Surgery

On Thanksgiving Day 2022, Kathy Stark watched as her husband of 35 years, Bobby Ray Stark, caught fire at a Nashville hospital. According to Clint Kelly, Kathy Stark’s attorney, the hospital staff was performing cardioversion to restore Bobby Ray’s heart rhythm when a spark ignited the oxygen and set the patient aflame.

Mr. Stark, 64, died of “a combination of cardiovascular disease and thermal burns,” according to a local news report. In May, Kathy Stark filed a malpractice lawsuit in U.S. District Court. Mr. Kelly hopes that the lawsuit will help improve patient safety. Meanwhile, Kathy Stark “goes to bed at night and sees her husband on fire,” Mr. Kelly says. A similar incident occurred last December in the operating room at Oregon Health & Science University, resulting in minor injuries to a patient.

Surgical fires happen rarely, but they can pose serious threats to patients and result in litigation against physicians and hospitals.
 

Underreported, but likely dropping

Reliable data on the incidence of surgical fires is lacking because incidents may go unreported over litigation fears, says Jeffrey Feldman, MD, MSE, anesthesiologist at Children’s Hospital of Philadelphia and chair of the Anesthesia Patient Safety Foundation’s Committee on Technology.

The Pennsylvania Patient Safety Authority has been tracking surgical fires for decades, however, and experts have used the agency’s data to extrapolate how often they occur in the United States.

In 2005, nationwide incidence was estimated to be somewhere in the neighborhood of 550-600 fires annually, says Barbara G. Malanga, acting director of health care incident investigation and technology consulting at ECRI (formerly the Emergency Care Research Institute). By 2011, that number appeared to have dropped to 200-240 incidents per year.

A similar analysis in 2018 found the incidence may now be as low as 88-105 a year. The drop is likely a result of increased awareness because of educational efforts on the part of the ECRI and the APSF, including a widely disseminated video on fire safety.

The decline of surgical fires “sounds great,” says Dr. Feldman, “except that it’s a 100% preventable complication, and they’re still happening.”
 

Accidents waiting to happen

How do these fires happen? It comes down to the ‘fire triangle’ often taught in grade school. Fire requires three things: an ignition source, fuel, and oxygen or an oxidizing agent. Ignition sources are plentiful in a surgical suite, including any of a variety of electrical devices commonly used in surgical procedures, including defibrillators. Gowns, gauze, drapes, sponges, oxygen masks, nasal cannulae, a patient’s hair or their clothing – all provide the necessary fuel.

But the key factor for surgical fire risk is the presence of high concentrations of oxygen.
 

Safety protocols

The best and most obvious way to mitigate risk is to reduce the amount of supplemental oxygen, explains Dr. Feldman.

“Many patients do not require a high concentration of oxygen during sedation,” he says.

When a patient does require a higher concentration for their safety, the APSF and ECRI recommend placing an endotracheal tube or supraglottic airway rather than using an oxygen mask or a nasal cannula. “You want to deliver the oxygen in such a way that high concentration doesn’t exist in the surgical field,” Dr. Feldman says. In cases where supplemental oxygen is necessary, ECRI and APSF recommend reducing the oxygen concentration to less than 30%.

In addition, safety protocols include giving flammable prep solutions time to dry before applying towels or drapes and beginning the procedure. These precautions to ensure the safety of patients take just a moment, says Chester H. Lake Jr, MD, MS, of the department of anesthesiology at the University of Mississippi Medical Center, Jackson.
 

Making fire safety part of the preop routine

These safety protocols are straightforward but not always observed, experts say. Part of the reason is a matter of culture. Both anesthesiologists and surgeons have absorbed the attitude that placing an airway escalates the procedure beyond what the patient needs, says Dr. Feldman. And indeed, according to a 2013 analysis of the American Society of Anesthesiologists closed claims database, 85% of surgical fires occur in outpatient settings where airways are less likely to be placed, and 81% of those claims were for procedures that used monitored anesthesia care.

In an article on prevention of surgical fires, Dr. Lake and colleagues recommend in-house education on preventing and responding to fires at least once a year. But it shouldn’t stop there. Because these fires – horrific as they are – are fairly rare, it’s important to maintain awareness. Making fire safety a regular part of the surgical “time-out” can help further reduce incidents, he says. ECRI and the APSF have teamed up to create a poster that can help surgical teams make fire safety a regular part of their routines.

Although the national decline in surgical fires is encouraging, the problem remains serious. “You can classify these incidents as low, but it’s not low if it happens to you or a family member,” says Dr. Lake. “One is too many.”

ECRI’s Ms. Malanga agrees. “I do like to emphasize that it’s rare,” she says. “But I’d like to see us reduce this until it’s zero.”

A version of this article originally appeared on Medscape.com.

On Thanksgiving Day 2022, Kathy Stark watched as her husband of 35 years, Bobby Ray Stark, caught fire at a Nashville hospital. According to Clint Kelly, Kathy Stark’s attorney, the hospital staff was performing cardioversion to restore Bobby Ray’s heart rhythm when a spark ignited the oxygen and set the patient aflame.

Mr. Stark, 64, died of “a combination of cardiovascular disease and thermal burns,” according to a local news report. In May, Kathy Stark filed a malpractice lawsuit in U.S. District Court. Mr. Kelly hopes that the lawsuit will help improve patient safety. Meanwhile, Kathy Stark “goes to bed at night and sees her husband on fire,” Mr. Kelly says. A similar incident occurred last December in the operating room at Oregon Health & Science University, resulting in minor injuries to a patient.

Surgical fires happen rarely, but they can pose serious threats to patients and result in litigation against physicians and hospitals.
 

Underreported, but likely dropping

Reliable data on the incidence of surgical fires is lacking because incidents may go unreported over litigation fears, says Jeffrey Feldman, MD, MSE, anesthesiologist at Children’s Hospital of Philadelphia and chair of the Anesthesia Patient Safety Foundation’s Committee on Technology.

The Pennsylvania Patient Safety Authority has been tracking surgical fires for decades, however, and experts have used the agency’s data to extrapolate how often they occur in the United States.

In 2005, nationwide incidence was estimated to be somewhere in the neighborhood of 550-600 fires annually, says Barbara G. Malanga, acting director of health care incident investigation and technology consulting at ECRI (formerly the Emergency Care Research Institute). By 2011, that number appeared to have dropped to 200-240 incidents per year.

A similar analysis in 2018 found the incidence may now be as low as 88-105 a year. The drop is likely a result of increased awareness because of educational efforts on the part of the ECRI and the APSF, including a widely disseminated video on fire safety.

The decline of surgical fires “sounds great,” says Dr. Feldman, “except that it’s a 100% preventable complication, and they’re still happening.”
 

Accidents waiting to happen

How do these fires happen? It comes down to the ‘fire triangle’ often taught in grade school. Fire requires three things: an ignition source, fuel, and oxygen or an oxidizing agent. Ignition sources are plentiful in a surgical suite, including any of a variety of electrical devices commonly used in surgical procedures, including defibrillators. Gowns, gauze, drapes, sponges, oxygen masks, nasal cannulae, a patient’s hair or their clothing – all provide the necessary fuel.

But the key factor for surgical fire risk is the presence of high concentrations of oxygen.
 

Safety protocols

The best and most obvious way to mitigate risk is to reduce the amount of supplemental oxygen, explains Dr. Feldman.

“Many patients do not require a high concentration of oxygen during sedation,” he says.

When a patient does require a higher concentration for their safety, the APSF and ECRI recommend placing an endotracheal tube or supraglottic airway rather than using an oxygen mask or a nasal cannula. “You want to deliver the oxygen in such a way that high concentration doesn’t exist in the surgical field,” Dr. Feldman says. In cases where supplemental oxygen is necessary, ECRI and APSF recommend reducing the oxygen concentration to less than 30%.

In addition, safety protocols include giving flammable prep solutions time to dry before applying towels or drapes and beginning the procedure. These precautions to ensure the safety of patients take just a moment, says Chester H. Lake Jr, MD, MS, of the department of anesthesiology at the University of Mississippi Medical Center, Jackson.
 

Making fire safety part of the preop routine

These safety protocols are straightforward but not always observed, experts say. Part of the reason is a matter of culture. Both anesthesiologists and surgeons have absorbed the attitude that placing an airway escalates the procedure beyond what the patient needs, says Dr. Feldman. And indeed, according to a 2013 analysis of the American Society of Anesthesiologists closed claims database, 85% of surgical fires occur in outpatient settings where airways are less likely to be placed, and 81% of those claims were for procedures that used monitored anesthesia care.

In an article on prevention of surgical fires, Dr. Lake and colleagues recommend in-house education on preventing and responding to fires at least once a year. But it shouldn’t stop there. Because these fires – horrific as they are – are fairly rare, it’s important to maintain awareness. Making fire safety a regular part of the surgical “time-out” can help further reduce incidents, he says. ECRI and the APSF have teamed up to create a poster that can help surgical teams make fire safety a regular part of their routines.

Although the national decline in surgical fires is encouraging, the problem remains serious. “You can classify these incidents as low, but it’s not low if it happens to you or a family member,” says Dr. Lake. “One is too many.”

ECRI’s Ms. Malanga agrees. “I do like to emphasize that it’s rare,” she says. “But I’d like to see us reduce this until it’s zero.”

A version of this article originally appeared on Medscape.com.

On Thanksgiving Day 2022, Kathy Stark watched as her husband of 35 years, Bobby Ray Stark, caught fire at a Nashville hospital. According to Clint Kelly, Kathy Stark’s attorney, the hospital staff was performing cardioversion to restore Bobby Ray’s heart rhythm when a spark ignited the oxygen and set the patient aflame.

Mr. Stark, 64, died of “a combination of cardiovascular disease and thermal burns,” according to a local news report. In May, Kathy Stark filed a malpractice lawsuit in U.S. District Court. Mr. Kelly hopes that the lawsuit will help improve patient safety. Meanwhile, Kathy Stark “goes to bed at night and sees her husband on fire,” Mr. Kelly says. A similar incident occurred last December in the operating room at Oregon Health & Science University, resulting in minor injuries to a patient.

Surgical fires happen rarely, but they can pose serious threats to patients and result in litigation against physicians and hospitals.
 

Underreported, but likely dropping

Reliable data on the incidence of surgical fires is lacking because incidents may go unreported over litigation fears, says Jeffrey Feldman, MD, MSE, anesthesiologist at Children’s Hospital of Philadelphia and chair of the Anesthesia Patient Safety Foundation’s Committee on Technology.

The Pennsylvania Patient Safety Authority has been tracking surgical fires for decades, however, and experts have used the agency’s data to extrapolate how often they occur in the United States.

In 2005, nationwide incidence was estimated to be somewhere in the neighborhood of 550-600 fires annually, says Barbara G. Malanga, acting director of health care incident investigation and technology consulting at ECRI (formerly the Emergency Care Research Institute). By 2011, that number appeared to have dropped to 200-240 incidents per year.

A similar analysis in 2018 found the incidence may now be as low as 88-105 a year. The drop is likely a result of increased awareness because of educational efforts on the part of the ECRI and the APSF, including a widely disseminated video on fire safety.

The decline of surgical fires “sounds great,” says Dr. Feldman, “except that it’s a 100% preventable complication, and they’re still happening.”
 

Accidents waiting to happen

How do these fires happen? It comes down to the ‘fire triangle’ often taught in grade school. Fire requires three things: an ignition source, fuel, and oxygen or an oxidizing agent. Ignition sources are plentiful in a surgical suite, including any of a variety of electrical devices commonly used in surgical procedures, including defibrillators. Gowns, gauze, drapes, sponges, oxygen masks, nasal cannulae, a patient’s hair or their clothing – all provide the necessary fuel.

But the key factor for surgical fire risk is the presence of high concentrations of oxygen.
 

Safety protocols

The best and most obvious way to mitigate risk is to reduce the amount of supplemental oxygen, explains Dr. Feldman.

“Many patients do not require a high concentration of oxygen during sedation,” he says.

When a patient does require a higher concentration for their safety, the APSF and ECRI recommend placing an endotracheal tube or supraglottic airway rather than using an oxygen mask or a nasal cannula. “You want to deliver the oxygen in such a way that high concentration doesn’t exist in the surgical field,” Dr. Feldman says. In cases where supplemental oxygen is necessary, ECRI and APSF recommend reducing the oxygen concentration to less than 30%.

In addition, safety protocols include giving flammable prep solutions time to dry before applying towels or drapes and beginning the procedure. These precautions to ensure the safety of patients take just a moment, says Chester H. Lake Jr, MD, MS, of the department of anesthesiology at the University of Mississippi Medical Center, Jackson.
 

Making fire safety part of the preop routine

These safety protocols are straightforward but not always observed, experts say. Part of the reason is a matter of culture. Both anesthesiologists and surgeons have absorbed the attitude that placing an airway escalates the procedure beyond what the patient needs, says Dr. Feldman. And indeed, according to a 2013 analysis of the American Society of Anesthesiologists closed claims database, 85% of surgical fires occur in outpatient settings where airways are less likely to be placed, and 81% of those claims were for procedures that used monitored anesthesia care.

In an article on prevention of surgical fires, Dr. Lake and colleagues recommend in-house education on preventing and responding to fires at least once a year. But it shouldn’t stop there. Because these fires – horrific as they are – are fairly rare, it’s important to maintain awareness. Making fire safety a regular part of the surgical “time-out” can help further reduce incidents, he says. ECRI and the APSF have teamed up to create a poster that can help surgical teams make fire safety a regular part of their routines.

Although the national decline in surgical fires is encouraging, the problem remains serious. “You can classify these incidents as low, but it’s not low if it happens to you or a family member,” says Dr. Lake. “One is too many.”

ECRI’s Ms. Malanga agrees. “I do like to emphasize that it’s rare,” she says. “But I’d like to see us reduce this until it’s zero.”

A version of this article originally appeared on Medscape.com.

TOPLINE:

Among Korean women younger than 50 years, hysterectomy is associated with an increased risk of cardiovascular disease (CVD), especially stroke, a new cohort study shows.

METHODOLOGY:

• Risk of CVD rapidly increases after menopause, possibly owing to loss of protective effects of female sex hormones and hemorheologic changes.
• Results of previous studies of the association between hysterectomy and CVD were mixed.
• Using national health insurance data, this cohort study included 55,539 South Korean women (median age, 45 years) who underwent a hysterectomy and a propensity-matched group of women.
• The primary outcome was CVD, including myocardial infarction (MI), coronary artery revascularization, and stroke.

TAKEAWAY:

• During follow-up of just under 8 years, the hysterectomy group had an increased risk of CVD compared with the non-hysterectomy group (hazard ratio [HR] 1.25; 95% confidence interval [CI], 1.09-1.44; P = .002)
• The incidence of MI and coronary revascularization was comparable between groups, but the risk of stroke was significantly higher among those who had had a hysterectomy (HR, 1.31; 95% CI, 1.12-1.53; P < .001)
• This increase in risk was similar after excluding patients who also underwent adnexal surgery.

IN PRACTICE:

Early hysterectomy was linked to higher CVD risk, especially stroke, but since the CVD incidence wasn’t high, a change in clinical practice may not be needed, said the authors.

STUDY DETAILS:

The study was conducted by Jin-Sung Yuk, MD, PhD, Department of Obstetrics and Gynecology, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea, and colleagues. It was published online June 12 in JAMA Network Open.

LIMITATIONS:

The study was retrospective and observational and used administrative databases that may be prone to inaccurate coding. The findings may not be generalizable outside Korea.

DISCLOSURES:

The study was supported by a National Research Foundation of Korea grant funded by the Korea government. The authors report no conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

Among Korean women younger than 50 years, hysterectomy is associated with an increased risk of cardiovascular disease (CVD), especially stroke, a new cohort study shows.

METHODOLOGY:

• Risk of CVD rapidly increases after menopause, possibly owing to loss of protective effects of female sex hormones and hemorheologic changes.
• Results of previous studies of the association between hysterectomy and CVD were mixed.
• Using national health insurance data, this cohort study included 55,539 South Korean women (median age, 45 years) who underwent a hysterectomy and a propensity-matched group of women.
• The primary outcome was CVD, including myocardial infarction (MI), coronary artery revascularization, and stroke.

