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Saturday, April 6, 2019

Mysterious Infection Spanning the Globe in a Climate of Secrecy

Last May, an elderly man was admitted to the Brooklyn branch of Mount Sinai Hospital for abdominal surgery. A blood test revealed that he was infected with a newly discovered germ as deadly as it was mysterious. Doctors swiftly isolated him in the intensive care unit.
The germ, a fungus called Candida auris, preys on people with weakened immune systems, and it is quietly spreading across the globe. Over the last five years, it has hit a neonatal unit in Venezuela, swept through a hospital in Spain, forced a prestigious British medical center to shut down its intensive care unit, and taken root in India, Pakistan and South Africa.
Recently C. auris reached New York, New Jersey and Illinois, leading the federal Centers for Disease Control and Prevention to add it to a list of germs deemed “urgent threats.”
The man at Mount Sinai died after 90 days in the hospital, but C. auris did not. Tests showed it was everywhere in his room, so invasive that the hospital needed special cleaning equipment and had to rip out some of the ceiling and floor tiles to eradicate it.

“Everything was positive — the walls, the bed, the doors, the curtains, the phones, the sink, the whiteboard, the poles, the pump,” said Dr. Scott Lorin, the hospital’s president. “The mattress, the bed rails, the canister holes, the window shades, the ceiling, everything in the room was positive.”
C. auris is so tenacious, in part, because it is impervious to major antifungal medications, making it a new example of one of the world’s most intractable health threats: the rise of drug-resistant infections.
Dr. Shawn Lockhart, a fungal disease expert at the Centers for Disease Control and Prevention, holding a microscope slide with inactive Candida auris collected from an American patient.CreditMelissa Golden for The New York Times
For decades, public health experts have warned that the overuse of antibiotics was reducing the effectiveness of drugs that have lengthened life spans by curing bacterial infections once commonly fatal. But lately, there has been an explosion of resistant fungi as well, adding a new and frightening dimension to a phenomenon that is undermining a pillar of modern medicine.
“It’s an enormous problem,” said Matthew Fisher, a professor of fungal epidemiology at Imperial College London, who was a co-author of a recent scientific review on the rise of resistant fungi. “We depend on being able to treat those patients with antifungals.”

Simply put, fungi, just like bacteria, are evolving defenses to survive modern medicines.
Yet even as world health leaders have pleaded for more restraint in prescribing antimicrobial drugs to combat bacteria and fungi — convening the United Nations General Assembly in 2016 to manage an emerging crisis — gluttonous overuse of them in hospitals, clinics and farming has continued.
Resistant germs are often called “superbugs,” but this is simplistic because they don’t typically kill everyone. Instead, they are most lethal to people with immature or compromised immune systems, including newborns and the elderly, smokers, diabetics and people with autoimmune disorders who take steroids that suppress the body’s defenses.
Scientists say that unless more effective new medicines are developed and unnecessary use of antimicrobial drugs is sharply curbed, risk will spread to healthier populations. A study the British government funded projects that if policies are not put in place to slow the rise of drug resistance, 10 million people could die worldwide of all such infections in 2050, eclipsing the eight million expected to die that year from cancer.
Dr. Johanna Rhodes, an infectious disease expert at Imperial College London. “We are driving this with the use of antifungicides on crops,” she said of drug-resistant germs.CreditTom Jamieson for The New York Times
In the United States, two million people contract resistant infections annually, and 23,000 die from them, according to the official C.D.C. estimate. That number was based on 2010 figures; more recent estimates from researchers at Washington University School of Medicine put the death toll at 162,000. Worldwide fatalities from resistant infections are estimated at 700,000.
Antibiotics and antifungals are both essential to combat infections in people, but antibiotics are also used widely to prevent disease in farm animals, and antifungals are also applied to prevent agricultural plants from rotting. Some scientists cite evidence that rampant use of fungicides on crops is contributing to the surge in drug-resistant fungi infecting humans.
What You Need to Know About Candida Auris
C. auris is a mysterious and dangerous fungal infection that is among a growing number of germs that have evolved defenses against common medicines. Here are some basic facts about it.
Yet as the problem grows, it is little understood by the public — in part because the very existence of resistant infections is often cloaked in secrecy.

