BOSTON – It’s been just a year since Bani Chander Roland, MD, FACG, was awarded the 2017 AGA-Medtronic Research & Development Pilot Award in Technology by the AGA Research Foundation, and her team already has recruited 30 patients with irritable bowel syndrome (IBS) and small intestinal bacterial overgrowth (SIBO) for a study of the gut microbiome and its function. Interim data from her grant will be presented at Digestive Disease Week^® 2018 in June in Washington as a poster of distinction.

“Dr. Roland’s research is innovative and clinically relevant. It’s great to see the progress her team has made since receiving this grant from the AGA Research Foundation,” said Robert S. Sandler, MD, MPH, AGAF, chair of the AGA Research Foundation. “I want to thank Medtronic for their partnership on this award and their shared commitment to funding innovative research projects.”

Dr. Roland and her team are testing the hypothesis that IBS and SIBO result from several distinct pathophysiological mechanisms, each of which are associated with their own distinct microbial and inflammatory profile. For the study, they are using a wireless motility capsule (PillCam) – just the kind of technology fostered by the AGA GI Center for Innovation and Technology – to assess alterations in gastrointestinal pathophysiology in patients with suspected IBS and SIBO. They also are obtaining microflora from oropharyngeal, gastric, small bowel, and fecal samples for DNA sequencing. In addition, the team is beginning to study serum samples to test the hypothesis that patients with both IBS and SIBO have increased expression of proinflammatory markers, compared with those with IBS only; they are attempting to correlate the inflammatory markers to specific bacteria.

“IBS is a very common gastrointestinal disorder, and we’re continuing to see an increase in prevalence in Western countries without understanding the etiology for this syndrome,” said Dr. Roland, the director of gastrointestinal motility at Lenox Hill Hospital and Northwell Health System in New York. “Unfortunately, we don’t have any specific or targeted therapies for this patient population because the underlying physiological mechanisms that cause IBS are not very well understood. When we treat these patients with antibiotics, often their symptoms come right back. If we can target the causes of disease in subsets of these patients, we may be able to successfully treat them.”

“We’re very excited to see what changes in the microbiome exist in this patient population, to determine if the microbiome may be another potential area that we can target for treatment,” she added.

To capture the data to be presented in the DDW poster, Dr. Roland’s team used the wireless motility capsule to measure the gastrointestinal transit times, pH, and ileocecal junction pressures of patients with IBS and SIBO as compared with patients who have IBS without evidence of SIBO

“Interestingly, patients who had IBS and SIBO had significantly higher contraction frequency in the stomach and small bowel compared to patients with IBS alone,” Dr. Roland said. Those with both conditions also had lower ileocecal junction pressures. “These are physiological mechanisms that have not been well understood before,” Dr. Roland said. “We have been able to begin delineating some of the underlying physiological mechanisms in this challenging patient population for the first time, using a noninvasive, wireless motility capsule.”

 

Dr. Roland’s team is now partnering with the hospital’s endocrinology division to compare the circulating inflammatory markers in patients with IBS and SIBO, such as tumor necrosis factor–alpha and interleukin 6, with those in patients who have only IBS. They will use their data to apply for future funding.

Since 2014, the AGA Research Foundation has partnered with medical technology companies such as Medtronic to provide a total of over $450,000 in research grants to six investigators working on novel and innovative technology projects. The AGA Research Foundation will begin accepting applications for the next round of research grants in summer 2018. Stay tuned to www.gastro.org/research-funding.

[email protected]

 

BOSTON – It’s been just a year since Bani Chander Roland, MD, FACG, was awarded the 2017 AGA-Medtronic Research & Development Pilot Award in Technology by the AGA Research Foundation, and her team already has recruited 30 patients with irritable bowel syndrome (IBS) and small intestinal bacterial overgrowth (SIBO) for a study of the gut microbiome and its function. Interim data from her grant will be presented at Digestive Disease Week^® 2018 in June in Washington as a poster of distinction.

“Dr. Roland’s research is innovative and clinically relevant. It’s great to see the progress her team has made since receiving this grant from the AGA Research Foundation,” said Robert S. Sandler, MD, MPH, AGAF, chair of the AGA Research Foundation. “I want to thank Medtronic for their partnership on this award and their shared commitment to funding innovative research projects.”

Dr. Roland and her team are testing the hypothesis that IBS and SIBO result from several distinct pathophysiological mechanisms, each of which are associated with their own distinct microbial and inflammatory profile. For the study, they are using a wireless motility capsule (PillCam) – just the kind of technology fostered by the AGA GI Center for Innovation and Technology – to assess alterations in gastrointestinal pathophysiology in patients with suspected IBS and SIBO. They also are obtaining microflora from oropharyngeal, gastric, small bowel, and fecal samples for DNA sequencing. In addition, the team is beginning to study serum samples to test the hypothesis that patients with both IBS and SIBO have increased expression of proinflammatory markers, compared with those with IBS only; they are attempting to correlate the inflammatory markers to specific bacteria.

“IBS is a very common gastrointestinal disorder, and we’re continuing to see an increase in prevalence in Western countries without understanding the etiology for this syndrome,” said Dr. Roland, the director of gastrointestinal motility at Lenox Hill Hospital and Northwell Health System in New York. “Unfortunately, we don’t have any specific or targeted therapies for this patient population because the underlying physiological mechanisms that cause IBS are not very well understood. When we treat these patients with antibiotics, often their symptoms come right back. If we can target the causes of disease in subsets of these patients, we may be able to successfully treat them.”

“We’re very excited to see what changes in the microbiome exist in this patient population, to determine if the microbiome may be another potential area that we can target for treatment,” she added.

To capture the data to be presented in the DDW poster, Dr. Roland’s team used the wireless motility capsule to measure the gastrointestinal transit times, pH, and ileocecal junction pressures of patients with IBS and SIBO as compared with patients who have IBS without evidence of SIBO

“Interestingly, patients who had IBS and SIBO had significantly higher contraction frequency in the stomach and small bowel compared to patients with IBS alone,” Dr. Roland said. Those with both conditions also had lower ileocecal junction pressures. “These are physiological mechanisms that have not been well understood before,” Dr. Roland said. “We have been able to begin delineating some of the underlying physiological mechanisms in this challenging patient population for the first time, using a noninvasive, wireless motility capsule.”

 

Dr. Roland’s team is now partnering with the hospital’s endocrinology division to compare the circulating inflammatory markers in patients with IBS and SIBO, such as tumor necrosis factor–alpha and interleukin 6, with those in patients who have only IBS. They will use their data to apply for future funding.

Since 2014, the AGA Research Foundation has partnered with medical technology companies such as Medtronic to provide a total of over $450,000 in research grants to six investigators working on novel and innovative technology projects. The AGA Research Foundation will begin accepting applications for the next round of research grants in summer 2018. Stay tuned to www.gastro.org/research-funding.

[email protected]

 

BOSTON – It’s been just a year since Bani Chander Roland, MD, FACG, was awarded the 2017 AGA-Medtronic Research & Development Pilot Award in Technology by the AGA Research Foundation, and her team already has recruited 30 patients with irritable bowel syndrome (IBS) and small intestinal bacterial overgrowth (SIBO) for a study of the gut microbiome and its function. Interim data from her grant will be presented at Digestive Disease Week^® 2018 in June in Washington as a poster of distinction.

“Dr. Roland’s research is innovative and clinically relevant. It’s great to see the progress her team has made since receiving this grant from the AGA Research Foundation,” said Robert S. Sandler, MD, MPH, AGAF, chair of the AGA Research Foundation. “I want to thank Medtronic for their partnership on this award and their shared commitment to funding innovative research projects.”

Dr. Roland and her team are testing the hypothesis that IBS and SIBO result from several distinct pathophysiological mechanisms, each of which are associated with their own distinct microbial and inflammatory profile. For the study, they are using a wireless motility capsule (PillCam) – just the kind of technology fostered by the AGA GI Center for Innovation and Technology – to assess alterations in gastrointestinal pathophysiology in patients with suspected IBS and SIBO. They also are obtaining microflora from oropharyngeal, gastric, small bowel, and fecal samples for DNA sequencing. In addition, the team is beginning to study serum samples to test the hypothesis that patients with both IBS and SIBO have increased expression of proinflammatory markers, compared with those with IBS only; they are attempting to correlate the inflammatory markers to specific bacteria.

“IBS is a very common gastrointestinal disorder, and we’re continuing to see an increase in prevalence in Western countries without understanding the etiology for this syndrome,” said Dr. Roland, the director of gastrointestinal motility at Lenox Hill Hospital and Northwell Health System in New York. “Unfortunately, we don’t have any specific or targeted therapies for this patient population because the underlying physiological mechanisms that cause IBS are not very well understood. When we treat these patients with antibiotics, often their symptoms come right back. If we can target the causes of disease in subsets of these patients, we may be able to successfully treat them.”

“We’re very excited to see what changes in the microbiome exist in this patient population, to determine if the microbiome may be another potential area that we can target for treatment,” she added.

To capture the data to be presented in the DDW poster, Dr. Roland’s team used the wireless motility capsule to measure the gastrointestinal transit times, pH, and ileocecal junction pressures of patients with IBS and SIBO as compared with patients who have IBS without evidence of SIBO

“Interestingly, patients who had IBS and SIBO had significantly higher contraction frequency in the stomach and small bowel compared to patients with IBS alone,” Dr. Roland said. Those with both conditions also had lower ileocecal junction pressures. “These are physiological mechanisms that have not been well understood before,” Dr. Roland said. “We have been able to begin delineating some of the underlying physiological mechanisms in this challenging patient population for the first time, using a noninvasive, wireless motility capsule.”

 

Dr. Roland’s team is now partnering with the hospital’s endocrinology division to compare the circulating inflammatory markers in patients with IBS and SIBO, such as tumor necrosis factor–alpha and interleukin 6, with those in patients who have only IBS. They will use their data to apply for future funding.

Since 2014, the AGA Research Foundation has partnered with medical technology companies such as Medtronic to provide a total of over $450,000 in research grants to six investigators working on novel and innovative technology projects. The AGA Research Foundation will begin accepting applications for the next round of research grants in summer 2018. Stay tuned to www.gastro.org/research-funding.

[email protected]

Terminal patients who have exhausted all approved drug options would be able to seek out investigational treatments – even if they do not qualify for clinical trials – under a bill passed in the U.S. House, despite opposition from more than 100 patient and physician groups.

The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right To Try Act of 2018 (H.R. 5247) passed by a 267-149 vote, promising improved access to experimental treatments.

Alicia Ault/Frontline Medical News

H.R. 5247 creates a new, alternative pathway for patients who do not qualify for clinical trials to access experimental medications and requires informed consent to access these treatments.

For an unapproved drug to be made available to patients, it must have an active application that is not subject to any kind of clinical hold. Sponsors and manufacturers must notify the Food and Drug Administration when an unapproved drug is made available to the patient.

The bill also includes safeguards to prevent manufacturers from purposefully misbranding or mislabeling drugs.

H.R. 5247 provides liability protections to manufacturers, sponsors, physicians, clinical investigators, and hospitals that participate in providing experimental drugs to terminal patients through this new alternative pathway, although it does not shield them from liability stemming from reckless misconduct, gross negligence, or any other intentional violations. It requires sponsors and manufacturers to report all adverse events to the FDA.

It also provides certainty to manufacturers as to how the FDA will use patient outcomes from the use of treatments outside of clinical trials when it is evaluating the applications on these new drugs.

Rep. Michael Burgess (R-Tex.), the House Energy & Commerce Health Subcommittee chairman and a physician, spoke in support of the bill during a debate on the House floor.

 

“Mr. Speaker, as a physician, I understand that access to investigational drugs and therapies is a deeply personal priority for those seeking treatment for their loved ones with serious, life-threatening conditions,” he said. “To my friends on the other side of the aisle, I have a simple question: Why do you not want to allow these patients to exercise their right to fight for their future?”

Rep. Frank Pallone (D-N.J.), the top-ranking Democrat on the House Energy & Commerce Committee, responded by asking, “if this is such a patient-centered bill, then why does every major patient organization overwhelmingly oppose it?”

In a March 19 letter to congressional leaders, a coalition of more than 100 physician and patient advocacy groups called the alternative pathway laid out in legislation “less safe” for patients than the FDA’s current expanded access process.

 

“This alternative pathway would allow for a 7-day lag between access to investigational therapies (as well as potential ensuing adverse effects) and FDA notification. FDA also is prohibited from halting access to these experimental therapies short of placing a clinical hold on all clinical research on the therapy in question, which is a blunt and disproportionate measure. The legislation would also remove FDA’s consultation on dosing, route of administration, dosing schedule, and other important safety measures available under FDA’s current expanded access program,” the groups wrote.