TAKEAWAY:

• During follow-up of just under 8 years, the hysterectomy group had an increased risk of CVD compared with the non-hysterectomy group (hazard ratio [HR] 1.25; 95% confidence interval [CI], 1.09-1.44; P = .002)
• The incidence of MI and coronary revascularization was comparable between groups, but the risk of stroke was significantly higher among those who had had a hysterectomy (HR, 1.31; 95% CI, 1.12-1.53; P < .001)
• This increase in risk was similar after excluding patients who also underwent adnexal surgery.

IN PRACTICE:

Early hysterectomy was linked to higher CVD risk, especially stroke, but since the CVD incidence wasn’t high, a change in clinical practice may not be needed, said the authors.

STUDY DETAILS:

The study was conducted by Jin-Sung Yuk, MD, PhD, Department of Obstetrics and Gynecology, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea, and colleagues. It was published online June 12 in JAMA Network Open.

LIMITATIONS:

The study was retrospective and observational and used administrative databases that may be prone to inaccurate coding. The findings may not be generalizable outside Korea.

DISCLOSURES:

The study was supported by a National Research Foundation of Korea grant funded by the Korea government. The authors report no conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

Among Korean women younger than 50 years, hysterectomy is associated with an increased risk of cardiovascular disease (CVD), especially stroke, a new cohort study shows.

METHODOLOGY:

• Risk of CVD rapidly increases after menopause, possibly owing to loss of protective effects of female sex hormones and hemorheologic changes.
• Results of previous studies of the association between hysterectomy and CVD were mixed.
• Using national health insurance data, this cohort study included 55,539 South Korean women (median age, 45 years) who underwent a hysterectomy and a propensity-matched group of women.
• The primary outcome was CVD, including myocardial infarction (MI), coronary artery revascularization, and stroke.

TAKEAWAY:

• During follow-up of just under 8 years, the hysterectomy group had an increased risk of CVD compared with the non-hysterectomy group (hazard ratio [HR] 1.25; 95% confidence interval [CI], 1.09-1.44; P = .002)
• The incidence of MI and coronary revascularization was comparable between groups, but the risk of stroke was significantly higher among those who had had a hysterectomy (HR, 1.31; 95% CI, 1.12-1.53; P < .001)
• This increase in risk was similar after excluding patients who also underwent adnexal surgery.

IN PRACTICE:

Early hysterectomy was linked to higher CVD risk, especially stroke, but since the CVD incidence wasn’t high, a change in clinical practice may not be needed, said the authors.

STUDY DETAILS:

The study was conducted by Jin-Sung Yuk, MD, PhD, Department of Obstetrics and Gynecology, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea, and colleagues. It was published online June 12 in JAMA Network Open.

LIMITATIONS:

The study was retrospective and observational and used administrative databases that may be prone to inaccurate coding. The findings may not be generalizable outside Korea.

DISCLOSURES:

The study was supported by a National Research Foundation of Korea grant funded by the Korea government. The authors report no conflicts of interest.

A version of this article first appeared on Medscape.com.

Heart transplantation using the new strategy of donation after circulatory death (DCD) resulted in similar 6-month survival among recipients as the traditional method of using hearts donated after brain death (DBD) in the first randomized trial comparing the two approaches.

“This randomized trial showing recipient survival with DCD to be similar to DBD should lead to DCD becoming the standard of care alongside DBD,” lead author Jacob Schroder, MD, surgical director, heart transplantation program, Duke University Medical Center, Durham, N.C., said in an interview.

“This should enable many more heart transplants to take place and for us to be able to cast the net further and wider for donors,” he said.

The trial was published online in the New England Journal of Medicine.

Dr. Schroder estimated that only around one-fifth of the 120 U.S. heart transplant centers currently carry out DCD transplants, but he is hopeful that the publication of this study will encourage more transplant centers to do these DCD procedures.

“The problem is there are many low-volume heart transplant centers, which may not be keen to do DCD transplants as they are a bit more complicated and expensive than DBD heart transplants,” he said. “But we need to look at the big picture of how many lives can be saved by increasing the number of heart transplant procedures and the money saved by getting more patients off the waiting list.”

The authors explain that heart transplantation has traditionally been limited to the use of hearts obtained from donors after brain death, which allows in situ assessment of cardiac function and of the suitability for transplantation of the donor allograft before surgical procurement.

But because the need for heart transplants far exceeds the availability of suitable donors, the use of DCD hearts has been investigated and this approach is now being pursued in many countries. In the DCD approach, the heart will have stopped beating in the donor, and perfusion techniques are used to restart the organ.

There are two different approaches to restarting the heart in DCD. The first approach involves the heart being removed from the donor and reanimated, preserved, assessed, and transported with the use of a portable extracorporeal perfusion and preservation system (Organ Care System, TransMedics). The second involves restarting the heart in the donor’s body for evaluation before removal and transportation under the traditional cold storage method used for donations after brain death.

The current trial was designed to compare clinical outcomes in patients who had received a heart from a circulatory death donor using the portable extracorporeal perfusion method for DCD transplantation, with outcomes from the traditional method of heart transplantation using organs donated after brain death.

For the randomized, noninferiority trial, adult candidates for heart transplantation were assigned to receive a heart after the circulatory death of the donor or a heart from a donor after brain death if that heart was available first (circulatory-death group) or to receive only a heart that had been preserved with the use of traditional cold storage after the brain death of the donor (brain-death group).

The primary end point was the risk-adjusted survival at 6 months in the as-treated circulatory-death group, as compared with the brain-death group. The primary safety end point was serious adverse events associated with the heart graft at 30 days after transplantation.

A total of 180 patients underwent transplantation, 90 of whom received a heart donated after circulatory death and 90 who received a heart donated after brain death. A total of 166 transplant recipients were included in the as-treated primary analysis (80 who received a heart from a circulatory-death donor and 86 who received a heart from a brain-death donor).

The risk-adjusted 6-month survival in the as-treated population was 94% among recipients of a heart from a circulatory-death donor, as compared with 90% among recipients of a heart from a brain-death donor (P < .001 for noninferiority).

There were no substantial between-group differences in the mean per-patient number of serious adverse events associated with the heart graft at 30 days after transplantation.

Of 101 hearts from circulatory-death donors that were preserved with the use of the perfusion system, 90 were successfully transplanted according to the criteria for lactate trend and overall contractility of the donor heart, which resulted in overall utilization percentage of 89%.

More patients who received a heart from a circulatory-death donor had moderate or severe primary graft dysfunction (22%) than those who received a heart from a brain-death donor (10%). However, graft failure that resulted in retransplantation occurred in two (2.3%) patients who received a heart from a brain-death donor versus zero patients who received a heart from a circulatory-death donor.

The researchers note that the higher incidence of primary graft dysfunction in the circulatory-death group is expected, given the period of warm ischemia that occurs in this approach. But they point out that this did not affect patient or graft survival at 30 days or 1 year.

“Primary graft dysfunction is when the heart doesn’t fully work immediately after transplant and some mechanical support is needed,” Dr. Schroder commented to this news organization. “This occurred more often in the DCD group, but this mechanical support is only temporary, and generally only needed for a day or two.

“It looks like it might take the heart a little longer to start fully functioning after DCD, but our results show this doesn’t seem to affect recipient survival.”

He added: “We’ve started to become more comfortable with DCD. Sometimes it may take a little longer to get the heart working properly on its own, but the rate of mechanical support is now much lower than when we first started doing these procedures. And cardiac MRI on the recipient patients before discharge have shown that the DCD hearts are not more damaged than those from DBD donors.”

The authors also report that there were six donor hearts in the DCD group for which there were protocol deviations of functional warm ischemic time greater than 30 minutes or continuously rising lactate levels and these hearts did not show primary graft dysfunction.

On this observation, Dr. Schroder said: “I think we need to do more work on understanding the ischemic time limits. The current 30 minutes time limit was estimated in animal studies. We need to look more closely at data from actual DCD transplants. While 30 minutes may be too long for a heart from an older donor, the heart from a younger donor may be fine for a longer period of ischemic time as it will be healthier.”


 

“Exciting” results

In an editorial, Nancy K. Sweitzer, MD, PhD, vice chair of clinical research, department of medicine, and director of clinical research, division of cardiology, Washington University in St. Louis, describes the results of the current study as “exciting,” adding that, “They clearly show the feasibility and safety of transplantation of hearts from circulatory-death donors.”

However, Dr. Sweitzer points out that the sickest patients in the study – those who were United Network for Organ Sharing (UNOS) status 1 and 2 – were more likely to receive a DBD heart and the more stable patients (UNOS 3-6) were more likely to receive a DCD heart.

“This imbalance undoubtedly contributed to the success of the trial in meeting its noninferiority end point. Whether transplantation of hearts from circulatory-death donors is truly safe in our sickest patients with heart failure is not clear,” she says.

However, she concludes, “Although caution and continuous evaluation of data are warranted, the increased use of hearts from circulatory-death donors appears to be safe in the hands of experienced transplantation teams and will launch an exciting phase of learning and improvement.”

“A safely expanded pool of heart donors has the potential to increase fairness and equity in heart transplantation, allowing more persons with heart failure to have access to this lifesaving therapy,” she adds. “Organ donors and transplantation teams will save increasing numbers of lives with this most precious gift.”

The current study was supported by TransMedics. Dr. Schroder reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Heart transplantation using the new strategy of donation after circulatory death (DCD) resulted in similar 6-month survival among recipients as the traditional method of using hearts donated after brain death (DBD) in the first randomized trial comparing the two approaches.

“This randomized trial showing recipient survival with DCD to be similar to DBD should lead to DCD becoming the standard of care alongside DBD,” lead author Jacob Schroder, MD, surgical director, heart transplantation program, Duke University Medical Center, Durham, N.C., said in an interview.

“This should enable many more heart transplants to take place and for us to be able to cast the net further and wider for donors,” he said.

The trial was published online in the New England Journal of Medicine.

Dr. Schroder estimated that only around one-fifth of the 120 U.S. heart transplant centers currently carry out DCD transplants, but he is hopeful that the publication of this study will encourage more transplant centers to do these DCD procedures.

“The problem is there are many low-volume heart transplant centers, which may not be keen to do DCD transplants as they are a bit more complicated and expensive than DBD heart transplants,” he said. “But we need to look at the big picture of how many lives can be saved by increasing the number of heart transplant procedures and the money saved by getting more patients off the waiting list.”

The authors explain that heart transplantation has traditionally been limited to the use of hearts obtained from donors after brain death, which allows in situ assessment of cardiac function and of the suitability for transplantation of the donor allograft before surgical procurement.

But because the need for heart transplants far exceeds the availability of suitable donors, the use of DCD hearts has been investigated and this approach is now being pursued in many countries. In the DCD approach, the heart will have stopped beating in the donor, and perfusion techniques are used to restart the organ.

There are two different approaches to restarting the heart in DCD. The first approach involves the heart being removed from the donor and reanimated, preserved, assessed, and transported with the use of a portable extracorporeal perfusion and preservation system (Organ Care System, TransMedics). The second involves restarting the heart in the donor’s body for evaluation before removal and transportation under the traditional cold storage method used for donations after brain death.

The current trial was designed to compare clinical outcomes in patients who had received a heart from a circulatory death donor using the portable extracorporeal perfusion method for DCD transplantation, with outcomes from the traditional method of heart transplantation using organs donated after brain death.

For the randomized, noninferiority trial, adult candidates for heart transplantation were assigned to receive a heart after the circulatory death of the donor or a heart from a donor after brain death if that heart was available first (circulatory-death group) or to receive only a heart that had been preserved with the use of traditional cold storage after the brain death of the donor (brain-death group).

The primary end point was the risk-adjusted survival at 6 months in the as-treated circulatory-death group, as compared with the brain-death group. The primary safety end point was serious adverse events associated with the heart graft at 30 days after transplantation.

A total of 180 patients underwent transplantation, 90 of whom received a heart donated after circulatory death and 90 who received a heart donated after brain death. A total of 166 transplant recipients were included in the as-treated primary analysis (80 who received a heart from a circulatory-death donor and 86 who received a heart from a brain-death donor).

The risk-adjusted 6-month survival in the as-treated population was 94% among recipients of a heart from a circulatory-death donor, as compared with 90% among recipients of a heart from a brain-death donor (P < .001 for noninferiority).

There were no substantial between-group differences in the mean per-patient number of serious adverse events associated with the heart graft at 30 days after transplantation.

Of 101 hearts from circulatory-death donors that were preserved with the use of the perfusion system, 90 were successfully transplanted according to the criteria for lactate trend and overall contractility of the donor heart, which resulted in overall utilization percentage of 89%.

More patients who received a heart from a circulatory-death donor had moderate or severe primary graft dysfunction (22%) than those who received a heart from a brain-death donor (10%). However, graft failure that resulted in retransplantation occurred in two (2.3%) patients who received a heart from a brain-death donor versus zero patients who received a heart from a circulatory-death donor.

The researchers note that the higher incidence of primary graft dysfunction in the circulatory-death group is expected, given the period of warm ischemia that occurs in this approach. But they point out that this did not affect patient or graft survival at 30 days or 1 year.

“Primary graft dysfunction is when the heart doesn’t fully work immediately after transplant and some mechanical support is needed,” Dr. Schroder commented to this news organization. “This occurred more often in the DCD group, but this mechanical support is only temporary, and generally only needed for a day or two.

“It looks like it might take the heart a little longer to start fully functioning after DCD, but our results show this doesn’t seem to affect recipient survival.”

He added: “We’ve started to become more comfortable with DCD. Sometimes it may take a little longer to get the heart working properly on its own, but the rate of mechanical support is now much lower than when we first started doing these procedures. And cardiac MRI on the recipient patients before discharge have shown that the DCD hearts are not more damaged than those from DBD donors.”

The authors also report that there were six donor hearts in the DCD group for which there were protocol deviations of functional warm ischemic time greater than 30 minutes or continuously rising lactate levels and these hearts did not show primary graft dysfunction.

On this observation, Dr. Schroder said: “I think we need to do more work on understanding the ischemic time limits. The current 30 minutes time limit was estimated in animal studies. We need to look more closely at data from actual DCD transplants. While 30 minutes may be too long for a heart from an older donor, the heart from a younger donor may be fine for a longer period of ischemic time as it will be healthier.”


 

“Exciting” results

In an editorial, Nancy K. Sweitzer, MD, PhD, vice chair of clinical research, department of medicine, and director of clinical research, division of cardiology, Washington University in St. Louis, describes the results of the current study as “exciting,” adding that, “They clearly show the feasibility and safety of transplantation of hearts from circulatory-death donors.”

However, Dr. Sweitzer points out that the sickest patients in the study – those who were United Network for Organ Sharing (UNOS) status 1 and 2 – were more likely to receive a DBD heart and the more stable patients (UNOS 3-6) were more likely to receive a DCD heart.

“This imbalance undoubtedly contributed to the success of the trial in meeting its noninferiority end point. Whether transplantation of hearts from circulatory-death donors is truly safe in our sickest patients with heart failure is not clear,” she says.

However, she concludes, “Although caution and continuous evaluation of data are warranted, the increased use of hearts from circulatory-death donors appears to be safe in the hands of experienced transplantation teams and will launch an exciting phase of learning and improvement.”

“A safely expanded pool of heart donors has the potential to increase fairness and equity in heart transplantation, allowing more persons with heart failure to have access to this lifesaving therapy,” she adds. “Organ donors and transplantation teams will save increasing numbers of lives with this most precious gift.”

The current study was supported by TransMedics. Dr. Schroder reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Heart transplantation using the new strategy of donation after circulatory death (DCD) resulted in similar 6-month survival among recipients as the traditional method of using hearts donated after brain death (DBD) in the first randomized trial comparing the two approaches.

“This randomized trial showing recipient survival with DCD to be similar to DBD should lead to DCD becoming the standard of care alongside DBD,” lead author Jacob Schroder, MD, surgical director, heart transplantation program, Duke University Medical Center, Durham, N.C., said in an interview.

“This should enable many more heart transplants to take place and for us to be able to cast the net further and wider for donors,” he said.

The trial was published online in the New England Journal of Medicine.

