
Excellent Initiative That Sholud Be Implemented Everywhere

An ablative procedure intended to promote regrowth of duodenal mucosa was safe and had disease-modifying metabolic effects in a randomized study including patients with type 2 diabetes, according to investigators.
A single duodenal mucosal resurfacing (DMR) procedure improved glycemic, hepatic, and body weight measures at 24 weeks in the multicenter study, investigators will report at the annual meeting of the American Association for the Study of Liver Diseases.
The novel and minimally invasive endoscopic procedure treats the duodenum, which is increasingly recognized as a key metabolic signaling center, according to the study authors, including senior author Arun Sanyal, MD, professor in the gastroenterology division of the department of internal medicine at Virginia Commonwealth University School of Medicine in Richmond.
“Duodenal mucosal hyperplasia is a potential therapeutic target for insulin-resistance–related metabolic diseases,” Dr. Sanyal and coauthors said in a late-breaking abstract for the study published in the AASLD meeting proceedings.
In a previous international open-label, prospective, multicenter study, published in July in the journal Gut, DMR was feasible and safe, producing durable glycemic improvement in patients with type 2 diabetes with suboptimal control on oral glucose-lowering mediation, according to investigators.
The present study, conducted at nine sites in the European Union and two in Brazil, is the first sham-controlled, double-blind, and prospective study of the modality in patients with suboptimally controlled type 2 diabetes, according to Dr. Sanyal and coauthors.
A total of 39 patients in the study underwent DMR, while 36 underwent a sham procedure, according to the published abstract. The mean HbA1c for those patients was 8.3, BMI was 31.1 kg/m2, and most (77%) were male.
Median change in HbA1c from baseline to 24 weeks, one of two primary endpoints in the study, was –0.6% for DMR, and –0.3% for the sham procedure (P less than 0.05), according to the study abstract.
Likewise, the primary efficacy endpoint of change in a nonalcoholic steatohepatitis (NASH) biomarker favored the DMR arm. The median change in liver magnetic resonance imaging-proton density fat fraction (MRI-PDFF) from baseline to 12 weeks was –5.4% for DMR and –2.4% for the sham procedure (P less than 0.05), according to the reported data.
Hypoglycemia rates were similar in the DMR and sham arms, and over 24 weeks of study, there were no unanticipated adverse effects attributable to the device, and no serious adverse events, Dr. Sanyal and colleagues reported.
Dr. Sanyal reported disclosures related to Fractyl Laboratories, Sanyal Bio, Exhalenz, Akarna, Genfit, Durect, Indalo, Tiziana, Novartis, Merck, Galectin, Janssen, Merck, and more.
Source : Medscape
Doctors who transplanted a complete penis and scrota onto the body of a soldier wounded by an improvised explosive device in Afghanistan reported Wednesday that the man has regained near-normal erections and the ability to achieve orgasm more than one year after the surgery was completed.
The landmark 14-hour operation was done at Johns Hopkins Hospital in Baltimore, Maryland, on March 26, 2018, by nine plastic surgeons and two urological surgeons.
The transplant included part of the abdominal wall, but not the testicles. Previously, only four successful penis-only transplants have been reported.
“His recovery has exceeded expectations,” Dr. Richard Redett III, a professor of plastic and reconstructive surgery at Johns Hopkins, told Reuters Health in an email.
He and his colleagues report in a letter to the New England Journal of Medicine, online November 6, that the soldier, who lost both legs above the knee as a result of the IED, “has normal sensation to the shaft and tip of the transplanted penis and can localize touch sensation.”
“The patient urinates while standing, without straining, frequency, or urgency, with the urine discharged in a strong stream,” the Redett team writes in its report. “The patient has returned to school full-time and continues to live independently using leg prostheses. He reports an improved self-image and ‘feeling whole’ again and states that he is very satisfied with the transplant and the implications it carries for his future.”
The team had been preparing for such surgery on the man since 2013, Redett said. “Our patient was initially referred for an evaluation using conventional reconstructive techniques. Because he had concomitant extremity injuries (flap donor sites) and his defect was so large and included the lower abdominal wall, penis and scrotum, and some medial thigh tissue, conventional reconstructive options were very limited. At the same time, we had started exploring penile transplantation.”
The man was on a wait-list for 15 months.
