Postmarketing surveillance in patients with cardiac pace-makers or automatic implantable defibrillators

This article includes an overview of the actual French control and regulation system of the safety alerts involving pacemakers and implantable cardioverter-defibrillator and an evaluation of the general information and trends about the characteristics of the reported incidents obtained in the last years in that field. The national security agencies have the mission to collect the data on safety and efficacy of medical devices but manufacturers, physicians and patients also have a role to play. The technical appreciation of the necessity of a notification is not easy in some cases but the lack of notification of a severe incident may lead to heavy penal consequences. If doubtful cases, one should keep in mind the spirit of these safety systems: a collective insurance against the risks related to the use of medical devices. In the 10 last years, the annual advisory rate was increased. The pacemakers were recalled more frequently than implantable cardioverter-defibrillators in absolute value but less frequently in relative value (advisories per 100 person-years). This increase may be related to the growing number of device implants and expanding indications for device therapy, to the increasing sophistication of the devices and to the modifications in the regulation aspects of these problems with a closer attention of users and physicians to the several types of malfunctions.     

Clinical Hepatic Impairment after the Duodenal Switch

Background: Nonalcoholic steatohepatitis (NASH) is the most common histological finding in morbidly obese patients undergoing liver biopsy. Biliopancreatic diversion has been widely used for the treatment of morbid obesity and hepatic steatosis, and very few cases of liver impairment as a complication of this operation have been reported. Methods: During the last 9 years, 470 morbidly obese patients were operated by means of a biliopancreatic diversion with duodenal switch ( BPD-DS), and 93 of them were performed laparoscopically. Results: 10 cases of clinical hepatic impairment occurred after the BPD-DS. The clinical course of these patients ranged from transient subclinical alterations of liver function tests to severe cases of jaundice and one death from liver failure. Conclusion: Randomized prospective studies with standardization of BPD-DS are needed, to know the real incidence of hepatic impairment and the proper treatment for this condition. Careful follow-up and correction of possible malnutrition should be addressed to avoid hepatic impairment and/or progression of liver disease.     

Invasive disease caused by Haemophilus influenzae: the sensitivity of statutory reporting

PURPOSE: The objective of the study was to investigate the sensitivity of the statutory reporting of Haemophilus influenzae invasive disease (HIID) during the period between 1996 and 1997 in Catalonia, Spain. METHODS: The incidence of HIID reported passively by clinicians was compared with the cases detected by a system of microbiological surveillance. In all cases isolated, the age of the patient, the clinical form and the serotype were investigated. RESULTS: Sixty-six cases were passively reported and 111 were detected by microbiological surveillance. Overall sensitivity of reporting was 59.5% (95% CI, 50.7-69.1), with differences being observed according to the variables studied. The highest values were obtained in children under 5 years (87.8%; 95% CI, 73.7-95.9), in cases with meningitis and/or sepsis (64.3%; 95% CI, 50.4-76.6) and in serotype b (73.0%; 95% CI, 60.3-83.4). In the logistical regression analysis, only age under 5 years was associated with greater reporting (OR= 9.8; 95% CI, 2.5-37.8). CONCLUSIONS: Reported morbidity in children under 5 years is a good estimate of the true incidence of HIID in Catalonia (underreporting was 12.2%), but not for those above this age in whom the underreporting was 57.2%.     

Kinematics of treadmill locomotion in rats conceived, born, and reared in a hypergravity field (2 g). Adaptation to 1 g

The kinematics of treadmill locomotion in rats conceived, born, and raised in a hypergravity environment (HG: 2 g) until the age of 3 months was investigated for 5 weeks after their exposition to earth’s gravity. The locomotor performance of the HG rats (N=7) was compared to that of age-matched control rats (N=8) housed at 1 g for the same period. Kinematic analysis of treadmill locomotion was performed up to 35 days of terrestrial life by an optoelectronic motion analyzer (ELITE system). Results showed that the HG rats exhibited a faster locomotor rhythm (increased number of steps/s), walked closer to the ground, and had a more dorsiflexed foot position. Also, HG rats had shorter steps. The data also highlight a fast adaptation to normal gravity since all the locomotor parameters returned to normal values within 3 weeks. The locomotor modifications may be seen as the persistence of a hypergravity-induced posturo-locomotor adaptation in the centrifuge and/or to more functional changes of sensorimotor systems. Because locomotor performance of HG rats is not severely affected, it is concluded that early development of locomotion processes is highly resistant to gravito-inertial changes.     

Expression of the nucleoprotein of the Puumala virus from the recombinant Semliki Forest virus replicon: characterization and use as a potential diagnostic tool

Puumala virus (Bunyaviridae family, Hantavirus genus) causes a mild form of hemorrhagic fever with renal syndrome (HFRS) called nephropathia epidemica in northern and central Europe. Serological tests are used for diagnosis, but antigen production is difficult because the virus grows poorly in tissue culture. We expressed the N protein (nucleoprotein) of Puumala virus via the Semliki Forest virus (SFV) replicon in mammalian cells and compared its antigenic properties with those of the native antigen derived from Puumala virus-infected cells. Detection of immunoglobulin G or immunoglobulin M by enzyme-linked immunosorbent assay (ELISA), micro -capture ELISA, and indirect immunofluorescence assay was (at least) as effective with the recombinant antigen as with the native antigen when HFRS patient sera or organ washes from wild rodents were tested. No nonspecific reaction was observed. Thus, the SFV-expressed N protein of Puumala virus appears as a valid antigen, specific and sensitive for serological investigations.     

