WASHINGTON – Genetic developments may create a new medical model for patients with rare diseases and the doctors who treat them, according to Marshall Summar, MD, chief of genetics and metabolism at Children’s National Medical Center in Washington, D.C.

In an interview at the NORD Rare Summit, held by the National Organization for Rare Disorders, Dr. Summar and Peter L. Saltonstall, president and CEO of NORD, discussed hot topics in the rare disease field. Those include new knowledge of the natural history of rare diseases, made possible by the creation of patient databases and the expansion of genetic technology. In addition, some DNA therapies “are finally crossing the finish line,” said Dr. Summar. That means clinicians will be looking at some rare diseases as acute conditions rather than chronic.

However, patients with rare diseases continue to face challenges in terms of the need for prior authorization and for drug access. One of NORD’s missions is to help patients access treatment. “We are seeing these prior authorizations take weeks or even longer,” Mr. Saltonstall said – and meanwhile, patients aren’t receiving therapy.

Visit rarediseases.org for more information about NORD’s ongoing research and advocacy efforts.

Dr. Summar and Mr. Saltonstall had no financial conflicts to disclose.

WASHINGTON – Genetic developments may create a new medical model for patients with rare diseases and the doctors who treat them, according to Marshall Summar, MD, chief of genetics and metabolism at Children’s National Medical Center in Washington, D.C.

In an interview at the NORD Rare Summit, held by the National Organization for Rare Disorders, Dr. Summar and Peter L. Saltonstall, president and CEO of NORD, discussed hot topics in the rare disease field. Those include new knowledge of the natural history of rare diseases, made possible by the creation of patient databases and the expansion of genetic technology. In addition, some DNA therapies “are finally crossing the finish line,” said Dr. Summar. That means clinicians will be looking at some rare diseases as acute conditions rather than chronic.

However, patients with rare diseases continue to face challenges in terms of the need for prior authorization and for drug access. One of NORD’s missions is to help patients access treatment. “We are seeing these prior authorizations take weeks or even longer,” Mr. Saltonstall said – and meanwhile, patients aren’t receiving therapy.

Visit rarediseases.org for more information about NORD’s ongoing research and advocacy efforts.

Dr. Summar and Mr. Saltonstall had no financial conflicts to disclose.

WASHINGTON – Genetic developments may create a new medical model for patients with rare diseases and the doctors who treat them, according to Marshall Summar, MD, chief of genetics and metabolism at Children’s National Medical Center in Washington, D.C.

In an interview at the NORD Rare Summit, held by the National Organization for Rare Disorders, Dr. Summar and Peter L. Saltonstall, president and CEO of NORD, discussed hot topics in the rare disease field. Those include new knowledge of the natural history of rare diseases, made possible by the creation of patient databases and the expansion of genetic technology. In addition, some DNA therapies “are finally crossing the finish line,” said Dr. Summar. That means clinicians will be looking at some rare diseases as acute conditions rather than chronic.

However, patients with rare diseases continue to face challenges in terms of the need for prior authorization and for drug access. One of NORD’s missions is to help patients access treatment. “We are seeing these prior authorizations take weeks or even longer,” Mr. Saltonstall said – and meanwhile, patients aren’t receiving therapy.

Visit rarediseases.org for more information about NORD’s ongoing research and advocacy efforts.

Dr. Summar and Mr. Saltonstall had no financial conflicts to disclose.

WASHINGTON – Physicians in primary and specialty care can provide guidance and support to patients with rare diseases by educating themselves about the resources available, according to Tim Boyd, director of state policy for the National Organization for Rare Disorders (NORD).

In an interview at the NORD Rare Summit, held by the National Organization for Rare Disorders, Mr. Boyd and Melinda Burnworth, PharmD, a pharmacist and NORD state volunteer from Arizona, discussed challenges faced by patients with rare diseases, including securing a correct diagnosis, accessing medication, and managing treatment going forward.

Physicians who understand some of the barriers to medication access can help advocate for their patients, explained Mr. Boyd, and those who know about resources for rare disorders can help make a diagnosis.

“All health care providers have an opportunity to enhance care for patients with rare disorders,” said Dr. Burnworth, author of the Rare Disease eResource Guide, available through the American Society of Health-System Pharmacists. Visit rarediseases.org for more information about NORD’s ongoing research and advocacy efforts.

Mr. Boyd and Dr. Burnworth had no financial conflicts to disclose.

WASHINGTON – Physicians in primary and specialty care can provide guidance and support to patients with rare diseases by educating themselves about the resources available, according to Tim Boyd, director of state policy for the National Organization for Rare Disorders (NORD).

In an interview at the NORD Rare Summit, held by the National Organization for Rare Disorders, Mr. Boyd and Melinda Burnworth, PharmD, a pharmacist and NORD state volunteer from Arizona, discussed challenges faced by patients with rare diseases, including securing a correct diagnosis, accessing medication, and managing treatment going forward.

Physicians who understand some of the barriers to medication access can help advocate for their patients, explained Mr. Boyd, and those who know about resources for rare disorders can help make a diagnosis.

“All health care providers have an opportunity to enhance care for patients with rare disorders,” said Dr. Burnworth, author of the Rare Disease eResource Guide, available through the American Society of Health-System Pharmacists. Visit rarediseases.org for more information about NORD’s ongoing research and advocacy efforts.

Mr. Boyd and Dr. Burnworth had no financial conflicts to disclose.

WASHINGTON – Physicians in primary and specialty care can provide guidance and support to patients with rare diseases by educating themselves about the resources available, according to Tim Boyd, director of state policy for the National Organization for Rare Disorders (NORD).

In an interview at the NORD Rare Summit, held by the National Organization for Rare Disorders, Mr. Boyd and Melinda Burnworth, PharmD, a pharmacist and NORD state volunteer from Arizona, discussed challenges faced by patients with rare diseases, including securing a correct diagnosis, accessing medication, and managing treatment going forward.

Physicians who understand some of the barriers to medication access can help advocate for their patients, explained Mr. Boyd, and those who know about resources for rare disorders can help make a diagnosis.

“All health care providers have an opportunity to enhance care for patients with rare disorders,” said Dr. Burnworth, author of the Rare Disease eResource Guide, available through the American Society of Health-System Pharmacists. Visit rarediseases.org for more information about NORD’s ongoing research and advocacy efforts.

Mr. Boyd and Dr. Burnworth had no financial conflicts to disclose.

Laparoscopic gynecologic surgery is associated with a significantly lower risk of postoperative venous thromboembolism (VTE) than laparotomy, according to a study published in Obstetrics & Gynecology.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

The retrospective cohort study looked at data from 37,485 patients who underwent 43,751 gynecologic surgical procedures, including hysterectomy and myomectomy, at two tertiary care academic hospitals.

Overall, 96 patients (0.2%) were diagnosed with postoperative venous thromboembolism. However patients who underwent laparoscopic or vaginal surgery had a significant 78% and 93% lower risk of venous thromboembolism, respectively, than those who underwent laparotomy, even after adjusting for potential confounders such as age, cancer, race, pharmacologic thromboprophylaxis, and surgical time.

The incidence of postoperative thromboembolism was significantly higher among patients undergoing gynecologic surgery for cancer (1.1%). The incidence among those undergoing surgery for benign indications was only 0.2%, and the highest incidence was among patients with cancer who underwent laparotomy (2.2%).

“This study adds to data demonstrating that venous thromboembolism is rare in gynecologic surgery, particularly when a patient undergoes a minimally invasive procedure for benign indications,” wrote Dr. Elisa M. Jorgensen of Beth Israel Deaconess Medical Center, and her coauthors.

Among the 8,273 patients who underwent a hysterectomy, there were 55 cases of venous thromboembolism – representing an 0.7% incidence. However patients who underwent laparotomy had a 1% incidence of postoperative venous thromboembolism, while those who underwent laparoscopic hysterectomy had an 0.3% incidence and those who underwent vaginal hysterectomy had an 0.1% incidence.

Laparotomy was the most common mode of surgery for hysterectomy – accounting for 57% of operations – while 34% were laparoscopic and 9% were vaginal.

However, the authors noted that the use of laparoscopy increased and laparotomy declined over the 9 years of the study. In 2006, 12% of hysterectomies were laparoscopic, compared with 55% in 2015, while over that same period the percentage of laparotomies dropped from 74% to 41%, and the percentage of vaginal procedures declined from 14% to 4%.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

“Because current practice guidelines do not account for mode of surgery, we find them to be insufficient for the modern gynecologic surgeon to counsel patients on their individual venous thromboembolism risk or to make ideal decisions regarding selection of thromboprophylaxis,” Dr. Jorgenson and her associates wrote.

Only 5 patients of the 2,851 who underwent myomectomy developed postoperative VTE – an overall incidence of 0.2% – and the authors said numbers were too small to analyze. Vaginal or hysteroscopic myomectomy was the most common surgical method, accounting for 62% of procedures, compared with 23% for laparotomies and 15% for laparoscopies.

More than 90% of patients who experienced postoperative thromboembolism had received some form of thromboprophylaxis before surgery, either mechanical, pharmacologic, or both. In comparison, only 55% of the group who didn’t experience thromboembolism had received thromboprophylaxis.

“The high rate of prophylaxis among patients who developed postoperative venous thromboembolism may reflect surgeons’ abilities to preoperatively identify patients at increased risk, guiding appropriate selection of thromboprophylaxis,” Dr. Jorgenson and her associates wrote.

Addressing the study’s limitations, the authors noted that they were not able to capture data on patients’ body mass index and also were unable to account for patients who might have been diagnosed and treated for postoperative VTE at other hospitals.

No conflicts of interest were declared.

SOURCE: Jorgensen EM et al. Obstet Gynecol. 2018 Nov;132:1275-84.

Laparoscopic gynecologic surgery is associated with a significantly lower risk of postoperative venous thromboembolism (VTE) than laparotomy, according to a study published in Obstetrics & Gynecology.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

The retrospective cohort study looked at data from 37,485 patients who underwent 43,751 gynecologic surgical procedures, including hysterectomy and myomectomy, at two tertiary care academic hospitals.

Overall, 96 patients (0.2%) were diagnosed with postoperative venous thromboembolism. However patients who underwent laparoscopic or vaginal surgery had a significant 78% and 93% lower risk of venous thromboembolism, respectively, than those who underwent laparotomy, even after adjusting for potential confounders such as age, cancer, race, pharmacologic thromboprophylaxis, and surgical time.

The incidence of postoperative thromboembolism was significantly higher among patients undergoing gynecologic surgery for cancer (1.1%). The incidence among those undergoing surgery for benign indications was only 0.2%, and the highest incidence was among patients with cancer who underwent laparotomy (2.2%).

“This study adds to data demonstrating that venous thromboembolism is rare in gynecologic surgery, particularly when a patient undergoes a minimally invasive procedure for benign indications,” wrote Dr. Elisa M. Jorgensen of Beth Israel Deaconess Medical Center, and her coauthors.