Dr. Schroder estimated that only around one-fifth of the 120 U.S. heart transplant centers currently carry out DCD transplants, but he is hopeful that the publication of this study will encourage more transplant centers to do these DCD procedures.

“The problem is there are many low-volume heart transplant centers, which may not be keen to do DCD transplants as they are a bit more complicated and expensive than DBD heart transplants,” he said. “But we need to look at the big picture of how many lives can be saved by increasing the number of heart transplant procedures and the money saved by getting more patients off the waiting list.”

The authors explain that heart transplantation has traditionally been limited to the use of hearts obtained from donors after brain death, which allows in situ assessment of cardiac function and of the suitability for transplantation of the donor allograft before surgical procurement.

But because the need for heart transplants far exceeds the availability of suitable donors, the use of DCD hearts has been investigated and this approach is now being pursued in many countries. In the DCD approach, the heart will have stopped beating in the donor, and perfusion techniques are used to restart the organ.

There are two different approaches to restarting the heart in DCD. The first approach involves the heart being removed from the donor and reanimated, preserved, assessed, and transported with the use of a portable extracorporeal perfusion and preservation system (Organ Care System, TransMedics). The second involves restarting the heart in the donor’s body for evaluation before removal and transportation under the traditional cold storage method used for donations after brain death.

The current trial was designed to compare clinical outcomes in patients who had received a heart from a circulatory death donor using the portable extracorporeal perfusion method for DCD transplantation, with outcomes from the traditional method of heart transplantation using organs donated after brain death.

For the randomized, noninferiority trial, adult candidates for heart transplantation were assigned to receive a heart after the circulatory death of the donor or a heart from a donor after brain death if that heart was available first (circulatory-death group) or to receive only a heart that had been preserved with the use of traditional cold storage after the brain death of the donor (brain-death group).

The primary end point was the risk-adjusted survival at 6 months in the as-treated circulatory-death group, as compared with the brain-death group. The primary safety end point was serious adverse events associated with the heart graft at 30 days after transplantation.

A total of 180 patients underwent transplantation, 90 of whom received a heart donated after circulatory death and 90 who received a heart donated after brain death. A total of 166 transplant recipients were included in the as-treated primary analysis (80 who received a heart from a circulatory-death donor and 86 who received a heart from a brain-death donor).

The risk-adjusted 6-month survival in the as-treated population was 94% among recipients of a heart from a circulatory-death donor, as compared with 90% among recipients of a heart from a brain-death donor (P < .001 for noninferiority).

There were no substantial between-group differences in the mean per-patient number of serious adverse events associated with the heart graft at 30 days after transplantation.

Of 101 hearts from circulatory-death donors that were preserved with the use of the perfusion system, 90 were successfully transplanted according to the criteria for lactate trend and overall contractility of the donor heart, which resulted in overall utilization percentage of 89%.

More patients who received a heart from a circulatory-death donor had moderate or severe primary graft dysfunction (22%) than those who received a heart from a brain-death donor (10%). However, graft failure that resulted in retransplantation occurred in two (2.3%) patients who received a heart from a brain-death donor versus zero patients who received a heart from a circulatory-death donor.

The researchers note that the higher incidence of primary graft dysfunction in the circulatory-death group is expected, given the period of warm ischemia that occurs in this approach. But they point out that this did not affect patient or graft survival at 30 days or 1 year.

“Primary graft dysfunction is when the heart doesn’t fully work immediately after transplant and some mechanical support is needed,” Dr. Schroder commented to this news organization. “This occurred more often in the DCD group, but this mechanical support is only temporary, and generally only needed for a day or two.

“It looks like it might take the heart a little longer to start fully functioning after DCD, but our results show this doesn’t seem to affect recipient survival.”

He added: “We’ve started to become more comfortable with DCD. Sometimes it may take a little longer to get the heart working properly on its own, but the rate of mechanical support is now much lower than when we first started doing these procedures. And cardiac MRI on the recipient patients before discharge have shown that the DCD hearts are not more damaged than those from DBD donors.”

The authors also report that there were six donor hearts in the DCD group for which there were protocol deviations of functional warm ischemic time greater than 30 minutes or continuously rising lactate levels and these hearts did not show primary graft dysfunction.

On this observation, Dr. Schroder said: “I think we need to do more work on understanding the ischemic time limits. The current 30 minutes time limit was estimated in animal studies. We need to look more closely at data from actual DCD transplants. While 30 minutes may be too long for a heart from an older donor, the heart from a younger donor may be fine for a longer period of ischemic time as it will be healthier.”


 

“Exciting” results

In an editorial, Nancy K. Sweitzer, MD, PhD, vice chair of clinical research, department of medicine, and director of clinical research, division of cardiology, Washington University in St. Louis, describes the results of the current study as “exciting,” adding that, “They clearly show the feasibility and safety of transplantation of hearts from circulatory-death donors.”

However, Dr. Sweitzer points out that the sickest patients in the study – those who were United Network for Organ Sharing (UNOS) status 1 and 2 – were more likely to receive a DBD heart and the more stable patients (UNOS 3-6) were more likely to receive a DCD heart.

“This imbalance undoubtedly contributed to the success of the trial in meeting its noninferiority end point. Whether transplantation of hearts from circulatory-death donors is truly safe in our sickest patients with heart failure is not clear,” she says.

However, she concludes, “Although caution and continuous evaluation of data are warranted, the increased use of hearts from circulatory-death donors appears to be safe in the hands of experienced transplantation teams and will launch an exciting phase of learning and improvement.”

“A safely expanded pool of heart donors has the potential to increase fairness and equity in heart transplantation, allowing more persons with heart failure to have access to this lifesaving therapy,” she adds. “Organ donors and transplantation teams will save increasing numbers of lives with this most precious gift.”

The current study was supported by TransMedics. Dr. Schroder reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

CHICAGO – When it comes to preventing pelvic recurrence in low-risk cervical cancer, simple hysterectomy is not inferior to radical hysterectomy, according to results from a phase 3, randomized, controlled trial.

“Following adequate and rigorous preoperative assessment, and that’s key – very careful [patient selection] – simple hysterectomies can now be considered the new standard of care for patients with low-risk early-stage cervical cancer,” said Marie Plante, MD, during a presentation of the study at the annual meeting of the American Society of Clinical Oncology. A simple hysterectomy removes the uterus and cervix, while a radical hysterectomy also removes the parametrium and upper vagina.

Cervical cancer incidence has gone down over the past 2 decades as a result of improved screening, and patients tend to be lower in age and are more likely to have low-risk, early-stage disease, according to Dr. Plante. “Although radical surgery is highly effective for the treatment of low-risk disease, women are at risk of suffering survivorship issues related to long-term surgical side effects including compromised bladder, bowel, and sexual function,” said Dr. Plante, who is a professor of obstetrics and gynecology at Laval University and head of clinical research at l’Hôtel-Dieu de Québec, both in Quebec City.

Retrospective studies found that infiltration of the parametrium is quite rare in low-risk cases, “suggesting that less radical surgery may be a safe option associated with decreased morbidity – what we call surgical de-escalation,” said Dr. Plante.

To test that idea more rigorously, the researchers designed the SHAPE trial, which randomized 700 women to a simple hysterectomy or radical hysterectomy. Patients were carefully selected to be low risk, having squamous cell, adenocarcinoma, or adenosquamous carcinoma, stage IA2 or IB2 tumors, fewer than 10 mm of stromal invasion on loop electrosurgical excision procedure or cone biopsy, less than 50% stromal invasion seen in MRI, and a maximum tumor dimension of 20 mm or less. Tumors were grade I-III or not assessable.

Over a median follow-up of 4.5 years, pelvic recurrence was 2.52% in the simple hysterectomy group and 2.17% in the radical hysterectomy group. The difference between the recurrence rate between the two groups was 0.35%, with an upper 95% confidence limit of 2.32%, below the threshold of 4% which had been predetermined as a benchmark for similar outcomes between the two groups. “Therefore, noninferiority of simple hysterectomy to radical hysterectomy could be concluded,” said Dr. Plante.

There were no statistically significant differences in intraoperative complications or mortality between the groups.
 

Surgery-related adverse events greater in radical hysterectomy group

There were some differences between the groups with respect to surgery-related adverse events. Within 4 weeks of surgery, there was a greater incidence of any adverse event in the radical hysterectomy group (50.6% vs. 42.6%; P = .04), as well as greater incidences of urinary incontinence (5.5% vs. 2.4%; P = .048) and urinary retention (11.0% vs. 0.6%; P < .0001). In the 4 weeks following surgery, there was a trend toward more surgery-related adverse events in the radical hysterectomy group (60.5% vs. 53.6%; P = .08) and higher incidences of urinary incontinence (11.0% vs. 4.7%; P = .003) and urinary retention (9.9% vs. 0.6%; P < .0001).

“Urinary incontinence and urinary retention are statistically worse in the radical hysterectomy group – both acutely, as well as [during] the following four weeks after surgery, suggesting that the problem persisted over time,” said Dr. Plante.

Dr. Plante also presented the study at a premeeting virtual press conference, during which Kathleen Moore, MD, provided comments on the study. She expressed enthusiasm about the results.

“Amongst those carefully selected tumors, radical hysterectomy can be converted to a simple hysterectomy, including minimally invasive. You still have to do nodes – that’s an important thing to remember – but you can do this without loss of oncologic control. And importantly, with reduction in surgical complications, postop morbidity, specifically neurologic morbidity. The moment this is presented [at the ASCO conference] this will be the new standard of care, and it represents a huge step forward in the care of women with early-stage cervical cancer,” said Dr. Moore, who is a professor of gynecologic oncology at the University of Oklahoma Health Sciences Center, Oklahoma City.

Also in the press conference, Dr. Plante emphasized the importance of a thorough understanding of the tumor, including size, imaging, and pathology. “The more conservative one wants to be, the more meticulous, the more careful one has to be to make sure that we’re truly dealing with low-risk patients.”

During the question-and-answer session following her presentation at the ASCO session, a moderator asked Dr. Plante if the presence of lymph vascular space invasion (LVSI) should prompt a radical hysterectomy.

Dr. Plante noted that about 13% of both radical and simple hysterectomy groups had LVSI present. “I think the key thing is careful selection, but I’m not sure that we should exclude LVSI [from consideration for simple hysterectomy] de facto,” she said.

Dr. Plante has consulted or advised Merck Serono and has received travel, accommodations, or other expenses from AstraZeneca. Dr. Moore has consulted, advised, and received research funding and travel expenses from numerous pharmaceutical companies.

CHICAGO – When it comes to preventing pelvic recurrence in low-risk cervical cancer, simple hysterectomy is not inferior to radical hysterectomy, according to results from a phase 3, randomized, controlled trial.

“Following adequate and rigorous preoperative assessment, and that’s key – very careful [patient selection] – simple hysterectomies can now be considered the new standard of care for patients with low-risk early-stage cervical cancer,” said Marie Plante, MD, during a presentation of the study at the annual meeting of the American Society of Clinical Oncology. A simple hysterectomy removes the uterus and cervix, while a radical hysterectomy also removes the parametrium and upper vagina.

Cervical cancer incidence has gone down over the past 2 decades as a result of improved screening, and patients tend to be lower in age and are more likely to have low-risk, early-stage disease, according to Dr. Plante. “Although radical surgery is highly effective for the treatment of low-risk disease, women are at risk of suffering survivorship issues related to long-term surgical side effects including compromised bladder, bowel, and sexual function,” said Dr. Plante, who is a professor of obstetrics and gynecology at Laval University and head of clinical research at l’Hôtel-Dieu de Québec, both in Quebec City.

Retrospective studies found that infiltration of the parametrium is quite rare in low-risk cases, “suggesting that less radical surgery may be a safe option associated with decreased morbidity – what we call surgical de-escalation,” said Dr. Plante.

To test that idea more rigorously, the researchers designed the SHAPE trial, which randomized 700 women to a simple hysterectomy or radical hysterectomy. Patients were carefully selected to be low risk, having squamous cell, adenocarcinoma, or adenosquamous carcinoma, stage IA2 or IB2 tumors, fewer than 10 mm of stromal invasion on loop electrosurgical excision procedure or cone biopsy, less than 50% stromal invasion seen in MRI, and a maximum tumor dimension of 20 mm or less. Tumors were grade I-III or not assessable.

Over a median follow-up of 4.5 years, pelvic recurrence was 2.52% in the simple hysterectomy group and 2.17% in the radical hysterectomy group. The difference between the recurrence rate between the two groups was 0.35%, with an upper 95% confidence limit of 2.32%, below the threshold of 4% which had been predetermined as a benchmark for similar outcomes between the two groups. “Therefore, noninferiority of simple hysterectomy to radical hysterectomy could be concluded,” said Dr. Plante.

There were no statistically significant differences in intraoperative complications or mortality between the groups.
 

Surgery-related adverse events greater in radical hysterectomy group

There were some differences between the groups with respect to surgery-related adverse events. Within 4 weeks of surgery, there was a greater incidence of any adverse event in the radical hysterectomy group (50.6% vs. 42.6%; P = .04), as well as greater incidences of urinary incontinence (5.5% vs. 2.4%; P = .048) and urinary retention (11.0% vs. 0.6%; P < .0001). In the 4 weeks following surgery, there was a trend toward more surgery-related adverse events in the radical hysterectomy group (60.5% vs. 53.6%; P = .08) and higher incidences of urinary incontinence (11.0% vs. 4.7%; P = .003) and urinary retention (9.9% vs. 0.6%; P < .0001).

“Urinary incontinence and urinary retention are statistically worse in the radical hysterectomy group – both acutely, as well as [during] the following four weeks after surgery, suggesting that the problem persisted over time,” said Dr. Plante.

Dr. Plante also presented the study at a premeeting virtual press conference, during which Kathleen Moore, MD, provided comments on the study. She expressed enthusiasm about the results.

“Amongst those carefully selected tumors, radical hysterectomy can be converted to a simple hysterectomy, including minimally invasive. You still have to do nodes – that’s an important thing to remember – but you can do this without loss of oncologic control. And importantly, with reduction in surgical complications, postop morbidity, specifically neurologic morbidity. The moment this is presented [at the ASCO conference] this will be the new standard of care, and it represents a huge step forward in the care of women with early-stage cervical cancer,” said Dr. Moore, who is a professor of gynecologic oncology at the University of Oklahoma Health Sciences Center, Oklahoma City.

Also in the press conference, Dr. Plante emphasized the importance of a thorough understanding of the tumor, including size, imaging, and pathology. “The more conservative one wants to be, the more meticulous, the more careful one has to be to make sure that we’re truly dealing with low-risk patients.”

During the question-and-answer session following her presentation at the ASCO session, a moderator asked Dr. Plante if the presence of lymph vascular space invasion (LVSI) should prompt a radical hysterectomy.

Dr. Plante noted that about 13% of both radical and simple hysterectomy groups had LVSI present. “I think the key thing is careful selection, but I’m not sure that we should exclude LVSI [from consideration for simple hysterectomy] de facto,” she said.

Dr. Plante has consulted or advised Merck Serono and has received travel, accommodations, or other expenses from AstraZeneca. Dr. Moore has consulted, advised, and received research funding and travel expenses from numerous pharmaceutical companies.

CHICAGO – When it comes to preventing pelvic recurrence in low-risk cervical cancer, simple hysterectomy is not inferior to radical hysterectomy, according to results from a phase 3, randomized, controlled trial.

“Following adequate and rigorous preoperative assessment, and that’s key – very careful [patient selection] – simple hysterectomies can now be considered the new standard of care for patients with low-risk early-stage cervical cancer,” said Marie Plante, MD, during a presentation of the study at the annual meeting of the American Society of Clinical Oncology. A simple hysterectomy removes the uterus and cervix, while a radical hysterectomy also removes the parametrium and upper vagina.

Cervical cancer incidence has gone down over the past 2 decades as a result of improved screening, and patients tend to be lower in age and are more likely to have low-risk, early-stage disease, according to Dr. Plante. “Although radical surgery is highly effective for the treatment of low-risk disease, women are at risk of suffering survivorship issues related to long-term surgical side effects including compromised bladder, bowel, and sexual function,” said Dr. Plante, who is a professor of obstetrics and gynecology at Laval University and head of clinical research at l’Hôtel-Dieu de Québec, both in Quebec City.

