Impact of routine angiographic follow-up after percutaneous coronary intervention with drug-eluting stents in the SPIRIT III randomized trial at three years

Routine angiographic follow-up after bare-metal stent implantation has been associated with an increase in coronary revascularization. The impact of angiographic follow-up after drug-eluting stent placement remains poorly characterized. The prospective, randomized, single-blinded SPIRIT III trial assigned patients to the everolimus-eluting stent or the paclitaxel-eluting stent (PES). Major adverse cardiovascular events (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization [ID-TLR]) at 3 years were assessed by angiographic versus clinical-only follow-up at 8 months ± 28 days and a landmark survival analysis from 9 months to 3 years. Of 1,002 patients, 564 patients were assigned to angiographic follow-up at 8 months ± 28 days and 438 patients underwent clinical follow-up alone. Three-year major adverse cardiovascular event rates were 10.6% in the angiographic group and 12.0% in the clinical follow-up group (p = 0.64). Ischemia-driven revascularization increased twofold at 9 months, but no difference was noted in ID-TLR for either device. Non-ID-TLR was significantly higher in patients in the angiographic group (4.5% vs 1.0%, p = 0.002), a difference resulting from PES (9.1% vs 0.7%, p = 0.0007) rather than everolimus-eluting stent (2.2% vs 1.1%, p = 0.36) treatment. The landmark analysis showed no significant differences between the angiographic and clinical follow-up groups from 9 months to 3 years of major clinical outcomes. In conclusion, routine angiographic follow-up in SPIRIT III did not increase rates of ID-TLR compared to clinical follow-up alone. Despite higher nonischemia-driven revascularization rates with angiographic follow-up of patients with PESs, none of the safety end points were adversely affected.     

Ofatumumab monotherapy in rituximab-refractory follicular lymphoma: results from a multicenter study

New treatments are required for rituximab-refractory follicular lymphoma (FL). In the present study, patients with rituximab-refractory FL received 8 weekly infusions of ofatumumab (CD20 mAb; dose 1, 300 mg and doses 2-8, 500 or 1000 mg; N = 116). The median age of these patients was 61 years, 47% had high-risk Follicular Lymphoma International Prognostic Index scores, 65% were chemotherapy-refractory, and the median number of prior therapies was 4. The overall response rate was 13% and 10% for the 500-mg and 1000-mg arms, respectively. Among 27 patients refractory to rituximab monotherapy, the overall response rate was 22%. The median progression-free survival was 5.8 months. Forty-six percent of patients demonstrated tumor reduction 3 months after therapy initiation, and the median progression-free survival for these patients was 9.1 months. The most common adverse events included infections, rash, urticaria, fatigue, and pruritus. Three patients experienced grade 3 infusion-related reactions, none of which were considered serious events. Grade 3-4 neutropenia, leukopenia, anemia, and thrombocytopenia occurred in a subset of patients. Ofatumumab was well tolerated and modestly active in this heavily pretreated, rituximab-refractory population and is therefore now being studied in less refractory FL and in combination with other agents in various B-cell neoplasms. The present study was registered at www.clinicaltrials.gov as NCT00394836.     

Quantitative assessment of chronic lung disease of infancy using computed tomography

The aims of this study were to determine whether infants and toddlers with chronic lung disease of infancy (CLDI) have smaller airways and lower lung density compared with full-term healthy controls. Multi-slice computed tomography (CT) chest scans were obtained at elevated lung volumes during a brief respiratory pause in sedated infants and toddlers; 38 CLDI were compared with 39 full-term controls. For CLDI subjects, gestational age at birth ranged from 25 to 29 weeks. Airway size was measured for the trachea and the next three to four generations into the right lower lobe; lung volumes and tissue density were also measured. The relationship between airway size and airway generation differed between the CLDI and full-term groups; the sizes of the first and second airway generations were larger in the shorter CLDI than in the shorter full-term subjects. The increased size in the airways in the CLDI subjects was associated with increasing mechanical ventilation time in the neonatal period. CLDI subjects had a greater heterogeneity of lung density compared with full-term subjects. Our results indicate that quantitative analysis of multi-slice CT scans at elevated volumes provides important insights into the pulmonary pathology of infants and toddlers with CLDI.     

