 tests is comparable. CTPA requires a contrast injection that can cause adverse reactions in a small number of patients. No significant risk, however, has been demonstrated with the radiopharmaceuticals involved in V/Q scans.