In addition to matching blood and tissue types, the procedure, known as vascularized composite allograft (VCA) surgery, “also requires matching other features such as skin tone, size and age of the graft,” Redett noted. “When people sign up as an organ donor they are not authorizing a VCA donation. The family makes the decision about VCA donation after death, which adds another step to the approval process.”
The process included infusions of bone marrow from the donor to the soldier beginning two weeks after the surgery to tamp down the immune system’s response to the donated tissue.
The marrow transplant was designed to allow the patient to only need a single small dose of the drug tacrolimus each day to suppress immune rejection of the transplant.
Source : Medscape
A quick injection that blocks the stellate ganglion relieves symptoms of posttraumatic stress disorder (PTSD) and may represent a new and urgently needed treatment option.
Results of a randomized, sham-controlled trial in active-duty military members showed that stellate ganglion block (SGB) relieved distress, anxiety, and depression in this cohort.
Interestingly, those with the most severe PTSD achieved the greatest benefit.
“SGB can represent a new treatment option for PTSD but should be used as much as possible in concert with psychotherapy,” principal investigator Kristine L. Rae Olmsted, MSPH, a research epidemiologist at Research Triangle Institute, Durham, North Carolina, told Medscape Medical News.
The study was published online November 6 in JAMA Psychiatry.
Research suggests that extreme trauma may stimulate the sympathetic nervous system. The stellate ganglion, a collection of nerves located at the base of the neck, is part of that nervous system and is “sort of a weigh station for the fight or flight” reaction, said Rae Olmsted.
The SGB procedure involves injecting a short-acting local anesthetic in and around the stellate ganglion to temporarily block its function. The procedure is “very quick,” taking only about 5 minutes, said Rae Olmsted.
It’s unclear how SGB works with respect to PTSD, but some experts believe it “reboots” the sympathetic nervous system to its pretrauma state, perhaps by providing feedback to the amygdala, which is closely aligned with emotional processing.
The procedure isn’t new; it has been used to treat pain conditions since the 1940s. Several case studies showed promising results in patients with PTSD, although in one clinical trial, the results were negative.
The new study included 113 active-duty military personnel (100 men and 13 women; mean age, 37.3 years) at three sites. Participants were required to have been diagnosed with PTSD and to have been stable through the use of psychotropic medication for a period of at least 3 months. Patients were excluded from the study if they had a history of moderate or severe traumatic brain injury.
Patients were randomly assigned to receive two right-sided SGB treatments or sham procedures 2 weeks apart. None of the participants had a patient-physician relationship with the clinician who administered the treatment.
Those in the active-SGB group were injected with 7 to 10 mL of ropivacaine 0.5% around and into the ganglion at the level of the C6 anterior tubercle. The sham-treatment group received 1 to 2 mL of preservative-free normal saline injected into deep musculature anterolateral to the anterior tubercle of C6.
Participants were blinded with respect to which procedure they received; drapes were used to limit their field of vision. Although clinicians could not be blinded, their interactions with participants were scripted.
Of the total, 108 individuals (95.6%) remained in the study through the 8-week follow-up.
The study’s primary outcome was change in overall total symptom severity scores on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Scores on that scale range from 0 to 80 points, with higher scores indicating greater PTSD symptom severity. A 10-point change in the CAPS score was considered clinically meaningful.
The analysis showed that at 8 weeks, the SGB group benefited more than the sham-treatment participants. The mean symptom change after adjustment for study site and baseline CAPS-5 score was –12.6 points for SGB group compared with –6.1 points for the sham-treatment group, which represented a significant difference.
The treatment appeared to work better for those with more severe PTSD symptoms. For each 1-point increase in initial CAPS-5 score, there was an estimated additional 0.2-point reduction at 8 weeks.
The reasons for this are unclear, but other studies have reported similar findings, said Rae Olmsted. She speculated that patients with more severe symptoms may have “more opportunity to get better.”
Secondary outcomes included scores for a number of symptoms highly correlated with PTSD, including depression, distress, anxiety, pain, physical functioning, and mental functioning. For all these outcomes, those receiving SGB had significantly improved scores on relevant scales compared with those receiving the sham procedure.
Six adverse events were reported, including coughing as well as pain and redness at the injection site. None of these were serious.
