MRI Monitors Liver Fat Response to Bariatric Surgery


Quantitative chemical shift-encoded magnetic resonance imaging (CSE-MRI) is an effective, noninvasive way to monitor liver fat levels over time after bariatric surgery, a study published today in Radiology reports.

Common in obese people, nonalcoholic fatty liver disease (NAFLD) can progress to fibrosis, cirrhosis, and cancer. Although weight loss can reduce the extent of NAFLD, biopsy has been the only possible method of assessing the long-term impact of weight loss on hepatic steatosis.

B. Dustin Pooler, MD, an adjunct assistant professor at the University of Wisconsin School of Medicine and Public Health and a radiologist at Madison Radiologists, S.C., in Madison, Wisconsin, and colleagues used the noninvasive MRI technique to measure average liver proton density fat fraction (PDFF) in 50 patients before bariatric surgery and at several points during the year afterward. They compared this MRI biomarker with postsurgical changes in body mass index (BMI), weight, and waist circumference.

The study cohort, which included 43 women and seven men and was recruited from 2010 to 2015 from medical centers at the University of California San Diego and the University of Wisconsin-Madison, had a mean age of 51.0 years and a mean BMI of 44.9 kg/m2.

Presurgical preparation entailed a very low-calorie diet of 600 to 900 calories per day, started at a mean of 2.6 weeks before surgery. Bariatric procedures included gastric banding (n = 2), gastric bypass (n = 28), gastric sleeve (n = 19), and gastric plication (n = 1). PDFF was assessed presurgically before and after the diet, and along with anthropomorphic measurements was assessed at 1, 3, and 6 months after surgery.

Liver fat content began to normalize early during the low-calorie diet and soon after surgery, suggesting metabolic disturbances of NAFLD begin to correct rapidly in response to the caloric deficit of the presurgical diet even before substantial weight loss.

Overall, 32 (64%) of 50 study participants saw their liver fat normalized and an estimated 90% reached that goal by 42 weeks. Six to 10 months postsurgery, patients’ mean PDFF had returned to the normal range of < 5%, falling from 18.1% to 4.9%, with a mean estimated time to normalization of 22.5 weeks.

Mean BMI fell to 34.5 kg/m2 (mean decrease 10.4), and the cohort’s final mean weight of 91.6 kg represented am overall reduction of 29.9 kg. The final mean waist circumference of 110.9 cm represented a mean decrease of 21.3 cm. All reductions were statistically significant (P < .0001)

Rohit Loomba, MD, director of the NAFLD Research Center at the University of California San Diego and chair of the NAFLD Special Interest Group for the American Association for the Study of Liver Diseases, told Medscape Medical News the findings are an important contribution to the field of liver study.

“Previously the MOZART trial conducted by our group demonstrated the role of MRI-PDFF in assessing treatment response in [nonalcoholic steatohepatitis; NASH] trials. This excellent study clearly extends those findings to examine longitudinal changes in liver fat by MRI-PDFF specifically after bariatric surgery,” said Loomba, who was not involved in the research.

Loomba noted that further studies are needed to examine longitudinal changes that might suggest progressive NAFLD, including biomarkers of fibrosis and inflammation.

Earlier this year, Duke University researchers confirmed MRI’s utility for detecting NAFLD, but concluded it was not sufficiently accurate to replace biopsy in distinguishing between NAFLD and its more advanced relative, nonalcoholic steatohepatitis.

Interestingly, whereas initial PDFF level strongly predicted both rate of liver fat change and time to normalization, body anthropometrics did not predict either outcome. “Decreases in liver fat content were only weakly correlated with starting weight and the amount of overall weight loss, suggesting possible utility in monitoring liver fat with MRI following bariatric surgery, independent of monitoring weight loss,” Pooler and colleagues write.

They suggest that PDFF measurements could also help identify appropriate candidates for bariatric surgery as a result of this robust association between liver fat reduction and pretreatment steatosis levels.

According to the authors, their study is the first longitudinal analysis of changes in liver fat over time in a bariatric surgery population.

Advertisements

The Impact of Bariatric Surgery on Cancer Incidence


What is the impact of bariatric surgery on cancer incidence? To answer this question, the authors of a study published in the British Journal of Surgery[1] compared cancer frequency following various types of obesity surgery in 8794 obese patients in England (average age, 42 years) who were operated versus in an equal number of nonoperated patients.

