Does the rate of inappropriate therapy differ in implantable cardioverter–defibrillators from different manufacturers?

Objective We conducted this study to compare the rate of ≥1 inappropriate therapy between ICDs from two manufacturers which use different discriminatory protocols. Method One hundred sixty two patients (mean age 58 ± 13 years, 126 male) who received ICDs between January 2001 and 2005 were included in the study. Clinical, electrocardiographic, and ICD stored data and electrograms were collected and analyzed. Immediately after implantation all the detection and discrimination criteria were activated with the nominal values in order to compare the two discriminatory protocols under the default manufacturer’s settings. Results During the follow up period of 14.3 ± 10 months, 49 (30%) patients received ≥1 inappropriate ICD therapy. The rate of ≥1 inappropriate ICD therapy in manufacturer A and B ICDs was 26% (n = 29) and 41% (n = 20), respectively. Comparing the rate of ≥1 inappropriate ICD therapy between the two groups by Kaplan–Meier analysis and the log rank test resulted in P = 0.04. Conclusion Having all discriminatory variables activated with the nominal values, discriminatory performance differs between the two manufacturers. Further larger-scale studies are warranted to prospectively compare the performance of various available ICDs’ discriminatory protocols, and define the optimum combination of discriminators in each ICD to decrease the rate of inappropriate therapy.     

Efficacy of clofibrate on severe neonatal jaundice associated with glucose-6-phosphate dehydrogenase deficiency (a randomized clinical trial)

Glucose-6-phosphate dehydrogenase (G6PD) deficiency may cause severe hyperbilirubinemia with bilirubin encephalopathy unless intervention is initiated. The aim of this study was to assess the efficacy of clofibrate in full term G6PD deficient neonates with jaundice. A randomized clinical trial study was performed in two groups of full-term G6PD deficient jaundiced neonates (clofibrate treated group, n = 21; control group, n = 19). Infants in the clofibrate group received a single oral dose of 100 mg/kg clofibrate, whereas control group received nothing. Both groups were treated with phototherapy. Serum total and direct bilirubin levels were measured at the onset of treatments, 16, 24 and 48 hours later. On enrollment, the mean total serum bilirubin (TSB) level in the clofibrate treated group was 18.40 +/- 2.41 and in the control group was 17.49 +/- 1.03 (p = 0.401). At 16, 24 and 48 hours of treatment, the mean TSB in the clofibrate group were 15.2 +/- 1.9, 12.6 +/- 2.4, and 10.1 +/- 2.4 and in the control group were 16.5 +/- 1.2, 13.3 +/- 2.2 and 11.4 +/- 2.4, respectively (p = 0.047). At 48 hours, 7 (33%) cases in the clofibrate group and one (5%) case in the control group were discharged with a TSB < 10 mg/dl (p = 0.031). No side effects were observed on serial examinations during hospitalization, or on the 1st and 7th days after discharge. The results show that clofibrate induces a faster decline in serum total bilirubin level, a shorter duration of phototherapy, and hospitalization with no side effects in full-term G6PD deficient neonates with jaundice.     

Association of Long-Term Diet Quality with Hippocampal Volume: Longitudinal Cohort Study

BACKGROUND

Diet quality is associated with brain aging outcomes. However, few studies have explored in humans the brain structures potentially affected by long-term diet quality. We examined whether cumulative average of the Alternative Healthy Eating Index 2010 (AHEI-2010) score during adult life (an 11-year exposure period) is associated with hippocampal volume.

Post-transplant infections: single center experience from the developing world.

OBJECTIVE: To describe our experience of post-transplant infections in allogeneic stem cell transplants at the Armed Forces Bone Marrow Transplant Centre, Rawalpindi, Pakistan. METHODS: From July 2001 to September 2006, patients with malignant and non-malignant hematological disorders having human leukocyte antigen (HLA)-matched sibling donors were selected for transplant. Pre-transplant infection surveillance was carried out, and strict prophylaxis against infection was observed. After admission to the hospital, patients were kept in protective isolation rooms, equipped with a HEPA filter positive-pressure laminar airflow ventilation system. Bone marrow and/or peripheral blood stem cells were used as the stem cell source. Cyclosporin and prednisolone were used as prophylaxis against graft-versus-host disease (GVHD). The engraftment was monitored with cytogenetic/molecular analysis and change of blood group. Survival was calculated from the date of transplant to death or last follow-up. RESULTS: One hundred and fifty-four patients received allogeneic stem cell transplants from HLA-matched siblings for various hematological disorders at the Armed Forces Bone Marrow Transplant Centre, Rawalpindi, Pakistan between July 2001 and September 2006. Indications for transplant included aplastic anemia (n=66), beta-thalassemia major (n=40), chronic myeloid leukemia (n=33), acute leukemia (n=8), and miscellaneous disorders (n=7). One hundred and twenty patients were male and 34 were female. The median age of the patient cohort was 14 years (range 1 1/4-54 years). One hundred and thirty-six patients and 135 donors were cytomegalovirus (CMV) IgG-positive. One hundred and forty patients (90.9%) developed febrile episodes in different phases of post-transplant recovery. Infective organisms were isolated in 150 microbiological culture specimens out of 651 specimens from different sites of infections (23.0% culture positivity). Post-transplant infections were confirmed in 120 patients (77.9%) on the basis of clinical assessment and microbiological, virological, and histopathological examination. Mortality related to infections was 13.0%. Fatal infections included CMV disease (100% mortality, 6/6), disseminated aspergillosis (66.7% mortality, 4/6), pseudomonas septicemia (42.9% mortality, 9/21), and tuberculosis (25% mortality, 1/4). CONCLUSIONS: More than 90% of our patients developed febrile episodes with relatively low culture yield. The majority of infections were treated effectively, however CMV, aspergillosis, and pseudomonas infections remained problematic with high mortality.     