Among the 8,273 patients who underwent a hysterectomy, there were 55 cases of venous thromboembolism – representing an 0.7% incidence. However patients who underwent laparotomy had a 1% incidence of postoperative venous thromboembolism, while those who underwent laparoscopic hysterectomy had an 0.3% incidence and those who underwent vaginal hysterectomy had an 0.1% incidence.

Laparotomy was the most common mode of surgery for hysterectomy – accounting for 57% of operations – while 34% were laparoscopic and 9% were vaginal.

However, the authors noted that the use of laparoscopy increased and laparotomy declined over the 9 years of the study. In 2006, 12% of hysterectomies were laparoscopic, compared with 55% in 2015, while over that same period the percentage of laparotomies dropped from 74% to 41%, and the percentage of vaginal procedures declined from 14% to 4%.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

“Because current practice guidelines do not account for mode of surgery, we find them to be insufficient for the modern gynecologic surgeon to counsel patients on their individual venous thromboembolism risk or to make ideal decisions regarding selection of thromboprophylaxis,” Dr. Jorgenson and her associates wrote.

Only 5 patients of the 2,851 who underwent myomectomy developed postoperative VTE – an overall incidence of 0.2% – and the authors said numbers were too small to analyze. Vaginal or hysteroscopic myomectomy was the most common surgical method, accounting for 62% of procedures, compared with 23% for laparotomies and 15% for laparoscopies.

More than 90% of patients who experienced postoperative thromboembolism had received some form of thromboprophylaxis before surgery, either mechanical, pharmacologic, or both. In comparison, only 55% of the group who didn’t experience thromboembolism had received thromboprophylaxis.

“The high rate of prophylaxis among patients who developed postoperative venous thromboembolism may reflect surgeons’ abilities to preoperatively identify patients at increased risk, guiding appropriate selection of thromboprophylaxis,” Dr. Jorgenson and her associates wrote.

Addressing the study’s limitations, the authors noted that they were not able to capture data on patients’ body mass index and also were unable to account for patients who might have been diagnosed and treated for postoperative VTE at other hospitals.

No conflicts of interest were declared.

SOURCE: Jorgensen EM et al. Obstet Gynecol. 2018 Nov;132:1275-84.

Laparoscopic gynecologic surgery is associated with a significantly lower risk of postoperative venous thromboembolism (VTE) than laparotomy, according to a study published in Obstetrics & Gynecology.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

The retrospective cohort study looked at data from 37,485 patients who underwent 43,751 gynecologic surgical procedures, including hysterectomy and myomectomy, at two tertiary care academic hospitals.

Overall, 96 patients (0.2%) were diagnosed with postoperative venous thromboembolism. However patients who underwent laparoscopic or vaginal surgery had a significant 78% and 93% lower risk of venous thromboembolism, respectively, than those who underwent laparotomy, even after adjusting for potential confounders such as age, cancer, race, pharmacologic thromboprophylaxis, and surgical time.

The incidence of postoperative thromboembolism was significantly higher among patients undergoing gynecologic surgery for cancer (1.1%). The incidence among those undergoing surgery for benign indications was only 0.2%, and the highest incidence was among patients with cancer who underwent laparotomy (2.2%).

“This study adds to data demonstrating that venous thromboembolism is rare in gynecologic surgery, particularly when a patient undergoes a minimally invasive procedure for benign indications,” wrote Dr. Elisa M. Jorgensen of Beth Israel Deaconess Medical Center, and her coauthors.

Among the 8,273 patients who underwent a hysterectomy, there were 55 cases of venous thromboembolism – representing an 0.7% incidence. However patients who underwent laparotomy had a 1% incidence of postoperative venous thromboembolism, while those who underwent laparoscopic hysterectomy had an 0.3% incidence and those who underwent vaginal hysterectomy had an 0.1% incidence.

Laparotomy was the most common mode of surgery for hysterectomy – accounting for 57% of operations – while 34% were laparoscopic and 9% were vaginal.

However, the authors noted that the use of laparoscopy increased and laparotomy declined over the 9 years of the study. In 2006, 12% of hysterectomies were laparoscopic, compared with 55% in 2015, while over that same period the percentage of laparotomies dropped from 74% to 41%, and the percentage of vaginal procedures declined from 14% to 4%.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

“Because current practice guidelines do not account for mode of surgery, we find them to be insufficient for the modern gynecologic surgeon to counsel patients on their individual venous thromboembolism risk or to make ideal decisions regarding selection of thromboprophylaxis,” Dr. Jorgenson and her associates wrote.

Only 5 patients of the 2,851 who underwent myomectomy developed postoperative VTE – an overall incidence of 0.2% – and the authors said numbers were too small to analyze. Vaginal or hysteroscopic myomectomy was the most common surgical method, accounting for 62% of procedures, compared with 23% for laparotomies and 15% for laparoscopies.

More than 90% of patients who experienced postoperative thromboembolism had received some form of thromboprophylaxis before surgery, either mechanical, pharmacologic, or both. In comparison, only 55% of the group who didn’t experience thromboembolism had received thromboprophylaxis.

“The high rate of prophylaxis among patients who developed postoperative venous thromboembolism may reflect surgeons’ abilities to preoperatively identify patients at increased risk, guiding appropriate selection of thromboprophylaxis,” Dr. Jorgenson and her associates wrote.

Addressing the study’s limitations, the authors noted that they were not able to capture data on patients’ body mass index and also were unable to account for patients who might have been diagnosed and treated for postoperative VTE at other hospitals.

No conflicts of interest were declared.

SOURCE: Jorgensen EM et al. Obstet Gynecol. 2018 Nov;132:1275-84.

AUSTIN, TEX. – Mass shootings make up only a tiny percentage of annual gun violence deaths in the United States, but they capture the attention of the nation – and of media that do not always accurately represent their context.

Experts tend to identify the first modern U.S. mass shooting event as the University of Texas Tower shooting in Austin by Charles Whitman in 1966, Corina Freitas, MD, said at the annual meeting of the American Academy of Psychiatry and the Law.

But two previous incidents preceded Whitman’s: Howard Unruh’s 12-minute killing spree in his neighborhood in Camden, N.J., in 1949, and Andrew Kehoe’s 1927 series of bombings that killed 43 people in the Bath School disaster in Michigan. Studies of these events and the hundreds since have led to a better understanding of what motivates mass shooters (or bombers in Kehoe’s case) and how to potentially identify them and prevent such events, said Dr. Freitas, of the department of psychiatry and behavioral sciences at George Washington University in Washington.

Dr. Freitas provided an overview of mass shooting history in the United States before Karen B. Rosenbaum, MD, clinical assistant professor at New York University and clinical instructor at New York Presbyterian–Weill Cornell Medical Center, spoke about the social, political, and legal implications of the intersection between mental illness and mass shootings.

She began by explaining how the FBI’s definition of mass shootings has changed from “four or more people at one location within one event” in 2005 to its redefinition in 2012-2013 to “three or more killings in a single incident and in a place of public use.”

Mass shootings usually are not impulse kills, Dr. Freitas said, noting that 77% of shooters plan their shooting for at least a week, and 46% of people spend about a week preparing. The perpetrators are potentially recognizable, typically displaying four to five concerning behaviors up to 1 year before the shooting, such as talking about their plans or purchasing supplies. But only a minority of people who observe these behaviors ever speak up about them or take any actions, she said.

The most common driver of shooters is feeling aggrieved (44%), followed by anger and social alienation, but they also display numerous other psychosocial characteristics, such as self-esteem issues, paranoia, narcissism, depression, and suicidality.

“Almost half of them are suicidal, and they actually proclaim it up to 1 year ahead of the shooting,” Dr. Freitas said. “We could catch them if we paid more attention to that.”

Mass killers tend to fall into three categories, as classified by psychiatrist Park Dietz, MD, in 1986:

• Family annihilators, such as George Banks, are typically depressed, paranoid, suicidal older males who might be intoxicated at the time of their attack. Banks shot 13 people, including 5 of his own children and 2 other children and their mothers, in Pennsylvania in 1982.
• Pseudocommandos, such as Charles Whitman, are usually preoccupied with firearms and plan heavily. “They usually end up killing themselves by cop,” Dr. Freitas said.
• Set-and-run killers, the rarest type, include perpetrators like Kehoe; their method of killing gives them an escape (though Kehoe blew himself up as well).

But mental illness is not a major feature of mass killers: Only about a quarter of mass shooters have a diagnosed mental illness, and the illness might not necessarily be related to their crime. Of that quarter, about 75% of mass shooters had a mood disorder, 25% had an anxiety disorder,19% had psychosis, and 1% had the developmental condition, such as autism spectrum disorder.

Yet, as mass shootings have dramatically increased, mental illness has become inextricably associated with these events in the media and popular opinion, Dr. Rosenbaum said. There have been 74 school shootings since the Newtown, Conn., tragedy, and mental illness is repeatedly brought up as a contributor, she said.

A 2014 study that analyzed 25% of a random sample of news stories from 1997 to 2012 on serious mental illness and gun violence (before Newtown) found that most of the coverage occurred after mass shootings and “ ‘dangerous people’ with serious mental illness were more likely to be mentioned than ‘dangerous weapons’ as a cause of gun violence” (Am J Public Health. 2014 Mar;104[3]:406-13).

Yet this association does not reflect reality, Dr. Rosenbaum said. One meta-analysis found that prevention of one stranger homicide by someone with psychosis would require detaining 35,000 people with schizophrenia who had been judged as being at high risk for violence (Schizophr Bull. 2011 May;37[3]:572-9).

Further, the relationship between violence and mental illness is not simple. Complex historical factors are usually involved, including past violence, juvenile detection, physical abuse, substance abuse, age, parental arrest record, and life circumstances – such as a recent divorce, unemployment, or victimization.

The greater danger of a person with mental illness is the harm they will do to themselves, research shows. A study of 255 recently discharged psychiatric patients and 490 matched community residents found that the patients were no more likely to perpetuate violence than were the community members, but they were significantly more likely to report being suicidal (Int J Law Psychiatry. 2018 Jan-Feb;56:44-9).

Rather than mental illness, what is associated with violence is substance use and access to weapons, Dr. Rosenbaum said.

“The United States is one of only three countries in the world with a constitutionally protected right to own firearms,” Dr. Rosenbaum said, citing a 2017 study by John S. Rozel, MD, and Edward P. Mulvey, PhD, (Annu Rev Clin Psychol. 2017 May 8;13:445-9). And the United States has few restrictions on that right. With more than 350 million privately owned firearms – approximately 30% of all privately owned firearms in the world – the U.S. population exceeds all other countries in both per capita and absolute gun ownership.

And research shows that guns don’t make a country safer: Guns per capita are significantly correlated with firearm-related deaths; mental illness is only of borderline significance (Am J Med. 2013 Oct;126[10]:873-6).