During a median follow-up period of 55 months, the risk for hormone-related cancers was significantly reduced in the operated group compared with the nonoperated group (odds ratio [OR], 0.23; 95% confidence interval [CI], 0.18-0.30). In contrast, for colorectal cancer following gastric bypass (but not banding or sleeve gastrectomy), there was an overall increase in the risk for colorectal cancer (OR, 2.63; 95% CI, 1.17-5.95).

Gastric Bypass Increased the Risk for Colorectal Cancer

This report provides valuable information about cancer risk following bariatric surgery, one of the most common procedures performed by general surgeons. The risk reduction for hormonally dependent cancers was seen in both males (prostate) and females (breast, endometrium), and the benefit became more pronounced with increasing duration of follow-up. On the basis of a total of 16 patients with colorectal cancer, gastric bypass resulted in a more than twofold increased risk.

If confirmed with studies with longer follow-up and more patients, the findings in this report suggest that the age for screening for colorectal cancer following bariatric surgery should be lowered. One study weakness is that the dataset only listed obesity as a comorbidity and did not include actual information to calculate body mass index. Nevertheless, the results seem biologically plausible and are consistent with those from other research reports.

Excellent 25-Year Survival After Tetralogy of Fallot Correction


Long-term survival in a large cohort of young patients who underwent surgery to repair tetralogy of Fallot, the most common type of congenital heart disease, is excellent, researchers report in a new study.

Overall, 94.5% of individuals in a US registry who underwent this surgery were alive and had not received a heart transplant 25 years later. Most of the patients were infants at the time they underwent the surgery.

The study by Clayton A. Smith, MD, Emory University School of Medicine, Atlanta, Georgia, and colleagues was published online December 19 in JAMA Cardiology.

Individuals who underwent surgery to repair this cyanotic heart disorder had a biphasic increased risk for mortality, the investigators report, with “an early steep hazard during the first 4 years,…and a late hazard with a slow increase in mortality after 6 years and acceleration 20 years later.”

The risk for mortality within 6 years was greater in patients who underwent a two-stage procedure, with a palliative shunt placed first, or who underwent non-valve-sparing surgery or had a genetic abnormality. The risk for dying later was tied only to genetic abnormality.

“The data highlight the shortcomings of early repair, staged, and non-valve-sparing approaches in the early period following repair,” Smith and colleagues write. “Long-term transplant-free survival beyond the first 6 years following repair is excellent and influenced primarily by the coexistence of an associated genetic condition.”

Most individuals who died had arrhythmias or congestive heart failure, so “continuous surveillance of this cohort is important,” the authors note, “in identifying additional risks resulting from the interaction of underlying conditions with cardiovascular morbidities expected with aging.”

This study “highlights the value of teams that provide intensive post discharge care, a growing trend in congenital cardiology,” Roger Andrew de Freitas, MD, Ann and Robert H. Lurie Children’s Hospital of Chicago, writes in an accompanying commentary.

“This robust analysis of a large, contemporary, multicenter database answers an important question about how surgical factors affect mortality over the first several decades of life,” he notes, “an essential outcome to be considered along with functional outcomes in evaluating the long-term value of any surgical strategy.”

Long-term Survival

Until now, there had been no information about long-term transplant-free survival following repair of tetralogy of Fallot in a large, multicenter US cohort, the authors write.

For this analysis, the investigators linked data from 3283 patients in the Pediatric Cardiac Care Consortium registry who had undergone surgery to repair tetralogy of Fallot from 1982 to 2006 with data from the National Death Index and the Organ Procurement and Transplantation Network.

About half of the patients (56%) were male, and about half (54%) underwent the surgery when they were younger than 1 year; the rest underwent the surgery when they were 1 to <5 years old (38%) or 5 to 21 years old (8%).

Most underwent nonstaged (81%) and non-valve-sparing (68%) surgery.

Most procedures were performed during 1990 to 1999 (59%), and the rest were done during 2000 to 2006 (25%) or 1982 to 1989 (17%).

Alcohol Abuse After Bariatric Surgery Common, Concerning


Individuals who undergo bariatric surgery, particularly Roux-en-Y gastric bypass (RYGP), have a significantly increased risk of developing a substance use disorder (SUD), in particular alcohol use disorder (AUD), new research shows.