The groups that signed the letter included the American Society of Clinical Oncology, the Cystic Fibrosis Foundation, Friends of Cancer Research, the Leukemia & Lymphoma Society, the National Comprehensive Cancer Network, the National Organization for Rare Disorders, the Platelet Disorder Support Association, and Vietnam Veterans of America.

“The current compassionate use program at the Food and Drug Administration does make a good faith effort to help patients who do not qualify for clinical trials,” Rep. Burgess said. “But ‘right to try’ would actually offer patients an alternative pathway to access eligible investigational drugs, so long as they are certified by a physician who is in good standing and abides by the rules laid out in the bill.”

 

But Rep. Pallone noted that a review by the Government Accountability Office found that the FDA approves 99% of the requests submitted to the agency. Of the nearly 1,700 requests the FDA received in 2017, just 9 were not approved. However, the agency also adjusted applications for 11% of the patients in order to improve patient safety protections and that type of review should be allowed to continue, he said.

Patient groups expressed disappointment following the House vote. “The House has voted for a proposal that would create a less-safe, redundant pathway for accessing investigational therapies outside of clinical trials,” the National Organization for Rare Disorders said in a statement. “We hope the Senate will recognize that patients deserve legislation that will genuinely increase access. For example, senators should focus on legislation that reduces the financial disincentives companies encounter in offering their therapy through expanded access.”

The Senate passed a version of “right to try” in 2017 through the unanimous consent process (S. 204). No schedule has been set yet to either combine the two bills in committee or for the Senate to take up the House bill. President Trump voiced support for “right to try” legislation during his 2018 State of the Union address.

[email protected]

Terminal patients who have exhausted all approved drug options would be able to seek out investigational treatments – even if they do not qualify for clinical trials – under a bill passed in the U.S. House, despite opposition from more than 100 patient and physician groups.

The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right To Try Act of 2018 (H.R. 5247) passed by a 267-149 vote, promising improved access to experimental treatments.

Alicia Ault/Frontline Medical News

H.R. 5247 creates a new, alternative pathway for patients who do not qualify for clinical trials to access experimental medications and requires informed consent to access these treatments.

For an unapproved drug to be made available to patients, it must have an active application that is not subject to any kind of clinical hold. Sponsors and manufacturers must notify the Food and Drug Administration when an unapproved drug is made available to the patient.

The bill also includes safeguards to prevent manufacturers from purposefully misbranding or mislabeling drugs.

H.R. 5247 provides liability protections to manufacturers, sponsors, physicians, clinical investigators, and hospitals that participate in providing experimental drugs to terminal patients through this new alternative pathway, although it does not shield them from liability stemming from reckless misconduct, gross negligence, or any other intentional violations. It requires sponsors and manufacturers to report all adverse events to the FDA.

It also provides certainty to manufacturers as to how the FDA will use patient outcomes from the use of treatments outside of clinical trials when it is evaluating the applications on these new drugs.

Rep. Michael Burgess (R-Tex.), the House Energy & Commerce Health Subcommittee chairman and a physician, spoke in support of the bill during a debate on the House floor.

 

“Mr. Speaker, as a physician, I understand that access to investigational drugs and therapies is a deeply personal priority for those seeking treatment for their loved ones with serious, life-threatening conditions,” he said. “To my friends on the other side of the aisle, I have a simple question: Why do you not want to allow these patients to exercise their right to fight for their future?”

Rep. Frank Pallone (D-N.J.), the top-ranking Democrat on the House Energy & Commerce Committee, responded by asking, “if this is such a patient-centered bill, then why does every major patient organization overwhelmingly oppose it?”

In a March 19 letter to congressional leaders, a coalition of more than 100 physician and patient advocacy groups called the alternative pathway laid out in legislation “less safe” for patients than the FDA’s current expanded access process.

 

“This alternative pathway would allow for a 7-day lag between access to investigational therapies (as well as potential ensuing adverse effects) and FDA notification. FDA also is prohibited from halting access to these experimental therapies short of placing a clinical hold on all clinical research on the therapy in question, which is a blunt and disproportionate measure. The legislation would also remove FDA’s consultation on dosing, route of administration, dosing schedule, and other important safety measures available under FDA’s current expanded access program,” the groups wrote.

The groups that signed the letter included the American Society of Clinical Oncology, the Cystic Fibrosis Foundation, Friends of Cancer Research, the Leukemia & Lymphoma Society, the National Comprehensive Cancer Network, the National Organization for Rare Disorders, the Platelet Disorder Support Association, and Vietnam Veterans of America.

“The current compassionate use program at the Food and Drug Administration does make a good faith effort to help patients who do not qualify for clinical trials,” Rep. Burgess said. “But ‘right to try’ would actually offer patients an alternative pathway to access eligible investigational drugs, so long as they are certified by a physician who is in good standing and abides by the rules laid out in the bill.”

 

But Rep. Pallone noted that a review by the Government Accountability Office found that the FDA approves 99% of the requests submitted to the agency. Of the nearly 1,700 requests the FDA received in 2017, just 9 were not approved. However, the agency also adjusted applications for 11% of the patients in order to improve patient safety protections and that type of review should be allowed to continue, he said.

Patient groups expressed disappointment following the House vote. “The House has voted for a proposal that would create a less-safe, redundant pathway for accessing investigational therapies outside of clinical trials,” the National Organization for Rare Disorders said in a statement. “We hope the Senate will recognize that patients deserve legislation that will genuinely increase access. For example, senators should focus on legislation that reduces the financial disincentives companies encounter in offering their therapy through expanded access.”

The Senate passed a version of “right to try” in 2017 through the unanimous consent process (S. 204). No schedule has been set yet to either combine the two bills in committee or for the Senate to take up the House bill. President Trump voiced support for “right to try” legislation during his 2018 State of the Union address.

[email protected]

Terminal patients who have exhausted all approved drug options would be able to seek out investigational treatments – even if they do not qualify for clinical trials – under a bill passed in the U.S. House, despite opposition from more than 100 patient and physician groups.

The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right To Try Act of 2018 (H.R. 5247) passed by a 267-149 vote, promising improved access to experimental treatments.

Alicia Ault/Frontline Medical News

H.R. 5247 creates a new, alternative pathway for patients who do not qualify for clinical trials to access experimental medications and requires informed consent to access these treatments.

For an unapproved drug to be made available to patients, it must have an active application that is not subject to any kind of clinical hold. Sponsors and manufacturers must notify the Food and Drug Administration when an unapproved drug is made available to the patient.

The bill also includes safeguards to prevent manufacturers from purposefully misbranding or mislabeling drugs.

H.R. 5247 provides liability protections to manufacturers, sponsors, physicians, clinical investigators, and hospitals that participate in providing experimental drugs to terminal patients through this new alternative pathway, although it does not shield them from liability stemming from reckless misconduct, gross negligence, or any other intentional violations. It requires sponsors and manufacturers to report all adverse events to the FDA.

It also provides certainty to manufacturers as to how the FDA will use patient outcomes from the use of treatments outside of clinical trials when it is evaluating the applications on these new drugs.

Rep. Michael Burgess (R-Tex.), the House Energy & Commerce Health Subcommittee chairman and a physician, spoke in support of the bill during a debate on the House floor.

 

“Mr. Speaker, as a physician, I understand that access to investigational drugs and therapies is a deeply personal priority for those seeking treatment for their loved ones with serious, life-threatening conditions,” he said. “To my friends on the other side of the aisle, I have a simple question: Why do you not want to allow these patients to exercise their right to fight for their future?”

Rep. Frank Pallone (D-N.J.), the top-ranking Democrat on the House Energy & Commerce Committee, responded by asking, “if this is such a patient-centered bill, then why does every major patient organization overwhelmingly oppose it?”

In a March 19 letter to congressional leaders, a coalition of more than 100 physician and patient advocacy groups called the alternative pathway laid out in legislation “less safe” for patients than the FDA’s current expanded access process.

 

“This alternative pathway would allow for a 7-day lag between access to investigational therapies (as well as potential ensuing adverse effects) and FDA notification. FDA also is prohibited from halting access to these experimental therapies short of placing a clinical hold on all clinical research on the therapy in question, which is a blunt and disproportionate measure. The legislation would also remove FDA’s consultation on dosing, route of administration, dosing schedule, and other important safety measures available under FDA’s current expanded access program,” the groups wrote.

The groups that signed the letter included the American Society of Clinical Oncology, the Cystic Fibrosis Foundation, Friends of Cancer Research, the Leukemia & Lymphoma Society, the National Comprehensive Cancer Network, the National Organization for Rare Disorders, the Platelet Disorder Support Association, and Vietnam Veterans of America.

“The current compassionate use program at the Food and Drug Administration does make a good faith effort to help patients who do not qualify for clinical trials,” Rep. Burgess said. “But ‘right to try’ would actually offer patients an alternative pathway to access eligible investigational drugs, so long as they are certified by a physician who is in good standing and abides by the rules laid out in the bill.”

 

But Rep. Pallone noted that a review by the Government Accountability Office found that the FDA approves 99% of the requests submitted to the agency. Of the nearly 1,700 requests the FDA received in 2017, just 9 were not approved. However, the agency also adjusted applications for 11% of the patients in order to improve patient safety protections and that type of review should be allowed to continue, he said.

Patient groups expressed disappointment following the House vote. “The House has voted for a proposal that would create a less-safe, redundant pathway for accessing investigational therapies outside of clinical trials,” the National Organization for Rare Disorders said in a statement. “We hope the Senate will recognize that patients deserve legislation that will genuinely increase access. For example, senators should focus on legislation that reduces the financial disincentives companies encounter in offering their therapy through expanded access.”

The Senate passed a version of “right to try” in 2017 through the unanimous consent process (S. 204). No schedule has been set yet to either combine the two bills in committee or for the Senate to take up the House bill. President Trump voiced support for “right to try” legislation during his 2018 State of the Union address.

[email protected]

 

There is an increased focus on reducing the costs of health care delivery, and one major driver of surgical cost is length of hospitalization. A minimally invasive surgical approach to hysterectomy is a strategy that significantly enhances recovery and shortens hospital stay, although many patients who can safely be considered for same-day discharge (SDD), including many with cancer, are still admitted to the hospital overnight. Much has been published on the predictors and pathways for successful same-day discharge after minimally invasive hysterectomy, and in this column we will review how to best predict who is a good candidate for SDD and how to optimize the success of this approach with respect to safety and patient satisfaction.

What are the benefits to SDD?

Certainly, decreased hospitalization costs are an attractive feature of SDD following hysterectomy, although surgeons should also be mindful that patient-centered outcomes, such as pain control, managing nausea, and patient satisfaction, also are considered with equal emphasis. Several studies have shown that, in appropriate candidates and when proactive pathways are used, patient satisfaction is preserved with SDD following hysterectomy.¹

Choosing patient candidates

Same day discharge is most successfully accomplished in patients of good general baseline health.² Diabetic patients, particularly those on insulin, are generally not good candidates for SDD because it is important to monitor and intervene in blood glucose changes that are influenced by a nothing-by-mouth status and surgical stress. We recommend observing patients overnight with a history of pulmonary disease who may have transient increased postoperative O₂ needs. Similarly, patients with significant cardiac disease (including heart failure and coronary disease) may benefit from prolonged overnight observation.

Particular caution should be paid to patients with obstructive sleep apnea, which may be occult but anticipated in patients with very high body mass indexes (greater than 40 kg/m²). General anesthetic drugs, the trauma of intubation, and opioids all couple with the underlying airway compromise such that these patients are at risk for postoperative apnea, which, in severe cases, can result in anoxia and death. These patients should be considered for continuous pulse-ox monitoring for at least 12-24 hours postoperatively and are not good candidates for same-day discharge.

Patients who have baseline anticoagulation that has been stopped or bridged preoperatively should have prolonged observation with recheck of their postoperative hemoglobin prior to discharge.

Patients who live alone or are very elderly with baseline frailty are poor candidates for SDD and may benefit from nursing observation overnight while they metabolize their anesthesia. Patients who have chronic opioid dependency present a greater challenge to control postoperative pain; these patients are generally less good candidates for SDD.

