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Saturday, August 31, 2019

ESC: New guidance on potentially fatal blood clots published

The European Society of Cardiology (ESC) Guidelines on acute pulmonary embolism are published online today in European Heart Journal(1), and on the ESC website.(2) They were developed in collaboration with the European Respiratory Society (ERS).
Acute pulmonary embolism is the third most common cause of cardiovascular death in Europe, after heart attack and stroke, contributing to more than 350,000 deaths each year. A blood clot (thrombus) in a deep vein, usually in the legs, is dislodged and travels to the lungs where it blocks one or more vessels. This typically occurs if the vein wall is damaged, blood flow is too slow, or the blood becomes too thick.
Major surgery such as knee or hip replacement, serious injury, prolonged bed rest and cancer are common risk factors for acute pulmonary embolism. It can also happen after long travel and in women who are pregnant or taking the oral contraceptive pill.
“Symptoms including shortness of breath and chest pain resemble other diseases so the diagnosis is often missed, or the severity of the situation is underestimated, and many patients die before getting appropriate therapy,” said Professor Stavros Konstantinides, Chairperson of the guidelines Task Force and medical director, Centre for Thrombosis and Haemostasis, Johannes Gutenberg University Mainz, Germany.
The guidelines clarify how to diagnose acute pulmonary embolism step by step. The process begins with clinical suspicion based on symptoms combined with blood tests (D-dimers). Depending on the severity and urgency of the scenario, a computed tomography (CT) scan may be used to visualise the lung vessels, or cardiac ultrasound to look at the heart chambers.
A new table shows how CT scans and lung scans compare in their ability to diagnose or exclude pulmonary embolism, and how much radiation the patient receives with each of these tests.
“The aim is to get to the diagnosis as reliably and quickly as possible, in order to start lifesaving therapy and prevent other clots from reaching the lungs,” said Professor Guy Meyer, Co-Chairperson of the guidelines Task Force and respiratory medicine physician, Hôpital Européen Georges-Pompidou, Paris, France.
Anticoagulant drugs (blood thinners) help the body dissolve clots and reopen the blocked vessels. If the patient is in shock and about to collapse, the clot must be removed immediately, and this can be achieved using thrombolytic drugs (clot busters), catheters, or surgery.
The guidelines recommend how to judge the severity of pulmonary embolism based on a combination of clinical, imaging and laboratory results. This will dictate whether blood thinners alone are sufficient or if clot busters, a catheter intervention, or surgical removal is necessary. There is new advice on how to distinguish, in the CT scan, fresh thrombi in the lungs from chronic obstructions due to a disease called chronic thromboembolic pulmonary hypertension (CTEPH), which requires a different type of therapy.
Also new is the guidance on which drugs to use in a patient with pulmonary embolism and cancer. Patients with cancer have a high risk of recurrence, and indefinite anticoagulation is often necessary.
Acute pulmonary embolism is a leading cause of maternal death in high-income countries, but diagnosis can be challenging because symptoms often overlap with those of normal pregnancy. Novel recommendations outline how to diagnose and treat pulmonary embolism in the pregnant patient.
Updated instructions state when it is safe to send patients home from the hospital. Some have a lifelong increased risk of another event. Anticoagulants are used to treat the acute episode and prevent recurrence but raise the risk of bleeding. The guidelines describe how to decide the duration of treatment. They also specify when and how (with which tools and tests) to follow patients, and which findings suggest chronic disease (CTEPH) requiring diagnosis and treatment in an expert centre.
Last but not least, the 2019 ESC Guidelines endorse a multidisciplinary approach to pulmonary embolism after the acute phase and discharge of the patient. Teams should include physicians, appropriately qualified nurses, and other allied health professionals, aiming to ensure smooth transitions between hospital specialists and practitioners, optimised long term care and prevention of recurrence.
Advice for patients
  • Be aware of conditions that predispose to acute pulmonary embolism.
  • If you are at increased risk or have previously had pulmonary embolism or deep vein thrombosis, and are admitted to hospital for another disease, ask what is being done to prevent thrombosis.
  • If you have one or more risk factors for pulmonary embolism and feel shortness of breath, chest discomfort or chest pain, lightheaded or faint, call a doctor or ambulance immediately. Lie down and do not move around. Do not walk or drive to the hospital or physician’s practice.
  • If you had an acute pulmonary embolism and are on blood thinners, when you are discharged from hospital ask when you need to see a doctor again. At the follow-up visit, report any bleeding and whether you have returned to normal or still have symptoms such as shortness of breath.
###

Authors: ESC Press Office
Mobile: +33 (0) 7 8531 2036
Email: press@escardio.org

The hashtag for ESC Congress 2019 together with the World Congress of Cardiology is #ESCCongress
Funding: None.
Disclosures: The disclosure forms of all experts involved in the development of these guidelines are available on the ESC website http://www.escardio.org/guidelines.

