CHICAGO – Five years of extended intermittent letrozole provided no overall improvement in disease-free survival (DFS) when compared with continuous treatment with the aromatase inhibitor among postmenopausal women who received 4-6 years of endocrine therapy for hormone receptor–positive, lymph node–positive early breast cancer in the randomized phase III Study of Letrozole Extension (SOLE).

However, the similarities in DFS and adverse events incidence in the intermittent and continuous treatment groups – and improvements in a number of quality of life measures with intermittent treatment – suggest that temporary treatment breaks are acceptable in those who could benefit from them, Marco Colleoni, MD, reported at the annual meeting of the American Society of Clinical Oncology.

The DFS among 2,425 women who received 5 years of intermittent letrozole after completing 4-6 years of adjuvant endocrine therapy was 85.8%, compared with 87.5% among 2,426 women who received 5 years of continuous letrozole after adjuvant therapy (hazard ratio, 1.08) said Dr. Colleoni of the European Institute of Oncology, Milan, Italy.

Similar outcomes were observed for breast cancer–free interval (HR, 0.98), distant recurrence-free interval (HR, 0.88), and overall survival (HR, 0.85), he said.

Of note, trends toward greater improvement on both the primary and secondary endpoints were seen with continuous therapy among those who received prior selective estrogen receptor modulator (SERM) vs. aromatase inhibitor (AI) therapy, but the differences did not reach statistical significance, he said.

Adjuvant extended endocrine therapy with letrozole has been recommended after initial tamoxifen for postmenopausal women with hormone receptor–positive (HR+) breast cancer, but the magnitude of the beneficial effect of extended letrozole in women who previously received an aromatase inhibitor has been limited, Dr. Colleoni said.

“Therefore, based on available data, the use of an AI for 10 years should be discussed on an individualized basis,” he said.

However, there is rationale for the intermittent use of letrozole as a therapeutic option to prolong sensitivity to endocrine therapies,” he noted.

“Breast cancer cells, in fact, can develop resistance following antihormonal therapy. In particular, cells that are maintained estrogen-free for years start to grow spontaneously. It has been shown ... that minimal concentrations of estrogen, similar to those achievable through interruption of treatment with aromatase inhibitors, can produce a cytocidal effect on cells that are deprived of estrogen,” he explained. “Moreover, in breast cancer cells transplanted into animal models, a response to a 6-week withdrawal of letrozole was observed when the treatment was started again.”

Thus, the SOLE study was designed to look at the value of extended adjuvant therapy in patients with HR+ breast cancer, the role of intermittent administration of letrozole in patients previously treated with AIs, the impact of intermittent vs. continuous administration on the side effect profile and quality of life and adherence to intermittent administration, he said.

Study participants were women with a median age of 60 years who were enrolled from 240 centers in 22 countries between November 2007 and July 2012. They had HR+ invasive breast cancer, any HER2 status, and disease confined to the breast and axillary lymph nodes. All had received SERM, AI, or combination SERM and AI treatment for 4-6 years but must have discontinued that therapy within 1 year prior to randomization.

Women in the intermittent treatment group were treated for the first 9 months of years 1-4 and for 12 months in year 5. Those in the continuous treatment group received 2.5 mg of letrozole daily for 5 years.

The adverse events were as expected, with 36.2% and 34.5% of patients in the intermittent and continuous treatment groups experiencing grade 3 or 5 events, respectively, and were similar, Dr. Colleoni said.

Treatment was discontinued for DFS events in 8% of patients and for other reasons in 24% of patients. Treatment was completed by 39% of patients and currently is ongoing in 29%, he said.

“When we designed the SOLE study, we were worried about ... the treatment gap. We’re delighted to observe that more than 90% of the patients regularly resumed [treatment] after interruption, ... reassuring [us of] the feasibility of a treatment gap during extended adjuvant letrozole,” he said.

Additionally, a quality of life substudy of 955 patients from the SOLE trial, who were assessed at baseline and at 6, 12, 18, and 24 months, showed a consistent pattern favoring intermittent therapy on patient-reported quality of life measures. Specifically, there was significantly less worsening from baseline with respect to vaginal problems, musculoskeletal pain, sleep disturbance, physical wellbeing, and mood at 12 months in the intermittent vs. continuous letrozole group and significantly greater improvement in hot flashes at 24 months in the intermittent vs. continuous group, he said.

“The results ... provide clinically relevant information on intermittent administration of extended letrozole for patients who could benefit from temporary treatment breaks,” he concluded, noting that translational studies are ongoing, such as measurement of estradiol levels during treatment gaps.

The SOLE trial was supported by Novartis. Dr. Colleoni reported receiving honoraria from Novartis, and serving as a consultant or advisor for AstraZeneca, Celldex, OBI Pharma, Pfizer, Pierre Fabre, and Puma Biotechnology.

[email protected]

CHICAGO – Five years of extended intermittent letrozole provided no overall improvement in disease-free survival (DFS) when compared with continuous treatment with the aromatase inhibitor among postmenopausal women who received 4-6 years of endocrine therapy for hormone receptor–positive, lymph node–positive early breast cancer in the randomized phase III Study of Letrozole Extension (SOLE).

However, the similarities in DFS and adverse events incidence in the intermittent and continuous treatment groups – and improvements in a number of quality of life measures with intermittent treatment – suggest that temporary treatment breaks are acceptable in those who could benefit from them, Marco Colleoni, MD, reported at the annual meeting of the American Society of Clinical Oncology.

The DFS among 2,425 women who received 5 years of intermittent letrozole after completing 4-6 years of adjuvant endocrine therapy was 85.8%, compared with 87.5% among 2,426 women who received 5 years of continuous letrozole after adjuvant therapy (hazard ratio, 1.08) said Dr. Colleoni of the European Institute of Oncology, Milan, Italy.

Similar outcomes were observed for breast cancer–free interval (HR, 0.98), distant recurrence-free interval (HR, 0.88), and overall survival (HR, 0.85), he said.

Of note, trends toward greater improvement on both the primary and secondary endpoints were seen with continuous therapy among those who received prior selective estrogen receptor modulator (SERM) vs. aromatase inhibitor (AI) therapy, but the differences did not reach statistical significance, he said.

Adjuvant extended endocrine therapy with letrozole has been recommended after initial tamoxifen for postmenopausal women with hormone receptor–positive (HR+) breast cancer, but the magnitude of the beneficial effect of extended letrozole in women who previously received an aromatase inhibitor has been limited, Dr. Colleoni said.

“Therefore, based on available data, the use of an AI for 10 years should be discussed on an individualized basis,” he said.

However, there is rationale for the intermittent use of letrozole as a therapeutic option to prolong sensitivity to endocrine therapies,” he noted.

“Breast cancer cells, in fact, can develop resistance following antihormonal therapy. In particular, cells that are maintained estrogen-free for years start to grow spontaneously. It has been shown ... that minimal concentrations of estrogen, similar to those achievable through interruption of treatment with aromatase inhibitors, can produce a cytocidal effect on cells that are deprived of estrogen,” he explained. “Moreover, in breast cancer cells transplanted into animal models, a response to a 6-week withdrawal of letrozole was observed when the treatment was started again.”

Thus, the SOLE study was designed to look at the value of extended adjuvant therapy in patients with HR+ breast cancer, the role of intermittent administration of letrozole in patients previously treated with AIs, the impact of intermittent vs. continuous administration on the side effect profile and quality of life and adherence to intermittent administration, he said.

Study participants were women with a median age of 60 years who were enrolled from 240 centers in 22 countries between November 2007 and July 2012. They had HR+ invasive breast cancer, any HER2 status, and disease confined to the breast and axillary lymph nodes. All had received SERM, AI, or combination SERM and AI treatment for 4-6 years but must have discontinued that therapy within 1 year prior to randomization.

Women in the intermittent treatment group were treated for the first 9 months of years 1-4 and for 12 months in year 5. Those in the continuous treatment group received 2.5 mg of letrozole daily for 5 years.

The adverse events were as expected, with 36.2% and 34.5% of patients in the intermittent and continuous treatment groups experiencing grade 3 or 5 events, respectively, and were similar, Dr. Colleoni said.

Treatment was discontinued for DFS events in 8% of patients and for other reasons in 24% of patients. Treatment was completed by 39% of patients and currently is ongoing in 29%, he said.

“When we designed the SOLE study, we were worried about ... the treatment gap. We’re delighted to observe that more than 90% of the patients regularly resumed [treatment] after interruption, ... reassuring [us of] the feasibility of a treatment gap during extended adjuvant letrozole,” he said.

Additionally, a quality of life substudy of 955 patients from the SOLE trial, who were assessed at baseline and at 6, 12, 18, and 24 months, showed a consistent pattern favoring intermittent therapy on patient-reported quality of life measures. Specifically, there was significantly less worsening from baseline with respect to vaginal problems, musculoskeletal pain, sleep disturbance, physical wellbeing, and mood at 12 months in the intermittent vs. continuous letrozole group and significantly greater improvement in hot flashes at 24 months in the intermittent vs. continuous group, he said.

“The results ... provide clinically relevant information on intermittent administration of extended letrozole for patients who could benefit from temporary treatment breaks,” he concluded, noting that translational studies are ongoing, such as measurement of estradiol levels during treatment gaps.

The SOLE trial was supported by Novartis. Dr. Colleoni reported receiving honoraria from Novartis, and serving as a consultant or advisor for AstraZeneca, Celldex, OBI Pharma, Pfizer, Pierre Fabre, and Puma Biotechnology.

[email protected]

CHICAGO – Five years of extended intermittent letrozole provided no overall improvement in disease-free survival (DFS) when compared with continuous treatment with the aromatase inhibitor among postmenopausal women who received 4-6 years of endocrine therapy for hormone receptor–positive, lymph node–positive early breast cancer in the randomized phase III Study of Letrozole Extension (SOLE).

However, the similarities in DFS and adverse events incidence in the intermittent and continuous treatment groups – and improvements in a number of quality of life measures with intermittent treatment – suggest that temporary treatment breaks are acceptable in those who could benefit from them, Marco Colleoni, MD, reported at the annual meeting of the American Society of Clinical Oncology.

The DFS among 2,425 women who received 5 years of intermittent letrozole after completing 4-6 years of adjuvant endocrine therapy was 85.8%, compared with 87.5% among 2,426 women who received 5 years of continuous letrozole after adjuvant therapy (hazard ratio, 1.08) said Dr. Colleoni of the European Institute of Oncology, Milan, Italy.

Similar outcomes were observed for breast cancer–free interval (HR, 0.98), distant recurrence-free interval (HR, 0.88), and overall survival (HR, 0.85), he said.

Of note, trends toward greater improvement on both the primary and secondary endpoints were seen with continuous therapy among those who received prior selective estrogen receptor modulator (SERM) vs. aromatase inhibitor (AI) therapy, but the differences did not reach statistical significance, he said.

Adjuvant extended endocrine therapy with letrozole has been recommended after initial tamoxifen for postmenopausal women with hormone receptor–positive (HR+) breast cancer, but the magnitude of the beneficial effect of extended letrozole in women who previously received an aromatase inhibitor has been limited, Dr. Colleoni said.

“Therefore, based on available data, the use of an AI for 10 years should be discussed on an individualized basis,” he said.

However, there is rationale for the intermittent use of letrozole as a therapeutic option to prolong sensitivity to endocrine therapies,” he noted.

“Breast cancer cells, in fact, can develop resistance following antihormonal therapy. In particular, cells that are maintained estrogen-free for years start to grow spontaneously. It has been shown ... that minimal concentrations of estrogen, similar to those achievable through interruption of treatment with aromatase inhibitors, can produce a cytocidal effect on cells that are deprived of estrogen,” he explained. “Moreover, in breast cancer cells transplanted into animal models, a response to a 6-week withdrawal of letrozole was observed when the treatment was started again.”

Thus, the SOLE study was designed to look at the value of extended adjuvant therapy in patients with HR+ breast cancer, the role of intermittent administration of letrozole in patients previously treated with AIs, the impact of intermittent vs. continuous administration on the side effect profile and quality of life and adherence to intermittent administration, he said.

Study participants were women with a median age of 60 years who were enrolled from 240 centers in 22 countries between November 2007 and July 2012. They had HR+ invasive breast cancer, any HER2 status, and disease confined to the breast and axillary lymph nodes. All had received SERM, AI, or combination SERM and AI treatment for 4-6 years but must have discontinued that therapy within 1 year prior to randomization.

Women in the intermittent treatment group were treated for the first 9 months of years 1-4 and for 12 months in year 5. Those in the continuous treatment group received 2.5 mg of letrozole daily for 5 years.

The adverse events were as expected, with 36.2% and 34.5% of patients in the intermittent and continuous treatment groups experiencing grade 3 or 5 events, respectively, and were similar, Dr. Colleoni said.

Treatment was discontinued for DFS events in 8% of patients and for other reasons in 24% of patients. Treatment was completed by 39% of patients and currently is ongoing in 29%, he said.

“When we designed the SOLE study, we were worried about ... the treatment gap. We’re delighted to observe that more than 90% of the patients regularly resumed [treatment] after interruption, ... reassuring [us of] the feasibility of a treatment gap during extended adjuvant letrozole,” he said.

Additionally, a quality of life substudy of 955 patients from the SOLE trial, who were assessed at baseline and at 6, 12, 18, and 24 months, showed a consistent pattern favoring intermittent therapy on patient-reported quality of life measures. Specifically, there was significantly less worsening from baseline with respect to vaginal problems, musculoskeletal pain, sleep disturbance, physical wellbeing, and mood at 12 months in the intermittent vs. continuous letrozole group and significantly greater improvement in hot flashes at 24 months in the intermittent vs. continuous group, he said.

“The results ... provide clinically relevant information on intermittent administration of extended letrozole for patients who could benefit from temporary treatment breaks,” he concluded, noting that translational studies are ongoing, such as measurement of estradiol levels during treatment gaps.

The SOLE trial was supported by Novartis. Dr. Colleoni reported receiving honoraria from Novartis, and serving as a consultant or advisor for AstraZeneca, Celldex, OBI Pharma, Pfizer, Pierre Fabre, and Puma Biotechnology.

[email protected]

SAAVS meeting a success

The Sixth Annual meeting of the South Asian American Vascular Society (SAVVS), an affiliate of the Society for Vascular Surgery, was held on May 31 during the Vascular Annual Meeting.

The Society was formed to provide a forum for scientific, clinical, cultural, charitable and social interaction among American physicians and healthcare providers of South Asian origin involved in the management of vascular disease. SAAVS also works as a forum to collaborate with Vascular Societies across South Asia .

Member benefits include being able to support vascular surgery in our countries of origin; sharing business knowledge and experience with members related to vendors, office practices, and opening centers for access/veins; mentoring of younger surgeons and medical students; assisting with new techniques and endovascular training; guiding job placement, contracts, and privileging issues; networking with friends and colleagues all over the world; taking a greater role in national societies; and taking advantage of the network for assistance in locating/obtaining training positions for family members.

The first annual meeting of the SAAVS was held in 2010. Past Presidents have included Drs. Krishna Jain, Bhagwan Satiani, Brajesh Lal, Anil Hingorani, Dipankar Mukherjee, and Ravi Veeraswamy. During VAM 2017, the current president, Faisal Aziz, MD, of Penn State gave his annual report and the society then inducted its future president Raghu Motaganahalli, MD, from Indiana University into office. Dr. Motaganahalli was also recently appointed as Director of the Division of Vascular Surgery at Indiana University. Peter Lawrence, MD, provided a keynote address highlighting opportunities for conducting research to improve patient care.

Other officers for 2017-2018 include President Elect Sachinder Hans, MD; Secretary Raj Sarkar, MD; Treasurer Krish Soundararajan, MD; Membership Committee: Kapil Gopal, MD, and Syed Alam, MD; Bylaws: Bhagwan Satiani, MD; Industry Relations: Krishna Jain, MD.

A regular feature of the meeting is an abstract/presentation contest for medical students and fellows interested in Vascular Surgery. First place winners from each category are offered cash prizes. In the future, SAAVS plans to have traveling fellowship programs for physicians from South Asia, as well as the United States, for collaborative clinical and educational exchange. Two members have already visited India and Pakistan for collaboration and assistance with endovascular procedures.

The website is www.saavsociety.org

Bhagwan Satiani, MD, The Ohio State University College of Medicine, Columbus.

Study established for “precision” surveillance for PAD

During the Vascular Annual Meeting (VAM) in San Diego, the Centers for Medicaid and Medicaid Services (CMS) announced its decision to reimburse supervised exercise therapy (SET) for beneficiaries with PAD. This decision was based on evidence which concluded that SET improves health outcomes for Medicare beneficiaries with intermittent claudication due to PAD. Up to this point physician-prescribed supervised exercise therapy was only covered exclusively for Cardiac Rehabilitation.

SET for PAD covers up to 36 sessions over a 12 week period if sessions 1) last 30-60 minutes; 2) are conducted in a hospital outpatient setting or physician’s office; and 3) are delivered by qualified auxiliary personnel to ensure benefits exceed harm and if 4) beneficiaries are under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist who must be trained in both basic and advanced life support techniques. Face-to-face visits with the physician responsible for PAD treatment is required for a SET referral. At this visit, the beneficiary must receive information regarding CV and PAD risk factor reduction, which could include education, counseling, behavior interventions and outcome assessments.

The widespread implementation of SET programs will require the adoption of a functional outcome assessment for PAD.

Here at the Division of Vascular Surgery at Stanford University, we are evaluating the use of a patient’s own smartphone to track and monitor walking activity. The research study called, VascTrac, was developed to provide a more “personalized” approach to surveillance for patients with intermittent claudication in line with precision medicine. We hypothesize that there is a direct correlation between a patient’s walking ability (functional status) and their disease burden.

Vascular surgeons today are finding themselves faced with an increasingly common problem: the “returning patient.” All too often, patients with peripheral artery disease are returning to clinic just months after treatment, frustrated by resurfacing symptoms. What was seemingly a straightforward femoral artery occlusion with an easy stent fix has somehow degraded into disabling claudication (Rutherford Class II/III) in a very short period of time. A staggering number of these patients have perfect-appearing completion angiograms, yet they return to clinic with complete re-occlusions. The tale of mild symptom return, typically beginning several months prior to the current visit, is becoming unsettlingly familiar. Inevitably, the story raises the question: “Why didn’t you come in sooner?”

This frustrating scenario calls for a new paradigm for surveillance of PAD – a more personalized approach in line with precision medicine.

Over the past decade, the prevalence of smartphones and other personal mobile devices has increased at a blistering pace. Today, over 700 million iPhones alone exist worldwide. These devices have an enormous potential to revolutionize the way we deliver care.

In 2014, Apple launched a secure personal mobile health repository called HealthKit, which now comes pre-loaded on every iPhone that is sold. This repository stores data ranging from step counts to blood glucose levels in a secure and structured way. As a bonus, every phone contains accelerometers which passively track a user’s daily activity. On the heels of HealthKit came the Apple ResearchKit framework, launched in 2015 as a means to standardize study enrollment, data collection, storage and transmission on the iPhone. The advent of this new study tool opened the door for remote patient monitoring and “siteless” clinical trials at scale.

These two new platforms have significant implications for health monitoring and diagnosis. While activity is the functional outcome that physicians aim to improve for disabling claudicants, the field currently lacks a means of objectively measuring patient activity and functional outcomes.

Traditional PAD monitoring focuses primarily on vessel patency and ankle brachial indices (ABIs) at 1-, 3-, 6- and 12-month intervals. The problem is that stents don’t fail at 1-, 3-, 6- and 12-month intervals, but ultrasounds and ABI’s require technicians and it’s challenging to perform those more often. There are too many gaps in knowledge, too many black holes, and a more granular approach is required. [NB: Seems to me just adding a 1 month reading would have solved the problem. The rest of the data points are perfect representations of the trend for which VascTrac provides no added benefit. The graph is not needed and would add even more “advertising flair.”

