Video

NEW YORK – Female physicians are at higher risk for burnout compared with their male counterparts, and the reasons and potential solutions for the problem were addressed at a symposium during the annual meeting of the American Psychiatric Association.

The work environment for women has improved over time, but lingering implicit and unconscious biases are part of the reason for the high burnout rate among women who are physicians, as are some inherent biological differences, according to Cynthia M. Stonnington, MD, of the Mayo Clinic, Phoenix.

In this video interview, Dr. Stonnington, symposium chair, discussed potential solutions, including facilitated peer mentorship and group support. She also reviewed recent data on how group support can be of benefit, and noted that “there is power in numbers.

“It is imperative that women ... band together and find a way to support each other,” she said.

Dr. Stonnington reported having no disclosures.

[email protected]

NEW YORK – Female physicians are at higher risk for burnout compared with their male counterparts, and the reasons and potential solutions for the problem were addressed at a symposium during the annual meeting of the American Psychiatric Association.

The work environment for women has improved over time, but lingering implicit and unconscious biases are part of the reason for the high burnout rate among women who are physicians, as are some inherent biological differences, according to Cynthia M. Stonnington, MD, of the Mayo Clinic, Phoenix.

In this video interview, Dr. Stonnington, symposium chair, discussed potential solutions, including facilitated peer mentorship and group support. She also reviewed recent data on how group support can be of benefit, and noted that “there is power in numbers.

“It is imperative that women ... band together and find a way to support each other,” she said.

Dr. Stonnington reported having no disclosures.

[email protected]

NEW YORK – Female physicians are at higher risk for burnout compared with their male counterparts, and the reasons and potential solutions for the problem were addressed at a symposium during the annual meeting of the American Psychiatric Association.

The work environment for women has improved over time, but lingering implicit and unconscious biases are part of the reason for the high burnout rate among women who are physicians, as are some inherent biological differences, according to Cynthia M. Stonnington, MD, of the Mayo Clinic, Phoenix.

In this video interview, Dr. Stonnington, symposium chair, discussed potential solutions, including facilitated peer mentorship and group support. She also reviewed recent data on how group support can be of benefit, and noted that “there is power in numbers.

“It is imperative that women ... band together and find a way to support each other,” she said.

Dr. Stonnington reported having no disclosures.

[email protected]

SANDESTIN, FLA. – Several drugs approved for other conditions may also have good effect in patients with systemic lupus erythematosus, Michelle Petri, MD, said in an interview at the annual Congress of Clinical Rheumatology.

The molecules target several different disease pathways, said Dr. Petri, director of the Hopkins Lupus Center at Johns Hopkins University, Baltimore.

Ustekinumab (Stelara) has accumulated the most data so far. A phase 2 study presented last fall at the annual meeting of the American College of Rheumatology found that it conferred significant benefits relative to placebo, including a 60% responder rate (29% better than placebo), a significantly lower flare rate, and improvements in musculoskeletal and mucocutaneous disease features. The rate of serious adverse events was acceptable (8.3% vs. 9.5% for placebo).

Baricitinib is also being investigated in SLE, Dr. Petri said. A phase 2 study conducted by Eli Lilly closed late last year and will be reported on June 13 at the European League Against Rheumatism’s opening plenary session (Wallace et al. EULAR 2018 abstract OP0019).

The three-armed, placebo-controlled study comprised 314 patients who were randomized to placebo or one of two baricitinib doses, given orally for 24 weeks. The primary outcome was remission of arthritis and/or rash as measured by the SLE Disease Activity Index 2000 (SLEDAI-2K). Secondary endpoints included responder rate, change from baseline in the SLEDAI-2K, change in the Global Assessment of Disease Activity score, and pharmacokinetic measures.

Dr. Petri disclosed relationships with Amgen, Boston Pharmaceuticals, Bristol-Myers Squibb, EMD Serono, Janssen, Novartis, and GlaxoSmithKline.

[email protected]

SANDESTIN, FLA. – Several drugs approved for other conditions may also have good effect in patients with systemic lupus erythematosus, Michelle Petri, MD, said in an interview at the annual Congress of Clinical Rheumatology.

The molecules target several different disease pathways, said Dr. Petri, director of the Hopkins Lupus Center at Johns Hopkins University, Baltimore.

Ustekinumab (Stelara) has accumulated the most data so far. A phase 2 study presented last fall at the annual meeting of the American College of Rheumatology found that it conferred significant benefits relative to placebo, including a 60% responder rate (29% better than placebo), a significantly lower flare rate, and improvements in musculoskeletal and mucocutaneous disease features. The rate of serious adverse events was acceptable (8.3% vs. 9.5% for placebo).

Baricitinib is also being investigated in SLE, Dr. Petri said. A phase 2 study conducted by Eli Lilly closed late last year and will be reported on June 13 at the European League Against Rheumatism’s opening plenary session (Wallace et al. EULAR 2018 abstract OP0019).

The three-armed, placebo-controlled study comprised 314 patients who were randomized to placebo or one of two baricitinib doses, given orally for 24 weeks. The primary outcome was remission of arthritis and/or rash as measured by the SLE Disease Activity Index 2000 (SLEDAI-2K). Secondary endpoints included responder rate, change from baseline in the SLEDAI-2K, change in the Global Assessment of Disease Activity score, and pharmacokinetic measures.

Dr. Petri disclosed relationships with Amgen, Boston Pharmaceuticals, Bristol-Myers Squibb, EMD Serono, Janssen, Novartis, and GlaxoSmithKline.

[email protected]

SANDESTIN, FLA. – Several drugs approved for other conditions may also have good effect in patients with systemic lupus erythematosus, Michelle Petri, MD, said in an interview at the annual Congress of Clinical Rheumatology.

The molecules target several different disease pathways, said Dr. Petri, director of the Hopkins Lupus Center at Johns Hopkins University, Baltimore.

Ustekinumab (Stelara) has accumulated the most data so far. A phase 2 study presented last fall at the annual meeting of the American College of Rheumatology found that it conferred significant benefits relative to placebo, including a 60% responder rate (29% better than placebo), a significantly lower flare rate, and improvements in musculoskeletal and mucocutaneous disease features. The rate of serious adverse events was acceptable (8.3% vs. 9.5% for placebo).

Baricitinib is also being investigated in SLE, Dr. Petri said. A phase 2 study conducted by Eli Lilly closed late last year and will be reported on June 13 at the European League Against Rheumatism’s opening plenary session (Wallace et al. EULAR 2018 abstract OP0019).

The three-armed, placebo-controlled study comprised 314 patients who were randomized to placebo or one of two baricitinib doses, given orally for 24 weeks. The primary outcome was remission of arthritis and/or rash as measured by the SLE Disease Activity Index 2000 (SLEDAI-2K). Secondary endpoints included responder rate, change from baseline in the SLEDAI-2K, change in the Global Assessment of Disease Activity score, and pharmacokinetic measures.

Dr. Petri disclosed relationships with Amgen, Boston Pharmaceuticals, Bristol-Myers Squibb, EMD Serono, Janssen, Novartis, and GlaxoSmithKline.

[email protected]

NEW YORK – Recent discoveries regarding the relationship between alcohol consumption and neuroinflammation suggest a possible role for adjunctive treatments and supplements in addiction treatment, according to Shram Shukla, MD.

For example, a qualitative review of the literature over the past 2-3 years showed that the “neuroinflammatory process in and of itself drives epigenetic changes, which ultimately upregulate neuroinflammation of the brain,” according to Dr. Shukla of Walter Reed National Military Medical Center, Bethesda, Md., who reported the findings in a poster at the annual meeting of the American Psychiatric Association.

In this video interview, he explained that this finding is important because “neuroinflammation leads to neurotoxicity, which leads to neuronal degeneration.”

“As we know, with patients who chronically abuse alcohol, they do have a level of cortical degeneration that we often see on imaging, so there is, perhaps, a role that this may play in that,” he added.

Dr. Shukla said he also found that the neuroinflammatory process, when it drives the epigenetic changes, affects the amygdala, which is known as a “high stress part of the brain.”

“What we found in animal models so far is that if we can impact where that epigenetic change occurs, we can prevent the anxiogenic behaviors we often see in alcohol withdrawal and abstinence; we associate that, in humans, to be the high-stress state we often see in patients when they ... are withdrawing from alcohol.”

This raised questions about whether certain medications and supplements, including vitamin C, pioglitazone, infliximab, and omega-3 fatty acids, could be of benefit, and it was shown that these do affect neuroinflammation and stop neurotoxicity from occurring – and also, in turn, prevent the epigenetic changes, he said.

The take-away is that there may be ways to augment what already is being done (using naltrexone, which works on the reward pathway, for example) to help patients with addiction.

“Now we have something, potentially ... that can do some of the ancillary stuff, working on the withdrawal effects, helping with the behavioral response that we see in patients that are suffering from addiction,” he said.

Dr. Shukla reported having no disclosures.

[email protected]

SOURCE: Shukla S et al. APA Poster Session 4, Poster 3.

NEW YORK – Recent discoveries regarding the relationship between alcohol consumption and neuroinflammation suggest a possible role for adjunctive treatments and supplements in addiction treatment, according to Shram Shukla, MD.

For example, a qualitative review of the literature over the past 2-3 years showed that the “neuroinflammatory process in and of itself drives epigenetic changes, which ultimately upregulate neuroinflammation of the brain,” according to Dr. Shukla of Walter Reed National Military Medical Center, Bethesda, Md., who reported the findings in a poster at the annual meeting of the American Psychiatric Association.

In this video interview, he explained that this finding is important because “neuroinflammation leads to neurotoxicity, which leads to neuronal degeneration.”

“As we know, with patients who chronically abuse alcohol, they do have a level of cortical degeneration that we often see on imaging, so there is, perhaps, a role that this may play in that,” he added.

Dr. Shukla said he also found that the neuroinflammatory process, when it drives the epigenetic changes, affects the amygdala, which is known as a “high stress part of the brain.”

“What we found in animal models so far is that if we can impact where that epigenetic change occurs, we can prevent the anxiogenic behaviors we often see in alcohol withdrawal and abstinence; we associate that, in humans, to be the high-stress state we often see in patients when they ... are withdrawing from alcohol.”

