Helical stent (SUPERA™) and drug-coated balloon (Passeo-18 Lux™) for recurrent cephalic arch stenosis: Rationale and design of arch V SUPERA-LUX Study.

BACKGROUND: The treatment options for cephalic arch stenosis are limited and standard of care remains at crossroads - none are ideal and there is currently no gold standard. Endovascular techniques are now the preferred primary therapeutic option because they are minimally invasive and better tolerated by haemodialysis patients who have multiple comorbidities. However, conventional plain old balloon angioplasty, bare metal stenting and stent grafts all have their limitations. The aim of this trial is to evaluate whether the helical SUPERA™ stent (Abbott Vascular, Santa Clara, CA, USA), which has a higher degree of flexibility and resistance to compressive forces compared to traditionally laser-cut nitinol stents, combined with a drug-coated balloon (Biotronik Passeo-18 Lux™) to minimize the neointimal hyperplasia effect, can improve patency and reduce reintervention rates. METHODS AND RESULTS: Arch V SUPERA-LUX is a pilot investigator-initiated single-centre, single-arm prospective study. Twenty patients with a brachiocephalic fistula within 6 months of initial plain old balloon angioplasty for significant cephalic arch stenosis will be recruited for treatment with SUPERA and drug-coated balloon. The primary objectives are immediate angiographic and procedural success, primary patency and functional fistula at 1 week, 8 weeks, 6 and 12 months. The results from eight patients treated prospectively as proof of concept have shown primary patency of 83.3% at 1 year with 100% technical and procedural success rates. Enrolment for the Arch V SUPERA-LUX study is expected to be completed at the end of 2019. CONCLUSION: The Arch V SUPERA-LUX study is the first trial to evaluate whether SUPERA stent implantation and drug-coated balloon use can provide superior protection against restenosis compared to traditional angioplasty, bare metal stents and stent grafts in recurrent cephalic arch stenosis. Initial pilot results are encouraging but longer follow-up is required to truly test this technique. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov NCT03891693.

Horizontal or vertical transmission of hepatitis B virus? A serological survey in family members of hepatitis B carriers in Singapore.

Hepatitis B serology was performed on 270 family members of 78 hepatitis B carriers and hepatitis B e antigen status determined in those found to be HBsAg positive. The mean age of index patients was 38 years (range 3-74) and that of family members was 28 years (range 1-71). 67 family members (25%) were HBsAg positive. The proportions of family members positive for HBsAg and those negative for HBsAg but positive for anti-HBs and/or anti-HBc were 25% and 20% for children, 10% and 68% for spouses, 36% and 26% for siblings and 29% and 55% for parents. For children of index parents the proportions positive for HBsAg and those negative for HBsAg but positive for anti-HBs and/or anti-HBc were similar whether the index patient was the mother (24% and 24%) or the father (26% and 18%). Our results suggest that horizontal transmission is a significant mode of spread of hepatitis B within the family in Singapore.

Morphology and properties of denture acrylic resins cured by microwave energy and conventional water bath.

OBJECTIVES: This study examined the influence of microwave energy levels on the morphology and properties of an impact resistant denture material poly(methyl methacrylate) with a thickness of 10 mm. METHODS: A microwave flask containing two resin blocks was processed at 80, 160, 240, and 560 W for 15, 10, 7, and 2 min, separately. Each Flask was then turned over, and cured for an additional 2 min at 560 W. The process using conventional methods was carried out at 70 degrees C for 9 h. The blocks were tested for hardness, porosity, flexural properties, solubility, and molecular weight. The morphology of the specimens after staining with osmium tetroxide was examined by transmission electron microscope. RESULTS: The changes in temperature with time were recorded during microwave heating at 80, 160, and 240 W, respectively. A significantly large difference in the curing temperature was observed when comparing these two processing methods. There was little difference in the mean values of surface hardness and the weight percent of the insoluble parts. The mean domain size and the volume fraction of the rubber phase favor of the water-bath method. However, the porosity in the water-bath-cured specimens was much less than that in the microwave-cured specimens. Thus, the conventionally cured specimens showed better flexural strength and flexural modulus than the microwave-cured specimens. SIGNIFICANCE: This study has shown that microwave energy can efficiently polymerize denture base polymer. Highly statistical differences in morphology and flexural properties favor of the water-bath method. Choice of a suitable microwave power and polymerization time is important in order to reduce porosity to a minimum level and increase the domain size and volume of the rubber phase.

Multiple endocrine neoplasia type 1--presenting with impotence.

A 35-year old man presented with a 4-year history of impotence. His past history was significant for hypercalcaemia, bilateral pyelolithotomies for renal calculi and parathyroidectomy for hyperparathyroidism. He had an episode of haemetemesis and malaena a year before being seen here. Endocrine investigations revealed hyperprolactinemia, hypergastrinemia and increased basal acid output. Magnetic resonance imaging of the brain was indicative of a pituitary microadenoma. Computed tomographic scan of the abdomen revealed a bulky pancreas which was suggestive of a gastrin-secreting islet cell tumour. This case illustrates an unusual presentation of multiple endocrine neoplasia type 1 (MEN-1) with impotence and hyperprolactinemia. A short review of the literature was done.