Using activity data as a surrogate for traditional measures of ABIs and vessel patency, we have designed algorithms to passively monitor patients’ daily activity using their personal smartphones. We have implemented these algorithms into an app and have now launched the VascTrac PAD Research Study.

VascTrac is an app available for download from the Apple App Store. Participants need an iPhone 5s (released in 2013) or a newer model. Enrollment, including consent, is all done on the phone. There are three short surveys focused on medical history, surgical history and PAD-specific history (including ABIs). Every two weeks, the app asks patients to perform a 6-minute walk test, and every quarter they are asked to complete the medical, surgical and PAD surveys. However, the majority of activity data is collected passively. Specifically, the app collects total steps per day, distance walked per day, and flights climbed per day and uses an algorithm developed by the team to gather data on a new unique metric, “Max Steps Without Stopping” (MSWS).

A motivated patient can walk 5 miles a day, but he or she may have to stop multiple times along the way. We believe MSWS will help catch the stopping due to the claudication. Patients are provided with a dashboard of their average activity for the week, month and year. They are also provided with links to PAD educational resources.

The VascTrac study is open to all, even non-PAD participants. The inclusion criteria are that a participant must be at least 18 years of age, live in the United States, speak English and have an iPhone 5s or newer model. The ideal patient, however, would be someone who is scheduled for an intervention. This way, the team can obtain a few weeks of baseline activity before evaluating the intervention’s effect on the patient’s functional activity.

Some of the questions our team hopes to answer are, What are the actual effects of our interventions (open vs. bypass) on a patient’s functional capacity? How stable are our interventions relative to a patient’s functional activity? What are the failure modes – is there a gradual decline in activity before failure or an abrupt decline? Can we predict failure of an intervention by doing a regression analysis of a patient’s functional activity trends?

We welcome the participation of any interested providers. More information can be found at www.vasctrac.stanford.edu, where providers can also request recruitment materials. Alternatively, the team can be contacted directly at [email protected].

This is an IRB-approved study and neither the researchers nor the university have any financial disclosures.

Oliver Aalami, MD, Stanford University School of Medicine/Palo Alto.

SAAVS meeting a success

The Sixth Annual meeting of the South Asian American Vascular Society (SAVVS), an affiliate of the Society for Vascular Surgery, was held on May 31 during the Vascular Annual Meeting.

The Society was formed to provide a forum for scientific, clinical, cultural, charitable and social interaction among American physicians and healthcare providers of South Asian origin involved in the management of vascular disease. SAAVS also works as a forum to collaborate with Vascular Societies across South Asia .

Member benefits include being able to support vascular surgery in our countries of origin; sharing business knowledge and experience with members related to vendors, office practices, and opening centers for access/veins; mentoring of younger surgeons and medical students; assisting with new techniques and endovascular training; guiding job placement, contracts, and privileging issues; networking with friends and colleagues all over the world; taking a greater role in national societies; and taking advantage of the network for assistance in locating/obtaining training positions for family members.

The first annual meeting of the SAAVS was held in 2010. Past Presidents have included Drs. Krishna Jain, Bhagwan Satiani, Brajesh Lal, Anil Hingorani, Dipankar Mukherjee, and Ravi Veeraswamy. During VAM 2017, the current president, Faisal Aziz, MD, of Penn State gave his annual report and the society then inducted its future president Raghu Motaganahalli, MD, from Indiana University into office. Dr. Motaganahalli was also recently appointed as Director of the Division of Vascular Surgery at Indiana University. Peter Lawrence, MD, provided a keynote address highlighting opportunities for conducting research to improve patient care.

Other officers for 2017-2018 include President Elect Sachinder Hans, MD; Secretary Raj Sarkar, MD; Treasurer Krish Soundararajan, MD; Membership Committee: Kapil Gopal, MD, and Syed Alam, MD; Bylaws: Bhagwan Satiani, MD; Industry Relations: Krishna Jain, MD.

A regular feature of the meeting is an abstract/presentation contest for medical students and fellows interested in Vascular Surgery. First place winners from each category are offered cash prizes. In the future, SAAVS plans to have traveling fellowship programs for physicians from South Asia, as well as the United States, for collaborative clinical and educational exchange. Two members have already visited India and Pakistan for collaboration and assistance with endovascular procedures.

The website is www.saavsociety.org

Bhagwan Satiani, MD, The Ohio State University College of Medicine, Columbus.

Study established for “precision” surveillance for PAD

During the Vascular Annual Meeting (VAM) in San Diego, the Centers for Medicaid and Medicaid Services (CMS) announced its decision to reimburse supervised exercise therapy (SET) for beneficiaries with PAD. This decision was based on evidence which concluded that SET improves health outcomes for Medicare beneficiaries with intermittent claudication due to PAD. Up to this point physician-prescribed supervised exercise therapy was only covered exclusively for Cardiac Rehabilitation.

SET for PAD covers up to 36 sessions over a 12 week period if sessions 1) last 30-60 minutes; 2) are conducted in a hospital outpatient setting or physician’s office; and 3) are delivered by qualified auxiliary personnel to ensure benefits exceed harm and if 4) beneficiaries are under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist who must be trained in both basic and advanced life support techniques. Face-to-face visits with the physician responsible for PAD treatment is required for a SET referral. At this visit, the beneficiary must receive information regarding CV and PAD risk factor reduction, which could include education, counseling, behavior interventions and outcome assessments.

The widespread implementation of SET programs will require the adoption of a functional outcome assessment for PAD.

Here at the Division of Vascular Surgery at Stanford University, we are evaluating the use of a patient’s own smartphone to track and monitor walking activity. The research study called, VascTrac, was developed to provide a more “personalized” approach to surveillance for patients with intermittent claudication in line with precision medicine. We hypothesize that there is a direct correlation between a patient’s walking ability (functional status) and their disease burden.

Vascular surgeons today are finding themselves faced with an increasingly common problem: the “returning patient.” All too often, patients with peripheral artery disease are returning to clinic just months after treatment, frustrated by resurfacing symptoms. What was seemingly a straightforward femoral artery occlusion with an easy stent fix has somehow degraded into disabling claudication (Rutherford Class II/III) in a very short period of time. A staggering number of these patients have perfect-appearing completion angiograms, yet they return to clinic with complete re-occlusions. The tale of mild symptom return, typically beginning several months prior to the current visit, is becoming unsettlingly familiar. Inevitably, the story raises the question: “Why didn’t you come in sooner?”

This frustrating scenario calls for a new paradigm for surveillance of PAD – a more personalized approach in line with precision medicine.

Over the past decade, the prevalence of smartphones and other personal mobile devices has increased at a blistering pace. Today, over 700 million iPhones alone exist worldwide. These devices have an enormous potential to revolutionize the way we deliver care.

In 2014, Apple launched a secure personal mobile health repository called HealthKit, which now comes pre-loaded on every iPhone that is sold. This repository stores data ranging from step counts to blood glucose levels in a secure and structured way. As a bonus, every phone contains accelerometers which passively track a user’s daily activity. On the heels of HealthKit came the Apple ResearchKit framework, launched in 2015 as a means to standardize study enrollment, data collection, storage and transmission on the iPhone. The advent of this new study tool opened the door for remote patient monitoring and “siteless” clinical trials at scale.

These two new platforms have significant implications for health monitoring and diagnosis. While activity is the functional outcome that physicians aim to improve for disabling claudicants, the field currently lacks a means of objectively measuring patient activity and functional outcomes.

Traditional PAD monitoring focuses primarily on vessel patency and ankle brachial indices (ABIs) at 1-, 3-, 6- and 12-month intervals. The problem is that stents don’t fail at 1-, 3-, 6- and 12-month intervals, but ultrasounds and ABI’s require technicians and it’s challenging to perform those more often. There are too many gaps in knowledge, too many black holes, and a more granular approach is required. [NB: Seems to me just adding a 1 month reading would have solved the problem. The rest of the data points are perfect representations of the trend for which VascTrac provides no added benefit. The graph is not needed and would add even more “advertising flair.”

Using activity data as a surrogate for traditional measures of ABIs and vessel patency, we have designed algorithms to passively monitor patients’ daily activity using their personal smartphones. We have implemented these algorithms into an app and have now launched the VascTrac PAD Research Study.

VascTrac is an app available for download from the Apple App Store. Participants need an iPhone 5s (released in 2013) or a newer model. Enrollment, including consent, is all done on the phone. There are three short surveys focused on medical history, surgical history and PAD-specific history (including ABIs). Every two weeks, the app asks patients to perform a 6-minute walk test, and every quarter they are asked to complete the medical, surgical and PAD surveys. However, the majority of activity data is collected passively. Specifically, the app collects total steps per day, distance walked per day, and flights climbed per day and uses an algorithm developed by the team to gather data on a new unique metric, “Max Steps Without Stopping” (MSWS).

A motivated patient can walk 5 miles a day, but he or she may have to stop multiple times along the way. We believe MSWS will help catch the stopping due to the claudication. Patients are provided with a dashboard of their average activity for the week, month and year. They are also provided with links to PAD educational resources.

The VascTrac study is open to all, even non-PAD participants. The inclusion criteria are that a participant must be at least 18 years of age, live in the United States, speak English and have an iPhone 5s or newer model. The ideal patient, however, would be someone who is scheduled for an intervention. This way, the team can obtain a few weeks of baseline activity before evaluating the intervention’s effect on the patient’s functional activity.

Some of the questions our team hopes to answer are, What are the actual effects of our interventions (open vs. bypass) on a patient’s functional capacity? How stable are our interventions relative to a patient’s functional activity? What are the failure modes – is there a gradual decline in activity before failure or an abrupt decline? Can we predict failure of an intervention by doing a regression analysis of a patient’s functional activity trends?

We welcome the participation of any interested providers. More information can be found at www.vasctrac.stanford.edu, where providers can also request recruitment materials. Alternatively, the team can be contacted directly at [email protected].

This is an IRB-approved study and neither the researchers nor the university have any financial disclosures.

Oliver Aalami, MD, Stanford University School of Medicine/Palo Alto.

SAAVS meeting a success

The Sixth Annual meeting of the South Asian American Vascular Society (SAVVS), an affiliate of the Society for Vascular Surgery, was held on May 31 during the Vascular Annual Meeting.

The Society was formed to provide a forum for scientific, clinical, cultural, charitable and social interaction among American physicians and healthcare providers of South Asian origin involved in the management of vascular disease. SAAVS also works as a forum to collaborate with Vascular Societies across South Asia .

Member benefits include being able to support vascular surgery in our countries of origin; sharing business knowledge and experience with members related to vendors, office practices, and opening centers for access/veins; mentoring of younger surgeons and medical students; assisting with new techniques and endovascular training; guiding job placement, contracts, and privileging issues; networking with friends and colleagues all over the world; taking a greater role in national societies; and taking advantage of the network for assistance in locating/obtaining training positions for family members.

The first annual meeting of the SAAVS was held in 2010. Past Presidents have included Drs. Krishna Jain, Bhagwan Satiani, Brajesh Lal, Anil Hingorani, Dipankar Mukherjee, and Ravi Veeraswamy. During VAM 2017, the current president, Faisal Aziz, MD, of Penn State gave his annual report and the society then inducted its future president Raghu Motaganahalli, MD, from Indiana University into office. Dr. Motaganahalli was also recently appointed as Director of the Division of Vascular Surgery at Indiana University. Peter Lawrence, MD, provided a keynote address highlighting opportunities for conducting research to improve patient care.

Other officers for 2017-2018 include President Elect Sachinder Hans, MD; Secretary Raj Sarkar, MD; Treasurer Krish Soundararajan, MD; Membership Committee: Kapil Gopal, MD, and Syed Alam, MD; Bylaws: Bhagwan Satiani, MD; Industry Relations: Krishna Jain, MD.

A regular feature of the meeting is an abstract/presentation contest for medical students and fellows interested in Vascular Surgery. First place winners from each category are offered cash prizes. In the future, SAAVS plans to have traveling fellowship programs for physicians from South Asia, as well as the United States, for collaborative clinical and educational exchange. Two members have already visited India and Pakistan for collaboration and assistance with endovascular procedures.

The website is www.saavsociety.org

Bhagwan Satiani, MD, The Ohio State University College of Medicine, Columbus.

Study established for “precision” surveillance for PAD

During the Vascular Annual Meeting (VAM) in San Diego, the Centers for Medicaid and Medicaid Services (CMS) announced its decision to reimburse supervised exercise therapy (SET) for beneficiaries with PAD. This decision was based on evidence which concluded that SET improves health outcomes for Medicare beneficiaries with intermittent claudication due to PAD. Up to this point physician-prescribed supervised exercise therapy was only covered exclusively for Cardiac Rehabilitation.

SET for PAD covers up to 36 sessions over a 12 week period if sessions 1) last 30-60 minutes; 2) are conducted in a hospital outpatient setting or physician’s office; and 3) are delivered by qualified auxiliary personnel to ensure benefits exceed harm and if 4) beneficiaries are under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist who must be trained in both basic and advanced life support techniques. Face-to-face visits with the physician responsible for PAD treatment is required for a SET referral. At this visit, the beneficiary must receive information regarding CV and PAD risk factor reduction, which could include education, counseling, behavior interventions and outcome assessments.

The widespread implementation of SET programs will require the adoption of a functional outcome assessment for PAD.

Here at the Division of Vascular Surgery at Stanford University, we are evaluating the use of a patient’s own smartphone to track and monitor walking activity. The research study called, VascTrac, was developed to provide a more “personalized” approach to surveillance for patients with intermittent claudication in line with precision medicine. We hypothesize that there is a direct correlation between a patient’s walking ability (functional status) and their disease burden.

Vascular surgeons today are finding themselves faced with an increasingly common problem: the “returning patient.” All too often, patients with peripheral artery disease are returning to clinic just months after treatment, frustrated by resurfacing symptoms. What was seemingly a straightforward femoral artery occlusion with an easy stent fix has somehow degraded into disabling claudication (Rutherford Class II/III) in a very short period of time. A staggering number of these patients have perfect-appearing completion angiograms, yet they return to clinic with complete re-occlusions. The tale of mild symptom return, typically beginning several months prior to the current visit, is becoming unsettlingly familiar. Inevitably, the story raises the question: “Why didn’t you come in sooner?”

This frustrating scenario calls for a new paradigm for surveillance of PAD – a more personalized approach in line with precision medicine.

Over the past decade, the prevalence of smartphones and other personal mobile devices has increased at a blistering pace. Today, over 700 million iPhones alone exist worldwide. These devices have an enormous potential to revolutionize the way we deliver care.

In 2014, Apple launched a secure personal mobile health repository called HealthKit, which now comes pre-loaded on every iPhone that is sold. This repository stores data ranging from step counts to blood glucose levels in a secure and structured way. As a bonus, every phone contains accelerometers which passively track a user’s daily activity. On the heels of HealthKit came the Apple ResearchKit framework, launched in 2015 as a means to standardize study enrollment, data collection, storage and transmission on the iPhone. The advent of this new study tool opened the door for remote patient monitoring and “siteless” clinical trials at scale.

These two new platforms have significant implications for health monitoring and diagnosis. While activity is the functional outcome that physicians aim to improve for disabling claudicants, the field currently lacks a means of objectively measuring patient activity and functional outcomes.

Traditional PAD monitoring focuses primarily on vessel patency and ankle brachial indices (ABIs) at 1-, 3-, 6- and 12-month intervals. The problem is that stents don’t fail at 1-, 3-, 6- and 12-month intervals, but ultrasounds and ABI’s require technicians and it’s challenging to perform those more often. There are too many gaps in knowledge, too many black holes, and a more granular approach is required. [NB: Seems to me just adding a 1 month reading would have solved the problem. The rest of the data points are perfect representations of the trend for which VascTrac provides no added benefit. The graph is not needed and would add even more “advertising flair.”

Using activity data as a surrogate for traditional measures of ABIs and vessel patency, we have designed algorithms to passively monitor patients’ daily activity using their personal smartphones. We have implemented these algorithms into an app and have now launched the VascTrac PAD Research Study.

VascTrac is an app available for download from the Apple App Store. Participants need an iPhone 5s (released in 2013) or a newer model. Enrollment, including consent, is all done on the phone. There are three short surveys focused on medical history, surgical history and PAD-specific history (including ABIs). Every two weeks, the app asks patients to perform a 6-minute walk test, and every quarter they are asked to complete the medical, surgical and PAD surveys. However, the majority of activity data is collected passively. Specifically, the app collects total steps per day, distance walked per day, and flights climbed per day and uses an algorithm developed by the team to gather data on a new unique metric, “Max Steps Without Stopping” (MSWS).

A motivated patient can walk 5 miles a day, but he or she may have to stop multiple times along the way. We believe MSWS will help catch the stopping due to the claudication. Patients are provided with a dashboard of their average activity for the week, month and year. They are also provided with links to PAD educational resources.

The VascTrac study is open to all, even non-PAD participants. The inclusion criteria are that a participant must be at least 18 years of age, live in the United States, speak English and have an iPhone 5s or newer model. The ideal patient, however, would be someone who is scheduled for an intervention. This way, the team can obtain a few weeks of baseline activity before evaluating the intervention’s effect on the patient’s functional activity.

Some of the questions our team hopes to answer are, What are the actual effects of our interventions (open vs. bypass) on a patient’s functional capacity? How stable are our interventions relative to a patient’s functional activity? What are the failure modes – is there a gradual decline in activity before failure or an abrupt decline? Can we predict failure of an intervention by doing a regression analysis of a patient’s functional activity trends?

We welcome the participation of any interested providers. More information can be found at www.vasctrac.stanford.edu, where providers can also request recruitment materials. Alternatively, the team can be contacted directly at [email protected].

This is an IRB-approved study and neither the researchers nor the university have any financial disclosures.

Oliver Aalami, MD, Stanford University School of Medicine/Palo Alto.

NEW YORK – Concurrent mitral-tricuspid valve surgery has similar outcomes to isolated minimally invasive mitral valve surgery, according to results of a 12-year review reported at the 2017 Mitral Valve Conclave, sponsored by the American Association for Thoracic Surgery.

Indications for minimally invasive tricuspid valve surgery done at the same time of mitral valve surgery have not been well established, in part because the outcomes of such combined procedures have been underreported.

NEW YORK – Concurrent mitral-tricuspid valve surgery has similar outcomes to isolated minimally invasive mitral valve surgery, according to results of a 12-year review reported at the 2017 Mitral Valve Conclave, sponsored by the American Association for Thoracic Surgery.

Indications for minimally invasive tricuspid valve surgery done at the same time of mitral valve surgery have not been well established, in part because the outcomes of such combined procedures have been underreported.

NEW YORK – Concurrent mitral-tricuspid valve surgery has similar outcomes to isolated minimally invasive mitral valve surgery, according to results of a 12-year review reported at the 2017 Mitral Valve Conclave, sponsored by the American Association for Thoracic Surgery.

Indications for minimally invasive tricuspid valve surgery done at the same time of mitral valve surgery have not been well established, in part because the outcomes of such combined procedures have been underreported.

Influenza vaccinations given through a microneedle patch (MNP) received higher patient approval compared with traditional inoculation methods, according to a small study funded by the National Institutes of Health.

In a phase I, randomized, placebo-controlled study, 100 patients between the ages of 18 and 49 years were split into four groups: one given the patch by a health care worker, one instructed to apply the patch at home, one given a vaccine through a traditional intramuscular injection, and one given a placebo.

Of those who took the patch, 70% (33 of 47) preferred the patch to intramuscular injection (The Lancet. 2017 Jun 27. doi: 10.1016/S0140-6736[17]30575-5).