With bacteria and fungi alike, hospitals and local governments are reluctant to disclose outbreaks for fear of being seen as infection hubs. Even the C.D.C., under its agreement with states, is not allowed to make public the location or name of hospitals involved in outbreaks. State governments have in many cases declined to publicly share information beyond acknowledging that they have had cases.
All the while, the germs are easily spread — carried on hands and equipment inside hospitals; ferried on meat and manure-fertilized vegetables from farms; transported across borders by travelers and on exports and imports; and transferred by patients from nursing home to hospital and back.
C. auris, which infected the man at Mount Sinai, is one of dozens of dangerous bacteria and fungi that have developed resistance.
A projection of the C. auris fungus on a microscope slide.CreditMelissa Golden for The New York Times
Other prominent strains of the fungus Candida — one of the most common causes of bloodstream infections in hospitals — have not developed significant resistance to drugs, but more than 90 percent of C. auris infections are resistant to at least one drug, and 30 percent are resistant to two or more drugs, the C.D.C. said.
Dr. Lynn Sosa, Connecticut’s deputy state epidemiologist, said she now saw C. auris as “the top” threat among resistant infections. “It’s pretty much unbeatable and difficult to identify,” she said.

Nearly half of patients who contract C. auris die within 90 days, according to the C.D.C. Yet the world’s experts have not nailed down where it came from in the first place.
“It is a creature from the black lagoon,” said Dr. Tom Chiller, who heads the fungal branch at the C.D.C., which is spearheading a global detective effort to find treatments and stop the spread. “It bubbled up and now it is everywhere.”

Candida Auris

A deadly, drug-resistant fungus is infecting patients in hospitals and nursing homes around the world. The fungus seems to have emerged in several locations at once, not from a single source.
EUROPE
The first large outbreak in Europe involved 72 cases in a London hospital in 2015–16.
COUNTRIES WITH
Multiple cases of
Candida auris infection
One reported case
BRITAIN
RUSSIA
CANADA
FRANCE
GERMANY
UNITED
STATES
UNITED STATES
The country has had at least 587 Candida auris infections since 2013.
SPAIN
JAPAN
CHINA
ISRAEL
KUWAIT
PAKISTAN
SOUTH
KOREA
SAUDI
ARABIA
INDIA
OMAN
PANAMA
VENEZUELA
SINGAPORE
COLOMBIA
KENYA
INDIA AND PAKISTAN
The two countries have some of the highest case counts in the world. A distinct strain appeared in Pakistan as early as 2008 and in Delhi by 2009.
CENTRAL AND
SOUTH AMERICA
The first documented outbreak in the Americas was from 2012–13 at a medical center in Venezuela. Five of 18 infected patients died.
AUSTRALIA
SOUTH
AFRICA
SOUTH AFRICA
A genetically distinct strain of Candida auris in South Africa infected at least 451 patients from 2012–16.
JAPAN
Candida auris (left) was discovered in 2009 in the infected ear of a 70-year-old Japanese woman.
By The New York Times | Sources: Centers for Disease Control and Prevention; Emerging Infectious Diseases; Emerging Microbes & Infections; Clinical Infectious Diseases; Journal of Infection; Mycoses; Doherty Institute. Image from Kazuo Satoh et al., Microbiology and Immunology
In late 2015, Dr. Johanna Rhodes, an infectious disease expert at Imperial College London, got a panicked call from the Royal Brompton Hospital, a British medical center outside London. C. auris had taken root there months earlier, and the hospital couldn’t clear it.
“‘We have no idea where it’s coming from. We’ve never heard of it. It’s just spread like wildfire,’” Dr. Rhodes said she was told. She agreed to help the hospital identify the fungus’s genetic profile and clean it from rooms.
Under her direction, hospital workers used a special device to spray aerosolized hydrogen peroxide around a room used for a patient with C. auris, the theory being that the vapor would scour each nook and cranny. They left the device going for a week. Then they put a “settle plate” in the middle of the room with a gel at the bottom that would serve as a place for any surviving microbes to grow, Dr. Rhodes said.
Only one organism grew back. C. auris.
It was spreading, but word of it was not. The hospital, a specialty lung and heart center that draws wealthy patients from the Middle East and around Europe, alerted the British government and told infected patients, but made no public announcement.