The new results contrast with those of the first pilot, randomized clinical trial of SGB for combat-associated PTSD. That study did not find a significant difference between the SGB group and the saline-injection control group.
The authors note the following differences between that study and the current one: the previous was smaller; it included a single site; it used only one SGB instead of two; it utilized less ropivacaine; and exclusion criteria were less rigorous.
The potential for participants to recognize signs of Horner syndrome is a limitation of the study. Horner syndrome, a possible side effect of the SGB procedure, is characterized by “a droopy eye, constricted pupil, and red eye on right-hand side,” said Rae Olmsted.
“This was a concern, but one we couldn’t control for. We had our clinicians and clinical staff tell everybody, regardless of treatment group, that it was potential outcome,” she said.
The fact that the study population was highly specified might limit clinical generalizability, say the authors. Also, the overall severity level of PTSD symptoms in the sample was low to moderate, which might limit generalizability with respect to patients routinely seen in outpatient practice.
“However, we view inclusion of active-duty service members with subthreshold signs as a strength, given emerging evidence suggesting PTSD symptoms may be best seen as a continuum,” the authors write.
The investigators are planning a large-scale, multisite cohort study that will follow PTSD patients for a year after they receive SGB. The researchers will assess factors such as symptom trajectory, the degree to which patients improve over time, and how long they remain better.
Commenting on the findings for Medscape Medical News, Gary H. Wynn, MD, Col, MC, Uniformed Services University of the Health Sciences, and senior scientist, Center for the Study of Traumatic Stress, Bethesda Maryland, said the study was “well done.”
These findings suggest that “SGB should be in the tool box for PTSD, but we’re just not sure how best to use the tool yet,” said Wynn.
“We have to figure out if we should we use it early in the process of treatment or later on in the process of treatment, in combination with psychotherapies or in combination with other medicines. Do you start off with this and wait until patients get some symptom relief and then initiate medicines?” he said.
Although questions still need to be answered about the treatment, Wynn said, “It’s very clear from this study that there is some validity to its use.”
He’s concerned that people will interpret these positive results to mean that SGB is “curative,” when “the truth is, this is a modest result.”
He also pointed out that the procedure must be performed by an anesthesiologist who is very familiar with SGB. “So there are some limitations to the construct of this that suggest we’re not going to roll this out to all 400,000 Veterans Affairs beneficiaries who have a diagnosis of PTSD.”
Also commenting, retired military psychiatrist Elspeth Cameron Ritchie, MD, chief of psychiatry at Medstar Washington Hospital Center, Washington, DC, who has expertise in PTSD among combat veterans, said she’s “really excited” by the findings.
This is the first study to show that the procedure works on a wide scale, said Ritchie, and that’s “incredibly significant.”
However, she pointed out that the treatment isn’t effective for everyone. “One of the challenges is to determine who it works for,” she said.
Ritchie agreed that study participants who developed Horner syndrome likely suspected that they had been given the active treatment. But she noted the difficulty of conducting a sham study that involves injecting an agent into the participants.
“No study is perfect, and the fact that they got as many people as they did into this one and that they showed a significant difference on the standardized measure is very exciting.”
Ritchie said she and her colleagues “would love” to see this type of study carried out in a Veterans Administration setting in which there is a “very large population of potential subjects” with chronic conditions.
Rae Olmsted reports having a cooperative agreement for the funding of this study with the US Army during the conduct of the study. Wynn and Ritchie report no relevant financial relationships.
JAMA Psychiatry. Published online November 6, 2019. Abstract
In July, Robert Chelsea became the first African American patient to have a full face transplant, Boston’s Brigham and Women’s Hospital announced. The procedure took 16 hours and involved a team of over 45 medical professionals.
Chelsea, 68, is also the oldest face transplant patient. He’s one of just 15 recipients in the United States, out of around 40 worldwide done since 2005.
“May God bless the donor and his family who chose to donate this precious gift and give me a second chance,” Chelsea said in a statement. “Words cannot describe how I feel. I am overwhelmed with gratitude and feel very blessed to receive such an amazing gift.”
A drunken driver slammed into his car in 2013, leaving Chelsea with third-degree burns covering half his body, according to Time. After having more than 30 surgeries, he was put on the transplant list in March 2018. Just 2 months later, a face became available, but the skin tone was much lighter than Chelsea’s. He turned it down, then waited more than a year for another opportunity.