The increased risk is not observed until after the first postoperative year, and risk factors include a preoperative history of substance use, especially alcohol; younger age; male sex; and smoking, said lead investigator Cameron Risma, MD, Pine Rest Christian Mental Health Services, Grand Rapids, Michigan.

In addition, people who chronically used opiates before the surgery tend to continue chronic use after surgery, Risma said.

Dr Cameron Risma

“We got the idea to study substance use disorders after bariatric surgery because we see a lot of it in our detox program at Pine Rest. It’s common. People come in years after surgery, and they never realized that this was an issue,” he told Medscape Medical News.

The findings were presented here at the American Academy of Addiction Psychiatry (AAAP) 29th Annual Meeting.

Fivefold Increased Risk

For the study, investigators conducted a PsychINFO and Web of Science search for articles published from 1996 to 2018 on the relationship between gastric bypass surgery and SUD.

They found that a 2013 prospective study that followed more than 4000 obese patients showed those who underwent bariatric surgery were nearly five times more likely to receive a diagnosis of alcohol abuse during a follow-up period of 8 to 22 years.

Another 2012 prospective study that followed almost 2500 bariatric surgery patients showed a significantly increased prevalence of symptoms of AUD during the second postoperative year compared to the first postoperative year (9.6% vs 7.3%).  There was no difference between the year immediately before (7.6%) or after (7.3%) the surgery.

The same study identified preoperative variables independently associated with increased risk of developing an AUD after bariatric surgery.  These included previous AUD, regular alcohol use (defined as >2 drinks per week), smoking, recreational drug use, male sex, RYGB, younger age, and low sense of belonging.

Two systematic reviews showed that approximately 8% of patients were chronic opiate users at the time of surgery, and that most continued using opioids in the year following surgery.

However, use of other substances after bariatric surgery remained unchanged.

Three hypotheses have been proposed to account for the link between bariatric surgery and addiction, Risma said.

“No one really knows exactly why, but one hypothesis is this idea of addiction transfer.  Binge eating can lead to obesity, so you get addicted to food. But after you have surgery, you can’t binge on food anymore so you turn to something else which happens to be a substance, to replace food. The idea is that you are using a substance to cope with a negative emotional state,” Risma said.

The next hypothesis is based on neurobiological mechanisms, supported by evidence from PET scans, which have shown similarly reduced D2 receptors in both pathologic obesity and addiction.

“It is possible that reduced striatal D2 receptors predispose an individual to search for strong dopaminergic reinforcement as a compensatory mechanism for dopamine hyposensitivity. This dopamine-based hypothesis is supported by neuroimaging studies showing that a rapid dopamine release is produced both by binge eating and IV alcohol infusion,” the authors write.

The third hypothesis is based on pharmacokinetic changes after RYGB, leading to a hypersensitivity to alcohol’s reinforcing effects.

“This is really interesting,” Risma said. “After Roux-en-Y gastric bypass, you get a hypersensitivity to alcohol’s effects, where even a small amount of alcohol can achieve very high blood alcohol concentrations.

“One drink can put you over the legal limit in less than 15 minutes, so it reaches a higher blood alcohol content and it takes longer for the alcohol to get out of your system. Some people report that even after a few sips they can feel a buzz. They go back to drinking the same amount, they get more drunk, and they can become addicted that way,” he said.

These changes are only observed in RYGB, and no other bariatric surgeries such as gastric banding or sleeve gastrectomy, Risma said.

“The results of our survey show that it’s primarily alcohol that becomes the substance of abuse,” he added. “But clinically, I’ll tell you, we see a lot of opiate use in our detox unit. This is something we would to like to investigate going forward, because we are seeing so much of it. People who have surgery have chronic pain, they can’t get off their opioids, and they come to us addicted and needing withdrawal and treatment afterwards.

“We would like to work with local bariatric surgical centers and ask how they are identifying people based on the risk factors we found in our survey, and then once they are identified, ask how they are treating them. Are you offering them classes, are you following up with them more often? We think that’s an area where we can make a clinical impact.”

A Growing Problem

Commenting on the findings for Medscape Medical News, Cornel N. Stanciu, MD, assistant professor of psychiatry, Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, said the number of individuals undergoing bariatric weight loss procedures is expected to grow by 6% to 8% annually in the coming years.

