Hypotension is an often-underestimated adversary. Even brief periods of intraoperative mean arterial pressure (MAP) <65 mm Hg increase the odds of both myocardial ischemia and acute kidney injury in the postoperative period. The threshold may be even higher in the postoperative critically ill population (Khanna, et al. Crit Care Med. 2018;46(1):71). Hypotension that is refractory to high-dose vasopressors is associated with an all-cause mortality of 50% to 80%.

The vasopressor toolbox centers around escalating doses of catecholamines with or without the addition of vasopressin. High-dose catecholamines, albeit a frequent choice, is associated with adverse cardiac events (Schmittinger, et al. Intensive Care Med. 2012;38[6]:950) and is an independent predictor of ICU mortality (Sviri, et al. J Crit Care. 2014;29[1]:157).
 

The evidence behind angiotensin II

Angiotensin II (AT II) is a naturally occurring hormone in the renin-angiotensin-aldosterone (RAA) system that modulates blood pressure through direct arterial vasoconstriction and direct stimulation of the kidneys and adrenal cortex to release vasopressin and aldosterone, respectively.

Positive results from the recent phase 3 trial for AT II have offered hope that this agent would add the needed balance to the current scarcity of vasopressor options (Khanna, et al. N Engl J Med. 2017;377[5]:419). AT II would provide the missing piece in the jigsaw that would allow the intensivist to manage refractory hypotension, while keeping a multimodal vasopressor dosing regimen within therapeutic limits.

Is there a downside?

Appropriate caution is necessary when interpreting these outcomes. One criticism that ATHOS-3 received was the use of a MAP goal of 75 mm Hg, a higher value than currently recommended by clinical guidelines, in the first 3 hours of AT II administration. Because this was a phase 3 trial, both the safety and efficacy of the drug were examined. These goals are difficult to accomplish if simultaneously manipulating other variables. Therefore, to isolate the effects of drug efficacy and safety, a higher MAP goal (75 mm Hg) was established to minimize any effect from varying background vasopressor doses during the first 3 hours of the study.

Furthermore, ATHOS-3 did find an increase in venous and arterial thromboembolic events in patients who received AT II (13% AT II vs 5% placebo). Previously, a systematic review of over 30,000 patients did not report this increased thromboembolic risk (Busse, et al. Crit Care. 2017;21[1]:324). According to the package insert, all patients receiving AT II should receive appropriate thromboembolic prophylaxis if medically indicated.
 

Where does AT II fit in our algorithm for resuscitation and the vasopressor toolbox?

Data from Wunderink et al indicate a potential mortality benefit in populations who are AT II depleted. However, we can only infer who these patients may be, as no commonly available assay can measure AT I and AT II levels. ATHOS and ATHOS-3 used AT II late during resuscitation, as did the Expanded Access Program (EAP) of the FDA, which gave physicians preliminary access to AT II while it was undergoing FDA review. Using similar inclusion criteria as ATHOS-3, the EAP did not permit patients to receive AT II until doses greater than or equal to 0.2 ug/kg/min of NE-equivalents were reached. In a recently published case report, AT II was successfully used in a patient with septic shock secondary to a colonic perforation (Chow, et al. Accepted for e-publication: A&A Practice. April 2018.). This individual was in vasodilatory shock despite standard resuscitation, 0.48 ug/kg/min of NE, and 0.04 units/min of vasopressin. Methylene blue and hydroxocobalamin had failed to relieve the vasoplegia, and only after the initiation of AT II at 40 ng/kg/min, the patient could be relieved of vasopressors and survived to be discharged from the hospital. In our opinion, best clinical practices would allow for an early multimodal vasopressor regimen that should include AT II at the earliest sign of rapid clinical decline (Jentzer, et al. Chest. 2018. Jan 9. pii: S0012-3692(18)30072-2. doi: 10.1016/j.chest.2017.12.021. [Epub ahead of print]).

Angiotensin II was recently approved by the FDA in December 2017 and is now available on the market for management of vasodilatory shock. This will undoubtedly have a profound impact on the way clinicians treat vasodilatory shock. Previously, we were confined to agents such methylene blue and hydroxocobalamin to rescue patients from profound vasoplegia. However, none of these agents are supported by robust evidence from randomized control trials.

Now, we can openly welcome a new challenger to the campaign, a new hue to the palette of vasopressor colors. This new class of vasopressor makes complete physiological sense and will provide an invaluable tool in our daily battle against sepsis and vasodilatory shock.

Dr. Chow is Assistant Professor, Division of Critical Care Medicine, Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD; Dr. Khana is Assistant Professor of Anesthesiology, Staff Intensivist, Vice-Chief for Research, Center for Critical Care, Department of Outcomes Research & General Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH

Editor’s note

For decades, our options to treat patients with profound vasoplegia have been limited to high-dose catecholamines and vasopressin. Clinicians are often faced with the need to initiate multiple catecholamine agents knowing that these drugs stimulate similar receptors. The recent ATHOS-3 trial introduces AT II as a new option for the management of patients with refractory vasodilatory shock. This drug has a distinct mechanism of action that complements the effect of other vasopressors. Moreover, recent data suggest that this new agent is most beneficial in patients who are AT II deficient. Just like cancer therapies have evolved to precision medicine, will we perhaps face the need to better understand and promptly identify patients with AT II deficiency? For now, we have a new player on our vasopressor team.

Angel Coz, MD, FCCP
Section Editor

Hypotension is an often-underestimated adversary. Even brief periods of intraoperative mean arterial pressure (MAP) <65 mm Hg increase the odds of both myocardial ischemia and acute kidney injury in the postoperative period. The threshold may be even higher in the postoperative critically ill population (Khanna, et al. Crit Care Med. 2018;46(1):71). Hypotension that is refractory to high-dose vasopressors is associated with an all-cause mortality of 50% to 80%.

The vasopressor toolbox centers around escalating doses of catecholamines with or without the addition of vasopressin. High-dose catecholamines, albeit a frequent choice, is associated with adverse cardiac events (Schmittinger, et al. Intensive Care Med. 2012;38[6]:950) and is an independent predictor of ICU mortality (Sviri, et al. J Crit Care. 2014;29[1]:157).
 

The evidence behind angiotensin II

Angiotensin II (AT II) is a naturally occurring hormone in the renin-angiotensin-aldosterone (RAA) system that modulates blood pressure through direct arterial vasoconstriction and direct stimulation of the kidneys and adrenal cortex to release vasopressin and aldosterone, respectively.

Positive results from the recent phase 3 trial for AT II have offered hope that this agent would add the needed balance to the current scarcity of vasopressor options (Khanna, et al. N Engl J Med. 2017;377[5]:419). AT II would provide the missing piece in the jigsaw that would allow the intensivist to manage refractory hypotension, while keeping a multimodal vasopressor dosing regimen within therapeutic limits.

Is there a downside?

Appropriate caution is necessary when interpreting these outcomes. One criticism that ATHOS-3 received was the use of a MAP goal of 75 mm Hg, a higher value than currently recommended by clinical guidelines, in the first 3 hours of AT II administration. Because this was a phase 3 trial, both the safety and efficacy of the drug were examined. These goals are difficult to accomplish if simultaneously manipulating other variables. Therefore, to isolate the effects of drug efficacy and safety, a higher MAP goal (75 mm Hg) was established to minimize any effect from varying background vasopressor doses during the first 3 hours of the study.