Substance use – including use of cocaine, hallucinogens, methamphetamine, ecstasy, and prescription medications – has a stronger correlation with gun-carrying and gun-related behaviors (Inj Prev. 2017 Dec; 23[6]:383-7 and Epidemiol Rev. 2016;38[1]:46-61). Both acute and chronic alcohol misuse also are linked to firearm ownership and violence toward others and one’s self (Prev Med. 2015 Oct;79:15-21).

Yet public misperceptions of mental illness as a contributor to violence persists, research shows (Aust N Z J Psychiatry. 2014 Aug;48[8]:764-71), further stigmatizing people with psychiatric conditions and potentially reducing the likelihood of their seeking treatment. Politicians contribute to these misperceptions; an example is House Speaker Paul Ryan’s comment after the Parkland, Fla., school shooting: “Mental health is often a big problem underlying these tragedies.”

“The media sensationalizes violent crimes committed by people with mental illness, especially after mass shooting, and this societal bias contributes to the stigma that leads to decreased treatment seeking and discrimination,” Dr. Rosenbaum said, citing research from Mohit Varshney, MD, and his associates (J Epidemiol Community Health. 2016 Mar;70[3]:223-5). “It is important to dissociate the concept of mental illness from dangerousness.”

AUSTIN, TEX. – Mass shootings make up only a tiny percentage of annual gun violence deaths in the United States, but they capture the attention of the nation – and of media that do not always accurately represent their context.

Experts tend to identify the first modern U.S. mass shooting event as the University of Texas Tower shooting in Austin by Charles Whitman in 1966, Corina Freitas, MD, said at the annual meeting of the American Academy of Psychiatry and the Law.

But two previous incidents preceded Whitman’s: Howard Unruh’s 12-minute killing spree in his neighborhood in Camden, N.J., in 1949, and Andrew Kehoe’s 1927 series of bombings that killed 43 people in the Bath School disaster in Michigan. Studies of these events and the hundreds since have led to a better understanding of what motivates mass shooters (or bombers in Kehoe’s case) and how to potentially identify them and prevent such events, said Dr. Freitas, of the department of psychiatry and behavioral sciences at George Washington University in Washington.

Dr. Freitas provided an overview of mass shooting history in the United States before Karen B. Rosenbaum, MD, clinical assistant professor at New York University and clinical instructor at New York Presbyterian–Weill Cornell Medical Center, spoke about the social, political, and legal implications of the intersection between mental illness and mass shootings.

She began by explaining how the FBI’s definition of mass shootings has changed from “four or more people at one location within one event” in 2005 to its redefinition in 2012-2013 to “three or more killings in a single incident and in a place of public use.”

Mass shootings usually are not impulse kills, Dr. Freitas said, noting that 77% of shooters plan their shooting for at least a week, and 46% of people spend about a week preparing. The perpetrators are potentially recognizable, typically displaying four to five concerning behaviors up to 1 year before the shooting, such as talking about their plans or purchasing supplies. But only a minority of people who observe these behaviors ever speak up about them or take any actions, she said.

The most common driver of shooters is feeling aggrieved (44%), followed by anger and social alienation, but they also display numerous other psychosocial characteristics, such as self-esteem issues, paranoia, narcissism, depression, and suicidality.

“Almost half of them are suicidal, and they actually proclaim it up to 1 year ahead of the shooting,” Dr. Freitas said. “We could catch them if we paid more attention to that.”

Mass killers tend to fall into three categories, as classified by psychiatrist Park Dietz, MD, in 1986:

• Family annihilators, such as George Banks, are typically depressed, paranoid, suicidal older males who might be intoxicated at the time of their attack. Banks shot 13 people, including 5 of his own children and 2 other children and their mothers, in Pennsylvania in 1982.
• Pseudocommandos, such as Charles Whitman, are usually preoccupied with firearms and plan heavily. “They usually end up killing themselves by cop,” Dr. Freitas said.
• Set-and-run killers, the rarest type, include perpetrators like Kehoe; their method of killing gives them an escape (though Kehoe blew himself up as well).

But mental illness is not a major feature of mass killers: Only about a quarter of mass shooters have a diagnosed mental illness, and the illness might not necessarily be related to their crime. Of that quarter, about 75% of mass shooters had a mood disorder, 25% had an anxiety disorder,19% had psychosis, and 1% had the developmental condition, such as autism spectrum disorder.

Yet, as mass shootings have dramatically increased, mental illness has become inextricably associated with these events in the media and popular opinion, Dr. Rosenbaum said. There have been 74 school shootings since the Newtown, Conn., tragedy, and mental illness is repeatedly brought up as a contributor, she said.

A 2014 study that analyzed 25% of a random sample of news stories from 1997 to 2012 on serious mental illness and gun violence (before Newtown) found that most of the coverage occurred after mass shootings and “ ‘dangerous people’ with serious mental illness were more likely to be mentioned than ‘dangerous weapons’ as a cause of gun violence” (Am J Public Health. 2014 Mar;104[3]:406-13).

Yet this association does not reflect reality, Dr. Rosenbaum said. One meta-analysis found that prevention of one stranger homicide by someone with psychosis would require detaining 35,000 people with schizophrenia who had been judged as being at high risk for violence (Schizophr Bull. 2011 May;37[3]:572-9).

Further, the relationship between violence and mental illness is not simple. Complex historical factors are usually involved, including past violence, juvenile detection, physical abuse, substance abuse, age, parental arrest record, and life circumstances – such as a recent divorce, unemployment, or victimization.

The greater danger of a person with mental illness is the harm they will do to themselves, research shows. A study of 255 recently discharged psychiatric patients and 490 matched community residents found that the patients were no more likely to perpetuate violence than were the community members, but they were significantly more likely to report being suicidal (Int J Law Psychiatry. 2018 Jan-Feb;56:44-9).

Rather than mental illness, what is associated with violence is substance use and access to weapons, Dr. Rosenbaum said.

“The United States is one of only three countries in the world with a constitutionally protected right to own firearms,” Dr. Rosenbaum said, citing a 2017 study by John S. Rozel, MD, and Edward P. Mulvey, PhD, (Annu Rev Clin Psychol. 2017 May 8;13:445-9). And the United States has few restrictions on that right. With more than 350 million privately owned firearms – approximately 30% of all privately owned firearms in the world – the U.S. population exceeds all other countries in both per capita and absolute gun ownership.

And research shows that guns don’t make a country safer: Guns per capita are significantly correlated with firearm-related deaths; mental illness is only of borderline significance (Am J Med. 2013 Oct;126[10]:873-6).

Substance use – including use of cocaine, hallucinogens, methamphetamine, ecstasy, and prescription medications – has a stronger correlation with gun-carrying and gun-related behaviors (Inj Prev. 2017 Dec; 23[6]:383-7 and Epidemiol Rev. 2016;38[1]:46-61). Both acute and chronic alcohol misuse also are linked to firearm ownership and violence toward others and one’s self (Prev Med. 2015 Oct;79:15-21).

Yet public misperceptions of mental illness as a contributor to violence persists, research shows (Aust N Z J Psychiatry. 2014 Aug;48[8]:764-71), further stigmatizing people with psychiatric conditions and potentially reducing the likelihood of their seeking treatment. Politicians contribute to these misperceptions; an example is House Speaker Paul Ryan’s comment after the Parkland, Fla., school shooting: “Mental health is often a big problem underlying these tragedies.”

“The media sensationalizes violent crimes committed by people with mental illness, especially after mass shooting, and this societal bias contributes to the stigma that leads to decreased treatment seeking and discrimination,” Dr. Rosenbaum said, citing research from Mohit Varshney, MD, and his associates (J Epidemiol Community Health. 2016 Mar;70[3]:223-5). “It is important to dissociate the concept of mental illness from dangerousness.”

AUSTIN, TEX. – Mass shootings make up only a tiny percentage of annual gun violence deaths in the United States, but they capture the attention of the nation – and of media that do not always accurately represent their context.

Experts tend to identify the first modern U.S. mass shooting event as the University of Texas Tower shooting in Austin by Charles Whitman in 1966, Corina Freitas, MD, said at the annual meeting of the American Academy of Psychiatry and the Law.

But two previous incidents preceded Whitman’s: Howard Unruh’s 12-minute killing spree in his neighborhood in Camden, N.J., in 1949, and Andrew Kehoe’s 1927 series of bombings that killed 43 people in the Bath School disaster in Michigan. Studies of these events and the hundreds since have led to a better understanding of what motivates mass shooters (or bombers in Kehoe’s case) and how to potentially identify them and prevent such events, said Dr. Freitas, of the department of psychiatry and behavioral sciences at George Washington University in Washington.

Dr. Freitas provided an overview of mass shooting history in the United States before Karen B. Rosenbaum, MD, clinical assistant professor at New York University and clinical instructor at New York Presbyterian–Weill Cornell Medical Center, spoke about the social, political, and legal implications of the intersection between mental illness and mass shootings.

She began by explaining how the FBI’s definition of mass shootings has changed from “four or more people at one location within one event” in 2005 to its redefinition in 2012-2013 to “three or more killings in a single incident and in a place of public use.”

Mass shootings usually are not impulse kills, Dr. Freitas said, noting that 77% of shooters plan their shooting for at least a week, and 46% of people spend about a week preparing. The perpetrators are potentially recognizable, typically displaying four to five concerning behaviors up to 1 year before the shooting, such as talking about their plans or purchasing supplies. But only a minority of people who observe these behaviors ever speak up about them or take any actions, she said.

The most common driver of shooters is feeling aggrieved (44%), followed by anger and social alienation, but they also display numerous other psychosocial characteristics, such as self-esteem issues, paranoia, narcissism, depression, and suicidality.

“Almost half of them are suicidal, and they actually proclaim it up to 1 year ahead of the shooting,” Dr. Freitas said. “We could catch them if we paid more attention to that.”

Mass killers tend to fall into three categories, as classified by psychiatrist Park Dietz, MD, in 1986:

• Family annihilators, such as George Banks, are typically depressed, paranoid, suicidal older males who might be intoxicated at the time of their attack. Banks shot 13 people, including 5 of his own children and 2 other children and their mothers, in Pennsylvania in 1982.
• Pseudocommandos, such as Charles Whitman, are usually preoccupied with firearms and plan heavily. “They usually end up killing themselves by cop,” Dr. Freitas said.
• Set-and-run killers, the rarest type, include perpetrators like Kehoe; their method of killing gives them an escape (though Kehoe blew himself up as well).

But mental illness is not a major feature of mass killers: Only about a quarter of mass shooters have a diagnosed mental illness, and the illness might not necessarily be related to their crime. Of that quarter, about 75% of mass shooters had a mood disorder, 25% had an anxiety disorder,19% had psychosis, and 1% had the developmental condition, such as autism spectrum disorder.

Yet, as mass shootings have dramatically increased, mental illness has become inextricably associated with these events in the media and popular opinion, Dr. Rosenbaum said. There have been 74 school shootings since the Newtown, Conn., tragedy, and mental illness is repeatedly brought up as a contributor, she said.