“Positive outcomes can be quite striking. However, there are certain aspects which could worsen or emerge. With both obesity and addictions being stigmatized and overlooked as disorders of poor self-control, with perhaps common genetic, behavioral, social, neurobiological and pharmacokinetic factors, one emerging issue noted has been the association of bariatric surgery with development of postoperative addictions,” Stanciu said.

Dr Cornel Stanciu

As with other surgeries, the biggest focus has been on limiting opioid use to prevent addictive tendencies, but here the biggest association seems to be with the development of risky alcohol use, he added.

“Some studies report this rate to be as high as 21% when the procedure is done via the RYGB method, and 11% when banding is done,” Stanciu said.

The finding of a delay in developing alcohol abuse patterns a year after surgery has significant implications. Historically, the most rigorous follow-up and aftercare occur immediately after the procedure and tapers off throughout the coming years.

“In an era that is shifting towards the ambulatory setting, providing prolonged aftercare and monitoring may present challenges,” he added.

Identifying factors that predispose individuals to alcohol abuse after their bypass should prompt implementation of additional safety nets, Stanciu said.

“Here, they found [that patients with] a history of alcohol use, undergoing the RYGB type of procedure, young age, male gender, and smokers may be predisposed. It’s important to implement better screening focused on these risk factors, as well as a more robust pre- and post-surgical education and closer follow-up.

“Also, because alcohol problems may not appear for years after the procedure, it is critical for all clinicians involved in the care of bariatric surgery patients to proactively assess alcohol consumption and be able to intervene early,” he said.

However, he added, the frequency of RYGB is decreasing, he noted.

“Initially, RYGB was more popular than banding as it led to more drastic weight loss. However, newer approaches such as sleeve gastrectomy and endoscopic modalities are rapidly taking over. Whether these may have a greater association with alcohol and other addictive behaviors is a great unknown at this time,” Stanciu said.

High Neoplasm Rate Seen After Conservative Treatment of Periappendicular Abscess


A trial comparing interval appendectomy to MRI follow-up after nonoperative treatment of periappendicular abscess was stopped prematurely after an interim analysis revealed a high neoplasm rate.

“The number of appendiceal tumors detected at interval appendectomy was alarming, and this is why the study was prematurely terminated due to ethical reasons,” Dr. Paulina Salminen of Turku University Hospital in Finland told Reuters Health.

“Periappendicular abscess is a form of complicated acute appendicitis that has already initially been treated conservatively, which is different from all other forms of complicated acute appendicitis (for example, perforated acute appendicitis),” she said by email. “The controversy with periappendicular abscess has been the need for interval – i.e., planned elective – appendectomy later on, after the initial successful conservative treatment.”

Dr. Salminen’s team had previously shown that antibiotic therapy can be effective as an initial treatment for acute uncomplicated appendicitis, with a five-year recurrence rate of 39%. (http://bit.ly/2IfaxmE).

For the current study, the team enrolled 60 patients (median age about 48; 60% men) who were diagnosed with periappendicular abscess in the emergency departments of five hospitals in Finland. Patients were randomized to either laparoscopic appendectomy or follow-up examinations with abdominal MRI. Both interventions were scheduled approximately three months after randomization.

As reported online November 28 in JAMA Surgery, a clinical suspicion of increased neoplasm risk among participants led to an unplanned interim analysis. The analysis revealed a 17% rate of neoplasms, with all cancers found in patients over age 40. The trial was terminated prematurely because of ethical concerns. Subsequently, two more neoplasms were diagnosed, resulting in an overall incidence of 20%.

At termination, the postoperative complication rate was 10% in the interval appendectomy group, and 33% of patients in the MRI follow-up group had undergone appendectomy at intervals ranging from 18 to 332 days.

Dr. Salminen said, “If this significant rate of neoplasms after periappendicular abscess is validated by future studies, it would argue (in favor of) routine interval appendectomy in this setting. We are planning on performing a prospective cohort study of periappendicular abscess patients in order to assess the associated neoplasm rate in a prospective national patient cohort.”

“What we can learn from (all) the data is that with acute uncomplicated appendicitis, laparoscopic appendectomy performed within 24 hours allows for same-day discharge of the patient and very few adverse events. This approach will also eliminate the doubt and risks associated with an incidental appendiceal tumor,” Dr. Kamal M.F. Itani of Boston University School of Medicine and the VA Boston Health Care System, told Reuters Health.