 

Studies have shown that the indication for the procedure (for example, cancer with staging, fibroids, endometriosis) is less critical in determining who is a good candidate for SDD.³ However, successful SDD rates are highest in more straightforward cases with few or no prior surgeries, small uteri (less than 14 weeks), a surgical duration of less than 3 hours, and a surgical start time before 2 p.m. Longer, more complex cases are typically associated with more blood loss, higher risk for occult complications, and more time under anesthesia (and in Trendelenburg), which can exacerbate airway edema. In preparation for such cases, it might be wise to prepare patients for the possibility that they may not be good candidates for discharge on the same day. In general, most SDD pathways exclude patients with very high BMI (greater than 50 kg/m²) because of concern for airway patency and because these cases may be more complex with higher underlying risk. In addition, many of these patients have diabetes and require perioperative metabolic interventions.

Patient preparation

A key component to successful SDD is setting patient expectations. Patients should be informed at their preoperative visit that, unless there is an unexpected occurrence or response to the surgery, they will be discharged to home the same day. This allows them to prepare their home (including transportation needs) in advance. They should be provided with information about what to expect that first night after surgery (including potential residual drowsiness or nausea from anesthesia and immediate postoperative pain).

On the day of surgery, under the influence of anesthesia and pain medication, patients will have difficulty retaining complex discharge instructions. The preoperative visit is critically important because it’s the best time to provide them with this information, including postoperative activity limitations, wound and dressing care, and follow-up instructions. This is also the best time to provide prescriptions for postoperative pain, nausea, and constipation prophylaxis with detailed instructions about best use. Patients should be encouraged to fill these prescriptions preoperatively so that they have these medications on hand on the evening of their discharge.

Many programs utilize a combination of educational strategies (in person, written, video) to maximize the likelihood of retention.¹ It is also important to offer an opportunity for patients to ask questions about this information after they have received it (for example, by phoning the patients prior to their procedure).
 

 

Preoperative strategies

Postoperative pain and nausea can be preempted with immediate preoperative doses of dexamethasone, gabapentin, ondansetron, celecoxib, and acetaminophen. Postoperative nausea is associated with dehydration; therefore, ensure patients are well hydrated preoperatively by avoiding bowel preparations and minimizing the duration of nothing-by-mouth status. Multimodal pain strategies have consistently shown improved perioperative pain control and decreased GI dysfunction.⁴

Intraoperative strategies

Consider in-and-out catheterization rather than placement of an indwelling catheter for anticipated short cases without complex bladder dissection.⁵ Minimize blood loss and maximally evacuate blood and clots with suction because hemoperitoneum can induce nausea and pain.

Pain from retained gas under the diaphragm can be reduced by bathing the diaphragms with 400 cc of dilute local anesthetic made by mixing 50 mL of 0.5% bupivacaine in 1000 mL normal saline prior to removal of pneumoperitoneum and while still in Trendelenburg. Ensure there is minimal retained intraperitoneal CO₂ at the completion of the surgery by asking the anesthesiologists to perform positive pressure ventilations prior to fascial closure. Consider injecting port sites (including the peritoneal and fascial layers) with a mixture of immediate and long-acting local anesthetics. Request that the anesthesia staff administer intraoperative doses of IV ketorolac, acetaminophen, and tramadol (in preference to opioids) and an aggressive perioperative cocktail of antiemetics.

 

Management in the recovery room

Surgeons should ensure that recovery room staff are well versed in the pathway for patients who are selected for SDD to ensure proactive implementation of analgesic and antiemetic regimens and to fast-track the various tasks and education required for discharge.⁵

Patients should be started on their home postoperative medication regimen in the recovery room, including an anti-inflammatory such as diclofenac, sublingual tramadol (in preference to an opioid, such as hydrocodone), docusate, and sennosides. IV opioids should be avoided because they can result in somnolence and nausea.

If placed intraoperatively, the Foley catheter should be removed early to allow adequate time to void. Backfilling the bladder prior to removal can hasten the urge to void and help objectively document completeness of evacuation. All patients should be seen by the anesthesiologist and/or surgeon prior to discharge.

For patients who are discharged same day, a follow-up phone call on postoperative day 1 is valuable to ensure that they have continued their successful postoperative transition to the home and to intervene early if there are concerns for patient satisfaction.

 

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Fountain CR et al. Promoting same-day discharge for gynecologic oncology patients in minimally invasive hysterectomy. J Minim Invasive Gynecol. 2017 Sep-Oct;24(6):932-9.

2. Rivard C et al. Factors influencing same-day hospital discharge and risk factors for readmission after robotic surgery in the gynecologic oncology patient population. J Minim Invasive Gynecol. 2015 Feb;22(2):219-26.

3. Lee SJ et al. The feasibility and safety of same-day discharge after robotic-assisted hysterectomy alone or with other procedures for benign and malignant indications. Gynecol Oncol. 2014 Jun;133(3):552-5.

4. Elia N et al. Does multimodal analgesia with acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Meta-analyses of randomized trials. Anesthesiology. 2005 Dec;103(6):1296-304.

5. Donnez O et al. Low pain score after total laparoscopic hysterectomy and same-day discharge within less than 5 hours: Results of a prospective observational study. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1293-9.

 

There is an increased focus on reducing the costs of health care delivery, and one major driver of surgical cost is length of hospitalization. A minimally invasive surgical approach to hysterectomy is a strategy that significantly enhances recovery and shortens hospital stay, although many patients who can safely be considered for same-day discharge (SDD), including many with cancer, are still admitted to the hospital overnight. Much has been published on the predictors and pathways for successful same-day discharge after minimally invasive hysterectomy, and in this column we will review how to best predict who is a good candidate for SDD and how to optimize the success of this approach with respect to safety and patient satisfaction.

What are the benefits to SDD?

Certainly, decreased hospitalization costs are an attractive feature of SDD following hysterectomy, although surgeons should also be mindful that patient-centered outcomes, such as pain control, managing nausea, and patient satisfaction, also are considered with equal emphasis. Several studies have shown that, in appropriate candidates and when proactive pathways are used, patient satisfaction is preserved with SDD following hysterectomy.¹

Choosing patient candidates

Same day discharge is most successfully accomplished in patients of good general baseline health.² Diabetic patients, particularly those on insulin, are generally not good candidates for SDD because it is important to monitor and intervene in blood glucose changes that are influenced by a nothing-by-mouth status and surgical stress. We recommend observing patients overnight with a history of pulmonary disease who may have transient increased postoperative O₂ needs. Similarly, patients with significant cardiac disease (including heart failure and coronary disease) may benefit from prolonged overnight observation.

Particular caution should be paid to patients with obstructive sleep apnea, which may be occult but anticipated in patients with very high body mass indexes (greater than 40 kg/m²). General anesthetic drugs, the trauma of intubation, and opioids all couple with the underlying airway compromise such that these patients are at risk for postoperative apnea, which, in severe cases, can result in anoxia and death. These patients should be considered for continuous pulse-ox monitoring for at least 12-24 hours postoperatively and are not good candidates for same-day discharge.

Patients who have baseline anticoagulation that has been stopped or bridged preoperatively should have prolonged observation with recheck of their postoperative hemoglobin prior to discharge.

Patients who live alone or are very elderly with baseline frailty are poor candidates for SDD and may benefit from nursing observation overnight while they metabolize their anesthesia. Patients who have chronic opioid dependency present a greater challenge to control postoperative pain; these patients are generally less good candidates for SDD.

 

Studies have shown that the indication for the procedure (for example, cancer with staging, fibroids, endometriosis) is less critical in determining who is a good candidate for SDD.³ However, successful SDD rates are highest in more straightforward cases with few or no prior surgeries, small uteri (less than 14 weeks), a surgical duration of less than 3 hours, and a surgical start time before 2 p.m. Longer, more complex cases are typically associated with more blood loss, higher risk for occult complications, and more time under anesthesia (and in Trendelenburg), which can exacerbate airway edema. In preparation for such cases, it might be wise to prepare patients for the possibility that they may not be good candidates for discharge on the same day. In general, most SDD pathways exclude patients with very high BMI (greater than 50 kg/m²) because of concern for airway patency and because these cases may be more complex with higher underlying risk. In addition, many of these patients have diabetes and require perioperative metabolic interventions.

Patient preparation

A key component to successful SDD is setting patient expectations. Patients should be informed at their preoperative visit that, unless there is an unexpected occurrence or response to the surgery, they will be discharged to home the same day. This allows them to prepare their home (including transportation needs) in advance. They should be provided with information about what to expect that first night after surgery (including potential residual drowsiness or nausea from anesthesia and immediate postoperative pain).

On the day of surgery, under the influence of anesthesia and pain medication, patients will have difficulty retaining complex discharge instructions. The preoperative visit is critically important because it’s the best time to provide them with this information, including postoperative activity limitations, wound and dressing care, and follow-up instructions. This is also the best time to provide prescriptions for postoperative pain, nausea, and constipation prophylaxis with detailed instructions about best use. Patients should be encouraged to fill these prescriptions preoperatively so that they have these medications on hand on the evening of their discharge.

Many programs utilize a combination of educational strategies (in person, written, video) to maximize the likelihood of retention.¹ It is also important to offer an opportunity for patients to ask questions about this information after they have received it (for example, by phoning the patients prior to their procedure).
 

 

Preoperative strategies

Postoperative pain and nausea can be preempted with immediate preoperative doses of dexamethasone, gabapentin, ondansetron, celecoxib, and acetaminophen. Postoperative nausea is associated with dehydration; therefore, ensure patients are well hydrated preoperatively by avoiding bowel preparations and minimizing the duration of nothing-by-mouth status. Multimodal pain strategies have consistently shown improved perioperative pain control and decreased GI dysfunction.⁴

Intraoperative strategies

Consider in-and-out catheterization rather than placement of an indwelling catheter for anticipated short cases without complex bladder dissection.⁵ Minimize blood loss and maximally evacuate blood and clots with suction because hemoperitoneum can induce nausea and pain.

Pain from retained gas under the diaphragm can be reduced by bathing the diaphragms with 400 cc of dilute local anesthetic made by mixing 50 mL of 0.5% bupivacaine in 1000 mL normal saline prior to removal of pneumoperitoneum and while still in Trendelenburg. Ensure there is minimal retained intraperitoneal CO₂ at the completion of the surgery by asking the anesthesiologists to perform positive pressure ventilations prior to fascial closure. Consider injecting port sites (including the peritoneal and fascial layers) with a mixture of immediate and long-acting local anesthetics. Request that the anesthesia staff administer intraoperative doses of IV ketorolac, acetaminophen, and tramadol (in preference to opioids) and an aggressive perioperative cocktail of antiemetics.

 

Management in the recovery room

Surgeons should ensure that recovery room staff are well versed in the pathway for patients who are selected for SDD to ensure proactive implementation of analgesic and antiemetic regimens and to fast-track the various tasks and education required for discharge.⁵

Patients should be started on their home postoperative medication regimen in the recovery room, including an anti-inflammatory such as diclofenac, sublingual tramadol (in preference to an opioid, such as hydrocodone), docusate, and sennosides. IV opioids should be avoided because they can result in somnolence and nausea.

If placed intraoperatively, the Foley catheter should be removed early to allow adequate time to void. Backfilling the bladder prior to removal can hasten the urge to void and help objectively document completeness of evacuation. All patients should be seen by the anesthesiologist and/or surgeon prior to discharge.

For patients who are discharged same day, a follow-up phone call on postoperative day 1 is valuable to ensure that they have continued their successful postoperative transition to the home and to intervene early if there are concerns for patient satisfaction.

 

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Fountain CR et al. Promoting same-day discharge for gynecologic oncology patients in minimally invasive hysterectomy. J Minim Invasive Gynecol. 2017 Sep-Oct;24(6):932-9.

2. Rivard C et al. Factors influencing same-day hospital discharge and risk factors for readmission after robotic surgery in the gynecologic oncology patient population. J Minim Invasive Gynecol. 2015 Feb;22(2):219-26.

3. Lee SJ et al. The feasibility and safety of same-day discharge after robotic-assisted hysterectomy alone or with other procedures for benign and malignant indications. Gynecol Oncol. 2014 Jun;133(3):552-5.

4. Elia N et al. Does multimodal analgesia with acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Meta-analyses of randomized trials. Anesthesiology. 2005 Dec;103(6):1296-304.

5. Donnez O et al. Low pain score after total laparoscopic hysterectomy and same-day discharge within less than 5 hours: Results of a prospective observational study. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1293-9.

 

There is an increased focus on reducing the costs of health care delivery, and one major driver of surgical cost is length of hospitalization. A minimally invasive surgical approach to hysterectomy is a strategy that significantly enhances recovery and shortens hospital stay, although many patients who can safely be considered for same-day discharge (SDD), including many with cancer, are still admitted to the hospital overnight. Much has been published on the predictors and pathways for successful same-day discharge after minimally invasive hysterectomy, and in this column we will review how to best predict who is a good candidate for SDD and how to optimize the success of this approach with respect to safety and patient satisfaction.