All nonplacebo groups were given Fluvirin, the 2014-2015 licensed trivalent inactivated influenza vaccine, according to the researchers.

Protection against the virus 6 months after vaccination was similar across all groups other than the placebo group: 20-24 (83%-100%) of 24 participants given the patch by a health care worker, 18-24 (75%-100%) of 24 in the group of patients who gave themselves the patch, and 20-25 (80%-100%) of 25 in the injection group having achieved seroprotection against the three influenza strains 6 months after vaccination.

When measuring reactogenicity, the investigators did find more patients (41 of 50) reported cases of pruritis in the microneedle group than in the injection group (4 of 25).

However, these cases were mostly mild, while the injection group reported more grade 2 and grade 3 reactions, with grade 4 being the most severe.

Given the storage temperature of 40° C and ease of use without a health care provider, the investigators discussed the financial and clinical prospects of the patch.

“Increased acceptability could enable increased rates of influenza vaccination, which are currently less than 50% in adult populations,” they noted. “Moreover, because participants were able to self-vaccinate and 70% or more preferred it, significant cost savings could be enabled by microneedle patches due to a reduction in health-care worker time devoted to vaccination.”

Along with storage life and simple application process, the fact that the microneedles dissolve safely into the skin creates the potential for use in patients’ homes and offices, the researchers noted.

There may also be potential for use among pediatric patients, who may be resistant to vaccinations because of the injection method, they added.

“Microneedle patches have the potential to become ideal candidates for vaccination programmes, not only in poorly resourced settings, but also for individuals who currently prefer not to get vaccinated, potentially even being an attractive vaccine for the paediatric population,” Katja Höschler, PhD, and Maria C. Zambon, PhD, of Public Health England, London, said in a comment published with the study (The Lancet. 2017 Jun 27. doi: 10.1016/S0140-6736[17]31364-8). “The delivery advantages could also be exploited for non-influenza vaccines.”

Further studies must be conducted to test the efficacy of this vaccination system, because this study was limited by its size, the researchers noted.

The population was less inclined to receive an influenza injection because of the method itself, which may have affected the levels of preference for the patch, they added.

Some of the researchers are employees of Micron Biomedical, a company that manufactures microneedle products, and are listed as inventors on the licensed patents of these products. The investigators reported no other relevant financial disclosures.

[email protected]

On Twitter@eaztweets

Influenza vaccinations given through a microneedle patch (MNP) received higher patient approval compared with traditional inoculation methods, according to a small study funded by the National Institutes of Health.

In a phase I, randomized, placebo-controlled study, 100 patients between the ages of 18 and 49 years were split into four groups: one given the patch by a health care worker, one instructed to apply the patch at home, one given a vaccine through a traditional intramuscular injection, and one given a placebo.

Of those who took the patch, 70% (33 of 47) preferred the patch to intramuscular injection (The Lancet. 2017 Jun 27. doi: 10.1016/S0140-6736[17]30575-5).

All nonplacebo groups were given Fluvirin, the 2014-2015 licensed trivalent inactivated influenza vaccine, according to the researchers.

Protection against the virus 6 months after vaccination was similar across all groups other than the placebo group: 20-24 (83%-100%) of 24 participants given the patch by a health care worker, 18-24 (75%-100%) of 24 in the group of patients who gave themselves the patch, and 20-25 (80%-100%) of 25 in the injection group having achieved seroprotection against the three influenza strains 6 months after vaccination.

When measuring reactogenicity, the investigators did find more patients (41 of 50) reported cases of pruritis in the microneedle group than in the injection group (4 of 25).

However, these cases were mostly mild, while the injection group reported more grade 2 and grade 3 reactions, with grade 4 being the most severe.

Given the storage temperature of 40° C and ease of use without a health care provider, the investigators discussed the financial and clinical prospects of the patch.

“Increased acceptability could enable increased rates of influenza vaccination, which are currently less than 50% in adult populations,” they noted. “Moreover, because participants were able to self-vaccinate and 70% or more preferred it, significant cost savings could be enabled by microneedle patches due to a reduction in health-care worker time devoted to vaccination.”

Along with storage life and simple application process, the fact that the microneedles dissolve safely into the skin creates the potential for use in patients’ homes and offices, the researchers noted.

There may also be potential for use among pediatric patients, who may be resistant to vaccinations because of the injection method, they added.

“Microneedle patches have the potential to become ideal candidates for vaccination programmes, not only in poorly resourced settings, but also for individuals who currently prefer not to get vaccinated, potentially even being an attractive vaccine for the paediatric population,” Katja Höschler, PhD, and Maria C. Zambon, PhD, of Public Health England, London, said in a comment published with the study (The Lancet. 2017 Jun 27. doi: 10.1016/S0140-6736[17]31364-8). “The delivery advantages could also be exploited for non-influenza vaccines.”

Further studies must be conducted to test the efficacy of this vaccination system, because this study was limited by its size, the researchers noted.

The population was less inclined to receive an influenza injection because of the method itself, which may have affected the levels of preference for the patch, they added.

Some of the researchers are employees of Micron Biomedical, a company that manufactures microneedle products, and are listed as inventors on the licensed patents of these products. The investigators reported no other relevant financial disclosures.

[email protected]

On Twitter@eaztweets

Influenza vaccinations given through a microneedle patch (MNP) received higher patient approval compared with traditional inoculation methods, according to a small study funded by the National Institutes of Health.

In a phase I, randomized, placebo-controlled study, 100 patients between the ages of 18 and 49 years were split into four groups: one given the patch by a health care worker, one instructed to apply the patch at home, one given a vaccine through a traditional intramuscular injection, and one given a placebo.

Of those who took the patch, 70% (33 of 47) preferred the patch to intramuscular injection (The Lancet. 2017 Jun 27. doi: 10.1016/S0140-6736[17]30575-5).

All nonplacebo groups were given Fluvirin, the 2014-2015 licensed trivalent inactivated influenza vaccine, according to the researchers.

Protection against the virus 6 months after vaccination was similar across all groups other than the placebo group: 20-24 (83%-100%) of 24 participants given the patch by a health care worker, 18-24 (75%-100%) of 24 in the group of patients who gave themselves the patch, and 20-25 (80%-100%) of 25 in the injection group having achieved seroprotection against the three influenza strains 6 months after vaccination.

When measuring reactogenicity, the investigators did find more patients (41 of 50) reported cases of pruritis in the microneedle group than in the injection group (4 of 25).

However, these cases were mostly mild, while the injection group reported more grade 2 and grade 3 reactions, with grade 4 being the most severe.

Given the storage temperature of 40° C and ease of use without a health care provider, the investigators discussed the financial and clinical prospects of the patch.

“Increased acceptability could enable increased rates of influenza vaccination, which are currently less than 50% in adult populations,” they noted. “Moreover, because participants were able to self-vaccinate and 70% or more preferred it, significant cost savings could be enabled by microneedle patches due to a reduction in health-care worker time devoted to vaccination.”

Along with storage life and simple application process, the fact that the microneedles dissolve safely into the skin creates the potential for use in patients’ homes and offices, the researchers noted.

There may also be potential for use among pediatric patients, who may be resistant to vaccinations because of the injection method, they added.

“Microneedle patches have the potential to become ideal candidates for vaccination programmes, not only in poorly resourced settings, but also for individuals who currently prefer not to get vaccinated, potentially even being an attractive vaccine for the paediatric population,” Katja Höschler, PhD, and Maria C. Zambon, PhD, of Public Health England, London, said in a comment published with the study (The Lancet. 2017 Jun 27. doi: 10.1016/S0140-6736[17]31364-8). “The delivery advantages could also be exploited for non-influenza vaccines.”

Further studies must be conducted to test the efficacy of this vaccination system, because this study was limited by its size, the researchers noted.

The population was less inclined to receive an influenza injection because of the method itself, which may have affected the levels of preference for the patch, they added.

Some of the researchers are employees of Micron Biomedical, a company that manufactures microneedle products, and are listed as inventors on the licensed patents of these products. The investigators reported no other relevant financial disclosures.

[email protected]

On Twitter@eaztweets

Physician burnout is rampant, and every seat was taken at a workshop on physician burnout and depression at this year’s APA annual meeting in San Diego.

In his book, “Why Physicians Die By Suicide” (Amazon, 2017), Michael F. Myers, MD, describes “burnout.”

Darrin Klimek/Thinkstock

Dr. Miller, who practices in Baltimore, is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care,” (Baltimore: Johns Hopkins University Press, 2016).

Physician burnout is rampant, and every seat was taken at a workshop on physician burnout and depression at this year’s APA annual meeting in San Diego.

In his book, “Why Physicians Die By Suicide” (Amazon, 2017), Michael F. Myers, MD, describes “burnout.”

Darrin Klimek/Thinkstock

Dr. Miller, who practices in Baltimore, is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care,” (Baltimore: Johns Hopkins University Press, 2016).

Physician burnout is rampant, and every seat was taken at a workshop on physician burnout and depression at this year’s APA annual meeting in San Diego.

In his book, “Why Physicians Die By Suicide” (Amazon, 2017), Michael F. Myers, MD, describes “burnout.”

Darrin Klimek/Thinkstock

Dr. Miller, who practices in Baltimore, is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care,” (Baltimore: Johns Hopkins University Press, 2016).

Experts describe the field of female genital cosmetic surgery as the “Wild West,” but the lack of regulation and consensus has not kept it from exploding in recent years.

More than 10,000 labiaplasties were performed in 2016, a 23% jump over the previous year, and the procedures are offered by more than 35% of all plastic surgeons, according to data from the American Society for Aesthetic Plastic Surgery. As another indicator of increasing attention to the appearance of female genitalia, a 2013 survey of U.S. women revealed that more than 80% performed some sort of pubic hair grooming (JAMA Dermatol. 2016;152[10]:1106-13).

Labiaplasty

The combination of a newly-hairless genital region, together with portrayals of adult women with a “Barbie doll” appearance, may contribute to women feeling self-conscious about labia minora protruding beyond the labia majora. Dr. Iglesia, who is section director for female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, Washington, D.C., said this is true even though the normal length of labia minora can range from 7 mm to 5 cm.

That’s where labiaplasty comes in. The procedure, which can be performed with conventional surgical techniques or with a laser, is sometimes done for functional reasons.

Fractional laser

The introduction of the fractional laser to gynecology is also adding to the debate about the appropriate integration of gynecologic procedures that may have nonmedical uses, such as vaginal “tightening.” Used primarily intravaginally, these devices have shallow penetration and are meant to stimulate collagen, proteoglycan, and hyaluronic acid synthesis with minimal tissue damage and downtime. One such device, the MonaLisa Touch, is marketed in the United States by Cynosure.

These energy sources hold great promise for the genitourinary syndrome of menopause (GSM) and other conditions, Dr. Karram said. “Many of these energy sources are being promoted for actual disease states, like vulvovaginal atrophy and lichen sclerosus,” he said.

Dr. Iglesia is not so sure: “This is not the fountain of youth.” She pointed out that the vasculature and innervation of the vagina and vulva are complex, with the outer one-eighth of the vagina being much more highly innervated. Laser treatment with a shallow penetration depth may not get at all of the issues that contribute to GSM.

“Is marketing ahead of the science? I would say yes,” she said. “There’s too much hype about this curing vaginal dryness and making your sex life better.”

Dr. Zahn also urged caution with the use of this technology. “The data are very limited, but, despite this, it’s become a very popular and highly-advertised approach. We need larger studies and more longitudinal data. This is especially true since one of the proposed ways this device works is by stimulating fibrosis. In every other body system, fibrosis stimulation may result in scarring. We have no idea if this is the case with this device. If it is, its application could result in worsening of bodily function, especially in regard to dyspareunia,” he said. “We clearly need more data.”

In 2016, ACOG issued a position statement about the fractional carbon dioxide and yttrium-aluminum-garnet laser systems that had received clearance from the Food and Drug Administration. The statement advised both ob.gyns. and patients that “this technology is, in fact, neither approved nor cleared by the FDA for the specific indication of treating vulvovaginal atrophy.”

Both Dr. Karram and Dr. Iglesia are investigators in an ongoing randomized, placebo- and sham-controlled trial comparing vaginal estrogen and laser therapy used both in conjunction and singly.

‘No-go’ procedures

Though Dr. Karram and Dr. Iglesia disagree on whether cosmetic labiaplasty is appropriate, they were in agreement that certain procedures are so untested, or have such potential risk with no proven benefit, that they should not be performed at all. The procedures on both physicians’ “no-go” lists included clitoral unhooding, G-spot amplification, “revirginification” in any form, vulval recontouring with autologous fat, and the so-called “O-shot,” injections of platelet-rich plasma that are touted as augmenting the sexual experience.

What’s to be done?

There is also agreement that a lack of common terminology is a significant problem. Step one, Dr. Karram said, is doing away with the term vaginal rejuvenation. “This is a terrible term. … There’s no real definition for this term.” He called for a multidisciplinary working group that would bring together gynecologists, plastic surgeons, and dermatologists to begin the work of terminology standardization.

From there, he proposed that the group develop a classification system that clarifies whether procedures are being done for cosmetic reasons, to enhance the sexual experience, or to address a specific disease state. Finally, he said, the group should recommend standardized outcome metrics that can be used to study the various interventions.

Dr. Zahn applauded this notion. “It’s a great point. I agree that multiple disciplines should be involved in examining outcomes, statistics, and criteria for evaluating procedures.”
And gynecologists should be leading this effort, Dr. Karram suggested. “Who knows this anatomy the best? We do.” He added, “If it’s going to be addressed, it should be addressed by us.”

But, Dr. Iglesia said she worries about vulnerable populations, such as adolescents and cancer survivors, who may undergo surgeries, for which the benefits may not outweigh the potential risks. For labiaplasty and laser resurfacing techniques, there have been a small number of studies on outcomes and patient satisfaction that have generally been conducted at single centers with no comparison arms and limited follow-up, she said.

“I also am concerned about pain, scarring, altered sensation, painful sex that could develop, wound complications, and what happens over time,” especially when these procedures may be performed on adolescents or women in their 20s or 30s who may later go on to have children, Dr. Iglesia said.

The question, she said, is not just whether gynecologists are better equipped than plastic surgeons or dermatologists to be performing female genital cosmetic surgery, “but should we be doing this at all?”

Dr. Zahn emphasized the need for evidence to guide decision making. “There has to be data that there is benefit and that the benefit outweighs the potential harm. There is no data on most cosmetic gynecologic procedures. If there are no data, they shouldn’t be done because we would not have the information necessary to appropriately counsel patients,” he said.

Dr. Karram has a financial relationship with Cynosure, which markets the MonaLisa Touch system in the United States. Dr. Iglesia reported that she had no relevant financial disclosures. Dr. Zahn is employed by ACOG.

[email protected]

On Twitter @karioakes

Experts describe the field of female genital cosmetic surgery as the “Wild West,” but the lack of regulation and consensus has not kept it from exploding in recent years.

More than 10,000 labiaplasties were performed in 2016, a 23% jump over the previous year, and the procedures are offered by more than 35% of all plastic surgeons, according to data from the American Society for Aesthetic Plastic Surgery. As another indicator of increasing attention to the appearance of female genitalia, a 2013 survey of U.S. women revealed that more than 80% performed some sort of pubic hair grooming (JAMA Dermatol. 2016;152[10]:1106-13).

Labiaplasty

The combination of a newly-hairless genital region, together with portrayals of adult women with a “Barbie doll” appearance, may contribute to women feeling self-conscious about labia minora protruding beyond the labia majora. Dr. Iglesia, who is section director for female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, Washington, D.C., said this is true even though the normal length of labia minora can range from 7 mm to 5 cm.

That’s where labiaplasty comes in. The procedure, which can be performed with conventional surgical techniques or with a laser, is sometimes done for functional reasons.

Fractional laser

The introduction of the fractional laser to gynecology is also adding to the debate about the appropriate integration of gynecologic procedures that may have nonmedical uses, such as vaginal “tightening.” Used primarily intravaginally, these devices have shallow penetration and are meant to stimulate collagen, proteoglycan, and hyaluronic acid synthesis with minimal tissue damage and downtime. One such device, the MonaLisa Touch, is marketed in the United States by Cynosure.

These energy sources hold great promise for the genitourinary syndrome of menopause (GSM) and other conditions, Dr. Karram said. “Many of these energy sources are being promoted for actual disease states, like vulvovaginal atrophy and lichen sclerosus,” he said.

Dr. Iglesia is not so sure: “This is not the fountain of youth.” She pointed out that the vasculature and innervation of the vagina and vulva are complex, with the outer one-eighth of the vagina being much more highly innervated. Laser treatment with a shallow penetration depth may not get at all of the issues that contribute to GSM.

“Is marketing ahead of the science? I would say yes,” she said. “There’s too much hype about this curing vaginal dryness and making your sex life better.”

Dr. Zahn also urged caution with the use of this technology. “The data are very limited, but, despite this, it’s become a very popular and highly-advertised approach. We need larger studies and more longitudinal data. This is especially true since one of the proposed ways this device works is by stimulating fibrosis. In every other body system, fibrosis stimulation may result in scarring. We have no idea if this is the case with this device. If it is, its application could result in worsening of bodily function, especially in regard to dyspareunia,” he said. “We clearly need more data.”

In 2016, ACOG issued a position statement about the fractional carbon dioxide and yttrium-aluminum-garnet laser systems that had received clearance from the Food and Drug Administration. The statement advised both ob.gyns. and patients that “this technology is, in fact, neither approved nor cleared by the FDA for the specific indication of treating vulvovaginal atrophy.”

Both Dr. Karram and Dr. Iglesia are investigators in an ongoing randomized, placebo- and sham-controlled trial comparing vaginal estrogen and laser therapy used both in conjunction and singly.

‘No-go’ procedures

Though Dr. Karram and Dr. Iglesia disagree on whether cosmetic labiaplasty is appropriate, they were in agreement that certain procedures are so untested, or have such potential risk with no proven benefit, that they should not be performed at all. The procedures on both physicians’ “no-go” lists included clitoral unhooding, G-spot amplification, “revirginification” in any form, vulval recontouring with autologous fat, and the so-called “O-shot,” injections of platelet-rich plasma that are touted as augmenting the sexual experience.

What’s to be done?

There is also agreement that a lack of common terminology is a significant problem. Step one, Dr. Karram said, is doing away with the term vaginal rejuvenation. “This is a terrible term. … There’s no real definition for this term.” He called for a multidisciplinary working group that would bring together gynecologists, plastic surgeons, and dermatologists to begin the work of terminology standardization.

From there, he proposed that the group develop a classification system that clarifies whether procedures are being done for cosmetic reasons, to enhance the sexual experience, or to address a specific disease state. Finally, he said, the group should recommend standardized outcome metrics that can be used to study the various interventions.

Dr. Zahn applauded this notion. “It’s a great point. I agree that multiple disciplines should be involved in examining outcomes, statistics, and criteria for evaluating procedures.”
And gynecologists should be leading this effort, Dr. Karram suggested. “Who knows this anatomy the best? We do.” He added, “If it’s going to be addressed, it should be addressed by us.”

But, Dr. Iglesia said she worries about vulnerable populations, such as adolescents and cancer survivors, who may undergo surgeries, for which the benefits may not outweigh the potential risks. For labiaplasty and laser resurfacing techniques, there have been a small number of studies on outcomes and patient satisfaction that have generally been conducted at single centers with no comparison arms and limited follow-up, she said.

“I also am concerned about pain, scarring, altered sensation, painful sex that could develop, wound complications, and what happens over time,” especially when these procedures may be performed on adolescents or women in their 20s or 30s who may later go on to have children, Dr. Iglesia said.

The question, she said, is not just whether gynecologists are better equipped than plastic surgeons or dermatologists to be performing female genital cosmetic surgery, “but should we be doing this at all?”