This raised questions about whether certain medications and supplements, including vitamin C, pioglitazone, infliximab, and omega-3 fatty acids, could be of benefit, and it was shown that these do affect neuroinflammation and stop neurotoxicity from occurring – and also, in turn, prevent the epigenetic changes, he said.

The take-away is that there may be ways to augment what already is being done (using naltrexone, which works on the reward pathway, for example) to help patients with addiction.

“Now we have something, potentially ... that can do some of the ancillary stuff, working on the withdrawal effects, helping with the behavioral response that we see in patients that are suffering from addiction,” he said.

Dr. Shukla reported having no disclosures.

[email protected]

SOURCE: Shukla S et al. APA Poster Session 4, Poster 3.

NEW YORK – Recent discoveries regarding the relationship between alcohol consumption and neuroinflammation suggest a possible role for adjunctive treatments and supplements in addiction treatment, according to Shram Shukla, MD.

For example, a qualitative review of the literature over the past 2-3 years showed that the “neuroinflammatory process in and of itself drives epigenetic changes, which ultimately upregulate neuroinflammation of the brain,” according to Dr. Shukla of Walter Reed National Military Medical Center, Bethesda, Md., who reported the findings in a poster at the annual meeting of the American Psychiatric Association.

In this video interview, he explained that this finding is important because “neuroinflammation leads to neurotoxicity, which leads to neuronal degeneration.”

“As we know, with patients who chronically abuse alcohol, they do have a level of cortical degeneration that we often see on imaging, so there is, perhaps, a role that this may play in that,” he added.

Dr. Shukla said he also found that the neuroinflammatory process, when it drives the epigenetic changes, affects the amygdala, which is known as a “high stress part of the brain.”

“What we found in animal models so far is that if we can impact where that epigenetic change occurs, we can prevent the anxiogenic behaviors we often see in alcohol withdrawal and abstinence; we associate that, in humans, to be the high-stress state we often see in patients when they ... are withdrawing from alcohol.”

This raised questions about whether certain medications and supplements, including vitamin C, pioglitazone, infliximab, and omega-3 fatty acids, could be of benefit, and it was shown that these do affect neuroinflammation and stop neurotoxicity from occurring – and also, in turn, prevent the epigenetic changes, he said.

The take-away is that there may be ways to augment what already is being done (using naltrexone, which works on the reward pathway, for example) to help patients with addiction.

“Now we have something, potentially ... that can do some of the ancillary stuff, working on the withdrawal effects, helping with the behavioral response that we see in patients that are suffering from addiction,” he said.

Dr. Shukla reported having no disclosures.

[email protected]

SOURCE: Shukla S et al. APA Poster Session 4, Poster 3.

BOSTON – Evidence from a twin study points to genes, rather than just adiposity, as the underlying factor in differences in appetite and satiety that have been observed in obesity.

The work adds a new dimension – and some questions – to previous research, which suggested individuals with obesity show heightened brain activation to food cues, especially calorically dense food.

“We thought it was fat mass…but when we controlled for everything that monozygotic pairs have in common, that relationship went away, implicating something that the monozygotic twins have in common, i.e., genetics,” said first author Jennifer Rosenbaum, MD, in a video interview at the annual meeting of the American Academy of Clinical Endocrinologists.

Dr. Rosenbaum, a fellow in the department of metabolism, endocrinology, and nutrition at the University of Washington, Seattle, and her collaborators made use of a statewide twin registry to conduct an extensive investigation of subjective and objective measures of appetite and satiety in the 42 twin pairs.

Twins had a mean age of 31 years; 27 of the twin pairs were monozygotic, Dr. Rosenbaum said. At least one member of each twin pair met criteria for obesity, and participants had a mean body mass index of 32.8 kg/m².

On the study day, participants arrived in fasting state, and had a fixed-calorie breakfast equivalent to 10% of their daily caloric needs. They then underwent dual-energy x-ray absorptiometry scanning to determine adiposity, and also filled out a behavioral questionnaire.

Then, participants received the first of two functional MRI scans; during the scan, they were shown images of high calorie foods, low calorie foods, and nonfood objects, completing ratings of how appealing they found each image. After consuming another standardized meal equivalent to 20% of daily caloric needs, the fMRI scan was repeated.

Finally, participants were given access to a buffet meal and allowed to eat as much as they chose; consumption was measured. Before and after each meal and scan, and at various points during the day, the investigators also obtained blood samples and asked participants to rate their hunger on a visual analog scale.

“When compared with how much fat mass they had, there was no relationship between how hungry or full they were when they were fasting, how hungry or full they were with a snack, or when they ate the buffet. It just didn’t matter how much fat mass they had” for subjective reporting of hunger and fullness, said Dr. Rosenbaum.

However, there was a direct correlation between fat mass and amount consumed at the ad libitum buffet. Additionally, the fMRI analysis showed that “the brain activation that we would expect to go down, didn’t seem to go down as much if you had more adiposity,” she said.

As fat mass went up, areas of the brain implicated in appetite and reward showed more activity when participants were presented with the tempting images of high calorie foods, regardless of the calories consumed. These areas include the ventral and dorsal striata, the amygdala, the insula, the ventral tegmental area, and the medial orbitofrontal cortex.

Next, the researchers looked for differences within the monozygotic twin pairs, who essentially share a genome. They compared the brain activation of the twin with the higher fat mass with that of the twin with lower fat mass. Instead of seeing the same correlation between higher adiposity and greater brain activation with tempting stimuli, “Suddenly, we lost that relationship between how many calories they would eat and how their brain activated with the food,” said Dr. Rosenbaum. This is a clue, she said, that genetics, rather than simple adiposity, is driving the different responses to food cues.

The study was funded by the National Institutes of Health. Dr. Rosenbaum reported no financial disclosures.

[email protected]

BOSTON – Evidence from a twin study points to genes, rather than just adiposity, as the underlying factor in differences in appetite and satiety that have been observed in obesity.

The work adds a new dimension – and some questions – to previous research, which suggested individuals with obesity show heightened brain activation to food cues, especially calorically dense food.

“We thought it was fat mass…but when we controlled for everything that monozygotic pairs have in common, that relationship went away, implicating something that the monozygotic twins have in common, i.e., genetics,” said first author Jennifer Rosenbaum, MD, in a video interview at the annual meeting of the American Academy of Clinical Endocrinologists.

Dr. Rosenbaum, a fellow in the department of metabolism, endocrinology, and nutrition at the University of Washington, Seattle, and her collaborators made use of a statewide twin registry to conduct an extensive investigation of subjective and objective measures of appetite and satiety in the 42 twin pairs.

Twins had a mean age of 31 years; 27 of the twin pairs were monozygotic, Dr. Rosenbaum said. At least one member of each twin pair met criteria for obesity, and participants had a mean body mass index of 32.8 kg/m².

On the study day, participants arrived in fasting state, and had a fixed-calorie breakfast equivalent to 10% of their daily caloric needs. They then underwent dual-energy x-ray absorptiometry scanning to determine adiposity, and also filled out a behavioral questionnaire.

Then, participants received the first of two functional MRI scans; during the scan, they were shown images of high calorie foods, low calorie foods, and nonfood objects, completing ratings of how appealing they found each image. After consuming another standardized meal equivalent to 20% of daily caloric needs, the fMRI scan was repeated.

Finally, participants were given access to a buffet meal and allowed to eat as much as they chose; consumption was measured. Before and after each meal and scan, and at various points during the day, the investigators also obtained blood samples and asked participants to rate their hunger on a visual analog scale.

“When compared with how much fat mass they had, there was no relationship between how hungry or full they were when they were fasting, how hungry or full they were with a snack, or when they ate the buffet. It just didn’t matter how much fat mass they had” for subjective reporting of hunger and fullness, said Dr. Rosenbaum.

However, there was a direct correlation between fat mass and amount consumed at the ad libitum buffet. Additionally, the fMRI analysis showed that “the brain activation that we would expect to go down, didn’t seem to go down as much if you had more adiposity,” she said.

As fat mass went up, areas of the brain implicated in appetite and reward showed more activity when participants were presented with the tempting images of high calorie foods, regardless of the calories consumed. These areas include the ventral and dorsal striata, the amygdala, the insula, the ventral tegmental area, and the medial orbitofrontal cortex.

Next, the researchers looked for differences within the monozygotic twin pairs, who essentially share a genome. They compared the brain activation of the twin with the higher fat mass with that of the twin with lower fat mass. Instead of seeing the same correlation between higher adiposity and greater brain activation with tempting stimuli, “Suddenly, we lost that relationship between how many calories they would eat and how their brain activated with the food,” said Dr. Rosenbaum. This is a clue, she said, that genetics, rather than simple adiposity, is driving the different responses to food cues.

The study was funded by the National Institutes of Health. Dr. Rosenbaum reported no financial disclosures.

[email protected]

BOSTON – Evidence from a twin study points to genes, rather than just adiposity, as the underlying factor in differences in appetite and satiety that have been observed in obesity.

The work adds a new dimension – and some questions – to previous research, which suggested individuals with obesity show heightened brain activation to food cues, especially calorically dense food.

“We thought it was fat mass…but when we controlled for everything that monozygotic pairs have in common, that relationship went away, implicating something that the monozygotic twins have in common, i.e., genetics,” said first author Jennifer Rosenbaum, MD, in a video interview at the annual meeting of the American Academy of Clinical Endocrinologists.

Dr. Rosenbaum, a fellow in the department of metabolism, endocrinology, and nutrition at the University of Washington, Seattle, and her collaborators made use of a statewide twin registry to conduct an extensive investigation of subjective and objective measures of appetite and satiety in the 42 twin pairs.

Twins had a mean age of 31 years; 27 of the twin pairs were monozygotic, Dr. Rosenbaum said. At least one member of each twin pair met criteria for obesity, and participants had a mean body mass index of 32.8 kg/m².

On the study day, participants arrived in fasting state, and had a fixed-calorie breakfast equivalent to 10% of their daily caloric needs. They then underwent dual-energy x-ray absorptiometry scanning to determine adiposity, and also filled out a behavioral questionnaire.

Then, participants received the first of two functional MRI scans; during the scan, they were shown images of high calorie foods, low calorie foods, and nonfood objects, completing ratings of how appealing they found each image. After consuming another standardized meal equivalent to 20% of daily caloric needs, the fMRI scan was repeated.