Dorian update, Aug. 31, 6 pm — Carnival Corp

URGENT – PORTMIAMI CLOSED FOR INBOUND TRAFFIC – CARNIVAL HORIZON 9/01/19 CRUISE DELAYED. SEE UPDATE BELOW.
Our Fleet Operations Center in Miami is actively monitoring Hurricane Dorian’s potential impact on the departures listed below. Given that storms can be so uncertain, this information reflects our plan for these sailings based on the current forecast.
As the safety of our guests and crew is our number one priority, we will continue to keep an eye on the storm and factor in guidance from the National Hurricane Center, U.S. Coast Guard and the local port authorities to provide timely updates as more information becomes available.
The following homeports and ships remain under watch:
CHARLESTON
Carnival Sunshine 09/02/19 – No change to itinerary, we plan to operate as scheduled. Please sign up for text alerts by texting CCL3 to CRUISE (278473).
FORT LAUDERDALE (PORT EVERGLADES)
Carnival Magic 08/31/19 – No change to itinerary; we plan to operate as scheduled. Please sign up for text alerts by texting CCL9 to CRUISE (278473).
JACKSONVILLE
Carnival Ecstasy 08/31/19 – No change to itinerary; we plan to operate as scheduled.
Carnival Ecstasy 09/05/19 – Still evaluating. Please sign up for text alerts by texting CCL12 to CRUISE (278473).
There is a possibility Carnival Ecstasy will not be able to return to Jacksonville on Thursday. If the port is closed, the ship will be in position to dock as soon as the authorities have reopened the port.
PORT CANAVERAL
Port Canaveral is expected to be closed on Sunday through the middle of next week. We are optimistic the port will reopen by Thursday.
Carnival Breeze 08/31/19 – No change to itinerary; we plan to operate as scheduled. Please sign up for text alerts by texting CCL10 to CRUISE (278473).
Carnival Liberty 09/02/19 – This cruise is cancelled. Guests will receive a full refund of their cruise fare and any pre-purchased items. More details to follow in our email.
Carnival Elation 09/02/19 – This cruise will now operate as a 2 day sailing, departing September 5th and returning September 7th with a visit to Nassau. Guests who sail will receive a pro-rated refund of their cruise fare and any pre-purchased beverage and Wi-Fi packages. Guests who wish to cancel will receive a future cruise credit for the full amount of their cruise fare. An email with additional details will follow.

American Beef Packers Recalls Products Deemed Unfit for Human Consumption

American Beef Packers, Inc., a Chino, Calif. establishment, is recalling approximately 24,428 pounds of raw beef products that are deemed unfit for human consumption, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
FSIS inspection personnel retained the carcass and collected a sample for further analysis. Prior to test results being received, the carcass was erroneously released and further processed into raw intact and non-intact beef products, which were distributed in commerce.
The raw beef items were produced and packaged on Aug. 21, 2019. The following products are subject to recall: [View Labels (PDF only)]
  • Bulk pack combo bins containing ‘AMERICAN BEEF PACKERS 85 BONELESS BEEF CHUCKS’ with LOT NO.110 and BIN No. 85 and BIN No. 86.
  • Bulk pack combo bins containing ‘AMERICAN BEEF PACKERS 90 BONELESS BEEF’ with LOT NO. 110 and BIN No. 81, BIN No. 82 and BIN No. 83.
  • Bulk pack combo bins containing ‘AMERICAN BEEF PACKERS 85 BONELESS BEEF’ with LOT NO. 25-110 and BIN No. 84 and LOT NO 110 and BIN No. 88.
  • Cases containing ‘AMERICAN BEEF PACKERS RIBEYE 8/10 #1’ with codes BT190821-1178, BT190821-1185, BT190821-1188, BT190821-1190, and BT190821-1194.
  • 66.2-lb. case containing ‘AMERICAN BEEF PACKERS RIBEYE 10 UP #1’ with code BT190821-1186.
  • Bulk pack combo bin containing ‘AMERICAN BEEF PACKERS 90 BONELESS BEEF SIRLOINS’ with LOT NO. 24-110 and BIN No. 80.
  • Cases containing ‘AMERICAN BEEF PACKERS TERDERLOIN 4 UP’ with codes BT190821-1160, BT190821-1161, BT190821-1162, BT190821-1163, BT190821-1167, BT190821-1168, BT190821-1169, and BT190821-1170.
  • Cases containing ‘AMERICAN BEEF PACKERS RIBEYE 10 UP’ with codes BT190821-1187 and BT190821-1192.
  • Cases containing ‘AMERICAN BEEF PACKERS TENDERLOIN 3/4’ with codes BT190821-1155, BT190821-1157, BT190821-1171, BT190821-1200, BT190821-1201, BT190821-1202, BT190821-1203, BT190821-1204, and BT190821-1205.
  • 50-lb. cases containing ‘AMERICAN BEEF PACKERS DESC: BEEF FOR FURTHER PROCESSING 75/25’ with lot code 08347412719.
The products subject to recall bear establishment number ‘EST. 34741′ inside the USDA mark of inspection. These items were shipped to federal establishments in California and Oregon.
The firm notified FSIS on Aug. 30, 2019 that a carcass that was pending laboratory results had been erroneously released and further processed into raw intact and non-intact beef products.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.
FSIS is concerned that some product may be frozen and consumers’ refrigerators or freezers or both. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.
Consumers and members of the media with questions about the recall can contact Kari Godbey Houchens, Regulatory Manager, American Beef Packers, Inc. at (909) 628-4888 ext. 123.
Consumers with food safety questions can ‘Ask Karen,’ the FSIS virtual representative available 24 hours a day at AskKaren.gov or via smartphone at m.askkaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from 10 a.m. to 6 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day. The online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at: http://www.fsis.usda.gov/reportproblem.