What are the benefits to SDD?

Certainly, decreased hospitalization costs are an attractive feature of SDD following hysterectomy, although surgeons should also be mindful that patient-centered outcomes, such as pain control, managing nausea, and patient satisfaction, also are considered with equal emphasis. Several studies have shown that, in appropriate candidates and when proactive pathways are used, patient satisfaction is preserved with SDD following hysterectomy.¹

Choosing patient candidates

Same day discharge is most successfully accomplished in patients of good general baseline health.² Diabetic patients, particularly those on insulin, are generally not good candidates for SDD because it is important to monitor and intervene in blood glucose changes that are influenced by a nothing-by-mouth status and surgical stress. We recommend observing patients overnight with a history of pulmonary disease who may have transient increased postoperative O₂ needs. Similarly, patients with significant cardiac disease (including heart failure and coronary disease) may benefit from prolonged overnight observation.

Particular caution should be paid to patients with obstructive sleep apnea, which may be occult but anticipated in patients with very high body mass indexes (greater than 40 kg/m²). General anesthetic drugs, the trauma of intubation, and opioids all couple with the underlying airway compromise such that these patients are at risk for postoperative apnea, which, in severe cases, can result in anoxia and death. These patients should be considered for continuous pulse-ox monitoring for at least 12-24 hours postoperatively and are not good candidates for same-day discharge.

Patients who have baseline anticoagulation that has been stopped or bridged preoperatively should have prolonged observation with recheck of their postoperative hemoglobin prior to discharge.

Patients who live alone or are very elderly with baseline frailty are poor candidates for SDD and may benefit from nursing observation overnight while they metabolize their anesthesia. Patients who have chronic opioid dependency present a greater challenge to control postoperative pain; these patients are generally less good candidates for SDD.

 

Studies have shown that the indication for the procedure (for example, cancer with staging, fibroids, endometriosis) is less critical in determining who is a good candidate for SDD.³ However, successful SDD rates are highest in more straightforward cases with few or no prior surgeries, small uteri (less than 14 weeks), a surgical duration of less than 3 hours, and a surgical start time before 2 p.m. Longer, more complex cases are typically associated with more blood loss, higher risk for occult complications, and more time under anesthesia (and in Trendelenburg), which can exacerbate airway edema. In preparation for such cases, it might be wise to prepare patients for the possibility that they may not be good candidates for discharge on the same day. In general, most SDD pathways exclude patients with very high BMI (greater than 50 kg/m²) because of concern for airway patency and because these cases may be more complex with higher underlying risk. In addition, many of these patients have diabetes and require perioperative metabolic interventions.

Patient preparation

A key component to successful SDD is setting patient expectations. Patients should be informed at their preoperative visit that, unless there is an unexpected occurrence or response to the surgery, they will be discharged to home the same day. This allows them to prepare their home (including transportation needs) in advance. They should be provided with information about what to expect that first night after surgery (including potential residual drowsiness or nausea from anesthesia and immediate postoperative pain).

On the day of surgery, under the influence of anesthesia and pain medication, patients will have difficulty retaining complex discharge instructions. The preoperative visit is critically important because it’s the best time to provide them with this information, including postoperative activity limitations, wound and dressing care, and follow-up instructions. This is also the best time to provide prescriptions for postoperative pain, nausea, and constipation prophylaxis with detailed instructions about best use. Patients should be encouraged to fill these prescriptions preoperatively so that they have these medications on hand on the evening of their discharge.

Many programs utilize a combination of educational strategies (in person, written, video) to maximize the likelihood of retention.¹ It is also important to offer an opportunity for patients to ask questions about this information after they have received it (for example, by phoning the patients prior to their procedure).
 

 

Preoperative strategies

Postoperative pain and nausea can be preempted with immediate preoperative doses of dexamethasone, gabapentin, ondansetron, celecoxib, and acetaminophen. Postoperative nausea is associated with dehydration; therefore, ensure patients are well hydrated preoperatively by avoiding bowel preparations and minimizing the duration of nothing-by-mouth status. Multimodal pain strategies have consistently shown improved perioperative pain control and decreased GI dysfunction.⁴

Intraoperative strategies

Consider in-and-out catheterization rather than placement of an indwelling catheter for anticipated short cases without complex bladder dissection.⁵ Minimize blood loss and maximally evacuate blood and clots with suction because hemoperitoneum can induce nausea and pain.

Pain from retained gas under the diaphragm can be reduced by bathing the diaphragms with 400 cc of dilute local anesthetic made by mixing 50 mL of 0.5% bupivacaine in 1000 mL normal saline prior to removal of pneumoperitoneum and while still in Trendelenburg. Ensure there is minimal retained intraperitoneal CO₂ at the completion of the surgery by asking the anesthesiologists to perform positive pressure ventilations prior to fascial closure. Consider injecting port sites (including the peritoneal and fascial layers) with a mixture of immediate and long-acting local anesthetics. Request that the anesthesia staff administer intraoperative doses of IV ketorolac, acetaminophen, and tramadol (in preference to opioids) and an aggressive perioperative cocktail of antiemetics.

 

Management in the recovery room

Surgeons should ensure that recovery room staff are well versed in the pathway for patients who are selected for SDD to ensure proactive implementation of analgesic and antiemetic regimens and to fast-track the various tasks and education required for discharge.⁵

Patients should be started on their home postoperative medication regimen in the recovery room, including an anti-inflammatory such as diclofenac, sublingual tramadol (in preference to an opioid, such as hydrocodone), docusate, and sennosides. IV opioids should be avoided because they can result in somnolence and nausea.

If placed intraoperatively, the Foley catheter should be removed early to allow adequate time to void. Backfilling the bladder prior to removal can hasten the urge to void and help objectively document completeness of evacuation. All patients should be seen by the anesthesiologist and/or surgeon prior to discharge.

For patients who are discharged same day, a follow-up phone call on postoperative day 1 is valuable to ensure that they have continued their successful postoperative transition to the home and to intervene early if there are concerns for patient satisfaction.

 

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Fountain CR et al. Promoting same-day discharge for gynecologic oncology patients in minimally invasive hysterectomy. J Minim Invasive Gynecol. 2017 Sep-Oct;24(6):932-9.

2. Rivard C et al. Factors influencing same-day hospital discharge and risk factors for readmission after robotic surgery in the gynecologic oncology patient population. J Minim Invasive Gynecol. 2015 Feb;22(2):219-26.

3. Lee SJ et al. The feasibility and safety of same-day discharge after robotic-assisted hysterectomy alone or with other procedures for benign and malignant indications. Gynecol Oncol. 2014 Jun;133(3):552-5.

4. Elia N et al. Does multimodal analgesia with acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Meta-analyses of randomized trials. Anesthesiology. 2005 Dec;103(6):1296-304.

5. Donnez O et al. Low pain score after total laparoscopic hysterectomy and same-day discharge within less than 5 hours: Results of a prospective observational study. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1293-9.

 

The Food and Drug Administration has approved tildrakizumab, an interleukin-23 antagonist, for the treatment of moderate to severe plaque psoriasis in adults who are eligible for systemic therapy or phototherapy, according to a statement from Sun Pharma.

Tildrakizumab is administered at a dose of 100 mg, subcutaneously, at weeks 0 and 4, then every 12 weeks. Approval is based on data from two phase 3, identically designed clinical trials, reSURFACE1 and reSURFACE2. Both studies were multicenter, randomized, double-blind, and placebo controlled. In the studies, 926 patients received tildrakizumab (616 patients) or placebo (310 patients).

Both studies demonstrated the effectiveness of tildrakizumab compared with placebo, based on Psoriasis Area and Sensitivity Index (PASI 75) responses and a Physician’s Global Assessment (PGA) score of clear or minimal at week 12 after receiving two doses. At week 12, 64% and 61% of those on tildrakizumab had achieved a PASI 75 score, compared with 6% of those on placebo; 58% and 55% of those on tildrakizumab had a PGA score of 0 or 1 (clear or minimal), compared with 7% and 4% of those on placebo.

The effectiveness of tildrakizumab extended beyond 12 weeks, with 74% of patients achieving a PASI 75 at 28 weeks after three doses. This percentage grew to 84% at week 64 in patients who continued treatment. Similar results were observed with PGA scores, with 69% of patients who had a PGA score of 0 or 1 at 12 weeks maintaining that score at week 28.

Tildrakizumab has been associated with serious side effects, including serious allergic reactions including skin rash, swelling of the face and mouth, trouble breathing, and chest tightness. It may also increase patient susceptibility to infection. It is approved with a Medication Guide for patients, explaining the potential risks associated with treatment.

Tildrakizumab will be marketed as Ilumya.

Sun Pharma is working with the FDA on postapproval commitments, and once that has been completed, they will have a better idea of when it will become available, according to a spokesperson for the manufacturer. The cost is not yet available.

[email protected]

 

The Food and Drug Administration has approved tildrakizumab, an interleukin-23 antagonist, for the treatment of moderate to severe plaque psoriasis in adults who are eligible for systemic therapy or phototherapy, according to a statement from Sun Pharma.

Tildrakizumab is administered at a dose of 100 mg, subcutaneously, at weeks 0 and 4, then every 12 weeks. Approval is based on data from two phase 3, identically designed clinical trials, reSURFACE1 and reSURFACE2. Both studies were multicenter, randomized, double-blind, and placebo controlled. In the studies, 926 patients received tildrakizumab (616 patients) or placebo (310 patients).

Both studies demonstrated the effectiveness of tildrakizumab compared with placebo, based on Psoriasis Area and Sensitivity Index (PASI 75) responses and a Physician’s Global Assessment (PGA) score of clear or minimal at week 12 after receiving two doses. At week 12, 64% and 61% of those on tildrakizumab had achieved a PASI 75 score, compared with 6% of those on placebo; 58% and 55% of those on tildrakizumab had a PGA score of 0 or 1 (clear or minimal), compared with 7% and 4% of those on placebo.

The effectiveness of tildrakizumab extended beyond 12 weeks, with 74% of patients achieving a PASI 75 at 28 weeks after three doses. This percentage grew to 84% at week 64 in patients who continued treatment. Similar results were observed with PGA scores, with 69% of patients who had a PGA score of 0 or 1 at 12 weeks maintaining that score at week 28.

Tildrakizumab has been associated with serious side effects, including serious allergic reactions including skin rash, swelling of the face and mouth, trouble breathing, and chest tightness. It may also increase patient susceptibility to infection. It is approved with a Medication Guide for patients, explaining the potential risks associated with treatment.

Tildrakizumab will be marketed as Ilumya.

Sun Pharma is working with the FDA on postapproval commitments, and once that has been completed, they will have a better idea of when it will become available, according to a spokesperson for the manufacturer. The cost is not yet available.

[email protected]

 

The Food and Drug Administration has approved tildrakizumab, an interleukin-23 antagonist, for the treatment of moderate to severe plaque psoriasis in adults who are eligible for systemic therapy or phototherapy, according to a statement from Sun Pharma.

Tildrakizumab is administered at a dose of 100 mg, subcutaneously, at weeks 0 and 4, then every 12 weeks. Approval is based on data from two phase 3, identically designed clinical trials, reSURFACE1 and reSURFACE2. Both studies were multicenter, randomized, double-blind, and placebo controlled. In the studies, 926 patients received tildrakizumab (616 patients) or placebo (310 patients).

Both studies demonstrated the effectiveness of tildrakizumab compared with placebo, based on Psoriasis Area and Sensitivity Index (PASI 75) responses and a Physician’s Global Assessment (PGA) score of clear or minimal at week 12 after receiving two doses. At week 12, 64% and 61% of those on tildrakizumab had achieved a PASI 75 score, compared with 6% of those on placebo; 58% and 55% of those on tildrakizumab had a PGA score of 0 or 1 (clear or minimal), compared with 7% and 4% of those on placebo.

The effectiveness of tildrakizumab extended beyond 12 weeks, with 74% of patients achieving a PASI 75 at 28 weeks after three doses. This percentage grew to 84% at week 64 in patients who continued treatment. Similar results were observed with PGA scores, with 69% of patients who had a PGA score of 0 or 1 at 12 weeks maintaining that score at week 28.

Tildrakizumab has been associated with serious side effects, including serious allergic reactions including skin rash, swelling of the face and mouth, trouble breathing, and chest tightness. It may also increase patient susceptibility to infection. It is approved with a Medication Guide for patients, explaining the potential risks associated with treatment.

Tildrakizumab will be marketed as Ilumya.