Stewart-Treves syndrome following mastectomy for breast cancer: a case report

INTRODUCTION: Stewart-Treves syndrome has been defined by the eponymous authors as a lymphangiosarcoma in a setting of postmastectomy upper extremity lymphoedema. EXEGESIS: The clinical record of one patient with Stewart-Treves syndrome is analyzed. The primary angiosarcoma of the skin represented by a purple nodule occurred on a chronic lymphoedematous arm following radical mastectomy and axillary lymph node dissection for breast carcinoma performed 9 years earlier. Immunohistochemistry tests formally eliminated epithelial cutaneous metastasis and produced evidence in favour of conjunctive vascular tissue origin of the tumor. CONCLUSION: Conservative surgery for breast cancer, application of axillary sentinel node biopsy in the lymphatic staging and prevention of arm lymphoedema should reduce the incidence of this syndrome.     

Direct diagnosis by DNA analysis of the fragile X syndrome of mental retardation

BACKGROUND. The fragile X syndrome, the most common form of inherited mental retardation, is caused by mutations that increase the size of a specific DNA fragment of the X chromosome (in Xq27.3). Affected persons have both a full mutation and abnormal DNA methylation. Persons with a smaller increase in the size of this DNA fragment (a premutation) have little or no risk of retardation but are at high risk of having affected children or grandchildren. The passage from premutation to full-mutation status occurs only with transmission from the mother. We have devised a method of identifying carriers of these mutations by direct DNA analysis. METHOD. We studied 511 persons from 63 families with the fragile X syndrome. Mutations and abnormal methylation were detected by Southern blotting with a probe adjacent to the mutation target. Analysis of EcoRI and EagI digests of DNA distinguished clearly in a single test between the normal genotype, the premutation, and the full mutation. RESULTS. DNA analysis unambiguously established the genetic status at the fragile X locus for all samples tested. This method was much more powerful and reliable than cytogenetic testing or segregation studies with closely linked polymorphic markers. The frequency of mental retardation in persons with premutations was similar to that in the general population, whereas all 103 males and 31 of 59 females with full mutations had mental retardation. About 15 percent of those with full mutations had some cells carrying only the premutation. All the mothers of affected children were carriers of either a premutation or a full mutation. CONCLUSIONS. Direct diagnosis by DNA analysis is now an efficient and reliable primary test for the diagnosis of the fragile X syndrome after birth, as well as for prenatal diagnosis and genetic counseling.     

An analysis of inpatient pediatric sickle cell disease: Incidence,costs, and outcomes

1 Objective

To identify characteristics of pediatric sickle cell disease (SCD) hospitalizations and to examine admission demographics and medical expenditures.

2 Methods

Admissions with SCD were identified from the 2009 and 2012 releases of the Healthcare and Cost Utilization Project's Kids Inpatient Database. Disease‐specific secondary diagnoses including acute chest syndrome (ACS), vaso‐occlusive pain crisis (VOC), splenic sequestration, and stroke/transient ischemic attack were analyzed for patient and hospital demographics. Analytical endpoints included total healthcare expenditures and mortality.

3 Results

We reviewed 75,234 inpatient hospitalizations with a diagnosis of SCD. Over $900,000,000 was spent annually in associated healthcare expenditure. The median length of hospitalization stay (LOS) for all admissions was 3 days (interquartile range [IQR] 2–5 days). VOC was the most frequent secondary diagnosis, recording 48,698 total hospitalizations and a median LOS of 3 days (IQR 2–6 days). Of the 8,490 hospitalizations with ACS, the infant population had a significantly higher mortality rate compared to other age groups (2% vs. 0.3%, P < 0.001). Cerebral vascular accidents incurred the second highest median hospitalization cost ($18,956), behind ACS ($22,631). A high proportion of Caucasian patients died during hospitalization for VOC (0.4% vs. 0.1%, P = 0.014) and ACS (4% vs. 0.2%, P < 0.001) when compared to non‐Caucasians.

4 Conclusion

Inpatient hospitalizations for secondary manifestations of pediatric SCD were associated with significant healthcare expenditures. Patients with an increased statistical risk for death during hospitalization included Caucasians with SCD complications of ACS and VOC, and patients <1‐year‐old with ACS. Further research is needed to substantiate the associated clinical significance of these findings.     

Gastroesophageal reflux disease,obesity and laparoscopic sleeve gastrectomy: The burning questions

Obesity is a global health epidemic with considerable economic burden.Surgical solutions have become increasingly popular following technical advances leading to sustained efficacy and reduced risk.Sleeve gastrectomy accounts for almost half of all bariatric surgeries worldwide but concerns regarding its relationship with gastroesophageal reflux disease(GERD)has been a topic of debate.GERD,including erosive esophagitis,is highly prevalent in the obese population.The role of pre-operative endoscopy in bariatric surgery has been controversial.Two schools of thought exist on the matter,one that believes routine upper endoscopy before bariatric surgery is not warranted in the absence of symptoms and another that believes that symptoms are poor predictors of underlying esophageal pathology.This debate is particularly important considering the evidence for the association of laparoscopic sleeve gastrectomy(LSG)with de novo and/or worsening GERD compared to the less popular Roux-en-Y gastric bypass procedure.In this paper,we try to address 3 burning questions regarding the inter-relationship of obesity,GERD,and LSG:(1)What is the prevalence of GERD and erosive esophagitis in obese patients considered for bariatric surgery?(2)Is it necessary to perform an upper endoscopy in obese patients considered for bariatric surgery?And(3)What are the long-term effects of sleeve gastrectomy on GERD and should LSG be done in patients with pre-existing GERD?