Dr. Zahn emphasized the need for evidence to guide decision making. “There has to be data that there is benefit and that the benefit outweighs the potential harm. There is no data on most cosmetic gynecologic procedures. If there are no data, they shouldn’t be done because we would not have the information necessary to appropriately counsel patients,” he said.

Dr. Karram has a financial relationship with Cynosure, which markets the MonaLisa Touch system in the United States. Dr. Iglesia reported that she had no relevant financial disclosures. Dr. Zahn is employed by ACOG.

[email protected]

On Twitter @karioakes

Experts describe the field of female genital cosmetic surgery as the “Wild West,” but the lack of regulation and consensus has not kept it from exploding in recent years.

More than 10,000 labiaplasties were performed in 2016, a 23% jump over the previous year, and the procedures are offered by more than 35% of all plastic surgeons, according to data from the American Society for Aesthetic Plastic Surgery. As another indicator of increasing attention to the appearance of female genitalia, a 2013 survey of U.S. women revealed that more than 80% performed some sort of pubic hair grooming (JAMA Dermatol. 2016;152[10]:1106-13).

Labiaplasty

The combination of a newly-hairless genital region, together with portrayals of adult women with a “Barbie doll” appearance, may contribute to women feeling self-conscious about labia minora protruding beyond the labia majora. Dr. Iglesia, who is section director for female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, Washington, D.C., said this is true even though the normal length of labia minora can range from 7 mm to 5 cm.

That’s where labiaplasty comes in. The procedure, which can be performed with conventional surgical techniques or with a laser, is sometimes done for functional reasons.

Fractional laser

The introduction of the fractional laser to gynecology is also adding to the debate about the appropriate integration of gynecologic procedures that may have nonmedical uses, such as vaginal “tightening.” Used primarily intravaginally, these devices have shallow penetration and are meant to stimulate collagen, proteoglycan, and hyaluronic acid synthesis with minimal tissue damage and downtime. One such device, the MonaLisa Touch, is marketed in the United States by Cynosure.

These energy sources hold great promise for the genitourinary syndrome of menopause (GSM) and other conditions, Dr. Karram said. “Many of these energy sources are being promoted for actual disease states, like vulvovaginal atrophy and lichen sclerosus,” he said.

Dr. Iglesia is not so sure: “This is not the fountain of youth.” She pointed out that the vasculature and innervation of the vagina and vulva are complex, with the outer one-eighth of the vagina being much more highly innervated. Laser treatment with a shallow penetration depth may not get at all of the issues that contribute to GSM.

“Is marketing ahead of the science? I would say yes,” she said. “There’s too much hype about this curing vaginal dryness and making your sex life better.”

Dr. Zahn also urged caution with the use of this technology. “The data are very limited, but, despite this, it’s become a very popular and highly-advertised approach. We need larger studies and more longitudinal data. This is especially true since one of the proposed ways this device works is by stimulating fibrosis. In every other body system, fibrosis stimulation may result in scarring. We have no idea if this is the case with this device. If it is, its application could result in worsening of bodily function, especially in regard to dyspareunia,” he said. “We clearly need more data.”

In 2016, ACOG issued a position statement about the fractional carbon dioxide and yttrium-aluminum-garnet laser systems that had received clearance from the Food and Drug Administration. The statement advised both ob.gyns. and patients that “this technology is, in fact, neither approved nor cleared by the FDA for the specific indication of treating vulvovaginal atrophy.”

Both Dr. Karram and Dr. Iglesia are investigators in an ongoing randomized, placebo- and sham-controlled trial comparing vaginal estrogen and laser therapy used both in conjunction and singly.

‘No-go’ procedures

Though Dr. Karram and Dr. Iglesia disagree on whether cosmetic labiaplasty is appropriate, they were in agreement that certain procedures are so untested, or have such potential risk with no proven benefit, that they should not be performed at all. The procedures on both physicians’ “no-go” lists included clitoral unhooding, G-spot amplification, “revirginification” in any form, vulval recontouring with autologous fat, and the so-called “O-shot,” injections of platelet-rich plasma that are touted as augmenting the sexual experience.

What’s to be done?

There is also agreement that a lack of common terminology is a significant problem. Step one, Dr. Karram said, is doing away with the term vaginal rejuvenation. “This is a terrible term. … There’s no real definition for this term.” He called for a multidisciplinary working group that would bring together gynecologists, plastic surgeons, and dermatologists to begin the work of terminology standardization.

From there, he proposed that the group develop a classification system that clarifies whether procedures are being done for cosmetic reasons, to enhance the sexual experience, or to address a specific disease state. Finally, he said, the group should recommend standardized outcome metrics that can be used to study the various interventions.

Dr. Zahn applauded this notion. “It’s a great point. I agree that multiple disciplines should be involved in examining outcomes, statistics, and criteria for evaluating procedures.”
And gynecologists should be leading this effort, Dr. Karram suggested. “Who knows this anatomy the best? We do.” He added, “If it’s going to be addressed, it should be addressed by us.”

But, Dr. Iglesia said she worries about vulnerable populations, such as adolescents and cancer survivors, who may undergo surgeries, for which the benefits may not outweigh the potential risks. For labiaplasty and laser resurfacing techniques, there have been a small number of studies on outcomes and patient satisfaction that have generally been conducted at single centers with no comparison arms and limited follow-up, she said.

“I also am concerned about pain, scarring, altered sensation, painful sex that could develop, wound complications, and what happens over time,” especially when these procedures may be performed on adolescents or women in their 20s or 30s who may later go on to have children, Dr. Iglesia said.

The question, she said, is not just whether gynecologists are better equipped than plastic surgeons or dermatologists to be performing female genital cosmetic surgery, “but should we be doing this at all?”

Dr. Zahn emphasized the need for evidence to guide decision making. “There has to be data that there is benefit and that the benefit outweighs the potential harm. There is no data on most cosmetic gynecologic procedures. If there are no data, they shouldn’t be done because we would not have the information necessary to appropriately counsel patients,” he said.

Dr. Karram has a financial relationship with Cynosure, which markets the MonaLisa Touch system in the United States. Dr. Iglesia reported that she had no relevant financial disclosures. Dr. Zahn is employed by ACOG.

[email protected]

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Almost half of Crohn disease (CD) patients experience a dermatologic manifestation of the disease. A rare entity, metastatic CD (MCD) presents a diagnostic challenge without a high index of suspicion. Its etiology is not well defined; however, it appears to be an autoimmune response to gut antigens. Herein, we review the etiology/epidemiology, diagnostic criteria, and treatment for this uncommon condition.

Epidemiology and Clinical Characteristics of MCD

Metastatic CD was first described by Parks et al1 in 1965 and refers to a diverse collection of macroscopic dermatologic manifestations in tissue not contiguous with the gastrointestinal (GI) tract. To be classified as MCD, the tissue must demonstrate characteristic histopathologic findings, which invariably include noncaseating granulomas.

Crohn disease may affect any part of the GI tract from the mouth to anus, with a multitude of associated cutaneous manifestations having been described. The terminal ileum is the most commonly affected portion of the GI tract in CD, but the large intestine also may be involved in 55% to 80% of cases.² The incidence of non-MCD-associated anal lesions seems to correlate with intestinal involvement in that as few as 25% of patients with ileal-localized CD have anal lesions compared to nearly 80% of patients with large intestinal involvement.³

It has been estimated that 18% to 44% of patients with CD have some form of cutaneous manifestation,⁴ with MCD being a rare subcategory. As few as 100 cases have been described from 1965 to the present.⁵ The presence of MCD does not correlate well with severity of intestinal CD, and although a majority of MCD cases present after at least 6 months of GI symptoms,⁶ there are instances in which MCD presents without prior or existing evidence of intestinal CD.⁷

With regard to MCD, the term metastatic is sometimes supplanted in the literature by cutaneous to avoid any implication of cancer; however, due to a myriad of dermatologic manifestations, both terms can cause confusion. The categorization of the various types of cutaneous findings in CD is well summarized in a review by Palamaras et al8 with the following classifications: (1) granulomatous by direct extension (oral or perianal), (2) MCD lesions (genital and nongenital), (3) immune-related lesions, and (4) lesions from nutritional deficiencies. Of the cutaneous manifestations relating to CD, MCD is the least common cutaneous categorical manifestation and is further divided into subcategories of genital and nongenital lesions.⁸

The nongenital distribution of MCD is the more common variety in adults and particularly seems to affect the legs and plantar surfaces (38%), the trunk and abdomen (24%), and the face (15%).^5,9 These nongenital MCD manifestations are most commonly described as nodules, ulcerations, or erythematous to purple plaques, and less commonly described as abscesses, pustules, or papules.

The sequence of cutaneous symptoms of MCD relative to intestinal disease depends to some degree on patient age. In adults diagnosed with MCD, it has been noted that a GI flare is expected 2 months to 4 years after diagnosis; however, in children the subsequent GI flare has been noted to vary more widely from 9 months to 14 years following presentation of MCD.⁸ Furthermore, roughly 50% of children diagnosed with MCD present concomitantly with their first symptoms of a GI flare, whereas 70% of adults with MCD had been previously diagnosed with intestinal CD.⁸ In one review of 80 reported cases of MCD, 20% (16/80) had no symptoms of intestinal disease at the time of MCD diagnosis, and the majority of the asymptomatic cases were in children; interestingly, the majority of these same children were diagnosed with CD months to years later.⁹

Both the location and characteristics of cutaneous findings in MCD correlate with age.⁹ Metastatic CD has been identified in all age groups; however, lymphedema is more common in children/young adults, while nodules, ulceration, and fistulating disease are more often seen in adults.¹⁰ Affected children and adolescents with MCD range from 5 to 17 years of age, with a mean age at disease onset of 11.1 years and equal incidence in males and females.⁸ Adults with MCD range from 18 to 78 years of age, with a mean age at presentation of 38.4 years.^8,11

Concerning anatomic location of disease, adults with MCD most commonly have nodules with or without plaques on the arms and legs and less commonly in the genital area.⁸ In contrast, children with MCD are more prone to genital lesions, with up to 85% of cases including some degree of genital erythematous or nonerythematous swelling with or without induration.⁸ Genitourinary complications of CD as a broad category, however, are estimated to occur in only 5% to 20% of intestinal CD cases in both children and adults.¹²

There have been conflicting reports regarding gender predilection in MCD. Based on a review by Samitz et al¹³ of 200 cases of CD over an 18-year period, 22% of patients with CD were found to have cutaneous manifestations--presumably not MCD but rather perianal, perineal, vulvar fistulae, fissures, or abscesses--with a male to female preponderance of almost 2 to 1. A more recent review of the literature by Palamaras et al⁸ in 2008 reported that contiguous non-MCD affects adult females and children more often than adult males, with 63% adult cases being female. This review seems to be more congruent with other reports in the literature implicating that females are twice as commonly affected by MCD than males.^9,14

Pathophysiology

The etiology of MCD has not been well defined. One proposed mechanism of the distal tissue involvement of MCD is through passage of antigens to the skin with subsequent granulomatous response at the level of the dermis.¹⁰ Another proposed mechanism suggests antibody sensitization to gut antigens, possibly bacterial antigens, that then coincidentally cross-react with analogous skin antigens.^8,14 Burgdorf¹¹ supported this notion in a 1981 report in which it was suggested that the granulomatous reaction was related to deposition of immune complexes in the skin. Slater et al¹⁵ and Tatnall et al¹⁶ offered a variation of Burgdorf's notion, suggesting that it was sensitized T cells to circulating antigens that were the initiators of granuloma formation in the periphery.

An examination of MCD tissue in 1990 by Shum and Guenther¹⁷ under electron microscopy and immunofluorescence provided evidence against prior studies that purported to have identified immune complexes as the causative agents of MCD. In this study, the authors found no evidence of immune complexes in the dermis of MCD lesions. In addition, an attempt to react serum antibodies of a patient with MCD, which were postulated to have IgG, IgM, and IgA antibodies to specific gut antigens, yielded no response when reacted with the tongue, ileum, and colon tissue from a rat. As a culminant finding, the authors also noted MCD dermis tissue with granulomas without vasculitis, suggesting a T-cell mediated type IV hypersensitivity response with a secondary vasculitis from T-cell origin lymphokines and T-cell mediated monocyte activation.¹⁷

Research implicating other immunologic entities involved in the pathophysiology of CD such as β-2 integrin,¹⁸ CD14⁺ monocytes,¹⁹ and the role of the DNA repair gene MLH1 (mutL homolog 1)²⁰ have been considered but without a clearly definitive role in the manifestations of MCD.

The utility of metronidazole in the treatment of MCD has been suggested as evidence that certain bacteria in the gut may either serve as the causative antigen or may induce its formation²¹; however, the causative antigen has yet to be identified, and whether it travels distally to the skin or merely resembles a similar antigen normally present in the dermis has not yet been determined. Some research has used in situ polymerase chain reaction techniques to attempt to detect similar microbial pathogens in both the vasculature of active bowel lesions and in the skin, but to date, bacterial RNA noted to be present in the gut vasculature adjacent to CD lesions has not been detected in skin lesions.²²

Diagnosis

Physical Findings

Overall, it is estimated that roughly 56% of all MCD cases affect the external genitalia.²³ The classic appearance of MCD includes well-demarcated ulcerations in the areas of intertriginous skin folds with or without diffuse edema and tenderness to palpation.²³ Although MCD has been historically noted as having a predilection for moist skin folds, there are numerous case reports of MCD all over the body, including the face,^7,24-29 retroauricular areas,³⁰ arms and legs,^16,17,31-34 lower abdomen,^3,5 under the breasts,¹ perineum,³⁵ external genitalia,^1,9,36-40 and even the lungs⁴¹ and bladder.⁴²

As a dermatologic disease, MCD has been referred to as yet another great imitator, both on the macroscopic and microscopic levels.⁸ As such, more common causes of genital edema should be considered first and investigated based on the patient's history, physical examination, skin biopsy, lymphangiogram, ultrasound, and cystogram.⁴³ Ultrasonography and color Doppler sonography have been shown to be helpful in patients with genital involvement. This modality can evaluate not only the presence of normal testes but also intratesticular and scrotal wall fluid, especially when the physical examination reveals swelling that makes testicle palpation more difficult.⁶ Clinically, the correct diagnosis of MCD often is made through suspicion of inflammatory bowel disease based on classic symptoms and/or physical findings including abdominal pain, weight loss, bloody stool, diarrhea, perianal skin tags, and anal fissures or fistulas. Any of these GI findings should prompt an intestinal biopsy to rule out any histologic evidence of CD.

Metastatic CD affecting the vulva often presents with vulvar pain and pruritus and may clinically mimic a more benign disease such as balanitis plasmacellularis, also referred to as Zoon vulvitis.²³ Similar to MCD on any given body surface, there is dramatic variation in the macroscopic presentation of vulvar MCD, with physical examination findings ranging from bilateral diffuse, edematous, deeply macerated, red, ulcerated lesions over the vulva with lymphadenopathy to findings of bilateral vulvar pain with yellow drainage from the labia majora.²³ There have been cases of vulvar MCD that include exquisite vulvar pain but without structural abnormalities including normal uterus, cervix, adnexa, rectovaginal septum, and rectum. In these more nebulous cases of vulvar MCD, the diagnosis often is discovered incidentally when nonspecific diagnostic imaging suggests underlying CD.²³

Beyond the case-by-case variations on physical examination, the great difficulty in diagnosis, particularly in children, occurs in the absence of any GI symptoms and therefore no logical consideration of underlying CD. Consequently, there have been cases of children presenting with irritation of the vulva who were eventually diagnosed with MCD only after erroneous treatment of contact dermatitis, candidiasis, and even consideration of sexual abuse.³⁷ Because it is so rare and obscure among practicing clinicians, the diagnosis of MCD often is considered only after irritation or swelling of the external genitalia has not responded to standard therapies. If and when the diagnosis of MCD is considered in children, it has been suggested to screen patients for anorectal stricture, as case studies have found the condition to be relatively common in this subpopulation.⁴⁴

In the less common case of adults with genitourinary symptoms that suggest possible MCD, the differential diagnosis for penile or vaginal ulcers should include contact and irritant dermatitis, chronic infectious lesions (eg, hidradenitis suppurativa, actinomycosis, tuberculosis),⁴⁵ sexually transmitted ulcerative diseases (eg, chancroid, lymphogranuloma venereum, herpes genitalia, granuloma inguinale),⁴⁶ drug reactions, and even extramammary Paget disease.⁴⁷

Histologic Findings

Because MCD has so much macroscopic variation and can present anywhere on the surface of the body, formal diagnosis relies on microscopy. As an added measure of difficulty in diagnosis, one random biopsy of a suspicious segment of tissue may not contain the expected histologic findings; therefore, clinical suspicion may warrant a second biopsy.¹⁰ There have been reported cases of an adult patient without history of CD presenting with a lesion that resembled a more common pathology, such as a genital wart, and the correct diagnosis of MCD with pseudocondylomatous morphology was made only after intestinal manifestations prompted the clinician to consider such an unusual diagnosis.⁴⁸

From a histopathologic perspective, MCD is characterized by discrete, noncaseating, sarcoidlike granulomas with abundant multinucleated giant cells (Langhans giant cells) in the superficial dermis (papillary), deep dermis (reticular), and adipose tissue (Figure).^8,17 In the presence of concomitant intestinal disease, the granulomas of both the intestinal and dermal tissues should share the same microscopic characteristics.⁸ In addition, copious neutrophils and granulomas surrounding the microvasculature have been described,³⁴ as well as general lymphocyte and plasma cell infiltrate.⁴⁵ Some histologic samples have included collagen degeneration termed necrobiosis in the middle dermal layer as another variable finding in MCD.^14,34

On microscopy, it has been reported that use of Verhoeff-van Gieson staining may be helpful to highlight the presence of neutrophil obstruction within the dermal vasculature, particularly the arterial lumen, as well as to aid in highlighting swelling of the endothelium with fragmentation of the internal elastic lamina.¹⁷ Although not part of the routine diagnosis, electron microscopy of MCD tissue samples have confirmed hypertrophy of the endothelial cells composing the capillaries with resulting extravasation of fibrin, red blood cells, lymphocytes, and epithelioid histiocytes.¹⁷ Observation of tissue under direct immunofluorescence has been less helpful, as it has shown only nonspecific fibrinogen deposition within the dermis and dermal vessels.¹⁷

In an article on treatment of MCD, Escher et al⁴³ reinforced that the macroscopic findings of MCD are diverse, and the microscopic findings characteristic of MCD also can be mimicked by other etiologies such as sarcoidosis, tuberculosis, fungal infections, lymphogranuloma venereum, leishmaniasis, and connective tissue disorders.⁴³ As such, the workup to rule out infectious, anatomic, and autoimmune etiologies should be diverse. Often, the workup for MCD will include special stains such as Ziehl-Neelsen stain to rule out Mycobacterium tuberculosis and acid-fast bacilli and Fite stain to consider atypical mycobacteria. Other tests such as tissue culture, chest radiograph, tuberculin skin test (Mantoux test), IFN-γ release assay, or polarized light microscopy may rule out infectious etiologies.^9,49 Serologic testing might include VDRL test, Treponema pallidum hemagglutination assay, hepatitis B, hepatitis C, and human immunodeficiency virus.⁵

Crohn disease is characterized histologically by sarcoidlike noncaseating granulomas, and as such, it is important to differentiate MCD from sarcoidosis prior to histologic analysis. Sarcoidosis also can be considered much less likely with a normal chest radiograph and in the absence of increased serum calcium and angiotensin-converting enzyme levels.⁷ The differentiation of sarcoidosis from MCD on the microscopic scale is subtle but is sometimes facilitated in the presence of an ulcerated epidermis or lymphocytic/eosinophilic infiltrate and edema within the dermis, all suggestive of MCD.¹⁴