Finally, participants were given access to a buffet meal and allowed to eat as much as they chose; consumption was measured. Before and after each meal and scan, and at various points during the day, the investigators also obtained blood samples and asked participants to rate their hunger on a visual analog scale.

“When compared with how much fat mass they had, there was no relationship between how hungry or full they were when they were fasting, how hungry or full they were with a snack, or when they ate the buffet. It just didn’t matter how much fat mass they had” for subjective reporting of hunger and fullness, said Dr. Rosenbaum.

However, there was a direct correlation between fat mass and amount consumed at the ad libitum buffet. Additionally, the fMRI analysis showed that “the brain activation that we would expect to go down, didn’t seem to go down as much if you had more adiposity,” she said.

As fat mass went up, areas of the brain implicated in appetite and reward showed more activity when participants were presented with the tempting images of high calorie foods, regardless of the calories consumed. These areas include the ventral and dorsal striata, the amygdala, the insula, the ventral tegmental area, and the medial orbitofrontal cortex.

Next, the researchers looked for differences within the monozygotic twin pairs, who essentially share a genome. They compared the brain activation of the twin with the higher fat mass with that of the twin with lower fat mass. Instead of seeing the same correlation between higher adiposity and greater brain activation with tempting stimuli, “Suddenly, we lost that relationship between how many calories they would eat and how their brain activated with the food,” said Dr. Rosenbaum. This is a clue, she said, that genetics, rather than simple adiposity, is driving the different responses to food cues.

The study was funded by the National Institutes of Health. Dr. Rosenbaum reported no financial disclosures.

[email protected]

The risk of lower urinary tract injury (bladder or ureters) at the time of benign gynecologic surgery is estimated to be between 0.3% and 4%. The majority are bladder injuries, with ureteral injuries occurring in 0.3%-1.8% of hysterectomies. While urologic procedures account for the majority of iatrogenic ureteral injuries, gynecologic surgery is the second leading cause, followed by general surgery and colorectal surgery.

With respect to hysterectomy in particular, the risk of ureteral injury is less than 1%. In a large prospective cohort of women undergoing hysterectomy for benign indications in 53 hospitals in Finland, rates of ureteral injury varied based on the route of hysterectomy, with laparoscopic and abdominal routes having an injury rate of 0.3% and the vaginal route having an injury rate of 0.04% (Human Reprod. 2011;26[7]:1741-51). The risk generally is higher with procedures for endometriosis, large fibroids, cancer, or pelvic organ prolapse.

During hysterectomy and with gynecologic surgery overall, ureteral injuries occur most commonly at three locations: at the level of the infundibulopelvic ligament and ovarian vessels, at the level of the uterine artery, and near the vaginal cuff. Identification and knowledge of the course of the ureter at these three locations is essential in preventing ureteral injury during pelvic surgery.

Vidyard Video

SOURCE: DR. MUELLER AND DR. KENTON

Perioperative ureteral stenting has been proposed as a method of preventing iatrogenic injury by allowing surgeons to more easily identify the ureters during surgery. Available reports suggest, however, that the actual risk of injury is not decreased and may even be increased by placing prophylactic ureteral stents, and most surgeons have moved away from this practice. The use of lighted ureteral stents during complex laparoscopic endometriosis resections may be helpful.

Many health care systems recommend intraoperative cystoscopy with bladder and ureteral survey to evaluate the integrity of the lower urinary tract at the time of all hysterectomies. A recent study of nearly 3,000 women undergoing benign hysterectomies at the University of Michigan, Ann Arbor, showed a significant decrease in the rate of delayed diagnosis of urinary tract injuries with implementation of a universal cystoscopy policy. While the rate of lower urinary tract injury was fairly consistent before and after implementation of the policy (2.6% and 1.8%, respectively), the rate of delayed detection of a lower urinary tract injury decreased from 0.7% before the policy to 0.1% after implementation (Obstet Gynecol. 2016;127[2]:369-75). The study also showed that hospital costs nearly doubled with a delayed detection of a lower urinary tract injury.

Unfortunately, even a normal postoperative cystoscopy does not ensure there is no lower urinary tract injury, especially considering that thermal injuries resulting from the use of energy devices typically do not present until 7-14 days after surgery. Overall, however, ureteral injury detection rates with universal cystoscopy approach 97% (Obstet Gynecol. 2009;113:6-10).

 

 

 

Identifying injuries

Intraoperative recognition and repair always is preferred, and when ureteral injuries are discovered or suspected in the operating room, cystoscopy and retrograde pyelography is the most helpful imaging tool. Contrast dye is injected during cystoscopy directly into the renal collecting system through the ureteral orifices; with fluoroscopy, the surgeon can visualize the integrity of the ureter from the bladder to the renal pelvis to diagnosis a ureteral injury, including ureteral transection, kinking, or ligation caused by a suture or sealing device.

If retrograde pyelography shows a transection or injury from a crushing clamp or sealing device, we recommend ureteroureteral anastomosis or urethral neocystostomy depending on the extent and location of the injury. If the ureter just appears kinked, sometime simply releasing the cuff sutures or uterosacral ligament sutures will resolve the obstruction. If there is extravasation of contrast suggesting a partial tear, placing a double-J ureteral stent for 6-8 weeks is frequently sufficient.

Patients with delayed iatrogenic ureteral injuries present with symptoms that often are nonspecific and that include abdominal or flank pain, fever, nausea, vomiting, back pain, and leukocytosis.

We recommend that patients with a history of surgery and symptoms suggestive of a ureteral injury be initially evaluated with CT urography that images the renal collecting system both as contrast dye is instilled and again several minutes later as it has progressed through the entire urinary tract. Alternatively, if CT urography is unavailable, a retrograde pyelogram can be performed as an emergency procedure to determine the location of renal injury.

Surgical management

Delayed ureteral injuries resulting in partial ureteral obstruction or extravasation of urine into the pelvis can sometimes be managed conservatively though placement of an internalized double J stent. The stent can be placed in a retrograde fashion via cystoscopy by a urogynecologist or urologist or antegrade through a percutaneous nephrostomy tube by an interventional radiologist. Several small case series suggest high success rates with this approach.

 

 

We typically manage delayed ureteral injuries that are not amenable to, or do not heal with, ureteral stenting with ureteroneocystotomy, or ureteral reimplantation, into the bladder. This technique is effective for distal ureteral injuries that result in obstruction or fistula and are in close proximity to the bladder (most iatrogenic gynecologic injuries). We perform ureteroneocystotomy via an open, robotic, or laparoscopic route of access depending on the circumstance.

Our preferred route of access is minimally invasive with the da Vinci robot. A camera port is placed at the umbilicus, two robotic ports are placed on the patient’s left side at the level of the umbilicus, and one is placed on the patient’s right side at the level of the umbilicus with an additional assistant port on the right side. It is helpful if each port is at least 8 cm apart. If obstruction or transection is suspected to be more proximal, the ports may have been shifted above the umbilicus to optimally mobilize the ureter.

First, the ureter is identified and dissected. Regardless of the site of injury, which is usually identifiable with inflammation and scar tissue, it is always easiest to identify the ureter at the bifurcation of the common iliac vessels. The isolated ureter is inspected proximally and above the area of injury, and we find it helpful to place a vessel loop around the ureter for easy manipulation and counter traction. Care must be taken not to disturb the adventitia and blood supply. We do not transect the ureter until we’re ready to reimplant it in the bladder.

To mobilize the bladder and prepare for a tension-free anastomosis, an adequate retropubic dissection is performed, starting with an incision in the anterior abdominal wall peritoneum and taking it down to the level of the pubic bone and into the retropubic space. It is important to be mindful of the location of the obturator neurovascular bundle when performing this dissection.

Achieving a tension-free and water-tight anastomosis of the ureter to the bladder is critical. The bladder should be mobilized such that it reaches to above the injured portion of the ureter. The bladder is retrograde filled with approximately 300 mL and a reimplantation site of the posterior bladder is identified. When there is concern about tension, a psoas hitch suture can be placed to keep the bladder in a superior position with reduced tension. Because of high rates of the congenital absence of the psoas tendon minor, we advocate direct visualization of the genitofemoral nerve by incising the peritoneum; this will avoid nerve entrapment.

Once the bladder is mobilized and the ureter isolated, we perform an intentional cystotomy in the posterior lateral aspect of the bladder. The ureter, which is on the vessel loop, must be transected proximal to the site of injury. To facilitate this, we spatulate the ureter, making a vertical incision of often about 5 mm in length to increase our surface area for anastomosis. Placement of a suture at the apex of the spatulated ureter helps us maintain orientation.

 

 

Anastomosis of the ureter and bladder is achieved in a mucosa-to-mucosa fashion using a series of interrupted monofilament fine absorbable sutures; we use a 3-0 monocryl suture. The most posterior anastomotic sutures are placed first to allow for optimal visualization, and prior to completing the anastomosis, a guide wire is placed through the open ureter and a double-J stent is introduced into the renal pelvis. The wire is then removed and the distal end of the stent coiled in the bladder. This stent will protect the ureter for about 6 weeks while it heals. The anastomosis is then completed on the anterior aspect, with a watertight closure ensured.

Postoperatively, we routinely perform an x-ray to ensure proper placement of the stent in the reimplanted ureter. To determine correct stent placement, the last rib is identified at T12 vertebrae. The renal pelvis is located at the level of the L2-L3 with the left being slightly higher than the right. A Foley catheter is maintained in the bladder for approximately 2 weeks, and the stent is maintained for approximately 6 weeks. Both the catheter and the stent can be removed in the office with cystoscopic guidance.

Imaging at 4-6 weeks after removal of the stent is performed to rule out development of an obstruction or a stricture. In patients who did not have a dilated ureter and renal collecting system prior to reimplantation, a renal ultrasound is sufficient to identify hydroureter/hydronephrosis or a urinoma. Many patients with a markedly dilated renal-collecting system prior to ureteral reimplantation will have persistent hydroureter/hydronephrosis (similar to a latex balloon that does not return to its original size after it is blown up) after reimplantation. A Lasix renal scan is a better imaging modality in these patients because it can differentiate a ureter that is dilated from one that is dilated and obstructed.