Sun Pharma is working with the FDA on postapproval commitments, and once that has been completed, they will have a better idea of when it will become available, according to a spokesperson for the manufacturer. The cost is not yet available.

[email protected]

 

MAUI, HAWAII – Methotrexate is the most effective therapy for granulomatous mastitis, according to Anna Postolova, MD, a rheumatology fellow at Stanford (Calif.) University.

Granulomatous mastitis is a rare inflammatory disease of the breast of uncertain but possibly autoimmune etiology. The most common treatments – antibiotics, prednisone, and incision and drainage – are often ineffective and have a roughly 50% recurrence rate. That’s why Stanford rheumatologists began using methotrexate more than a decade ago with impressive results, she explained at the 2018 Rheumatology Winter Clinical Symposium.

Bruce Jancin/MDedge News

Presenting symptoms of granulomatous mastitis include unilateral or bilateral pain, palpable mass, redness, swelling, skin induration, erythema, abscess and/or fistula formation, and discharge. The differential diagnosis involves periductal mastitis, breast cancer, infection, sarcoidosis, and granulomatosis with polyangiitis. Diagnosis of granulomatous mastitis requires histologic examination of a biopsy specimen.

 

Dr. Postolova presented a retrospective series of 19 women referred to Stanford for recurrent or refractory granulomatous mastitis. At diagnosis, they averaged 33.5 years of age with a 6-month history of symptoms prior to diagnosis. Of the 19 women, 11 were Hispanic, and only 2 were Caucasian. A total of 17 women were multiparous, with an average of two children, and 3 women were breastfeeding at symptom onset.

The women were placed on methotrexate at 15 mg/week. At 3 months, 17 of the 19 patients showed improvement, but none had disease resolution. At that point the dose was raised to 20 mg/week. After 3 months at the higher dose, 16 of 18 patients were improved and 4 had experienced resolution of their granulomatous mastitis. After 9 months on methotrexate – 6 at the higher dose – the granulomatous mastitis showed continued improvement in 13 of 15 women and resolution in 8. One woman experienced recurrent disease at 9 months of follow-up after her methotrexate was withheld because of liver test abnormalities and lack of birth control; however, she went into remission upon restarting therapy.

By 12 months, 12 of 15 women, or 80%, had experienced disease resolution. Their methotrexate was then slowly tapered over the course of 18-24 months without disease recurrence.

On the other hand, two women who had previously shown improvement were experiencing mild recurrences at the 12-month mark. They were switched to subcutaneous methotrexate. One responded favorably to the change, and the other had not yet returned for follow-up.

 

Dr. Postolova reported having no financial conflicts of interest regarding her presentation.

[email protected]

 

MAUI, HAWAII – Methotrexate is the most effective therapy for granulomatous mastitis, according to Anna Postolova, MD, a rheumatology fellow at Stanford (Calif.) University.

Granulomatous mastitis is a rare inflammatory disease of the breast of uncertain but possibly autoimmune etiology. The most common treatments – antibiotics, prednisone, and incision and drainage – are often ineffective and have a roughly 50% recurrence rate. That’s why Stanford rheumatologists began using methotrexate more than a decade ago with impressive results, she explained at the 2018 Rheumatology Winter Clinical Symposium.

Bruce Jancin/MDedge News

Presenting symptoms of granulomatous mastitis include unilateral or bilateral pain, palpable mass, redness, swelling, skin induration, erythema, abscess and/or fistula formation, and discharge. The differential diagnosis involves periductal mastitis, breast cancer, infection, sarcoidosis, and granulomatosis with polyangiitis. Diagnosis of granulomatous mastitis requires histologic examination of a biopsy specimen.

 

Dr. Postolova presented a retrospective series of 19 women referred to Stanford for recurrent or refractory granulomatous mastitis. At diagnosis, they averaged 33.5 years of age with a 6-month history of symptoms prior to diagnosis. Of the 19 women, 11 were Hispanic, and only 2 were Caucasian. A total of 17 women were multiparous, with an average of two children, and 3 women were breastfeeding at symptom onset.

The women were placed on methotrexate at 15 mg/week. At 3 months, 17 of the 19 patients showed improvement, but none had disease resolution. At that point the dose was raised to 20 mg/week. After 3 months at the higher dose, 16 of 18 patients were improved and 4 had experienced resolution of their granulomatous mastitis. After 9 months on methotrexate – 6 at the higher dose – the granulomatous mastitis showed continued improvement in 13 of 15 women and resolution in 8. One woman experienced recurrent disease at 9 months of follow-up after her methotrexate was withheld because of liver test abnormalities and lack of birth control; however, she went into remission upon restarting therapy.

By 12 months, 12 of 15 women, or 80%, had experienced disease resolution. Their methotrexate was then slowly tapered over the course of 18-24 months without disease recurrence.

On the other hand, two women who had previously shown improvement were experiencing mild recurrences at the 12-month mark. They were switched to subcutaneous methotrexate. One responded favorably to the change, and the other had not yet returned for follow-up.

 

Dr. Postolova reported having no financial conflicts of interest regarding her presentation.

[email protected]

 

MAUI, HAWAII – Methotrexate is the most effective therapy for granulomatous mastitis, according to Anna Postolova, MD, a rheumatology fellow at Stanford (Calif.) University.

Granulomatous mastitis is a rare inflammatory disease of the breast of uncertain but possibly autoimmune etiology. The most common treatments – antibiotics, prednisone, and incision and drainage – are often ineffective and have a roughly 50% recurrence rate. That’s why Stanford rheumatologists began using methotrexate more than a decade ago with impressive results, she explained at the 2018 Rheumatology Winter Clinical Symposium.

Bruce Jancin/MDedge News

Presenting symptoms of granulomatous mastitis include unilateral or bilateral pain, palpable mass, redness, swelling, skin induration, erythema, abscess and/or fistula formation, and discharge. The differential diagnosis involves periductal mastitis, breast cancer, infection, sarcoidosis, and granulomatosis with polyangiitis. Diagnosis of granulomatous mastitis requires histologic examination of a biopsy specimen.

 

Dr. Postolova presented a retrospective series of 19 women referred to Stanford for recurrent or refractory granulomatous mastitis. At diagnosis, they averaged 33.5 years of age with a 6-month history of symptoms prior to diagnosis. Of the 19 women, 11 were Hispanic, and only 2 were Caucasian. A total of 17 women were multiparous, with an average of two children, and 3 women were breastfeeding at symptom onset.

The women were placed on methotrexate at 15 mg/week. At 3 months, 17 of the 19 patients showed improvement, but none had disease resolution. At that point the dose was raised to 20 mg/week. After 3 months at the higher dose, 16 of 18 patients were improved and 4 had experienced resolution of their granulomatous mastitis. After 9 months on methotrexate – 6 at the higher dose – the granulomatous mastitis showed continued improvement in 13 of 15 women and resolution in 8. One woman experienced recurrent disease at 9 months of follow-up after her methotrexate was withheld because of liver test abnormalities and lack of birth control; however, she went into remission upon restarting therapy.

By 12 months, 12 of 15 women, or 80%, had experienced disease resolution. Their methotrexate was then slowly tapered over the course of 18-24 months without disease recurrence.

On the other hand, two women who had previously shown improvement were experiencing mild recurrences at the 12-month mark. They were switched to subcutaneous methotrexate. One responded favorably to the change, and the other had not yet returned for follow-up.

 

Dr. Postolova reported having no financial conflicts of interest regarding her presentation.

[email protected]

 

Important advances in neuroscience and clinical psychiatry have been achieved in recent years, but there are significant gaps in knowledge and much that we don’t understand about the brain and behavior. Further advances depend on cultivating and supporting a new generation of dedicated basic science and clinical investigators. While there is a compelling need to attract, recruit, and encourage talented individuals to pursue scholarly interests, competing life and career demands often prove daunting.

The 2018 Promising Scholars Award Program, jointly sponsored by Neurocrine Biosciences and the Neuroleptic Malignant Syndrome Information Service (NMSIS), provides a unique opportunity for early career psychiatrists to gain experience in scholarly activities and research. Residents, students, and fellows are invited to submit a manuscript on the topic, “Tardive Dyskinesia,” for first- and second-place awards in the amounts of $2,500 and $1,500, respectively. Two winners will be selected to receive the awards, which will be presented at the Institute for Psychiatric Services: The Mental Health Services Conference, to be held in October in Chicago.

The theme of the competition this year concerning tardive dyskinesia is timely and consistent with the mission of NMSIS to promote knowledge on neurologic side effects of antipsychotic drugs. Tardive dyskinesia can have a negative impact on the social, psychological, and physical well-being of patients; it remains a legacy of past treatment with antipsychotics; it is an increasing concern among an ever widening population of patients receiving even newer antipsychotics; and there are now two Food and Drug Administration–approved treatments for the disorder. Early career psychiatrists may have had limited instruction on tardive dyskinesia, which has not received prominent attention in curricular programs in recent years. Thus, in addition to supporting scholarly work and research experience, the 2018 Promising Scholars Award Program aims to promote knowledge and skills in managing patients with tardive dyskinesia.

Specific learning objectives are:

• Participants will learn the steps necessary to prepare a scientific manuscript for publication.
• Participants will review comments by expert referees and learn to incorporate and respond to the peer review process.
• Participants will review the evidence related to the diagnosis and treatment of tardive dyskinesia.
• Participants will be introduced to the spectrum of educational and networking opportunities at the Institute for Psychiatric Services conference.

In the past, this program was very popular and gained national recognition among psychiatric trainees. Numerous submitted papers were accepted for publication in peer-reviewed journals after the competition was completed.

 

Instructions for manuscript preparation are:

• First author must be a student, resident, or fellow.
• Papers should address specific issues related to the theme of tardive dyskinesia and be no longer than 15 double-spaced typed pages in length (excluding references and illustrations).
• Literature reviews, case reports, or studies that are original and newly developed or recently published are acceptable.
• Reviews and feedback will be provided by a panel of academic psychiatrists.
• Papers will be judged on relevance to tardive dyskinesia, originality, scholarship, scientific rigor, valid methodology, clinical significance, and organization.

To participate, papers and curriculum vitae of the first author must be submitted by July 1, 2018, to Dianne Daugherty by email at [email protected]. Winners will be announced by Aug. 10, 2018. For additional information, write to [email protected] or visit www.mhaus.org/nmsis/about-us/what-is-nmsis.
 

Dr. Caroff, professor of psychiatry, Corporal Michael J. Crescenz VA Medical Center and at the University of Pennsylvania, both in Philadelphia, is director of the NMSIS. He served as consultant to Neurocrine Biosciences and Teva Pharmaceutical Industries, and receives research grant funding from Neurocrine Biosciences.

 

Important advances in neuroscience and clinical psychiatry have been achieved in recent years, but there are significant gaps in knowledge and much that we don’t understand about the brain and behavior. Further advances depend on cultivating and supporting a new generation of dedicated basic science and clinical investigators. While there is a compelling need to attract, recruit, and encourage talented individuals to pursue scholarly interests, competing life and career demands often prove daunting.

The 2018 Promising Scholars Award Program, jointly sponsored by Neurocrine Biosciences and the Neuroleptic Malignant Syndrome Information Service (NMSIS), provides a unique opportunity for early career psychiatrists to gain experience in scholarly activities and research. Residents, students, and fellows are invited to submit a manuscript on the topic, “Tardive Dyskinesia,” for first- and second-place awards in the amounts of $2,500 and $1,500, respectively. Two winners will be selected to receive the awards, which will be presented at the Institute for Psychiatric Services: The Mental Health Services Conference, to be held in October in Chicago.

The theme of the competition this year concerning tardive dyskinesia is timely and consistent with the mission of NMSIS to promote knowledge on neurologic side effects of antipsychotic drugs. Tardive dyskinesia can have a negative impact on the social, psychological, and physical well-being of patients; it remains a legacy of past treatment with antipsychotics; it is an increasing concern among an ever widening population of patients receiving even newer antipsychotics; and there are now two Food and Drug Administration–approved treatments for the disorder. Early career psychiatrists may have had limited instruction on tardive dyskinesia, which has not received prominent attention in curricular programs in recent years. Thus, in addition to supporting scholarly work and research experience, the 2018 Promising Scholars Award Program aims to promote knowledge and skills in managing patients with tardive dyskinesia.

Specific learning objectives are:

• Participants will learn the steps necessary to prepare a scientific manuscript for publication.
• Participants will review comments by expert referees and learn to incorporate and respond to the peer review process.
• Participants will review the evidence related to the diagnosis and treatment of tardive dyskinesia.
• Participants will be introduced to the spectrum of educational and networking opportunities at the Institute for Psychiatric Services conference.