“There was no need to put out a news release during the outbreak,” said Oliver Wilkinson, a spokesman for the hospital.
This hushed panic is playing out in hospitals around the world. Individual institutions and national, state and local governments have been reluctant to publicize outbreaks of resistant infections, arguing there is no point in scaring patients — or prospective ones.
“Somehow, it made a jump almost seemingly simultaneously, and seemed to spread and it is drug resistant, which is really mind-boggling,” said Dr. Snigdha Vallabhaneni, a fungal expert and epidemiologist at the C.D.C.CreditMelissa Golden for The New York Times
Dr. Silke Schelenz, Royal Brompton’s infectious disease specialist, found the lack of urgency from the government and hospital in the early stages of the outbreak “very, very frustrating.”
“They obviously didn’t want to lose reputation,” Dr. Schelenz said. “It hadn’t impacted our surgical outcomes.”
By the end of June 2016, a scientific paper reported “an ongoing outbreak of 50 C. auris cases” at Royal Brompton, and the hospital took an extraordinary step: It shut down its I.C.U. for 11 days, moving intensive care patients to another floor, again with no announcement.
Days later the hospital finally acknowledged to a newspaper that it had a problem. A headline in The Daily Telegraph warned, “Intensive Care Unit Closed After Deadly New Superbug Emerges in the U.K.” (Later research said there were eventually 72 total cases, though some patients were only carriers and were not infected by the fungus.)

Yet the issue remained little known internationally, while an even bigger outbreak had begun in Valencia, Spain, at the 992-bed Hospital Universitari i Politècnic La Fe. There, unbeknown to the public or unaffected patients, 372 people were colonized — meaning they had the germ on their body but were not sick with it — and 85 developed bloodstream infections. A paper in the journal Mycoses reported that 41 percent of the infected patients died within 30 days.
A statement from the hospital said it was not necessarily C. auris that killed them. “It is very difficult to discern whether patients die from the pathogen or with it, since they are patients with many underlying diseases and in very serious general condition,” the statement said.
As with Royal Brompton, the hospital in Spain did not make any public announcement. It still has not.
One author of the article in Mycoses, a doctor at the hospital, said in an email that the hospital did not want him to speak to journalists because it “is concerned about the public image of the hospital.”
The secrecy infuriates patient advocates, who say people have a right to know if there is an outbreak so they can decide whether to go to a hospital, particularly when dealing with a nonurgent matter, like elective surgery.
Outside the Royal Brompton Hospital near London. By June 2016, the hospital had seen at least 50 “proven or possible” cases of C. auris, and decided to shut down its intensive care unit for 11 days to address the contamination.CreditTom Jamieson for The New York Times
“Why the heck are we reading about an outbreak almost a year and a half later — and not have it front-page news the day after it happens?” said Dr. Kevin Kavanagh, a physician in Kentucky and board chairman of Health Watch USA, a nonprofit patient advocacy group. “You wouldn’t tolerate this at a restaurant with a food poisoning outbreak.”

Health officials say that disclosing outbreaks frightens patients about a situation they can do nothing about, particularly when the risks are unclear.
“It’s hard enough with these organisms for health care providers to wrap their heads around it,” said Dr. Anna Yaffee, a former C.D.C. outbreak investigator who dealt with resistant infection outbreaks in Kentucky in which the hospitals were not publicly disclosed. “It’s really impossible to message to the public.”
Officials in London did alert the C.D.C. to the Royal Brompton outbreak while it was occurring. And the C.D.C. realized it needed to get the word to American hospitals. On June 24, 2016, the C.D.C. blasted a nationwide warning to hospitals and medical groups and set up an email address, candidaauris@cdc.gov, to field queries. Dr. Snigdha Vallabhaneni, a key member of the fungal team, expected to get a trickle — “maybe a message every month.”
Instead, within weeks, her inbox exploded.
In the United States, 587 cases of people having contracted C. auris have been reported, concentrated with 309 in New York, 104 in New Jersey and 144 in Illinois, according to the C.D.C.
The symptoms — fever, aches and fatigue — are seemingly ordinary, but when a person gets infected, particularly someone already unhealthy, such commonplace symptoms can be fatal.
The earliest known case in the United States involved a woman who arrived at a New York hospital on May 6, 2013, seeking care for respiratory failure. She was 61 and from the United Arab Emirates, and she died a week later, after testing positive for the fungus. At the time, the hospital hadn’t thought much of it, but three years later, it sent the case to the C.D.C. after reading the agency’s June 2016 advisory.