Furthermore, ATHOS-3 did find an increase in venous and arterial thromboembolic events in patients who received AT II (13% AT II vs 5% placebo). Previously, a systematic review of over 30,000 patients did not report this increased thromboembolic risk (Busse, et al. Crit Care. 2017;21[1]:324). According to the package insert, all patients receiving AT II should receive appropriate thromboembolic prophylaxis if medically indicated.
 

Where does AT II fit in our algorithm for resuscitation and the vasopressor toolbox?

Data from Wunderink et al indicate a potential mortality benefit in populations who are AT II depleted. However, we can only infer who these patients may be, as no commonly available assay can measure AT I and AT II levels. ATHOS and ATHOS-3 used AT II late during resuscitation, as did the Expanded Access Program (EAP) of the FDA, which gave physicians preliminary access to AT II while it was undergoing FDA review. Using similar inclusion criteria as ATHOS-3, the EAP did not permit patients to receive AT II until doses greater than or equal to 0.2 ug/kg/min of NE-equivalents were reached. In a recently published case report, AT II was successfully used in a patient with septic shock secondary to a colonic perforation (Chow, et al. Accepted for e-publication: A&A Practice. April 2018.). This individual was in vasodilatory shock despite standard resuscitation, 0.48 ug/kg/min of NE, and 0.04 units/min of vasopressin. Methylene blue and hydroxocobalamin had failed to relieve the vasoplegia, and only after the initiation of AT II at 40 ng/kg/min, the patient could be relieved of vasopressors and survived to be discharged from the hospital. In our opinion, best clinical practices would allow for an early multimodal vasopressor regimen that should include AT II at the earliest sign of rapid clinical decline (Jentzer, et al. Chest. 2018. Jan 9. pii: S0012-3692(18)30072-2. doi: 10.1016/j.chest.2017.12.021. [Epub ahead of print]).

Angiotensin II was recently approved by the FDA in December 2017 and is now available on the market for management of vasodilatory shock. This will undoubtedly have a profound impact on the way clinicians treat vasodilatory shock. Previously, we were confined to agents such methylene blue and hydroxocobalamin to rescue patients from profound vasoplegia. However, none of these agents are supported by robust evidence from randomized control trials.

Now, we can openly welcome a new challenger to the campaign, a new hue to the palette of vasopressor colors. This new class of vasopressor makes complete physiological sense and will provide an invaluable tool in our daily battle against sepsis and vasodilatory shock.

Dr. Chow is Assistant Professor, Division of Critical Care Medicine, Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD; Dr. Khana is Assistant Professor of Anesthesiology, Staff Intensivist, Vice-Chief for Research, Center for Critical Care, Department of Outcomes Research & General Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH

Editor’s note

For decades, our options to treat patients with profound vasoplegia have been limited to high-dose catecholamines and vasopressin. Clinicians are often faced with the need to initiate multiple catecholamine agents knowing that these drugs stimulate similar receptors. The recent ATHOS-3 trial introduces AT II as a new option for the management of patients with refractory vasodilatory shock. This drug has a distinct mechanism of action that complements the effect of other vasopressors. Moreover, recent data suggest that this new agent is most beneficial in patients who are AT II deficient. Just like cancer therapies have evolved to precision medicine, will we perhaps face the need to better understand and promptly identify patients with AT II deficiency? For now, we have a new player on our vasopressor team.

Angel Coz, MD, FCCP
Section Editor

Hypotension is an often-underestimated adversary. Even brief periods of intraoperative mean arterial pressure (MAP) <65 mm Hg increase the odds of both myocardial ischemia and acute kidney injury in the postoperative period. The threshold may be even higher in the postoperative critically ill population (Khanna, et al. Crit Care Med. 2018;46(1):71). Hypotension that is refractory to high-dose vasopressors is associated with an all-cause mortality of 50% to 80%.

The vasopressor toolbox centers around escalating doses of catecholamines with or without the addition of vasopressin. High-dose catecholamines, albeit a frequent choice, is associated with adverse cardiac events (Schmittinger, et al. Intensive Care Med. 2012;38[6]:950) and is an independent predictor of ICU mortality (Sviri, et al. J Crit Care. 2014;29[1]:157).
 

The evidence behind angiotensin II

Angiotensin II (AT II) is a naturally occurring hormone in the renin-angiotensin-aldosterone (RAA) system that modulates blood pressure through direct arterial vasoconstriction and direct stimulation of the kidneys and adrenal cortex to release vasopressin and aldosterone, respectively.

Positive results from the recent phase 3 trial for AT II have offered hope that this agent would add the needed balance to the current scarcity of vasopressor options (Khanna, et al. N Engl J Med. 2017;377[5]:419). AT II would provide the missing piece in the jigsaw that would allow the intensivist to manage refractory hypotension, while keeping a multimodal vasopressor dosing regimen within therapeutic limits.

Is there a downside?

Appropriate caution is necessary when interpreting these outcomes. One criticism that ATHOS-3 received was the use of a MAP goal of 75 mm Hg, a higher value than currently recommended by clinical guidelines, in the first 3 hours of AT II administration. Because this was a phase 3 trial, both the safety and efficacy of the drug were examined. These goals are difficult to accomplish if simultaneously manipulating other variables. Therefore, to isolate the effects of drug efficacy and safety, a higher MAP goal (75 mm Hg) was established to minimize any effect from varying background vasopressor doses during the first 3 hours of the study.

Furthermore, ATHOS-3 did find an increase in venous and arterial thromboembolic events in patients who received AT II (13% AT II vs 5% placebo). Previously, a systematic review of over 30,000 patients did not report this increased thromboembolic risk (Busse, et al. Crit Care. 2017;21[1]:324). According to the package insert, all patients receiving AT II should receive appropriate thromboembolic prophylaxis if medically indicated.
 

Where does AT II fit in our algorithm for resuscitation and the vasopressor toolbox?

Data from Wunderink et al indicate a potential mortality benefit in populations who are AT II depleted. However, we can only infer who these patients may be, as no commonly available assay can measure AT I and AT II levels. ATHOS and ATHOS-3 used AT II late during resuscitation, as did the Expanded Access Program (EAP) of the FDA, which gave physicians preliminary access to AT II while it was undergoing FDA review. Using similar inclusion criteria as ATHOS-3, the EAP did not permit patients to receive AT II until doses greater than or equal to 0.2 ug/kg/min of NE-equivalents were reached. In a recently published case report, AT II was successfully used in a patient with septic shock secondary to a colonic perforation (Chow, et al. Accepted for e-publication: A&A Practice. April 2018.). This individual was in vasodilatory shock despite standard resuscitation, 0.48 ug/kg/min of NE, and 0.04 units/min of vasopressin. Methylene blue and hydroxocobalamin had failed to relieve the vasoplegia, and only after the initiation of AT II at 40 ng/kg/min, the patient could be relieved of vasopressors and survived to be discharged from the hospital. In our opinion, best clinical practices would allow for an early multimodal vasopressor regimen that should include AT II at the earliest sign of rapid clinical decline (Jentzer, et al. Chest. 2018. Jan 9. pii: S0012-3692(18)30072-2. doi: 10.1016/j.chest.2017.12.021. [Epub ahead of print]).

Angiotensin II was recently approved by the FDA in December 2017 and is now available on the market for management of vasodilatory shock. This will undoubtedly have a profound impact on the way clinicians treat vasodilatory shock. Previously, we were confined to agents such methylene blue and hydroxocobalamin to rescue patients from profound vasoplegia. However, none of these agents are supported by robust evidence from randomized control trials.