In the past, this program was very popular and gained national recognition among psychiatric trainees. Numerous submitted papers were accepted for publication in peer-reviewed journals after the competition was completed.

 

Instructions for manuscript preparation are:

• First author must be a student, resident, or fellow.
• Papers should address specific issues related to the theme of tardive dyskinesia and be no longer than 15 double-spaced typed pages in length (excluding references and illustrations).
• Literature reviews, case reports, or studies that are original and newly developed or recently published are acceptable.
• Reviews and feedback will be provided by a panel of academic psychiatrists.
• Papers will be judged on relevance to tardive dyskinesia, originality, scholarship, scientific rigor, valid methodology, clinical significance, and organization.

To participate, papers and curriculum vitae of the first author must be submitted by July 1, 2018, to Dianne Daugherty by email at [email protected]. Winners will be announced by Aug. 10, 2018. For additional information, write to [email protected] or visit www.mhaus.org/nmsis/about-us/what-is-nmsis.
 

Dr. Caroff, professor of psychiatry, Corporal Michael J. Crescenz VA Medical Center and at the University of Pennsylvania, both in Philadelphia, is director of the NMSIS. He served as consultant to Neurocrine Biosciences and Teva Pharmaceutical Industries, and receives research grant funding from Neurocrine Biosciences.

 

Important advances in neuroscience and clinical psychiatry have been achieved in recent years, but there are significant gaps in knowledge and much that we don’t understand about the brain and behavior. Further advances depend on cultivating and supporting a new generation of dedicated basic science and clinical investigators. While there is a compelling need to attract, recruit, and encourage talented individuals to pursue scholarly interests, competing life and career demands often prove daunting.

The 2018 Promising Scholars Award Program, jointly sponsored by Neurocrine Biosciences and the Neuroleptic Malignant Syndrome Information Service (NMSIS), provides a unique opportunity for early career psychiatrists to gain experience in scholarly activities and research. Residents, students, and fellows are invited to submit a manuscript on the topic, “Tardive Dyskinesia,” for first- and second-place awards in the amounts of $2,500 and $1,500, respectively. Two winners will be selected to receive the awards, which will be presented at the Institute for Psychiatric Services: The Mental Health Services Conference, to be held in October in Chicago.

The theme of the competition this year concerning tardive dyskinesia is timely and consistent with the mission of NMSIS to promote knowledge on neurologic side effects of antipsychotic drugs. Tardive dyskinesia can have a negative impact on the social, psychological, and physical well-being of patients; it remains a legacy of past treatment with antipsychotics; it is an increasing concern among an ever widening population of patients receiving even newer antipsychotics; and there are now two Food and Drug Administration–approved treatments for the disorder. Early career psychiatrists may have had limited instruction on tardive dyskinesia, which has not received prominent attention in curricular programs in recent years. Thus, in addition to supporting scholarly work and research experience, the 2018 Promising Scholars Award Program aims to promote knowledge and skills in managing patients with tardive dyskinesia.

Specific learning objectives are:

• Participants will learn the steps necessary to prepare a scientific manuscript for publication.
• Participants will review comments by expert referees and learn to incorporate and respond to the peer review process.
• Participants will review the evidence related to the diagnosis and treatment of tardive dyskinesia.
• Participants will be introduced to the spectrum of educational and networking opportunities at the Institute for Psychiatric Services conference.

In the past, this program was very popular and gained national recognition among psychiatric trainees. Numerous submitted papers were accepted for publication in peer-reviewed journals after the competition was completed.

 

Instructions for manuscript preparation are:

• First author must be a student, resident, or fellow.
• Papers should address specific issues related to the theme of tardive dyskinesia and be no longer than 15 double-spaced typed pages in length (excluding references and illustrations).
• Literature reviews, case reports, or studies that are original and newly developed or recently published are acceptable.
• Reviews and feedback will be provided by a panel of academic psychiatrists.
• Papers will be judged on relevance to tardive dyskinesia, originality, scholarship, scientific rigor, valid methodology, clinical significance, and organization.

To participate, papers and curriculum vitae of the first author must be submitted by July 1, 2018, to Dianne Daugherty by email at [email protected]. Winners will be announced by Aug. 10, 2018. For additional information, write to [email protected] or visit www.mhaus.org/nmsis/about-us/what-is-nmsis.
 

Dr. Caroff, professor of psychiatry, Corporal Michael J. Crescenz VA Medical Center and at the University of Pennsylvania, both in Philadelphia, is director of the NMSIS. He served as consultant to Neurocrine Biosciences and Teva Pharmaceutical Industries, and receives research grant funding from Neurocrine Biosciences.

One of the most severe complications of systemic medications is the development of a life-threatening rash, especially toxic epidermal necrolysis (TEN). Most patients can expect a full recovery if the complicating medication is discontinued early on in its course.¹ When suspected TEN does not improve despite discontinuation of the detrimental medication, other diseases must be considered, particularly immunobullous and infectious etiologies. Treatment of these diseases differs substantially; therefore, a quick diagnosis is crucial. We present a case of a patient with an acute blistering eruption that was initially diagnosed and managed as TEN but physical examination and histopathologic confirmed another diagnosis. We review key examination findings that can help differentiate the causes of an acute blistering eruption with mucosal involvement, allowing for earlier diagnosis and treatment of these patients.

Case Report

An 85-year-old immunocompetent man was admitted to an outside hospital with a pruritic blistering eruption associated with myalgia, weakness, and fatigue of 3 weeks’ duration. The eruption initiated on the scalp and face and then spread down to the trunk and proximal arms and legs, with oral erosions also reported. An outside dermatologist was consulted on admission and performed a skin biopsy; the initial pathology was read as TEN. The patient was admitted to our institution on the same day, and all potentially complicating medications were stopped. He was treated with intravenous (IV) methylprednisolone sodium succinate 125 mg twice daily for 4 days and prednisone 40 mg daily for 9 days. With the rash worsening, the patient was restarted on methylprednisolone sodium succinate 40 mg every 8 hours approximately 3 weeks after admission, along with IV immunoglobulin at 2 g/kg over 3 days. When the patient did not respond to treatment, he was transferred to the University of California Irvine Medical Center for a higher level of care.

At that time, physical examination revealed numerous confluent erosions with honey-colored crust involving the entire face (Figure 1A) and sharp demarcation at the cutaneous lip (Figure 1B). There was a large erosion on the dorsal aspect of the tongue, but the rest of the oral mucosa was spared. The trunk and proximal extremities showed numerous grouped, punched-out erosions with scalloped borders (Figure 1C). A repeat skin biopsy showed an ulcer with viral cytopathic changes. Immunoperoxidase studies demonstrated positive staining for herpes simplex virus (HSV) type 1 (Figure 2). The original slides were a frozen section from an outside facility and could not be obtained. A tissue culture and direct fluorescent antibody also confirmed HSV-1, and the patient was diagnosed with disseminated herpes. He was rapidly tapered off of the steroids and started on IV acyclovir 10 mg/kg every 8 hours for 21 days. All prior erosions reepithelialized within 7 days of treatment (Figure 3). The patient had an otherwise uncomplicated hospital course and was discharged on hospital day 21.

 

Comment

A patient with an acute generalized blistering eruption requires urgent workup and treatment given the potentially devastating sequelae. Toxic epidermal necrolysis and immunobullous diseases often are the first diagnoses to be ruled out. Certainly infections such as HSV can cause a vesicular and erosive eruption, especially in the setting of a poorly controlled dermatitis, but they typically are not in the same differential as the other diagnoses.

Clinical Presentation
This case highlights 2 key physical examination findings that can alert the clinician to a possible underlying herpetic infection. First, the distribution of this patient’s oral lesions was telling. In most cases of TEN or pemphigus vulgaris, there is notable involvement of the oral mucosa, particularly the buccal and labial mucosa. Although herpes can involve any mucocutaneous surface, it does have a predilection for keratinized tissue, with the tongue and cutaneous lip commonly involved.^2,3 Our patient had a solitary linear erosion on the dorsal aspect of the tongue, but the rest of the oral cavity was strikingly spared. In addition, the erosions around the mouth stopped right at the cutaneous lip, sparing the labial mucosa (Figure 1B).

Second, the configuration of the erosions on the trunk, arms, and legs was diagnostic. Herpes classically presents as a cluster of vesicles overlying an erythematous base. When these vesicles rupture, punched-out erosions are left behind. Because these vesicles often are grouped, they can develop a scalloped border, which is a helpful indicator of HSV (Figure 1C). When these erosions become more confluent and irregular, the distinction from other conditions may not be as clear. A careful skin examination often can show areas that have preserved this herpetiform configuration.

Immune Compromise
Additionally, this case is illustrative of how immunosuppression and immunocompromise can affect the clinical presentation of HSV infection. Herpetic infections in the immunocompromised host tend to have a more protracted course, with chronic enlarging ulcers involving multiple sites. Furthermore, the morphology often is atypical, with ulcerodestructive, pustular, exophytic, and verrucous features as illustrated in this case. It is important to be mindful of these characteristics of HSV to properly diagnose an immunocompromised host.

Conclusion

This case is a good reminder that not everything that blisters and involves the mucosa is due to a hypersensitivity state such as TEN and Stevens-Johnson syndrome or an immunobullous disorder such as pemphigus vulgaris and pemphigus vegetans. The fact that this patient was worsening despite drug cessation, high-dose steroids, and IV immunoglobulin should have indicated a misdiagnosis. This case also shows that the early histopathologic findings of disseminated HSV and TEN can be nonspecific, and viral cytopathic changes may not always be obvious early in the disease.

Disseminated HSV should be considered in the differential diagnosis of a patient with an acute blistering eruption with mucosal involvement, and careful history and physical examination should be taken to rule out a viral etiology.

One of the most severe complications of systemic medications is the development of a life-threatening rash, especially toxic epidermal necrolysis (TEN). Most patients can expect a full recovery if the complicating medication is discontinued early on in its course.¹ When suspected TEN does not improve despite discontinuation of the detrimental medication, other diseases must be considered, particularly immunobullous and infectious etiologies. Treatment of these diseases differs substantially; therefore, a quick diagnosis is crucial. We present a case of a patient with an acute blistering eruption that was initially diagnosed and managed as TEN but physical examination and histopathologic confirmed another diagnosis. We review key examination findings that can help differentiate the causes of an acute blistering eruption with mucosal involvement, allowing for earlier diagnosis and treatment of these patients.

Case Report

An 85-year-old immunocompetent man was admitted to an outside hospital with a pruritic blistering eruption associated with myalgia, weakness, and fatigue of 3 weeks’ duration. The eruption initiated on the scalp and face and then spread down to the trunk and proximal arms and legs, with oral erosions also reported. An outside dermatologist was consulted on admission and performed a skin biopsy; the initial pathology was read as TEN. The patient was admitted to our institution on the same day, and all potentially complicating medications were stopped. He was treated with intravenous (IV) methylprednisolone sodium succinate 125 mg twice daily for 4 days and prednisone 40 mg daily for 9 days. With the rash worsening, the patient was restarted on methylprednisolone sodium succinate 40 mg every 8 hours approximately 3 weeks after admission, along with IV immunoglobulin at 2 g/kg over 3 days. When the patient did not respond to treatment, he was transferred to the University of California Irvine Medical Center for a higher level of care.

At that time, physical examination revealed numerous confluent erosions with honey-colored crust involving the entire face (Figure 1A) and sharp demarcation at the cutaneous lip (Figure 1B). There was a large erosion on the dorsal aspect of the tongue, but the rest of the oral mucosa was spared. The trunk and proximal extremities showed numerous grouped, punched-out erosions with scalloped borders (Figure 1C). A repeat skin biopsy showed an ulcer with viral cytopathic changes. Immunoperoxidase studies demonstrated positive staining for herpes simplex virus (HSV) type 1 (Figure 2). The original slides were a frozen section from an outside facility and could not be obtained. A tissue culture and direct fluorescent antibody also confirmed HSV-1, and the patient was diagnosed with disseminated herpes. He was rapidly tapered off of the steroids and started on IV acyclovir 10 mg/kg every 8 hours for 21 days. All prior erosions reepithelialized within 7 days of treatment (Figure 3). The patient had an otherwise uncomplicated hospital course and was discharged on hospital day 21.

 

Comment

A patient with an acute generalized blistering eruption requires urgent workup and treatment given the potentially devastating sequelae. Toxic epidermal necrolysis and immunobullous diseases often are the first diagnoses to be ruled out. Certainly infections such as HSV can cause a vesicular and erosive eruption, especially in the setting of a poorly controlled dermatitis, but they typically are not in the same differential as the other diagnoses.