Spinal cord injuries related to cervical spine fractures in elderly patients: factors affecting mortality

Background contextSpinal cord injuries (SCIs) related to cervical spine (C-spine) fractures can cause significant morbidity and mortality. Aggressive treatment often required to manage instability associated with C-spine fractures is complicated and hazardous in the elderly population.PurposeTo determine the mortality rate of elderly patients with SCIs related to C-spine fractures and identify factors that contribute toward a higher risk for negative outcomes.Study design/settingRetrospective cohort study at two Level 1 trauma centers.Patient sampleThirty-seven consecutive patients aged 60 years and older who had SCIs related to C-spine fractures.Outcome measuresLevel of injury, injury severity, preinjury medical comorbidities, treatment (operative vs. nonoperative), and cause of death.MethodsHospital medical records were reviewed independently. Baseline radiographs and computed tomography or magnetic resonance imaging scans were examined to permit categorization according to the mechanistic classification by Allen and Ferguson of subaxial C-spine injuries. Univariate logistic regression analyses were performed to identify factors related to in-hospital mortality and ambulation at discharge. There were no funding sources or potential conflicts of interest to disclose.ResultsThe in-hospital mortality rate was 38%. Respiratory failure was the leading cause of death. Preinjury medical comorbidities, age, and operative versus nonoperative treatment did not affect mortality. Injury level at or above C4 was associated with a 7.1 times higher risk of mortality compared with injuries below C4 (p=.01). Complete SCI was associated with a 5.1 times higher risk of mortality compared with incomplete SCI (p=.03). Neurological recovery was uncommon. Apart from severity of initial SCI, no other factor was related to ambulatory disposition at discharge.ConclusionsIn this elderly population, neurological recovery was poor and the in-hospital mortality rate was high. The strongest risk factors for mortality were injury level and severity of SCI. Although each case of SCI related to C-spine fractures is different, physicians may be able to use these findings to help better determine the prognosis and guide subsequent treatment.     

School and cognitive functioning problems in adolescent bariatric surgery candidates

BackgroundPrior studies have reported that students with overweight and obesity have impairments in performance IQ and executive function and worse school functioning in comparison with peers of normal weight. The present study assessed school and cognitive functioning in a sample of adolescents with severe obesity being evaluated for laparoscopic adjustable gastric banding.MethodsEligible candidates for bariatric surgery were referred for psychiatric evaluation, which included a semistructured clinical interview measuring school functioning and the vocabulary and matrix reasoning subtests of the Wechsler Abbreviated Scale of Intelligence (WASI).ResultsSelf-reported school problems were common, with 55.5% of adolescents failing a grade or subject, 38.7% attending summer school, and 17.8% failing a citywide examination. A significant relationship was observed between body mass index, estimated WASI IQ (r = ?.250; P = .005), and the vocabulary subtest (r = ?.241; P = .006), but not matrix reasoning (r = ?.126; P = NS).ConclusionEven among a sample of adolescents with severe obesity, increased body mass index was associated with lower WASI IQ and vocabulary subtest scores. Increasing awareness of potential cognitive and school problems in bariatric candidates among teachers, school counselors, and other mental health providers is an important first step to improving academic support and educational systems deficiencies for students with overweight and obesity.     

Methotrexate does not affect ovarian reserve or subsequent assisted reproductive technology outcomes

Purpose

The purpose of this research was to study whether methotrexate (MTX) as treatment for ectopic pregnancy (EP) impacts the future fertility of women undergoing assisted reproductive technology (ART)

Methods

In a systematic review and multi-center retrospective cohort from four academic and private fertility centers, 214 women underwent an ART cycle before and after receiving MTX as treatment for an EP. Measures of ovarian reserve and responsiveness and rates of clinical pregnancy (CP) and live birth (LB) were compared in the ART cycles prior and subsequent to MTX.