A 2014 study that analyzed 25% of a random sample of news stories from 1997 to 2012 on serious mental illness and gun violence (before Newtown) found that most of the coverage occurred after mass shootings and “ ‘dangerous people’ with serious mental illness were more likely to be mentioned than ‘dangerous weapons’ as a cause of gun violence” (Am J Public Health. 2014 Mar;104[3]:406-13).

Yet this association does not reflect reality, Dr. Rosenbaum said. One meta-analysis found that prevention of one stranger homicide by someone with psychosis would require detaining 35,000 people with schizophrenia who had been judged as being at high risk for violence (Schizophr Bull. 2011 May;37[3]:572-9).

Further, the relationship between violence and mental illness is not simple. Complex historical factors are usually involved, including past violence, juvenile detection, physical abuse, substance abuse, age, parental arrest record, and life circumstances – such as a recent divorce, unemployment, or victimization.

The greater danger of a person with mental illness is the harm they will do to themselves, research shows. A study of 255 recently discharged psychiatric patients and 490 matched community residents found that the patients were no more likely to perpetuate violence than were the community members, but they were significantly more likely to report being suicidal (Int J Law Psychiatry. 2018 Jan-Feb;56:44-9).

Rather than mental illness, what is associated with violence is substance use and access to weapons, Dr. Rosenbaum said.

“The United States is one of only three countries in the world with a constitutionally protected right to own firearms,” Dr. Rosenbaum said, citing a 2017 study by John S. Rozel, MD, and Edward P. Mulvey, PhD, (Annu Rev Clin Psychol. 2017 May 8;13:445-9). And the United States has few restrictions on that right. With more than 350 million privately owned firearms – approximately 30% of all privately owned firearms in the world – the U.S. population exceeds all other countries in both per capita and absolute gun ownership.

And research shows that guns don’t make a country safer: Guns per capita are significantly correlated with firearm-related deaths; mental illness is only of borderline significance (Am J Med. 2013 Oct;126[10]:873-6).

Substance use – including use of cocaine, hallucinogens, methamphetamine, ecstasy, and prescription medications – has a stronger correlation with gun-carrying and gun-related behaviors (Inj Prev. 2017 Dec; 23[6]:383-7 and Epidemiol Rev. 2016;38[1]:46-61). Both acute and chronic alcohol misuse also are linked to firearm ownership and violence toward others and one’s self (Prev Med. 2015 Oct;79:15-21).

Yet public misperceptions of mental illness as a contributor to violence persists, research shows (Aust N Z J Psychiatry. 2014 Aug;48[8]:764-71), further stigmatizing people with psychiatric conditions and potentially reducing the likelihood of their seeking treatment. Politicians contribute to these misperceptions; an example is House Speaker Paul Ryan’s comment after the Parkland, Fla., school shooting: “Mental health is often a big problem underlying these tragedies.”

“The media sensationalizes violent crimes committed by people with mental illness, especially after mass shooting, and this societal bias contributes to the stigma that leads to decreased treatment seeking and discrimination,” Dr. Rosenbaum said, citing research from Mohit Varshney, MD, and his associates (J Epidemiol Community Health. 2016 Mar;70[3]:223-5). “It is important to dissociate the concept of mental illness from dangerousness.”

ST. LOUIS – A patient with a nontraumatic vascular emergency is significantly less likely to die today than a decade ago, with few exceptions, according to a new national analysis looking at 10 years of data. Unsurprisingly, endovascular surgery rates climbed over the study period, as did rates of acute limb ischemia, said Todd Vogel, MD, who discussed the study at the annual meeting of the Midwestern Vascular Surgical Society.

With an objective of evaluating trends for management of nontraumatic vascular emergencies in the United States, Dr. Vogel, who is chief of vascular and endovascular surgery at the University of Missouri–Columbia, and his colleagues examined frequencies of vascular emergencies, mortality rates, and how open versus endoscopic procedure technique affected the data.

To do this, the investigators used the U.S. National Inpatient Sample from 2005 to 2014 to identify nontraumatic vascular emergencies.

Using ICD-9 clinical management diagnosis and procedure codes allowed the investigators to capture a wide array of vascular emergencies, Dr. Vogel said. These included ruptured abdominal, thoracic, and thoracoabdominal aortic aneurysms (rAAAs, rTAAs, and rTAAAs, respectively), as well as acute limb ischemia, acute mesenteric ischemia, and ruptured visceral artery aneurysms.

Among the outcomes analyzed in the study were a trend analysis looking at how outcomes changed over time and an analysis of in-hospital mortality. Dr. Vogel and his colleagues also examined hospital resource utilization including length of stay and total hospital cost, inflation adjusted to 2014 costs.

The prevalence of endovascular intervention increased sharply over the study period, as one would expect, Dr. Vogel said. “At the beginning, we had about 24% of patients getting endovascular intervention for vascular emergencies, and currently, it’s 36%.” (P for trend, less than .0001).

Mortality dropped steeply overall, with overall mortality going from 13.80% to 9.14% during the study period (P less than .0001). Much of this decrease could be attributed to mortality for open procedures decreasing by over a third, from 16.5% to 10.7%, over the study period (P less than .0001). Endovascular procedure–related mortality decreased from 8.3% to 7.9% (P = .03).

Ruptured abdominal and thoracic aortic aneurysms were much less likely to be fatal in 2014 than in 2005. The overall mortality rate for rAAA went from 41.4% to 27.6% (P less than .0001) and rates for rTAAs dropped overall from 41.2% to 23.0% (P = .002).

However, endovascular rTAA repair mortality jumped from 14.9% to 27.4% (P = .0003) while mortality for open procedures plummeted from 51.3% to 16.7% (P less than .0001).

In-hospital mortality for some conditions didn’t change much over time: rTAAA mortality, for example, increased, but by a nonsignificant amount (44.7% vs. 47.6%; P = .06). “Mortality rates for rTAAA have remained static, despite the advances in treatment,” Dr. Vogel said.

Discussing these “concerning” results, Dr. Vogel noted that the increase in mortality “suggests an increased use of endovascular repair on higher-risk patients.” The mortality rate for ruptured visceral artery aneurysms did not change significantly either (16.7% vs. 6.7%, P = .09).

Overall, patients were 44% female and 66% white. “Over half of the patients were aged 70 or greater,” he said.

Acute limb ischemia was by far the most common vascular emergency, accounting for 82.4% of the total. Next most common were rAAAs, which made up just 10.79% of the vascular emergencies studied.

Looking at hospitalization trends over time, acute limb ischemia showed a slight trend up over the study period, from an occurrence rate of about 8.2 per 100,000 individuals at the beginning to about 9.0 per 100,000 by 2014.

Acute mesenteric ischemia also trended up, from an occurrence rate of about 4 per 1 million individuals in 2005 to about 6 per 1 million in 2014; rAAAs trended down, from about 13 per 1 million to a little over 9 per 1 million over the study period.

Among the other vascular emergencies incurring hospitalization, rTAAAs and ruptured visceral artery aneurysms were both rare, occurring in fewer than 7 per 10 million individuals, but both showed a slight upward trend over the study period. Slightly more common were rTAAs, which occurred at a rate of about 12 per 10 million individuals at the beginning of the study period and at slightly less than 15 per 10 million by the end.

Looking at hospital resource utilization, length of stay dropped significantly (P less than .004), but costs, unsurprisingly, increased over the study period, from about $25,000 to about $30,000 per occurrence (P less than .0001).

“The overall frequency of vascular emergencies has significantly increased over time,” Dr. Vogel said, “but in subgroup analysis ruptured abdominal [aortic] aneurysms are decreasing.” As endovascular procedures have increased, “The overall mortality has decreased, so we actually are doing better.” Some of this drop “may be due to improved perioperative care” as well as the increase in endovascular utilization, he noted.

In sum, though mortality has generally improved as endovascular procedures have become more common in vascular emergencies, “increased implementation of endovascular repair may not always improve outcomes,” Dr. Vogel said, especially in the context of an increasingly complex and aging patient population.

Dr. Vogel reported no conflicts of interest and no outside sources of funding.

[email protected]

ST. LOUIS – A patient with a nontraumatic vascular emergency is significantly less likely to die today than a decade ago, with few exceptions, according to a new national analysis looking at 10 years of data. Unsurprisingly, endovascular surgery rates climbed over the study period, as did rates of acute limb ischemia, said Todd Vogel, MD, who discussed the study at the annual meeting of the Midwestern Vascular Surgical Society.

With an objective of evaluating trends for management of nontraumatic vascular emergencies in the United States, Dr. Vogel, who is chief of vascular and endovascular surgery at the University of Missouri–Columbia, and his colleagues examined frequencies of vascular emergencies, mortality rates, and how open versus endoscopic procedure technique affected the data.

To do this, the investigators used the U.S. National Inpatient Sample from 2005 to 2014 to identify nontraumatic vascular emergencies.

Using ICD-9 clinical management diagnosis and procedure codes allowed the investigators to capture a wide array of vascular emergencies, Dr. Vogel said. These included ruptured abdominal, thoracic, and thoracoabdominal aortic aneurysms (rAAAs, rTAAs, and rTAAAs, respectively), as well as acute limb ischemia, acute mesenteric ischemia, and ruptured visceral artery aneurysms.

Among the outcomes analyzed in the study were a trend analysis looking at how outcomes changed over time and an analysis of in-hospital mortality. Dr. Vogel and his colleagues also examined hospital resource utilization including length of stay and total hospital cost, inflation adjusted to 2014 costs.

The prevalence of endovascular intervention increased sharply over the study period, as one would expect, Dr. Vogel said. “At the beginning, we had about 24% of patients getting endovascular intervention for vascular emergencies, and currently, it’s 36%.” (P for trend, less than .0001).

Mortality dropped steeply overall, with overall mortality going from 13.80% to 9.14% during the study period (P less than .0001). Much of this decrease could be attributed to mortality for open procedures decreasing by over a third, from 16.5% to 10.7%, over the study period (P less than .0001). Endovascular procedure–related mortality decreased from 8.3% to 7.9% (P = .03).

Ruptured abdominal and thoracic aortic aneurysms were much less likely to be fatal in 2014 than in 2005. The overall mortality rate for rAAA went from 41.4% to 27.6% (P less than .0001) and rates for rTAAs dropped overall from 41.2% to 23.0% (P = .002).

However, endovascular rTAA repair mortality jumped from 14.9% to 27.4% (P = .0003) while mortality for open procedures plummeted from 51.3% to 16.7% (P less than .0001).

In-hospital mortality for some conditions didn’t change much over time: rTAAA mortality, for example, increased, but by a nonsignificant amount (44.7% vs. 47.6%; P = .06). “Mortality rates for rTAAA have remained static, despite the advances in treatment,” Dr. Vogel said.

Discussing these “concerning” results, Dr. Vogel noted that the increase in mortality “suggests an increased use of endovascular repair on higher-risk patients.” The mortality rate for ruptured visceral artery aneurysms did not change significantly either (16.7% vs. 6.7%, P = .09).

Overall, patients were 44% female and 66% white. “Over half of the patients were aged 70 or greater,” he said.