Metastatic CD also should be differentiated from erythema nodosum and pyoderma gangrenosum, which are among the most common cutaneous findings associated with CD.¹⁴ Pyoderma gangrenosum can be distinguished histologically by identifying copious neutrophilic infiltrate with pseudoepitheliomatous hyperplasia.⁵⁰

Treatment

Because MCD is relatively rare, there are no known randomized trials suggesting a particular medical or surgical treatment. In a review of perineal MCD from 2007, the 40-year-old recommendation by Moutain³ opting for surgical debridement versus medical management still resonates, particularly for perineal disease, as an effective measure in all but the mildest of presentations.⁵¹ However, recent case reports also suggest that the tumor necrosis factor α (TNF-α) inhibitors such as infliximab and adalimumab should be considered prior to surgery even with severe perineal MCD.⁵¹ Moreover, even if medical management with TNF-α inhibitors or some combination of immunosuppressants and antibiotics does not eradicate the disease, it often helps reduce the size of the ulcers prior to surgery.⁵² With a limited understanding of MCD, one might think that removal of the affected bowel would eliminate cutaneous disease, but it has been shown that this strategy is not effective.^53,54

The composition and location of the particular lesion affects the trajectory of treatment. For example, MCD manifesting as local ulcers and plaques has been described as responding well to topical and intralesional steroids.^10,55,56 In the case of penile swelling and/or phimosis, circumcision has been helpful to improve the patient's ability to void as well as to attain and maintain erection.¹⁰ In the case of scrotal swelling secondary to MCD, early treatment (ie, within 4 to 6 months) with oral steroids and/or metronidazole is likely beneficial to prevent refractory edematous organization of the tissue.⁵⁷

As a general rule, an effective treatment will include a combination of an immunosuppressant, antibiotic therapy, and sometimes surgery. The most commonly used immunosuppressant agents include topical or intralesional steroids, infliximab,^43,58 cyclosporine A,^59,60 dapsone, minocycline, thalidomide, methotrexate, mycophenolate mofetil, sulfasalazine, azathioprine, tacrolimus, and 6-mercaptopurine.⁴ Steroids have been the conventional treatment of extraintestinal manifestations of CD⁶¹; however, perineal CD has been poorly controlled with systemic steroids.⁶² If steroids are found not to be effective, sometimes agents such as dapsone or thalidomide are considered. One case report noted stabilization of MCD penile ulcers with oral thalidomide 300 mg once daily, oral minocycline 100 mg once daily, and topical tacrolimus 0.3% with benzocaine twice daily with continuation of prednisolone and methotrexate as parts of previously unsuccessful regimen.⁵²

Metronidazole is perhaps the most commonly used antibiotic, having been a component of many successful regimens.^4,63 For example, a 27-year-old patient with MCD presenting as a nonhealing ulcerative lesion in the subcoronal area of the penis and scrotum was treated successfully with a 6-month course of mesalamine, prednisone, and metronidazole.⁴⁵ Another case report of vulvar MCD reported initial success with intravenous methylprednisolone, ciprofloxacin, and metronidazole.²³ The primary limitation of metronidazole is that subsequent tapering of the dose seems to result in recurrence of disease.⁶⁴ Consequently, patients must remain on the antibiotic for an indeterminate course, with dosages ranging from 5 mg/kg daily in adolescents⁶⁵ to 1000 to 1500 mg daily in adults.⁶⁶

Of the various immunosuppressants available, infliximab has been listed in numerous reports as a successful agent in both the induction and maintenance of extraintestinal manifestations of CD including MCD.^67-71 Infliximab has been reported to be effective in the treatment of penile and scrotal edema secondary to MCD that did not respond to other immunosuppressants including oral prednisolone, azathioprine, and cyclosporine.⁴³ Infliximab may be a good option to help heal draining fistulas, particularly in combination with an antibiotic such as metronidazole and ciprofloxacin, which helps to prevent abscess formation during healing.⁷² The response to infliximab has been dramatic, with resolution of cutaneous lesions after just 6 weeks in some cases.⁷³ The dosing regimen of infliximab has been suggested at 5 mg/kg administered at 0, 2, and 6 weeks, with subsequent maintenance infusions every 10 weeks,⁷⁰ or at 0, 4, and 12 weeks, with subsequent infusions every 8 weeks.⁴³

Adalimumab may be considered as an alternative to infliximab and is potentially less allergenic as a fully humanized monoclonal antibody to TNF-α, which also has been used successfully to both induce and maintain remission of moderate to severe CD.^42,74,75 Proposed dosing of adalimumab includes a loading dose of 160 mg subcutaneously on day 1, followed by an 80-mg dose 2 weeks later and a 40-mg maintenance dose every other week indefinitely.⁴⁸ Of note, adalimumab has been noted in the literature to have many potential side effects, including one particular case in which severe headaches were attributed to its use.⁵⁹ As a consequence of the headaches, the patient was switched from adalimumab to cyclosporine and responded well with no subsequent flare-ups on follow-up.

In summary, treatment of MCD depends on cutaneous location, severity, physician experience with certain antibiotics or immunosuppressants, availability of medication, and patient disposition. It seems reasonable to attempt medical management with one or more medical regimens before committing to surgical intervention. Furthermore, even with debridement, curettage, skin graft, or other surgical strategy, the patient is likely to require some period of immunosuppression to provide long-lasting remission.

Conclusion

Patients with inflammatory bowel disease often develop dermatologic sequelae, with MCD being a rare but serious process. Patients may present with a wide array of physical concerns and symptoms, many resembling other disease processes. As such, education and a high index of suspicion are needed for proper diagnosis and treatment.

Almost half of Crohn disease (CD) patients experience a dermatologic manifestation of the disease. A rare entity, metastatic CD (MCD) presents a diagnostic challenge without a high index of suspicion. Its etiology is not well defined; however, it appears to be an autoimmune response to gut antigens. Herein, we review the etiology/epidemiology, diagnostic criteria, and treatment for this uncommon condition.

Epidemiology and Clinical Characteristics of MCD

Metastatic CD was first described by Parks et al1 in 1965 and refers to a diverse collection of macroscopic dermatologic manifestations in tissue not contiguous with the gastrointestinal (GI) tract. To be classified as MCD, the tissue must demonstrate characteristic histopathologic findings, which invariably include noncaseating granulomas.

Crohn disease may affect any part of the GI tract from the mouth to anus, with a multitude of associated cutaneous manifestations having been described. The terminal ileum is the most commonly affected portion of the GI tract in CD, but the large intestine also may be involved in 55% to 80% of cases.² The incidence of non-MCD-associated anal lesions seems to correlate with intestinal involvement in that as few as 25% of patients with ileal-localized CD have anal lesions compared to nearly 80% of patients with large intestinal involvement.³

It has been estimated that 18% to 44% of patients with CD have some form of cutaneous manifestation,⁴ with MCD being a rare subcategory. As few as 100 cases have been described from 1965 to the present.⁵ The presence of MCD does not correlate well with severity of intestinal CD, and although a majority of MCD cases present after at least 6 months of GI symptoms,⁶ there are instances in which MCD presents without prior or existing evidence of intestinal CD.⁷

With regard to MCD, the term metastatic is sometimes supplanted in the literature by cutaneous to avoid any implication of cancer; however, due to a myriad of dermatologic manifestations, both terms can cause confusion. The categorization of the various types of cutaneous findings in CD is well summarized in a review by Palamaras et al8 with the following classifications: (1) granulomatous by direct extension (oral or perianal), (2) MCD lesions (genital and nongenital), (3) immune-related lesions, and (4) lesions from nutritional deficiencies. Of the cutaneous manifestations relating to CD, MCD is the least common cutaneous categorical manifestation and is further divided into subcategories of genital and nongenital lesions.⁸

The nongenital distribution of MCD is the more common variety in adults and particularly seems to affect the legs and plantar surfaces (38%), the trunk and abdomen (24%), and the face (15%).^5,9 These nongenital MCD manifestations are most commonly described as nodules, ulcerations, or erythematous to purple plaques, and less commonly described as abscesses, pustules, or papules.

The sequence of cutaneous symptoms of MCD relative to intestinal disease depends to some degree on patient age. In adults diagnosed with MCD, it has been noted that a GI flare is expected 2 months to 4 years after diagnosis; however, in children the subsequent GI flare has been noted to vary more widely from 9 months to 14 years following presentation of MCD.⁸ Furthermore, roughly 50% of children diagnosed with MCD present concomitantly with their first symptoms of a GI flare, whereas 70% of adults with MCD had been previously diagnosed with intestinal CD.⁸ In one review of 80 reported cases of MCD, 20% (16/80) had no symptoms of intestinal disease at the time of MCD diagnosis, and the majority of the asymptomatic cases were in children; interestingly, the majority of these same children were diagnosed with CD months to years later.⁹

Both the location and characteristics of cutaneous findings in MCD correlate with age.⁹ Metastatic CD has been identified in all age groups; however, lymphedema is more common in children/young adults, while nodules, ulceration, and fistulating disease are more often seen in adults.¹⁰ Affected children and adolescents with MCD range from 5 to 17 years of age, with a mean age at disease onset of 11.1 years and equal incidence in males and females.⁸ Adults with MCD range from 18 to 78 years of age, with a mean age at presentation of 38.4 years.^8,11

Concerning anatomic location of disease, adults with MCD most commonly have nodules with or without plaques on the arms and legs and less commonly in the genital area.⁸ In contrast, children with MCD are more prone to genital lesions, with up to 85% of cases including some degree of genital erythematous or nonerythematous swelling with or without induration.⁸ Genitourinary complications of CD as a broad category, however, are estimated to occur in only 5% to 20% of intestinal CD cases in both children and adults.¹²

There have been conflicting reports regarding gender predilection in MCD. Based on a review by Samitz et al¹³ of 200 cases of CD over an 18-year period, 22% of patients with CD were found to have cutaneous manifestations--presumably not MCD but rather perianal, perineal, vulvar fistulae, fissures, or abscesses--with a male to female preponderance of almost 2 to 1. A more recent review of the literature by Palamaras et al⁸ in 2008 reported that contiguous non-MCD affects adult females and children more often than adult males, with 63% adult cases being female. This review seems to be more congruent with other reports in the literature implicating that females are twice as commonly affected by MCD than males.^9,14

Pathophysiology

The etiology of MCD has not been well defined. One proposed mechanism of the distal tissue involvement of MCD is through passage of antigens to the skin with subsequent granulomatous response at the level of the dermis.¹⁰ Another proposed mechanism suggests antibody sensitization to gut antigens, possibly bacterial antigens, that then coincidentally cross-react with analogous skin antigens.^8,14 Burgdorf¹¹ supported this notion in a 1981 report in which it was suggested that the granulomatous reaction was related to deposition of immune complexes in the skin. Slater et al¹⁵ and Tatnall et al¹⁶ offered a variation of Burgdorf's notion, suggesting that it was sensitized T cells to circulating antigens that were the initiators of granuloma formation in the periphery.

An examination of MCD tissue in 1990 by Shum and Guenther¹⁷ under electron microscopy and immunofluorescence provided evidence against prior studies that purported to have identified immune complexes as the causative agents of MCD. In this study, the authors found no evidence of immune complexes in the dermis of MCD lesions. In addition, an attempt to react serum antibodies of a patient with MCD, which were postulated to have IgG, IgM, and IgA antibodies to specific gut antigens, yielded no response when reacted with the tongue, ileum, and colon tissue from a rat. As a culminant finding, the authors also noted MCD dermis tissue with granulomas without vasculitis, suggesting a T-cell mediated type IV hypersensitivity response with a secondary vasculitis from T-cell origin lymphokines and T-cell mediated monocyte activation.¹⁷

Research implicating other immunologic entities involved in the pathophysiology of CD such as β-2 integrin,¹⁸ CD14⁺ monocytes,¹⁹ and the role of the DNA repair gene MLH1 (mutL homolog 1)²⁰ have been considered but without a clearly definitive role in the manifestations of MCD.

The utility of metronidazole in the treatment of MCD has been suggested as evidence that certain bacteria in the gut may either serve as the causative antigen or may induce its formation²¹; however, the causative antigen has yet to be identified, and whether it travels distally to the skin or merely resembles a similar antigen normally present in the dermis has not yet been determined. Some research has used in situ polymerase chain reaction techniques to attempt to detect similar microbial pathogens in both the vasculature of active bowel lesions and in the skin, but to date, bacterial RNA noted to be present in the gut vasculature adjacent to CD lesions has not been detected in skin lesions.²²

Diagnosis

Physical Findings

Overall, it is estimated that roughly 56% of all MCD cases affect the external genitalia.²³ The classic appearance of MCD includes well-demarcated ulcerations in the areas of intertriginous skin folds with or without diffuse edema and tenderness to palpation.²³ Although MCD has been historically noted as having a predilection for moist skin folds, there are numerous case reports of MCD all over the body, including the face,^7,24-29 retroauricular areas,³⁰ arms and legs,^16,17,31-34 lower abdomen,^3,5 under the breasts,¹ perineum,³⁵ external genitalia,^1,9,36-40 and even the lungs⁴¹ and bladder.⁴²

As a dermatologic disease, MCD has been referred to as yet another great imitator, both on the macroscopic and microscopic levels.⁸ As such, more common causes of genital edema should be considered first and investigated based on the patient's history, physical examination, skin biopsy, lymphangiogram, ultrasound, and cystogram.⁴³ Ultrasonography and color Doppler sonography have been shown to be helpful in patients with genital involvement. This modality can evaluate not only the presence of normal testes but also intratesticular and scrotal wall fluid, especially when the physical examination reveals swelling that makes testicle palpation more difficult.⁶ Clinically, the correct diagnosis of MCD often is made through suspicion of inflammatory bowel disease based on classic symptoms and/or physical findings including abdominal pain, weight loss, bloody stool, diarrhea, perianal skin tags, and anal fissures or fistulas. Any of these GI findings should prompt an intestinal biopsy to rule out any histologic evidence of CD.

Metastatic CD affecting the vulva often presents with vulvar pain and pruritus and may clinically mimic a more benign disease such as balanitis plasmacellularis, also referred to as Zoon vulvitis.²³ Similar to MCD on any given body surface, there is dramatic variation in the macroscopic presentation of vulvar MCD, with physical examination findings ranging from bilateral diffuse, edematous, deeply macerated, red, ulcerated lesions over the vulva with lymphadenopathy to findings of bilateral vulvar pain with yellow drainage from the labia majora.²³ There have been cases of vulvar MCD that include exquisite vulvar pain but without structural abnormalities including normal uterus, cervix, adnexa, rectovaginal septum, and rectum. In these more nebulous cases of vulvar MCD, the diagnosis often is discovered incidentally when nonspecific diagnostic imaging suggests underlying CD.²³

Beyond the case-by-case variations on physical examination, the great difficulty in diagnosis, particularly in children, occurs in the absence of any GI symptoms and therefore no logical consideration of underlying CD. Consequently, there have been cases of children presenting with irritation of the vulva who were eventually diagnosed with MCD only after erroneous treatment of contact dermatitis, candidiasis, and even consideration of sexual abuse.³⁷ Because it is so rare and obscure among practicing clinicians, the diagnosis of MCD often is considered only after irritation or swelling of the external genitalia has not responded to standard therapies. If and when the diagnosis of MCD is considered in children, it has been suggested to screen patients for anorectal stricture, as case studies have found the condition to be relatively common in this subpopulation.⁴⁴

In the less common case of adults with genitourinary symptoms that suggest possible MCD, the differential diagnosis for penile or vaginal ulcers should include contact and irritant dermatitis, chronic infectious lesions (eg, hidradenitis suppurativa, actinomycosis, tuberculosis),⁴⁵ sexually transmitted ulcerative diseases (eg, chancroid, lymphogranuloma venereum, herpes genitalia, granuloma inguinale),⁴⁶ drug reactions, and even extramammary Paget disease.⁴⁷

Histologic Findings

Because MCD has so much macroscopic variation and can present anywhere on the surface of the body, formal diagnosis relies on microscopy. As an added measure of difficulty in diagnosis, one random biopsy of a suspicious segment of tissue may not contain the expected histologic findings; therefore, clinical suspicion may warrant a second biopsy.¹⁰ There have been reported cases of an adult patient without history of CD presenting with a lesion that resembled a more common pathology, such as a genital wart, and the correct diagnosis of MCD with pseudocondylomatous morphology was made only after intestinal manifestations prompted the clinician to consider such an unusual diagnosis.⁴⁸

From a histopathologic perspective, MCD is characterized by discrete, noncaseating, sarcoidlike granulomas with abundant multinucleated giant cells (Langhans giant cells) in the superficial dermis (papillary), deep dermis (reticular), and adipose tissue (Figure).^8,17 In the presence of concomitant intestinal disease, the granulomas of both the intestinal and dermal tissues should share the same microscopic characteristics.⁸ In addition, copious neutrophils and granulomas surrounding the microvasculature have been described,³⁴ as well as general lymphocyte and plasma cell infiltrate.⁴⁵ Some histologic samples have included collagen degeneration termed necrobiosis in the middle dermal layer as another variable finding in MCD.^14,34

On microscopy, it has been reported that use of Verhoeff-van Gieson staining may be helpful to highlight the presence of neutrophil obstruction within the dermal vasculature, particularly the arterial lumen, as well as to aid in highlighting swelling of the endothelium with fragmentation of the internal elastic lamina.¹⁷ Although not part of the routine diagnosis, electron microscopy of MCD tissue samples have confirmed hypertrophy of the endothelial cells composing the capillaries with resulting extravasation of fibrin, red blood cells, lymphocytes, and epithelioid histiocytes.¹⁷ Observation of tissue under direct immunofluorescence has been less helpful, as it has shown only nonspecific fibrinogen deposition within the dermis and dermal vessels.¹⁷

In an article on treatment of MCD, Escher et al⁴³ reinforced that the macroscopic findings of MCD are diverse, and the microscopic findings characteristic of MCD also can be mimicked by other etiologies such as sarcoidosis, tuberculosis, fungal infections, lymphogranuloma venereum, leishmaniasis, and connective tissue disorders.⁴³ As such, the workup to rule out infectious, anatomic, and autoimmune etiologies should be diverse. Often, the workup for MCD will include special stains such as Ziehl-Neelsen stain to rule out Mycobacterium tuberculosis and acid-fast bacilli and Fite stain to consider atypical mycobacteria. Other tests such as tissue culture, chest radiograph, tuberculin skin test (Mantoux test), IFN-γ release assay, or polarized light microscopy may rule out infectious etiologies.^9,49 Serologic testing might include VDRL test, Treponema pallidum hemagglutination assay, hepatitis B, hepatitis C, and human immunodeficiency virus.⁵

Crohn disease is characterized histologically by sarcoidlike noncaseating granulomas, and as such, it is important to differentiate MCD from sarcoidosis prior to histologic analysis. Sarcoidosis also can be considered much less likely with a normal chest radiograph and in the absence of increased serum calcium and angiotensin-converting enzyme levels.⁷ The differentiation of sarcoidosis from MCD on the microscopic scale is subtle but is sometimes facilitated in the presence of an ulcerated epidermis or lymphocytic/eosinophilic infiltrate and edema within the dermis, all suggestive of MCD.¹⁴

Metastatic CD also should be differentiated from erythema nodosum and pyoderma gangrenosum, which are among the most common cutaneous findings associated with CD.¹⁴ Pyoderma gangrenosum can be distinguished histologically by identifying copious neutrophilic infiltrate with pseudoepitheliomatous hyperplasia.⁵⁰