It is important to note that prompt ureteroneocystotomy is feasible only when the delayed ureteral injury presents within approximately 7 days of surgery. If the patient presents more than a week after surgery, inflammation is so significant that conservative management is necessary with reevaluation for reimplantation in another 6 weeks. Decompression of the system prior to reimplantation can be achieved through either stent placement or placement of a percutaneous nephrostomy tube. We prefer the latter because it reduces inflammation around the ureter that may make subsequent dissection and surgery more difficult.
 

Dr. Kenton is chief of urogynecology, Northwestern University, Chicago, and Dr. Mueller also is in the division of female pelvic medicine and reconstructive surgery–urogynecology at Northwestern. Dr. Kenton discloses grant funding from Boston Scientific.

The risk of lower urinary tract injury (bladder or ureters) at the time of benign gynecologic surgery is estimated to be between 0.3% and 4%. The majority are bladder injuries, with ureteral injuries occurring in 0.3%-1.8% of hysterectomies. While urologic procedures account for the majority of iatrogenic ureteral injuries, gynecologic surgery is the second leading cause, followed by general surgery and colorectal surgery.

With respect to hysterectomy in particular, the risk of ureteral injury is less than 1%. In a large prospective cohort of women undergoing hysterectomy for benign indications in 53 hospitals in Finland, rates of ureteral injury varied based on the route of hysterectomy, with laparoscopic and abdominal routes having an injury rate of 0.3% and the vaginal route having an injury rate of 0.04% (Human Reprod. 2011;26[7]:1741-51). The risk generally is higher with procedures for endometriosis, large fibroids, cancer, or pelvic organ prolapse.

During hysterectomy and with gynecologic surgery overall, ureteral injuries occur most commonly at three locations: at the level of the infundibulopelvic ligament and ovarian vessels, at the level of the uterine artery, and near the vaginal cuff. Identification and knowledge of the course of the ureter at these three locations is essential in preventing ureteral injury during pelvic surgery.

Vidyard Video

SOURCE: DR. MUELLER AND DR. KENTON

Perioperative ureteral stenting has been proposed as a method of preventing iatrogenic injury by allowing surgeons to more easily identify the ureters during surgery. Available reports suggest, however, that the actual risk of injury is not decreased and may even be increased by placing prophylactic ureteral stents, and most surgeons have moved away from this practice. The use of lighted ureteral stents during complex laparoscopic endometriosis resections may be helpful.

Many health care systems recommend intraoperative cystoscopy with bladder and ureteral survey to evaluate the integrity of the lower urinary tract at the time of all hysterectomies. A recent study of nearly 3,000 women undergoing benign hysterectomies at the University of Michigan, Ann Arbor, showed a significant decrease in the rate of delayed diagnosis of urinary tract injuries with implementation of a universal cystoscopy policy. While the rate of lower urinary tract injury was fairly consistent before and after implementation of the policy (2.6% and 1.8%, respectively), the rate of delayed detection of a lower urinary tract injury decreased from 0.7% before the policy to 0.1% after implementation (Obstet Gynecol. 2016;127[2]:369-75). The study also showed that hospital costs nearly doubled with a delayed detection of a lower urinary tract injury.

Unfortunately, even a normal postoperative cystoscopy does not ensure there is no lower urinary tract injury, especially considering that thermal injuries resulting from the use of energy devices typically do not present until 7-14 days after surgery. Overall, however, ureteral injury detection rates with universal cystoscopy approach 97% (Obstet Gynecol. 2009;113:6-10).

 

 

 

Identifying injuries

Intraoperative recognition and repair always is preferred, and when ureteral injuries are discovered or suspected in the operating room, cystoscopy and retrograde pyelography is the most helpful imaging tool. Contrast dye is injected during cystoscopy directly into the renal collecting system through the ureteral orifices; with fluoroscopy, the surgeon can visualize the integrity of the ureter from the bladder to the renal pelvis to diagnosis a ureteral injury, including ureteral transection, kinking, or ligation caused by a suture or sealing device.

If retrograde pyelography shows a transection or injury from a crushing clamp or sealing device, we recommend ureteroureteral anastomosis or urethral neocystostomy depending on the extent and location of the injury. If the ureter just appears kinked, sometime simply releasing the cuff sutures or uterosacral ligament sutures will resolve the obstruction. If there is extravasation of contrast suggesting a partial tear, placing a double-J ureteral stent for 6-8 weeks is frequently sufficient.

Patients with delayed iatrogenic ureteral injuries present with symptoms that often are nonspecific and that include abdominal or flank pain, fever, nausea, vomiting, back pain, and leukocytosis.

We recommend that patients with a history of surgery and symptoms suggestive of a ureteral injury be initially evaluated with CT urography that images the renal collecting system both as contrast dye is instilled and again several minutes later as it has progressed through the entire urinary tract. Alternatively, if CT urography is unavailable, a retrograde pyelogram can be performed as an emergency procedure to determine the location of renal injury.

Surgical management

Delayed ureteral injuries resulting in partial ureteral obstruction or extravasation of urine into the pelvis can sometimes be managed conservatively though placement of an internalized double J stent. The stent can be placed in a retrograde fashion via cystoscopy by a urogynecologist or urologist or antegrade through a percutaneous nephrostomy tube by an interventional radiologist. Several small case series suggest high success rates with this approach.

 

 

We typically manage delayed ureteral injuries that are not amenable to, or do not heal with, ureteral stenting with ureteroneocystotomy, or ureteral reimplantation, into the bladder. This technique is effective for distal ureteral injuries that result in obstruction or fistula and are in close proximity to the bladder (most iatrogenic gynecologic injuries). We perform ureteroneocystotomy via an open, robotic, or laparoscopic route of access depending on the circumstance.

Our preferred route of access is minimally invasive with the da Vinci robot. A camera port is placed at the umbilicus, two robotic ports are placed on the patient’s left side at the level of the umbilicus, and one is placed on the patient’s right side at the level of the umbilicus with an additional assistant port on the right side. It is helpful if each port is at least 8 cm apart. If obstruction or transection is suspected to be more proximal, the ports may have been shifted above the umbilicus to optimally mobilize the ureter.

First, the ureter is identified and dissected. Regardless of the site of injury, which is usually identifiable with inflammation and scar tissue, it is always easiest to identify the ureter at the bifurcation of the common iliac vessels. The isolated ureter is inspected proximally and above the area of injury, and we find it helpful to place a vessel loop around the ureter for easy manipulation and counter traction. Care must be taken not to disturb the adventitia and blood supply. We do not transect the ureter until we’re ready to reimplant it in the bladder.

To mobilize the bladder and prepare for a tension-free anastomosis, an adequate retropubic dissection is performed, starting with an incision in the anterior abdominal wall peritoneum and taking it down to the level of the pubic bone and into the retropubic space. It is important to be mindful of the location of the obturator neurovascular bundle when performing this dissection.

Achieving a tension-free and water-tight anastomosis of the ureter to the bladder is critical. The bladder should be mobilized such that it reaches to above the injured portion of the ureter. The bladder is retrograde filled with approximately 300 mL and a reimplantation site of the posterior bladder is identified. When there is concern about tension, a psoas hitch suture can be placed to keep the bladder in a superior position with reduced tension. Because of high rates of the congenital absence of the psoas tendon minor, we advocate direct visualization of the genitofemoral nerve by incising the peritoneum; this will avoid nerve entrapment.

Once the bladder is mobilized and the ureter isolated, we perform an intentional cystotomy in the posterior lateral aspect of the bladder. The ureter, which is on the vessel loop, must be transected proximal to the site of injury. To facilitate this, we spatulate the ureter, making a vertical incision of often about 5 mm in length to increase our surface area for anastomosis. Placement of a suture at the apex of the spatulated ureter helps us maintain orientation.

 

 

Anastomosis of the ureter and bladder is achieved in a mucosa-to-mucosa fashion using a series of interrupted monofilament fine absorbable sutures; we use a 3-0 monocryl suture. The most posterior anastomotic sutures are placed first to allow for optimal visualization, and prior to completing the anastomosis, a guide wire is placed through the open ureter and a double-J stent is introduced into the renal pelvis. The wire is then removed and the distal end of the stent coiled in the bladder. This stent will protect the ureter for about 6 weeks while it heals. The anastomosis is then completed on the anterior aspect, with a watertight closure ensured.

Postoperatively, we routinely perform an x-ray to ensure proper placement of the stent in the reimplanted ureter. To determine correct stent placement, the last rib is identified at T12 vertebrae. The renal pelvis is located at the level of the L2-L3 with the left being slightly higher than the right. A Foley catheter is maintained in the bladder for approximately 2 weeks, and the stent is maintained for approximately 6 weeks. Both the catheter and the stent can be removed in the office with cystoscopic guidance.

Imaging at 4-6 weeks after removal of the stent is performed to rule out development of an obstruction or a stricture. In patients who did not have a dilated ureter and renal collecting system prior to reimplantation, a renal ultrasound is sufficient to identify hydroureter/hydronephrosis or a urinoma. Many patients with a markedly dilated renal-collecting system prior to ureteral reimplantation will have persistent hydroureter/hydronephrosis (similar to a latex balloon that does not return to its original size after it is blown up) after reimplantation. A Lasix renal scan is a better imaging modality in these patients because it can differentiate a ureter that is dilated from one that is dilated and obstructed.

It is important to note that prompt ureteroneocystotomy is feasible only when the delayed ureteral injury presents within approximately 7 days of surgery. If the patient presents more than a week after surgery, inflammation is so significant that conservative management is necessary with reevaluation for reimplantation in another 6 weeks. Decompression of the system prior to reimplantation can be achieved through either stent placement or placement of a percutaneous nephrostomy tube. We prefer the latter because it reduces inflammation around the ureter that may make subsequent dissection and surgery more difficult.
 

Dr. Kenton is chief of urogynecology, Northwestern University, Chicago, and Dr. Mueller also is in the division of female pelvic medicine and reconstructive surgery–urogynecology at Northwestern. Dr. Kenton discloses grant funding from Boston Scientific.