NYC bicyclists are killing pedestrians and the city won’t stop it

Mayor Bill de Blasio has aggressively pushed a bike-friendly agenda, adding about 100 miles of dedicated lanes for cyclists amid a spike in rider collisions, but he’s done little to address the danger that bikers themselves pose.
Since 2011, bicyclists have injured more than 2,250 pedestrians — including at least seven who died — according to stats from the city Department of Transportation and published reports.
Injuries are up 12 percent this year, rising to 127 through June 30 from 113 over the same period in 2018, the NYPD says.
Most of the injured last year were in Manhattan, where 134 pedestrians got hurt, nearly half the citywide total of 270.
Flatiron/Gramercy Park’s 13th Precinct topped the list with 16 injuries, followed by Chinatown/Little Italy with 13, and lower Manhattan with 12. There were 10 on the Upper West Side.
Although data show the number of hurt pedestrians dipped from 315 in 2017 to 270 last year, roughly 300 people a year have been hurt by cyclists since the city began tracking such accidents in 2011, including a high of 361 injuries in 2015 and three deaths in 2014.
Two pedestrians have been killed so far this year.



The latest was Michael Collopy, a 60-year-old Chelsea resident who was plowed into by a bicyclist while standing in a bike lane in the Flatiron District on July 31 and died a week later. The bicyclist fled.
“He was one of the good ones in the building, a nice person,” said Jay, a doorman in West 23rd Street apartment complex where Collopy lived. “He was always full of jokes.”
Also killed was Donna Strum, 67, who was smashed by a cyclist on April 24 while crossing West 57th Street near Sixth Avenue. She was in the crosswalk.
An unidentified 40-year-old cyclist ran a red light and struck her, fracturing her skull. She died on May 4. The biker told cops that his gears malfunctioned and his brakes failed. Cops issued him a summons and he was released.
“People are mad,” said Adrienne Rivetti Jensen, an Upper West Side resident whose 5-year-old daughter, Mabel, suffered a gash on her forehead when a speeding biker clipped the girl in Riverside Park on April 8.



Mabel, now with an inch-long scar, was at first afraid to return to the park after the accident, said the mother.
“She got hit while we were just walking on the pathway — and a lot of cyclists were speeding past us, yelling at us to get out of the way,” the mother recalled. “In the Uber to the hospital, I started to feel really angry. He could have killed her. He was going really fast.”
She said other parents on the Upper West Side are worried that their children aren’t safe.
“Every New Yorker I meet has a story about someone getting hit,” she said, including a mom in the neighborhood with three children who have all been injured by riders.
“It should be a public conversation. All these bicyclists have lobbying groups and are getting expanded accessibility to the city.”
Hizzoner has been putting in place a plan to install 30 new miles of bicycle lanes per year, reduce parking spaces and add hundreds of Citi Bikes.
Some of the lanes defy logic.
One that was recently installed next to the FDR Drive, between 33rd and 34th Streets, gobbled up a walkway and a vehicle lane used by ambulances trying to get to Bellevue Hospital.
Another on Eighth Avenue in Midtown stands out as an example of a poorly planned path that pits pedestrians against cyclists in a battle for limited pavement.
Tens of thousands of commuters headed to and from the Port Authority bus terminal on 42nd Street everyday overflow the narrow sidewalks onto the Eighth Avenue roadway, where the city inexplicably installed both a bike lane and parking lane in 2006.