According to the hospital, Chelsea “is likely to achieve near normal sensation and about 60 percent restoration of facial motor function within a year, including the ability to eat, smile and speak normally.” His was the ninth face transplant procedure done at Brigham and Women’s Hospital.
“The face symbolically is such an important part of our bodies, to some people it’s almost who we are,” says Jerry McCauley, MD, chief of nephrology at Thomas Jefferson University Hospital and former chairman of minority affairs at the United Network of Organ Sharing (UNOS). “African Americans have a wide variety of skin colors, so there could be a major difference. When you’re doing cosmetic transplants you want to match as closely as you can: What will my lips look like, my nose? Will I resemble people in my family?”
Until recently, African Americans were less likely than white people to receive transplants of any kind. At one point, they waited almost three times as long, McCauley says. In 2015, UNOS rolled out a new allocation system that removed much of the systemic bias. Today, the wait time for kidneys is approximately the same for both races, though there’s still a disparity among heart and lung recipients.
“That may have to do with some of the diseases that African Americans have, compared to whites. Also, the number of people even being evaluated for heart and lung transplants is lower in the African American population than in the white population,” says McCauley. UNOS is working on the allocation system for those organs, aiming to achieve equal sharing among races. “With UNOS, it’s a good story/bad story. The bad is, it took so long to fix it, and the good is they’re all in now,” he says.
According to Organdonor.gov, African Americans make up nearly 30% of the wait list for transplants, compared to almost 41% for white people — yet African Americans only receive about 21% of transplants, while white people get more than 55%. Black people make up around 13% of the U.S. population.
“That may have to do with physician selection, socioeconomics, even where you’re being evaluated,” says McCauley. “And the final issue may be the discrimination factor that nobody likes to talk about.”
For many years, there was also a substantial racial disparity in the number of donors. Distrust of the medical system, certain religious beliefs, and other concerns kept many black people from donating. In 1988, for example, there were only 359 African American deceased donors. Because of a joint effort to increase donations, by 2018, that number had surpassed 7,000. The percentage of donors who are black now reflects their percentage in the population, even though allocation of organs remains uneven.
When it comes to organs and non-cosmetic transplants, race isn’t a factor — we’re all the same beneath the skin. But body parts like the face, hands, and reproductive organs require composite tissue transplants. Those take multiple tissue types, including skin, bones, nerves, and blood vessels, and when skin is involved, appearances count. Thanks to the increased rate of donation among African Americans, the larger pool of skin tone matches may have helped bring about Chelsea’s transplant, McCauley says.
“It’s going to be exciting,” says McCauley. “Other African Americans will see this gentleman and know this is for them, too. You don’t have to worry about getting a transplant with a white face. You can have a face that makes sense for you.”
Courtesy : Medscape
Scientists have found that two biomarkers — high-sensitivity troponin (hs-TnT and N-terminal prohormone BNP (NT-proBNP) — are linked to increased risk for poor cardiovascular outcomes in patients with chronic kidney disease (CKD).
The study was published in Mayo Clinic Proceedings by Shravya Vinnakota, MBBS, of the Department of Internal Medicine at the Mayo Clinic, Rochester, and colleagues.
NT-proBNP, a precursor to brain natriuretic peptide (BNP), and hs-troponin are both cleared by the kidneys. Clinicians have therefore been hesitant to use them to predict cardiovascular outcomes in people with CKD because of concerns that they may be falsely elevated in these patients.
But, “In this study we demonstrated that NT-proBNP and hs-TnT have prognostic value regardless of kidney function,” senior author Horng H. Chen, MB, BCh, told Medscape Medical News by email.
“Hence, these two biomarkers can be used to help clinicians…identify patients with kidney disease who are at highest risk for adverse cardiac events and [who] would be candidates for aggressive risk factor modification to prevent adverse outcomes,” added Chen, a cardiologist who specializes in heart failure at the Mayo Clinic.
Cardiovascular disease (CVD) claims more lives in people with CKD than complications of kidney disease. This can be explained in part by shared common risk factors including hypertension, diabetes, hyperlipidemia, smoking, and obesity.