The risk of lower urinary tract injury (bladder or ureters) at the time of benign gynecologic surgery is estimated to be between 0.3% and 4%. The majority are bladder injuries, with ureteral injuries occurring in 0.3%-1.8% of hysterectomies. While urologic procedures account for the majority of iatrogenic ureteral injuries, gynecologic surgery is the second leading cause, followed by general surgery and colorectal surgery.

With respect to hysterectomy in particular, the risk of ureteral injury is less than 1%. In a large prospective cohort of women undergoing hysterectomy for benign indications in 53 hospitals in Finland, rates of ureteral injury varied based on the route of hysterectomy, with laparoscopic and abdominal routes having an injury rate of 0.3% and the vaginal route having an injury rate of 0.04% (Human Reprod. 2011;26[7]:1741-51). The risk generally is higher with procedures for endometriosis, large fibroids, cancer, or pelvic organ prolapse.

During hysterectomy and with gynecologic surgery overall, ureteral injuries occur most commonly at three locations: at the level of the infundibulopelvic ligament and ovarian vessels, at the level of the uterine artery, and near the vaginal cuff. Identification and knowledge of the course of the ureter at these three locations is essential in preventing ureteral injury during pelvic surgery.

Vidyard Video

SOURCE: DR. MUELLER AND DR. KENTON

Perioperative ureteral stenting has been proposed as a method of preventing iatrogenic injury by allowing surgeons to more easily identify the ureters during surgery. Available reports suggest, however, that the actual risk of injury is not decreased and may even be increased by placing prophylactic ureteral stents, and most surgeons have moved away from this practice. The use of lighted ureteral stents during complex laparoscopic endometriosis resections may be helpful.

Many health care systems recommend intraoperative cystoscopy with bladder and ureteral survey to evaluate the integrity of the lower urinary tract at the time of all hysterectomies. A recent study of nearly 3,000 women undergoing benign hysterectomies at the University of Michigan, Ann Arbor, showed a significant decrease in the rate of delayed diagnosis of urinary tract injuries with implementation of a universal cystoscopy policy. While the rate of lower urinary tract injury was fairly consistent before and after implementation of the policy (2.6% and 1.8%, respectively), the rate of delayed detection of a lower urinary tract injury decreased from 0.7% before the policy to 0.1% after implementation (Obstet Gynecol. 2016;127[2]:369-75). The study also showed that hospital costs nearly doubled with a delayed detection of a lower urinary tract injury.

Unfortunately, even a normal postoperative cystoscopy does not ensure there is no lower urinary tract injury, especially considering that thermal injuries resulting from the use of energy devices typically do not present until 7-14 days after surgery. Overall, however, ureteral injury detection rates with universal cystoscopy approach 97% (Obstet Gynecol. 2009;113:6-10).

 

 

 

Identifying injuries

Intraoperative recognition and repair always is preferred, and when ureteral injuries are discovered or suspected in the operating room, cystoscopy and retrograde pyelography is the most helpful imaging tool. Contrast dye is injected during cystoscopy directly into the renal collecting system through the ureteral orifices; with fluoroscopy, the surgeon can visualize the integrity of the ureter from the bladder to the renal pelvis to diagnosis a ureteral injury, including ureteral transection, kinking, or ligation caused by a suture or sealing device.

If retrograde pyelography shows a transection or injury from a crushing clamp or sealing device, we recommend ureteroureteral anastomosis or urethral neocystostomy depending on the extent and location of the injury. If the ureter just appears kinked, sometime simply releasing the cuff sutures or uterosacral ligament sutures will resolve the obstruction. If there is extravasation of contrast suggesting a partial tear, placing a double-J ureteral stent for 6-8 weeks is frequently sufficient.

Patients with delayed iatrogenic ureteral injuries present with symptoms that often are nonspecific and that include abdominal or flank pain, fever, nausea, vomiting, back pain, and leukocytosis.

We recommend that patients with a history of surgery and symptoms suggestive of a ureteral injury be initially evaluated with CT urography that images the renal collecting system both as contrast dye is instilled and again several minutes later as it has progressed through the entire urinary tract. Alternatively, if CT urography is unavailable, a retrograde pyelogram can be performed as an emergency procedure to determine the location of renal injury.

Surgical management

Delayed ureteral injuries resulting in partial ureteral obstruction or extravasation of urine into the pelvis can sometimes be managed conservatively though placement of an internalized double J stent. The stent can be placed in a retrograde fashion via cystoscopy by a urogynecologist or urologist or antegrade through a percutaneous nephrostomy tube by an interventional radiologist. Several small case series suggest high success rates with this approach.

 

 

We typically manage delayed ureteral injuries that are not amenable to, or do not heal with, ureteral stenting with ureteroneocystotomy, or ureteral reimplantation, into the bladder. This technique is effective for distal ureteral injuries that result in obstruction or fistula and are in close proximity to the bladder (most iatrogenic gynecologic injuries). We perform ureteroneocystotomy via an open, robotic, or laparoscopic route of access depending on the circumstance.

Our preferred route of access is minimally invasive with the da Vinci robot. A camera port is placed at the umbilicus, two robotic ports are placed on the patient’s left side at the level of the umbilicus, and one is placed on the patient’s right side at the level of the umbilicus with an additional assistant port on the right side. It is helpful if each port is at least 8 cm apart. If obstruction or transection is suspected to be more proximal, the ports may have been shifted above the umbilicus to optimally mobilize the ureter.

First, the ureter is identified and dissected. Regardless of the site of injury, which is usually identifiable with inflammation and scar tissue, it is always easiest to identify the ureter at the bifurcation of the common iliac vessels. The isolated ureter is inspected proximally and above the area of injury, and we find it helpful to place a vessel loop around the ureter for easy manipulation and counter traction. Care must be taken not to disturb the adventitia and blood supply. We do not transect the ureter until we’re ready to reimplant it in the bladder.

To mobilize the bladder and prepare for a tension-free anastomosis, an adequate retropubic dissection is performed, starting with an incision in the anterior abdominal wall peritoneum and taking it down to the level of the pubic bone and into the retropubic space. It is important to be mindful of the location of the obturator neurovascular bundle when performing this dissection.

Achieving a tension-free and water-tight anastomosis of the ureter to the bladder is critical. The bladder should be mobilized such that it reaches to above the injured portion of the ureter. The bladder is retrograde filled with approximately 300 mL and a reimplantation site of the posterior bladder is identified. When there is concern about tension, a psoas hitch suture can be placed to keep the bladder in a superior position with reduced tension. Because of high rates of the congenital absence of the psoas tendon minor, we advocate direct visualization of the genitofemoral nerve by incising the peritoneum; this will avoid nerve entrapment.

Once the bladder is mobilized and the ureter isolated, we perform an intentional cystotomy in the posterior lateral aspect of the bladder. The ureter, which is on the vessel loop, must be transected proximal to the site of injury. To facilitate this, we spatulate the ureter, making a vertical incision of often about 5 mm in length to increase our surface area for anastomosis. Placement of a suture at the apex of the spatulated ureter helps us maintain orientation.

 

 

Anastomosis of the ureter and bladder is achieved in a mucosa-to-mucosa fashion using a series of interrupted monofilament fine absorbable sutures; we use a 3-0 monocryl suture. The most posterior anastomotic sutures are placed first to allow for optimal visualization, and prior to completing the anastomosis, a guide wire is placed through the open ureter and a double-J stent is introduced into the renal pelvis. The wire is then removed and the distal end of the stent coiled in the bladder. This stent will protect the ureter for about 6 weeks while it heals. The anastomosis is then completed on the anterior aspect, with a watertight closure ensured.

Postoperatively, we routinely perform an x-ray to ensure proper placement of the stent in the reimplanted ureter. To determine correct stent placement, the last rib is identified at T12 vertebrae. The renal pelvis is located at the level of the L2-L3 with the left being slightly higher than the right. A Foley catheter is maintained in the bladder for approximately 2 weeks, and the stent is maintained for approximately 6 weeks. Both the catheter and the stent can be removed in the office with cystoscopic guidance.

Imaging at 4-6 weeks after removal of the stent is performed to rule out development of an obstruction or a stricture. In patients who did not have a dilated ureter and renal collecting system prior to reimplantation, a renal ultrasound is sufficient to identify hydroureter/hydronephrosis or a urinoma. Many patients with a markedly dilated renal-collecting system prior to ureteral reimplantation will have persistent hydroureter/hydronephrosis (similar to a latex balloon that does not return to its original size after it is blown up) after reimplantation. A Lasix renal scan is a better imaging modality in these patients because it can differentiate a ureter that is dilated from one that is dilated and obstructed.

It is important to note that prompt ureteroneocystotomy is feasible only when the delayed ureteral injury presents within approximately 7 days of surgery. If the patient presents more than a week after surgery, inflammation is so significant that conservative management is necessary with reevaluation for reimplantation in another 6 weeks. Decompression of the system prior to reimplantation can be achieved through either stent placement or placement of a percutaneous nephrostomy tube. We prefer the latter because it reduces inflammation around the ureter that may make subsequent dissection and surgery more difficult.
 

Dr. Kenton is chief of urogynecology, Northwestern University, Chicago, and Dr. Mueller also is in the division of female pelvic medicine and reconstructive surgery–urogynecology at Northwestern. Dr. Kenton discloses grant funding from Boston Scientific.

BOSTON – Results from two recent trials suggest that cardiologists may have a new way to improve outcomes in patients with heart failure with reduced ejection fraction if they also have atrial fibrillation: Cut the patient’s atrial fibrillation burden with catheter ablation.

This seemingly off-target approach to improving survival, avoiding heart failure hospitalizations, and possibly reducing other adverse events first gained attention with results from the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) randomized trial, first reported in 2017. The study showed in 363 patients that atrial fibrillation (AF) ablation in patients with heart failure with reduced ejection fraction (HFrEF) led to a statistically significant 38% relative reduction in the primary endpoint of mortality or heart failure hospitalization during a median 38 months of follow-up (N Engl J Med. 2018 Feb 1;378[5]:417-27).