Candida Auris by State

Most cases in the United States have been in nursing homes in New York City, Chicago and New Jersey.
Mass.
N.Y.
Conn.
N.J.
Ill.
Ind.
Md.
Calif.
Va.
Okla.
200
Tex.
100
Fla.
25
Confirmed and
probable cases,
2013–19
1
By The New York Times | Source: Centers for Disease Control and Prevention

This woman probably was not America’s first C. auris patient. She carried a strain different from the South Asian one most common here. It killed a 56-year-old American woman who had traveled to India in March 2017 for elective abdominal surgery, contracted C. auris and was airlifted back to a hospital in Connecticut that officials will not identify. She was later transferred to a Texas hospital, where she died.
The germ has spread into long-term care facilities. In Chicago, 50 percent of the residents at some nursing homes have tested positive for it, the C.D.C. has reported. The fungus can grow on intravenous lines and ventilators.
Workers who care for patients infected with C. auris worry for their own safety. Dr. Matthew McCarthy, who has treated several C. auris patients at Weill Cornell Medical Center in New York, described experiencing an unusual fear when treating a 30-year-old man.
“I found myself not wanting to touch the guy,” he said. “I didn’t want to take it from the guy and bring it to someone else.” He did his job and thoroughly examined the patient, but said, “There was an overwhelming feeling of being terrified of accidentally picking it up on a sock or tie or gown.”
Dr. Tom Chiller, head of the fungal branch at the C.D.C. “It is a creature from the black lagoon,” he said of C. auris.CreditMelissa Golden for The New York Times
As the C.D.C. works to limit the spread of drug-resistant C. auris, its investigators have been trying to answer the vexing question: Where in the world did it come from?
The first time doctors encountered C. auris was in the ear of a woman in Japan in 2009 (auris is Latin for ear). It seemed innocuous at the time, a cousin of common, easily treated fungal infections.

Three years later, it appeared in an unusual test result in the lab of Dr. Jacques Meis, a microbiologist in Nijmegen, the Netherlands, who was analyzing a bloodstream infection in 18 patients from four hospitals in India. Soon, new clusters of C. auris seemed to emerge with each passing month in different parts of the world.
The C.D.C. investigators theorized that C. auris started in Asia and spread across the globe. But when the agency compared the entire genome of auris samples from India and Pakistan, Venezuela, South Africa and Japan, it found that its origin was not a single place, and there was not a single auris strain.
The C.D.C. in miniature. In the United States, two million people contract resistant infections each year, and 23,000 die from them, according to the official C.D.C. estimate.CreditMelissa Golden for The New York Times
The genome sequencing showed that there were four distinctive versions of the fungus, with differences so profound that they suggested that these strains had diverged thousands of years ago and emerged as resistant pathogens from harmless environmental strains in four different places at the same time.
“Somehow, it made a jump almost seemingly simultaneously, and seemed to spread and it is drug resistant, which is really mind-boggling,” Dr. Vallabhaneni said.
There are different theories as to what happened with C. auris. Dr. Meis, the Dutch researcher, said he believed that drug-resistant fungi were developing thanks to heavy use of fungicides on crops.
Dr. Meis became intrigued by resistant fungi when he heard about the case of a 63-year-old patient in the Netherlands who died in 2005 from a fungus called Aspergillus. It proved resistant to a front-line antifungal treatment called itraconazole. That drug is a virtual copy of the azole pesticides that are used to dust crops the world over and account for more than one-third of all fungicide sales.

