Final 5-Year Report of the Randomized BIO-RESORT Trial Comparing 3 Contemporary Drug-Eluting Stents in All-Comers.

Background In a previous trial, higher 5-year mortality was observed following treatment with biodegradable polymer Orsiro sirolimus-eluting stents (SES). We assessed 5-year safety and efficacy of all-comers as well as patients with diabetes treated with SES or Synergy everolimus-eluting stents (EES) versus durable polymer Resolute Integrity zotarolimus-eluting stents (ZES). Methods and Results The randomized BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) trial enrolled 3514 all-comer patients at 4 Dutch cardiac centers. Patients aged ≥18 years who required percutaneous coronary intervention were eligible. Participants were stratified for diabetes and randomized to treatment with SES, EES, or ZES (1:1:1). The main end point was target vessel failure (cardiac mortality, target vessel myocardial infarction, or target vessel revascularization). Five-year follow-up was available in 3183 of 3514 (90.6%) patients. The main end point target vessel failure occurred in 142 of 1169 (12.7%) patients treated with SES, 130 of 1172 (11.6%) treated with EES, versus 157 of 1173 (14.1%) treated with ZES (hazard ratio [HR], 0.89 [95% CI, 0.71-1.12], Plog-rank=0.31; and HR, 0.82 [95% CI, 0.65-1.04], Plog-rank=0.10, respectively). Individual components of target vessel failure showed no significant between-stent difference. Very late definite stent thrombosis rates were low and similar (SES, 1.1%; EES, 0.6%; ZES, 0.9%). In patients with diabetes, target vessel failure did not differ significantly between stent-groups (SES, 19.8%; EES, 19.2%; versus ZES, 21.1% [Plog-rank=0.69 and Plog-rank=0.63]). Conclusions Orsiro SES, Synergy EES, and Resolute Integrity ZES showed similar 5-year outcomes of safety and efficacy, including mortality. A prespecified stent comparison in patients with diabetes also revealed no significant differences in 5-year clinical outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01674803.

Gastrointestinal, influenza-like illness and dermatological complaints following exposure to floodwater: a cross-sectional survey in The Netherlands.

Extreme rainfall events may cause pluvial flooding, increasing the transmission of several waterborne pathogens. However, the risk of experiencing clinically overt infections following exposure to pluvial floodwater is poorly estimated. A retrospective cross-sectional survey was performed to quantify the occurrence of self-reported gastrointestinal, influenza-like illness (ILI) and dermatological complaints, and the frequency of visits to the general practitioner (GP), during a 4-week observation period following pluvial flooding at seven locations in The Netherlands. Questionnaires were sent to 817 flooded households, 149 (17%) of which returned the questionnaire reporting information for 199 participants. Contact with floodwater was significantly associated with increased occurrence of gastrointestinal [odds ratio (OR 4·44)], ILI (OR 2·75) and dermatological (OR 6·67) complaints, and GP visits (OR 2·72). Having hand contact with floodwater was associated with gastrointestinal and dermatological complaints, whereas ILI complaints were associated with being engaged in post-flooding cleaning operations and having walked/cycled through floodwater. This study shows that floodwater-associated diseases occur in urban settings following extreme rainfall events in a high-income country. As pluvial floods are expected to escalate in the future due to global climate change, further research is warranted to determine the disease burden of pluvial flooding and to assess the effect of different interventions, including raising awareness among stakeholders.

Risk factors and monitoring for water quality to determine best management practices for splash parks.

Splash parks have been associated with infectious disease outbreaks as a result of exposure to poor water quality. To be able to protect public health, risk factors were identified that determine poor water quality. Samples were taken at seven splash parks where operators were willing to participate in the study. Higher concentrations of Escherichia coli were measured in water of splash parks filled with rainwater or surface water as compared with sites filled with tap water, independent of routine inspection intervals and employed disinfection. Management practices to prevent fecal contamination and guarantee maintaining good water quality at splash parks should include selection of source water of acceptable quality.

Health risk assessment for splash parks that use rainwater as source water.

In the Netherlands, rainwater becomes more and more popular as an economic and environmentally sustainable water source for splash parks, however, the associated public health risk and underlying risk factors are unknown. Since splash parks have been associated with outbreaks of infectious diseases, a quantitative microbial risk assessment was performed using Legionella pneumophila as a target pathogen to quantify the risk of infection for exposure due to inhalation and Campylobacter jejuni for ingestion. Data for L. pneumophila and C. jejuni concentrations in rainfall generated surface runoff from streets were extracted from literature. Data for exposure were obtained by observing 604 people at splash parks, of whom 259 were children. Exposure volumes were estimated using data from literature to determine the volume of exposure through inhalation at 0.394 µL/min (95% CI-range 0.0446-1.27 µL/min), hand-to-mouth contact at 22.6 µL/min, (95% CI-range 2.02-81.0 µL/min), ingestion of water droplets at 94.4 µL/min (95% CI-range 5.1-279 µL/min) and ingestion of mouthfuls of water at 21.5·10(3) µL/min (95% CI-range 1.17 ·10(3)-67.0·10(3) µL/min). The corresponding risk of infection for the mean exposure duration of 3.5 min was 9.3·10(-5) (95% CI-range 0-2.4·10(-4)) for inhalation of L. pneumophila and 3.6·10(-2) (95% CI-range 0-5.3·10(-1)) for ingestion of C. jejuni. This study provided a methodology to quantify exposure volumes using observations on site. We estimated that using rainwater as source water for splash parks may pose a health risk, however, further detailed quantitative microbial analysis is required to confirm this finding. Furthermore we give insight into the effect of water quality standards, which may limit infection risks from exposure at splash parks.