Hordes of bikers weave through idling cabs and throngs of pedestrians, creating collisions and even sparking fistfights.
But the mayor has ignored the growing threat to walkers.
The one cyclist group he has attacked is electric-bike riders, who are primarily food-delivery workers. He has blasted them for going the wrong way on streets and riding on sidewalks and has launched a crackdown against them.
But just nine of the 270 reported pedestrian injuries from bikers last year were caused by e-bikes, according to a report on the transportation-news site Streetsblog.
A woman whose jogger husband was killed by a bike rider in Central Park in 2014 told the site that the bicyclists need to see themselves both as victims and “predators.”
“One careless move on a bike and we can take down a runner, a walker, a child skipping along,” said Hindy Schachter, whose husband, Irving, 75, was training for the New York City Marathon when he was hit on the East Loop of the park near 72nd Street by a 17-year-old cyclist.
“As we want car drivers to be alert to our rights, so too we must act to protect the rights of other people.”



It would seem that not all accidents and injuries are getting reported.
Central Park remains a hot spot for danger, as racing riders routinely blow through red lights and pedestrians risk injury merely by crossing the road.
But last year there were only four reported cyclist-caused injuries in the park’s 22nd Precinct, the data show.
The NYPD has stepped up its enforcement of rule-breaking riders.
Cops issued 19,949 moving violations to cyclists this year through June 30, up from 18,148 over the same period last year, a 10 percent increase.

ESC: Guidelines on diabetes and cardiovascular diseases published

The European Society of Cardiology (ESC) Guidelines on diabetes, pre-diabetes and cardiovascular diseases are published online today in European Heart Journal,(1) and on the ESC website.(2) They were developed in collaboration with the European Association for the Study of Diabetes (EASD).
Professor Francesco Cosentino, ESC Chairperson of the guidelines Task Force and professor of cardiology at the Karolinska Institute and Karolinska University Hospital in Stockholm, Sweden said: “The emphasis of these guidelines is to provide state of the art information on how to prevent and manage the effects of diabetes on the heart and vasculature, with a focus on new data that has emerged since the 2013 document.”
Professor Peter J. Grant, EASD Chairperson of the guidelines Task Force and professor of medicine at the University of Leeds, UK said: “Recent trials have shown the cardiovascular safety and efficacy of SGLT2 inhibitors and GLP-1 receptor agonists for type 2 diabetes. We provide clear recommendations here.”
The global prevalence of diabetes continues to increase. It is predicted that more than 600 million individuals will develop type 2 diabetes worldwide by 2045, with around the same number developing pre-diabetes. Estimates state that diabetes affects 10% of populations in previously underdeveloped countries such as China and India, which are now adopting western lifestyles, and 60 million Europeans, of which half are undiagnosed.
“These figures pose serious questions to developing economies, where the very individuals who support economic growth are those most likely to develop type 2 diabetes and to die of premature cardiovascular disease,” states the document.
Healthy behaviours are the mainstay of preventing cardiovascular disease. Lifestyle changes are now advised to avoid or delay the conversion of pre-diabetes states, such as impaired glucose tolerance, to diabetes. Physical activity, for example, delays conversion, improves glycaemic control and reduces cardiovascular complications.
The document states that moderate alcohol intake should not be promoted as a means to protect against cardiovascular disease. “There has been a long-standing view that moderate alcohol intake has beneficial effects on the prevalence of cardiovascular disease,” said Prof Grant. “Two high-profile analyses have reported this is not the case and that alcohol consumption does not appear to be beneficial. On the basis of these new findings we changed our recommendations.”
Self-monitoring of blood glucose and blood pressure is advocated for patients with diabetes to achieve better control. Data has emerged to implicate glucose variability in the causes of heart disease in diabetes. In addition, glucose variation at night is particularly linked with hypoglycaemia and deterioration in quality of life.
“This indicates that it is no longer appropriate to depend on occasional glucose measures to manage control, particularly in type 1 diabetes,” said Prof Cosentino. “At the same time, flash technology has been developed which uses a small sensor worn on the skin to continuously monitor glucose levels. Similar arguments pertain to home blood pressure monitoring.”
Statins are not recommended in diabetic women of childbearing potential and should be used with caution in young people. “We have no experience of the effects of 50 or 60 years of statin use in an individual and we do not advocate non-essential drugs in pregnancy when the potential adverse effects on the unborn child are unknown,” explained Prof Grant.
Clinical trials on the cardiovascular safety of medications for type 2 diabetes have led to a paradigm shift in glucose-lowering treatment. Two groups of diabetes drugs – GLP-1 receptor agonists and gliflozins – showed cardiovascular safety and benefit in patients with diabetes who either already had heart disease and/or had multiple risk factors.
“Our main recommendation in the light of these findings is that GLP-1 receptor agonists and gliflozins should be used as first line treatment in type 2 diabetes patients with established cardiovascular disease or at high risk of cardiovascular disease,” said Prof Cosentino.
Drugs that prevent blood clots – non-vitamin K antagonist oral anticoagulants, specifically rivaroxaban – have been reported to benefit peripheral vascular disease and should be considered in combination with aspirin for patients with diabetes who have poor circulation in the legs.
PCSK9 inhibitors are advised for patients with diabetes at very high risk of cardiovascular disease who do not achieve low-density lipoprotein (LDL) cholesterol goals despite treatment with statins. In these patients, a more ambitious LDL cholesterol target of below 1.4 mmol/L is recommended.
Lifestyle advice for patients with diabetes and pre-diabetes
  • Quit smoking.
  • Reduce calorie intake to lower excessive body weight.
  • Adopt a Mediterranean diet supplemented with olive oil and/or nuts to lower the risk of cardiovascular events.
  • Avoid alcohol.
  • Do moderate-to-vigorous physical activity (a combination of aerobic and resistance exercise) at least 150 minutes per week to prevent/control diabetes – unless contraindicated, such as in patients with severe comorbidities or limited life expectancy.
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Authors: ESC Press Office
Mobile: +33 (0) 7 8531 2036
Email: press@escardio.org
The hashtag for ESC Congress 2019 together with the World Congress of Cardiology is #ESCCongress
Funding: None.
Disclosures: The disclosure forms of all experts involved in the development of these guidelines are available on the ESC website http://www.escardio.org/guidelines.