Treatment

Because MCD is relatively rare, there are no known randomized trials suggesting a particular medical or surgical treatment. In a review of perineal MCD from 2007, the 40-year-old recommendation by Moutain³ opting for surgical debridement versus medical management still resonates, particularly for perineal disease, as an effective measure in all but the mildest of presentations.⁵¹ However, recent case reports also suggest that the tumor necrosis factor α (TNF-α) inhibitors such as infliximab and adalimumab should be considered prior to surgery even with severe perineal MCD.⁵¹ Moreover, even if medical management with TNF-α inhibitors or some combination of immunosuppressants and antibiotics does not eradicate the disease, it often helps reduce the size of the ulcers prior to surgery.⁵² With a limited understanding of MCD, one might think that removal of the affected bowel would eliminate cutaneous disease, but it has been shown that this strategy is not effective.^53,54

The composition and location of the particular lesion affects the trajectory of treatment. For example, MCD manifesting as local ulcers and plaques has been described as responding well to topical and intralesional steroids.^10,55,56 In the case of penile swelling and/or phimosis, circumcision has been helpful to improve the patient's ability to void as well as to attain and maintain erection.¹⁰ In the case of scrotal swelling secondary to MCD, early treatment (ie, within 4 to 6 months) with oral steroids and/or metronidazole is likely beneficial to prevent refractory edematous organization of the tissue.⁵⁷

As a general rule, an effective treatment will include a combination of an immunosuppressant, antibiotic therapy, and sometimes surgery. The most commonly used immunosuppressant agents include topical or intralesional steroids, infliximab,^43,58 cyclosporine A,^59,60 dapsone, minocycline, thalidomide, methotrexate, mycophenolate mofetil, sulfasalazine, azathioprine, tacrolimus, and 6-mercaptopurine.⁴ Steroids have been the conventional treatment of extraintestinal manifestations of CD⁶¹; however, perineal CD has been poorly controlled with systemic steroids.⁶² If steroids are found not to be effective, sometimes agents such as dapsone or thalidomide are considered. One case report noted stabilization of MCD penile ulcers with oral thalidomide 300 mg once daily, oral minocycline 100 mg once daily, and topical tacrolimus 0.3% with benzocaine twice daily with continuation of prednisolone and methotrexate as parts of previously unsuccessful regimen.⁵²

Metronidazole is perhaps the most commonly used antibiotic, having been a component of many successful regimens.^4,63 For example, a 27-year-old patient with MCD presenting as a nonhealing ulcerative lesion in the subcoronal area of the penis and scrotum was treated successfully with a 6-month course of mesalamine, prednisone, and metronidazole.⁴⁵ Another case report of vulvar MCD reported initial success with intravenous methylprednisolone, ciprofloxacin, and metronidazole.²³ The primary limitation of metronidazole is that subsequent tapering of the dose seems to result in recurrence of disease.⁶⁴ Consequently, patients must remain on the antibiotic for an indeterminate course, with dosages ranging from 5 mg/kg daily in adolescents⁶⁵ to 1000 to 1500 mg daily in adults.⁶⁶

Of the various immunosuppressants available, infliximab has been listed in numerous reports as a successful agent in both the induction and maintenance of extraintestinal manifestations of CD including MCD.^67-71 Infliximab has been reported to be effective in the treatment of penile and scrotal edema secondary to MCD that did not respond to other immunosuppressants including oral prednisolone, azathioprine, and cyclosporine.⁴³ Infliximab may be a good option to help heal draining fistulas, particularly in combination with an antibiotic such as metronidazole and ciprofloxacin, which helps to prevent abscess formation during healing.⁷² The response to infliximab has been dramatic, with resolution of cutaneous lesions after just 6 weeks in some cases.⁷³ The dosing regimen of infliximab has been suggested at 5 mg/kg administered at 0, 2, and 6 weeks, with subsequent maintenance infusions every 10 weeks,⁷⁰ or at 0, 4, and 12 weeks, with subsequent infusions every 8 weeks.⁴³

Adalimumab may be considered as an alternative to infliximab and is potentially less allergenic as a fully humanized monoclonal antibody to TNF-α, which also has been used successfully to both induce and maintain remission of moderate to severe CD.^42,74,75 Proposed dosing of adalimumab includes a loading dose of 160 mg subcutaneously on day 1, followed by an 80-mg dose 2 weeks later and a 40-mg maintenance dose every other week indefinitely.⁴⁸ Of note, adalimumab has been noted in the literature to have many potential side effects, including one particular case in which severe headaches were attributed to its use.⁵⁹ As a consequence of the headaches, the patient was switched from adalimumab to cyclosporine and responded well with no subsequent flare-ups on follow-up.

In summary, treatment of MCD depends on cutaneous location, severity, physician experience with certain antibiotics or immunosuppressants, availability of medication, and patient disposition. It seems reasonable to attempt medical management with one or more medical regimens before committing to surgical intervention. Furthermore, even with debridement, curettage, skin graft, or other surgical strategy, the patient is likely to require some period of immunosuppression to provide long-lasting remission.

Conclusion

Patients with inflammatory bowel disease often develop dermatologic sequelae, with MCD being a rare but serious process. Patients may present with a wide array of physical concerns and symptoms, many resembling other disease processes. As such, education and a high index of suspicion are needed for proper diagnosis and treatment.

Almost half of Crohn disease (CD) patients experience a dermatologic manifestation of the disease. A rare entity, metastatic CD (MCD) presents a diagnostic challenge without a high index of suspicion. Its etiology is not well defined; however, it appears to be an autoimmune response to gut antigens. Herein, we review the etiology/epidemiology, diagnostic criteria, and treatment for this uncommon condition.

Epidemiology and Clinical Characteristics of MCD

Metastatic CD was first described by Parks et al1 in 1965 and refers to a diverse collection of macroscopic dermatologic manifestations in tissue not contiguous with the gastrointestinal (GI) tract. To be classified as MCD, the tissue must demonstrate characteristic histopathologic findings, which invariably include noncaseating granulomas.

Crohn disease may affect any part of the GI tract from the mouth to anus, with a multitude of associated cutaneous manifestations having been described. The terminal ileum is the most commonly affected portion of the GI tract in CD, but the large intestine also may be involved in 55% to 80% of cases.² The incidence of non-MCD-associated anal lesions seems to correlate with intestinal involvement in that as few as 25% of patients with ileal-localized CD have anal lesions compared to nearly 80% of patients with large intestinal involvement.³

It has been estimated that 18% to 44% of patients with CD have some form of cutaneous manifestation,⁴ with MCD being a rare subcategory. As few as 100 cases have been described from 1965 to the present.⁵ The presence of MCD does not correlate well with severity of intestinal CD, and although a majority of MCD cases present after at least 6 months of GI symptoms,⁶ there are instances in which MCD presents without prior or existing evidence of intestinal CD.⁷

With regard to MCD, the term metastatic is sometimes supplanted in the literature by cutaneous to avoid any implication of cancer; however, due to a myriad of dermatologic manifestations, both terms can cause confusion. The categorization of the various types of cutaneous findings in CD is well summarized in a review by Palamaras et al8 with the following classifications: (1) granulomatous by direct extension (oral or perianal), (2) MCD lesions (genital and nongenital), (3) immune-related lesions, and (4) lesions from nutritional deficiencies. Of the cutaneous manifestations relating to CD, MCD is the least common cutaneous categorical manifestation and is further divided into subcategories of genital and nongenital lesions.⁸

The nongenital distribution of MCD is the more common variety in adults and particularly seems to affect the legs and plantar surfaces (38%), the trunk and abdomen (24%), and the face (15%).^5,9 These nongenital MCD manifestations are most commonly described as nodules, ulcerations, or erythematous to purple plaques, and less commonly described as abscesses, pustules, or papules.

The sequence of cutaneous symptoms of MCD relative to intestinal disease depends to some degree on patient age. In adults diagnosed with MCD, it has been noted that a GI flare is expected 2 months to 4 years after diagnosis; however, in children the subsequent GI flare has been noted to vary more widely from 9 months to 14 years following presentation of MCD.⁸ Furthermore, roughly 50% of children diagnosed with MCD present concomitantly with their first symptoms of a GI flare, whereas 70% of adults with MCD had been previously diagnosed with intestinal CD.⁸ In one review of 80 reported cases of MCD, 20% (16/80) had no symptoms of intestinal disease at the time of MCD diagnosis, and the majority of the asymptomatic cases were in children; interestingly, the majority of these same children were diagnosed with CD months to years later.⁹

Both the location and characteristics of cutaneous findings in MCD correlate with age.⁹ Metastatic CD has been identified in all age groups; however, lymphedema is more common in children/young adults, while nodules, ulceration, and fistulating disease are more often seen in adults.¹⁰ Affected children and adolescents with MCD range from 5 to 17 years of age, with a mean age at disease onset of 11.1 years and equal incidence in males and females.⁸ Adults with MCD range from 18 to 78 years of age, with a mean age at presentation of 38.4 years.^8,11

Concerning anatomic location of disease, adults with MCD most commonly have nodules with or without plaques on the arms and legs and less commonly in the genital area.⁸ In contrast, children with MCD are more prone to genital lesions, with up to 85% of cases including some degree of genital erythematous or nonerythematous swelling with or without induration.⁸ Genitourinary complications of CD as a broad category, however, are estimated to occur in only 5% to 20% of intestinal CD cases in both children and adults.¹²

There have been conflicting reports regarding gender predilection in MCD. Based on a review by Samitz et al¹³ of 200 cases of CD over an 18-year period, 22% of patients with CD were found to have cutaneous manifestations--presumably not MCD but rather perianal, perineal, vulvar fistulae, fissures, or abscesses--with a male to female preponderance of almost 2 to 1. A more recent review of the literature by Palamaras et al⁸ in 2008 reported that contiguous non-MCD affects adult females and children more often than adult males, with 63% adult cases being female. This review seems to be more congruent with other reports in the literature implicating that females are twice as commonly affected by MCD than males.^9,14

Pathophysiology

The etiology of MCD has not been well defined. One proposed mechanism of the distal tissue involvement of MCD is through passage of antigens to the skin with subsequent granulomatous response at the level of the dermis.¹⁰ Another proposed mechanism suggests antibody sensitization to gut antigens, possibly bacterial antigens, that then coincidentally cross-react with analogous skin antigens.^8,14 Burgdorf¹¹ supported this notion in a 1981 report in which it was suggested that the granulomatous reaction was related to deposition of immune complexes in the skin. Slater et al¹⁵ and Tatnall et al¹⁶ offered a variation of Burgdorf's notion, suggesting that it was sensitized T cells to circulating antigens that were the initiators of granuloma formation in the periphery.

An examination of MCD tissue in 1990 by Shum and Guenther¹⁷ under electron microscopy and immunofluorescence provided evidence against prior studies that purported to have identified immune complexes as the causative agents of MCD. In this study, the authors found no evidence of immune complexes in the dermis of MCD lesions. In addition, an attempt to react serum antibodies of a patient with MCD, which were postulated to have IgG, IgM, and IgA antibodies to specific gut antigens, yielded no response when reacted with the tongue, ileum, and colon tissue from a rat. As a culminant finding, the authors also noted MCD dermis tissue with granulomas without vasculitis, suggesting a T-cell mediated type IV hypersensitivity response with a secondary vasculitis from T-cell origin lymphokines and T-cell mediated monocyte activation.¹⁷

Research implicating other immunologic entities involved in the pathophysiology of CD such as β-2 integrin,¹⁸ CD14⁺ monocytes,¹⁹ and the role of the DNA repair gene MLH1 (mutL homolog 1)²⁰ have been considered but without a clearly definitive role in the manifestations of MCD.

The utility of metronidazole in the treatment of MCD has been suggested as evidence that certain bacteria in the gut may either serve as the causative antigen or may induce its formation²¹; however, the causative antigen has yet to be identified, and whether it travels distally to the skin or merely resembles a similar antigen normally present in the dermis has not yet been determined. Some research has used in situ polymerase chain reaction techniques to attempt to detect similar microbial pathogens in both the vasculature of active bowel lesions and in the skin, but to date, bacterial RNA noted to be present in the gut vasculature adjacent to CD lesions has not been detected in skin lesions.²²

Diagnosis

Physical Findings

Overall, it is estimated that roughly 56% of all MCD cases affect the external genitalia.²³ The classic appearance of MCD includes well-demarcated ulcerations in the areas of intertriginous skin folds with or without diffuse edema and tenderness to palpation.²³ Although MCD has been historically noted as having a predilection for moist skin folds, there are numerous case reports of MCD all over the body, including the face,^7,24-29 retroauricular areas,³⁰ arms and legs,^16,17,31-34 lower abdomen,^3,5 under the breasts,¹ perineum,³⁵ external genitalia,^1,9,36-40 and even the lungs⁴¹ and bladder.⁴²

As a dermatologic disease, MCD has been referred to as yet another great imitator, both on the macroscopic and microscopic levels.⁸ As such, more common causes of genital edema should be considered first and investigated based on the patient's history, physical examination, skin biopsy, lymphangiogram, ultrasound, and cystogram.⁴³ Ultrasonography and color Doppler sonography have been shown to be helpful in patients with genital involvement. This modality can evaluate not only the presence of normal testes but also intratesticular and scrotal wall fluid, especially when the physical examination reveals swelling that makes testicle palpation more difficult.⁶ Clinically, the correct diagnosis of MCD often is made through suspicion of inflammatory bowel disease based on classic symptoms and/or physical findings including abdominal pain, weight loss, bloody stool, diarrhea, perianal skin tags, and anal fissures or fistulas. Any of these GI findings should prompt an intestinal biopsy to rule out any histologic evidence of CD.

Metastatic CD affecting the vulva often presents with vulvar pain and pruritus and may clinically mimic a more benign disease such as balanitis plasmacellularis, also referred to as Zoon vulvitis.²³ Similar to MCD on any given body surface, there is dramatic variation in the macroscopic presentation of vulvar MCD, with physical examination findings ranging from bilateral diffuse, edematous, deeply macerated, red, ulcerated lesions over the vulva with lymphadenopathy to findings of bilateral vulvar pain with yellow drainage from the labia majora.²³ There have been cases of vulvar MCD that include exquisite vulvar pain but without structural abnormalities including normal uterus, cervix, adnexa, rectovaginal septum, and rectum. In these more nebulous cases of vulvar MCD, the diagnosis often is discovered incidentally when nonspecific diagnostic imaging suggests underlying CD.²³

Beyond the case-by-case variations on physical examination, the great difficulty in diagnosis, particularly in children, occurs in the absence of any GI symptoms and therefore no logical consideration of underlying CD. Consequently, there have been cases of children presenting with irritation of the vulva who were eventually diagnosed with MCD only after erroneous treatment of contact dermatitis, candidiasis, and even consideration of sexual abuse.³⁷ Because it is so rare and obscure among practicing clinicians, the diagnosis of MCD often is considered only after irritation or swelling of the external genitalia has not responded to standard therapies. If and when the diagnosis of MCD is considered in children, it has been suggested to screen patients for anorectal stricture, as case studies have found the condition to be relatively common in this subpopulation.⁴⁴

In the less common case of adults with genitourinary symptoms that suggest possible MCD, the differential diagnosis for penile or vaginal ulcers should include contact and irritant dermatitis, chronic infectious lesions (eg, hidradenitis suppurativa, actinomycosis, tuberculosis),⁴⁵ sexually transmitted ulcerative diseases (eg, chancroid, lymphogranuloma venereum, herpes genitalia, granuloma inguinale),⁴⁶ drug reactions, and even extramammary Paget disease.⁴⁷

Histologic Findings

Because MCD has so much macroscopic variation and can present anywhere on the surface of the body, formal diagnosis relies on microscopy. As an added measure of difficulty in diagnosis, one random biopsy of a suspicious segment of tissue may not contain the expected histologic findings; therefore, clinical suspicion may warrant a second biopsy.¹⁰ There have been reported cases of an adult patient without history of CD presenting with a lesion that resembled a more common pathology, such as a genital wart, and the correct diagnosis of MCD with pseudocondylomatous morphology was made only after intestinal manifestations prompted the clinician to consider such an unusual diagnosis.⁴⁸

From a histopathologic perspective, MCD is characterized by discrete, noncaseating, sarcoidlike granulomas with abundant multinucleated giant cells (Langhans giant cells) in the superficial dermis (papillary), deep dermis (reticular), and adipose tissue (Figure).^8,17 In the presence of concomitant intestinal disease, the granulomas of both the intestinal and dermal tissues should share the same microscopic characteristics.⁸ In addition, copious neutrophils and granulomas surrounding the microvasculature have been described,³⁴ as well as general lymphocyte and plasma cell infiltrate.⁴⁵ Some histologic samples have included collagen degeneration termed necrobiosis in the middle dermal layer as another variable finding in MCD.^14,34

On microscopy, it has been reported that use of Verhoeff-van Gieson staining may be helpful to highlight the presence of neutrophil obstruction within the dermal vasculature, particularly the arterial lumen, as well as to aid in highlighting swelling of the endothelium with fragmentation of the internal elastic lamina.¹⁷ Although not part of the routine diagnosis, electron microscopy of MCD tissue samples have confirmed hypertrophy of the endothelial cells composing the capillaries with resulting extravasation of fibrin, red blood cells, lymphocytes, and epithelioid histiocytes.¹⁷ Observation of tissue under direct immunofluorescence has been less helpful, as it has shown only nonspecific fibrinogen deposition within the dermis and dermal vessels.¹⁷

In an article on treatment of MCD, Escher et al⁴³ reinforced that the macroscopic findings of MCD are diverse, and the microscopic findings characteristic of MCD also can be mimicked by other etiologies such as sarcoidosis, tuberculosis, fungal infections, lymphogranuloma venereum, leishmaniasis, and connective tissue disorders.⁴³ As such, the workup to rule out infectious, anatomic, and autoimmune etiologies should be diverse. Often, the workup for MCD will include special stains such as Ziehl-Neelsen stain to rule out Mycobacterium tuberculosis and acid-fast bacilli and Fite stain to consider atypical mycobacteria. Other tests such as tissue culture, chest radiograph, tuberculin skin test (Mantoux test), IFN-γ release assay, or polarized light microscopy may rule out infectious etiologies.^9,49 Serologic testing might include VDRL test, Treponema pallidum hemagglutination assay, hepatitis B, hepatitis C, and human immunodeficiency virus.⁵

Crohn disease is characterized histologically by sarcoidlike noncaseating granulomas, and as such, it is important to differentiate MCD from sarcoidosis prior to histologic analysis. Sarcoidosis also can be considered much less likely with a normal chest radiograph and in the absence of increased serum calcium and angiotensin-converting enzyme levels.⁷ The differentiation of sarcoidosis from MCD on the microscopic scale is subtle but is sometimes facilitated in the presence of an ulcerated epidermis or lymphocytic/eosinophilic infiltrate and edema within the dermis, all suggestive of MCD.¹⁴

Metastatic CD also should be differentiated from erythema nodosum and pyoderma gangrenosum, which are among the most common cutaneous findings associated with CD.¹⁴ Pyoderma gangrenosum can be distinguished histologically by identifying copious neutrophilic infiltrate with pseudoepitheliomatous hyperplasia.⁵⁰

Treatment

Because MCD is relatively rare, there are no known randomized trials suggesting a particular medical or surgical treatment. In a review of perineal MCD from 2007, the 40-year-old recommendation by Moutain³ opting for surgical debridement versus medical management still resonates, particularly for perineal disease, as an effective measure in all but the mildest of presentations.⁵¹ However, recent case reports also suggest that the tumor necrosis factor α (TNF-α) inhibitors such as infliximab and adalimumab should be considered prior to surgery even with severe perineal MCD.⁵¹ Moreover, even if medical management with TNF-α inhibitors or some combination of immunosuppressants and antibiotics does not eradicate the disease, it often helps reduce the size of the ulcers prior to surgery.⁵² With a limited understanding of MCD, one might think that removal of the affected bowel would eliminate cutaneous disease, but it has been shown that this strategy is not effective.^53,54