This groundbreaking finding then received some degree of confirmation when Douglas L. Packer, MD, reported primary results from CABANA (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) at the annual scientific sessions of the Heart Rhythm Society. CABANA compared upfront ablation against first-line medical management of AF in 2,203 patients. While the primary endpoint of the cumulative rate of all-cause death, disabling stroke, serious bleeding, or cardiac arrest over a median follow-up of just over 4 years was neutral, with no statistically significant difference between the two treatment arms, a subgroup analysis showed a tantalizing suggestion of benefit in the 337 enrolled patients with a history of congestive heart failure (15% of the total study group).

In this subgroup, treatment with ablation cut the primary endpoint by 39% relative to those treated upfront with medical management, an effect that came close to statistical significance. In addition, Dr. Packer took special note of the per-protocol analysis, which censored out the crossover patients who constituted roughly a fifth of all enrolled patients. In the subgroup analysis using the per-protocol data, ablation was linked with a statistically significant 49% relative reduction in the primary endpoint among patients with a history of heart failure.

The patients for whom there may be the quickest shift to upfront ablation to treat AF based on the CABANA results will be those with heart failure and others with high underlying risk, Dr. Packer predicted at the meeting.

“The CASTLE-AF results were interesting, but in fewer than 400 patients. Now we’ve basically seen the same thing” in CABANA, said Dr. Packer, professor and a cardiac electrophysiologist at the Mayo Clinic in Rochester, Minn.

Notably however, the results Dr. Packer reported on the heart failure subgroup did not include any information on how many of these were patients who had HFrEF or heart failure with preserved ejection fraction and how the apparent benefit from AF ablation affected each of these two heart failure types. In addition, the reported CABANA results did not have an endpoint result that completely matched the mortality and heart failure hospitalization composite endpoint used in CASTLE-AF. The closest endpoint that Dr. Packer reported from CABANA was a composite of mortality and cardiovascular hospitalization that showed, for the entire CABANA cohort, a statistically significant 17% relative reduction with ablation in the intention-to-treat analysis. Dr. Packer gave no data on how this outcome shook out in the subgroup of heart failure patients.

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

[email protected]

BOSTON – Results from two recent trials suggest that cardiologists may have a new way to improve outcomes in patients with heart failure with reduced ejection fraction if they also have atrial fibrillation: Cut the patient’s atrial fibrillation burden with catheter ablation.

This seemingly off-target approach to improving survival, avoiding heart failure hospitalizations, and possibly reducing other adverse events first gained attention with results from the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) randomized trial, first reported in 2017. The study showed in 363 patients that atrial fibrillation (AF) ablation in patients with heart failure with reduced ejection fraction (HFrEF) led to a statistically significant 38% relative reduction in the primary endpoint of mortality or heart failure hospitalization during a median 38 months of follow-up (N Engl J Med. 2018 Feb 1;378[5]:417-27).

This groundbreaking finding then received some degree of confirmation when Douglas L. Packer, MD, reported primary results from CABANA (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) at the annual scientific sessions of the Heart Rhythm Society. CABANA compared upfront ablation against first-line medical management of AF in 2,203 patients. While the primary endpoint of the cumulative rate of all-cause death, disabling stroke, serious bleeding, or cardiac arrest over a median follow-up of just over 4 years was neutral, with no statistically significant difference between the two treatment arms, a subgroup analysis showed a tantalizing suggestion of benefit in the 337 enrolled patients with a history of congestive heart failure (15% of the total study group).

In this subgroup, treatment with ablation cut the primary endpoint by 39% relative to those treated upfront with medical management, an effect that came close to statistical significance. In addition, Dr. Packer took special note of the per-protocol analysis, which censored out the crossover patients who constituted roughly a fifth of all enrolled patients. In the subgroup analysis using the per-protocol data, ablation was linked with a statistically significant 49% relative reduction in the primary endpoint among patients with a history of heart failure.

The patients for whom there may be the quickest shift to upfront ablation to treat AF based on the CABANA results will be those with heart failure and others with high underlying risk, Dr. Packer predicted at the meeting.

“The CASTLE-AF results were interesting, but in fewer than 400 patients. Now we’ve basically seen the same thing” in CABANA, said Dr. Packer, professor and a cardiac electrophysiologist at the Mayo Clinic in Rochester, Minn.

Notably however, the results Dr. Packer reported on the heart failure subgroup did not include any information on how many of these were patients who had HFrEF or heart failure with preserved ejection fraction and how the apparent benefit from AF ablation affected each of these two heart failure types. In addition, the reported CABANA results did not have an endpoint result that completely matched the mortality and heart failure hospitalization composite endpoint used in CASTLE-AF. The closest endpoint that Dr. Packer reported from CABANA was a composite of mortality and cardiovascular hospitalization that showed, for the entire CABANA cohort, a statistically significant 17% relative reduction with ablation in the intention-to-treat analysis. Dr. Packer gave no data on how this outcome shook out in the subgroup of heart failure patients.

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

[email protected]

BOSTON – Results from two recent trials suggest that cardiologists may have a new way to improve outcomes in patients with heart failure with reduced ejection fraction if they also have atrial fibrillation: Cut the patient’s atrial fibrillation burden with catheter ablation.

This seemingly off-target approach to improving survival, avoiding heart failure hospitalizations, and possibly reducing other adverse events first gained attention with results from the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) randomized trial, first reported in 2017. The study showed in 363 patients that atrial fibrillation (AF) ablation in patients with heart failure with reduced ejection fraction (HFrEF) led to a statistically significant 38% relative reduction in the primary endpoint of mortality or heart failure hospitalization during a median 38 months of follow-up (N Engl J Med. 2018 Feb 1;378[5]:417-27).

This groundbreaking finding then received some degree of confirmation when Douglas L. Packer, MD, reported primary results from CABANA (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) at the annual scientific sessions of the Heart Rhythm Society. CABANA compared upfront ablation against first-line medical management of AF in 2,203 patients. While the primary endpoint of the cumulative rate of all-cause death, disabling stroke, serious bleeding, or cardiac arrest over a median follow-up of just over 4 years was neutral, with no statistically significant difference between the two treatment arms, a subgroup analysis showed a tantalizing suggestion of benefit in the 337 enrolled patients with a history of congestive heart failure (15% of the total study group).

In this subgroup, treatment with ablation cut the primary endpoint by 39% relative to those treated upfront with medical management, an effect that came close to statistical significance. In addition, Dr. Packer took special note of the per-protocol analysis, which censored out the crossover patients who constituted roughly a fifth of all enrolled patients. In the subgroup analysis using the per-protocol data, ablation was linked with a statistically significant 49% relative reduction in the primary endpoint among patients with a history of heart failure.

The patients for whom there may be the quickest shift to upfront ablation to treat AF based on the CABANA results will be those with heart failure and others with high underlying risk, Dr. Packer predicted at the meeting.

“The CASTLE-AF results were interesting, but in fewer than 400 patients. Now we’ve basically seen the same thing” in CABANA, said Dr. Packer, professor and a cardiac electrophysiologist at the Mayo Clinic in Rochester, Minn.

Notably however, the results Dr. Packer reported on the heart failure subgroup did not include any information on how many of these were patients who had HFrEF or heart failure with preserved ejection fraction and how the apparent benefit from AF ablation affected each of these two heart failure types. In addition, the reported CABANA results did not have an endpoint result that completely matched the mortality and heart failure hospitalization composite endpoint used in CASTLE-AF. The closest endpoint that Dr. Packer reported from CABANA was a composite of mortality and cardiovascular hospitalization that showed, for the entire CABANA cohort, a statistically significant 17% relative reduction with ablation in the intention-to-treat analysis. Dr. Packer gave no data on how this outcome shook out in the subgroup of heart failure patients.

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

[email protected]

Elinore F. McCance-Katz, MD, PhD, is by turns passionate and impatient, empathetic and brusquely no-nonsense. She is a person who knows what she wants to do and knows how to do it.

Accomplishing that on the idealogic battlefield of a presidential appointment is the focus of her considerable energy.

Dr. McCance-Katz carries the newly minted banner of assistant secretary for mental health and substance use. Her troops comprise more than 100 related federal agencies. Her charge is at once simple and mind-numbingly complex: Overhaul the nation’s mental health care system. Her strategy: People with serious mental illnesses and substance use disorders need prompt, evidence-based treatment for their illnesses before they can begin to heal.

It’s the precise opposite of the Substance Abuse and Mental Health Services Administration’s prior targeting, which focused heavily on providing healthy social support for patients with mental health and substance abuse disorders. To Dr. McCance-Katz’s way of thinking, dollars spent on such are largely wasted, because terribly ill people simply can’t function in healthy ways until they begin to get better. Why, she reasoned, should the government waste money on peer-support services while ignoring – or even openly rejecting – evidence-based psychiatric treatment paradigms that are proven to help heal?

It’s this philosophical dichotomy – combined with what she perceived as a palpable dismissal of psychiatric science – that drove her away from her first SAMHSA appointment as the agency’s first chief medical officer. She aired her frustration in an editorial, published 2 years ago in Psychiatric Times.

“There is a perceptible hostility toward psychiatric medicine: a resistance to addressing the treatment needs of those with serious mental illness and a questioning by some at SAMHSA as to whether mental disorders even exist – for example, is psychosis just a ‘different way of thinking for some experiencing stress?’ … Nowhere in SAMHSA’s strategic initiatives is psychiatric treatment of mental illness a priority. The occasional vague reference to treatment is no substitute for the urgent need for programs that address these issues.”

In the same letter, she outlined a new battle plan, one that includes funding for better outpatient treatments, more psychiatric hospital beds, clinician education and support, and money to beef up the dwindling supply of psychiatrists, advanced-practice psychiatric nurses, and psychologists.

In an exclusive video interview, Dr. McCance-Katz sat down with MDedge Psychiatry to discuss the path that brought her to this station and the long road ahead.

[email protected]

Elinore F. McCance-Katz, MD, PhD, is by turns passionate and impatient, empathetic and brusquely no-nonsense. She is a person who knows what she wants to do and knows how to do it.

Accomplishing that on the idealogic battlefield of a presidential appointment is the focus of her considerable energy.

Dr. McCance-Katz carries the newly minted banner of assistant secretary for mental health and substance use. Her troops comprise more than 100 related federal agencies. Her charge is at once simple and mind-numbingly complex: Overhaul the nation’s mental health care system. Her strategy: People with serious mental illnesses and substance use disorders need prompt, evidence-based treatment for their illnesses before they can begin to heal.