ESC: Guidelines on management of fast heartbeat published

The European Society of Cardiology (ESC) Guidelines on supraventricular tachycardia are published online today in European Heart Journal,(1) and on the ESC website.(2) The document highlights how catheter ablation is revolutionising care for this group of common arrhythmias.
Supraventricular tachycardia (SVT) refers to a heart rate above 100 beats per minute (normal resting heart rate is 60 to 100). It occurs when there is a fault with the electric system that controls the heart’s rhythm. SVTs are frequent arrhythmias, with a prevalence of approximately 0.2% in the general population. Women have a risk of developing SVT that is two times greater than men, while people 65 years or older have more than five times the risk of developing SVT than younger people.
SVTs usually start and stop suddenly. They arise in the atria of the heart and the conduction system above the ventricles, and are rarely life-threatening in the acute phase, unlike arrhythmias from the ventricles. However, most SVTs, if left untreated, are lifelong conditions that affect the heart’s function, increase the risk of stroke, and affect quality of life. Symptoms include palpitations, fatigue, light-headedness, chest discomfort, shortness of breath, and altered consciousness.
The guidelines provide treatment recommendations for all types of SVTs. Drug therapies for SVT have not fundamentally changed since the previous guidelines were published in 2003.
But Professor Josep Brugada, Chairperson of the guidelines Task Force and professor of medicine, University of Barcelona, Spain, said: “We do have more data on the potential benefits and risks associated with several drugs, and we know how to use them in a safer way. In addition, some new antiarrhythmic drugs are available.”
Antiarrhythmic drugs are useful for acute episodes. For long-term treatment these drugs are of limited value due to relatively low efficacy and related side-effects.
The main change in clinical practice over the last 16 years is related to the availability of more efficient and safe invasive methods for eradication of the arrhythmia through catheter ablation. This therapy uses heat or freezing to destroy the heart tissue causing the arrhythmia.
Professor Demosthenes Katritsis, Chairperson of the guidelines Task Force and director of the 3rd Cardiology Department, Hygeia Hospital, Athens, Greece, said: “Catheter ablation techniques and technology have evolved in a way that we can now offer this treatment modality to most of our patients with SVT.”
SVT is linked with a higher risk of complications during pregnancy, and specific recommendations are provided for pregnant women. All antiarrhythmic drugs should be avoided, if possible, within the first trimester of pregnancy. However, if necessary, some drugs may be used with caution during that period.
“Pregnant women with persistent arrhythmias that do not respond to drugs, or for whom drug therapy is contraindicated or not desirable, can now be treated with catheter ablation using new techniques that avoid exposing themselves or their baby to harmful levels of radiation,” said Prof Katritsis.
What should people do if they experience a fast heartbeat? “Always seek medical help and advice if you have a fast heartbeat,” said Prof Brugada. “If SVT is suspected, you should undergo electrophysiology studies with a view to catheter ablation, since several of the underlying conditions may have serious long-term side effects and inadvertently affect your wellbeing. Prevention of recurrences depends on the particular type of SVT, so ask your doctor for advice. Catheter ablation is safe and cures most SVTs.”
###
Authors: ESC Press Office
Mobile: +33 (0) 7 8531 2036
Email: press@escardio.org
Funding: None.
Disclosures: The disclosure forms of all experts involved in the development of these guidelines are available on the ESC website http://www.escardio.org/guidelines.