Now, we can openly welcome a new challenger to the campaign, a new hue to the palette of vasopressor colors. This new class of vasopressor makes complete physiological sense and will provide an invaluable tool in our daily battle against sepsis and vasodilatory shock.

Dr. Chow is Assistant Professor, Division of Critical Care Medicine, Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD; Dr. Khana is Assistant Professor of Anesthesiology, Staff Intensivist, Vice-Chief for Research, Center for Critical Care, Department of Outcomes Research & General Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH

Editor’s note

For decades, our options to treat patients with profound vasoplegia have been limited to high-dose catecholamines and vasopressin. Clinicians are often faced with the need to initiate multiple catecholamine agents knowing that these drugs stimulate similar receptors. The recent ATHOS-3 trial introduces AT II as a new option for the management of patients with refractory vasodilatory shock. This drug has a distinct mechanism of action that complements the effect of other vasopressors. Moreover, recent data suggest that this new agent is most beneficial in patients who are AT II deficient. Just like cancer therapies have evolved to precision medicine, will we perhaps face the need to better understand and promptly identify patients with AT II deficiency? For now, we have a new player on our vasopressor team.

Angel Coz, MD, FCCP
Section Editor

How it all started

The study abroad project was truly a goal and vision that came about after returning to Guyana after approximately 46 years. I was born in Guyana but left as a child and returned later and joined a mission group. In 2015, I began a personal journey of missionary service with the team of Bridge Global Medical Missions (BGMM) in Georgetown, Guyana. I was the first respiratory therapist to join the team.

I remember during the first few days in the hospitals I was told that there was “a lot of wheezing” in the EDs. Treating patients consisted of just administrating short-acting nebulizer treatments, but I remember being very impressed with the ICU at the main public hospital, Georgetown Public Hospital Corporation (GPHC), because they had the ventilators I could use. However, physicians only managed the patients while the nurses were left to monitor the ventilators and equipment, which they did not understand.

Study abroad and respiratory care

Then the vision of my project began, because I needed to show him the scope of the practice of a respiratory therapist. I asked Dr. Heyliger-Thomas of BGMM if she could assist me in promoting a study abroad program in Guyana with the Ministry of Health. It was very important for me to bring my students to Guyana for many reasons, the most important being the profession was needed there, and our students would be excellent representatives.

In 2015, the study “Introduction of spirometry into clinical practice in Georgetown, Guyana: quality and diagnostic outcomes” highlighted increased physician referral to the country’s only COPD/asthma clinic. I wanted to promote the importance of study abroad and international mission work, especially when promoting the care of asthma and the pulmonary patient, which I believe we did. The main project during study abroad was to test the school-aged children in Linden, thereby showing that there was undiagnosed asthma.

The effect of the CHEST Foundation grant

Applying for the CHEST Foundation community service grant was the largest grant I had ever attempted. Having a support system behind you is the most important piece of advice I can give to future grant applicants. I could not have completed my grant without our grant team at Texas State University. They truly had my back; and close to the deadline when it seemed insurmountable, they helped push me through it. The other piece of advice is to have a true vision and stick to that vision. The most difficult part of my project was the budget, prioritizing the things or people that I needed. Honestly, I needed help here, because for me, I needed everything. I had to make choices and leave some things out. I focused on what the actual need was for the many.

My ultimate goal for Guyana is to promote and show the need for respiratory care professionals to have that education offered at the University of Guyana as part of its allied health program and assist those in the application to the International Fellowship Program of the American Association of Respiratory Care—there has never been a fellow from Guyana. I believe that Guyana will have the resources, and with assistance, could achieve the goal. My vision and goal started in 2016, and I want to achieve it in the next 10 years.

How it all started

The study abroad project was truly a goal and vision that came about after returning to Guyana after approximately 46 years. I was born in Guyana but left as a child and returned later and joined a mission group. In 2015, I began a personal journey of missionary service with the team of Bridge Global Medical Missions (BGMM) in Georgetown, Guyana. I was the first respiratory therapist to join the team.

I remember during the first few days in the hospitals I was told that there was “a lot of wheezing” in the EDs. Treating patients consisted of just administrating short-acting nebulizer treatments, but I remember being very impressed with the ICU at the main public hospital, Georgetown Public Hospital Corporation (GPHC), because they had the ventilators I could use. However, physicians only managed the patients while the nurses were left to monitor the ventilators and equipment, which they did not understand.

Study abroad and respiratory care

Then the vision of my project began, because I needed to show him the scope of the practice of a respiratory therapist. I asked Dr. Heyliger-Thomas of BGMM if she could assist me in promoting a study abroad program in Guyana with the Ministry of Health. It was very important for me to bring my students to Guyana for many reasons, the most important being the profession was needed there, and our students would be excellent representatives.

In 2015, the study “Introduction of spirometry into clinical practice in Georgetown, Guyana: quality and diagnostic outcomes” highlighted increased physician referral to the country’s only COPD/asthma clinic. I wanted to promote the importance of study abroad and international mission work, especially when promoting the care of asthma and the pulmonary patient, which I believe we did. The main project during study abroad was to test the school-aged children in Linden, thereby showing that there was undiagnosed asthma.

The effect of the CHEST Foundation grant

Applying for the CHEST Foundation community service grant was the largest grant I had ever attempted. Having a support system behind you is the most important piece of advice I can give to future grant applicants. I could not have completed my grant without our grant team at Texas State University. They truly had my back; and close to the deadline when it seemed insurmountable, they helped push me through it. The other piece of advice is to have a true vision and stick to that vision. The most difficult part of my project was the budget, prioritizing the things or people that I needed. Honestly, I needed help here, because for me, I needed everything. I had to make choices and leave some things out. I focused on what the actual need was for the many.

My ultimate goal for Guyana is to promote and show the need for respiratory care professionals to have that education offered at the University of Guyana as part of its allied health program and assist those in the application to the International Fellowship Program of the American Association of Respiratory Care—there has never been a fellow from Guyana. I believe that Guyana will have the resources, and with assistance, could achieve the goal. My vision and goal started in 2016, and I want to achieve it in the next 10 years.

How it all started

The study abroad project was truly a goal and vision that came about after returning to Guyana after approximately 46 years. I was born in Guyana but left as a child and returned later and joined a mission group. In 2015, I began a personal journey of missionary service with the team of Bridge Global Medical Missions (BGMM) in Georgetown, Guyana. I was the first respiratory therapist to join the team.

I remember during the first few days in the hospitals I was told that there was “a lot of wheezing” in the EDs. Treating patients consisted of just administrating short-acting nebulizer treatments, but I remember being very impressed with the ICU at the main public hospital, Georgetown Public Hospital Corporation (GPHC), because they had the ventilators I could use. However, physicians only managed the patients while the nurses were left to monitor the ventilators and equipment, which they did not understand.

Study abroad and respiratory care

Then the vision of my project began, because I needed to show him the scope of the practice of a respiratory therapist. I asked Dr. Heyliger-Thomas of BGMM if she could assist me in promoting a study abroad program in Guyana with the Ministry of Health. It was very important for me to bring my students to Guyana for many reasons, the most important being the profession was needed there, and our students would be excellent representatives.