The composition and location of the particular lesion affects the trajectory of treatment. For example, MCD manifesting as local ulcers and plaques has been described as responding well to topical and intralesional steroids.^10,55,56 In the case of penile swelling and/or phimosis, circumcision has been helpful to improve the patient's ability to void as well as to attain and maintain erection.¹⁰ In the case of scrotal swelling secondary to MCD, early treatment (ie, within 4 to 6 months) with oral steroids and/or metronidazole is likely beneficial to prevent refractory edematous organization of the tissue.⁵⁷

As a general rule, an effective treatment will include a combination of an immunosuppressant, antibiotic therapy, and sometimes surgery. The most commonly used immunosuppressant agents include topical or intralesional steroids, infliximab,^43,58 cyclosporine A,^59,60 dapsone, minocycline, thalidomide, methotrexate, mycophenolate mofetil, sulfasalazine, azathioprine, tacrolimus, and 6-mercaptopurine.⁴ Steroids have been the conventional treatment of extraintestinal manifestations of CD⁶¹; however, perineal CD has been poorly controlled with systemic steroids.⁶² If steroids are found not to be effective, sometimes agents such as dapsone or thalidomide are considered. One case report noted stabilization of MCD penile ulcers with oral thalidomide 300 mg once daily, oral minocycline 100 mg once daily, and topical tacrolimus 0.3% with benzocaine twice daily with continuation of prednisolone and methotrexate as parts of previously unsuccessful regimen.⁵²

Metronidazole is perhaps the most commonly used antibiotic, having been a component of many successful regimens.^4,63 For example, a 27-year-old patient with MCD presenting as a nonhealing ulcerative lesion in the subcoronal area of the penis and scrotum was treated successfully with a 6-month course of mesalamine, prednisone, and metronidazole.⁴⁵ Another case report of vulvar MCD reported initial success with intravenous methylprednisolone, ciprofloxacin, and metronidazole.²³ The primary limitation of metronidazole is that subsequent tapering of the dose seems to result in recurrence of disease.⁶⁴ Consequently, patients must remain on the antibiotic for an indeterminate course, with dosages ranging from 5 mg/kg daily in adolescents⁶⁵ to 1000 to 1500 mg daily in adults.⁶⁶

Of the various immunosuppressants available, infliximab has been listed in numerous reports as a successful agent in both the induction and maintenance of extraintestinal manifestations of CD including MCD.^67-71 Infliximab has been reported to be effective in the treatment of penile and scrotal edema secondary to MCD that did not respond to other immunosuppressants including oral prednisolone, azathioprine, and cyclosporine.⁴³ Infliximab may be a good option to help heal draining fistulas, particularly in combination with an antibiotic such as metronidazole and ciprofloxacin, which helps to prevent abscess formation during healing.⁷² The response to infliximab has been dramatic, with resolution of cutaneous lesions after just 6 weeks in some cases.⁷³ The dosing regimen of infliximab has been suggested at 5 mg/kg administered at 0, 2, and 6 weeks, with subsequent maintenance infusions every 10 weeks,⁷⁰ or at 0, 4, and 12 weeks, with subsequent infusions every 8 weeks.⁴³

Adalimumab may be considered as an alternative to infliximab and is potentially less allergenic as a fully humanized monoclonal antibody to TNF-α, which also has been used successfully to both induce and maintain remission of moderate to severe CD.^42,74,75 Proposed dosing of adalimumab includes a loading dose of 160 mg subcutaneously on day 1, followed by an 80-mg dose 2 weeks later and a 40-mg maintenance dose every other week indefinitely.⁴⁸ Of note, adalimumab has been noted in the literature to have many potential side effects, including one particular case in which severe headaches were attributed to its use.⁵⁹ As a consequence of the headaches, the patient was switched from adalimumab to cyclosporine and responded well with no subsequent flare-ups on follow-up.

In summary, treatment of MCD depends on cutaneous location, severity, physician experience with certain antibiotics or immunosuppressants, availability of medication, and patient disposition. It seems reasonable to attempt medical management with one or more medical regimens before committing to surgical intervention. Furthermore, even with debridement, curettage, skin graft, or other surgical strategy, the patient is likely to require some period of immunosuppression to provide long-lasting remission.

Conclusion

Patients with inflammatory bowel disease often develop dermatologic sequelae, with MCD being a rare but serious process. Patients may present with a wide array of physical concerns and symptoms, many resembling other disease processes. As such, education and a high index of suspicion are needed for proper diagnosis and treatment.

With more than 1,000 diseases for which genetic testing is available, and with the completion of the Human Genome Project, more patients are requesting genetic testing and more clinicians are utilizing such testing; it has become mainstream.¹ This increased utilization has resulted in increased cost as well, say Ruzzo and colleagues, who presented research on genetic testing costs and compliance with clinical best practices at the 2017 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists (ACOG).² But, according to previous research say Ruzzo and colleagues, these costs can be quelled by involving genetic counselors in the test-ordering process.

Just how much cost savings can be achieved? In their quality improvement project, the investigators found that 38.6% of 44 genetic tests reviewed were inappropriately ordered—either they were not indicated (21%), misordered for false reassurance (7%), or inadequately ordered (10.5%). If the tests were ordered as appropriately recommended, a cost savings of $20,912.58 would have been realized, according to the researchers.

Ruzzo and colleagues reviewed 114 charts over a 3-month period for adherence with published clinical practice guidelines. All of the charts were associated with a genetic test billing code for common tests ordered through LabCorp (for cystic fibrosis, BRCA mutation, factor V Leiden, prothrombin, alpha-thalassemia, hemochromatosis, and cell-free DNA).

The researchers concluded that genetic counselor review or involvement in genetic test ordering can decrease inappropriate spending and improve patient care. They pointed out that the 114 charts reviewed represent a fraction of genetic tests ordered at their institution, and further study should broaden the research scope to determine the full extent of the problem.

Ruzzo and colleagues were awarded first prize for their research as presented at ACOG.
 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

With more than 1,000 diseases for which genetic testing is available, and with the completion of the Human Genome Project, more patients are requesting genetic testing and more clinicians are utilizing such testing; it has become mainstream.¹ This increased utilization has resulted in increased cost as well, say Ruzzo and colleagues, who presented research on genetic testing costs and compliance with clinical best practices at the 2017 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists (ACOG).² But, according to previous research say Ruzzo and colleagues, these costs can be quelled by involving genetic counselors in the test-ordering process.

Just how much cost savings can be achieved? In their quality improvement project, the investigators found that 38.6% of 44 genetic tests reviewed were inappropriately ordered—either they were not indicated (21%), misordered for false reassurance (7%), or inadequately ordered (10.5%). If the tests were ordered as appropriately recommended, a cost savings of $20,912.58 would have been realized, according to the researchers.

Ruzzo and colleagues reviewed 114 charts over a 3-month period for adherence with published clinical practice guidelines. All of the charts were associated with a genetic test billing code for common tests ordered through LabCorp (for cystic fibrosis, BRCA mutation, factor V Leiden, prothrombin, alpha-thalassemia, hemochromatosis, and cell-free DNA).

The researchers concluded that genetic counselor review or involvement in genetic test ordering can decrease inappropriate spending and improve patient care. They pointed out that the 114 charts reviewed represent a fraction of genetic tests ordered at their institution, and further study should broaden the research scope to determine the full extent of the problem.

Ruzzo and colleagues were awarded first prize for their research as presented at ACOG.
 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

With more than 1,000 diseases for which genetic testing is available, and with the completion of the Human Genome Project, more patients are requesting genetic testing and more clinicians are utilizing such testing; it has become mainstream.¹ This increased utilization has resulted in increased cost as well, say Ruzzo and colleagues, who presented research on genetic testing costs and compliance with clinical best practices at the 2017 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists (ACOG).² But, according to previous research say Ruzzo and colleagues, these costs can be quelled by involving genetic counselors in the test-ordering process.

Just how much cost savings can be achieved? In their quality improvement project, the investigators found that 38.6% of 44 genetic tests reviewed were inappropriately ordered—either they were not indicated (21%), misordered for false reassurance (7%), or inadequately ordered (10.5%). If the tests were ordered as appropriately recommended, a cost savings of $20,912.58 would have been realized, according to the researchers.

Ruzzo and colleagues reviewed 114 charts over a 3-month period for adherence with published clinical practice guidelines. All of the charts were associated with a genetic test billing code for common tests ordered through LabCorp (for cystic fibrosis, BRCA mutation, factor V Leiden, prothrombin, alpha-thalassemia, hemochromatosis, and cell-free DNA).

The researchers concluded that genetic counselor review or involvement in genetic test ordering can decrease inappropriate spending and improve patient care. They pointed out that the 114 charts reviewed represent a fraction of genetic tests ordered at their institution, and further study should broaden the research scope to determine the full extent of the problem.

Ruzzo and colleagues were awarded first prize for their research as presented at ACOG.
 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

NEW ORLEANS – The integration of lifestyle, alternative, and conventional medicine into the care of patients with multiple sclerosis can be transformative for patients and clinicians alike, according to Allen C. Bowling, MD, PhD.

This approach not only emphasizes health and wellness of the whole person, it supports the clinician-patient relationship since neurologists serve as point persons for MS patients, Dr. Bowling said at the annual meeting of the Consortium of Multiple Sclerosis Centers. “It’s critical to not just think about MS the disease, but to think about the patient’s overall health, maintaining health,” he said. “That’s a big mind shift. I think sometimes people hear the term ‘integrative medicine’ and they start walking out of the room or think it’s getting ‘woo-woo,’ but there is a very evidence-based approach to integrative medicine. The core of it still is not familiar to a lot of physicians.”

Harness ‘built-in’ resources

Dr. Bowling, author of “Optimal Health With Multiple Sclerosis: A Guide to Integrating Lifestyle, Alternative, and Conventional Medicine” (New York: Demos Medical Publishing, 2014) and developer of a website devoted to integrative care and MS (www.neurologycare.net), said that some of best treatment approaches may be those that use the “built-in” resources of the human body and do not require any medications, supplements, devices, or technology. “The most effective and long-lasting changes in lifestyle may be those that are small and consistent,” he said. For example, when he first started applying integrative care principles to his practice more than 16 years ago, some patients told him that MS was “one of the best things that happened to them, and that it was a gift in that it helped them clean up their lifestyle.” In the summer of 2001, one such patient came to see Dr. Bowling and said, “Since my last appointment I’ve lost 20 pounds, bought a bike. I exercise four times weekly. My wife and I have changed our diet. This is real; I’m on it.”

“I said. ‘Very impressive. How did that happen? What motivated you?’ ”

“He said, ‘You did.’ This was like a turning point in his life.”

As of May 2017, this patient has maintained his healthy lifestyle changes.

Dr. Bowling told meeting attendees that early in his neurology career he didn’t always consider other ways he could impact MS patients beyond helping them determine the best disease-modifying treatment and/or assisting them in managing symptoms. Thinking to counsel them in areas such as a balanced diet, exercise, and emotional wellness “was a mind shift for me, and made me realize how narrow my focus was,” he said. “It transformed me to go back to thinking more about general medicine. I’m a detail-oriented guy, but I don’t think that’s in the best interests of our patients. I think we need to combine very disease-specific advice with very general advice. We’re at a very important place with our patients where we can potentially have a very significant impact with our recommendations about MS as well as other medical conditions and health maintenance.”

Take baby steps

Dr. Bowling recommended that clinicians take baby steps to incorporate aspects of integrated care, including use of brief, strong supportive statements; focusing on only one issue per visit; referring patients to information resources; and sharing or transferring responsibility/accountability with other providers. Excessive focus on one therapy – including unusual and unproven CAM therapies – may detract from, or be used to avoid, other valuable approaches. For example, some of Dr. Bowling’s patients may come in very enchanted with a particular dietary supplement yet their own diet is unhealthy. “I don’t scold them, but I say, ‘I don’t think this supplement’s going to hurt you but there’s much more evidence that we should shift the focus of your motivation and drive to dietary approaches.’ ”

Use leverage to tackle emotional health

In the area of emotional health, Dr. Bowling said that an MS diagnosis often serves as a springboard to help young patients develop emotional literacy so that they don’t develop high levels of stress and anxiety. “What I find are people on the verge of entering into depression or anxiety and not really knowing how to address those emotional issues or even to do basic identification and processing of emotions, and getting attached to mind-body approaches, which I think have a clear benefit, but for many patients it does not lead to emotional literacy,” he said. “I emphasize ‘I can’t be with you 24/7. That’s your piece of the equation.’ You can also help patients identify things that give them joy, meaning, and fun in life. That’s a motivator for a lot of them – to keep doing what they find joyful, meaningful, and fun.” Dr. Bowling said that this kind of approach brings “plain old common sense” to the clinician-patient relationship. “I think we all have lots of leverage with our patients, but there’s no cookbook or algorithm here; you need to start where patients are,” he said. “Our younger patients in particular are not really listening to their primary care doctor too much. They’re paying very close attention to what we’re talking about: disease-modifying therapies and symptomatic management.”

In Dr. Bowling’s clinical experience, men often struggle with emotional health and emotional literacy issues. “I have seen amazing transformations of men in their early 20s with very low emotional literacy, and working with them, sometimes with psychodynamic psychotherapy and other methods, sometimes just talking with friends and family – really encouraging them before there’s serious anxiety or depression.” One patient told him that MS “forced me to do a year of psychotherapy and some intensive introspection for a few years. This helped me and also my family.” He recommended that clinicians tread carefully when advising men about tobacco and alcohol use, and when advising women about weight management. “Be prepared; it’s a little different every time you bring those potential issues up,” he said.

Dr. Bowling added that MS often affects how patients view the aging process itself. “It can be a crash course in how to understand the body and best use it before people technically get to the aging years,” he said. “There’s also more acceptance of disability in people who are older.” In the setting of patients who experience disease flare-ups, they may ask you if there’s anything they can do from a lifestyle standpoint to make them go away. “Be primed for these teaching moments and opportunities where there’s a seed of motivation,” he advised.


Approach treats, prevents clinician burnout

Dr. Bowling described the integrative approach to treating MS patients as “an ever-changing skill set. There’s all this talk about neurologist burnout, which is very real. If you practice this way, this is a great treatment and preventive approach for clinician burnout because your patients check you out to see if you ‘walk the walk’ on advice you give them. My success with my patients in some of these areas is less than 50%. But when there’s a real change, it’s for the life of that person. That’s the most rewarding part of my career at this point.”

Dr. Bowling disclosed that he has received research, consulting, advising, and speaking fees from Acorda, Biogen, EMD Serono, Genentech, Genzyme, Sanofi-Aventis, Teva, the American Academy of Neurology, the CMSC, the Mandell Center for Multiple Sclerosis, and the National MS Society.

[email protected]

NEW ORLEANS – The integration of lifestyle, alternative, and conventional medicine into the care of patients with multiple sclerosis can be transformative for patients and clinicians alike, according to Allen C. Bowling, MD, PhD.

This approach not only emphasizes health and wellness of the whole person, it supports the clinician-patient relationship since neurologists serve as point persons for MS patients, Dr. Bowling said at the annual meeting of the Consortium of Multiple Sclerosis Centers. “It’s critical to not just think about MS the disease, but to think about the patient’s overall health, maintaining health,” he said. “That’s a big mind shift. I think sometimes people hear the term ‘integrative medicine’ and they start walking out of the room or think it’s getting ‘woo-woo,’ but there is a very evidence-based approach to integrative medicine. The core of it still is not familiar to a lot of physicians.”

Harness ‘built-in’ resources

Dr. Bowling, author of “Optimal Health With Multiple Sclerosis: A Guide to Integrating Lifestyle, Alternative, and Conventional Medicine” (New York: Demos Medical Publishing, 2014) and developer of a website devoted to integrative care and MS (www.neurologycare.net), said that some of best treatment approaches may be those that use the “built-in” resources of the human body and do not require any medications, supplements, devices, or technology. “The most effective and long-lasting changes in lifestyle may be those that are small and consistent,” he said. For example, when he first started applying integrative care principles to his practice more than 16 years ago, some patients told him that MS was “one of the best things that happened to them, and that it was a gift in that it helped them clean up their lifestyle.” In the summer of 2001, one such patient came to see Dr. Bowling and said, “Since my last appointment I’ve lost 20 pounds, bought a bike. I exercise four times weekly. My wife and I have changed our diet. This is real; I’m on it.”

“I said. ‘Very impressive. How did that happen? What motivated you?’ ”

“He said, ‘You did.’ This was like a turning point in his life.”

As of May 2017, this patient has maintained his healthy lifestyle changes.

Dr. Bowling told meeting attendees that early in his neurology career he didn’t always consider other ways he could impact MS patients beyond helping them determine the best disease-modifying treatment and/or assisting them in managing symptoms. Thinking to counsel them in areas such as a balanced diet, exercise, and emotional wellness “was a mind shift for me, and made me realize how narrow my focus was,” he said. “It transformed me to go back to thinking more about general medicine. I’m a detail-oriented guy, but I don’t think that’s in the best interests of our patients. I think we need to combine very disease-specific advice with very general advice. We’re at a very important place with our patients where we can potentially have a very significant impact with our recommendations about MS as well as other medical conditions and health maintenance.”

Take baby steps

Dr. Bowling recommended that clinicians take baby steps to incorporate aspects of integrated care, including use of brief, strong supportive statements; focusing on only one issue per visit; referring patients to information resources; and sharing or transferring responsibility/accountability with other providers. Excessive focus on one therapy – including unusual and unproven CAM therapies – may detract from, or be used to avoid, other valuable approaches. For example, some of Dr. Bowling’s patients may come in very enchanted with a particular dietary supplement yet their own diet is unhealthy. “I don’t scold them, but I say, ‘I don’t think this supplement’s going to hurt you but there’s much more evidence that we should shift the focus of your motivation and drive to dietary approaches.’ ”

Use leverage to tackle emotional health

In the area of emotional health, Dr. Bowling said that an MS diagnosis often serves as a springboard to help young patients develop emotional literacy so that they don’t develop high levels of stress and anxiety. “What I find are people on the verge of entering into depression or anxiety and not really knowing how to address those emotional issues or even to do basic identification and processing of emotions, and getting attached to mind-body approaches, which I think have a clear benefit, but for many patients it does not lead to emotional literacy,” he said. “I emphasize ‘I can’t be with you 24/7. That’s your piece of the equation.’ You can also help patients identify things that give them joy, meaning, and fun in life. That’s a motivator for a lot of them – to keep doing what they find joyful, meaningful, and fun.” Dr. Bowling said that this kind of approach brings “plain old common sense” to the clinician-patient relationship. “I think we all have lots of leverage with our patients, but there’s no cookbook or algorithm here; you need to start where patients are,” he said. “Our younger patients in particular are not really listening to their primary care doctor too much. They’re paying very close attention to what we’re talking about: disease-modifying therapies and symptomatic management.”

In Dr. Bowling’s clinical experience, men often struggle with emotional health and emotional literacy issues. “I have seen amazing transformations of men in their early 20s with very low emotional literacy, and working with them, sometimes with psychodynamic psychotherapy and other methods, sometimes just talking with friends and family – really encouraging them before there’s serious anxiety or depression.” One patient told him that MS “forced me to do a year of psychotherapy and some intensive introspection for a few years. This helped me and also my family.” He recommended that clinicians tread carefully when advising men about tobacco and alcohol use, and when advising women about weight management. “Be prepared; it’s a little different every time you bring those potential issues up,” he said.

Dr. Bowling added that MS often affects how patients view the aging process itself. “It can be a crash course in how to understand the body and best use it before people technically get to the aging years,” he said. “There’s also more acceptance of disability in people who are older.” In the setting of patients who experience disease flare-ups, they may ask you if there’s anything they can do from a lifestyle standpoint to make them go away. “Be primed for these teaching moments and opportunities where there’s a seed of motivation,” he advised.