Some states, towns skeptical over proposed opioid settlement

An offer from OxyContin maker Purdue Pharma and the Sackler family to settle some 2,000 lawsuits over their contribution to the national opioid crisis is receiving growing pushback from state and local officials who say the proposed deal doesn’t include enough money or accountability.
Connecticut Attorney General William Tong on Friday called for the company, which is headquartered in the state, to be forced out of the opioid business altogether.
“At a minimum, Connecticut demands that Purdue be broken up and shut down, and that its assets be liquidated,” Tong said in a statement.
He said he wants the controlling Sackler  to pay billions of dollars “they siphoned out of Purdue,” with the money going toward addiction research and treatment.
Massachusetts Attorney General Maura Healey said she wants any  to include more money than the $10 billion to $12 billion offered by Purdue and the $3 billion offered from the Sacklers, an amount that represents just a portion of the family’s fortune. Much of their money which appears to be overseas.
“We owe it to families in Massachusetts and across the country to hold Purdue and the Sacklers accountable, ensure that the evidence of what they did is made public, and make them pay for the damage they have caused,” Healey said in a statement.
The company and the family did not answer questions Friday about criticism of the settlement proposal, under which Purdue would file for bankruptcy and transform itself into a “public benefit trust corporation.” The trust’s profits from drug sales would go to the plaintiffs under the company’s settlement offer.
Purdue also has been considering filing for  on its own, an action that would upend the settlement talks involving state attorneys general and lawyers representing nearly  around the country.
Over the past few years, nearly every state and about 2,000 local and tribal governments have sued over the toll of the opioid epidemic. Purdue is a defendant in most of the lawsuits and members of the Sackler family are named in several, including lawsuits in Connecticut and Massachusetts.
The federal litigation is being overseen by a judge in Cleveland, who has been pushing for a national settlement before the first trial starts in October. That is proving difficult.
As details of Purdue’s settlement offer became public this week, some  said it wasn’t good enough.
In Delbarton, West Virginia, Mayor Elmer Spence’s son and nephew are two of the more than 400,000 people in the U.S. who have died from opioid overdoses since 2000. If Purdue’s offer of a settlement is accepted, the town would receive less than $50,000.
“That’s a drop in the bucket for what it’s really cost this community,” he said of a crisis that has driven up costs for police, ambulances and courts.
He said residents in the town of roughly 500 people have grown accustomed to losing loved ones: “I mean it’s really a slap in the face.”

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More vaping illnesses reported, many involving marijuana

Health officials are recommending people who vape consider avoiding e-cigarettes while they investigate more cases of a breathing ailment linked to the devices.
While the cause remains unclear, officials said Friday that many reports involve products that contain THC, the mind-altering substance in marijuana.
Officials from the Centers for Disease Control and Prevention said they are looking at 215 possible cases across 25 states. All the cases involve teens or adults who have used e-cigarettes or other vaping devices. Symptoms of the disease include coughing, shortness of breath, chest pain, fatigue, nausea and vomiting.
The CDC and Food and Drug Administration warned the public not to buy vaping products off the street. And officials recommended people concerned about the “consider refraining from using e-cigarette products.”
Health and Human Services Secretary Alex Azar said in a statement the government is “using every tool we have to get to the bottom of this deeply concerning outbreak.”
E-cigarettes generally heat a flavored nicotine solution into an inhalable aerosol. The products have been used in the U.S. for more than a decade and are generally considered safer than traditional cigarettes because they don’t create all the cancer-causing byproducts of burning tobacco.
But some vaping products have been found to contain other potentially harmful substances, including flavoring chemicals and oils used for vaping marijuana, experts say.
The mysterious illness underscores the complicated nature of the vaping market, which includes both government-regulated nicotine products and THC-based vape pens, which are considered illegal under federal law.
Eleven states and the District of Columbia allow marijuana for . THC-based products in these regulated markets are generally inspected for quality and safety, but there is a largely unregulated gray market.
On Thursday, top  in the Trump administration reiterated warnings against marijuana use by adolescents and pregnant women, emphasizing the increasing potency of the drug.