Clinical Presentation
This case highlights 2 key physical examination findings that can alert the clinician to a possible underlying herpetic infection. First, the distribution of this patient’s oral lesions was telling. In most cases of TEN or pemphigus vulgaris, there is notable involvement of the oral mucosa, particularly the buccal and labial mucosa. Although herpes can involve any mucocutaneous surface, it does have a predilection for keratinized tissue, with the tongue and cutaneous lip commonly involved.^2,3 Our patient had a solitary linear erosion on the dorsal aspect of the tongue, but the rest of the oral cavity was strikingly spared. In addition, the erosions around the mouth stopped right at the cutaneous lip, sparing the labial mucosa (Figure 1B).

Second, the configuration of the erosions on the trunk, arms, and legs was diagnostic. Herpes classically presents as a cluster of vesicles overlying an erythematous base. When these vesicles rupture, punched-out erosions are left behind. Because these vesicles often are grouped, they can develop a scalloped border, which is a helpful indicator of HSV (Figure 1C). When these erosions become more confluent and irregular, the distinction from other conditions may not be as clear. A careful skin examination often can show areas that have preserved this herpetiform configuration.

Immune Compromise
Additionally, this case is illustrative of how immunosuppression and immunocompromise can affect the clinical presentation of HSV infection. Herpetic infections in the immunocompromised host tend to have a more protracted course, with chronic enlarging ulcers involving multiple sites. Furthermore, the morphology often is atypical, with ulcerodestructive, pustular, exophytic, and verrucous features as illustrated in this case. It is important to be mindful of these characteristics of HSV to properly diagnose an immunocompromised host.

Conclusion

This case is a good reminder that not everything that blisters and involves the mucosa is due to a hypersensitivity state such as TEN and Stevens-Johnson syndrome or an immunobullous disorder such as pemphigus vulgaris and pemphigus vegetans. The fact that this patient was worsening despite drug cessation, high-dose steroids, and IV immunoglobulin should have indicated a misdiagnosis. This case also shows that the early histopathologic findings of disseminated HSV and TEN can be nonspecific, and viral cytopathic changes may not always be obvious early in the disease.

Disseminated HSV should be considered in the differential diagnosis of a patient with an acute blistering eruption with mucosal involvement, and careful history and physical examination should be taken to rule out a viral etiology.

One of the most severe complications of systemic medications is the development of a life-threatening rash, especially toxic epidermal necrolysis (TEN). Most patients can expect a full recovery if the complicating medication is discontinued early on in its course.¹ When suspected TEN does not improve despite discontinuation of the detrimental medication, other diseases must be considered, particularly immunobullous and infectious etiologies. Treatment of these diseases differs substantially; therefore, a quick diagnosis is crucial. We present a case of a patient with an acute blistering eruption that was initially diagnosed and managed as TEN but physical examination and histopathologic confirmed another diagnosis. We review key examination findings that can help differentiate the causes of an acute blistering eruption with mucosal involvement, allowing for earlier diagnosis and treatment of these patients.

Case Report

An 85-year-old immunocompetent man was admitted to an outside hospital with a pruritic blistering eruption associated with myalgia, weakness, and fatigue of 3 weeks’ duration. The eruption initiated on the scalp and face and then spread down to the trunk and proximal arms and legs, with oral erosions also reported. An outside dermatologist was consulted on admission and performed a skin biopsy; the initial pathology was read as TEN. The patient was admitted to our institution on the same day, and all potentially complicating medications were stopped. He was treated with intravenous (IV) methylprednisolone sodium succinate 125 mg twice daily for 4 days and prednisone 40 mg daily for 9 days. With the rash worsening, the patient was restarted on methylprednisolone sodium succinate 40 mg every 8 hours approximately 3 weeks after admission, along with IV immunoglobulin at 2 g/kg over 3 days. When the patient did not respond to treatment, he was transferred to the University of California Irvine Medical Center for a higher level of care.

At that time, physical examination revealed numerous confluent erosions with honey-colored crust involving the entire face (Figure 1A) and sharp demarcation at the cutaneous lip (Figure 1B). There was a large erosion on the dorsal aspect of the tongue, but the rest of the oral mucosa was spared. The trunk and proximal extremities showed numerous grouped, punched-out erosions with scalloped borders (Figure 1C). A repeat skin biopsy showed an ulcer with viral cytopathic changes. Immunoperoxidase studies demonstrated positive staining for herpes simplex virus (HSV) type 1 (Figure 2). The original slides were a frozen section from an outside facility and could not be obtained. A tissue culture and direct fluorescent antibody also confirmed HSV-1, and the patient was diagnosed with disseminated herpes. He was rapidly tapered off of the steroids and started on IV acyclovir 10 mg/kg every 8 hours for 21 days. All prior erosions reepithelialized within 7 days of treatment (Figure 3). The patient had an otherwise uncomplicated hospital course and was discharged on hospital day 21.

 

Comment

A patient with an acute generalized blistering eruption requires urgent workup and treatment given the potentially devastating sequelae. Toxic epidermal necrolysis and immunobullous diseases often are the first diagnoses to be ruled out. Certainly infections such as HSV can cause a vesicular and erosive eruption, especially in the setting of a poorly controlled dermatitis, but they typically are not in the same differential as the other diagnoses.

Clinical Presentation
This case highlights 2 key physical examination findings that can alert the clinician to a possible underlying herpetic infection. First, the distribution of this patient’s oral lesions was telling. In most cases of TEN or pemphigus vulgaris, there is notable involvement of the oral mucosa, particularly the buccal and labial mucosa. Although herpes can involve any mucocutaneous surface, it does have a predilection for keratinized tissue, with the tongue and cutaneous lip commonly involved.^2,3 Our patient had a solitary linear erosion on the dorsal aspect of the tongue, but the rest of the oral cavity was strikingly spared. In addition, the erosions around the mouth stopped right at the cutaneous lip, sparing the labial mucosa (Figure 1B).

Second, the configuration of the erosions on the trunk, arms, and legs was diagnostic. Herpes classically presents as a cluster of vesicles overlying an erythematous base. When these vesicles rupture, punched-out erosions are left behind. Because these vesicles often are grouped, they can develop a scalloped border, which is a helpful indicator of HSV (Figure 1C). When these erosions become more confluent and irregular, the distinction from other conditions may not be as clear. A careful skin examination often can show areas that have preserved this herpetiform configuration.

Immune Compromise
Additionally, this case is illustrative of how immunosuppression and immunocompromise can affect the clinical presentation of HSV infection. Herpetic infections in the immunocompromised host tend to have a more protracted course, with chronic enlarging ulcers involving multiple sites. Furthermore, the morphology often is atypical, with ulcerodestructive, pustular, exophytic, and verrucous features as illustrated in this case. It is important to be mindful of these characteristics of HSV to properly diagnose an immunocompromised host.

Conclusion

This case is a good reminder that not everything that blisters and involves the mucosa is due to a hypersensitivity state such as TEN and Stevens-Johnson syndrome or an immunobullous disorder such as pemphigus vulgaris and pemphigus vegetans. The fact that this patient was worsening despite drug cessation, high-dose steroids, and IV immunoglobulin should have indicated a misdiagnosis. This case also shows that the early histopathologic findings of disseminated HSV and TEN can be nonspecific, and viral cytopathic changes may not always be obvious early in the disease.

Disseminated HSV should be considered in the differential diagnosis of a patient with an acute blistering eruption with mucosal involvement, and careful history and physical examination should be taken to rule out a viral etiology.

 

My lease is up later this year, after 5 1/2 years. It doesn’t seem that long. Some days it feels like I just moved in.

As a result, I had an email exchange recently with the building’s manager and we hashed out an agreement on a new 10-year contract. In the process, I realized that sort of time frame might (and, again, I say might) take me into retirement.

Hemera Technologies/©Thinkstock

That’s a pretty striking thought. Medicine, over time, is a career that becomes an indispensable aspect of who we are as people. I clearly remember applying and being accepted to medical school, starting medical school, then residency, then fellowship. I recall my first day as an attending and even the first patient I saw on my own.

And now I’m starting to think about retiring and the career endgame.

Granted, it’s still 10 years away, and knowing me I’ll probably want to work another 5 years or so beyond that if I can. I like what I do and would probably go stir crazy without this job. Besides, given the current anti-doctor financial climate, I may not be able to retire in 10 years, even if I want to.

But still, it’s an odd realization to think that, after all those applications, and classes, and tests, and rotations, and all the other things you went through ... that your career is closer to wrapping up than it is to the beginning.

How did that happen?

 

Looking through my computer, I’ve seen maybe 25,000-30,000 people over time. That seems like a lot, more than a large NBA arena. Imagine that arena packed with fans, and I’m there to be everyone’s neurologist. I see them one by one, and, almost 20 years later, here I am. I’d like to think that I was able to do something to help the majority of them. I certainly try.

And I’ll continue to try. Even after the halfway point I still get up each morning wanting to help people. The same sentiments I expressed in a personal statement so long ago are still there, and hopefully always will be. When they’re gone, it’s time to leave. Hopefully, they’ll be with me until I’m ready to sign off.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

 

My lease is up later this year, after 5 1/2 years. It doesn’t seem that long. Some days it feels like I just moved in.

As a result, I had an email exchange recently with the building’s manager and we hashed out an agreement on a new 10-year contract. In the process, I realized that sort of time frame might (and, again, I say might) take me into retirement.

Hemera Technologies/©Thinkstock

That’s a pretty striking thought. Medicine, over time, is a career that becomes an indispensable aspect of who we are as people. I clearly remember applying and being accepted to medical school, starting medical school, then residency, then fellowship. I recall my first day as an attending and even the first patient I saw on my own.

And now I’m starting to think about retiring and the career endgame.

Granted, it’s still 10 years away, and knowing me I’ll probably want to work another 5 years or so beyond that if I can. I like what I do and would probably go stir crazy without this job. Besides, given the current anti-doctor financial climate, I may not be able to retire in 10 years, even if I want to.

But still, it’s an odd realization to think that, after all those applications, and classes, and tests, and rotations, and all the other things you went through ... that your career is closer to wrapping up than it is to the beginning.

How did that happen?

 

Looking through my computer, I’ve seen maybe 25,000-30,000 people over time. That seems like a lot, more than a large NBA arena. Imagine that arena packed with fans, and I’m there to be everyone’s neurologist. I see them one by one, and, almost 20 years later, here I am. I’d like to think that I was able to do something to help the majority of them. I certainly try.

And I’ll continue to try. Even after the halfway point I still get up each morning wanting to help people. The same sentiments I expressed in a personal statement so long ago are still there, and hopefully always will be. When they’re gone, it’s time to leave. Hopefully, they’ll be with me until I’m ready to sign off.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

 

My lease is up later this year, after 5 1/2 years. It doesn’t seem that long. Some days it feels like I just moved in.

As a result, I had an email exchange recently with the building’s manager and we hashed out an agreement on a new 10-year contract. In the process, I realized that sort of time frame might (and, again, I say might) take me into retirement.

Hemera Technologies/©Thinkstock

That’s a pretty striking thought. Medicine, over time, is a career that becomes an indispensable aspect of who we are as people. I clearly remember applying and being accepted to medical school, starting medical school, then residency, then fellowship. I recall my first day as an attending and even the first patient I saw on my own.

And now I’m starting to think about retiring and the career endgame.

Granted, it’s still 10 years away, and knowing me I’ll probably want to work another 5 years or so beyond that if I can. I like what I do and would probably go stir crazy without this job. Besides, given the current anti-doctor financial climate, I may not be able to retire in 10 years, even if I want to.

But still, it’s an odd realization to think that, after all those applications, and classes, and tests, and rotations, and all the other things you went through ... that your career is closer to wrapping up than it is to the beginning.

How did that happen?

 

Looking through my computer, I’ve seen maybe 25,000-30,000 people over time. That seems like a lot, more than a large NBA arena. Imagine that arena packed with fans, and I’m there to be everyone’s neurologist. I see them one by one, and, almost 20 years later, here I am. I’d like to think that I was able to do something to help the majority of them. I certainly try.

And I’ll continue to try. Even after the halfway point I still get up each morning wanting to help people. The same sentiments I expressed in a personal statement so long ago are still there, and hopefully always will be. When they’re gone, it’s time to leave. Hopefully, they’ll be with me until I’m ready to sign off.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

 

The Food and Drug Administration has received 414 reports of cases of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL), including nine deaths.

This figure includes all medical device reports received by the agency between 2011 and September 2017. The FDA recently provided an update on ALCL linked to breast implants and an estimate of lifetime risk of developing ALCL.