Approach treats, prevents clinician burnout

Dr. Bowling described the integrative approach to treating MS patients as “an ever-changing skill set. There’s all this talk about neurologist burnout, which is very real. If you practice this way, this is a great treatment and preventive approach for clinician burnout because your patients check you out to see if you ‘walk the walk’ on advice you give them. My success with my patients in some of these areas is less than 50%. But when there’s a real change, it’s for the life of that person. That’s the most rewarding part of my career at this point.”

Dr. Bowling disclosed that he has received research, consulting, advising, and speaking fees from Acorda, Biogen, EMD Serono, Genentech, Genzyme, Sanofi-Aventis, Teva, the American Academy of Neurology, the CMSC, the Mandell Center for Multiple Sclerosis, and the National MS Society.

[email protected]

NEW ORLEANS – The integration of lifestyle, alternative, and conventional medicine into the care of patients with multiple sclerosis can be transformative for patients and clinicians alike, according to Allen C. Bowling, MD, PhD.

This approach not only emphasizes health and wellness of the whole person, it supports the clinician-patient relationship since neurologists serve as point persons for MS patients, Dr. Bowling said at the annual meeting of the Consortium of Multiple Sclerosis Centers. “It’s critical to not just think about MS the disease, but to think about the patient’s overall health, maintaining health,” he said. “That’s a big mind shift. I think sometimes people hear the term ‘integrative medicine’ and they start walking out of the room or think it’s getting ‘woo-woo,’ but there is a very evidence-based approach to integrative medicine. The core of it still is not familiar to a lot of physicians.”

Harness ‘built-in’ resources

Dr. Bowling, author of “Optimal Health With Multiple Sclerosis: A Guide to Integrating Lifestyle, Alternative, and Conventional Medicine” (New York: Demos Medical Publishing, 2014) and developer of a website devoted to integrative care and MS (www.neurologycare.net), said that some of best treatment approaches may be those that use the “built-in” resources of the human body and do not require any medications, supplements, devices, or technology. “The most effective and long-lasting changes in lifestyle may be those that are small and consistent,” he said. For example, when he first started applying integrative care principles to his practice more than 16 years ago, some patients told him that MS was “one of the best things that happened to them, and that it was a gift in that it helped them clean up their lifestyle.” In the summer of 2001, one such patient came to see Dr. Bowling and said, “Since my last appointment I’ve lost 20 pounds, bought a bike. I exercise four times weekly. My wife and I have changed our diet. This is real; I’m on it.”

“I said. ‘Very impressive. How did that happen? What motivated you?’ ”

“He said, ‘You did.’ This was like a turning point in his life.”

As of May 2017, this patient has maintained his healthy lifestyle changes.

Dr. Bowling told meeting attendees that early in his neurology career he didn’t always consider other ways he could impact MS patients beyond helping them determine the best disease-modifying treatment and/or assisting them in managing symptoms. Thinking to counsel them in areas such as a balanced diet, exercise, and emotional wellness “was a mind shift for me, and made me realize how narrow my focus was,” he said. “It transformed me to go back to thinking more about general medicine. I’m a detail-oriented guy, but I don’t think that’s in the best interests of our patients. I think we need to combine very disease-specific advice with very general advice. We’re at a very important place with our patients where we can potentially have a very significant impact with our recommendations about MS as well as other medical conditions and health maintenance.”

Take baby steps

Dr. Bowling recommended that clinicians take baby steps to incorporate aspects of integrated care, including use of brief, strong supportive statements; focusing on only one issue per visit; referring patients to information resources; and sharing or transferring responsibility/accountability with other providers. Excessive focus on one therapy – including unusual and unproven CAM therapies – may detract from, or be used to avoid, other valuable approaches. For example, some of Dr. Bowling’s patients may come in very enchanted with a particular dietary supplement yet their own diet is unhealthy. “I don’t scold them, but I say, ‘I don’t think this supplement’s going to hurt you but there’s much more evidence that we should shift the focus of your motivation and drive to dietary approaches.’ ”

Use leverage to tackle emotional health

In the area of emotional health, Dr. Bowling said that an MS diagnosis often serves as a springboard to help young patients develop emotional literacy so that they don’t develop high levels of stress and anxiety. “What I find are people on the verge of entering into depression or anxiety and not really knowing how to address those emotional issues or even to do basic identification and processing of emotions, and getting attached to mind-body approaches, which I think have a clear benefit, but for many patients it does not lead to emotional literacy,” he said. “I emphasize ‘I can’t be with you 24/7. That’s your piece of the equation.’ You can also help patients identify things that give them joy, meaning, and fun in life. That’s a motivator for a lot of them – to keep doing what they find joyful, meaningful, and fun.” Dr. Bowling said that this kind of approach brings “plain old common sense” to the clinician-patient relationship. “I think we all have lots of leverage with our patients, but there’s no cookbook or algorithm here; you need to start where patients are,” he said. “Our younger patients in particular are not really listening to their primary care doctor too much. They’re paying very close attention to what we’re talking about: disease-modifying therapies and symptomatic management.”

In Dr. Bowling’s clinical experience, men often struggle with emotional health and emotional literacy issues. “I have seen amazing transformations of men in their early 20s with very low emotional literacy, and working with them, sometimes with psychodynamic psychotherapy and other methods, sometimes just talking with friends and family – really encouraging them before there’s serious anxiety or depression.” One patient told him that MS “forced me to do a year of psychotherapy and some intensive introspection for a few years. This helped me and also my family.” He recommended that clinicians tread carefully when advising men about tobacco and alcohol use, and when advising women about weight management. “Be prepared; it’s a little different every time you bring those potential issues up,” he said.

Dr. Bowling added that MS often affects how patients view the aging process itself. “It can be a crash course in how to understand the body and best use it before people technically get to the aging years,” he said. “There’s also more acceptance of disability in people who are older.” In the setting of patients who experience disease flare-ups, they may ask you if there’s anything they can do from a lifestyle standpoint to make them go away. “Be primed for these teaching moments and opportunities where there’s a seed of motivation,” he advised.


Approach treats, prevents clinician burnout

Dr. Bowling described the integrative approach to treating MS patients as “an ever-changing skill set. There’s all this talk about neurologist burnout, which is very real. If you practice this way, this is a great treatment and preventive approach for clinician burnout because your patients check you out to see if you ‘walk the walk’ on advice you give them. My success with my patients in some of these areas is less than 50%. But when there’s a real change, it’s for the life of that person. That’s the most rewarding part of my career at this point.”

Dr. Bowling disclosed that he has received research, consulting, advising, and speaking fees from Acorda, Biogen, EMD Serono, Genentech, Genzyme, Sanofi-Aventis, Teva, the American Academy of Neurology, the CMSC, the Mandell Center for Multiple Sclerosis, and the National MS Society.

[email protected]

Several times a year, I’m privileged to step away from my role as chief medical officer of a health insurance company and return to a previous role I cherish – teaching.

This isn’t the clinical teaching that I used to do as a hospital medicine attending or palliative medicine consultant. These are mostly 4th-year medical students who have 90 minutes or so set aside during their primary care rotation to learn about “the business of medicine.”

I always begin by telling them that when I went to medical school, “I always intended to become a health insurance executive – NOT!” (If I get a few laughs, I know the time will fly by.) I share the history of my improbable career arc and how I wound up doing something I didn’t even know existed when I was their age. And, I still try to impart some pearls of wisdom in case they remember any of this discussion as they embark on their own personal and professional journeys, knowing that at this stage in their young careers, they will be almost totally immersed in their clinical training.

1. Do what you love

Sounds simple, but too many of us make the expedient choice, or the one expected of us. Work is hard enough without being able to find some joy and meaning every day in what you do. Every job has aspects that must be tolerated, but if you don’t find a greater purpose in practicing medicine, then find a way to get it back – or think about doing something else.

2. When opportunity knocks, be prepared to answer the door

For me, I enjoyed caring for patients one at a time, perhaps 15 or so during any particular day. Being a hospitalist is important and fulfilling work. But my experience as a hospitalist enabled me to recognize the “quality chasms” that existed in my hospital and across the “system,” namely lost opportunities to provide better end-of-life care and to better coordinate care within the hospital and across the care continuum. A new mission evolved for me: to do whatever I could to improve the safety, quality, and efficiency of the care we provided, and to make the hospital a better place to work. I taught myself the clinical skills to practice palliative medicine, and I attended courses that helped me prepare to become a service line medical director in hopes of starting a program at my hospital. I also took on the role of medical director of care management at my hospital, which in a sense allowed me to help take care of several hundred patients at a time – the beginning of my transition to population health.

3. Be a lifelong learner

When these opportunities arose, I was prepared for the challenges thanks to training opportunities I actively sought out, and thanks to the support of my mentors and my medical group to attend leadership training, such as SHM’s Leadership Academy. No matter what your role in your group or at your hospital, gaining these valuable skills outside of the usual medical training will help position you for new opportunities that can only help you create a more sustainable career. And although I never went back to school to earn another advanced degree such as an MBA or MHA, additional formal education is something to consider. You can never have too many tools in your toolkit.

4. Diversify!

It’s good advice from your financial adviser, and it’s good advice for your career. I’m not suggesting you take on a side job as a lawyer or a carpenter, but you might want to think about becoming an expert in a related field like perioperative medicine, primary palliative care, or postacute care. Or consider developing a niche as a sought-after leader for hospital-based committees, such as Quality or P&T. Or maybe consider clinical research, even if you’re not at an academic medical center. The point I’m making – and I know this may seem controversial – is that practicing medicine 100% of the time is probably no longer a sustainable plan for the entire 30- to 40-year span of your postgraduate career. Find an area that you can develop into protected, paid time apart from providing direct clinical care.

5. If you are thinking of changing jobs or even careers, run toward something – not away from something else

When I was first recruited to be a medical director at another health plan, I struggled mightily as to whether leaving full-time practice was an opportunity or a foolish, dead-end career move. Ultimately, I made my decision not to avoid night call or working every other weekend; I did it because I felt I had made a difference in the hospital where I had worked for 15 years and was ready to take on a new challenge by learning the business side of health care. It provided me the opportunity to positively impact the care of not just several hundred patients, but as many as two million! My current position now allows me to have even greater influence in pursuing my personal mission to improve the quality, safety, and affordability of health care.

6. Seek balance in life

Again, sounds trite, but think about it. Most health care professionals, especially physicians, have spent most of their adult lives focused on a single goal – and that often comes at a great cost, both financially and personally. (By the way, I say “seek” because at this point in my career, I doubt any of us ever really find balance.) The best you can hope for is to be wise enough to know that amongst all the balls we are juggling, there are a few that you just can’t let drop without possibly breaking without repair.

As I conclude my talks, I tell those young medical students to practice resiliency; the only constant is change. Remain inquisitive, open yourself to whatever life may bring and enjoy the ride. With a specialty as dynamic and diverse as hospital medicine, you never know where it will take you.
 

Dr. Epstein is executive vice president & chief medical officer at PreferredOne, and adjunct assistant professor of medicine at the University of Minnesota, Minneapolis. He also serves as Board Secretary of SHM.

Several times a year, I’m privileged to step away from my role as chief medical officer of a health insurance company and return to a previous role I cherish – teaching.

This isn’t the clinical teaching that I used to do as a hospital medicine attending or palliative medicine consultant. These are mostly 4th-year medical students who have 90 minutes or so set aside during their primary care rotation to learn about “the business of medicine.”

I always begin by telling them that when I went to medical school, “I always intended to become a health insurance executive – NOT!” (If I get a few laughs, I know the time will fly by.) I share the history of my improbable career arc and how I wound up doing something I didn’t even know existed when I was their age. And, I still try to impart some pearls of wisdom in case they remember any of this discussion as they embark on their own personal and professional journeys, knowing that at this stage in their young careers, they will be almost totally immersed in their clinical training.

1. Do what you love

Sounds simple, but too many of us make the expedient choice, or the one expected of us. Work is hard enough without being able to find some joy and meaning every day in what you do. Every job has aspects that must be tolerated, but if you don’t find a greater purpose in practicing medicine, then find a way to get it back – or think about doing something else.

2. When opportunity knocks, be prepared to answer the door

For me, I enjoyed caring for patients one at a time, perhaps 15 or so during any particular day. Being a hospitalist is important and fulfilling work. But my experience as a hospitalist enabled me to recognize the “quality chasms” that existed in my hospital and across the “system,” namely lost opportunities to provide better end-of-life care and to better coordinate care within the hospital and across the care continuum. A new mission evolved for me: to do whatever I could to improve the safety, quality, and efficiency of the care we provided, and to make the hospital a better place to work. I taught myself the clinical skills to practice palliative medicine, and I attended courses that helped me prepare to become a service line medical director in hopes of starting a program at my hospital. I also took on the role of medical director of care management at my hospital, which in a sense allowed me to help take care of several hundred patients at a time – the beginning of my transition to population health.

3. Be a lifelong learner

When these opportunities arose, I was prepared for the challenges thanks to training opportunities I actively sought out, and thanks to the support of my mentors and my medical group to attend leadership training, such as SHM’s Leadership Academy. No matter what your role in your group or at your hospital, gaining these valuable skills outside of the usual medical training will help position you for new opportunities that can only help you create a more sustainable career. And although I never went back to school to earn another advanced degree such as an MBA or MHA, additional formal education is something to consider. You can never have too many tools in your toolkit.

4. Diversify!

It’s good advice from your financial adviser, and it’s good advice for your career. I’m not suggesting you take on a side job as a lawyer or a carpenter, but you might want to think about becoming an expert in a related field like perioperative medicine, primary palliative care, or postacute care. Or consider developing a niche as a sought-after leader for hospital-based committees, such as Quality or P&T. Or maybe consider clinical research, even if you’re not at an academic medical center. The point I’m making – and I know this may seem controversial – is that practicing medicine 100% of the time is probably no longer a sustainable plan for the entire 30- to 40-year span of your postgraduate career. Find an area that you can develop into protected, paid time apart from providing direct clinical care.

5. If you are thinking of changing jobs or even careers, run toward something – not away from something else

When I was first recruited to be a medical director at another health plan, I struggled mightily as to whether leaving full-time practice was an opportunity or a foolish, dead-end career move. Ultimately, I made my decision not to avoid night call or working every other weekend; I did it because I felt I had made a difference in the hospital where I had worked for 15 years and was ready to take on a new challenge by learning the business side of health care. It provided me the opportunity to positively impact the care of not just several hundred patients, but as many as two million! My current position now allows me to have even greater influence in pursuing my personal mission to improve the quality, safety, and affordability of health care.

6. Seek balance in life

Again, sounds trite, but think about it. Most health care professionals, especially physicians, have spent most of their adult lives focused on a single goal – and that often comes at a great cost, both financially and personally. (By the way, I say “seek” because at this point in my career, I doubt any of us ever really find balance.) The best you can hope for is to be wise enough to know that amongst all the balls we are juggling, there are a few that you just can’t let drop without possibly breaking without repair.

As I conclude my talks, I tell those young medical students to practice resiliency; the only constant is change. Remain inquisitive, open yourself to whatever life may bring and enjoy the ride. With a specialty as dynamic and diverse as hospital medicine, you never know where it will take you.
 

Dr. Epstein is executive vice president & chief medical officer at PreferredOne, and adjunct assistant professor of medicine at the University of Minnesota, Minneapolis. He also serves as Board Secretary of SHM.

Several times a year, I’m privileged to step away from my role as chief medical officer of a health insurance company and return to a previous role I cherish – teaching.

This isn’t the clinical teaching that I used to do as a hospital medicine attending or palliative medicine consultant. These are mostly 4th-year medical students who have 90 minutes or so set aside during their primary care rotation to learn about “the business of medicine.”

I always begin by telling them that when I went to medical school, “I always intended to become a health insurance executive – NOT!” (If I get a few laughs, I know the time will fly by.) I share the history of my improbable career arc and how I wound up doing something I didn’t even know existed when I was their age. And, I still try to impart some pearls of wisdom in case they remember any of this discussion as they embark on their own personal and professional journeys, knowing that at this stage in their young careers, they will be almost totally immersed in their clinical training.

1. Do what you love

Sounds simple, but too many of us make the expedient choice, or the one expected of us. Work is hard enough without being able to find some joy and meaning every day in what you do. Every job has aspects that must be tolerated, but if you don’t find a greater purpose in practicing medicine, then find a way to get it back – or think about doing something else.

2. When opportunity knocks, be prepared to answer the door

For me, I enjoyed caring for patients one at a time, perhaps 15 or so during any particular day. Being a hospitalist is important and fulfilling work. But my experience as a hospitalist enabled me to recognize the “quality chasms” that existed in my hospital and across the “system,” namely lost opportunities to provide better end-of-life care and to better coordinate care within the hospital and across the care continuum. A new mission evolved for me: to do whatever I could to improve the safety, quality, and efficiency of the care we provided, and to make the hospital a better place to work. I taught myself the clinical skills to practice palliative medicine, and I attended courses that helped me prepare to become a service line medical director in hopes of starting a program at my hospital. I also took on the role of medical director of care management at my hospital, which in a sense allowed me to help take care of several hundred patients at a time – the beginning of my transition to population health.

3. Be a lifelong learner

When these opportunities arose, I was prepared for the challenges thanks to training opportunities I actively sought out, and thanks to the support of my mentors and my medical group to attend leadership training, such as SHM’s Leadership Academy. No matter what your role in your group or at your hospital, gaining these valuable skills outside of the usual medical training will help position you for new opportunities that can only help you create a more sustainable career. And although I never went back to school to earn another advanced degree such as an MBA or MHA, additional formal education is something to consider. You can never have too many tools in your toolkit.

4. Diversify!

It’s good advice from your financial adviser, and it’s good advice for your career. I’m not suggesting you take on a side job as a lawyer or a carpenter, but you might want to think about becoming an expert in a related field like perioperative medicine, primary palliative care, or postacute care. Or consider developing a niche as a sought-after leader for hospital-based committees, such as Quality or P&T. Or maybe consider clinical research, even if you’re not at an academic medical center. The point I’m making – and I know this may seem controversial – is that practicing medicine 100% of the time is probably no longer a sustainable plan for the entire 30- to 40-year span of your postgraduate career. Find an area that you can develop into protected, paid time apart from providing direct clinical care.

5. If you are thinking of changing jobs or even careers, run toward something – not away from something else

When I was first recruited to be a medical director at another health plan, I struggled mightily as to whether leaving full-time practice was an opportunity or a foolish, dead-end career move. Ultimately, I made my decision not to avoid night call or working every other weekend; I did it because I felt I had made a difference in the hospital where I had worked for 15 years and was ready to take on a new challenge by learning the business side of health care. It provided me the opportunity to positively impact the care of not just several hundred patients, but as many as two million! My current position now allows me to have even greater influence in pursuing my personal mission to improve the quality, safety, and affordability of health care.

6. Seek balance in life

Again, sounds trite, but think about it. Most health care professionals, especially physicians, have spent most of their adult lives focused on a single goal – and that often comes at a great cost, both financially and personally. (By the way, I say “seek” because at this point in my career, I doubt any of us ever really find balance.) The best you can hope for is to be wise enough to know that amongst all the balls we are juggling, there are a few that you just can’t let drop without possibly breaking without repair.

As I conclude my talks, I tell those young medical students to practice resiliency; the only constant is change. Remain inquisitive, open yourself to whatever life may bring and enjoy the ride. With a specialty as dynamic and diverse as hospital medicine, you never know where it will take you.
 

Dr. Epstein is executive vice president & chief medical officer at PreferredOne, and adjunct assistant professor of medicine at the University of Minnesota, Minneapolis. He also serves as Board Secretary of SHM.