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ESC: Microbes may play a role in heart attack onset

Microorganisms in the body may contribute to destabilisation of coronary plaques and subsequent heart attack, according to late breaking research presented today at ESC Congress 2019 together with the World Congress of Cardiology.
The study found that unlike gut bacteria, the bacteria in coronary plaques were pro-inflammatory. In addition, patients with  () had different bacteria in their guts compared to patients with stable angina.
Diet, smoking, pollution, age, and medications have a major impact on cell physiology, the immune system, and metabolism. Previous research indicates that these effects are mediated by microorganisms in the intestinal tract. This study investigated the contribution of the microbiota to the instability of coronary plaques.
The study enrolled 30 patients with acute coronary syndrome and ten patients with stable angina. The researchers isolated  from faeces samples. Coronary plaque bacteria were extracted from angioplasty balloons.
Comparison of microbiota in faeces and coronary plaques revealed a different composition in the two sites. While faecal bacteria had a heterogeneous composition, and a pronounced presence of Bacteroidetes and Firmicutes, coronary plaques primarily contained microbes with pro-inflammatory phenotypes belonging to Proteobacteria and Actinobacteria.
First author Eugenia Pisano, of the Catholic University of the Sacred Heart, Rome, Italy said: “This suggests a selective retention of pro-inflammatory bacteria in , which could provoke an inflammatory response and plaque rupture.”
The analyses also revealed differences in gut microbiota between the two groups of patients. Those with acute coronary syndrome had more Firmicutes, Fusobacteria and Actinobacteria, while Bacteroidetes and Proteobacteria were more abundant in those with stable angina.
Ms Pisano said: “We found a different make-up of the gut microbiome in acute and stable patients. The varying chemicals emitted by these  might affect plaque destabilisation and consequent heart attack. Studies are needed to examine whether these metabolites do influence plaque instability.”
She noted that to date, research has not convincingly shown that infections and the ensuing inflammation are directly involved in the process of plaque instability and  attack onset. As an example, antibiotics against Chlamydia Pneumoniae failed to reduce the risk of cardiac events.
But she said: “While this is a small study, the results are important because they regenerate the notion that, at least in a subset of patients, infectious triggers might play a direct role in plaque destabilisation. Further research will tell us if antibiotics can prevent cardiovascular events in certain patients.”
Ms Pisano concluded: “Microbiota in the gut and coronary plaque could have a pathogenetic function in the process of plaque destabilisation and might become a potential therapeutic target.”

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More information: The abstract “A different microbial signature in plaque and gut of patients presenting with ACS: a possible role for coronary instability” will be presented during the session Late Breaking Basic and Translational Science – Acute Coronary Syndromes and Heart failure on Saturday 31 August at 13:50 to 15:00 CEST in room Pristina – Village 3.

Joint Commission sets maternal safety standards for hospital accreditation

Starting next July, the Joint Commission will require accredited hospitals to have 13 policies in place to help prevent the likelihood of hemorrhage and severe hypertension for pregnant patients.
The new standards, which will go into effect July 1, 2020, are in response to many hospitals adopting evidence-based practices to prevent maternal mortality due to hemorrhage and hypertension, two of the most common reasons for death in pregnant women.
“There has been a lot learned about what needs to be done to reduce maternal mortality rates,” said Dr. David Baker, executive vice president for healthcare quality evaluation at the Joint Commission. “We thought it was time to take those (best practices) and turn them into requirements to ensure that all hospitals try to follow them.”
The U.S. has a higher maternal mortality rate than other developed countries, with about 700 pregnancy-related deaths occurring each year, and 60% of those are preventable.
Hospitals’ compliance with the standards will be evaluated during Joint Commission accreditation surveys, which occur every three years.
The requirements were selected based on input from the Alliance for Innovation on Maternal Health and the California Maternal Quality Care Collaborative, which has been successful in reducing maternal mortality rates through evidence-based practices in the state.
Prior to finalizing the standards, the Joint Commission also visited hospitals throughout the U.S. to get their feedback. Baker said hospitals were overwhelmingly positive.
The American Hospital Association is also supportive of the new requirements.
“These standards play a vital role for pregnant and postpartum women, as well as their families,” Thomas Nickels, executive vice president of the AHA, wrote in a letter to the Joint Commission. “Maternal hemorrhage risk and severe hypertension/preeclampsia are two of the most common complications that occur in pregnant and postpartum women. Ensuring that hospitals and providers are trained and prepared to diagnose, manage and effectively treat such complications is critical.”
Some of the standards are providing education to all staff who treat pregnant and postpartum patients about the organization’s hemorrhage and hypertension procedures; conducting drills at least once per year to determine issues with ongoing quality improvement work and offering education to patients and their families about symptoms of postpartum hemorrhage and severe hypertension.
Baker said the Joint Commission attempted to select standards that all hospitals, no matter their resources, could comply with. For instance, the Joint Commission opted not to include a component of the safety bundles developed by the Alliance for Innovation on Maternal Health related to counting blood loss. Baker said there was concern that it would be too difficult for small hospitals to comply with.
“We see this as an ongoing process,” he said. “We want to make sure that all hospitals can meet these new requirements, but we will continue to look at what we can do as hospitals get more experience with these things. They might be able to do additional things in the future.”
In the coming months, the Joint Commission plans to host webinars with its accredited hospitals to explain the changes in more depth. Additionally, the Joint Commission is offering the Alliance for Innovation on Maternal Health and the California Maternal Quality Care Collaborative as resources for hospitals to successfully comply with the standards.