Based on available medical literature, the lifetime risk of developing BIA-ALCL for patients with textured breast implants ranges from 1 in 3,817 to 1 in 30,000, according to the update.

Of the 272 reports with data on surface type, 242 were textured implants and 30 were smooth implants. In addition, 413 reports include information on the implant fill type: 234 used silicone gel and 179 were saline filled.

“The FDA has been closely tracking the relationship between breast implants and a rare type of non-Hodgkin’s lymphoma since we first identified this possible association. We’ve been working to gather additional information to better characterize and quantify the risk so that patients and providers can have more informed discussions about breast implants,” said Binita Ashar, MD, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health. “As part of that effort, we are working to update and enhance the information we have on this association, including updating the total number of known cases of BIA-ALCL and the lifetime risk of developing BIA-ALCL as reported in medical literature.”

The possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL) was first identified in 2011. At that time, there were not enough cases of to determine what factors increased a patient’s risk of developing the disease. As more information became available, the World Health Organization designated BIA-ALCL as a T-cell lymphoma that can develop following breast implants.

[email protected]

 

The Food and Drug Administration has received 414 reports of cases of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL), including nine deaths.

This figure includes all medical device reports received by the agency between 2011 and September 2017. The FDA recently provided an update on ALCL linked to breast implants and an estimate of lifetime risk of developing ALCL.

Based on available medical literature, the lifetime risk of developing BIA-ALCL for patients with textured breast implants ranges from 1 in 3,817 to 1 in 30,000, according to the update.

Of the 272 reports with data on surface type, 242 were textured implants and 30 were smooth implants. In addition, 413 reports include information on the implant fill type: 234 used silicone gel and 179 were saline filled.

“The FDA has been closely tracking the relationship between breast implants and a rare type of non-Hodgkin’s lymphoma since we first identified this possible association. We’ve been working to gather additional information to better characterize and quantify the risk so that patients and providers can have more informed discussions about breast implants,” said Binita Ashar, MD, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health. “As part of that effort, we are working to update and enhance the information we have on this association, including updating the total number of known cases of BIA-ALCL and the lifetime risk of developing BIA-ALCL as reported in medical literature.”

The possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL) was first identified in 2011. At that time, there were not enough cases of to determine what factors increased a patient’s risk of developing the disease. As more information became available, the World Health Organization designated BIA-ALCL as a T-cell lymphoma that can develop following breast implants.

[email protected]

 

The Food and Drug Administration has received 414 reports of cases of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL), including nine deaths.

This figure includes all medical device reports received by the agency between 2011 and September 2017. The FDA recently provided an update on ALCL linked to breast implants and an estimate of lifetime risk of developing ALCL.

Based on available medical literature, the lifetime risk of developing BIA-ALCL for patients with textured breast implants ranges from 1 in 3,817 to 1 in 30,000, according to the update.

Of the 272 reports with data on surface type, 242 were textured implants and 30 were smooth implants. In addition, 413 reports include information on the implant fill type: 234 used silicone gel and 179 were saline filled.

“The FDA has been closely tracking the relationship between breast implants and a rare type of non-Hodgkin’s lymphoma since we first identified this possible association. We’ve been working to gather additional information to better characterize and quantify the risk so that patients and providers can have more informed discussions about breast implants,” said Binita Ashar, MD, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health. “As part of that effort, we are working to update and enhance the information we have on this association, including updating the total number of known cases of BIA-ALCL and the lifetime risk of developing BIA-ALCL as reported in medical literature.”

The possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL) was first identified in 2011. At that time, there were not enough cases of to determine what factors increased a patient’s risk of developing the disease. As more information became available, the World Health Organization designated BIA-ALCL as a T-cell lymphoma that can develop following breast implants.

[email protected]

 

BOSTON – Just out of fellowship, Christopher C. Thompson, MD, director of therapeutic endoscopy, Brigham and Women’s Hospital, Boston, adapted an antireflux suturing device for use in a bariatric procedure. It worked so well he began using it routinely and taught others the technique. That was the first step in a journey that has taken him from consulting with industry to a founder of start-ups.

“The device company heard about what we were doing and were interested,” Dr. Thompson recounted during his How-I-Did-It lecture at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. In the end, he served as a consultant in the development of a new suturing device specific for the bariatric procedure. This included helping secure a patent and learning first-hand what steps are needed to get a device to market.

“It was a great learning experience. I now knew something about the role of a consultant and the process of product innovation,” Dr. Thompson explained. He also learned that the low-risk participation of a consultant is a low-reward proposition. The new product was successful, but Dr. Thompson received no stock, and the licensing fee went to the hospital.

“I do not have any regrets. It was good for my career and fun to be involved, but there was not much financial gain for me or for my department,” Dr. Thompson said.

His subsequent experience with licensing was an incremental step forward. In one example, he worked on developing an endoscopic simulator, an important unmet need both for teaching and evaluating skills in diagnostic colonoscopy, including a kinematic analysis that helped identify techniques that are associated with high levels of skill.

“We developed the technology in-house through a series of grants. The risks were low, but the rewards were better because the money helped fund activities in our department,” he said.

That device, too, has been very successful, but Dr. Thompson said it is important to recognize how far innovation can go when the work stays in the academic setting and the goal is licensing the technology. More recently, he took a nonsurgical anastomosis device through preclinical testing, but he was then unable to attract a device company for the next steps of development.

 

“With no one interested, we created a start-up,” Dr. Thompson said. The company, GI Windows, has now taken this product, a magnetic endo-luminal anastomosis bypass device for the treatment of diabetes mellitus, into advanced stages of clinical testing. Relative to licensing arrangements, this involved a different level of participation.

“A start-up means creating a board, raising money, and being involved in details that can involve a lot of heavy lifting,” Dr. Thompson said. “It is basically a second job.”

The ongoing clinical studies in patients with diabetes have been very encouraging. Dr. Thompson reported that a large proportion of patients with diabetes fitted with the device have been able to reduce or discontinue their antidiabetic medications, and high rates of excess weight loss have been documented.

GI Windows was created for the sole purpose of developing the anastomosis device, but Dr. Thompson was also involved in creating another company, now sold, that started without a specific device in mind.

 

“The products we developed were just from brainstorming on unmet needs, and we had several successes. That was a chance to learn new areas of the business, including building a sales force and learning how to get involved in international distribution, which were separate from trying simply to produce a viable clinical tool,” he said.

Creating companies, rather than licensing ideas, trades higher risk for greater reward, but Dr. Thompson emphasized that these rewards are not just financial.

“It is exciting to develop a team you trust, get a successful company off the ground, and watch it grow,” Dr. Thompson said. He indicated that the risk-to-reward calculation should not be undertaken independent of the value of the learning experience.

 

BOSTON – Just out of fellowship, Christopher C. Thompson, MD, director of therapeutic endoscopy, Brigham and Women’s Hospital, Boston, adapted an antireflux suturing device for use in a bariatric procedure. It worked so well he began using it routinely and taught others the technique. That was the first step in a journey that has taken him from consulting with industry to a founder of start-ups.

“The device company heard about what we were doing and were interested,” Dr. Thompson recounted during his How-I-Did-It lecture at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. In the end, he served as a consultant in the development of a new suturing device specific for the bariatric procedure. This included helping secure a patent and learning first-hand what steps are needed to get a device to market.

“It was a great learning experience. I now knew something about the role of a consultant and the process of product innovation,” Dr. Thompson explained. He also learned that the low-risk participation of a consultant is a low-reward proposition. The new product was successful, but Dr. Thompson received no stock, and the licensing fee went to the hospital.

“I do not have any regrets. It was good for my career and fun to be involved, but there was not much financial gain for me or for my department,” Dr. Thompson said.

His subsequent experience with licensing was an incremental step forward. In one example, he worked on developing an endoscopic simulator, an important unmet need both for teaching and evaluating skills in diagnostic colonoscopy, including a kinematic analysis that helped identify techniques that are associated with high levels of skill.

“We developed the technology in-house through a series of grants. The risks were low, but the rewards were better because the money helped fund activities in our department,” he said.

That device, too, has been very successful, but Dr. Thompson said it is important to recognize how far innovation can go when the work stays in the academic setting and the goal is licensing the technology. More recently, he took a nonsurgical anastomosis device through preclinical testing, but he was then unable to attract a device company for the next steps of development.

 

“With no one interested, we created a start-up,” Dr. Thompson said. The company, GI Windows, has now taken this product, a magnetic endo-luminal anastomosis bypass device for the treatment of diabetes mellitus, into advanced stages of clinical testing. Relative to licensing arrangements, this involved a different level of participation.

“A start-up means creating a board, raising money, and being involved in details that can involve a lot of heavy lifting,” Dr. Thompson said. “It is basically a second job.”

The ongoing clinical studies in patients with diabetes have been very encouraging. Dr. Thompson reported that a large proportion of patients with diabetes fitted with the device have been able to reduce or discontinue their antidiabetic medications, and high rates of excess weight loss have been documented.

GI Windows was created for the sole purpose of developing the anastomosis device, but Dr. Thompson was also involved in creating another company, now sold, that started without a specific device in mind.

 

“The products we developed were just from brainstorming on unmet needs, and we had several successes. That was a chance to learn new areas of the business, including building a sales force and learning how to get involved in international distribution, which were separate from trying simply to produce a viable clinical tool,” he said.

Creating companies, rather than licensing ideas, trades higher risk for greater reward, but Dr. Thompson emphasized that these rewards are not just financial.

“It is exciting to develop a team you trust, get a successful company off the ground, and watch it grow,” Dr. Thompson said. He indicated that the risk-to-reward calculation should not be undertaken independent of the value of the learning experience.

 

BOSTON – Just out of fellowship, Christopher C. Thompson, MD, director of therapeutic endoscopy, Brigham and Women’s Hospital, Boston, adapted an antireflux suturing device for use in a bariatric procedure. It worked so well he began using it routinely and taught others the technique. That was the first step in a journey that has taken him from consulting with industry to a founder of start-ups.

“The device company heard about what we were doing and were interested,” Dr. Thompson recounted during his How-I-Did-It lecture at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. In the end, he served as a consultant in the development of a new suturing device specific for the bariatric procedure. This included helping secure a patent and learning first-hand what steps are needed to get a device to market.

“It was a great learning experience. I now knew something about the role of a consultant and the process of product innovation,” Dr. Thompson explained. He also learned that the low-risk participation of a consultant is a low-reward proposition. The new product was successful, but Dr. Thompson received no stock, and the licensing fee went to the hospital.

“I do not have any regrets. It was good for my career and fun to be involved, but there was not much financial gain for me or for my department,” Dr. Thompson said.

His subsequent experience with licensing was an incremental step forward. In one example, he worked on developing an endoscopic simulator, an important unmet need both for teaching and evaluating skills in diagnostic colonoscopy, including a kinematic analysis that helped identify techniques that are associated with high levels of skill.

“We developed the technology in-house through a series of grants. The risks were low, but the rewards were better because the money helped fund activities in our department,” he said.

That device, too, has been very successful, but Dr. Thompson said it is important to recognize how far innovation can go when the work stays in the academic setting and the goal is licensing the technology. More recently, he took a nonsurgical anastomosis device through preclinical testing, but he was then unable to attract a device company for the next steps of development.

 

“With no one interested, we created a start-up,” Dr. Thompson said. The company, GI Windows, has now taken this product, a magnetic endo-luminal anastomosis bypass device for the treatment of diabetes mellitus, into advanced stages of clinical testing. Relative to licensing arrangements, this involved a different level of participation.

“A start-up means creating a board, raising money, and being involved in details that can involve a lot of heavy lifting,” Dr. Thompson said. “It is basically a second job.”

The ongoing clinical studies in patients with diabetes have been very encouraging. Dr. Thompson reported that a large proportion of patients with diabetes fitted with the device have been able to reduce or discontinue their antidiabetic medications, and high rates of excess weight loss have been documented.

GI Windows was created for the sole purpose of developing the anastomosis device, but Dr. Thompson was also involved in creating another company, now sold, that started without a specific device in mind.

 

“The products we developed were just from brainstorming on unmet needs, and we had several successes. That was a chance to learn new areas of the business, including building a sales force and learning how to get involved in international distribution, which were separate from trying simply to produce a viable clinical tool,” he said.

Creating companies, rather than licensing ideas, trades higher risk for greater reward, but Dr. Thompson emphasized that these rewards are not just financial.

“It is exciting to develop a team you trust, get a successful company off the ground, and watch it grow,” Dr. Thompson said. He indicated that the risk-to-reward calculation should not be undertaken independent of the value of the learning experience.