“This approach should be the gold standard against which any other intervention is measured for treatment failure, hospital length of stay, readmissions, complications, quality of life and costs,” he said by email.

By contrast, “for perforated appendicitis, after addressing the abscess, an interval appendectomy should be the standard of care,” Dr. Itani said. “A 20% rate of undetected tumor if appendectomy is not performed is unacceptable.”

“In the event a patient is treated with antibiotics for uncomplicated or complicated appendicitis as definitive early therapy either because of patient’s choice or severe comorbidities, I recommend an interval appendectomy or close follow up to rule out the possibility of an appendiceal tumor,” he concluded.

SOURCE:

JAMA Surgery 2018.

High Neoplasm Rate Seen After Conservative Treatment of Periappendicular Abscess


A trial comparing interval appendectomy to MRI follow-up after nonoperative treatment of periappendicular abscess was stopped prematurely after an interim analysis revealed a high neoplasm rate.

“The number of appendiceal tumors detected at interval appendectomy was alarming, and this is why the study was prematurely terminated due to ethical reasons,” Dr. Paulina Salminen of Turku University Hospital in Finland told Reuters Health.

“Periappendicular abscess is a form of complicated acute appendicitis that has already initially been treated conservatively, which is different from all other forms of complicated acute appendicitis (for example, perforated acute appendicitis),” she said by email. “The controversy with periappendicular abscess has been the need for interval – i.e., planned elective – appendectomy later on, after the initial successful conservative treatment.”

Dr. Salminen’s team had previously shown that antibiotic therapy can be effective as an initial treatment for acute uncomplicated appendicitis, with a five-year recurrence rate of 39%. (http://bit.ly/2IfaxmE).

For the current study, the team enrolled 60 patients (median age about 48; 60% men) who were diagnosed with periappendicular abscess in the emergency departments of five hospitals in Finland. Patients were randomized to either laparoscopic appendectomy or follow-up examinations with abdominal MRI. Both interventions were scheduled approximately three months after randomization.

As reported online November 28 in JAMA Surgery, a clinical suspicion of increased neoplasm risk among participants led to an unplanned interim analysis. The analysis revealed a 17% rate of neoplasms, with all cancers found in patients over age 40. The trial was terminated prematurely because of ethical concerns. Subsequently, two more neoplasms were diagnosed, resulting in an overall incidence of 20%.

At termination, the postoperative complication rate was 10% in the interval appendectomy group, and 33% of patients in the MRI follow-up group had undergone appendectomy at intervals ranging from 18 to 332 days.

Dr. Salminen said, “If this significant rate of neoplasms after periappendicular abscess is validated by future studies, it would argue (in favor of) routine interval appendectomy in this setting. We are planning on performing a prospective cohort study of periappendicular abscess patients in order to assess the associated neoplasm rate in a prospective national patient cohort.”

“What we can learn from (all) the data is that with acute uncomplicated appendicitis, laparoscopic appendectomy performed within 24 hours allows for same-day discharge of the patient and very few adverse events. This approach will also eliminate the doubt and risks associated with an incidental appendiceal tumor,” Dr. Kamal M.F. Itani of Boston University School of Medicine and the VA Boston Health Care System, told Reuters Health.

“This approach should be the gold standard against which any other intervention is measured for treatment failure, hospital length of stay, readmissions, complications, quality of life and costs,” he said by email.

By contrast, “for perforated appendicitis, after addressing the abscess, an interval appendectomy should be the standard of care,” Dr. Itani said. “A 20% rate of undetected tumor if appendectomy is not performed is unacceptable.”

“In the event a patient is treated with antibiotics for uncomplicated or complicated appendicitis as definitive early therapy either because of patient’s choice or severe comorbidities, I recommend an interval appendectomy or close follow up to rule out the possibility of an appendiceal tumor,” he concluded.

SOURCE:

JAMA Surgery 2018.

Bone loss, deterioration persist 5 years after gastric bypass


Adults with obesity who underwent Roux-en-Y gastric bypass experienced high-turnover bone loss and bone microarchitectural deterioration that persisted 5 years after the procedure, according to findings published in The Journal of Clinical Endocrinology & Metabolism.