However, there is growing evidence that impaired kidney function and raised albuminuria levels are risk factors for CVD independent of traditional factors such as hypertension and diabetes.
In addition, there are pathologic mechanisms that are unique to CKD that promote vascular disease, thus contributing to the increased burden of CVD, Vinnakota and colleagues explain.
However, there is a paucity of studies stratifying cardiovascular risk in patients with CKD, they add.
The researchers therefore set out to classify participants by renal function, characterize trends of cardiac biomarker activation and left ventricular function, and report cardiovascular outcomes over a 10-year follow-up period using data from a retrospective study, including 1981 participants from the Olmsted County Heart Function Study.
Participants were aged 45 years and older between January 1997 and December 2000, and had had a clinical evaluation, medical record review, lab tests, and echocardiogram. Follow-up was a median 10.2 years. Results were adjusted for age and sex.
The prevalence of stage 3 CKD (eGFR < 60 mL/min/1.73m2) was 6.4% (126/1981). In the remainder of the group, 52.3% (1036/1981) had mild renal insufficiency (eGFR 60-89 mL/min/1.73m2) and 41.3% (819/1981) had normal kidney function.
Compared to participants with normal kidney function, those with stage 3 CKD had a 38% increased risk of the primary outcome, a composite of myocardial infarction (MI), congestive heart failure (CHF), stroke, and all-cause mortality (HR, 1.38; P = .02).
Similarly, those with stage 3 CKD had almost double the MI risk (HR, 1.95; P = .006), and were also at higher risk for stroke, CHF, and death individually, compared with those with normal kidney function, although the latter three results were not statistically significant.
Furthermore, people with NT-proBNP and hs-TnT levels in the highest tertile were at greater risk for adverse cardiovascular outcomes including CHF, MI, stroke, and all-cause mortality, compared to those with lower levels of the biomarkers.
And the degree of kidney impairment, as estimated by eGFR, did not significantly affect the results, suggesting renal impairment was not the only reason for elevation of the biomarkers
The authors note some study limitations, however.
Because most participants were white, the results may not apply to more diverse groups. The study also lacked information about duration and severity of coexisting medical conditions and cardiac medications, which could have affected outcomes. And cardiac biomarkers were only measured at the start of the study, so whether they changed over time is unknown.
Further analysis suggested an optimal cut-point for the overall study group of 97.1 pg/mL for NT-proBNP and 3.8 ng/L for hs-TnT; these values were similar to the third tertile for both biomarkers, say the researchers.
“In comparison with prior studies, these data suggest lower thresholds of both biomarkers for prediction of poor outcomes,” they note.
“Our findings validate the importance of monitoring these levels in patients with CKD and propose an additional tool to identify those at highest risk for adverse cardiovascular events,” the authors state.
Nevertheless, more work is needed to confirm the results and whether “these cardiac biomarkers could identify high-risk CKD patients for aggressive management of cardiovascular risk factors,” they conclude.
Courtesy : Medscape
Higher serum trans-fat levels have been associated with a significantly elevated risk of dementia, including Alzheimer’s disease (AD), results of a large, longitudinal study show.
Participants with the highest concentrations of serum elaidic acid, a major trans-fatty acid formed in the partial hydrogenation of vegetable oils, had a 53% increased risk of dementia. This group also had a 43% higher likelihood for developing AD compared with those with the lowest levels.
“We found that higher serum elaidic acid levels were associated with greater risk of developing all-cause dementia and Alzheimer’s disease, after adjustment for traditional risk factors as well as dietary saturated and polyunsaturated fatty acids intake,” principal investigator Toshiharu Ninomiya, MD, PhD, told Medscape Medical News.
“In addition, the self-reported intake of breads, margarine and confectioneries were correlated with serum elaidic acid levels, although the magnitude of the correlation was not strong,” added Ninomiya, a professor in the Departments of Epidemiology and Public Health and the Center for Cohort Studies, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
The study was published online October 23 in Neurology.
Previousresearch has linked excessive consumption of trans fats to the development of coronary artery disease, diabetes, and other conditions.
Given these health concerns, the FDA banned artificial trans fats from grocery store and restaurant foods in June 2018. The agency permits foods with less than 0.5 grams of trans fats to be labeled as containing zero grams of trans fats, so some foods still contain partially hydrogenated oils.