The diagnostic yield of upper gastrointestinal endoscopy in the investigation of anaemia.

Computer records of patients endoscoped over a 34-month period were studied to assess the diagnostic yield of gastrointestinal endoscopy in patients with anaemia. Patients with obvious gastrointestinal bleeding and known gastrointestinal pathology were excluded. On hundred and thirty-six patients were endoscoped for anaemia. Eighty-three of them (61%) had iron deficiency anaemia and 53 (39%) had other types of anaemia. The ages of the patients with iron deficiency anaemia (mean 56 years) were significantly lower than those of other anaemias (means 65 years), (p less than 0.003). Patient characteristics were otherwise comparable. There were significant endoscopic findings (ulcers, carcinoma and haemorrhagic or erosive gastritis) in 26 of 83 patients (31%) with iron deficiency anaemia, in 11 of 53 patients with other anaemias (21%) and 37 of 136 patients (27%) combined. Significant endoscopic findings were found in 506 of 2224 patients (23%) endoscoped during this period who were not anaemic, did not have obvious gastrointestinal haemorrhage and were not known to have gastrointestinal diseases. The diagnostic yield for iron deficiency anaemia was significantly higher than for the non anaemic group (p less than 0.05). There was no difference between the diagnostic yields of iron deficiency and other anaemias, other anaemias and the non anaemic group, or total anaemias and the non anaemic group. Gastrointestinal symptoms and history of analgesic or steroid usage did not appear to increase the incidence of gastrointestinal lesions in either iron deficiency anaemia or other anaemias. Twenty-three of 41 patients (56%) who had no cause for anaemia found at the end of all investigations were colonscoped.(ABSTRACT TRUNCATED AT 250 WORDS)

Primary biliary cirrhosis--an uncommon disease in Singapore.

Primary biliary cirrhosis (PBC) is uncommon in Singapore. Twelve consecutive patients with PBC were seen between 1987 and 1994 at the National University Hospital. Eleven were women and the mean age at presentation was 53 years. Three patients presented with pruritus and jaundice whilst three had decompensated cirrhosis. The remaining six patients had no symptoms attributed to their liver disease when first detected, three of them presented with associated conditions including sicca syndrome and interstitial lung fibrosis, lichen planus, and carcinoma of breast. All patients had elevated serum alkaline phosphatase and positive anti-mitochondrial antibodies. Liver histology (10/12) showed Stage II disease (2), Stage III (5) and Stage IV (3). Three patients also had co-existing gall bladder stones but their endoscopic retrograde cholangiograms were normal. The mean follow-up period was 32.6 months and four patients died during follow-up. The only male patient had liver transplantation, two patients had symptomatic treatment while the rest were treated with ursodeoxycholic acid. In conclusion, local patients tended to presented relatively early in the course of the disease with 50% being asymptomatic and in the precirrhotic Stages.

Seroprevalence of antibodies against hepatitis A (anti-HAV) in Singapore: the NFDD experience.

At the 4th National Foundation for Digestive Disease (NFDD) Day in 1991 where public lectures on prevention of hepatitis and early detection of hepatocellular carcinoma were given, screening of sera obtained from 364 registrants for antibodies to Hepatitis A (IgG) was undertaken. The overall sero-prevalence rate was 50%, with 55% for males and 46% for females with antibodies for HAV. None of the subjects below 20 years old had antibodies to HAV. This rose to 16% for those 21-30 years old and 92% for those above 61 years. This study shows that in Singapore, prevalence of anti-HAV antibodies rise with age and is approaching the low endemicity pattern that is seen in developed countries.

Seroprevalence of antibodies to the hepatitis C virus in Singapore.

The prevalence of antibodies to the hepatitis C virus (anti-HCV) in Singapore was assessed using a recombinant-based enzyme linked immunoassay system. 1004 serum samples were obtained from normal subjects (463), hemodialysis patients (112), hepatitis B virus (HBV) carriers (188), patients with hepatocellular carcinoma (HCC) (58) and patients with non-hepatitis B virus related liver diseases (183). Anti-HCV was found to be positive in 1.7% of healthy subjects, and in 20% of patients on regular hemodialysis. Three percent of HBV carriers were positive for anti-HCV. Twelve percent of patients with acute hepatitis with no known causes and 20% patients with chronic hepatitis with no known causes were positive for anti-HCV. Among patients with cirrhosis for which no known causes were found 33% were positive for anti-HCV. Thirty six percent of patients with HCC not associated with the presence of HBsAg were positive of anti-HCV. None of the patients with known causes of liver disease were positive for anti-HCV.

Reversal of azoospermia in an insulin dependent diabetic.

A 32-year old Chinese man with insulin dependent diabetes developed impotence and infertility with total azoospermia. The azoospermia was reversed following improved diabetic control with soluble insulin three times daily. With the reversal of azoospermia, his wife conceived five months later.

Hepatitis B vaccination in chronic renal failure patients undergoing haemodialysis: the immunogenicity of an increased dose of a recombinant DNA hepatitis B vaccine.