Retrospective studies found that infiltration of the parametrium is quite rare in low-risk cases, “suggesting that less radical surgery may be a safe option associated with decreased morbidity – what we call surgical de-escalation,” said Dr. Plante.

To test that idea more rigorously, the researchers designed the SHAPE trial, which randomized 700 women to a simple hysterectomy or radical hysterectomy. Patients were carefully selected to be low risk, having squamous cell, adenocarcinoma, or adenosquamous carcinoma, stage IA2 or IB2 tumors, fewer than 10 mm of stromal invasion on loop electrosurgical excision procedure or cone biopsy, less than 50% stromal invasion seen in MRI, and a maximum tumor dimension of 20 mm or less. Tumors were grade I-III or not assessable.

Over a median follow-up of 4.5 years, pelvic recurrence was 2.52% in the simple hysterectomy group and 2.17% in the radical hysterectomy group. The difference between the recurrence rate between the two groups was 0.35%, with an upper 95% confidence limit of 2.32%, below the threshold of 4% which had been predetermined as a benchmark for similar outcomes between the two groups. “Therefore, noninferiority of simple hysterectomy to radical hysterectomy could be concluded,” said Dr. Plante.

There were no statistically significant differences in intraoperative complications or mortality between the groups.
 

Surgery-related adverse events greater in radical hysterectomy group

There were some differences between the groups with respect to surgery-related adverse events. Within 4 weeks of surgery, there was a greater incidence of any adverse event in the radical hysterectomy group (50.6% vs. 42.6%; P = .04), as well as greater incidences of urinary incontinence (5.5% vs. 2.4%; P = .048) and urinary retention (11.0% vs. 0.6%; P < .0001). In the 4 weeks following surgery, there was a trend toward more surgery-related adverse events in the radical hysterectomy group (60.5% vs. 53.6%; P = .08) and higher incidences of urinary incontinence (11.0% vs. 4.7%; P = .003) and urinary retention (9.9% vs. 0.6%; P < .0001).

“Urinary incontinence and urinary retention are statistically worse in the radical hysterectomy group – both acutely, as well as [during] the following four weeks after surgery, suggesting that the problem persisted over time,” said Dr. Plante.

Dr. Plante also presented the study at a premeeting virtual press conference, during which Kathleen Moore, MD, provided comments on the study. She expressed enthusiasm about the results.

“Amongst those carefully selected tumors, radical hysterectomy can be converted to a simple hysterectomy, including minimally invasive. You still have to do nodes – that’s an important thing to remember – but you can do this without loss of oncologic control. And importantly, with reduction in surgical complications, postop morbidity, specifically neurologic morbidity. The moment this is presented [at the ASCO conference] this will be the new standard of care, and it represents a huge step forward in the care of women with early-stage cervical cancer,” said Dr. Moore, who is a professor of gynecologic oncology at the University of Oklahoma Health Sciences Center, Oklahoma City.

Also in the press conference, Dr. Plante emphasized the importance of a thorough understanding of the tumor, including size, imaging, and pathology. “The more conservative one wants to be, the more meticulous, the more careful one has to be to make sure that we’re truly dealing with low-risk patients.”

During the question-and-answer session following her presentation at the ASCO session, a moderator asked Dr. Plante if the presence of lymph vascular space invasion (LVSI) should prompt a radical hysterectomy.

Dr. Plante noted that about 13% of both radical and simple hysterectomy groups had LVSI present. “I think the key thing is careful selection, but I’m not sure that we should exclude LVSI [from consideration for simple hysterectomy] de facto,” she said.

Dr. Plante has consulted or advised Merck Serono and has received travel, accommodations, or other expenses from AstraZeneca. Dr. Moore has consulted, advised, and received research funding and travel expenses from numerous pharmaceutical companies.

More children are getting surgical procedures to lose weight, according to a report published in JAMA Pediatrics.

Metabolic and bariatric surgeries have been on the rise among youths aged 10 to 19 since 2016, the report says. From 2020 to 2021, the number shot up by 19%.

The procedures change parts of the digestive system, helping the person feel more full and less hungry – thereby contributing to weight loss.

Among American children, obesity affects 20%, or 15 million people between 2 and 19. In addition, more are becoming afflicted with severe obesity, with a body mass index 20% higher than the marker for obesity.

“Behavioral lifestyle interventions alone do not result in long-term, clinically important weight loss among youth with severe obesity,” the study’s authors wrote. “Metabolic and bariatric surgery (MBS) is a safe and effective treatment.”

The American Academy of Pediatrics updated its guidelines for the treatment of obesity this year for the first time in 15 years, CNN reported. “The new guidelines urge prompt use of behavior therapy and lifestyle changes and, for the first time, recommend surgery and medications for some young people,” CNN wrote.

Black and Hispanic children have higher rates of childhood obesity, the CDC says. Use of surgeries rose 42% among Black youths and 53% among Hispanic youths between 2020 and 2021.

A version of this article first appeared on WebMD.com.

More children are getting surgical procedures to lose weight, according to a report published in JAMA Pediatrics.

Metabolic and bariatric surgeries have been on the rise among youths aged 10 to 19 since 2016, the report says. From 2020 to 2021, the number shot up by 19%.

The procedures change parts of the digestive system, helping the person feel more full and less hungry – thereby contributing to weight loss.

Among American children, obesity affects 20%, or 15 million people between 2 and 19. In addition, more are becoming afflicted with severe obesity, with a body mass index 20% higher than the marker for obesity.

“Behavioral lifestyle interventions alone do not result in long-term, clinically important weight loss among youth with severe obesity,” the study’s authors wrote. “Metabolic and bariatric surgery (MBS) is a safe and effective treatment.”

The American Academy of Pediatrics updated its guidelines for the treatment of obesity this year for the first time in 15 years, CNN reported. “The new guidelines urge prompt use of behavior therapy and lifestyle changes and, for the first time, recommend surgery and medications for some young people,” CNN wrote.

Black and Hispanic children have higher rates of childhood obesity, the CDC says. Use of surgeries rose 42% among Black youths and 53% among Hispanic youths between 2020 and 2021.

A version of this article first appeared on WebMD.com.

More children are getting surgical procedures to lose weight, according to a report published in JAMA Pediatrics.

Metabolic and bariatric surgeries have been on the rise among youths aged 10 to 19 since 2016, the report says. From 2020 to 2021, the number shot up by 19%.

The procedures change parts of the digestive system, helping the person feel more full and less hungry – thereby contributing to weight loss.

Among American children, obesity affects 20%, or 15 million people between 2 and 19. In addition, more are becoming afflicted with severe obesity, with a body mass index 20% higher than the marker for obesity.

“Behavioral lifestyle interventions alone do not result in long-term, clinically important weight loss among youth with severe obesity,” the study’s authors wrote. “Metabolic and bariatric surgery (MBS) is a safe and effective treatment.”

The American Academy of Pediatrics updated its guidelines for the treatment of obesity this year for the first time in 15 years, CNN reported. “The new guidelines urge prompt use of behavior therapy and lifestyle changes and, for the first time, recommend surgery and medications for some young people,” CNN wrote.

Black and Hispanic children have higher rates of childhood obesity, the CDC says. Use of surgeries rose 42% among Black youths and 53% among Hispanic youths between 2020 and 2021.

A version of this article first appeared on WebMD.com.

In a first-of-its-kind in utero surgery, researchers have successfully repaired a cerebrovascular malformation, which often leads to heart failure, severe brain injury, or possibly death soon after birth.
 

The team from Boston Children’s Hospital and Brigham and Women’s Hospital used ultrasound guidance to repair the vein of Galen malformation, which causes excessively high blood flow, resulting in both neurologic and cardiac complications. 

The surgery was performed in a fetus at 34 weeks’ gestational age, with remarkable results. Since birth, the baby girl, who was identified in utero as being at high risk of suffering serious complications of the malformation, has required no medication to treat heart failure and no postnatal surgery.

Repeated echocardiograms after birth displayed marked improvement in cardiac output, and brain MRI showed no brain injury and a normal neurologic exam.

“This is incredibly exciting. The hope is that this baby, and others with this condition who receive this in utero surgery in future, will go on to have a normal life,” lead researcher Darren B. Orbach, MD, PhD, said in an interview.

“We were thrilled to see that the aggressive decline usually seen after birth simply did not appear. We are pleased to report that at 6 weeks, the infant is progressing remarkably well, on no medications, eating normally, gaining weight and is back home. There are no signs of any negative effects on the brain,” he added.

Dr. Orbach, codirector of the Cerebrovascular Surgery & Interventions Center at Boston Children’s Hospital, and colleagues described this first case report of the in utero vein of Galen malformation repair in a research letter, published online in the journal Stroke.
 

Vein of Galen malformation

Dr. Orbach explained that vein of Galen malformation, which occurs in around 1 in every 60,000 births, is a cerebrovascular anomaly in which the arterial system is directly connected to the venous system rather than to capillaries that are necessary to slow blood flow and deliver oxygen to surrounding brain tissue.

“The arterial and venous systems are fundamentally very different. The arterial system is high pressure, high flow; while the venous system is low pressure, low flow. They shouldn’t be directly connected,” he noted.

The vein of Galen malformation is the most extreme version of such an anomaly. Developing in early gestation, it is associated with a large increase in blood flow through the brain which grows over time and can sometimes result in twice the total cardiac output of the body or even more, Dr. Orbach said.

The placenta is believed to be protective as most babies don’t have overt physiologic problems in utero, but they can run into crisis after birth, with the abnormally high blood flow causing an immense stress to the heart.

Babies typically present with heart failure as their first major symptom soon after birth, Dr. Orbach said. “Although the anatomical problem is in the brain, the clinical manifestation is high-output heart failure. The heart is trying to do double its normal work, pumping the blood to the malformation and immediately back to the heart and that blood is not performing any useful function.

“These newborns can get very sick. They need multiple medications to support their cardiovascular system and we need to do procedures to try and reduce the blood flow,” he explained. 

Brain injury is also a common problem. “The brain circulation is very abnormal. The blood is being shunted through the malformation rather than circulating through the brain tissue which can become ischemic,” Dr. Orbach commented.

“The babies who get sick would have a very high mortality (up to 90%) without expert care. Even those who do receive expert care at a specialty center have a mortality rate of 30% to 40% and those who survive have a high risk of neurologic and cognitive impairment,” he added.

The current treatment for babies born with the condition involves transarterial embolization, by which a catheter is inserted into the arterial system to enable the malformation to be occluded by various techniques. 

But Dr. Orbach pointed out that some babies are born too sick to have the postnatal intervention. “The heart failure and brain injury is so overwhelming that no matter what we do, we cannot reverse it, and these babies normally do not survive. What we are doing with the fetal surgery is trying to help those babies who cannot be treated with the current postnatal approach,” he said.

The first stage of this research involved trying to identify these very-high-risk babies in utero, and the researchers found that on fetal MRI a particular measurement of one of the venous sinuses that drains the main malformation was a good predictor of how the baby would fare after birth. The babies predicted to do poorly from this test are the targets for the fetal surgery.

The technique used for the postnatal intervention is too technically challenging to perform in utero. “So we have developed a different approach for the in utero surgery that involves navigating into the accepting vein in the malformation with a needle under ultrasound guidance, and then packing the vein with metal coils to dramatically reduce the blood flow,” Dr. Orbach explained.

This procedure was performed in this first patient on March 15. The surgery was part of a clinical trial that is planned to include 20 cases in total.

“The immediate goal is to see whether we can transform those fetuses who are at very high risk of getting sick after birth into babies who do well in the [neonatal] ICU and are able to be sent home for elective treatment at a few months of age,” Dr. Orbach noted. “The study is continuing as it is vital that we continue and show efficacy and safety in other patients as well,” he added.

Dr. Orbach said the results of this first case were extremely encouraging. “Each stage was exciting – the technical success of the procedure, and then seeing the [blood] flow diminish on the ultrasound right there during the procedure; then the next day we did a fetal echocardiogram, and we could see that the abnormal cardiac output was dramatically reduced, and a fetal MRI scan also showed the malformation was already coming down in size.”

The baby was born prematurely 2 days after the procedure because of ruptured membranes with a birth weight of 1.9 kg (4.2 lb). She has not required any cardiovascular support or postnatal embolization.

“We were waiting with bated breath until the baby was born to see how she did clinically. I was trying to be conservative in my expectations, but it was quickly apparent that she was going to do great,” he said. Now at home, she has some oxygen treatment for the first few weeks, “but right now her neurological status is completely intact and essentially she looks like any other baby,” Dr. Orbach commented.

It is not yet known whether the infant will need any additional procedures. “We will follow her closely and make a decision on whether further treatment is needed based on whether the malformation is growing or not,” Dr. Orbach said. Longer term follow-up will also assess secondary problems sometimes seen, such as learning problems and seizures.

Although other fetal surgeries are now routinely performed, this is believed to be the first in utero surgery aimed at the cerebrovascular system.

“There were a lot of uncertainties,” Dr. Orbach said. “We didn’t even know if we would be able to see our instruments on ultrasound.” To model the procedure, the researchers had a phantom fetal skull and brain constructed with a vein of Galen malformation, which was key to obtaining Food and Drug Administration approval for the study.

If the study shows success in the other patients too, the technique could be rolled out to other centers. “There definitely needs to be fetal surgery and neurointerventional teams familiar with vein of Galen malformation in place, and ready to manage complications after delivery regardless of outcome. But we are not the only center with those capabilities, so if our trial pans out, yes, the hope is that other teams in specialist children’s hospitals around the world could do this too,” he added.
 

Pioneering work

Commenting on the case report in an American Heart Association press release, Colin Derdeyn, MD, a neurointerventional radiologist at University of Iowa Health Care, Iowa City, who performs vein of Galen malformation embolizations on neonates, said: “The key advance here is to intervene before the physiologic events of birth can cause life-threatening heart failure.”

Dr. Derdeyn, who is a past chair of the American Heart Association’s Stroke Council, cautioned that one successful case is not enough experience to conclude that the risks of this procedure are worth the benefits.

But, he added: “The positive hemodynamic changes that they observed in utero and after birth – reduction in flow, reduction in size of the draining vein, reversal of the abnormal reversed flow in the aorta – are really encouraging. These are some of the most exciting and surprising aspects of this case report. This is pioneering work being done in a very careful and responsible way.”

The study was funded by a grant from the Sage Schermerhorn Chair for Image-Guided Therapy.

A version of this article first appeared on Medscape.com.

In a first-of-its-kind in utero surgery, researchers have successfully repaired a cerebrovascular malformation, which often leads to heart failure, severe brain injury, or possibly death soon after birth.
 

The team from Boston Children’s Hospital and Brigham and Women’s Hospital used ultrasound guidance to repair the vein of Galen malformation, which causes excessively high blood flow, resulting in both neurologic and cardiac complications. 

The surgery was performed in a fetus at 34 weeks’ gestational age, with remarkable results. Since birth, the baby girl, who was identified in utero as being at high risk of suffering serious complications of the malformation, has required no medication to treat heart failure and no postnatal surgery.

Repeated echocardiograms after birth displayed marked improvement in cardiac output, and brain MRI showed no brain injury and a normal neurologic exam.

“This is incredibly exciting. The hope is that this baby, and others with this condition who receive this in utero surgery in future, will go on to have a normal life,” lead researcher Darren B. Orbach, MD, PhD, said in an interview.

“We were thrilled to see that the aggressive decline usually seen after birth simply did not appear. We are pleased to report that at 6 weeks, the infant is progressing remarkably well, on no medications, eating normally, gaining weight and is back home. There are no signs of any negative effects on the brain,” he added.

Dr. Orbach, codirector of the Cerebrovascular Surgery & Interventions Center at Boston Children’s Hospital, and colleagues described this first case report of the in utero vein of Galen malformation repair in a research letter, published online in the journal Stroke.
 

Vein of Galen malformation

Dr. Orbach explained that vein of Galen malformation, which occurs in around 1 in every 60,000 births, is a cerebrovascular anomaly in which the arterial system is directly connected to the venous system rather than to capillaries that are necessary to slow blood flow and deliver oxygen to surrounding brain tissue.