“These results give us even more reason to avoid trans fats,” Ninomiya said in a news release. “In the United States, the small amounts still allowed in foods can really add up if people eat multiple servings of these foods, and trans fats are still allowed in many other countries.”
The World Health Organization also is taking action with an initiative to eliminate industrial trans fat from the global food supply by 2023.
However, less is known about any potential association between trans fat and dementia. The few studies in the literature have yielded inconsistent results, the researchers note.
In search of a more definitive answer, the investigators assessed data from 1628 participants in the ongoing, prospective Hisayama Study. The 925 women and 703 men completed questionnaires and provided blood samples in 2002 to 2003. All were 60 years or older at baseline.
The researchers also classified serum levels of elaidic acid into quartiles, and then followed participants prospectively for a median of 10.3 years.
Participants completed the Diet History Questionnaire, reporting intake of 150 food items in 23 categories. The researchers focused on seven of these food groups known to contain trans fats, including cereals, confectioneries, animal and plant fat, sugar and sweeteners, seasonings, meat, and dairy products.
Participants self-reported educational status, smoking, alcohol intake, regular exercise, and any treatments for hypertension or diabetes.
Over more than a decade of follow-up, 377 participants developed all-cause dementia, including 247 who developed AD and 102 who developed vascular dementia.
Using the lowest quartile of serum elaidic age concentration group as a reference, the likelihood for developing all-cause dementia significantly increased with higher serum trans-fat groups. For example, the second quartile cohort had a hazard ratio (HR) of 1.24 (95% confidence interval [CI], 0.92 – 1.68; P = .16).
Findings for the third quartile (HR, 1.63; 95% CI, 1.21 – 2.18; P = .001) and the fourth and highest serum quartile (HR, 1.53; 95% CI, 1.14 – 2.04; P = .004) also were noteworthy.
“Although significant linear trends were observed, the risk of developing dementia and AD appeared to increase at the level of the third quartile,” the researchers note.
Again, using the lowest serum trans-fat cohort as reference, the risk for developing AD increased with increasing concentrations of elaidic acid. The hazard ratios were 1.22, 1.79, and 1.43 for the second, third, and fourth quartiles, respectively.
The association between serum elaidic acid and risk of all-cause dementia and AD remained in a multivariable model that adjusted for age, sex, education, hypertension, diabetes, total cholesterol, BMI, history of stroke, and other traditional risk factors. This model also adjusted for total energy intake, as well as intake of saturated and polyunsaturated fatty acids.
Investigators found no significant association between higher elaidic acid levels and risk of vascular dementia.
“Since serum elaidic acid levels are likely to reflect industrially produced trans-fat intake, our findings raise the possibility that avoiding the intake of foods high in trans fat may reduce the risk of future onset of dementia,” Ninomiya said.
Sweet pastries were the strongest predictor of higher serum elaidic levels, followed by margarine and sugar confections such as candy, caramels, and chewing gum. Croissants, nondairy creamers, ice cream, and rice crackers were also associated with higher trans-fat levels in the study.
“Public health policy to augment food industry efforts to reduce trans-fatty acids in the food supply and to educate the public about healthy food choices may additively contribute to the primary prevention of dementia,” the researchers note.
The mechanisms underlying the link between serum elaidic acid levels and dementia are still unknown, Ninomiya said. More research is necessary to confirm these findings, she added.
A potential limitation is that all participants were from the same town in Japan and levels of trans fats in the diet vary by country, region, and time period. Therefore, the results may not apply to other populations, the researchers note.
The study is “definitely interesting. There is a growing body of evidence between diet and risk of dementia. And it’s probably about people not getting enough green leafy vegetables, nutrients, or vitamin B, for example,” Keith Fargo, PhD, director of scientific programs and outreach at the Alzheimer’s Association in Chicago, told Medscape Medical News.
“The risk could also be related to environmental toxins, where people are exposed via food or environmental pollution,” he added.
Caution is warranted but the study is about associations and not causation, Fargo noted. “The authors did a good job of controlling for other factors, but it is impossible to control for everything,” he said.
“I would consider this a good news story. In the US, we have largely banned trans fats, and this could be good news for future dementia levels,” Fargo said. “This is another piece of evidence to support the FDA’s actions.”
Courtesy : Medscape
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