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

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

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

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).

ilacy@mdedge.com

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).

ilacy@mdedge.com

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).

ilacy@mdedge.com

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

bjancin@mdedge.com

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

bjancin@mdedge.com

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

bjancin@mdedge.com

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.

• 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 dianne@mhaus.org. Winners will be announced by Aug. 10, 2018. For additional information, write to dianne@mhaus.org 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.

• 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 dianne@mhaus.org. Winners will be announced by Aug. 10, 2018. For additional information, write to dianne@mhaus.org 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.

• 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 dianne@mhaus.org. Winners will be announced by Aug. 10, 2018. For additional information, write to dianne@mhaus.org 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

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

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

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.

ilacy@mdedge.com

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.

ilacy@mdedge.com

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.

ilacy@mdedge.com

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.

“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.

“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.

“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.

Patients with the most severe cases of rheumatoid arthritis are more likely to suffer flares after knee or hip replacement surgery, a new study finds, and it doesn’t seem to matter whether they stop taking biologics before their operation.

“We found that the majority of patients had active disease at the time of surgery, contrary to prior statements that RA patients have inactive disease at the time they go for hip or knee replacement. In fact, the majority – 65% of the patients – reported a flare of RA within 6 weeks of surgery,” lead author Susan M. Goodman, MD, of Cornell University and the Hospital for Special Surgery, New York, said in an interview. “Surprisingly, although more of the flaring patients were taking potent biologics that had been withheld preoperatively, the major risk factor for flares was their baseline disease activity.”

rhnews@mdedge.com

SOURCE: Goodman S et al. J Rheumatol. 2018 Mar 15. doi: 10.3899/jrheum.170366

Patients with the most severe cases of rheumatoid arthritis are more likely to suffer flares after knee or hip replacement surgery, a new study finds, and it doesn’t seem to matter whether they stop taking biologics before their operation.

“We found that the majority of patients had active disease at the time of surgery, contrary to prior statements that RA patients have inactive disease at the time they go for hip or knee replacement. In fact, the majority – 65% of the patients – reported a flare of RA within 6 weeks of surgery,” lead author Susan M. Goodman, MD, of Cornell University and the Hospital for Special Surgery, New York, said in an interview. “Surprisingly, although more of the flaring patients were taking potent biologics that had been withheld preoperatively, the major risk factor for flares was their baseline disease activity.”

rhnews@mdedge.com

SOURCE: Goodman S et al. J Rheumatol. 2018 Mar 15. doi: 10.3899/jrheum.170366

Patients with the most severe cases of rheumatoid arthritis are more likely to suffer flares after knee or hip replacement surgery, a new study finds, and it doesn’t seem to matter whether they stop taking biologics before their operation.

“We found that the majority of patients had active disease at the time of surgery, contrary to prior statements that RA patients have inactive disease at the time they go for hip or knee replacement. In fact, the majority – 65% of the patients – reported a flare of RA within 6 weeks of surgery,” lead author Susan M. Goodman, MD, of Cornell University and the Hospital for Special Surgery, New York, said in an interview. “Surprisingly, although more of the flaring patients were taking potent biologics that had been withheld preoperatively, the major risk factor for flares was their baseline disease activity.”

rhnews@mdedge.com

SOURCE: Goodman S et al. J Rheumatol. 2018 Mar 15. doi: 10.3899/jrheum.170366

SALT LAKE CITY – A multicenter study confirmed that diversity of gut microbiota is associated with better survival after allogeneic hematopoietic cell transplantation (HCT), while low diversity and the predominance of pathogenic bacteria are linked to graft versus host disease (GVHD).

Lower calorie intake and exposure to broad-spectrum antibiotics were both associated with lower diversity, the study found.

“One of the striking findings early on was this association between diversity in the gut and overall survival,” said Jonathan Peled, MD, PhD, noting that his research group also saw that high gut diversity was associated with lower rates of GVHD-related mortality.

“The first question that I want to ask today is ‘Are the patterns of microbiota injury that have been described in single-center studies and their association with clinical outcomes consistent across geography?’” Dr. Peled said during a top abstracts session at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.