“The arterial and venous systems are fundamentally very different. The arterial system is high pressure, high flow; while the venous system is low pressure, low flow. They shouldn’t be directly connected,” he noted.

The vein of Galen malformation is the most extreme version of such an anomaly. Developing in early gestation, it is associated with a large increase in blood flow through the brain which grows over time and can sometimes result in twice the total cardiac output of the body or even more, Dr. Orbach said.

The placenta is believed to be protective as most babies don’t have overt physiologic problems in utero, but they can run into crisis after birth, with the abnormally high blood flow causing an immense stress to the heart.

Babies typically present with heart failure as their first major symptom soon after birth, Dr. Orbach said. “Although the anatomical problem is in the brain, the clinical manifestation is high-output heart failure. The heart is trying to do double its normal work, pumping the blood to the malformation and immediately back to the heart and that blood is not performing any useful function.

“These newborns can get very sick. They need multiple medications to support their cardiovascular system and we need to do procedures to try and reduce the blood flow,” he explained. 

Brain injury is also a common problem. “The brain circulation is very abnormal. The blood is being shunted through the malformation rather than circulating through the brain tissue which can become ischemic,” Dr. Orbach commented.

“The babies who get sick would have a very high mortality (up to 90%) without expert care. Even those who do receive expert care at a specialty center have a mortality rate of 30% to 40% and those who survive have a high risk of neurologic and cognitive impairment,” he added.

The current treatment for babies born with the condition involves transarterial embolization, by which a catheter is inserted into the arterial system to enable the malformation to be occluded by various techniques. 

But Dr. Orbach pointed out that some babies are born too sick to have the postnatal intervention. “The heart failure and brain injury is so overwhelming that no matter what we do, we cannot reverse it, and these babies normally do not survive. What we are doing with the fetal surgery is trying to help those babies who cannot be treated with the current postnatal approach,” he said.

The first stage of this research involved trying to identify these very-high-risk babies in utero, and the researchers found that on fetal MRI a particular measurement of one of the venous sinuses that drains the main malformation was a good predictor of how the baby would fare after birth. The babies predicted to do poorly from this test are the targets for the fetal surgery.

The technique used for the postnatal intervention is too technically challenging to perform in utero. “So we have developed a different approach for the in utero surgery that involves navigating into the accepting vein in the malformation with a needle under ultrasound guidance, and then packing the vein with metal coils to dramatically reduce the blood flow,” Dr. Orbach explained.

This procedure was performed in this first patient on March 15. The surgery was part of a clinical trial that is planned to include 20 cases in total.

“The immediate goal is to see whether we can transform those fetuses who are at very high risk of getting sick after birth into babies who do well in the [neonatal] ICU and are able to be sent home for elective treatment at a few months of age,” Dr. Orbach noted. “The study is continuing as it is vital that we continue and show efficacy and safety in other patients as well,” he added.

Dr. Orbach said the results of this first case were extremely encouraging. “Each stage was exciting – the technical success of the procedure, and then seeing the [blood] flow diminish on the ultrasound right there during the procedure; then the next day we did a fetal echocardiogram, and we could see that the abnormal cardiac output was dramatically reduced, and a fetal MRI scan also showed the malformation was already coming down in size.”

The baby was born prematurely 2 days after the procedure because of ruptured membranes with a birth weight of 1.9 kg (4.2 lb). She has not required any cardiovascular support or postnatal embolization.

“We were waiting with bated breath until the baby was born to see how she did clinically. I was trying to be conservative in my expectations, but it was quickly apparent that she was going to do great,” he said. Now at home, she has some oxygen treatment for the first few weeks, “but right now her neurological status is completely intact and essentially she looks like any other baby,” Dr. Orbach commented.

It is not yet known whether the infant will need any additional procedures. “We will follow her closely and make a decision on whether further treatment is needed based on whether the malformation is growing or not,” Dr. Orbach said. Longer term follow-up will also assess secondary problems sometimes seen, such as learning problems and seizures.

Although other fetal surgeries are now routinely performed, this is believed to be the first in utero surgery aimed at the cerebrovascular system.

“There were a lot of uncertainties,” Dr. Orbach said. “We didn’t even know if we would be able to see our instruments on ultrasound.” To model the procedure, the researchers had a phantom fetal skull and brain constructed with a vein of Galen malformation, which was key to obtaining Food and Drug Administration approval for the study.

If the study shows success in the other patients too, the technique could be rolled out to other centers. “There definitely needs to be fetal surgery and neurointerventional teams familiar with vein of Galen malformation in place, and ready to manage complications after delivery regardless of outcome. But we are not the only center with those capabilities, so if our trial pans out, yes, the hope is that other teams in specialist children’s hospitals around the world could do this too,” he added.
 

Pioneering work

Commenting on the case report in an American Heart Association press release, Colin Derdeyn, MD, a neurointerventional radiologist at University of Iowa Health Care, Iowa City, who performs vein of Galen malformation embolizations on neonates, said: “The key advance here is to intervene before the physiologic events of birth can cause life-threatening heart failure.”

Dr. Derdeyn, who is a past chair of the American Heart Association’s Stroke Council, cautioned that one successful case is not enough experience to conclude that the risks of this procedure are worth the benefits.

But, he added: “The positive hemodynamic changes that they observed in utero and after birth – reduction in flow, reduction in size of the draining vein, reversal of the abnormal reversed flow in the aorta – are really encouraging. These are some of the most exciting and surprising aspects of this case report. This is pioneering work being done in a very careful and responsible way.”

The study was funded by a grant from the Sage Schermerhorn Chair for Image-Guided Therapy.

A version of this article first appeared on Medscape.com.

In a first-of-its-kind in utero surgery, researchers have successfully repaired a cerebrovascular malformation, which often leads to heart failure, severe brain injury, or possibly death soon after birth.
 

The team from Boston Children’s Hospital and Brigham and Women’s Hospital used ultrasound guidance to repair the vein of Galen malformation, which causes excessively high blood flow, resulting in both neurologic and cardiac complications. 

The surgery was performed in a fetus at 34 weeks’ gestational age, with remarkable results. Since birth, the baby girl, who was identified in utero as being at high risk of suffering serious complications of the malformation, has required no medication to treat heart failure and no postnatal surgery.

Repeated echocardiograms after birth displayed marked improvement in cardiac output, and brain MRI showed no brain injury and a normal neurologic exam.

“This is incredibly exciting. The hope is that this baby, and others with this condition who receive this in utero surgery in future, will go on to have a normal life,” lead researcher Darren B. Orbach, MD, PhD, said in an interview.

“We were thrilled to see that the aggressive decline usually seen after birth simply did not appear. We are pleased to report that at 6 weeks, the infant is progressing remarkably well, on no medications, eating normally, gaining weight and is back home. There are no signs of any negative effects on the brain,” he added.

Dr. Orbach, codirector of the Cerebrovascular Surgery & Interventions Center at Boston Children’s Hospital, and colleagues described this first case report of the in utero vein of Galen malformation repair in a research letter, published online in the journal Stroke.
 

Vein of Galen malformation

Dr. Orbach explained that vein of Galen malformation, which occurs in around 1 in every 60,000 births, is a cerebrovascular anomaly in which the arterial system is directly connected to the venous system rather than to capillaries that are necessary to slow blood flow and deliver oxygen to surrounding brain tissue.

“The arterial and venous systems are fundamentally very different. The arterial system is high pressure, high flow; while the venous system is low pressure, low flow. They shouldn’t be directly connected,” he noted.

The vein of Galen malformation is the most extreme version of such an anomaly. Developing in early gestation, it is associated with a large increase in blood flow through the brain which grows over time and can sometimes result in twice the total cardiac output of the body or even more, Dr. Orbach said.

The placenta is believed to be protective as most babies don’t have overt physiologic problems in utero, but they can run into crisis after birth, with the abnormally high blood flow causing an immense stress to the heart.

Babies typically present with heart failure as their first major symptom soon after birth, Dr. Orbach said. “Although the anatomical problem is in the brain, the clinical manifestation is high-output heart failure. The heart is trying to do double its normal work, pumping the blood to the malformation and immediately back to the heart and that blood is not performing any useful function.

“These newborns can get very sick. They need multiple medications to support their cardiovascular system and we need to do procedures to try and reduce the blood flow,” he explained. 

Brain injury is also a common problem. “The brain circulation is very abnormal. The blood is being shunted through the malformation rather than circulating through the brain tissue which can become ischemic,” Dr. Orbach commented.

“The babies who get sick would have a very high mortality (up to 90%) without expert care. Even those who do receive expert care at a specialty center have a mortality rate of 30% to 40% and those who survive have a high risk of neurologic and cognitive impairment,” he added.

The current treatment for babies born with the condition involves transarterial embolization, by which a catheter is inserted into the arterial system to enable the malformation to be occluded by various techniques. 

But Dr. Orbach pointed out that some babies are born too sick to have the postnatal intervention. “The heart failure and brain injury is so overwhelming that no matter what we do, we cannot reverse it, and these babies normally do not survive. What we are doing with the fetal surgery is trying to help those babies who cannot be treated with the current postnatal approach,” he said.

The first stage of this research involved trying to identify these very-high-risk babies in utero, and the researchers found that on fetal MRI a particular measurement of one of the venous sinuses that drains the main malformation was a good predictor of how the baby would fare after birth. The babies predicted to do poorly from this test are the targets for the fetal surgery.

The technique used for the postnatal intervention is too technically challenging to perform in utero. “So we have developed a different approach for the in utero surgery that involves navigating into the accepting vein in the malformation with a needle under ultrasound guidance, and then packing the vein with metal coils to dramatically reduce the blood flow,” Dr. Orbach explained.

This procedure was performed in this first patient on March 15. The surgery was part of a clinical trial that is planned to include 20 cases in total.

“The immediate goal is to see whether we can transform those fetuses who are at very high risk of getting sick after birth into babies who do well in the [neonatal] ICU and are able to be sent home for elective treatment at a few months of age,” Dr. Orbach noted. “The study is continuing as it is vital that we continue and show efficacy and safety in other patients as well,” he added.

Dr. Orbach said the results of this first case were extremely encouraging. “Each stage was exciting – the technical success of the procedure, and then seeing the [blood] flow diminish on the ultrasound right there during the procedure; then the next day we did a fetal echocardiogram, and we could see that the abnormal cardiac output was dramatically reduced, and a fetal MRI scan also showed the malformation was already coming down in size.”

The baby was born prematurely 2 days after the procedure because of ruptured membranes with a birth weight of 1.9 kg (4.2 lb). She has not required any cardiovascular support or postnatal embolization.

“We were waiting with bated breath until the baby was born to see how she did clinically. I was trying to be conservative in my expectations, but it was quickly apparent that she was going to do great,” he said. Now at home, she has some oxygen treatment for the first few weeks, “but right now her neurological status is completely intact and essentially she looks like any other baby,” Dr. Orbach commented.

It is not yet known whether the infant will need any additional procedures. “We will follow her closely and make a decision on whether further treatment is needed based on whether the malformation is growing or not,” Dr. Orbach said. Longer term follow-up will also assess secondary problems sometimes seen, such as learning problems and seizures.

Although other fetal surgeries are now routinely performed, this is believed to be the first in utero surgery aimed at the cerebrovascular system.

“There were a lot of uncertainties,” Dr. Orbach said. “We didn’t even know if we would be able to see our instruments on ultrasound.” To model the procedure, the researchers had a phantom fetal skull and brain constructed with a vein of Galen malformation, which was key to obtaining Food and Drug Administration approval for the study.

If the study shows success in the other patients too, the technique could be rolled out to other centers. “There definitely needs to be fetal surgery and neurointerventional teams familiar with vein of Galen malformation in place, and ready to manage complications after delivery regardless of outcome. But we are not the only center with those capabilities, so if our trial pans out, yes, the hope is that other teams in specialist children’s hospitals around the world could do this too,” he added.
 

Pioneering work

Commenting on the case report in an American Heart Association press release, Colin Derdeyn, MD, a neurointerventional radiologist at University of Iowa Health Care, Iowa City, who performs vein of Galen malformation embolizations on neonates, said: “The key advance here is to intervene before the physiologic events of birth can cause life-threatening heart failure.”

Dr. Derdeyn, who is a past chair of the American Heart Association’s Stroke Council, cautioned that one successful case is not enough experience to conclude that the risks of this procedure are worth the benefits.

But, he added: “The positive hemodynamic changes that they observed in utero and after birth – reduction in flow, reduction in size of the draining vein, reversal of the abnormal reversed flow in the aorta – are really encouraging. These are some of the most exciting and surprising aspects of this case report. This is pioneering work being done in a very careful and responsible way.”

The study was funded by a grant from the Sage Schermerhorn Chair for Image-Guided Therapy.

A version of this article first appeared on Medscape.com.

A family physician whom a young patient’s mother accused of being impaired at work has won his lawsuit against a Kentucky hospital.
 

A jury on May 2 awarded John M. Farmer, MD, $3.7 million for emotional distress and contract damages against Baptist Health Madisonville and Baptist Health Medical Group for a series of actions they took against Dr. Farmer after the impairment complaint.

“It’s been the worst thing that I’ve ever gone through in my entire life,” Dr. Farmer said in an interview. “My career was disrupted, because I couldn’t finish residency on time, and I had difficulty finding full-time employment comparable to what I expected to obtain immediately following residency. It continues to significantly impact my life and my job, because I remain subject to random drug testing at any time and must check in every day to see whether I have to get drug tested.”

Dr. Farmer was in his third year of residency at the hospital when the mother of two young patients accused the doctor of being “on something” during a visit with her children, said Kathleen DeLaney, an Indianapolis-based attorney who represented Dr. Farmer in the case.

According to the lawsuit, the hospital violated its fitness for duty and drug testing policy by not immediately notifying Dr. Farmer of the complaint nor immediately testing him to prove whether or not there was a factual basis for the allegation. Repercussions from the unproven complaint damaged Dr. Farmer’s personal and professional reputation. It severely limited his job prospects and earning potential, the suit alleged.

Baptist Health spokeswoman Rebecca Towles Brown said Baptist Health is exploring its legal options after the jury’s decision. “We strongly disagree with the allegations made against Baptist Health in this case and are disappointed in the jury’s verdict. Baptist Health followed its medical staff policies and appropriately responded to concerns raised about Dr. Farmer’s well-being and behavior on the date in question. We are evaluating our postverdict options, as we believe the facts as they occurred do not support the verdict. Our primary focus remains providing high-quality care to our patients and families.”
 

What sparked the complaint?

On Nov. 4, 2019, Dr. Farmer worked a full day in the clinic at Baptist Health, visiting and treating patients and interacting with colleagues, according to court documents. In the late afternoon, he conducted a routine appointment with two children while their mother, her boyfriend, and a medical student were present.

Following the afternoon appointment, the mother issued a complaint to an office manager that Dr. Farmer was impaired, noting that he was “touching his nose a lot,” according to the lawsuit.

The next morning, hospital administrators met with Dr. Farmer and asked whether he was impaired the day before, to which he replied, “Absolutely not,” court documents state. Dr. Farmer asked to be given a urine drug screen immediately, but administrators allegedly said he needed to be tested at the Kentucky Physicians Health Foundation in Louisville.

Dr. Farmer immediately made the 3-hour drive to the facility, and Baptist Health placed him on leave, pending the evaluation. The health foundation sent Dr. Farmer to a third-party vendor to complete a urine drug screen, which returned a result of “dilute.” (A “dilute” result occurs when the urine concentration is weak because of too much water in the urine and testers are unable to detect whether alcohol or drugs are present.)

He was then instructed to go to a separate alcohol treatment facility for a 96-hour evaluation, where he was ultimately diagnosed with mild alcohol use disorder, according to Ms. DeLaney. The facility did not recommend that he receive any inpatient care.

Hospital administrators later sent a letter to the Kentucky Board of Medical Licensure alerting them of the patient’s complaint. The board opened an investigation, and Farmer was required to sign an interim order in which he agreed not to practice medicine until approved by the board, according to court documents. The order was reported to the National Practitioner’s Data Bank.