In 2015, the study “Introduction of spirometry into clinical practice in Georgetown, Guyana: quality and diagnostic outcomes” highlighted increased physician referral to the country’s only COPD/asthma clinic. I wanted to promote the importance of study abroad and international mission work, especially when promoting the care of asthma and the pulmonary patient, which I believe we did. The main project during study abroad was to test the school-aged children in Linden, thereby showing that there was undiagnosed asthma.

The effect of the CHEST Foundation grant

Applying for the CHEST Foundation community service grant was the largest grant I had ever attempted. Having a support system behind you is the most important piece of advice I can give to future grant applicants. I could not have completed my grant without our grant team at Texas State University. They truly had my back; and close to the deadline when it seemed insurmountable, they helped push me through it. The other piece of advice is to have a true vision and stick to that vision. The most difficult part of my project was the budget, prioritizing the things or people that I needed. Honestly, I needed help here, because for me, I needed everything. I had to make choices and leave some things out. I focused on what the actual need was for the many.

My ultimate goal for Guyana is to promote and show the need for respiratory care professionals to have that education offered at the University of Guyana as part of its allied health program and assist those in the application to the International Fellowship Program of the American Association of Respiratory Care—there has never been a fellow from Guyana. I believe that Guyana will have the resources, and with assistance, could achieve the goal. My vision and goal started in 2016, and I want to achieve it in the next 10 years.

You are invited to attend this open meeting on April 16, held at the FDA White Oak Campus in Silver Spring, Md. (https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm596147.htm). The FDA is soliciting ideas or opinions about criteria or processes for FDA review of medical devices to diagnose or treat sleep apnea. CHEST is represented by Dr. Neil Freedman (neilfreedman@comcast.net) and Dr. Barbara Phillips (bphil020@gmail.com) who also welcome your input by email prior to the meeting. Home testing, “apps,” and the criteria to diagnose sleep apnea and/or its resolution are among the topics to be discussed.

You are invited to attend this open meeting on April 16, held at the FDA White Oak Campus in Silver Spring, Md. (https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm596147.htm). The FDA is soliciting ideas or opinions about criteria or processes for FDA review of medical devices to diagnose or treat sleep apnea. CHEST is represented by Dr. Neil Freedman (neilfreedman@comcast.net) and Dr. Barbara Phillips (bphil020@gmail.com) who also welcome your input by email prior to the meeting. Home testing, “apps,” and the criteria to diagnose sleep apnea and/or its resolution are among the topics to be discussed.

You are invited to attend this open meeting on April 16, held at the FDA White Oak Campus in Silver Spring, Md. (https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm596147.htm). The FDA is soliciting ideas or opinions about criteria or processes for FDA review of medical devices to diagnose or treat sleep apnea. CHEST is represented by Dr. Neil Freedman (neilfreedman@comcast.net) and Dr. Barbara Phillips (bphil020@gmail.com) who also welcome your input by email prior to the meeting. Home testing, “apps,” and the criteria to diagnose sleep apnea and/or its resolution are among the topics to be discussed.

In 2018, ABIM is introducing the new Knowledge Check-In assessment option, an every-2-year assessment option serving as an alternative to the 10-year assessment model. Initially, for 2018, this option will be piloted for both Internal Medicine and Nephrology. In 2019, the Knowledge Check-In will expand to several additional specialties, including Pulmonary Disease. The remaining specialties, including Critical Care Medicine, will become available in 2020.

Previously, ABIM announced that physicians taking the Knowledge Check-In in 2018—the initial year it is offered in Internal Medicine or Nephrology—would have another chance to take it again 2 years later if they were unsuccessful, even if they were due to pass the exam that year. Based on feedback ABIM received from the physician community, this feature is now being extended to include all other Internal Medicine subspecialties in the future. Therefore, if a physician opts to take the Knowledge Check-In the first year it is offered in their subspecialty and is unsuccessful, they will get at least one additional opportunity to take it 2 years later.

For more information visit www.abim.org/checkin.

In 2018, ABIM is introducing the new Knowledge Check-In assessment option, an every-2-year assessment option serving as an alternative to the 10-year assessment model. Initially, for 2018, this option will be piloted for both Internal Medicine and Nephrology. In 2019, the Knowledge Check-In will expand to several additional specialties, including Pulmonary Disease. The remaining specialties, including Critical Care Medicine, will become available in 2020.

Previously, ABIM announced that physicians taking the Knowledge Check-In in 2018—the initial year it is offered in Internal Medicine or Nephrology—would have another chance to take it again 2 years later if they were unsuccessful, even if they were due to pass the exam that year. Based on feedback ABIM received from the physician community, this feature is now being extended to include all other Internal Medicine subspecialties in the future. Therefore, if a physician opts to take the Knowledge Check-In the first year it is offered in their subspecialty and is unsuccessful, they will get at least one additional opportunity to take it 2 years later.

For more information visit www.abim.org/checkin.

In 2018, ABIM is introducing the new Knowledge Check-In assessment option, an every-2-year assessment option serving as an alternative to the 10-year assessment model. Initially, for 2018, this option will be piloted for both Internal Medicine and Nephrology. In 2019, the Knowledge Check-In will expand to several additional specialties, including Pulmonary Disease. The remaining specialties, including Critical Care Medicine, will become available in 2020.

Previously, ABIM announced that physicians taking the Knowledge Check-In in 2018—the initial year it is offered in Internal Medicine or Nephrology—would have another chance to take it again 2 years later if they were unsuccessful, even if they were due to pass the exam that year. Based on feedback ABIM received from the physician community, this feature is now being extended to include all other Internal Medicine subspecialties in the future. Therefore, if a physician opts to take the Knowledge Check-In the first year it is offered in their subspecialty and is unsuccessful, they will get at least one additional opportunity to take it 2 years later.

For more information visit www.abim.org/checkin.

We are pleased to announce the completion of a new, multiyear strategic plan for CHEST. Over the past few years, key stakeholders have provided essential input, resulting in a plan that identifies a very focused set of priorities we’ll pursue to help achieve our overarching strategy. Having selected these priorities, which leverage our strengths and strategic advantages, we are committed to dedicating sufficient resources toward their accomplishment over the next several years.

Each year, the plan will be reviewed and modified to reflect changes to CHEST priorities.

A strategic plan is an important tool for our organization because it truly does focus and direct our efforts and resources. Guided by our 2013-2017 strategic plan, we were able to accomplish the following:

• Developed events, products, and services that produced meaningful education for the CHEST community and generated positive financial margins;
• Optimized our membership model to increase engagement of all clinicians on the health-care team;
• Enhanced our global presence through guideline development and increased educational offerings;
• Launched a new Association Management System (AMS) and made strides to becoming a data-driven organization;
• Built and moved into a new building that enhanced our ability to develop and host courses in the CHEST Innovation, Simulation, and Training Center;
• Increased our visibility through our rebrand as “CHEST”;
• Fostered relationships and collaborated with other organizations to promote lung health through the CHEST Foundation; and
• Met our budget goals and financial covenants with our bank, and increased the CHEST Foundation’s corpus for grants and awards.

This new strategic plan can be found on chestnet.org under the “About” section. As members of CHEST, we invite you to review what’s outlined and become familiar with what the plan encompasses. This plan provides details to help you understand the future direction of CHEST, and we know you’ll support us in these important endeavors.

We are pleased to announce the completion of a new, multiyear strategic plan for CHEST. Over the past few years, key stakeholders have provided essential input, resulting in a plan that identifies a very focused set of priorities we’ll pursue to help achieve our overarching strategy. Having selected these priorities, which leverage our strengths and strategic advantages, we are committed to dedicating sufficient resources toward their accomplishment over the next several years.