Quantitative assessment of infection risk from exposure to waterborne pathogens in urban floodwater.

Flooding and heavy rainfall have been associated with waterborne infectious disease outbreaks, however, it is unclear to which extent they pose a risk for public health. Here, risks of infection from exposure to urban floodwater were assessed using quantitative microbial risk assessment (QMRA). To that aim, urban floodwaters were sampled in the Netherlands during 23 events in 2011 and 2012. The water contained Campylobacter jejuni (prevalence 61%, range 14- >10(3) MPN/l), Giardia spp. (35%, 0.1-142 cysts/l), Cryptosporidium (30%, 0.1-9.8 oocysts/l), noroviruses (29%, 10(2)-10(4) pdu/l) and enteroviruses (35%, 10(3)-10(4) pdu/l). Exposure data collected by questionnaire, revealed that children swallowed 1.7 ml (mean, 95% Confidence Interval 0-4.6 ml) per exposure event and adults swallowed 0.016 ml (mean, 95% CI 0-0.068 ml) due to hand-mouth contact. The mean risk of infection per event for children, who were exposed to floodwater originating from combined sewers, storm sewers and rainfall generated surface runoff was 33%, 23% and 3.5%, respectively, and for adults it was 3.9%, 0.58% and 0.039%. The annual risk of infection was calculated to compare flooding from different urban drainage systems. An exposure frequency of once every 10 years to flooding originating from combined sewers resulted in an annual risk of infection of 8%, which was equal to the risk of infection of flooding originating from rainfall generated surface runoff 2.3 times per year. However, these annual infection risks will increase with a higher frequency of urban flooding due to heavy rainfall as foreseen in climate change projections.

Human exposure to endotoxins and fecal indicators originating from water features.

Exposure to contaminated aerosols and water originating from water features may pose public health risks. Endotoxins in air and water and fecal bacteria in water of water features were measured as markers for exposure to microbial cell debris and enteric pathogens, respectively. Information was collected about wind direction, wind force, distance to the water feature, the height of the water feature and the tangibility of water spray. The mean concentration of endotoxins in air nearby and in water of 31 water features was 10 endotoxin units (EU)/m(3) (Geometric Mean (GM), range 0-85.5 EU/m(3) air) and 773 EU/mL (GM, range 9-18,170 EU/mL water), respectively. Such mean concentrations may be associated with respiratory health effects. The water quality of 26 of 88 water features was poor when compared to requirements for recreational water in the Bathing Water Directive 2006/7/EC. Concentrations greater than 1000 colony forming units (cfu) Escherichia coli per 100 mL and greater than 400 cfu intestinal enterococci per 100 mL increase the probability of acquiring gastrointestinal health complaints. Regression analyses showed that the endotoxin concentration in air was significantly influenced by the concentration of endotoxin in water, the distance to the water feature and the tangibility of water spray. Exposure to air and water near water features was shown to lead to exposure to endotoxins and fecal bacteria. The potential health risks resulting from such exposure to water features may be estimated by a quantitative microbial risk assessment (QMRA), however, such QMRA would require quantitative data on pathogen concentrations, exposure volumes and dose-response relationships. The present study provides estimates for aerosolisation ratios that can be used as input for QMRA to quantify exposure and to determine infection risks from exposure to water features.

Isolation of Legionella pneumophila from pluvial floods by amoebal coculture.

Viable Legionella pneumophila bacteria were isolated by amoebal coculture from pluvial floods after intense rainfall and from water collected at sewage treatment plants. Several isolated L. pneumophila strains belonged to sequence types that have been previously identified in patients.

[Direct enteral reinfusion of secretions produced in the upper part of the digestive tract]. / Directe enterale reïnfusie van secreties geproduceerd in de hogere digestieve tractus.

Two techniques are presented by which secretions from the upper intestinal tract are reinfused directly, into a more distal part of the intestine. The advantages of the methods described includes: no severe bacterial contamination; the enteral nutrition going on; the possibility to break off progressively; less needs of biochemical correction or compensation; no needs to take into account the production-rate or the release of gas.