A 2013 paper in Plos Pathogens said that it appeared to be no coincidence that drug-resistant Aspergillus was showing up in the environment where the azole fungicides were used. The fungus appeared in 12 percent of Dutch soil samples, for example, but also in “flower beds, compost, leaves, plant seeds, soil samples of tea gardens, paddy fields, hospital surroundings, and aerial samples of hospitals.”
Dr. Meis visited the C.D.C. last summer to share research and theorize that the same thing is happening with C. auris, which is also found in the soil: Azoles have created an environment so hostile that the fungi are evolving, with resistant strains surviving.
This is similar to concerns that resistant bacteria are growing because of excessive use of antibiotics in livestock for health and growth promotion. As with antibiotics in farm animals, azoles are used widely on crops.
“On everything — potatoes, beans, wheat, anything you can think of, tomatoes, onions,” said Dr. Rhodes, the infectious disease specialist who worked on the London outbreak. “We are driving this with the use of antifungicides on crops.”
Dr. Chiller theorizes that C. auris may have benefited from the heavy use of fungicides. His idea is that C. auris actually has existed for thousands of years, hidden in the world’s crevices, a not particularly aggressive bug. But as azoles began destroying more prevalent fungi, an opportunity arrived for C. auris to enter the breach, a germ that had the ability to readily resist fungicides now suitable for a world in which fungi less able to resist are under attack.
The mystery of C. auris’s emergence remains unsolved, and its origin seems, for the moment, to be less important than stopping its spread.
For now, the uncertainty around C. auris has led to a climate of fear, and sometimes denial.
Last spring, Jasmine Cutler, 29, went to visit her 72-year-old father at a hospital in New York City, where he had been admitted because of complications from a surgery the previous month.
When she arrived at his room, she discovered that he had been sitting for at least an hour in a recliner, in his own feces, because no one had come when he had called for help to use the bathroom. Ms. Cutler said it became clear to her that the staff was afraid to touch him because a test had shown that he was carrying C. auris.
“I saw doctors and nurses looking in the window of his room,” she said. “My father’s not a guinea pig. You’re not going to treat him like a freak at a show.”
He was eventually discharged and told he no longer carried the fungus. But he declined to be named, saying he feared being associated with the frightening infection.

Senators want to intervene in transplant organ allocation policy

Two senators are eying Congress’ appropriations authority to influence a contentious debate over a change to national organ distribution policy.
The issue was raised Thursday in a Senate health appropriations panel hearing with HHS Secretary Alex Azar. Panel Chair Roy Blunt (R-Mo.) and Sen. Jerry Moran (R-Kan.) are trying to intervene against a sweeping new policy that changes the geography-based system of liver allocation to one that prioritizes the sickest patients.
Blunt told Modern Healthcare he will look at the independent board tasked with setting national organ distribution policy.
“That group has a budget, and apparently the Congress hasn’t been able to get attention yet, and we’re going to look at that budget real closely this year,” he said.
He reiterated that the budget has to do with oversight rather than funding healthcare.
“But it’s an oversight budget, and the oversight is being poorly handled, in my view,” he said.
Moran said he wants to work with Blunt on “anything we can do to get (the Health Resources and Services Administration’s) attention and ultimately getting a different and better policy than the direction that they’re going.”
The new policy for livers was approved in early December by the board of the United Network for Organ Sharing. UNOS is an independent entity made up of transplant surgeons and recipients, organ donors and others.
UNOS is contracted to the Organ Procurement and Transplantation Network, or OPTN, which is tasked by HRSA to oversee the national distribution system.
The direct federal appropriation is expected to be roughly $4.5 million of the roughly $51 million total budget for OPTN, said UNOS spokesperson Joel Newman. The majority of the network’s funding comes from a one-time fee paid by a member organization when a patient joins the waiting list for a transplant.
About 8% of the OPTN budget goes to oversight of compliance with the organ allocation policies.
Organ allocation policy is intensely political because of the huge disparities in different regions of the country between the number of available livers and the amount of people awaiting transplants. The South and Midwest tend to have more donors than recipients, while other states–notably New York and California—have the reverse situation.
For health systems, national policy can have a huge financial impact on lucrative transplant programs. Constituent hospitals put immense pressure on their congressional representatives, and since UNOS is made up of stakeholders from around the country the board spent years in gridlock as the issue simmered.
Billy Wynne, who advocates in defense of the liver policy change as executive director of the National Coalition for Transplant Equity said it will reduce waitlist-related deaths by 8%.
“That’s really the whole ballgame here,” he said.
More than 80 House lawmakers last month sent a letter to Azar articulating their support for the policy change, which is due to take effect April 30. The letter rebutted points raised by Blunt, Moran and other senators who see the change as detrimental—including Senate Majority Leader Mitch McConnell (R-Ky.) and Senate Finance Committee Chair Chuck Grassley (R-Iowa).
In July, six people awaiting transplants in regions where few livers are available sued UNOS over the policy. One plaintiff, a Medicaid patient from New York, has died from liver disease while awaiting resolution.
After the lawsuit was filed, HRSA Administrator George Sigounas weighed in, telling the OPTN president in a letter that the group needed to eliminate the regional system by UNOS’ December 2018 meeting.
On Thursday, Moran asked Azar to commit HHS to a “full public disclosure and transparent public debate” on the organ allocation process. Azar said while he was happy to work on “what that might look like” he has limited authority to intervene.
“Congress deliberately took OPTN out of my hands,” he said, adding that he believes the OPTN decision was based on a “public process with a public record.”
Moran argued that Sigounas’ letter ran counter to that claim.
“The HRSA director is the one who wrote the OPTN letter, to implement the decision that was made,” he said at the hearing.
After the hearing Moran told Modern Healthcare that despite Azar’s statements, he’s “seen HRSA encourage the adoption of this policy. That doesn’t sound hands-off to me.”
“My hope is there’s still a way to convince the folks at HHS of the errors of their way, but we’ll try to do so in the appropriations process, and the conversations will continue,” he said.
Hospitals are expected to sue against the new policy, both Blunt and Moran said.
On the legislative front, Sen. Todd Young (R-Ind.) has been working on legislation that is now in the fine-tuning stage, according to an aide.
His office said the bill is focused on “transparency, oversight and accountability,” particularly around UNOS and the organ procurement organizations around the country that are responsible for acquiring organs.