Each year, the plan will be reviewed and modified to reflect changes to CHEST priorities.

A strategic plan is an important tool for our organization because it truly does focus and direct our efforts and resources. Guided by our 2013-2017 strategic plan, we were able to accomplish the following:

• Developed events, products, and services that produced meaningful education for the CHEST community and generated positive financial margins;
• Optimized our membership model to increase engagement of all clinicians on the health-care team;
• Enhanced our global presence through guideline development and increased educational offerings;
• Launched a new Association Management System (AMS) and made strides to becoming a data-driven organization;
• Built and moved into a new building that enhanced our ability to develop and host courses in the CHEST Innovation, Simulation, and Training Center;
• Increased our visibility through our rebrand as “CHEST”;
• Fostered relationships and collaborated with other organizations to promote lung health through the CHEST Foundation; and
• Met our budget goals and financial covenants with our bank, and increased the CHEST Foundation’s corpus for grants and awards.

This new strategic plan can be found on chestnet.org under the “About” section. As members of CHEST, we invite you to review what’s outlined and become familiar with what the plan encompasses. This plan provides details to help you understand the future direction of CHEST, and we know you’ll support us in these important endeavors.

We are pleased to announce the completion of a new, multiyear strategic plan for CHEST. Over the past few years, key stakeholders have provided essential input, resulting in a plan that identifies a very focused set of priorities we’ll pursue to help achieve our overarching strategy. Having selected these priorities, which leverage our strengths and strategic advantages, we are committed to dedicating sufficient resources toward their accomplishment over the next several years.

Each year, the plan will be reviewed and modified to reflect changes to CHEST priorities.

A strategic plan is an important tool for our organization because it truly does focus and direct our efforts and resources. Guided by our 2013-2017 strategic plan, we were able to accomplish the following:

• Developed events, products, and services that produced meaningful education for the CHEST community and generated positive financial margins;
• Optimized our membership model to increase engagement of all clinicians on the health-care team;
• Enhanced our global presence through guideline development and increased educational offerings;
• Launched a new Association Management System (AMS) and made strides to becoming a data-driven organization;
• Built and moved into a new building that enhanced our ability to develop and host courses in the CHEST Innovation, Simulation, and Training Center;
• Increased our visibility through our rebrand as “CHEST”;
• Fostered relationships and collaborated with other organizations to promote lung health through the CHEST Foundation; and
• Met our budget goals and financial covenants with our bank, and increased the CHEST Foundation’s corpus for grants and awards.

This new strategic plan can be found on chestnet.org under the “About” section. As members of CHEST, we invite you to review what’s outlined and become familiar with what the plan encompasses. This plan provides details to help you understand the future direction of CHEST, and we know you’ll support us in these important endeavors.

ORLANDO – Preoperative electrocardiograms (EKGs) had no effect on management or perioperative complications in women undergoing benign hysterectomy over a 12-month period at a single medical center, according to a review of records.

Of 587 patients included in the review, 182 (31%) underwent EKG as part of their preoperative evaluation, and the majority of those were indicated according to institutional criteria (166; 28%) or National Institute for Health Care Excellence (NICE) guidelines (177; 30%), Nemi M. Shah, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

“EKG was indicated in 91% of these patients according to institutional criteria, and in 97% of patients per NICE criteria,” said Dr. Shah, a third-year resident at the University of Texas Southwestern Medical Center, Dallas.

By institutional criteria, hypertension was the most common indication (68% of cases), and by NICE criteria, American Society of Anesthesia class 2 physical status was the most common indication (80% of cases), she noted, adding that obesity, which was present in 70% of patients, was the most common comorbidity classifying patients with American Society of Anesthesia class 2 or above.

Of the 182 EKGs performed, findings were abnormal in 89, but further workup was pursued in only 16 patients, and included repeat EKG, echocardiogram, and/or stress testing and cardiology consultation. Surgical delays of 1 and 4 months occurred in 2 patients as a result of the additional workup, and ultimately, all planned hysterectomies were completed by the primary surgical team without changes in management, she said.

Perioperative complications occurred in two patients, and included nonspecific postinduction EKG changes that led to surgery being aborted in one patient who had left ventricular hypertrophy on the preoperative EKG, and failed extubation in a patient with airway edema whose preoperative EKG showed a nonacute inferior infarct.

For the first, cardiology was consulted and determined the findings to be benign; the patient underwent hysterectomy at a later date without complications. The second patient was taken to the surgical intensive care unit for management, Dr. Shah said.

sworcester@mdedge.com

SOURCE: Shah N et al. SGS 2018 Oral Poster 3.

ORLANDO – Preoperative electrocardiograms (EKGs) had no effect on management or perioperative complications in women undergoing benign hysterectomy over a 12-month period at a single medical center, according to a review of records.

Of 587 patients included in the review, 182 (31%) underwent EKG as part of their preoperative evaluation, and the majority of those were indicated according to institutional criteria (166; 28%) or National Institute for Health Care Excellence (NICE) guidelines (177; 30%), Nemi M. Shah, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

“EKG was indicated in 91% of these patients according to institutional criteria, and in 97% of patients per NICE criteria,” said Dr. Shah, a third-year resident at the University of Texas Southwestern Medical Center, Dallas.

By institutional criteria, hypertension was the most common indication (68% of cases), and by NICE criteria, American Society of Anesthesia class 2 physical status was the most common indication (80% of cases), she noted, adding that obesity, which was present in 70% of patients, was the most common comorbidity classifying patients with American Society of Anesthesia class 2 or above.

Of the 182 EKGs performed, findings were abnormal in 89, but further workup was pursued in only 16 patients, and included repeat EKG, echocardiogram, and/or stress testing and cardiology consultation. Surgical delays of 1 and 4 months occurred in 2 patients as a result of the additional workup, and ultimately, all planned hysterectomies were completed by the primary surgical team without changes in management, she said.

Perioperative complications occurred in two patients, and included nonspecific postinduction EKG changes that led to surgery being aborted in one patient who had left ventricular hypertrophy on the preoperative EKG, and failed extubation in a patient with airway edema whose preoperative EKG showed a nonacute inferior infarct.

For the first, cardiology was consulted and determined the findings to be benign; the patient underwent hysterectomy at a later date without complications. The second patient was taken to the surgical intensive care unit for management, Dr. Shah said.

sworcester@mdedge.com

SOURCE: Shah N et al. SGS 2018 Oral Poster 3.

ORLANDO – Preoperative electrocardiograms (EKGs) had no effect on management or perioperative complications in women undergoing benign hysterectomy over a 12-month period at a single medical center, according to a review of records.

Of 587 patients included in the review, 182 (31%) underwent EKG as part of their preoperative evaluation, and the majority of those were indicated according to institutional criteria (166; 28%) or National Institute for Health Care Excellence (NICE) guidelines (177; 30%), Nemi M. Shah, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

“EKG was indicated in 91% of these patients according to institutional criteria, and in 97% of patients per NICE criteria,” said Dr. Shah, a third-year resident at the University of Texas Southwestern Medical Center, Dallas.

By institutional criteria, hypertension was the most common indication (68% of cases), and by NICE criteria, American Society of Anesthesia class 2 physical status was the most common indication (80% of cases), she noted, adding that obesity, which was present in 70% of patients, was the most common comorbidity classifying patients with American Society of Anesthesia class 2 or above.