Acute limb ischemia was by far the most common vascular emergency, accounting for 82.4% of the total. Next most common were rAAAs, which made up just 10.79% of the vascular emergencies studied.

Looking at hospitalization trends over time, acute limb ischemia showed a slight trend up over the study period, from an occurrence rate of about 8.2 per 100,000 individuals at the beginning to about 9.0 per 100,000 by 2014.

Acute mesenteric ischemia also trended up, from an occurrence rate of about 4 per 1 million individuals in 2005 to about 6 per 1 million in 2014; rAAAs trended down, from about 13 per 1 million to a little over 9 per 1 million over the study period.

Among the other vascular emergencies incurring hospitalization, rTAAAs and ruptured visceral artery aneurysms were both rare, occurring in fewer than 7 per 10 million individuals, but both showed a slight upward trend over the study period. Slightly more common were rTAAs, which occurred at a rate of about 12 per 10 million individuals at the beginning of the study period and at slightly less than 15 per 10 million by the end.

Looking at hospital resource utilization, length of stay dropped significantly (P less than .004), but costs, unsurprisingly, increased over the study period, from about $25,000 to about $30,000 per occurrence (P less than .0001).

“The overall frequency of vascular emergencies has significantly increased over time,” Dr. Vogel said, “but in subgroup analysis ruptured abdominal [aortic] aneurysms are decreasing.” As endovascular procedures have increased, “The overall mortality has decreased, so we actually are doing better.” Some of this drop “may be due to improved perioperative care” as well as the increase in endovascular utilization, he noted.

In sum, though mortality has generally improved as endovascular procedures have become more common in vascular emergencies, “increased implementation of endovascular repair may not always improve outcomes,” Dr. Vogel said, especially in the context of an increasingly complex and aging patient population.

Dr. Vogel reported no conflicts of interest and no outside sources of funding.

[email protected]

ST. LOUIS – A patient with a nontraumatic vascular emergency is significantly less likely to die today than a decade ago, with few exceptions, according to a new national analysis looking at 10 years of data. Unsurprisingly, endovascular surgery rates climbed over the study period, as did rates of acute limb ischemia, said Todd Vogel, MD, who discussed the study at the annual meeting of the Midwestern Vascular Surgical Society.

With an objective of evaluating trends for management of nontraumatic vascular emergencies in the United States, Dr. Vogel, who is chief of vascular and endovascular surgery at the University of Missouri–Columbia, and his colleagues examined frequencies of vascular emergencies, mortality rates, and how open versus endoscopic procedure technique affected the data.

To do this, the investigators used the U.S. National Inpatient Sample from 2005 to 2014 to identify nontraumatic vascular emergencies.

Using ICD-9 clinical management diagnosis and procedure codes allowed the investigators to capture a wide array of vascular emergencies, Dr. Vogel said. These included ruptured abdominal, thoracic, and thoracoabdominal aortic aneurysms (rAAAs, rTAAs, and rTAAAs, respectively), as well as acute limb ischemia, acute mesenteric ischemia, and ruptured visceral artery aneurysms.

Among the outcomes analyzed in the study were a trend analysis looking at how outcomes changed over time and an analysis of in-hospital mortality. Dr. Vogel and his colleagues also examined hospital resource utilization including length of stay and total hospital cost, inflation adjusted to 2014 costs.

The prevalence of endovascular intervention increased sharply over the study period, as one would expect, Dr. Vogel said. “At the beginning, we had about 24% of patients getting endovascular intervention for vascular emergencies, and currently, it’s 36%.” (P for trend, less than .0001).

Mortality dropped steeply overall, with overall mortality going from 13.80% to 9.14% during the study period (P less than .0001). Much of this decrease could be attributed to mortality for open procedures decreasing by over a third, from 16.5% to 10.7%, over the study period (P less than .0001). Endovascular procedure–related mortality decreased from 8.3% to 7.9% (P = .03).

Ruptured abdominal and thoracic aortic aneurysms were much less likely to be fatal in 2014 than in 2005. The overall mortality rate for rAAA went from 41.4% to 27.6% (P less than .0001) and rates for rTAAs dropped overall from 41.2% to 23.0% (P = .002).

However, endovascular rTAA repair mortality jumped from 14.9% to 27.4% (P = .0003) while mortality for open procedures plummeted from 51.3% to 16.7% (P less than .0001).

In-hospital mortality for some conditions didn’t change much over time: rTAAA mortality, for example, increased, but by a nonsignificant amount (44.7% vs. 47.6%; P = .06). “Mortality rates for rTAAA have remained static, despite the advances in treatment,” Dr. Vogel said.

Discussing these “concerning” results, Dr. Vogel noted that the increase in mortality “suggests an increased use of endovascular repair on higher-risk patients.” The mortality rate for ruptured visceral artery aneurysms did not change significantly either (16.7% vs. 6.7%, P = .09).

Overall, patients were 44% female and 66% white. “Over half of the patients were aged 70 or greater,” he said.

Acute limb ischemia was by far the most common vascular emergency, accounting for 82.4% of the total. Next most common were rAAAs, which made up just 10.79% of the vascular emergencies studied.

Looking at hospitalization trends over time, acute limb ischemia showed a slight trend up over the study period, from an occurrence rate of about 8.2 per 100,000 individuals at the beginning to about 9.0 per 100,000 by 2014.

Acute mesenteric ischemia also trended up, from an occurrence rate of about 4 per 1 million individuals in 2005 to about 6 per 1 million in 2014; rAAAs trended down, from about 13 per 1 million to a little over 9 per 1 million over the study period.

Among the other vascular emergencies incurring hospitalization, rTAAAs and ruptured visceral artery aneurysms were both rare, occurring in fewer than 7 per 10 million individuals, but both showed a slight upward trend over the study period. Slightly more common were rTAAs, which occurred at a rate of about 12 per 10 million individuals at the beginning of the study period and at slightly less than 15 per 10 million by the end.

Looking at hospital resource utilization, length of stay dropped significantly (P less than .004), but costs, unsurprisingly, increased over the study period, from about $25,000 to about $30,000 per occurrence (P less than .0001).

“The overall frequency of vascular emergencies has significantly increased over time,” Dr. Vogel said, “but in subgroup analysis ruptured abdominal [aortic] aneurysms are decreasing.” As endovascular procedures have increased, “The overall mortality has decreased, so we actually are doing better.” Some of this drop “may be due to improved perioperative care” as well as the increase in endovascular utilization, he noted.

In sum, though mortality has generally improved as endovascular procedures have become more common in vascular emergencies, “increased implementation of endovascular repair may not always improve outcomes,” Dr. Vogel said, especially in the context of an increasingly complex and aging patient population.

Dr. Vogel reported no conflicts of interest and no outside sources of funding.

[email protected]

Vidyard Video

Female sterilization is the most common method of contraception worldwide, and the second most common contraceptive method used in the United States. Approximately 643,000 sterilization procedures are performed annually.¹ Approximately 1% to 3% of women who undergo sterilization will subsequently undergo a sterilization reversal.² Although multiple variables have been identified, change in marital status is the most commonly cited reason for desiring a tubal reversal.^3,4 Tubal anastomosis can be a technically challenging surgical procedure when done by laparoscopy, especially given the microsurgical elements that are required. Several modifications, including limiting the number of sutures, have evolved as a result of its tedious nature.⁵ By leveraging 3D magnification, articulating instruments, and tremor filtration, it is only natural that robotic surgery has been applied to tubal anastomosis.

In this video, we review some background information surrounding a tubal reversal, followed by demonstration of a robotic interpretation of a 2-stitch anastomosis technique in a patient who successfully conceived and delivered.⁶ Overall robot-assisted laparoscopic tubal anastomosis is a feasible and safe option for women who desire reversal of surgical sterilization, with pregnancy and live-birth rates comparable to those observed when an open technique is utilized.⁷ I hope that you will find this video beneficial to your clinical practice.

Vidyard Video

Female sterilization is the most common method of contraception worldwide, and the second most common contraceptive method used in the United States. Approximately 643,000 sterilization procedures are performed annually.¹ Approximately 1% to 3% of women who undergo sterilization will subsequently undergo a sterilization reversal.² Although multiple variables have been identified, change in marital status is the most commonly cited reason for desiring a tubal reversal.^3,4 Tubal anastomosis can be a technically challenging surgical procedure when done by laparoscopy, especially given the microsurgical elements that are required. Several modifications, including limiting the number of sutures, have evolved as a result of its tedious nature.⁵ By leveraging 3D magnification, articulating instruments, and tremor filtration, it is only natural that robotic surgery has been applied to tubal anastomosis.

In this video, we review some background information surrounding a tubal reversal, followed by demonstration of a robotic interpretation of a 2-stitch anastomosis technique in a patient who successfully conceived and delivered.⁶ Overall robot-assisted laparoscopic tubal anastomosis is a feasible and safe option for women who desire reversal of surgical sterilization, with pregnancy and live-birth rates comparable to those observed when an open technique is utilized.⁷ I hope that you will find this video beneficial to your clinical practice.

Vidyard Video

Female sterilization is the most common method of contraception worldwide, and the second most common contraceptive method used in the United States. Approximately 643,000 sterilization procedures are performed annually.¹ Approximately 1% to 3% of women who undergo sterilization will subsequently undergo a sterilization reversal.² Although multiple variables have been identified, change in marital status is the most commonly cited reason for desiring a tubal reversal.^3,4 Tubal anastomosis can be a technically challenging surgical procedure when done by laparoscopy, especially given the microsurgical elements that are required. Several modifications, including limiting the number of sutures, have evolved as a result of its tedious nature.⁵ By leveraging 3D magnification, articulating instruments, and tremor filtration, it is only natural that robotic surgery has been applied to tubal anastomosis.

In this video, we review some background information surrounding a tubal reversal, followed by demonstration of a robotic interpretation of a 2-stitch anastomosis technique in a patient who successfully conceived and delivered.⁶ Overall robot-assisted laparoscopic tubal anastomosis is a feasible and safe option for women who desire reversal of surgical sterilization, with pregnancy and live-birth rates comparable to those observed when an open technique is utilized.⁷ I hope that you will find this video beneficial to your clinical practice.

Preeclampsia is one of the most significant medical complications in pregnancy because of the acute onset it can have in so many affected patients. This acute onset may then rapidly progress to eclampsia and to severe consequences, including maternal death. In addition, the disorder can occur as early as the late second trimester and can thus impact the timing of delivery and fetal age at birth.

It is an obstetrical syndrome with serious implications for the fetus, the infant at birth, and the mother, and it is one whose incidence has been increasing. A full knowledge of the disease state – its pathophysiology, clinical manifestations, and various therapeutic options, both medical and surgical – is critical for the health and well-being of both the mother and fetus.

A new classification system introduced in 2013 by the American College of Obstetricians and Gynecologists’ Task Force Report on Hypertension in Pregnancy has added further complexity to an already complicated disease. On one hand, attempting to precisely achieve a diagnosis with such an imprecise and insidious disease seems ill advised. On the other hand, it is important to achieve some level of clarity with respect to diagnosis and management. In doing so, we must lean toward overdiagnosis and maintain a low threshold for treatment and intervention in the interest of the mother and infant.