Publicly insured more likely to drop off liver transplant waitlist, study finds

Cancer patients with public health insurance were more likely to drop off the waitlist for a liver transplant than patients with private insurance, according to a study published Friday in JAMA Network Open.
Among 705 patients with a common type of liver cancer waiting for a transplant at the University of California, San Francisco, 46.7% of patients with public insurance dropped off the waiting list over a seven-year study period.
That compared with 28.7% of patients insured by Kaiser Permanente and 33.8% by other private insurers despite similar tumor-related characteristics,according to the study. In total, 246 patients dropped off the wait-list during the period that lasted from Jan. 1, 2010 to Dec. 31, 2016.
“When we think about patients with liver cancer who are listed for transplants, we typically think about the main reasons they don’t make it to transplant being clinical characteristics,” explained study author Dr. Neil Mehta, an associate professor medicine at UCSF. “But this study suggested that even though patients in all the different insurance categories had similar clinical characteristics, they had very different rates of dropping off the waitlist, specifically patients with public insurance.”
Of the 705 patients in the study, about a quarter of patients dropped off the waiting list specifically because of tumor progression or death. That included 19.2% of patients in the sample with Kaiser Permanente insurance, 26.1% of patients with private insurance and 33.2% with public insurance.
The study found that 416 patients received liver transplants from deceased donors, including 65.6% of patients with Kaiser Permanente insurance, 63.1% with other private insurance and 44.2% with public insurance. Others may have gotten liver transplants from live donors or a center outside of the study.
Researchers speculated that socioeconomic factors were to blame for public insurance being associated with a higher risk of dropping off the waitlist. Patients on Medicaid were more likely to be poor and unemployed and lack stable housing and social support, which could impact the patient’s ability to attend follow up appointments, for example.
Mehta explained that to remain eligible for transplant, liver cancer patients must get imaging done every three months to make sure the tumor stays within transplant criteria. Organizations such as Kaiser Permanente have care coordination programs to help patients navigate the testing and challenges that come with being on the waitlist, while publicly insured patients may not have that benefit, he said.
“Our main hypothesis is that if we can actually improve healthcare coordination delivery for these patients, that can hopefully reduce these disparities,” Mehta said.
In an emailed statement, Dr. Joanna Ready, chair of the Kaiser Permanente Liver Transplant Advisory Board for Northern California, said Kaiser Permanente ensures patients with chronic conditions have timely access to care.
“For our liver transplant patients, we provide comprehensive pre- and post-transplant services, including nurse coordinators, physicians, and sub-specialty care, such as radiology, oncology, and cardiology. This ensures critical conditions such cancer are identified early and managed efficiently throughout the transplant journey,” she said.
Half of the patients in the study sample had Kaiser Permanente insurance because UCSF has a contract with Kaiser Permanente in Northern California, but that organization did not sponsor the study, Mehta said.

Sanders proposes canceling $81 billion U.S. medical debt

U.S. presidential contender Bernie Sanders proposed a plan on Saturday to cancel $81 billion in existing past-due medical debt for Americans, but offered no details on how it would be financed.
Sanders, an independent U.S. senator from Vermont, said in a statement that under his plan, the government would negotiate and pay off past-due medical bills that have been reported to credit agencies. The proposal, he said, would also repeal some elements of the 2005 Bankruptcy reform bill and allow other existing and future medical debt to be discharged.
“In the United States of America, your financial life and future should not be destroyed because you or a member of your family gets sick,” said Sanders. “That is unacceptable. I am sick and tired of seeing over 500,000 Americans declare bankruptcy each year because they cannot pay off the outrageous cost of a medical emergency or a hospital stay.”
According to Sanders, medical debt is the leading cause of consumer bankruptcy, with more than half a million Americans filing due to medical expenses each year. He said the 2005 Bankruptcy reform bill made it difficult to discharge medical debt by imposing strict means tests and eliminated fundamental consumer protections for Americans.

“It also trapped families with medical debt in long-term poverty, mandated that they pay for credit counseling before filing for bankruptcy, and increased the need for expensive legal services when filing a case for medical bankruptcy,” the senator said.
Sanders is seeking the Democratic nomination, along with more than a dozen other candidates, for the right to challenge Republican President Donald Trump in November 2020.