The most exciting technology in orthopedics from 10 surgeons

Ten orthopedic surgeons discuss the technology trends most intriguing for 2019 and beyond.
James T. Caillouette, MD. Hoag Memorial Hospital and Hoag Orthopedic Institute (Irvine, Calif.): I believe that we are on the cusp of developing regional pain management drugs and technologies that will dramatically alter the surgical experience. If we are able to create a sensory block that lasts four to six weeks, it will have vast implications for surgery that would significantly benefit the patients and lower the overall cost of care.
Robert LaPrade, MD. Orthopedic Surgeon (Colorado): I am most excited about technology that will allow us to perform surgeries more efficiently and anatomically. These technologies will ultimately lead to better patient outcomes and more reproducible results among all surgeons. Currently, one of the big dilemmas in my field of complex knee surgery is that many of the procedures that we perform require experience to be able to accomplish the surgeries efficiently, anatomically and successfully. Thus, the development of virtual reality programs to allow aspiring and practicing surgeons to ‘practice’ complex surgeries should enable surgeons to significantly cut down on their learning curves and lead to more efficient and successful surgeries. In addition, the encroachment of the field of robotics into the field of sports medicine may also allow for these surgeries to be more reproducible and successful.
Keith Berend, MD. Joint Implant Surgeons (New Albany, Ohio): I’m excited about the Zimmer Biomet MyMobility Apple Watch platform. Not only is the technology exciting, but the data being collected on more than 10,000 arthroplasty patients will provide predictive analytics that will try to change outcomes.
Shane Nho, MD. Midwest Orthopaedics at Rush (Chicago): There are interesting technologies that incorporate intraoperative image guidance for hip arthroscopy. Stryker sports medicine is introducing a tablet that can be used during surgery to measure the size and location of hip femoroacetabular impingement deformities. In addition, the software is able to assess in real time when the surgical correction has been completed. For surgeons performing hip arthroscopy, the technology will provide the intraoperative guidance that has been missing. I believe that this will allow us to be more accurate as well as more efficient in the operating room.
Adam Yanke, MD. Midwest Orthopaedics at Rush (Chicago): While many surgical treatments are improving, I am currently the most excited about biological augmentation of non-operative and surgical treatments. The technologies that we are employing most frequently are platelet rich plasma, amniotic product injections and bone marrow aspirate injections. These can be applied for non-operative treatment of arthritis and tendonitis or during surgery to improve outcomes of rotator cuff repairs, anterior cruciate ligament reconstruction and meniscus tears.
David Fisher, MD. OrthoIndy (Indianapolis): The technology I am most excited about in the future is in the orthobiologics arena where there may be some breakthroughs in new treatments for musculoskeletal conditions.
Platforms that more efficiently allow surgeons to follow and treat their patients are also exciting.
James Weisstein, MD. Colorado Center of Orthopaedic Excellence (Colorado Springs):Interoperability. In today’s world it’s a necessity for systems to communicate with one another. I know vendors and other membership organizations are working diligently on this, and I also know it’s not as easy to enable this as we’d like to think.
Edward Wang, MD. Stony Brook (N.Y.) Medicine: Ultrasound imaging and office-based arthroscopy, stem-cell treatments for rotator cuff healing and enzymatic treatment of frozen shoulder with collagenase enzyme.