I have engaged Baha M. Sibai, MD, professor of obstetrics, gynecology, and reproductive sciences at the University of Texas McGovern Medical School, Houston, to introduce a practical approach for interpreting and utilizing the ACOG report. This installment is the first of a two-part series in which we hope to provide practical clinical strategies for this complex disease.

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].

Preeclampsia is one of the most significant medical complications in pregnancy because of the acute onset it can have in so many affected patients. This acute onset may then rapidly progress to eclampsia and to severe consequences, including maternal death. In addition, the disorder can occur as early as the late second trimester and can thus impact the timing of delivery and fetal age at birth.

It is an obstetrical syndrome with serious implications for the fetus, the infant at birth, and the mother, and it is one whose incidence has been increasing. A full knowledge of the disease state – its pathophysiology, clinical manifestations, and various therapeutic options, both medical and surgical – is critical for the health and well-being of both the mother and fetus.

A new classification system introduced in 2013 by the American College of Obstetricians and Gynecologists’ Task Force Report on Hypertension in Pregnancy has added further complexity to an already complicated disease. On one hand, attempting to precisely achieve a diagnosis with such an imprecise and insidious disease seems ill advised. On the other hand, it is important to achieve some level of clarity with respect to diagnosis and management. In doing so, we must lean toward overdiagnosis and maintain a low threshold for treatment and intervention in the interest of the mother and infant.

I have engaged Baha M. Sibai, MD, professor of obstetrics, gynecology, and reproductive sciences at the University of Texas McGovern Medical School, Houston, to introduce a practical approach for interpreting and utilizing the ACOG report. This installment is the first of a two-part series in which we hope to provide practical clinical strategies for this complex disease.

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].

Preeclampsia is one of the most significant medical complications in pregnancy because of the acute onset it can have in so many affected patients. This acute onset may then rapidly progress to eclampsia and to severe consequences, including maternal death. In addition, the disorder can occur as early as the late second trimester and can thus impact the timing of delivery and fetal age at birth.

It is an obstetrical syndrome with serious implications for the fetus, the infant at birth, and the mother, and it is one whose incidence has been increasing. A full knowledge of the disease state – its pathophysiology, clinical manifestations, and various therapeutic options, both medical and surgical – is critical for the health and well-being of both the mother and fetus.

A new classification system introduced in 2013 by the American College of Obstetricians and Gynecologists’ Task Force Report on Hypertension in Pregnancy has added further complexity to an already complicated disease. On one hand, attempting to precisely achieve a diagnosis with such an imprecise and insidious disease seems ill advised. On the other hand, it is important to achieve some level of clarity with respect to diagnosis and management. In doing so, we must lean toward overdiagnosis and maintain a low threshold for treatment and intervention in the interest of the mother and infant.

I have engaged Baha M. Sibai, MD, professor of obstetrics, gynecology, and reproductive sciences at the University of Texas McGovern Medical School, Houston, to introduce a practical approach for interpreting and utilizing the ACOG report. This installment is the first of a two-part series in which we hope to provide practical clinical strategies for this complex disease.

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].

Prenatal care always has been in part about identifying women with medical complications including preeclampsia. We have long measured blood pressure, checked the urine for high levels of protein, and monitored weight gain. We still do.

However, over the years, the diagnostic criteria for preeclampsia have evolved, first with the exclusion of edema and more recently with the exclusion of proteinuria as a necessary element of the diagnosis. The American College of Obstetricians and Gynecologists’ Task Force Report, Hypertension in Pregnancy, published in 2013, concluded that while preeclampsia may still be defined by the occurrence of hypertension with proteinuria, it also may be diagnosed when hypertension occurs in association with other multisystemic signs indicative of disease severity. The change came based on evidence that some women develop eclampsia, HELLP syndrome, and other serious complications in the absence of proteinuria.

The 2013 document also attempted to review and clarify various issues relating to the classifications, diagnosis, prediction and prevention, and management of hypertension during pregnancy, including the postpartum period. In many respects, it was successful in doing so. However, there is still much confusion regarding the diagnosis of certain categories of hypertensive disorders – particularly preeclampsia with severe features and superimposed preeclampsia with or without severe features.

While it is difficult to establish precise definitions given the often insidious nature of preeclampsia, it still is important to achieve a higher level of clarity with respect to these categories. Overdiagnosis may be preferable. However, improper classification also may influence management decisions that could prove detrimental to the fetus.
 

Severe gestational hypertension

ACOG’s 2013 Report on Hypertension in Pregnancy classifies hypertensive disorders of pregnancy into these categories: Gestational hypertension (GHTN), preeclampsia, preeclampsia with severe features (this includes HELLP), chronic hypertension (CHTN), superimposed preeclampsia with or without severe features, and eclampsia.

Some of the definitions and diagnostic criteria are clear. For instance, GHTN is defined as the new onset of hypertension after 20 weeks’ gestation in the absence of proteinuria or systemic findings such as thrombocytopenia or impaired liver function. CHTN is defined as hypertension that predates conception or is detected before 20 weeks’ gestation. In both cases there should be elevated blood pressure on two occasions at least 4 hours apart.

A major omission is the lack of a definition for severe GHTN. Removal of this previously well-understood classification category combined with unclear statements regarding preeclampsia with or without severe features has made it difficult for physicians to know in some cases of severe hypertension only what diagnosis a woman should receive and how she should be managed.

I recommend that we maintain the category of severe GHTN, and that it be defined as a systolic blood pressure (BP) greater than or equal to 160 mm Hg and/or diastolic BP greater than or equal to 110 mm Hg on at least two occasions at least 4 hours apart when antihypertensive medications have not been initiated. There should be no proteinuria or severe features such as thrombocytopenia or impaired liver function.

The physician may elect in these cases to administer antihypertensive medication and observe the patient in the hospital. An individualized decision can then be made regarding how the patient should be managed, including whether she should be admitted and whether the pregnancy should continue beyond 34 weeks. Blood pressure, gestational age at diagnosis, the presence or absence of symptoms, and laboratory tests all should be taken into consideration.
 

Preeclampsia with or without severe features

We need to clarify and simplify how we think about GHTN and preeclampsia with or without severe features.

Most cases of preeclampsia will involve new-onset proteinuria, with proteinuria being defined as greater than or equal to 300 mg/day or a protein-creatinine ratio of greater than or equal to 0.3 mg/dL. In cases in which a dipstick test must be used, proteinuria is suggested by a urine protein reading of 1+. (It is important to note that dipstick readings should be taken on two separate occasions.) According to the report, preeclampsia also may be established by the presence of GHTN in association with any one of a list of features that are generally referred to as “severe features.”

Various boxes and textual descriptions in the report offer a sometimes confusing picture, however, of the terms preeclampsia and preeclampsia with severe features and their differences. For clarification, I recommend that we define preeclampsia with severe features as GHTN (mild or severe) in association with any one of the severe features.
 

Severe features of preeclampsia

• Platelet count less than 100,000/microliter.
• Elevated hepatic transaminases greater than two times the upper limit of normal for specific laboratory adult reference ranges.
• Severe persistent right upper quadrant abdominal pain or epigastric pain unresponsive to analgesics and unexplained by other etiology.
• Serum creatinine greater than 1.1 mg/dL.
• Pulmonary edema.
• Persistent cerebral disturbances such as severe persistent new-onset headaches unresponsive to nonnarcotic analgesics, altered mental status or other neurologic deficits.
• Visual disturbances such as blurred vision, scotomata, photophobia, or loss of vision.

I also suggest that we think of “mild” GHTN (systolic BP of 140-159 mm Hg or diastolic BP 90-109 mm Hg) and preeclampsia without severe features as one in the same, and that we manage them similarly. The presence or absence of proteinuria is currently the only difference diagnostically. The only difference with respect to management – aside from a weekly urine protein check in the case of GHTN – is the frequency of nonstress testing (NST) and amniotic fluid index (AFI) measurement (currently once a week for GHTN and twice a week for preeclampsia).

Given that unnecessary time and energy may be spent differentiating the two when management is essentially the same, I suggest that preeclampsia be diagnosed in any patient with GHTN with or without proteinuria. All patients can then be managed with blood pressure checks twice a week; symptoms and kick count daily; NST and AFI twice a week; estimated fetal weight by ultrasound every third week; lab tests (CBC, liver enzymes, and creatinine) once a week, and delivery at 37 weeks.

Superimposed preeclampsia with or without severe features

As the report states, the recognition of preeclampsia superimposed on chronic hypertension is “perhaps the greatest challenge” in the diagnosis and management of hypertensive disorders in pregnancy. Overdiagnosis “may be preferable,” the report says, given the high risk of adverse pregnancy outcomes with superimposed preeclampsia. On the other hand, it says, a “more stratified approach based on severity and predictors of adverse outcome may be useful” in avoiding unnecessary preterm births.

Ultimately, the task force proposed that we utilize the two categories of “superimposed preeclampsia” and “superimposed preeclampsia with severe features,” and in doing so, it noted that there “often is ambiguity in the diagnosis of superimposed preeclampsia and that the clinical spectrum of disease is broad.” Indeed, the diagnosis of superimposed preeclampsia as presented in the report remains vague and open to interpretation. In my institution, it has created significant confusion.

The report states that superimposed preeclampsia is likely when any of the following are present: 1) a sudden increase in blood pressure that was previously well controlled or escalation of antihypertensive medications to control blood pressure, or 2) new onset of proteinuria or a sudden increase in proteinuria in a woman with known proteinuria before or early in pregnancy.

It is not clear, however, what is considered a sudden increase in blood pressure, and it is concerning that any escalation of medication could potentially prompt this diagnosis. Is an increase in systolic blood pressure from 140 mm Hg to 150 mm Hg or an increase in diastolic blood pressure from 90 mm Hg to 100 mm Hg between two prenatal visits considered a “sudden increase”? Does an increase in methyldopa dosage from 250 mg daily to 500 mg daily to keep blood pressure within the range of mild hypertension mean that the patient should be diagnosed with superimposed preeclampsia? Hypertension is likely to increase and require an escalation of antihypertensive medications as patients with chronic hypertension progress through their pregnancies.

Similarly, a “sudden increase in proteinuria” – or “sudden, substantial, and sustained increases in protein excretion,” as written elsewhere in the report with respect to superimposed preeclampsia – also is undefined. What exactly does this mean? That we lack clinically meaningful parameters and clear descriptions of acceptable criteria/scenarios for observation rather than intervention is troubling, particularly because some of these women may have preexisting renal disease with expected increases and fluctuations in protein excretion during advanced gestation.