Spinal Manipulation for Subacute and Chronic Lumbar Radiculopathy: A Randomized Controlled Trial

ObjectiveWe evaluated the efficacy of spinal manipulation for the management of nonacute lumbar radiculopathy.MethodsIn a university hospital we performed a randomized controlled trial with 2 parallel arms. Patients (n = 44) with unilateral radicular low back pain lasting more than 4 weeks were randomly allocated to manipulation and control groups. The primary outcome was the intensity of the low back pain on a visual analog scale. The secondary outcome was the Oswestry Disability Questionnaire score. We also measured spinal ranges of motion. The assessments were carried out at the baseline, immediately after intervention, and at 3 months’ follow-up. All patients underwent physiotherapy. The manipulation group received three sessions of manipulation therapy 1 week apart. For manipulation, we used Robert Maigne's technique.ResultsBoth groups experienced a decrease in back and leg pain significantly (all P ≤ 0.003). However, only the manipulation group showed significantly favorable results in the Oswestry scores (P < 0.001), and the straight leg raise test (P = 0.001). All ranges of motion increased significantly with manipulation (all P < 0.001), but the control group showed favorable results only in right and left rotations and in extension (all P < 0.001). Between-group analyses showed significantly better outcomes for manipulation in all measurements (all P ≤ 0.009) with large effect sizes.ConclusionSpinal manipulation improves the results of physiotherapy over a period of 3 months for patients with subacute or chronic lumbar radiculopathy.     

Investigational agents for treatment of traumatic brain injury

Introduction: Traumatic brain injury (TBI) is a major cause of death and disability worldwide. To date, there are no pharmacologic agents proven to improve outcomes from TBI because all the Phase III clinical trials in TBI have failed. Thus, there is a compelling need to develop treatments for TBI.

Areas covered: The following article provides an overview of select cell-based and pharmacological therapies under early development for the treatment of TBI. These therapies seek to enhance cognitive and neurological functional recovery through neuroprotective and neurorestorative strategies.

Expert opinion: TBI elicits both complex degenerative and regenerative tissue responses in the brain. TBI can lead to cognitive, behavioral, and motor deficits. Although numerous promising neuroprotective treatment options have emerged from preclinical studies that mainly target the lesion, translation of preclinical effective neuroprotective drugs to clinical trials has proven challenging. Accumulating evidence indicates that the mammalian brain has a significant, albeit limited, capacity for both structural and functional plasticity, as well as regeneration essential for spontaneous functional recovery after injury. A new therapeutic approach is to stimulate neurovascular remodeling by enhancing angiogenesis, neurogenesis, oligodendrogenesis, and axonal sprouting, which in concert, may improve neurological functional recovery after TBI.     

Automatic Computation of Left Ventricular Volume Changes Over a Cardiac Cycle from Echocardiography Images by Nonlinear Dimensionality Reduction

Curve of left ventricular (LV) volume changes throughout the cardiac cycle is a fundamental parameter for clinical evaluation of various cardiovascular diseases. Currently, this evaluation is often performed manually which is tedious and time consuming and suffers from significant interobserver and intraobserver variability. This paper introduces a new automatic method, based on nonlinear dimensionality reduction (NLDR) for extracting the curve of the LV volume changes over a cardiac cycle from two-dimensional (2-D) echocardiography images. Isometric feature mapping (Isomap) is one of the most popular NLDR algorithms. In this study, a modified version of Isomap algorithm, where image to image distance metric is computed using nonrigid registration, is applied on 2-D echocardiography images of one cycle of heart. Using this approach, the nonlinear information of these images is embedded in a 2-D manifold and each image is characterized by a symbol on the constructed manifold. This new representation visualizes the relationship between these images based on LV volume changes and allows extracting the curve of the LV volume changes automatically. Our method in comparison to the traditional segmentation algorithms does not need any LV myocardial segmentation and tracking, particularly difficult in the echocardiography images. Moreover, a large data set under various diseases for training is not required. The results obtained by our method are quantitatively evaluated to those obtained manually by the highly experienced echocardiographer on ten healthy volunteers and six patients which depict the usefulness of the presented method.