It’s the precise opposite of the Substance Abuse and Mental Health Services Administration’s prior targeting, which focused heavily on providing healthy social support for patients with mental health and substance abuse disorders. To Dr. McCance-Katz’s way of thinking, dollars spent on such are largely wasted, because terribly ill people simply can’t function in healthy ways until they begin to get better. Why, she reasoned, should the government waste money on peer-support services while ignoring – or even openly rejecting – evidence-based psychiatric treatment paradigms that are proven to help heal?

It’s this philosophical dichotomy – combined with what she perceived as a palpable dismissal of psychiatric science – that drove her away from her first SAMHSA appointment as the agency’s first chief medical officer. She aired her frustration in an editorial, published 2 years ago in Psychiatric Times.

“There is a perceptible hostility toward psychiatric medicine: a resistance to addressing the treatment needs of those with serious mental illness and a questioning by some at SAMHSA as to whether mental disorders even exist – for example, is psychosis just a ‘different way of thinking for some experiencing stress?’ … Nowhere in SAMHSA’s strategic initiatives is psychiatric treatment of mental illness a priority. The occasional vague reference to treatment is no substitute for the urgent need for programs that address these issues.”

In the same letter, she outlined a new battle plan, one that includes funding for better outpatient treatments, more psychiatric hospital beds, clinician education and support, and money to beef up the dwindling supply of psychiatrists, advanced-practice psychiatric nurses, and psychologists.

In an exclusive video interview, Dr. McCance-Katz sat down with MDedge Psychiatry to discuss the path that brought her to this station and the long road ahead.

[email protected]

Elinore F. McCance-Katz, MD, PhD, is by turns passionate and impatient, empathetic and brusquely no-nonsense. She is a person who knows what she wants to do and knows how to do it.

Accomplishing that on the idealogic battlefield of a presidential appointment is the focus of her considerable energy.

Dr. McCance-Katz carries the newly minted banner of assistant secretary for mental health and substance use. Her troops comprise more than 100 related federal agencies. Her charge is at once simple and mind-numbingly complex: Overhaul the nation’s mental health care system. Her strategy: People with serious mental illnesses and substance use disorders need prompt, evidence-based treatment for their illnesses before they can begin to heal.

It’s the precise opposite of the Substance Abuse and Mental Health Services Administration’s prior targeting, which focused heavily on providing healthy social support for patients with mental health and substance abuse disorders. To Dr. McCance-Katz’s way of thinking, dollars spent on such are largely wasted, because terribly ill people simply can’t function in healthy ways until they begin to get better. Why, she reasoned, should the government waste money on peer-support services while ignoring – or even openly rejecting – evidence-based psychiatric treatment paradigms that are proven to help heal?

It’s this philosophical dichotomy – combined with what she perceived as a palpable dismissal of psychiatric science – that drove her away from her first SAMHSA appointment as the agency’s first chief medical officer. She aired her frustration in an editorial, published 2 years ago in Psychiatric Times.

“There is a perceptible hostility toward psychiatric medicine: a resistance to addressing the treatment needs of those with serious mental illness and a questioning by some at SAMHSA as to whether mental disorders even exist – for example, is psychosis just a ‘different way of thinking for some experiencing stress?’ … Nowhere in SAMHSA’s strategic initiatives is psychiatric treatment of mental illness a priority. The occasional vague reference to treatment is no substitute for the urgent need for programs that address these issues.”

In the same letter, she outlined a new battle plan, one that includes funding for better outpatient treatments, more psychiatric hospital beds, clinician education and support, and money to beef up the dwindling supply of psychiatrists, advanced-practice psychiatric nurses, and psychologists.

In an exclusive video interview, Dr. McCance-Katz sat down with MDedge Psychiatry to discuss the path that brought her to this station and the long road ahead.

[email protected]

BOSTON – Efficacy and safety of two glucagonlike peptide 1 (GLP-1) receptor agonists in type 2 diabetes mellitus were similar between older and younger adults, according to a post hoc analysis of the SUSTAIN 7 clinical trial data.

However, clinicians should be alert for the greater potential for gastrointestinal upset in older patients with higher doses of GLP-1 receptor agonists, said the study’s first author, Vanita Aroda, MD, associate director for clinical diabetes research at Brigham and Women’s Hospital, Boston.

The SUSTAIN 7 trial compared low-dose semaglutide (0.5 mg) with low-dose dulaglutide (0.75 mg), and high-dose semaglutide (1.0 mg) with high-dose dulaglutide (1.5 mg) as add-on therapy to metformin for adults with type 2 diabetes. All medications were given as once-weekly subcutaneous injections.

Dr. Aroda and her collaborators performed a subgroup analysis of the SUSTAIN 7 data that compared 260 patients aged 65 years and older (mean, 69.3 years) with 939 patients younger than 65 years (mean, 51.9 years).

“What we found is that the efficacy results … were similar to what we saw in the general population. We did not lose the efficacy in the older adult population,” said Dr. Aroda in an interview at the annual meeting of the American Association for Clinical Endocrinology.

Weight loss was similar in older and younger patients, though there was “maybe a tiny bit more in the older adults,” said Dr. Aroda: Older participants had a 4.4-kg reduction in weight, compared with 4.9-kg reduction in the younger population, on low-dose semaglutide. For low-dose dulaglutide, losses were an average 2.6 kg in the elderly versus 2.2 kg in the younger participants.

The higher doses of each resulted in greater weight loss, up to a mean 6.7 kg in elderly participants on high-dose semaglutide, with the same marginally greater losses seen in older participants.

[email protected]

SOURCE: Aroda V et al. AACE 2018. Abstract 245.

BOSTON – Efficacy and safety of two glucagonlike peptide 1 (GLP-1) receptor agonists in type 2 diabetes mellitus were similar between older and younger adults, according to a post hoc analysis of the SUSTAIN 7 clinical trial data.

However, clinicians should be alert for the greater potential for gastrointestinal upset in older patients with higher doses of GLP-1 receptor agonists, said the study’s first author, Vanita Aroda, MD, associate director for clinical diabetes research at Brigham and Women’s Hospital, Boston.

The SUSTAIN 7 trial compared low-dose semaglutide (0.5 mg) with low-dose dulaglutide (0.75 mg), and high-dose semaglutide (1.0 mg) with high-dose dulaglutide (1.5 mg) as add-on therapy to metformin for adults with type 2 diabetes. All medications were given as once-weekly subcutaneous injections.

Dr. Aroda and her collaborators performed a subgroup analysis of the SUSTAIN 7 data that compared 260 patients aged 65 years and older (mean, 69.3 years) with 939 patients younger than 65 years (mean, 51.9 years).

“What we found is that the efficacy results … were similar to what we saw in the general population. We did not lose the efficacy in the older adult population,” said Dr. Aroda in an interview at the annual meeting of the American Association for Clinical Endocrinology.

Weight loss was similar in older and younger patients, though there was “maybe a tiny bit more in the older adults,” said Dr. Aroda: Older participants had a 4.4-kg reduction in weight, compared with 4.9-kg reduction in the younger population, on low-dose semaglutide. For low-dose dulaglutide, losses were an average 2.6 kg in the elderly versus 2.2 kg in the younger participants.

The higher doses of each resulted in greater weight loss, up to a mean 6.7 kg in elderly participants on high-dose semaglutide, with the same marginally greater losses seen in older participants.

[email protected]

SOURCE: Aroda V et al. AACE 2018. Abstract 245.

BOSTON – Efficacy and safety of two glucagonlike peptide 1 (GLP-1) receptor agonists in type 2 diabetes mellitus were similar between older and younger adults, according to a post hoc analysis of the SUSTAIN 7 clinical trial data.

However, clinicians should be alert for the greater potential for gastrointestinal upset in older patients with higher doses of GLP-1 receptor agonists, said the study’s first author, Vanita Aroda, MD, associate director for clinical diabetes research at Brigham and Women’s Hospital, Boston.

The SUSTAIN 7 trial compared low-dose semaglutide (0.5 mg) with low-dose dulaglutide (0.75 mg), and high-dose semaglutide (1.0 mg) with high-dose dulaglutide (1.5 mg) as add-on therapy to metformin for adults with type 2 diabetes. All medications were given as once-weekly subcutaneous injections.

Dr. Aroda and her collaborators performed a subgroup analysis of the SUSTAIN 7 data that compared 260 patients aged 65 years and older (mean, 69.3 years) with 939 patients younger than 65 years (mean, 51.9 years).

“What we found is that the efficacy results … were similar to what we saw in the general population. We did not lose the efficacy in the older adult population,” said Dr. Aroda in an interview at the annual meeting of the American Association for Clinical Endocrinology.

Weight loss was similar in older and younger patients, though there was “maybe a tiny bit more in the older adults,” said Dr. Aroda: Older participants had a 4.4-kg reduction in weight, compared with 4.9-kg reduction in the younger population, on low-dose semaglutide. For low-dose dulaglutide, losses were an average 2.6 kg in the elderly versus 2.2 kg in the younger participants.

The higher doses of each resulted in greater weight loss, up to a mean 6.7 kg in elderly participants on high-dose semaglutide, with the same marginally greater losses seen in older participants.

[email protected]

SOURCE: Aroda V et al. AACE 2018. Abstract 245.

Roseomonas mucosa bacteria obtained from healthy volunteers without atopic dermatitis reduced the severity of the disorder in a small, early-phase study of 10 adults and 5 children with atopic dermatitis.

The Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis trial; BACTERiAD I/II study, an open-label phase I/II trial, first looked at the therapeutic use of R. mucosa in 10 adults aged 18 years or older. Three sucrose mixtures with increasing doses of live R. mucosa bacteria were topically applied to two body areas – the antecubital fossae and a body surface of their choice – twice per week for 2 weeks per dose. At 6 weeks, the patients stopped using the mixtures and followed a 4-week washout phase.

Treatment was found to reduce mean antecubital SCORAD (SCORing Atopic Dermatitis) scores by 59.8%. Reduction in pruritus was even more pronounced, with a mean decrease of 78.5%. Treating the hands did not improve disease severity, even in patients whose symptoms improved in other body areas. One explanation may be the increased exposure of the hands to topical antimicrobials and environmental exposures, the researchers noted.