Tom Stanley, MD. OrthoIllinois (Algonquin, Ill.): Stem cells for spinal fusion. The outcomes are more consistent without the complications associated with other biologics.
Scott D. Gillogly, MD. ASPETAR Orthopaedic and Sports Medicine Hospital (Doha, Qatar):Undoubtedly, artificial intelligence is the pervading technology that is only limited by imagination. Sometimes as orthopedic surgeons we only see the cool technology in front of us that greatly enhances surgical challenges such as robotics, 3D image guided hardware placement or slick meniscus repair systems. However, we are so busy we can temporarily miss the extensive data science scope of AI in the ‘softer’ areas of healthcare such as big data mining, integrated treatment protocols and outcomes databases as well as machine learning guided imaging reading, consultation second opinions and complication risk stratification.
These same compelling features of AI driven enhancements extend to administrative areas, population medicine, revenue cycle and supply chain optimization and so on. We are clearly at the tip of the iceberg with AI and so if we are to make an impact to enhance the value of the patient experience and outcomes, this is the future.

Spinal manipulation can help ease low back pain

Spinal manipulation therapy isn’t routinely recommended as the initial treatment for low back pain, but a research review suggests this approach may work as well as interventions that doctors typically prescribe first.
Based on data from 47 previously conducted trials involving a total of 9,211 mostly middle-aged adults, spinal manipulation eased lower back pain as much as exercise, non-steroidal anti-inflammatory drugs (NSAID) and painkillers. Spinal manipulation also appeared better for improving short-term function.
“At the moment, spinal manipulation is considered a second-line or adjunctive treatment option in international guidelines,” said lead study author Sidney Rubinstein of the Vrije Universiteit in Amsterdam.
“These results would suggest that spinal manipulation is certainly on-par with these other recommended therapies, and can be considered an option,” Rubinstein said by email.
Lower-back pain is one of the leading causes of disability and doctor visits for adults worldwide. It often goes away within a few weeks. But when it persists, lower-back pain might be treated with spinal manipulation, medications like painkillers or muscle relaxers, heat, exercise or physical therapy.
Spinal manipulation is often done by chiropractors but may also be offered by physical therapists or physicians. It can include manually moving joints, massage and exercise. This type of treatment is designed to relieve pressure on joints and curb inflammation and it’s often used for back, neck or shoulder pain as well as for headaches.
For the current study, researchers focused on the gold standard for determining the effectiveness and safety of medical treatments: randomized controlled trials that compare outcomes for patients who are randomly assigned to a specific treatment or to a dummy treatment or no treatment at all.

Spinal manipulation worked better for pain relief than non-recommended interventions like light tissue massage, the current analysis found.
It also worked better than sham manipulation treatments, but the evidence was low-quality, Rubinstein’s team notes in The BMJ.
About half of the studies looked at side effects of spinal manipulation and found little evidence to conclude whether or not this is safer than other approaches. In one study, researchers found one serious adverse event that could potentially have been associated with spinal manipulation.
One limitation of the analysis is that the studies of spinal manipulation were done in different settings, tested different techniques and measured the effectiveness of this intervention in different ways, the study authors note.