We must be cautious about making a diagnosis of superimposed preeclampsia based on changes in blood pressure or urinary protein alone, lest we have unnecessary hospitalizations and interventions. I recommend that the diagnosis of superimposed preeclampsia be made based on either the new onset of proteinuria in association with mild hypertension after 20 weeks or on elevation in blood pressure to severe ranges (systolic BP greater than or equal to160 mm Hg and/or diastolic BP greater than or equal to 110 mm Hg) despite the use of maximum doses of one antihypertensive drug.

Regarding superimposed preeclampsia with severe features, I recommend that in the case of blood pressure elevation, it be diagnosed only after maximal doses of two medications have been used. Specifically, I recommend that superimposed preeclampsia with severe features be defined as either CHTN or superimposed preeclampsia in association with either systolic BP greater than or equal to 160 mm Hg and/or diastolic BP greater than or equal to 110 mm Hg on at least two occasions despite use of maximum doses of labetalol (2,400 mg/day) plus long-acting nifedipine (120 mg/day), or with any of the other severe features.

In a second installment of the Master Class, I will elaborate on the treatment of severe GHTN and address the management of preeclampsia with severe features as well as postpartum management of hypertension during pregnancy.
 

Suggested diagnostic definitions

• Preeclampsia with severe features: GHTN in association with severe features.
• Superimposed preeclampsia: CHTN with either the new onset of proteinuria in association with mild hypertension after 20 weeks, or an elevation in blood pressure to severe ranges (systolic BP greater than or equal to 160 mm Hg and/or diastolic BP greater than or equal to 110 mm Hg) despite the use of the maximal dose of one antihypertensive drug.
• Superimposed preeclampsia with severe features: CHTN or superimposed preeclampsia with severe features or with a rise in blood pressure to severe ranges despite the maximal doses of two antihypertensive drugs (e.g. 2,400 mg/day labetalol plus 120 mg/day long-acting nifedipine).

Note: These definitions reflect adaptations and clarifications of ACOG’s 2013 Task Force Report on Hypertension in Pregnancy.

Dr. Sibai is professor of obstetrics, gynecology, and reproductive sciences at the University of Texas McGovern Medical School, Houston.

Prenatal care always has been in part about identifying women with medical complications including preeclampsia. We have long measured blood pressure, checked the urine for high levels of protein, and monitored weight gain. We still do.

However, over the years, the diagnostic criteria for preeclampsia have evolved, first with the exclusion of edema and more recently with the exclusion of proteinuria as a necessary element of the diagnosis. The American College of Obstetricians and Gynecologists’ Task Force Report, Hypertension in Pregnancy, published in 2013, concluded that while preeclampsia may still be defined by the occurrence of hypertension with proteinuria, it also may be diagnosed when hypertension occurs in association with other multisystemic signs indicative of disease severity. The change came based on evidence that some women develop eclampsia, HELLP syndrome, and other serious complications in the absence of proteinuria.

The 2013 document also attempted to review and clarify various issues relating to the classifications, diagnosis, prediction and prevention, and management of hypertension during pregnancy, including the postpartum period. In many respects, it was successful in doing so. However, there is still much confusion regarding the diagnosis of certain categories of hypertensive disorders – particularly preeclampsia with severe features and superimposed preeclampsia with or without severe features.

While it is difficult to establish precise definitions given the often insidious nature of preeclampsia, it still is important to achieve a higher level of clarity with respect to these categories. Overdiagnosis may be preferable. However, improper classification also may influence management decisions that could prove detrimental to the fetus.
 

Severe gestational hypertension

ACOG’s 2013 Report on Hypertension in Pregnancy classifies hypertensive disorders of pregnancy into these categories: Gestational hypertension (GHTN), preeclampsia, preeclampsia with severe features (this includes HELLP), chronic hypertension (CHTN), superimposed preeclampsia with or without severe features, and eclampsia.

Some of the definitions and diagnostic criteria are clear. For instance, GHTN is defined as the new onset of hypertension after 20 weeks’ gestation in the absence of proteinuria or systemic findings such as thrombocytopenia or impaired liver function. CHTN is defined as hypertension that predates conception or is detected before 20 weeks’ gestation. In both cases there should be elevated blood pressure on two occasions at least 4 hours apart.

A major omission is the lack of a definition for severe GHTN. Removal of this previously well-understood classification category combined with unclear statements regarding preeclampsia with or without severe features has made it difficult for physicians to know in some cases of severe hypertension only what diagnosis a woman should receive and how she should be managed.

I recommend that we maintain the category of severe GHTN, and that it be defined as a systolic blood pressure (BP) greater than or equal to 160 mm Hg and/or diastolic BP greater than or equal to 110 mm Hg on at least two occasions at least 4 hours apart when antihypertensive medications have not been initiated. There should be no proteinuria or severe features such as thrombocytopenia or impaired liver function.

The physician may elect in these cases to administer antihypertensive medication and observe the patient in the hospital. An individualized decision can then be made regarding how the patient should be managed, including whether she should be admitted and whether the pregnancy should continue beyond 34 weeks. Blood pressure, gestational age at diagnosis, the presence or absence of symptoms, and laboratory tests all should be taken into consideration.
 

Preeclampsia with or without severe features

We need to clarify and simplify how we think about GHTN and preeclampsia with or without severe features.

Most cases of preeclampsia will involve new-onset proteinuria, with proteinuria being defined as greater than or equal to 300 mg/day or a protein-creatinine ratio of greater than or equal to 0.3 mg/dL. In cases in which a dipstick test must be used, proteinuria is suggested by a urine protein reading of 1+. (It is important to note that dipstick readings should be taken on two separate occasions.) According to the report, preeclampsia also may be established by the presence of GHTN in association with any one of a list of features that are generally referred to as “severe features.”

Various boxes and textual descriptions in the report offer a sometimes confusing picture, however, of the terms preeclampsia and preeclampsia with severe features and their differences. For clarification, I recommend that we define preeclampsia with severe features as GHTN (mild or severe) in association with any one of the severe features.
 

Severe features of preeclampsia

• Platelet count less than 100,000/microliter.
• Elevated hepatic transaminases greater than two times the upper limit of normal for specific laboratory adult reference ranges.
• Severe persistent right upper quadrant abdominal pain or epigastric pain unresponsive to analgesics and unexplained by other etiology.
• Serum creatinine greater than 1.1 mg/dL.
• Pulmonary edema.
• Persistent cerebral disturbances such as severe persistent new-onset headaches unresponsive to nonnarcotic analgesics, altered mental status or other neurologic deficits.
• Visual disturbances such as blurred vision, scotomata, photophobia, or loss of vision.

I also suggest that we think of “mild” GHTN (systolic BP of 140-159 mm Hg or diastolic BP 90-109 mm Hg) and preeclampsia without severe features as one in the same, and that we manage them similarly. The presence or absence of proteinuria is currently the only difference diagnostically. The only difference with respect to management – aside from a weekly urine protein check in the case of GHTN – is the frequency of nonstress testing (NST) and amniotic fluid index (AFI) measurement (currently once a week for GHTN and twice a week for preeclampsia).

Given that unnecessary time and energy may be spent differentiating the two when management is essentially the same, I suggest that preeclampsia be diagnosed in any patient with GHTN with or without proteinuria. All patients can then be managed with blood pressure checks twice a week; symptoms and kick count daily; NST and AFI twice a week; estimated fetal weight by ultrasound every third week; lab tests (CBC, liver enzymes, and creatinine) once a week, and delivery at 37 weeks.

Superimposed preeclampsia with or without severe features

As the report states, the recognition of preeclampsia superimposed on chronic hypertension is “perhaps the greatest challenge” in the diagnosis and management of hypertensive disorders in pregnancy. Overdiagnosis “may be preferable,” the report says, given the high risk of adverse pregnancy outcomes with superimposed preeclampsia. On the other hand, it says, a “more stratified approach based on severity and predictors of adverse outcome may be useful” in avoiding unnecessary preterm births.

Ultimately, the task force proposed that we utilize the two categories of “superimposed preeclampsia” and “superimposed preeclampsia with severe features,” and in doing so, it noted that there “often is ambiguity in the diagnosis of superimposed preeclampsia and that the clinical spectrum of disease is broad.” Indeed, the diagnosis of superimposed preeclampsia as presented in the report remains vague and open to interpretation. In my institution, it has created significant confusion.

The report states that superimposed preeclampsia is likely when any of the following are present: 1) a sudden increase in blood pressure that was previously well controlled or escalation of antihypertensive medications to control blood pressure, or 2) new onset of proteinuria or a sudden increase in proteinuria in a woman with known proteinuria before or early in pregnancy.

It is not clear, however, what is considered a sudden increase in blood pressure, and it is concerning that any escalation of medication could potentially prompt this diagnosis. Is an increase in systolic blood pressure from 140 mm Hg to 150 mm Hg or an increase in diastolic blood pressure from 90 mm Hg to 100 mm Hg between two prenatal visits considered a “sudden increase”? Does an increase in methyldopa dosage from 250 mg daily to 500 mg daily to keep blood pressure within the range of mild hypertension mean that the patient should be diagnosed with superimposed preeclampsia? Hypertension is likely to increase and require an escalation of antihypertensive medications as patients with chronic hypertension progress through their pregnancies.

Similarly, a “sudden increase in proteinuria” – or “sudden, substantial, and sustained increases in protein excretion,” as written elsewhere in the report with respect to superimposed preeclampsia – also is undefined. What exactly does this mean? That we lack clinically meaningful parameters and clear descriptions of acceptable criteria/scenarios for observation rather than intervention is troubling, particularly because some of these women may have preexisting renal disease with expected increases and fluctuations in protein excretion during advanced gestation.

We must be cautious about making a diagnosis of superimposed preeclampsia based on changes in blood pressure or urinary protein alone, lest we have unnecessary hospitalizations and interventions. I recommend that the diagnosis of superimposed preeclampsia be made based on either the new onset of proteinuria in association with mild hypertension after 20 weeks or on elevation in blood pressure to severe ranges (systolic BP greater than or equal to160 mm Hg and/or diastolic BP greater than or equal to 110 mm Hg) despite the use of maximum doses of one antihypertensive drug.

Regarding superimposed preeclampsia with severe features, I recommend that in the case of blood pressure elevation, it be diagnosed only after maximal doses of two medications have been used. Specifically, I recommend that superimposed preeclampsia with severe features be defined as either CHTN or superimposed preeclampsia in association with either systolic BP greater than or equal to 160 mm Hg and/or diastolic BP greater than or equal to 110 mm Hg on at least two occasions despite use of maximum doses of labetalol (2,400 mg/day) plus long-acting nifedipine (120 mg/day), or with any of the other severe features.

In a second installment of the Master Class, I will elaborate on the treatment of severe GHTN and address the management of preeclampsia with severe features as well as postpartum management of hypertension during pregnancy.
 

Suggested diagnostic definitions

• Preeclampsia with severe features: GHTN in association with severe features.
• Superimposed preeclampsia: CHTN with either the new onset of proteinuria in association with mild hypertension after 20 weeks, or an elevation in blood pressure to severe ranges (systolic BP greater than or equal to 160 mm Hg and/or diastolic BP greater than or equal to 110 mm Hg) despite the use of the maximal dose of one antihypertensive drug.
• Superimposed preeclampsia with severe features: CHTN or superimposed preeclampsia with severe features or with a rise in blood pressure to severe ranges despite the maximal doses of two antihypertensive drugs (e.g. 2,400 mg/day labetalol plus 120 mg/day long-acting nifedipine).