Thirty-two patients with end stage renal failure who were on haemodialysis and who had no previous exposure to hepatitis B virus were given four intramuscular injections of 40 micrograms (twice the recommended dose) recombinant DNA hepatitis B vaccine (Engerix B, Smith Kline Biologicals) at 0, 1, 2 and 6 months to determine the immunogenicity of this increased vaccine dose. The ages of these patients ranged from 23-54 years with a mean age of 40 years. There were 11 males and 21 females. Three patients underwent renal transplantation during the course of the study and were assessed separately. Antibody levels above 10 IU/L were noticed in 83% of the remaining 29 patients two months after the final dose with an anti-HBs geometric mean titre (GMT) of 2551 IU/L. The antibody response was 82% four months later although the GMT has fallen to 664 IU/L. Renal transplantation did not appear to affect the anti-HBs response to the above vaccination regime. None of the volunteers developed hepatitis B during the study. Our results were much better than results obtained in studies using twice the recommended doses given three times.

Comparison of culture and histology for the identification of Helicobacter pylori in endoscopic biopsies.

The aim of the study was to compare culture with microscopic examination of haematoxylin and eosin stained tissue sections in the identification of Helicobacter pylori in gastric antral mucosa. Duplicate gastric antral biopsies from 89 patients were cultured and examined histologically for H pylori. H pylori was cultured in 46 cases (51%) and identified histologically in 63 (71%). Results from the two tests concurred in 63 cases (71%). The presence of H pylori was strongly correlated with histological gastritis. Microscopic examination of haematoxylin and eosin stained tissue sections is therefore a reliable and convenient method of identifying H pylori.

Immunogenicity of a low dose recombinant DNA hepatitis B vaccine in healthy adults in Singapore.

The immunogenicity and safety of a standard dose of 10 micrograms of a yeast derived recombinant DNA hepatitis B vaccine (B-Hepavac II) was compared with that of a reduced dose of 5 micrograms in 84 healthy adult volunteers with no previous exposure to hepatitis B. Each subject received either a 10 micrograms or 5 micrograms dose of vaccine intramuscularly at 0, 1 and 6 months. One month after the second injection of vaccine the seroconversion rate in the two groups were 85 and 86 percent respectively. Two months after the third injection 100 percent of participants had sero-converted; 95 percent of the 10 micrograms group and 91 percent of the 5 micrograms group had titres of anti-HBs greater than 10 IU/L. The geometric mean titres (GMT) of anti-HBs levels at 2, 6, 8, and 12 months were 34, 61, 811 and 188 IU/L in the 10 micrograms group and 26, 45, 836 and 304 IU/L in the 5 micrograms group respectively. Adverse effects were mild and transient. The vaccine was safe and immunogenic in the doses given. The reduced dose of 5 micrograms was as effective as the standard 10 micrograms dose.

Chronic upper abdominal pain: site and radiation in various structural and functional disorders and the effect of various foods.

Pain site and radiation and the effect of various foods were studied prospectively in a consecutive series of patients with chronic upper abdominal pain. Patients followed for less than one year were excluded unless peptic ulcer or abdominal malignancy had been diagnosed or laparotomy had been carried out. A total of 632 patients were eligible for the first study and 431 for the second. Gastric ulcer pain was more likely to be left hypochondrial (17%) compared with pain from duodenal ulcer (4%) or from all other conditions (5%). It was less likely to be epigastric (54%) compared with duodenal ulcer pain (75%). Oesophageal pain was more likely to be both retrosternal and epigastric (25%) compared with non-oesophageal pain (2%). Radiation to the back was more common in peptic ulcer (31%) and biliary pain (35%) compared with functional pain (20%). Pain precipitation by fatty foods was commoner in biliary disease (40%) than in duodenal ulcer (11%), peptic ulcer (9%), or non-ulcer dyspepsia (19%). Orange, alcohol, and coffee precipitated pain more frequently in duodenal ulcer (41%, 50%, and 43% respectively) than in biliary disease (17%, 0%, and 14% respectively). Chilli precipitated pain in one quarter to one half of subjects regardless of diagnosis. Approximately one tenth of all subjects avoided chilli, curry, coffee, and tea because of medical or other advice.

Hepatitis B vaccination: half dose recombinant DNA hepatitis B vaccine (B-Hepavac II) is as immunogenic as the full recommended dose in healthy adults.

Sixty-seven healthy adult volunteers aged 20-40 years with no previous exposure to hepatitis B virus were randomized to receive either a 10 micrograms or 5 micrograms dose of recombinant DNA hepatitis B (HB) vaccine (B-Hepavac II) intramuscularly at 0, 1 and 6 months. Two months after the third injection 100% of subjects had seroconverted: 97% of the 10 micrograms group and 91% of the 5 micrograms group had antibody to HB surface antigen (anti-HBs) levels greater than 10 iu/L. The geometric mean titres (GMT) of anti-HBs levels at this time were 891 iu/L in the 10 micrograms dose group and 923 iu/L in the 5 micrograms dose group. These differences were not significant. Adverse effects included fever and mild pain at the injection site. The reduced dose of 5 micrograms was as effective as the standard 10 micrograms dose.