Of the 182 EKGs performed, findings were abnormal in 89, but further workup was pursued in only 16 patients, and included repeat EKG, echocardiogram, and/or stress testing and cardiology consultation. Surgical delays of 1 and 4 months occurred in 2 patients as a result of the additional workup, and ultimately, all planned hysterectomies were completed by the primary surgical team without changes in management, she said.

Perioperative complications occurred in two patients, and included nonspecific postinduction EKG changes that led to surgery being aborted in one patient who had left ventricular hypertrophy on the preoperative EKG, and failed extubation in a patient with airway edema whose preoperative EKG showed a nonacute inferior infarct.

For the first, cardiology was consulted and determined the findings to be benign; the patient underwent hysterectomy at a later date without complications. The second patient was taken to the surgical intensive care unit for management, Dr. Shah said.

sworcester@mdedge.com

SOURCE: Shah N et al. SGS 2018 Oral Poster 3.

NEW ORLEANS – Adding the anti-HER2 antibody trastuzumab to a standard chemotherapy regimen produced markedly improved responses among patients with an advanced stage or recurrent uterine serous carcinoma that also overexpressed the HER2/neu cell receptor protein in a controlled, multicenter, phase 2 study with 58 evaluable patients.

The 30 patients who received trastuzumab along with carboplatin plus paclitaxel had a median progression-free survival of 12.6 months compared with 8.0 months among the 28 control patients who received only carboplatin plus paclitaxel, a hazard reduction of 56% with trastuzumab that was statistically significant (P = .0052), Alessandro D. Santin, MD, said at the annual meeting of the Society of Gynecologic Oncology.

In the subgroup of 41 patients with advanced (not recurrent) uterine serous carcinoma (USC) the incremental difference in median progression-free survival among patients treated with trastuzumab was 8.6 months, based on a 17.9-month duration in the 20 patients who received trastuzumab and 9.3 months in 20 control patients on chemotherapy only (P = .013).

Mitchel L. Zoler/MDedge News

mzoler@mdedge.com

SOURCE: Fader A et al. Abstract 22. J Clin Oncol. 2018 Mar 27. doi: 10.1200/JCO.2017.76.5966.

NEW ORLEANS – Adding the anti-HER2 antibody trastuzumab to a standard chemotherapy regimen produced markedly improved responses among patients with an advanced stage or recurrent uterine serous carcinoma that also overexpressed the HER2/neu cell receptor protein in a controlled, multicenter, phase 2 study with 58 evaluable patients.

The 30 patients who received trastuzumab along with carboplatin plus paclitaxel had a median progression-free survival of 12.6 months compared with 8.0 months among the 28 control patients who received only carboplatin plus paclitaxel, a hazard reduction of 56% with trastuzumab that was statistically significant (P = .0052), Alessandro D. Santin, MD, said at the annual meeting of the Society of Gynecologic Oncology.

In the subgroup of 41 patients with advanced (not recurrent) uterine serous carcinoma (USC) the incremental difference in median progression-free survival among patients treated with trastuzumab was 8.6 months, based on a 17.9-month duration in the 20 patients who received trastuzumab and 9.3 months in 20 control patients on chemotherapy only (P = .013).

Mitchel L. Zoler/MDedge News

mzoler@mdedge.com

SOURCE: Fader A et al. Abstract 22. J Clin Oncol. 2018 Mar 27. doi: 10.1200/JCO.2017.76.5966.

NEW ORLEANS – Adding the anti-HER2 antibody trastuzumab to a standard chemotherapy regimen produced markedly improved responses among patients with an advanced stage or recurrent uterine serous carcinoma that also overexpressed the HER2/neu cell receptor protein in a controlled, multicenter, phase 2 study with 58 evaluable patients.

The 30 patients who received trastuzumab along with carboplatin plus paclitaxel had a median progression-free survival of 12.6 months compared with 8.0 months among the 28 control patients who received only carboplatin plus paclitaxel, a hazard reduction of 56% with trastuzumab that was statistically significant (P = .0052), Alessandro D. Santin, MD, said at the annual meeting of the Society of Gynecologic Oncology.

In the subgroup of 41 patients with advanced (not recurrent) uterine serous carcinoma (USC) the incremental difference in median progression-free survival among patients treated with trastuzumab was 8.6 months, based on a 17.9-month duration in the 20 patients who received trastuzumab and 9.3 months in 20 control patients on chemotherapy only (P = .013).

Mitchel L. Zoler/MDedge News

mzoler@mdedge.com

SOURCE: Fader A et al. Abstract 22. J Clin Oncol. 2018 Mar 27. doi: 10.1200/JCO.2017.76.5966.

In this interview, Dr David Henry, MD, the Editor-in-Chief of JCSO, and David Steensma, MD, of the Dana-Farber Cancer Institute in Boston, talk about myelodysplasic syndromes, from diagnosis, evaluation, and etiologies, to therapy options and molecular sequencing.

Listen to the podcast below, or click on the PDF icon at the top of this introduction to read a transcript of the interview.​

In this interview, Dr David Henry, MD, the Editor-in-Chief of JCSO, and David Steensma, MD, of the Dana-Farber Cancer Institute in Boston, talk about myelodysplasic syndromes, from diagnosis, evaluation, and etiologies, to therapy options and molecular sequencing.

Listen to the podcast below, or click on the PDF icon at the top of this introduction to read a transcript of the interview.​

In this interview, Dr David Henry, MD, the Editor-in-Chief of JCSO, and David Steensma, MD, of the Dana-Farber Cancer Institute in Boston, talk about myelodysplasic syndromes, from diagnosis, evaluation, and etiologies, to therapy options and molecular sequencing.

Listen to the podcast below, or click on the PDF icon at the top of this introduction to read a transcript of the interview.​

CHICAGO – It’s a good idea to look for eating disorders in young, athletic women who present with oligomenorrhea; they are at high risk for them and can be helped with estrogen replacement, especially with a patch, according to investigators from Massachusetts General Hospital, Boston.

Estrogen replacement will also help with stress fractures and other bone problems, but young, athletic women might resist the idea. They worry that it might hurt their performance and are often proud that they work out hard enough to stop their periods, according to investigator Vibha Singhal, MD, a pediatric endocrinologist and eating disorder specialist at the hospital.

M. Alexander Otto/MDedge News

Seventy OA women were then randomized to three groups: 25 to physiological estrogen replacement with an estradiol patch and cyclic progesterone for 12 days/month; 19 to replacement with contraceptive pills on the standard monthly schedule; and 26 to no replacement.

Over 12 months, women on the patch dropped their drive for thinness, body dissatisfaction, and uncontrolled eating scores. Body dissatisfaction scores on the Eating Disorder Inventory–2, for example, fell about two points, compared with staying about the same in the pill group and increasing by about two points in the no-estrogen group.

The pill seemed to help a bit on some measures, too, but the benefit of the pill versus that of no estrogen wasn’t generally statistically significant. Meanwhile, symptoms worsened in women who didn’t get estrogen. “The practice right now is the pill. We are shifting our practice with these data to the patch,” Dr. Singhal said.

Overall, “these findings emphasize the importance of normalizing estrogen levels in this population,” she and her colleagues concluded.

It’s a mystery why estrogen helps with eating disorders. Maybe it has something to do with the estrogen receptors in the appetite centers of the brain. Maybe the patch works better than the pill because there’s no first-pass through the liver, Dr. Singhal said.