With the success in the adult cohort, the researchers enrolled five children aged 7-17 years in the study. These patients were treated twice weekly for 16 weeks. The pediatric patients experienced a mean decrease of 70.3% in their SCORAD scores. The mean decrease in pruritis was 78.8%.

All adults who responded continued to report improved symptoms after the washout period. The pediatric patients are now being evaluated in a washout period.

Four patients did not respond; three of them had a family history of AD persisting into adulthood. “The association between these complex medical histories and the lack of clinical response suggests that differences in heritable host and/or microbial factors may impact treatment responses,” wrote Ian A. Myles, MD, and his colleagues.

“Overall, our findings suggest the safety of topical R. mucosa therapy and justify continuation of our ongoing trial to assess safety and activity in a pediatric cohort of patients with AD. These studies will additionally assess changes in host serum markers, skin metabolomics, and the skin microbiota by culture and genomic methods.”

The researchers noted that expanding to the pediatric population will deepen understanding of topical microbiome transplantation and lay the foundation for placebo-controlled trials to assess efficacy.

This work was supported by the Intramural Research Program of the National Institutes of Allergy and Infectious Diseases and the National Institutes of Health. The researchers had no disclosures.

[email protected]

SOURCE: Myles IA et al. JCI Insight. 2018 May 3. doi: 10.1172/jci.insight.120608.

Roseomonas mucosa bacteria obtained from healthy volunteers without atopic dermatitis reduced the severity of the disorder in a small, early-phase study of 10 adults and 5 children with atopic dermatitis.

The Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis trial; BACTERiAD I/II study, an open-label phase I/II trial, first looked at the therapeutic use of R. mucosa in 10 adults aged 18 years or older. Three sucrose mixtures with increasing doses of live R. mucosa bacteria were topically applied to two body areas – the antecubital fossae and a body surface of their choice – twice per week for 2 weeks per dose. At 6 weeks, the patients stopped using the mixtures and followed a 4-week washout phase.

Treatment was found to reduce mean antecubital SCORAD (SCORing Atopic Dermatitis) scores by 59.8%. Reduction in pruritus was even more pronounced, with a mean decrease of 78.5%. Treating the hands did not improve disease severity, even in patients whose symptoms improved in other body areas. One explanation may be the increased exposure of the hands to topical antimicrobials and environmental exposures, the researchers noted.

With the success in the adult cohort, the researchers enrolled five children aged 7-17 years in the study. These patients were treated twice weekly for 16 weeks. The pediatric patients experienced a mean decrease of 70.3% in their SCORAD scores. The mean decrease in pruritis was 78.8%.

All adults who responded continued to report improved symptoms after the washout period. The pediatric patients are now being evaluated in a washout period.

Four patients did not respond; three of them had a family history of AD persisting into adulthood. “The association between these complex medical histories and the lack of clinical response suggests that differences in heritable host and/or microbial factors may impact treatment responses,” wrote Ian A. Myles, MD, and his colleagues.

“Overall, our findings suggest the safety of topical R. mucosa therapy and justify continuation of our ongoing trial to assess safety and activity in a pediatric cohort of patients with AD. These studies will additionally assess changes in host serum markers, skin metabolomics, and the skin microbiota by culture and genomic methods.”

The researchers noted that expanding to the pediatric population will deepen understanding of topical microbiome transplantation and lay the foundation for placebo-controlled trials to assess efficacy.

This work was supported by the Intramural Research Program of the National Institutes of Allergy and Infectious Diseases and the National Institutes of Health. The researchers had no disclosures.

[email protected]

SOURCE: Myles IA et al. JCI Insight. 2018 May 3. doi: 10.1172/jci.insight.120608.

Roseomonas mucosa bacteria obtained from healthy volunteers without atopic dermatitis reduced the severity of the disorder in a small, early-phase study of 10 adults and 5 children with atopic dermatitis.

The Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis trial; BACTERiAD I/II study, an open-label phase I/II trial, first looked at the therapeutic use of R. mucosa in 10 adults aged 18 years or older. Three sucrose mixtures with increasing doses of live R. mucosa bacteria were topically applied to two body areas – the antecubital fossae and a body surface of their choice – twice per week for 2 weeks per dose. At 6 weeks, the patients stopped using the mixtures and followed a 4-week washout phase.

Treatment was found to reduce mean antecubital SCORAD (SCORing Atopic Dermatitis) scores by 59.8%. Reduction in pruritus was even more pronounced, with a mean decrease of 78.5%. Treating the hands did not improve disease severity, even in patients whose symptoms improved in other body areas. One explanation may be the increased exposure of the hands to topical antimicrobials and environmental exposures, the researchers noted.

With the success in the adult cohort, the researchers enrolled five children aged 7-17 years in the study. These patients were treated twice weekly for 16 weeks. The pediatric patients experienced a mean decrease of 70.3% in their SCORAD scores. The mean decrease in pruritis was 78.8%.

All adults who responded continued to report improved symptoms after the washout period. The pediatric patients are now being evaluated in a washout period.

Four patients did not respond; three of them had a family history of AD persisting into adulthood. “The association between these complex medical histories and the lack of clinical response suggests that differences in heritable host and/or microbial factors may impact treatment responses,” wrote Ian A. Myles, MD, and his colleagues.

“Overall, our findings suggest the safety of topical R. mucosa therapy and justify continuation of our ongoing trial to assess safety and activity in a pediatric cohort of patients with AD. These studies will additionally assess changes in host serum markers, skin metabolomics, and the skin microbiota by culture and genomic methods.”

The researchers noted that expanding to the pediatric population will deepen understanding of topical microbiome transplantation and lay the foundation for placebo-controlled trials to assess efficacy.

This work was supported by the Intramural Research Program of the National Institutes of Allergy and Infectious Diseases and the National Institutes of Health. The researchers had no disclosures.

[email protected]

SOURCE: Myles IA et al. JCI Insight. 2018 May 3. doi: 10.1172/jci.insight.120608.

SANDESTIN, FLA. – An array of potential new options for psoriatic arthritis offers new targeted options and poses challenges for how to use the drugs, Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, said in a video interview at the annual Congress of Clinical Rheumatology.

“We’re seeing a second wave – a second wave driven by the additional ways that we have to target aspects of the immune system relevant to psoriatic arthritis,” he said.

First used to treat rheumatoid arthritis, monoclonal antibodies to interleukin targets, including IL12 and IL23 (ustekinumab) and IL17 (secukinumab and ixekizumab), have become established psoriatic arthritis therapies. Additionally, the Janus kinase (JAK) inhibitor tofacitinib has become an option.

Other options in the pipeline include the JAK inhibitor baricitinib; the anti-IL23 monoclonal antibodies guselkumab, risankizumab, and tildrakizumab; and even more anti-IL17 therapies, including brodalumab and bimekizumab .

“Now we have the synergy of having novel therapeutic approaches to maybe address some of the different domains of disease,” he said. Despite efforts to develop better biomarkers, it’s hard to predict how an individual patient will respond to a specific therapy. The longer the menu of therapeutic options, the better it is for patients.

As methotrexate remains a go-to treatment for many patients, new data from the SEAM trial assessing etanercept and methotrexate will address the question of whether the conventional drug and tumor necrosis factor inhibitors create therapeutic synergy in patients with psoriatic arthritis.

Dr. Kavanaugh discussed the implications of the trial’s findings, which are expected to go public this summer.

SANDESTIN, FLA. – An array of potential new options for psoriatic arthritis offers new targeted options and poses challenges for how to use the drugs, Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, said in a video interview at the annual Congress of Clinical Rheumatology.

“We’re seeing a second wave – a second wave driven by the additional ways that we have to target aspects of the immune system relevant to psoriatic arthritis,” he said.

First used to treat rheumatoid arthritis, monoclonal antibodies to interleukin targets, including IL12 and IL23 (ustekinumab) and IL17 (secukinumab and ixekizumab), have become established psoriatic arthritis therapies. Additionally, the Janus kinase (JAK) inhibitor tofacitinib has become an option.

Other options in the pipeline include the JAK inhibitor baricitinib; the anti-IL23 monoclonal antibodies guselkumab, risankizumab, and tildrakizumab; and even more anti-IL17 therapies, including brodalumab and bimekizumab .

“Now we have the synergy of having novel therapeutic approaches to maybe address some of the different domains of disease,” he said. Despite efforts to develop better biomarkers, it’s hard to predict how an individual patient will respond to a specific therapy. The longer the menu of therapeutic options, the better it is for patients.

As methotrexate remains a go-to treatment for many patients, new data from the SEAM trial assessing etanercept and methotrexate will address the question of whether the conventional drug and tumor necrosis factor inhibitors create therapeutic synergy in patients with psoriatic arthritis.

Dr. Kavanaugh discussed the implications of the trial’s findings, which are expected to go public this summer.

SANDESTIN, FLA. – An array of potential new options for psoriatic arthritis offers new targeted options and poses challenges for how to use the drugs, Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, said in a video interview at the annual Congress of Clinical Rheumatology.

“We’re seeing a second wave – a second wave driven by the additional ways that we have to target aspects of the immune system relevant to psoriatic arthritis,” he said.

First used to treat rheumatoid arthritis, monoclonal antibodies to interleukin targets, including IL12 and IL23 (ustekinumab) and IL17 (secukinumab and ixekizumab), have become established psoriatic arthritis therapies. Additionally, the Janus kinase (JAK) inhibitor tofacitinib has become an option.

Other options in the pipeline include the JAK inhibitor baricitinib; the anti-IL23 monoclonal antibodies guselkumab, risankizumab, and tildrakizumab; and even more anti-IL17 therapies, including brodalumab and bimekizumab .

“Now we have the synergy of having novel therapeutic approaches to maybe address some of the different domains of disease,” he said. Despite efforts to develop better biomarkers, it’s hard to predict how an individual patient will respond to a specific therapy. The longer the menu of therapeutic options, the better it is for patients.

As methotrexate remains a go-to treatment for many patients, new data from the SEAM trial assessing etanercept and methotrexate will address the question of whether the conventional drug and tumor necrosis factor inhibitors create therapeutic synergy in patients with psoriatic arthritis.

Dr. Kavanaugh discussed the implications of the trial’s findings, which are expected to go public this summer.