“[Roux-en-Y gastric bypass]-associated skeletal fragility is mediated by accelerated, high-turnover bone loss and has been documented in the short term in multiple longitudinal studies,” Katherine G. Lindeman, of the endocrine unit at Massachusetts General Hospital, Boston, and colleagues wrote in the study background. “Collectively, these studies document that a decline in bone density up to 10% is common in the initial 1-2 years after [Roux-en-Y gastric bypass]. [Roux-en-Y gastric bypass] also leads to short-term declines in volumetric bone density of the axial and peripheral skeleton and weakening of peripheral bone microarchitecture. However, the long-term skeletal consequences of [Roux-en-Y gastric bypass] have not been well-characterized beyond these initial postsurgical years.”

In an observational study, researchers assessed longitudinal data on 21 patients with obesity undergoing Roux-en-Y gastric bypass at an academic medical center.

DXA was used to measure spine and hip areal bone mineral density, and quantitative CT was used to measure trabecular volumetric BMD of the spine. In a subset of participants, high-resolution peripheral quantitative CT was used to measure volumetric BMD and microarchitecture of the distal radius and tibia.

At each study visit, the researchers also measured serum type 1 collagen C-terminal telopeptide (CTX), which assesses bone resorption, and procollagen type 1 N-terminal propeptide (P1NP), which evaluates bone formation, and assessed physical activity. Study participants were advised to maintain a calcium intake between 1,200 mg and 1,500 mg daily and a vitamin D intake of 3,000 IU daily throughout the study.

At 5 years, researchers observed a mean 7.8% decrease in areal BMD at the spine and a mean 15.3% decrease in areal BMD at the total hip. However, the pace of spine areal BMD reduction slowed over time, with most of the bone loss observed within the first 2 years, according to researchers.

At the femoral neck, areal BMD decreased by a mean of 14.1% at 5 years. Additionally, researchers observed a mean 12.1% decrease in trabecular spine volumetric BMD at 5 years (P .001).

Peripheral sites showed continued and stable decreases over 5 years, with parallel reductions in cortical and trabecular microarchitecture. This led to a 20% decrease in estimated failure load at the radius and a 13% decrease at the tibia (P < .001), the researchers wrote.

After Roux-en-Y gastric bypass, significant increases in bone turnover markers were seen. At 2 years postoperatively, serum CTX was 196% higher vs. baseline levels and remained 150% above baseline at 5 years (P < .001). Increases were also seen in serum P1NP, reaching the highest point at 63% at 3.5 years after surgery, and remaining 34% higher at 5 years (P = .017 for comparisons vs. baseline).

“We found that areal and volumetric bone density and skeletal microarchitecture continue to deteriorate through 5 years after [Roux-en-Y gastric bypass] surgery, leading to substantial, cumulative bone loss,” the researchers wrote. “Adults undergoing [Roux-en-Y gastric bypass] warrant close follow-up to detect changes in bone density as well as to prevent secondary hyperparathyroidism and promote physical activity.” – by Jennifer Byrne

Corticosteroids therapy for sepsis: New Clinical guideline


https://speciality.medicaldialogues.in/corticosteroids-therapy-for-sepsis-new-clinical-guideline/

Doctors Replaced a Soldier’s Lost Ear Using a Wild Medical Technique


Army Pvt. Shamika Burrage almost died in 2016. The 19-year-old was returning back to base after visiting her family when her tire blew out, causing her to lose control of the car, which flipped and skidded for 700 feet before ejecting her. Thanks to prompt medical care, she only lost an ear instead of her life. But now, thanks to military plastic surgeons, she’s even got that back.

In a first for United States Army doctors, Burrage received an ear transplant that was grown from her own tissue inside her own body. A team, led by Lieutenant Colonel Owen Johnson III, the chief of plastic and reconstructive surgery at William Beaumont Army Medical Center in El Paso, Texas, harvested cartilage from Burrage’s ribs, carved it into the shape of an ear, and implanted it under the skin in her arm. There, it developed blood vessels, which Johnson says will allow Burrage to regain feeling in the ear once it’s healed. In an announcement released on Monday, Johnson called the operation a success.

ear growing under forearm skin
Army doctors grew a new ear for a soldier who lost one in a car crash.