Subjects were aged about 20 years, on average. OA women had a mean body mass index of 20.6 kg/m² and a mean estradiol level of 45 pg/mL. Subjects with regular periods had mean BMIs of about 22 kg/m²; mean estradiol levels were 70.2 pg/mL in eumenorrheic athletes and 83.6 pg/mL in nonathletic women.

The work was funded by the National Institutes of Health. The investigators didn’t have any relevant disclosures.

SOURCE: Plessow F et al. ENDO 2018, Abstract SAT-290.

CHICAGO – It’s a good idea to look for eating disorders in young, athletic women who present with oligomenorrhea; they are at high risk for them and can be helped with estrogen replacement, especially with a patch, according to investigators from Massachusetts General Hospital, Boston.

Estrogen replacement will also help with stress fractures and other bone problems, but young, athletic women might resist the idea. They worry that it might hurt their performance and are often proud that they work out hard enough to stop their periods, according to investigator Vibha Singhal, MD, a pediatric endocrinologist and eating disorder specialist at the hospital.

M. Alexander Otto/MDedge News

Seventy OA women were then randomized to three groups: 25 to physiological estrogen replacement with an estradiol patch and cyclic progesterone for 12 days/month; 19 to replacement with contraceptive pills on the standard monthly schedule; and 26 to no replacement.

Over 12 months, women on the patch dropped their drive for thinness, body dissatisfaction, and uncontrolled eating scores. Body dissatisfaction scores on the Eating Disorder Inventory–2, for example, fell about two points, compared with staying about the same in the pill group and increasing by about two points in the no-estrogen group.

The pill seemed to help a bit on some measures, too, but the benefit of the pill versus that of no estrogen wasn’t generally statistically significant. Meanwhile, symptoms worsened in women who didn’t get estrogen. “The practice right now is the pill. We are shifting our practice with these data to the patch,” Dr. Singhal said.

Overall, “these findings emphasize the importance of normalizing estrogen levels in this population,” she and her colleagues concluded.

It’s a mystery why estrogen helps with eating disorders. Maybe it has something to do with the estrogen receptors in the appetite centers of the brain. Maybe the patch works better than the pill because there’s no first-pass through the liver, Dr. Singhal said.

Subjects were aged about 20 years, on average. OA women had a mean body mass index of 20.6 kg/m² and a mean estradiol level of 45 pg/mL. Subjects with regular periods had mean BMIs of about 22 kg/m²; mean estradiol levels were 70.2 pg/mL in eumenorrheic athletes and 83.6 pg/mL in nonathletic women.

The work was funded by the National Institutes of Health. The investigators didn’t have any relevant disclosures.

SOURCE: Plessow F et al. ENDO 2018, Abstract SAT-290.

CHICAGO – It’s a good idea to look for eating disorders in young, athletic women who present with oligomenorrhea; they are at high risk for them and can be helped with estrogen replacement, especially with a patch, according to investigators from Massachusetts General Hospital, Boston.

Estrogen replacement will also help with stress fractures and other bone problems, but young, athletic women might resist the idea. They worry that it might hurt their performance and are often proud that they work out hard enough to stop their periods, according to investigator Vibha Singhal, MD, a pediatric endocrinologist and eating disorder specialist at the hospital.

M. Alexander Otto/MDedge News

Seventy OA women were then randomized to three groups: 25 to physiological estrogen replacement with an estradiol patch and cyclic progesterone for 12 days/month; 19 to replacement with contraceptive pills on the standard monthly schedule; and 26 to no replacement.

Over 12 months, women on the patch dropped their drive for thinness, body dissatisfaction, and uncontrolled eating scores. Body dissatisfaction scores on the Eating Disorder Inventory–2, for example, fell about two points, compared with staying about the same in the pill group and increasing by about two points in the no-estrogen group.

The pill seemed to help a bit on some measures, too, but the benefit of the pill versus that of no estrogen wasn’t generally statistically significant. Meanwhile, symptoms worsened in women who didn’t get estrogen. “The practice right now is the pill. We are shifting our practice with these data to the patch,” Dr. Singhal said.

Overall, “these findings emphasize the importance of normalizing estrogen levels in this population,” she and her colleagues concluded.

It’s a mystery why estrogen helps with eating disorders. Maybe it has something to do with the estrogen receptors in the appetite centers of the brain. Maybe the patch works better than the pill because there’s no first-pass through the liver, Dr. Singhal said.

Subjects were aged about 20 years, on average. OA women had a mean body mass index of 20.6 kg/m² and a mean estradiol level of 45 pg/mL. Subjects with regular periods had mean BMIs of about 22 kg/m²; mean estradiol levels were 70.2 pg/mL in eumenorrheic athletes and 83.6 pg/mL in nonathletic women.

The work was funded by the National Institutes of Health. The investigators didn’t have any relevant disclosures.

SOURCE: Plessow F et al. ENDO 2018, Abstract SAT-290.

The rate of major and minor 30-day complications from the treatment of uterine fibroids has increased significantly since the Food and Drug Administration’s black-box warning against the use of power morcellation, data suggest.

Researchers examined the incidence of 30-day posthysterectomy complications in 75,487 women who underwent treatment for benign gynecologic indications before and after November 2014, when the FDA’s edict was issued over concerns about the risk of disseminating benign or malignant disease. Of these women, 25,571 had uterine fibroids as the indication for hysterectomy.

The retrospective cohort study, published online April 11 in JAMA Surgery, showed that while the overall rate of complications in the cohort was relatively unchanged before and after the FDA’s warning, complication rates increased significantly in women undergoing treatment for uterine fibroids.

Before the FDA’s announcement, the 30-day major complication rate in women undergoing hysterectomy for uterine fibroids was 1.9%, which increased to 2.4% after the FDA’s warning (odds ratio, 1.23; 95% confidence interval, 1.04-1.47; P = .02). Similarly, the rate of minor 30-day complications increased from 2.7% before the warning to 3.3% after the warning (OR, 1.21; 95% CI, 1.04-1.40; P = .01), after adjustment for factors such as age, body mass index, comorbidities, and other associated procedures.

“This 20% increase in the odds of major and minor complications could translate into a large number of additional complications among the 200,000 hysterectomies performed annually for uterine fibroids in the United States,” wrote Francesco Multinu, MD, of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn., and his coauthors.

Overall, the researchers saw a much higher rate of major complications in women undergoing open abdominal surgery, compared with women who underwent minimally invasive surgery or vaginal hysterectomy (3.5% vs. 1.7% vs. 1.7%). A similar pattern was seen in the subgroup of women who underwent hysterectomy for uterine fibroids (2.8% vs. 1.8% vs. 1.8%).

However, minor 30-day complication rates were higher in women who underwent vaginal hysterectomy (4.5%), compared with open abdominal surgery (4.1%) and minimally invasive surgery (3.2%). In women with uterine fibroids, the minor complication rates were slightly higher in those who underwent open hysterectomy or vaginal hysterectomy than in those who had minimally invasive surgery, but this was not statistically significant.

The type of surgery in women with uterine fibroids changed significantly after the FDA announcement. Before the black-box warning against power morcellation was issued, 37.2% of hysterectomy procedures for uterine fibroids were open, 56.1% were minimally invasive, and 6.7% were vaginal. After the announcement, the percentage that were open procedures increased to 43%, minimally invasive procedures decreased to 49.7%, and vaginal hysterectomies increased to 7.3% (P less than .001).