To maintain his employment and complete his residency, Dr. Farmer was ultimately required to sign a 2-year agreement with Kentucky Physicians Health Foundation, which included regular testing, monitoring, and therapy. The board later extended the agreement to 5 years and made Dr. Farmer’s compliance a condition of retaining his medical license, according to legal records.

Dr. Farmer sued Baptist Health Medical Group and Baptist Heath Madisonville in 2021, alleging breach of contract and tortious interference with prospective business advantage.

At trial, coworkers, including Farmer’s attending physicians, testified that Dr. Farmer was not impaired on the date in question, Ms. DeLaney said. A key fact highlighted at trial is that Dr. Farmer has ADHD.

“My client has ADHD, so he’s normally a twitchy person,” she said. “There was lots of testimony about how he moves a lot and that he’s fidgety and doesn’t stand still. The two attending doctors that were supervising him at clinic that afternoon both said 100% he was not impaired; he was his usual self. They told the residency director that right after the incident. They both testified at trial they thought that would be the end of the matter.”

Baptist Health would not comment about whether it followed its fitness for duty and drug testing policy or whether leaders spoke with other medical professionals who worked with Dr. Farmer on the day of the complaint.

Dr. Farmer said he feels vindicated by the verdict and grateful to the jury.

“I intend to continue practicing as a family medicine doctor and hope to continue to grow and advance in my career,” he said.
 

Have you been falsely accused? Here’s what to do

Dr. Farmer is not alone in fighting back against allegations by hospitals regarding conduct associated with impairment.

In 2020, an ob.gyn. who had been accused of being under the influence while working won $4.75 million in fraud and defamation damages against St. Vincent Carmel (Ind.) Hospital and St. Vincent Carmel Medical Group for its treatment following an impairment complaint by a nurse.

It’s unclear how prevalent such scenarios are because frequently, physicians are embarrassed and keep quiet about the situation and how they were treated, said Louise B. Andrew, MD, JD, an emergency physician/internist and attorney who consults on physician health and wellness, litigation stress, and disability discrimination.

“Physicians are unlikely to reveal that it’s happened to them unless they happen to have had a good outcome” she said. “All we know is that we’re hearing more and more about it, and that might be because people are becoming more open and outraged when it happens. It’s quite easy for anyone in a hospital environment or in an office environment, for a competitor, a coworker, or even a disgruntled patient to allege a physician has ‘glazed eyes’ or ‘alcohol on the breath,’ and that’s all it takes to start the ball rolling.”

If you are falsely accused of being impaired at work or are suddenly confronted with a complaint, the first step is to remain calm, said Kernan Manion, MD, executive director for the Center for Physician Rights, a nonprofit organization that assists physicians who have been subject to unfair medical board, health program, or peer review processes.

“The first thing is to keep your wits about you,” he said, “because often, docs get frightened or angry, and they overact. You have to gain your composure and ask for documentation about the nature of the allegation.”

Obtain in writing any and all information that supports the allegation. Physicians who are asked to report to a physician health program should ask the reason they are being referred and whether it is for a medical evaluation or another type of evaluation, he said. If it’s a medical reason, the process needs to follow medical parameters in terms of confidentiality.

“The bottom line is that a doctor should not take everything at face value and follow the organization’s orders unquestioning,” Dr. Manion said. “They have a right to get their concerns addressed.”

Physicians who are accused of using substances on duty or being under the influence while working have to right to undergo testing immediately, Dr. Andrew said.

“If you’re told on the spot: ‘You need to submit to testing,’ then you should do it, but make sure it’s done properly,” she said. “Ensure that forensically, you give two samples and that they are sealed and the chain of evidence is maintained. The reason for that is if one of them is a false positive, the second one can be reviewed separately.”

If administrators do not allow for prompt testing, get yourself tested immediately on your own, she said.

As far as leaves of absence are concerned, ensure you know what type of leave is being executed, Dr. Manion said. Ask the nature of the leave and whether the leave counts as a suspension that will go against your medical license and be reportable to the NPDB. In such cases, the only reason to suspend a doctor’s privileges is because they are considered a danger to others, or, in other words, there’s been an allegation of unsafe care.

“If there is an allegation of unsafe care, the physician should ask for documentation of the patient safety issues in question and why they are being deemed unsafe to practice,” he said.

Ms. DeLaney recommended physicians not report to or communicate with any state medical association, physician health foundation, or licensing authority without first getting legal advice.

In addition, doctors will likely be tested for acute and long-term drug and alcohol use, so it’s a good idea to avoid any activity or substances that could result in a dilute sample or a positive result on a drug or alcohol test, she said.

As for broader solutions, it’s important that more physicians come out of the shadows and tell their stories when these injustices take place, said Dr. Andrew.

“Doctors need to be more open about this when it happens, which is not easy,” she said. “More need to be suing, which is certainly not cheap. Also, when they do come to settlements, they should not sign nondisclosure agreements so that they can talk about what happened and it can be publicized. This way, more doctors are aware of the types of tactics used against physicians and what other doctors have done that can help.”

A version of this article first appeared on Medscape.com.

A family physician whom a young patient’s mother accused of being impaired at work has won his lawsuit against a Kentucky hospital.
 

A jury on May 2 awarded John M. Farmer, MD, $3.7 million for emotional distress and contract damages against Baptist Health Madisonville and Baptist Health Medical Group for a series of actions they took against Dr. Farmer after the impairment complaint.

“It’s been the worst thing that I’ve ever gone through in my entire life,” Dr. Farmer said in an interview. “My career was disrupted, because I couldn’t finish residency on time, and I had difficulty finding full-time employment comparable to what I expected to obtain immediately following residency. It continues to significantly impact my life and my job, because I remain subject to random drug testing at any time and must check in every day to see whether I have to get drug tested.”

Dr. Farmer was in his third year of residency at the hospital when the mother of two young patients accused the doctor of being “on something” during a visit with her children, said Kathleen DeLaney, an Indianapolis-based attorney who represented Dr. Farmer in the case.

According to the lawsuit, the hospital violated its fitness for duty and drug testing policy by not immediately notifying Dr. Farmer of the complaint nor immediately testing him to prove whether or not there was a factual basis for the allegation. Repercussions from the unproven complaint damaged Dr. Farmer’s personal and professional reputation. It severely limited his job prospects and earning potential, the suit alleged.

Baptist Health spokeswoman Rebecca Towles Brown said Baptist Health is exploring its legal options after the jury’s decision. “We strongly disagree with the allegations made against Baptist Health in this case and are disappointed in the jury’s verdict. Baptist Health followed its medical staff policies and appropriately responded to concerns raised about Dr. Farmer’s well-being and behavior on the date in question. We are evaluating our postverdict options, as we believe the facts as they occurred do not support the verdict. Our primary focus remains providing high-quality care to our patients and families.”
 

What sparked the complaint?

On Nov. 4, 2019, Dr. Farmer worked a full day in the clinic at Baptist Health, visiting and treating patients and interacting with colleagues, according to court documents. In the late afternoon, he conducted a routine appointment with two children while their mother, her boyfriend, and a medical student were present.

Following the afternoon appointment, the mother issued a complaint to an office manager that Dr. Farmer was impaired, noting that he was “touching his nose a lot,” according to the lawsuit.

The next morning, hospital administrators met with Dr. Farmer and asked whether he was impaired the day before, to which he replied, “Absolutely not,” court documents state. Dr. Farmer asked to be given a urine drug screen immediately, but administrators allegedly said he needed to be tested at the Kentucky Physicians Health Foundation in Louisville.

Dr. Farmer immediately made the 3-hour drive to the facility, and Baptist Health placed him on leave, pending the evaluation. The health foundation sent Dr. Farmer to a third-party vendor to complete a urine drug screen, which returned a result of “dilute.” (A “dilute” result occurs when the urine concentration is weak because of too much water in the urine and testers are unable to detect whether alcohol or drugs are present.)

He was then instructed to go to a separate alcohol treatment facility for a 96-hour evaluation, where he was ultimately diagnosed with mild alcohol use disorder, according to Ms. DeLaney. The facility did not recommend that he receive any inpatient care.

Hospital administrators later sent a letter to the Kentucky Board of Medical Licensure alerting them of the patient’s complaint. The board opened an investigation, and Farmer was required to sign an interim order in which he agreed not to practice medicine until approved by the board, according to court documents. The order was reported to the National Practitioner’s Data Bank.

To maintain his employment and complete his residency, Dr. Farmer was ultimately required to sign a 2-year agreement with Kentucky Physicians Health Foundation, which included regular testing, monitoring, and therapy. The board later extended the agreement to 5 years and made Dr. Farmer’s compliance a condition of retaining his medical license, according to legal records.

Dr. Farmer sued Baptist Health Medical Group and Baptist Heath Madisonville in 2021, alleging breach of contract and tortious interference with prospective business advantage.

At trial, coworkers, including Farmer’s attending physicians, testified that Dr. Farmer was not impaired on the date in question, Ms. DeLaney said. A key fact highlighted at trial is that Dr. Farmer has ADHD.

“My client has ADHD, so he’s normally a twitchy person,” she said. “There was lots of testimony about how he moves a lot and that he’s fidgety and doesn’t stand still. The two attending doctors that were supervising him at clinic that afternoon both said 100% he was not impaired; he was his usual self. They told the residency director that right after the incident. They both testified at trial they thought that would be the end of the matter.”

Baptist Health would not comment about whether it followed its fitness for duty and drug testing policy or whether leaders spoke with other medical professionals who worked with Dr. Farmer on the day of the complaint.

Dr. Farmer said he feels vindicated by the verdict and grateful to the jury.

“I intend to continue practicing as a family medicine doctor and hope to continue to grow and advance in my career,” he said.
 

Have you been falsely accused? Here’s what to do

Dr. Farmer is not alone in fighting back against allegations by hospitals regarding conduct associated with impairment.

In 2020, an ob.gyn. who had been accused of being under the influence while working won $4.75 million in fraud and defamation damages against St. Vincent Carmel (Ind.) Hospital and St. Vincent Carmel Medical Group for its treatment following an impairment complaint by a nurse.

It’s unclear how prevalent such scenarios are because frequently, physicians are embarrassed and keep quiet about the situation and how they were treated, said Louise B. Andrew, MD, JD, an emergency physician/internist and attorney who consults on physician health and wellness, litigation stress, and disability discrimination.

“Physicians are unlikely to reveal that it’s happened to them unless they happen to have had a good outcome” she said. “All we know is that we’re hearing more and more about it, and that might be because people are becoming more open and outraged when it happens. It’s quite easy for anyone in a hospital environment or in an office environment, for a competitor, a coworker, or even a disgruntled patient to allege a physician has ‘glazed eyes’ or ‘alcohol on the breath,’ and that’s all it takes to start the ball rolling.”

If you are falsely accused of being impaired at work or are suddenly confronted with a complaint, the first step is to remain calm, said Kernan Manion, MD, executive director for the Center for Physician Rights, a nonprofit organization that assists physicians who have been subject to unfair medical board, health program, or peer review processes.

“The first thing is to keep your wits about you,” he said, “because often, docs get frightened or angry, and they overact. You have to gain your composure and ask for documentation about the nature of the allegation.”

Obtain in writing any and all information that supports the allegation. Physicians who are asked to report to a physician health program should ask the reason they are being referred and whether it is for a medical evaluation or another type of evaluation, he said. If it’s a medical reason, the process needs to follow medical parameters in terms of confidentiality.

“The bottom line is that a doctor should not take everything at face value and follow the organization’s orders unquestioning,” Dr. Manion said. “They have a right to get their concerns addressed.”

Physicians who are accused of using substances on duty or being under the influence while working have to right to undergo testing immediately, Dr. Andrew said.

“If you’re told on the spot: ‘You need to submit to testing,’ then you should do it, but make sure it’s done properly,” she said. “Ensure that forensically, you give two samples and that they are sealed and the chain of evidence is maintained. The reason for that is if one of them is a false positive, the second one can be reviewed separately.”

If administrators do not allow for prompt testing, get yourself tested immediately on your own, she said.

As far as leaves of absence are concerned, ensure you know what type of leave is being executed, Dr. Manion said. Ask the nature of the leave and whether the leave counts as a suspension that will go against your medical license and be reportable to the NPDB. In such cases, the only reason to suspend a doctor’s privileges is because they are considered a danger to others, or, in other words, there’s been an allegation of unsafe care.

“If there is an allegation of unsafe care, the physician should ask for documentation of the patient safety issues in question and why they are being deemed unsafe to practice,” he said.

Ms. DeLaney recommended physicians not report to or communicate with any state medical association, physician health foundation, or licensing authority without first getting legal advice.

In addition, doctors will likely be tested for acute and long-term drug and alcohol use, so it’s a good idea to avoid any activity or substances that could result in a dilute sample or a positive result on a drug or alcohol test, she said.

As for broader solutions, it’s important that more physicians come out of the shadows and tell their stories when these injustices take place, said Dr. Andrew.

“Doctors need to be more open about this when it happens, which is not easy,” she said. “More need to be suing, which is certainly not cheap. Also, when they do come to settlements, they should not sign nondisclosure agreements so that they can talk about what happened and it can be publicized. This way, more doctors are aware of the types of tactics used against physicians and what other doctors have done that can help.”

A version of this article first appeared on Medscape.com.

A family physician whom a young patient’s mother accused of being impaired at work has won his lawsuit against a Kentucky hospital.
 

A jury on May 2 awarded John M. Farmer, MD, $3.7 million for emotional distress and contract damages against Baptist Health Madisonville and Baptist Health Medical Group for a series of actions they took against Dr. Farmer after the impairment complaint.

“It’s been the worst thing that I’ve ever gone through in my entire life,” Dr. Farmer said in an interview. “My career was disrupted, because I couldn’t finish residency on time, and I had difficulty finding full-time employment comparable to what I expected to obtain immediately following residency. It continues to significantly impact my life and my job, because I remain subject to random drug testing at any time and must check in every day to see whether I have to get drug tested.”

Dr. Farmer was in his third year of residency at the hospital when the mother of two young patients accused the doctor of being “on something” during a visit with her children, said Kathleen DeLaney, an Indianapolis-based attorney who represented Dr. Farmer in the case.

According to the lawsuit, the hospital violated its fitness for duty and drug testing policy by not immediately notifying Dr. Farmer of the complaint nor immediately testing him to prove whether or not there was a factual basis for the allegation. Repercussions from the unproven complaint damaged Dr. Farmer’s personal and professional reputation. It severely limited his job prospects and earning potential, the suit alleged.

Baptist Health spokeswoman Rebecca Towles Brown said Baptist Health is exploring its legal options after the jury’s decision. “We strongly disagree with the allegations made against Baptist Health in this case and are disappointed in the jury’s verdict. Baptist Health followed its medical staff policies and appropriately responded to concerns raised about Dr. Farmer’s well-being and behavior on the date in question. We are evaluating our postverdict options, as we believe the facts as they occurred do not support the verdict. Our primary focus remains providing high-quality care to our patients and families.”
 

What sparked the complaint?

On Nov. 4, 2019, Dr. Farmer worked a full day in the clinic at Baptist Health, visiting and treating patients and interacting with colleagues, according to court documents. In the late afternoon, he conducted a routine appointment with two children while their mother, her boyfriend, and a medical student were present.

Following the afternoon appointment, the mother issued a complaint to an office manager that Dr. Farmer was impaired, noting that he was “touching his nose a lot,” according to the lawsuit.

The next morning, hospital administrators met with Dr. Farmer and asked whether he was impaired the day before, to which he replied, “Absolutely not,” court documents state. Dr. Farmer asked to be given a urine drug screen immediately, but administrators allegedly said he needed to be tested at the Kentucky Physicians Health Foundation in Louisville.

Dr. Farmer immediately made the 3-hour drive to the facility, and Baptist Health placed him on leave, pending the evaluation. The health foundation sent Dr. Farmer to a third-party vendor to complete a urine drug screen, which returned a result of “dilute.” (A “dilute” result occurs when the urine concentration is weak because of too much water in the urine and testers are unable to detect whether alcohol or drugs are present.)

He was then instructed to go to a separate alcohol treatment facility for a 96-hour evaluation, where he was ultimately diagnosed with mild alcohol use disorder, according to Ms. DeLaney. The facility did not recommend that he receive any inpatient care.