“The whole goal is by the time she’s done with all this, it looks good, it’s sensate, and in five years if somebody doesn’t know her they won’t notice,” said Johnson in the statement. “As a young active-duty Soldier, they deserve the best reconstruction they can get.” Johnson also used skin from Burrage’s arm to help conceal the borders of the transplant and make the reconstruction more seamless. Soon Burrage, who is now 21 years old, will bear few marks of her fateful crash.

This procedure may be the U.S. Army’s first such transplant, but it’s definitely not the first time doctors have grown ears for patients. In 2012, doctors at Johns Hopkins University grew an ear under the forearm skin of a cancer survivor. In January, doctors in China successfully grew and transplanted ears onto children born with a birth defect that affects natural ear growth. In 2015, a child who had suffered burn injuries received the first 3D-printed nose.

Recent history suggests that procedures like Burrage’s will likely become more and more commonplace. Some doctors have even predicted that 2019 will be the year we’ll regularly print new noses and ears with human cells. In the meantime, Burrage has a couple more surgeries before her procedure can be considered complete. She’s feeling good about the surgery, though.

The ear had closed up because of the trauma from the accident, but Burrage says she can hear just as well as she could before. “I didn’t lose any hearing and [Johnson] opened the canal back up.”

For all book lovers please visit my friend’s website.
URL: http://www.romancewithbooks.com

FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults


The U.S. Food and Drug Administration today permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults. The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than 6 months as part of its Breakthrough Devices Program.

Most patients with a suspected head injury are examined using a neurological scale, called the 15-point Glasgow Coma Scale, followed by a computed tomography or CT scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment; however, a majority of patients evaluated for mTBI/concussion do not have detectable intracranial lesions after having a CT scan. Availability of a blood test for concussion will help health care professionals determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients.

“Helping to deliver innovative testing technologies that minimize health impacts to patients while still providing accurate and reliable results to inform appropriate evaluation and treatment is an FDA priority. Today’s action supports the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging—an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose,” said FDA Commissioner Scott Gottlieb, M.D. “A blood-testing option for the evaluation of mTBI/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases. In addition, availability of a blood test for mTBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our health care system the cost of often unnecessary neuroimaging tests.”

According to the U.S. Centers for Disease Control and Prevention, in 2013 there were approximately 2.8 million TBI-related emergency department visits, hospitalizations and deaths in the U.S. Of these cases, TBI contributed to the deaths of nearly 50,000 people. TBI is caused by a bump, blow or jolt to the head or a penetrating head injury that disrupts the brain’s normal functioning. Its severity may range from mild to severe, with 75 percent of TBIs that occur each year being assessed as mTBIs or concussions. A majority of patients with concussion symptoms have a negative CT scan. Potential effects of TBI can include impaired thinking or memory, movement, sensation or emotional functioning.

“A blood test to aid in concussion evaluation is an important tool for the American public and for our Service Members abroad who need access to quick and accurate tests,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA’s review team worked closely with the test developer and the U.S. Department of Defense to expedite a blood test for the evaluation of mTBI that can be used both in the continental U.S. as well as foreign U.S. laboratories that service the American military.”

The Brain Trauma Indicator works by measuring levels of proteins, known as UCH-L1 and GFAP, that are released from the brain into blood and measured within 12 hours of head injury. Levels of these blood proteins after mTBI/concussion can help predict which patients may have intracranial lesions visible by CT scan and which won’t. Being able to predict if patients have a low probability of intracranial lesions can help health care professionals in their management of patients and the decision to perform a CT scan. Test results can be available within 3 to 4 hours.

The FDA evaluated data from a multi-center, prospective clinical study of 1,947 individual blood samples from adults with suspected mTBI/concussion and reviewed the product’s performance by comparing mTBI/concussion blood tests results with CT scan results. The Brain Trauma Indicator was able to predict the presence of intracranial lesions on a CT scan 97.5 percent of the time and those who did not have intracranial lesions on a CT scan 99.6 percent of the time. These findings indicate that the test can reliably predict the absence of intracranial lesions and that health care professionals can incorporate this tool into the standard of care for patients to rule out the need for a CT scan in at least one-third of patients who are suspected of having mTBI.

The Brain Trauma Indicator was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

The FDA is permitting marketing of the Brain Trauma Indicator to Banyan Biomarkers, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.