Results

Seven studies were identified in the systematic review, and primary data from four institutions was included in the final analysis. Women were significantly older in post-MTX cycles (35.3 vs 34.7 years). There were no differences in follicle stimulating hormone, antral follicle count, duration of stimulation, oocytes retrieved, or fertilization rate between pre- and post-MTX cycles. However, post-MTX cycles received a significantly higher total dose of gonadotropins (4206 vs 3961 IU). Overall, 42 % of women achieved a CP and 35 % achieved a LB in the post-MTX ART cycle, which is similar to national statistics. Although no factors were identified that were predictive of LB in young women, the number of oocytes retrieved in the previous ART cycle and current AFC were predictive of LB (AUC 0.76, 0.75) for the older women.

Conclusions

MTX does not influence ovarian reserve, response to gonadotropin stimulation, and CP or LB rate after ART. MTX remains a safe and effective treatment option for women with asymptomatic EPs.

     

Patient education in Parkinson's disease: Formative evaluation of a standardized programme in seven European countries

OBJECTIVE: To evaluate a newly developed education programme for Parkinson's disease (PD) patients. METHODS: The programme consisted of eight sessions and aimed at improving knowledge and skills related to self-monitoring, health promotion, stress management, depression, anxiety, social competence, and social support, all with special reference to PD. The programme was formatively evaluated in seven European countries (Spain, Finland, Italy, The Netherlands, United Kingdom, Estonia, Germany) with 151 patients diagnosed with idiopathic PD. The evaluation included patients' ratings of the comprehensibility and feasibility of the programme as well as mood ratings before and after each session. Patients also completed questionnaires at the beginning and end of the programme to explore possible changes in disease-related psychosocial problems, quality of life, and depression. RESULTS: The programme was feasible to run, and patients were able to understand its elements. Patients reported mood elevations following individual sessions and reduced disease-related psychosocial problems after completing the programme. There were no substantial differences in results between cultures. CONCLUSION: Patient education appears to have potential as a useful and feasible intervention, complementing medical treatment in PD. PRACTICE IMPLICATIONS: The present programme will soon be available in seven European languages and can be tested in different health care systems.     

Diesel engine exhaust exposure in underground mines: Comparison between different surrogates of particulate exposure

Exposure to diesel particulate matter (DPM) is frequently assessed by measuring indicators of carbon speciation, but these measurements may be affected by organic carbon (OC) interference. Furthermore, there are still questions regarding the reliability of direct-reading instruments (DRI) for measuring DPM, since these instruments are not specific and may be interfered by other aerosol sources. This study aimed to assess DPM exposure in 2 underground mines by filter-based methods and DRI and to assess the relationship between the measures of elemental carbon (EC) and the DRI to verify the association of these instruments to DPM. Filter-based methods of respirable combustible dust (RCD), EC, and total carbon (TC) were used to measure levels of personal and ambient DPM. For ambient measurements, DRI were used to monitor particle number concentration (PNC; PTrak), particle mass concentration (DustTrak DRX and DustTrak 8520), and the submicron fraction of EC (EC_1;Airtec). The association between ambient EC and the DRI was assessed by Spearman correlation. Geometric mean concentrations of RCD, respirable TC (TC_R) and respirable elemental EC (EC_R) were 170 µg/m³, 148 µg/m³, and 83 µg/m³ for personal samples, and 197 µg/m³, 151 µg/m³, and 100 µg/m³ for ambient samples. Personal measurements had higher TC_R:EC_R ratios compared to ambient samples (1.8 vs. 1.50) and weaker association between EC_R and TC_R. Among the DRI, the measures of EC₁ by the Airtec (ρ = 0.86; P < 0.001) and the respirable particles by the DustTrak 8520 (ρ = 0.74; P < 0.001) showed the strongest association with EC, while PNC showed a weak and non-significant association with EC. In conclusion, this study provided important information about the concentrations of DPM in underground mines by measuring several indicators using filter-based methods and DRI. Among the DRI, the Airtec proved to be a good tool for estimating EC concentrations and, although the DustTrak showed good association with EC, interferences from other aerosol sources should be considered when using this instrument to assess DPM.