A similar but less pronounced trend was seen across all hysterectomies for benign gynecological indications.

The authors noted that the study analyzed data on 30-day complications, so they weren’t able to draw conclusions about longer-term outcomes.

“Although caution is required to avoid morcellation of unexpected uterine malignant neoplasms, our results should be considered by women and clinicians during the process of shared decision making and by medical societies and regulatory bodies when issuing safety communications,” the authors wrote.

The study was supported by a grant from the National Center for Advancing Translational Sciences, and one author was supported by the University of Insubria, and by Fondo Miglierina, Varese, Italy. No conflicts of interest were declared.

SOURCE: Multinu F et al. JAMA Surg. 2018 Apr 11. doi: 10.1001/jamasurg.2018.0141.

The rate of major and minor 30-day complications from the treatment of uterine fibroids has increased significantly since the Food and Drug Administration’s black-box warning against the use of power morcellation, data suggest.

Researchers examined the incidence of 30-day posthysterectomy complications in 75,487 women who underwent treatment for benign gynecologic indications before and after November 2014, when the FDA’s edict was issued over concerns about the risk of disseminating benign or malignant disease. Of these women, 25,571 had uterine fibroids as the indication for hysterectomy.

The retrospective cohort study, published online April 11 in JAMA Surgery, showed that while the overall rate of complications in the cohort was relatively unchanged before and after the FDA’s warning, complication rates increased significantly in women undergoing treatment for uterine fibroids.

Before the FDA’s announcement, the 30-day major complication rate in women undergoing hysterectomy for uterine fibroids was 1.9%, which increased to 2.4% after the FDA’s warning (odds ratio, 1.23; 95% confidence interval, 1.04-1.47; P = .02). Similarly, the rate of minor 30-day complications increased from 2.7% before the warning to 3.3% after the warning (OR, 1.21; 95% CI, 1.04-1.40; P = .01), after adjustment for factors such as age, body mass index, comorbidities, and other associated procedures.

“This 20% increase in the odds of major and minor complications could translate into a large number of additional complications among the 200,000 hysterectomies performed annually for uterine fibroids in the United States,” wrote Francesco Multinu, MD, of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn., and his coauthors.

Overall, the researchers saw a much higher rate of major complications in women undergoing open abdominal surgery, compared with women who underwent minimally invasive surgery or vaginal hysterectomy (3.5% vs. 1.7% vs. 1.7%). A similar pattern was seen in the subgroup of women who underwent hysterectomy for uterine fibroids (2.8% vs. 1.8% vs. 1.8%).

However, minor 30-day complication rates were higher in women who underwent vaginal hysterectomy (4.5%), compared with open abdominal surgery (4.1%) and minimally invasive surgery (3.2%). In women with uterine fibroids, the minor complication rates were slightly higher in those who underwent open hysterectomy or vaginal hysterectomy than in those who had minimally invasive surgery, but this was not statistically significant.

The type of surgery in women with uterine fibroids changed significantly after the FDA announcement. Before the black-box warning against power morcellation was issued, 37.2% of hysterectomy procedures for uterine fibroids were open, 56.1% were minimally invasive, and 6.7% were vaginal. After the announcement, the percentage that were open procedures increased to 43%, minimally invasive procedures decreased to 49.7%, and vaginal hysterectomies increased to 7.3% (P less than .001).

A similar but less pronounced trend was seen across all hysterectomies for benign gynecological indications.

The authors noted that the study analyzed data on 30-day complications, so they weren’t able to draw conclusions about longer-term outcomes.

“Although caution is required to avoid morcellation of unexpected uterine malignant neoplasms, our results should be considered by women and clinicians during the process of shared decision making and by medical societies and regulatory bodies when issuing safety communications,” the authors wrote.

The study was supported by a grant from the National Center for Advancing Translational Sciences, and one author was supported by the University of Insubria, and by Fondo Miglierina, Varese, Italy. No conflicts of interest were declared.

SOURCE: Multinu F et al. JAMA Surg. 2018 Apr 11. doi: 10.1001/jamasurg.2018.0141.

The rate of major and minor 30-day complications from the treatment of uterine fibroids has increased significantly since the Food and Drug Administration’s black-box warning against the use of power morcellation, data suggest.

Researchers examined the incidence of 30-day posthysterectomy complications in 75,487 women who underwent treatment for benign gynecologic indications before and after November 2014, when the FDA’s edict was issued over concerns about the risk of disseminating benign or malignant disease. Of these women, 25,571 had uterine fibroids as the indication for hysterectomy.

The retrospective cohort study, published online April 11 in JAMA Surgery, showed that while the overall rate of complications in the cohort was relatively unchanged before and after the FDA’s warning, complication rates increased significantly in women undergoing treatment for uterine fibroids.

Before the FDA’s announcement, the 30-day major complication rate in women undergoing hysterectomy for uterine fibroids was 1.9%, which increased to 2.4% after the FDA’s warning (odds ratio, 1.23; 95% confidence interval, 1.04-1.47; P = .02). Similarly, the rate of minor 30-day complications increased from 2.7% before the warning to 3.3% after the warning (OR, 1.21; 95% CI, 1.04-1.40; P = .01), after adjustment for factors such as age, body mass index, comorbidities, and other associated procedures.

“This 20% increase in the odds of major and minor complications could translate into a large number of additional complications among the 200,000 hysterectomies performed annually for uterine fibroids in the United States,” wrote Francesco Multinu, MD, of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn., and his coauthors.

Overall, the researchers saw a much higher rate of major complications in women undergoing open abdominal surgery, compared with women who underwent minimally invasive surgery or vaginal hysterectomy (3.5% vs. 1.7% vs. 1.7%). A similar pattern was seen in the subgroup of women who underwent hysterectomy for uterine fibroids (2.8% vs. 1.8% vs. 1.8%).

However, minor 30-day complication rates were higher in women who underwent vaginal hysterectomy (4.5%), compared with open abdominal surgery (4.1%) and minimally invasive surgery (3.2%). In women with uterine fibroids, the minor complication rates were slightly higher in those who underwent open hysterectomy or vaginal hysterectomy than in those who had minimally invasive surgery, but this was not statistically significant.

The type of surgery in women with uterine fibroids changed significantly after the FDA announcement. Before the black-box warning against power morcellation was issued, 37.2% of hysterectomy procedures for uterine fibroids were open, 56.1% were minimally invasive, and 6.7% were vaginal. After the announcement, the percentage that were open procedures increased to 43%, minimally invasive procedures decreased to 49.7%, and vaginal hysterectomies increased to 7.3% (P less than .001).

A similar but less pronounced trend was seen across all hysterectomies for benign gynecological indications.

The authors noted that the study analyzed data on 30-day complications, so they weren’t able to draw conclusions about longer-term outcomes.

“Although caution is required to avoid morcellation of unexpected uterine malignant neoplasms, our results should be considered by women and clinicians during the process of shared decision making and by medical societies and regulatory bodies when issuing safety communications,” the authors wrote.

The study was supported by a grant from the National Center for Advancing Translational Sciences, and one author was supported by the University of Insubria, and by Fondo Miglierina, Varese, Italy. No conflicts of interest were declared.

SOURCE: Multinu F et al. JAMA Surg. 2018 Apr 11. doi: 10.1001/jamasurg.2018.0141.