To answer this, Dr. Peled and his associates at Memorial Sloan Kettering Cancer Center (MSKCC), New York, teamed up with a research group at Duke University, Durham, N.C., and with investigators in Regensburg, Germany. The international group devised a study that would use centralized sequencing and analysis to examine patient fecal samples from all three centers.

In all, 5,310 samples were obtained from 1,034 HCT patients. MSKCC contributed most of the samples (n = 908, 87.8%), with Regensburg contributing 79 (7.6%) and Duke contributing 47 (4.5%).

The most common malignancies treated were acute myeloid leukemia, myelodysplastic syndrome, and non-Hodgkin lymphoma. The balance of graft sources and conditioning intensity varied between centers, but overall, more than three-quarters of grafts were from peripheral blood stem cells and just over half of patients received myeloablative conditioning.

koakes@mdedge.com

SOURCE: Peled J et al. 2018 BMT Tandem Meetings, Abstract 3.

SALT LAKE CITY – A multicenter study confirmed that diversity of gut microbiota is associated with better survival after allogeneic hematopoietic cell transplantation (HCT), while low diversity and the predominance of pathogenic bacteria are linked to graft versus host disease (GVHD).

Lower calorie intake and exposure to broad-spectrum antibiotics were both associated with lower diversity, the study found.

“One of the striking findings early on was this association between diversity in the gut and overall survival,” said Jonathan Peled, MD, PhD, noting that his research group also saw that high gut diversity was associated with lower rates of GVHD-related mortality.

“The first question that I want to ask today is ‘Are the patterns of microbiota injury that have been described in single-center studies and their association with clinical outcomes consistent across geography?’” Dr. Peled said during a top abstracts session at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.

To answer this, Dr. Peled and his associates at Memorial Sloan Kettering Cancer Center (MSKCC), New York, teamed up with a research group at Duke University, Durham, N.C., and with investigators in Regensburg, Germany. The international group devised a study that would use centralized sequencing and analysis to examine patient fecal samples from all three centers.

In all, 5,310 samples were obtained from 1,034 HCT patients. MSKCC contributed most of the samples (n = 908, 87.8%), with Regensburg contributing 79 (7.6%) and Duke contributing 47 (4.5%).

The most common malignancies treated were acute myeloid leukemia, myelodysplastic syndrome, and non-Hodgkin lymphoma. The balance of graft sources and conditioning intensity varied between centers, but overall, more than three-quarters of grafts were from peripheral blood stem cells and just over half of patients received myeloablative conditioning.

koakes@mdedge.com

SOURCE: Peled J et al. 2018 BMT Tandem Meetings, Abstract 3.

SALT LAKE CITY – A multicenter study confirmed that diversity of gut microbiota is associated with better survival after allogeneic hematopoietic cell transplantation (HCT), while low diversity and the predominance of pathogenic bacteria are linked to graft versus host disease (GVHD).

Lower calorie intake and exposure to broad-spectrum antibiotics were both associated with lower diversity, the study found.

“One of the striking findings early on was this association between diversity in the gut and overall survival,” said Jonathan Peled, MD, PhD, noting that his research group also saw that high gut diversity was associated with lower rates of GVHD-related mortality.

“The first question that I want to ask today is ‘Are the patterns of microbiota injury that have been described in single-center studies and their association with clinical outcomes consistent across geography?’” Dr. Peled said during a top abstracts session at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.

To answer this, Dr. Peled and his associates at Memorial Sloan Kettering Cancer Center (MSKCC), New York, teamed up with a research group at Duke University, Durham, N.C., and with investigators in Regensburg, Germany. The international group devised a study that would use centralized sequencing and analysis to examine patient fecal samples from all three centers.

In all, 5,310 samples were obtained from 1,034 HCT patients. MSKCC contributed most of the samples (n = 908, 87.8%), with Regensburg contributing 79 (7.6%) and Duke contributing 47 (4.5%).

The most common malignancies treated were acute myeloid leukemia, myelodysplastic syndrome, and non-Hodgkin lymphoma. The balance of graft sources and conditioning intensity varied between centers, but overall, more than three-quarters of grafts were from peripheral blood stem cells and just over half of patients received myeloablative conditioning.

koakes@mdedge.com

SOURCE: Peled J et al. 2018 BMT Tandem Meetings, Abstract 3.