“Spinal manipulation may decrease pain from muscle strain, inflammation and spasm in your back muscles and/or impact the way that your body perceives pain through either the brain or the spinal cord,” said Christine Goertz, chief executive officer of the Spine Institute for Quality in Oskaloosa, Iowa.
“The most common side effects resulting from spinal manipulation are mild to moderate joint or muscle pain and/or stiffness,” Goertz, who wasn’t involved in the study, said by email. “These symptoms generally go away on their own within a day or two.”
SOURCE: bit.ly/2I7Y1as The BMJ, online March 13, 2019.

34 orthopedic devices receive FDA 510(k) clearance in March

The FDA granted 34 orthopedic- and spine-related device clearances in March.

1. Spectrum Spine Expandable Cages from Spectrum Spine.
2. Europa Pedicle Screw System from MiRus.
3. Mutars Proximal Femur Replacement System from implantcast.
4. MLP Special Locking Bone Plate System from Maxxion Medical.
5. Alteon Acetabular Cup System from Exactech.
6. Freedom Spinal Cord Stimulatory System from Stimwave Technologies.
7. ISS-Jazz Screw System and Jazz Cap from Implanet.
8. Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads from Arthrex.
9. Rosa One Spine application from Medtech.
10. MiRus Lumbar Interbody Fusion System from MiRus.
11. Wright Jones Fracture System from Wright Medical Technology.
12. Kuros TLIF Cage from Kuros Biosciences.
13. Mimics Medical from Materialise.
14. The Progressive Orthopaedic Company Total Knee System II from The Progressive Orthopaedic Company.
15. ChoiceSpine Stealth Cervical Spacer System from ChoiceSpine.
16. MectaLIF Anterior Stand Alone Extension from Medacta.
17. Modular Spinal Fixation System from Life Spine.
18. DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio from
Synthes USA.
19. Parcus Twist AP Suture Anchors from Parcus Medical.
20. Klassic Knee System from Total Joint Orthopaedics.
21. Arthrex TensionLoc System from Arthrex.
22. IdentiTi Porous Ti Interbody System from Alphatec Spine.
23. Duo Lumbar Interbody Fusion Device from Spineology.
24. SpineEx Sagittae Lateral Lumbar Interbody Fusion Devices from SpineEx.
25. Corus Spinal System from Providence Medical Technology.
26. Evos Small Fragment Upper Extremity Plates Line Additions from Smith & Nephew.
27. Provident II Hip Stem from StlKast.
28. Prostim Injectible Inductive Graft from Wright Medical Technology.
29. Scarlet AC-T Secured Anterior Cervical Cage from Spineart.
30. Zavation Spinal System from Zavation Medical Products.
31. NuVasive VersaTie System from NuVasive.
32. CastleLoc-P Anterior Cervical Plate System from L&K Biomed.
33. OsteoCentric Bone Plate and Screw System from OsteoCentric Trauma.
34. Responsive Arthroscopy Wedge Push-In Suture Anchors from Responsive Arthroscopy.

1.62M instrumented spinal fusions per year performed in US: 5 things to know

There are more than 1 million instrumented spinal procedures performed in the U.S. annually, according to an iData Research report.

The report authors analyzed data from several sources, including hospitals and government organizations, and examined hundreds of CPT and ICD codes for the report.
Five things to know:
1. Surgeons perform around 1.62 million instrumented spinal procedures every year, including surgeries that involve multiple procedures during the same visit.
2. There were more than 352,000 interbody fusions performed during the year examined in the report, making it the most common procedure.
3. In 2017, the report estimated that 85.5 percent of cervical fixation procedures in the U.S. were anterior, while the remaining were posterior. However, the analysts said, “Posterior procedures are gaining popularity and are expected to increase more rapidly than anterior procedures.”
4. While the number of spinal fusions is expected to increase, iData CEO Dr. Kamran Zamanian expects growth to slow in the future due to the “increasing prevalence of cervical artificial discs.”
5. While minimally invasive procedures have gained popularity, the report suggests a “significant portion” of interbody spinal fusions require the standard surgical methods.