Hospital administrators later sent a letter to the Kentucky Board of Medical Licensure alerting them of the patient’s complaint. The board opened an investigation, and Farmer was required to sign an interim order in which he agreed not to practice medicine until approved by the board, according to court documents. The order was reported to the National Practitioner’s Data Bank.

To maintain his employment and complete his residency, Dr. Farmer was ultimately required to sign a 2-year agreement with Kentucky Physicians Health Foundation, which included regular testing, monitoring, and therapy. The board later extended the agreement to 5 years and made Dr. Farmer’s compliance a condition of retaining his medical license, according to legal records.

Dr. Farmer sued Baptist Health Medical Group and Baptist Heath Madisonville in 2021, alleging breach of contract and tortious interference with prospective business advantage.

At trial, coworkers, including Farmer’s attending physicians, testified that Dr. Farmer was not impaired on the date in question, Ms. DeLaney said. A key fact highlighted at trial is that Dr. Farmer has ADHD.

“My client has ADHD, so he’s normally a twitchy person,” she said. “There was lots of testimony about how he moves a lot and that he’s fidgety and doesn’t stand still. The two attending doctors that were supervising him at clinic that afternoon both said 100% he was not impaired; he was his usual self. They told the residency director that right after the incident. They both testified at trial they thought that would be the end of the matter.”

Baptist Health would not comment about whether it followed its fitness for duty and drug testing policy or whether leaders spoke with other medical professionals who worked with Dr. Farmer on the day of the complaint.

Dr. Farmer said he feels vindicated by the verdict and grateful to the jury.

“I intend to continue practicing as a family medicine doctor and hope to continue to grow and advance in my career,” he said.
 

Have you been falsely accused? Here’s what to do

Dr. Farmer is not alone in fighting back against allegations by hospitals regarding conduct associated with impairment.

In 2020, an ob.gyn. who had been accused of being under the influence while working won $4.75 million in fraud and defamation damages against St. Vincent Carmel (Ind.) Hospital and St. Vincent Carmel Medical Group for its treatment following an impairment complaint by a nurse.

It’s unclear how prevalent such scenarios are because frequently, physicians are embarrassed and keep quiet about the situation and how they were treated, said Louise B. Andrew, MD, JD, an emergency physician/internist and attorney who consults on physician health and wellness, litigation stress, and disability discrimination.

“Physicians are unlikely to reveal that it’s happened to them unless they happen to have had a good outcome” she said. “All we know is that we’re hearing more and more about it, and that might be because people are becoming more open and outraged when it happens. It’s quite easy for anyone in a hospital environment or in an office environment, for a competitor, a coworker, or even a disgruntled patient to allege a physician has ‘glazed eyes’ or ‘alcohol on the breath,’ and that’s all it takes to start the ball rolling.”

If you are falsely accused of being impaired at work or are suddenly confronted with a complaint, the first step is to remain calm, said Kernan Manion, MD, executive director for the Center for Physician Rights, a nonprofit organization that assists physicians who have been subject to unfair medical board, health program, or peer review processes.

“The first thing is to keep your wits about you,” he said, “because often, docs get frightened or angry, and they overact. You have to gain your composure and ask for documentation about the nature of the allegation.”

Obtain in writing any and all information that supports the allegation. Physicians who are asked to report to a physician health program should ask the reason they are being referred and whether it is for a medical evaluation or another type of evaluation, he said. If it’s a medical reason, the process needs to follow medical parameters in terms of confidentiality.

“The bottom line is that a doctor should not take everything at face value and follow the organization’s orders unquestioning,” Dr. Manion said. “They have a right to get their concerns addressed.”

Physicians who are accused of using substances on duty or being under the influence while working have to right to undergo testing immediately, Dr. Andrew said.

“If you’re told on the spot: ‘You need to submit to testing,’ then you should do it, but make sure it’s done properly,” she said. “Ensure that forensically, you give two samples and that they are sealed and the chain of evidence is maintained. The reason for that is if one of them is a false positive, the second one can be reviewed separately.”

If administrators do not allow for prompt testing, get yourself tested immediately on your own, she said.

As far as leaves of absence are concerned, ensure you know what type of leave is being executed, Dr. Manion said. Ask the nature of the leave and whether the leave counts as a suspension that will go against your medical license and be reportable to the NPDB. In such cases, the only reason to suspend a doctor’s privileges is because they are considered a danger to others, or, in other words, there’s been an allegation of unsafe care.

“If there is an allegation of unsafe care, the physician should ask for documentation of the patient safety issues in question and why they are being deemed unsafe to practice,” he said.

Ms. DeLaney recommended physicians not report to or communicate with any state medical association, physician health foundation, or licensing authority without first getting legal advice.

In addition, doctors will likely be tested for acute and long-term drug and alcohol use, so it’s a good idea to avoid any activity or substances that could result in a dilute sample or a positive result on a drug or alcohol test, she said.

As for broader solutions, it’s important that more physicians come out of the shadows and tell their stories when these injustices take place, said Dr. Andrew.

“Doctors need to be more open about this when it happens, which is not easy,” she said. “More need to be suing, which is certainly not cheap. Also, when they do come to settlements, they should not sign nondisclosure agreements so that they can talk about what happened and it can be publicized. This way, more doctors are aware of the types of tactics used against physicians and what other doctors have done that can help.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared Beta Bionics’s iLet ACE Pump and the iLet Dosing Decision Software for people ages 6 years and older with type 1 diabetes.
 

Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.

Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.

In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).

The FDA had granted the iLet a breakthrough device designation in December 2019.

Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.

Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”

That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”

On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”

The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared Beta Bionics’s iLet ACE Pump and the iLet Dosing Decision Software for people ages 6 years and older with type 1 diabetes.
 

Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.

Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.

In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).

The FDA had granted the iLet a breakthrough device designation in December 2019.

Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.

Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”

That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”

On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”

The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared Beta Bionics’s iLet ACE Pump and the iLet Dosing Decision Software for people ages 6 years and older with type 1 diabetes.
 

Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.

Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.

In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).

The FDA had granted the iLet a breakthrough device designation in December 2019.

Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.

Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”

That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”

On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”

The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.

A version of this article first appeared on Medscape.com.

A new study urges people to continue wearing protective masks in medical settings, even though the U.S. public health emergency declaration around COVID-19 has expired.

Masks continue to lower the risk of catching the virus during medical visits, according to the study, published in Annals of Internal Medicine. And there was not much difference between wearing surgical masks and N95 respirators in health care settings.

The researchers reviewed 3 randomized trials and 21 observational studies to compare the effectiveness of those and cloth masks in reducing COVID-19 transmission.

“Masking in interactions between patients and health care personnel should continue to receive serious consideration as a patient safety measure,” Tara N. Palmore, MD, of George Washington University, Washington, and David K. Henderson, MD, of the National Institutes of Health, Bethesda, Md., wrote in an opinion article accompanying the study.

“In our enthusiasm to return to the appearance and feeling of normalcy, and as institutions decide which mitigation strategies to discontinue, we strongly advocate not discarding this important lesson learned for the sake of our patients’ safety,” Dr. Palmore and Dr. Henderson wrote.

Surgical masks limit the spread of aerosols and droplets from people who have the flu, coronaviruses or other respiratory viruses, CNN reported. And while masks are not 100% effective, they substantially lower the amount of virus put into the air via coughing and talking.

The study said one reason people should wear masks to medical settings is because “health care personnel are notorious for coming to work while ill.” Transmission from patient to staff and staff to patient is still possible, but rare, when both are masked.

The review authors reported no conflicts of interest. Dr. Palmore has received grants from the NIH, Rigel, Gilead, and AbbVie, and Dr. Henderson is a past president of the Society for Healthcare Epidemiology of America.

A version of this article first appeared on WebMD.com.

A new study urges people to continue wearing protective masks in medical settings, even though the U.S. public health emergency declaration around COVID-19 has expired.

Masks continue to lower the risk of catching the virus during medical visits, according to the study, published in Annals of Internal Medicine. And there was not much difference between wearing surgical masks and N95 respirators in health care settings.

The researchers reviewed 3 randomized trials and 21 observational studies to compare the effectiveness of those and cloth masks in reducing COVID-19 transmission.

“Masking in interactions between patients and health care personnel should continue to receive serious consideration as a patient safety measure,” Tara N. Palmore, MD, of George Washington University, Washington, and David K. Henderson, MD, of the National Institutes of Health, Bethesda, Md., wrote in an opinion article accompanying the study.

“In our enthusiasm to return to the appearance and feeling of normalcy, and as institutions decide which mitigation strategies to discontinue, we strongly advocate not discarding this important lesson learned for the sake of our patients’ safety,” Dr. Palmore and Dr. Henderson wrote.

Surgical masks limit the spread of aerosols and droplets from people who have the flu, coronaviruses or other respiratory viruses, CNN reported. And while masks are not 100% effective, they substantially lower the amount of virus put into the air via coughing and talking.

The study said one reason people should wear masks to medical settings is because “health care personnel are notorious for coming to work while ill.” Transmission from patient to staff and staff to patient is still possible, but rare, when both are masked.

The review authors reported no conflicts of interest. Dr. Palmore has received grants from the NIH, Rigel, Gilead, and AbbVie, and Dr. Henderson is a past president of the Society for Healthcare Epidemiology of America.

A version of this article first appeared on WebMD.com.

A new study urges people to continue wearing protective masks in medical settings, even though the U.S. public health emergency declaration around COVID-19 has expired.

Masks continue to lower the risk of catching the virus during medical visits, according to the study, published in Annals of Internal Medicine. And there was not much difference between wearing surgical masks and N95 respirators in health care settings.

The researchers reviewed 3 randomized trials and 21 observational studies to compare the effectiveness of those and cloth masks in reducing COVID-19 transmission.

“Masking in interactions between patients and health care personnel should continue to receive serious consideration as a patient safety measure,” Tara N. Palmore, MD, of George Washington University, Washington, and David K. Henderson, MD, of the National Institutes of Health, Bethesda, Md., wrote in an opinion article accompanying the study.

“In our enthusiasm to return to the appearance and feeling of normalcy, and as institutions decide which mitigation strategies to discontinue, we strongly advocate not discarding this important lesson learned for the sake of our patients’ safety,” Dr. Palmore and Dr. Henderson wrote.

Surgical masks limit the spread of aerosols and droplets from people who have the flu, coronaviruses or other respiratory viruses, CNN reported. And while masks are not 100% effective, they substantially lower the amount of virus put into the air via coughing and talking.

The study said one reason people should wear masks to medical settings is because “health care personnel are notorious for coming to work while ill.” Transmission from patient to staff and staff to patient is still possible, but rare, when both are masked.

The review authors reported no conflicts of interest. Dr. Palmore has received grants from the NIH, Rigel, Gilead, and AbbVie, and Dr. Henderson is a past president of the Society for Healthcare Epidemiology of America.

A version of this article first appeared on WebMD.com.

The Federal Trade Commission’s proposed regulation that would ban noncompete agreements across the country seems like potential good news for doctors. Of course, many hospitals and employers are against it. As a result, the FTC’s sweeping proposal has tongues wagging on both sides of the issue.

Many physicians are thrilled that they may soon have more control over their career and not be stuck in jobs where they feel frustrated, underpaid, or blocked in their progress.

If passed, the proposed ban would allow physicians to get a new job with a competing organization, bucking a long-standing trend that hospitals and health care systems have heavily relied on to keep staff in place. As of 2018, as many as 45% of primary care physicians had inked such agreements with their employers.

Typically, the agreements prevent physicians from practicing medicine with a new employer for a defined period within a specific geographic area. No matter how attractive an alternate offer of employment might be, doctors are bound by the agreements to say no if the offer exists in that defined area and time period.

The period for public comment on the proposed regulation ended on April 19, and there is currently no set date for a decision.

In a Medscape poll of 558 physicians, more than 9 out of 10 respondents said that they were either currently bound by a noncompete clause or that they had been bound by one in the past that had forced them to temporarily stop working, commute long distances, move to a different area, or switch fields.

The new proposal would make it illegal for an employer, such as a hospital or large group, to enter a noncompete with a worker; maintain a noncompete with a worker; or represent to a worker, under certain circumstances, that the worker is subject to a noncompete.

It also would not only ban future noncompete agreements but also retroactively invalidate existing ones. The FTC reasons that noncompete clauses could potentially increase worker earnings as well as lower health care costs by billions of dollars. If the ruling were to move forward, it would represent part of President Biden’s “worker-forward” priorities, focusing on how competition can be a good thing for employees. The President billed the FTC’s announcement as a “huge win for workers.”

In its statements on the proposed ban, the FTC claimed that it could lower consumer prices across the board by as much as $150 billion per year and return nearly $300 million to workers each year.

However, even if passed, the draft rule would keep in place nonsolicitation rules that many health care organizations have put into place. That means that, if a physician leaves an employer, he or she cannot reach out to former patients and colleagues to bring them along or invite them to switch to him or her in the new job.

Within that clause, however, the FTC has specified that if such nonsolicitation agreement has the “equivalent effect” of a noncompete, the agency would deem it such. That means, even if that rule stays, it could be contested and may be interpreted as violating the noncompete law. So there’s value in reading all the fine print should the ban move forward.
 

Could the ban bring potential downsides?

Most physicians view the potential to break free of a noncompete agreement as a victory. Peter Glennon, an employment litigation attorney with The Glennon Law Firm in Rochester, N.Y., says not so fast. “If you ask anyone if they’d prefer a noncompete agreement, of course they’re going to say no,” he said in an interview. “It sounds like a restriction, one that can hold you back.”

Mr. Glennon believes that there are actually upsides to physician noncompetes. For instance, many noncompetes come with sign-on bonuses that could potentially disappear without the agreements. There’s also the fact that when some physicians sign a noncompete agreement, they then receive pro bono training and continuing education along with marketing and promotion of their skills. Without signing a noncompete, employers may be less incentivized to provide all those benefits to their physician employers.

Those benefits – and the noncompetes – also vary by specialty, Mr. Glennon said. “In 2021, Washington, DC, banned noncompetes for doctors making less than $250,000. So, most generalists there can walk across the street and get a new job. For specialists like cardiologists or neurosurgeons, however, advanced training and marketing benefits matter, so many of them don’t want to lose noncompetes.”

Still, most physicians hope that the FTC’s ban takes hold. Manan Shah, MD, founder, and chief medical officer at Wyndly, an allergy relief startup practice, is one of them.

“Initially, it might disincentivize hospital systems from helping new physicians build up their name and practice because they might be concerned about a physician leaving and starting anew,” he said. “But in the long term, hospitals require physicians to bring their patients to them for care, so the best hospitals will always compete for the best physicians and support them as they build up their practice.”

Dr. Shah views noncompetes as overly prohibitive to physicians. “Right now, if a physician starts a job at a large hospital system and realizes they want to switch jobs, the noncompete distances are so wide they often have to move cities to continue practicing,” he said. “Picking up and starting over in a new city isn’t an option for everyone and can be especially difficult for someone with a family.”

Where Mr. Glennon argued that a physician leaving a team-based practice might harm patients, Shah takes a different perspective. “Imagine you have a doctor whom you trust and have been working with,” he said. “If something changes at their hospital and they decide to move, you literally have to find a new doctor instead of just being able to see them at another location down the street.”

Another potential burden of the noncompete agreements is that they could possibly squelch doctor’s desires to hang up their own shingle. According to Dr. Shah, the agreements make it so that if a physician wants to work independently, it’s nearly impossible to fly solo. “This is frustrating because independent practices have been shown to be more cost effective and allow patients to build better relationships with their doctors,” he claimed.

A 2016 study from Annals of Family Medicine supports that claim, at least for small general practices. Another study appearing in JAMA concurred. It does point out, however, that the cost equation is nuanced and that benefits of larger systems include more resilience to economic downturns and can provide more specialized care.
 

Will nonprofit hospitals be subject to this noncompete ban?

Further complicating the noncompete ban issue is how it might impact nonprofit institutions versus their for-profit peers. Most hospitals structured as nonprofits would be exempt from the rule because the FTC Act provides that it can enforce against “persons, partnerships, or corporations,” which are further defined as entities “organized to carry on business for their own profit or that of their members.”

The fallout from this, said Dr. Shah, is that it “would disproportionately affect health care providers, since many hospital systems are nonprofits. This is disconcerting because we know that many nonprofit systems make large profits anyway and can offer executive teams’ lucrative packages, while the nurses, assistants, and physicians providing the care are generally not well compensated.”

So far, about nine states plus Washington, D.C., have already put noncompete bans in place, and they may serve as a harbinger of things to come should the federal ban go into effect. Each varies in its specifics. Some, like Indiana, outright ban them, whereas others limit them based on variables like income and industry. “We’re seeing these states responding to local market conditions,” said Darryl Drevna, senior director of regulatory affairs at the American Medical Group Association. “Health care is a hyperlocal market. Depending on the situation, the bans adapt and respond specific to those states.”

Should the federal ban take hold, however, it will supersede whatever rules the individual states have in place.

Some opponents of the federal ban proposal question its authority to begin with, however, Mr. Glennon included. “Many people believe the FTC is overstepping,” he said. “Some people believe that Section 5 of the FTC Act does not give it the authority to police labor markets.”

Mr. Drevna noted that the FTC has taken an aggressive stance, one that will ultimately wind up in the courts. “How it works out is anyone’s guess,” he said. “Ideally, the FTC will consider the comments and concerns of groups like AMGA and realize that states are best suited to regulate in this area.”

In general, the ban’s supporters are employees/physicians; those who oppose it are their employers. Joining the AMGA in speaking out against the noncompete ban is the American Hospital Association, whereas the American College of Emergency Physicians has come out largely in support of the ban.

Still, doctors like Dr. Shah remain hopeful. “I am optimistic that perhaps my colleagues will not continue to be stuck in overrestrictive noncompetes, but I am also realistic,” he said. “Hospital systems are already coming out strongly against this and they have deep pockets, so I won’t be surprised if it does not come to pass.”

A version of this article first appeared on Medscape.com.

The Federal Trade Commission’s proposed regulation that would ban noncompete agreements across the country seems like potential good news for doctors. Of course, many hospitals and employers are against it. As a result, the FTC’s sweeping proposal has tongues wagging on both sides of the issue.

Many physicians are thrilled that they may soon have more control over their career and not be stuck in jobs where they feel frustrated, underpaid, or blocked in their progress.

If passed, the proposed ban would allow physicians to get a new job with a competing organization, bucking a long-standing trend that hospitals and health care systems have heavily relied on to keep staff in place. As of 2018, as many as 45% of primary care physicians had inked such agreements with their employers.

Typically, the agreements prevent physicians from practicing medicine with a new employer for a defined period within a specific geographic area. No matter how attractive an alternate offer of employment might be, doctors are bound by the agreements to say no if the offer exists in that defined area and time period.

The period for public comment on the proposed regulation ended on April 19, and there is currently no set date for a decision.

In a Medscape poll of 558 physicians, more than 9 out of 10 respondents said that they were either currently bound by a noncompete clause or that they had been bound by one in the past that had forced them to temporarily stop working, commute long distances, move to a different area, or switch fields.

The new proposal would make it illegal for an employer, such as a hospital or large group, to enter a noncompete with a worker; maintain a noncompete with a worker; or represent to a worker, under certain circumstances, that the worker is subject to a noncompete.

It also would not only ban future noncompete agreements but also retroactively invalidate existing ones. The FTC reasons that noncompete clauses could potentially increase worker earnings as well as lower health care costs by billions of dollars. If the ruling were to move forward, it would represent part of President Biden’s “worker-forward” priorities, focusing on how competition can be a good thing for employees. The President billed the FTC’s announcement as a “huge win for workers.”

In its statements on the proposed ban, the FTC claimed that it could lower consumer prices across the board by as much as $150 billion per year and return nearly $300 million to workers each year.

However, even if passed, the draft rule would keep in place nonsolicitation rules that many health care organizations have put into place. That means that, if a physician leaves an employer, he or she cannot reach out to former patients and colleagues to bring them along or invite them to switch to him or her in the new job.

Within that clause, however, the FTC has specified that if such nonsolicitation agreement has the “equivalent effect” of a noncompete, the agency would deem it such. That means, even if that rule stays, it could be contested and may be interpreted as violating the noncompete law. So there’s value in reading all the fine print should the ban move forward.
 

Could the ban bring potential downsides?

Most physicians view the potential to break free of a noncompete agreement as a victory. Peter Glennon, an employment litigation attorney with The Glennon Law Firm in Rochester, N.Y., says not so fast. “If you ask anyone if they’d prefer a noncompete agreement, of course they’re going to say no,” he said in an interview. “It sounds like a restriction, one that can hold you back.”

Mr. Glennon believes that there are actually upsides to physician noncompetes. For instance, many noncompetes come with sign-on bonuses that could potentially disappear without the agreements. There’s also the fact that when some physicians sign a noncompete agreement, they then receive pro bono training and continuing education along with marketing and promotion of their skills. Without signing a noncompete, employers may be less incentivized to provide all those benefits to their physician employers.

Those benefits – and the noncompetes – also vary by specialty, Mr. Glennon said. “In 2021, Washington, DC, banned noncompetes for doctors making less than $250,000. So, most generalists there can walk across the street and get a new job. For specialists like cardiologists or neurosurgeons, however, advanced training and marketing benefits matter, so many of them don’t want to lose noncompetes.”

Still, most physicians hope that the FTC’s ban takes hold. Manan Shah, MD, founder, and chief medical officer at Wyndly, an allergy relief startup practice, is one of them.

“Initially, it might disincentivize hospital systems from helping new physicians build up their name and practice because they might be concerned about a physician leaving and starting anew,” he said. “But in the long term, hospitals require physicians to bring their patients to them for care, so the best hospitals will always compete for the best physicians and support them as they build up their practice.”

Dr. Shah views noncompetes as overly prohibitive to physicians. “Right now, if a physician starts a job at a large hospital system and realizes they want to switch jobs, the noncompete distances are so wide they often have to move cities to continue practicing,” he said. “Picking up and starting over in a new city isn’t an option for everyone and can be especially difficult for someone with a family.”

Where Mr. Glennon argued that a physician leaving a team-based practice might harm patients, Shah takes a different perspective. “Imagine you have a doctor whom you trust and have been working with,” he said. “If something changes at their hospital and they decide to move, you literally have to find a new doctor instead of just being able to see them at another location down the street.”

Another potential burden of the noncompete agreements is that they could possibly squelch doctor’s desires to hang up their own shingle. According to Dr. Shah, the agreements make it so that if a physician wants to work independently, it’s nearly impossible to fly solo. “This is frustrating because independent practices have been shown to be more cost effective and allow patients to build better relationships with their doctors,” he claimed.

A 2016 study from Annals of Family Medicine supports that claim, at least for small general practices. Another study appearing in JAMA concurred. It does point out, however, that the cost equation is nuanced and that benefits of larger systems include more resilience to economic downturns and can provide more specialized care.
 

Will nonprofit hospitals be subject to this noncompete ban?

Further complicating the noncompete ban issue is how it might impact nonprofit institutions versus their for-profit peers. Most hospitals structured as nonprofits would be exempt from the rule because the FTC Act provides that it can enforce against “persons, partnerships, or corporations,” which are further defined as entities “organized to carry on business for their own profit or that of their members.”

The fallout from this, said Dr. Shah, is that it “would disproportionately affect health care providers, since many hospital systems are nonprofits. This is disconcerting because we know that many nonprofit systems make large profits anyway and can offer executive teams’ lucrative packages, while the nurses, assistants, and physicians providing the care are generally not well compensated.”

So far, about nine states plus Washington, D.C., have already put noncompete bans in place, and they may serve as a harbinger of things to come should the federal ban go into effect. Each varies in its specifics. Some, like Indiana, outright ban them, whereas others limit them based on variables like income and industry. “We’re seeing these states responding to local market conditions,” said Darryl Drevna, senior director of regulatory affairs at the American Medical Group Association. “Health care is a hyperlocal market. Depending on the situation, the bans adapt and respond specific to those states.”

Should the federal ban take hold, however, it will supersede whatever rules the individual states have in place.

Some opponents of the federal ban proposal question its authority to begin with, however, Mr. Glennon included. “Many people believe the FTC is overstepping,” he said. “Some people believe that Section 5 of the FTC Act does not give it the authority to police labor markets.”

Mr. Drevna noted that the FTC has taken an aggressive stance, one that will ultimately wind up in the courts. “How it works out is anyone’s guess,” he said. “Ideally, the FTC will consider the comments and concerns of groups like AMGA and realize that states are best suited to regulate in this area.”

In general, the ban’s supporters are employees/physicians; those who oppose it are their employers. Joining the AMGA in speaking out against the noncompete ban is the American Hospital Association, whereas the American College of Emergency Physicians has come out largely in support of the ban.

Still, doctors like Dr. Shah remain hopeful. “I am optimistic that perhaps my colleagues will not continue to be stuck in overrestrictive noncompetes, but I am also realistic,” he said. “Hospital systems are already coming out strongly against this and they have deep pockets, so I won’t be surprised if it does not come to pass.”

A version of this article first appeared on Medscape.com.

The Federal Trade Commission’s proposed regulation that would ban noncompete agreements across the country seems like potential good news for doctors. Of course, many hospitals and employers are against it. As a result, the FTC’s sweeping proposal has tongues wagging on both sides of the issue.

Many physicians are thrilled that they may soon have more control over their career and not be stuck in jobs where they feel frustrated, underpaid, or blocked in their progress.

If passed, the proposed ban would allow physicians to get a new job with a competing organization, bucking a long-standing trend that hospitals and health care systems have heavily relied on to keep staff in place. As of 2018, as many as 45% of primary care physicians had inked such agreements with their employers.

Typically, the agreements prevent physicians from practicing medicine with a new employer for a defined period within a specific geographic area. No matter how attractive an alternate offer of employment might be, doctors are bound by the agreements to say no if the offer exists in that defined area and time period.

The period for public comment on the proposed regulation ended on April 19, and there is currently no set date for a decision.

In a Medscape poll of 558 physicians, more than 9 out of 10 respondents said that they were either currently bound by a noncompete clause or that they had been bound by one in the past that had forced them to temporarily stop working, commute long distances, move to a different area, or switch fields.

The new proposal would make it illegal for an employer, such as a hospital or large group, to enter a noncompete with a worker; maintain a noncompete with a worker; or represent to a worker, under certain circumstances, that the worker is subject to a noncompete.

It also would not only ban future noncompete agreements but also retroactively invalidate existing ones. The FTC reasons that noncompete clauses could potentially increase worker earnings as well as lower health care costs by billions of dollars. If the ruling were to move forward, it would represent part of President Biden’s “worker-forward” priorities, focusing on how competition can be a good thing for employees. The President billed the FTC’s announcement as a “huge win for workers.”

In its statements on the proposed ban, the FTC claimed that it could lower consumer prices across the board by as much as $150 billion per year and return nearly $300 million to workers each year.

However, even if passed, the draft rule would keep in place nonsolicitation rules that many health care organizations have put into place. That means that, if a physician leaves an employer, he or she cannot reach out to former patients and colleagues to bring them along or invite them to switch to him or her in the new job.

Within that clause, however, the FTC has specified that if such nonsolicitation agreement has the “equivalent effect” of a noncompete, the agency would deem it such. That means, even if that rule stays, it could be contested and may be interpreted as violating the noncompete law. So there’s value in reading all the fine print should the ban move forward.
 

Could the ban bring potential downsides?

Most physicians view the potential to break free of a noncompete agreement as a victory. Peter Glennon, an employment litigation attorney with The Glennon Law Firm in Rochester, N.Y., says not so fast. “If you ask anyone if they’d prefer a noncompete agreement, of course they’re going to say no,” he said in an interview. “It sounds like a restriction, one that can hold you back.”

Mr. Glennon believes that there are actually upsides to physician noncompetes. For instance, many noncompetes come with sign-on bonuses that could potentially disappear without the agreements. There’s also the fact that when some physicians sign a noncompete agreement, they then receive pro bono training and continuing education along with marketing and promotion of their skills. Without signing a noncompete, employers may be less incentivized to provide all those benefits to their physician employers.

Those benefits – and the noncompetes – also vary by specialty, Mr. Glennon said. “In 2021, Washington, DC, banned noncompetes for doctors making less than $250,000. So, most generalists there can walk across the street and get a new job. For specialists like cardiologists or neurosurgeons, however, advanced training and marketing benefits matter, so many of them don’t want to lose noncompetes.”

Still, most physicians hope that the FTC’s ban takes hold. Manan Shah, MD, founder, and chief medical officer at Wyndly, an allergy relief startup practice, is one of them.

“Initially, it might disincentivize hospital systems from helping new physicians build up their name and practice because they might be concerned about a physician leaving and starting anew,” he said. “But in the long term, hospitals require physicians to bring their patients to them for care, so the best hospitals will always compete for the best physicians and support them as they build up their practice.”

Dr. Shah views noncompetes as overly prohibitive to physicians. “Right now, if a physician starts a job at a large hospital system and realizes they want to switch jobs, the noncompete distances are so wide they often have to move cities to continue practicing,” he said. “Picking up and starting over in a new city isn’t an option for everyone and can be especially difficult for someone with a family.”

Where Mr. Glennon argued that a physician leaving a team-based practice might harm patients, Shah takes a different perspective. “Imagine you have a doctor whom you trust and have been working with,” he said. “If something changes at their hospital and they decide to move, you literally have to find a new doctor instead of just being able to see them at another location down the street.”

Another potential burden of the noncompete agreements is that they could possibly squelch doctor’s desires to hang up their own shingle. According to Dr. Shah, the agreements make it so that if a physician wants to work independently, it’s nearly impossible to fly solo. “This is frustrating because independent practices have been shown to be more cost effective and allow patients to build better relationships with their doctors,” he claimed.

A 2016 study from Annals of Family Medicine supports that claim, at least for small general practices. Another study appearing in JAMA concurred. It does point out, however, that the cost equation is nuanced and that benefits of larger systems include more resilience to economic downturns and can provide more specialized care.
 

Will nonprofit hospitals be subject to this noncompete ban?

Further complicating the noncompete ban issue is how it might impact nonprofit institutions versus their for-profit peers. Most hospitals structured as nonprofits would be exempt from the rule because the FTC Act provides that it can enforce against “persons, partnerships, or corporations,” which are further defined as entities “organized to carry on business for their own profit or that of their members.”

The fallout from this, said Dr. Shah, is that it “would disproportionately affect health care providers, since many hospital systems are nonprofits. This is disconcerting because we know that many nonprofit systems make large profits anyway and can offer executive teams’ lucrative packages, while the nurses, assistants, and physicians providing the care are generally not well compensated.”

So far, about nine states plus Washington, D.C., have already put noncompete bans in place, and they may serve as a harbinger of things to come should the federal ban go into effect. Each varies in its specifics. Some, like Indiana, outright ban them, whereas others limit them based on variables like income and industry. “We’re seeing these states responding to local market conditions,” said Darryl Drevna, senior director of regulatory affairs at the American Medical Group Association. “Health care is a hyperlocal market. Depending on the situation, the bans adapt and respond specific to those states.”

Should the federal ban take hold, however, it will supersede whatever rules the individual states have in place.

Some opponents of the federal ban proposal question its authority to begin with, however, Mr. Glennon included. “Many people believe the FTC is overstepping,” he said. “Some people believe that Section 5 of the FTC Act does not give it the authority to police labor markets.”

Mr. Drevna noted that the FTC has taken an aggressive stance, one that will ultimately wind up in the courts. “How it works out is anyone’s guess,” he said. “Ideally, the FTC will consider the comments and concerns of groups like AMGA and realize that states are best suited to regulate in this area.”

In general, the ban’s supporters are employees/physicians; those who oppose it are their employers. Joining the AMGA in speaking out against the noncompete ban is the American Hospital Association, whereas the American College of Emergency Physicians has come out largely in support of the ban.

Still, doctors like Dr. Shah remain hopeful. “I am optimistic that perhaps my colleagues will not continue to be stuck in overrestrictive noncompetes, but I am also realistic,” he said. “Hospital systems are already coming out strongly against this and they have deep pockets, so I won’t be surprised if it does not come to pass.”

A version of this article first appeared on Medscape.com.