Note: These definitions reflect adaptations and clarifications of ACOG’s 2013 Task Force Report on Hypertension in Pregnancy.

Dr. Sibai is professor of obstetrics, gynecology, and reproductive sciences at the University of Texas McGovern Medical School, Houston.

Prenatal care always has been in part about identifying women with medical complications including preeclampsia. We have long measured blood pressure, checked the urine for high levels of protein, and monitored weight gain. We still do.

However, over the years, the diagnostic criteria for preeclampsia have evolved, first with the exclusion of edema and more recently with the exclusion of proteinuria as a necessary element of the diagnosis. The American College of Obstetricians and Gynecologists’ Task Force Report, Hypertension in Pregnancy, published in 2013, concluded that while preeclampsia may still be defined by the occurrence of hypertension with proteinuria, it also may be diagnosed when hypertension occurs in association with other multisystemic signs indicative of disease severity. The change came based on evidence that some women develop eclampsia, HELLP syndrome, and other serious complications in the absence of proteinuria.

The 2013 document also attempted to review and clarify various issues relating to the classifications, diagnosis, prediction and prevention, and management of hypertension during pregnancy, including the postpartum period. In many respects, it was successful in doing so. However, there is still much confusion regarding the diagnosis of certain categories of hypertensive disorders – particularly preeclampsia with severe features and superimposed preeclampsia with or without severe features.

While it is difficult to establish precise definitions given the often insidious nature of preeclampsia, it still is important to achieve a higher level of clarity with respect to these categories. Overdiagnosis may be preferable. However, improper classification also may influence management decisions that could prove detrimental to the fetus.
 

Severe gestational hypertension

ACOG’s 2013 Report on Hypertension in Pregnancy classifies hypertensive disorders of pregnancy into these categories: Gestational hypertension (GHTN), preeclampsia, preeclampsia with severe features (this includes HELLP), chronic hypertension (CHTN), superimposed preeclampsia with or without severe features, and eclampsia.

Some of the definitions and diagnostic criteria are clear. For instance, GHTN is defined as the new onset of hypertension after 20 weeks’ gestation in the absence of proteinuria or systemic findings such as thrombocytopenia or impaired liver function. CHTN is defined as hypertension that predates conception or is detected before 20 weeks’ gestation. In both cases there should be elevated blood pressure on two occasions at least 4 hours apart.

A major omission is the lack of a definition for severe GHTN. Removal of this previously well-understood classification category combined with unclear statements regarding preeclampsia with or without severe features has made it difficult for physicians to know in some cases of severe hypertension only what diagnosis a woman should receive and how she should be managed.

I recommend that we maintain the category of severe GHTN, and that it be defined as a systolic blood pressure (BP) greater than or equal to 160 mm Hg and/or diastolic BP greater than or equal to 110 mm Hg on at least two occasions at least 4 hours apart when antihypertensive medications have not been initiated. There should be no proteinuria or severe features such as thrombocytopenia or impaired liver function.

The physician may elect in these cases to administer antihypertensive medication and observe the patient in the hospital. An individualized decision can then be made regarding how the patient should be managed, including whether she should be admitted and whether the pregnancy should continue beyond 34 weeks. Blood pressure, gestational age at diagnosis, the presence or absence of symptoms, and laboratory tests all should be taken into consideration.
 

Preeclampsia with or without severe features

We need to clarify and simplify how we think about GHTN and preeclampsia with or without severe features.

Most cases of preeclampsia will involve new-onset proteinuria, with proteinuria being defined as greater than or equal to 300 mg/day or a protein-creatinine ratio of greater than or equal to 0.3 mg/dL. In cases in which a dipstick test must be used, proteinuria is suggested by a urine protein reading of 1+. (It is important to note that dipstick readings should be taken on two separate occasions.) According to the report, preeclampsia also may be established by the presence of GHTN in association with any one of a list of features that are generally referred to as “severe features.”

Various boxes and textual descriptions in the report offer a sometimes confusing picture, however, of the terms preeclampsia and preeclampsia with severe features and their differences. For clarification, I recommend that we define preeclampsia with severe features as GHTN (mild or severe) in association with any one of the severe features.
 

Severe features of preeclampsia

• Platelet count less than 100,000/microliter.
• Elevated hepatic transaminases greater than two times the upper limit of normal for specific laboratory adult reference ranges.
• Severe persistent right upper quadrant abdominal pain or epigastric pain unresponsive to analgesics and unexplained by other etiology.
• Serum creatinine greater than 1.1 mg/dL.
• Pulmonary edema.
• Persistent cerebral disturbances such as severe persistent new-onset headaches unresponsive to nonnarcotic analgesics, altered mental status or other neurologic deficits.
• Visual disturbances such as blurred vision, scotomata, photophobia, or loss of vision.

I also suggest that we think of “mild” GHTN (systolic BP of 140-159 mm Hg or diastolic BP 90-109 mm Hg) and preeclampsia without severe features as one in the same, and that we manage them similarly. The presence or absence of proteinuria is currently the only difference diagnostically. The only difference with respect to management – aside from a weekly urine protein check in the case of GHTN – is the frequency of nonstress testing (NST) and amniotic fluid index (AFI) measurement (currently once a week for GHTN and twice a week for preeclampsia).

Given that unnecessary time and energy may be spent differentiating the two when management is essentially the same, I suggest that preeclampsia be diagnosed in any patient with GHTN with or without proteinuria. All patients can then be managed with blood pressure checks twice a week; symptoms and kick count daily; NST and AFI twice a week; estimated fetal weight by ultrasound every third week; lab tests (CBC, liver enzymes, and creatinine) once a week, and delivery at 37 weeks.

Superimposed preeclampsia with or without severe features

As the report states, the recognition of preeclampsia superimposed on chronic hypertension is “perhaps the greatest challenge” in the diagnosis and management of hypertensive disorders in pregnancy. Overdiagnosis “may be preferable,” the report says, given the high risk of adverse pregnancy outcomes with superimposed preeclampsia. On the other hand, it says, a “more stratified approach based on severity and predictors of adverse outcome may be useful” in avoiding unnecessary preterm births.

Ultimately, the task force proposed that we utilize the two categories of “superimposed preeclampsia” and “superimposed preeclampsia with severe features,” and in doing so, it noted that there “often is ambiguity in the diagnosis of superimposed preeclampsia and that the clinical spectrum of disease is broad.” Indeed, the diagnosis of superimposed preeclampsia as presented in the report remains vague and open to interpretation. In my institution, it has created significant confusion.

The report states that superimposed preeclampsia is likely when any of the following are present: 1) a sudden increase in blood pressure that was previously well controlled or escalation of antihypertensive medications to control blood pressure, or 2) new onset of proteinuria or a sudden increase in proteinuria in a woman with known proteinuria before or early in pregnancy.

It is not clear, however, what is considered a sudden increase in blood pressure, and it is concerning that any escalation of medication could potentially prompt this diagnosis. Is an increase in systolic blood pressure from 140 mm Hg to 150 mm Hg or an increase in diastolic blood pressure from 90 mm Hg to 100 mm Hg between two prenatal visits considered a “sudden increase”? Does an increase in methyldopa dosage from 250 mg daily to 500 mg daily to keep blood pressure within the range of mild hypertension mean that the patient should be diagnosed with superimposed preeclampsia? Hypertension is likely to increase and require an escalation of antihypertensive medications as patients with chronic hypertension progress through their pregnancies.

Similarly, a “sudden increase in proteinuria” – or “sudden, substantial, and sustained increases in protein excretion,” as written elsewhere in the report with respect to superimposed preeclampsia – also is undefined. What exactly does this mean? That we lack clinically meaningful parameters and clear descriptions of acceptable criteria/scenarios for observation rather than intervention is troubling, particularly because some of these women may have preexisting renal disease with expected increases and fluctuations in protein excretion during advanced gestation.

We must be cautious about making a diagnosis of superimposed preeclampsia based on changes in blood pressure or urinary protein alone, lest we have unnecessary hospitalizations and interventions. I recommend that the diagnosis of superimposed preeclampsia be made based on either the new onset of proteinuria in association with mild hypertension after 20 weeks or on elevation in blood pressure to severe ranges (systolic BP greater than or equal to160 mm Hg and/or diastolic BP greater than or equal to 110 mm Hg) despite the use of maximum doses of one antihypertensive drug.

Regarding superimposed preeclampsia with severe features, I recommend that in the case of blood pressure elevation, it be diagnosed only after maximal doses of two medications have been used. Specifically, I recommend that superimposed preeclampsia with severe features be defined as either CHTN or superimposed preeclampsia in association with either systolic BP greater than or equal to 160 mm Hg and/or diastolic BP greater than or equal to 110 mm Hg on at least two occasions despite use of maximum doses of labetalol (2,400 mg/day) plus long-acting nifedipine (120 mg/day), or with any of the other severe features.

In a second installment of the Master Class, I will elaborate on the treatment of severe GHTN and address the management of preeclampsia with severe features as well as postpartum management of hypertension during pregnancy.
 

Suggested diagnostic definitions

• Preeclampsia with severe features: GHTN in association with severe features.
• Superimposed preeclampsia: CHTN with either the new onset of proteinuria in association with mild hypertension after 20 weeks, or an elevation in blood pressure to severe ranges (systolic BP greater than or equal to 160 mm Hg and/or diastolic BP greater than or equal to 110 mm Hg) despite the use of the maximal dose of one antihypertensive drug.
• Superimposed preeclampsia with severe features: CHTN or superimposed preeclampsia with severe features or with a rise in blood pressure to severe ranges despite the maximal doses of two antihypertensive drugs (e.g. 2,400 mg/day labetalol plus 120 mg/day long-acting nifedipine).

Note: These definitions reflect adaptations and clarifications of ACOG’s 2013 Task Force Report on Hypertension in Pregnancy.

Dr. Sibai is professor of obstetrics, gynecology, and reproductive sciences at the University of Texas McGovern Medical School, Houston.

As the Supreme Court sits for its second session on Oct. 29, legal analysts question what impact its newest Associate Justice, Brett M. Kavanaugh, may have on health care cases that might come before the court.

Collection of the Supreme Court of the United States

The addition of Justice Kavanaugh cements a conservative majority on the high court, said Eric J. Segall, a constitutional law professor at Georgia State University in Atlanta.

“Where Justice Kennedy was moderate or liberal, Justice Kavanaugh will move the court dramatically to the right in most areas of law,” Mr. Segall said in an interview.

One area drawing considerable attention is abortion, with abortion rights advocates raising concerns that Justice Kavanaugh’s appointment may mean the reversal of Roe v. Wade. Legal analysts, however, say fall of the momentous ruling is not probable.

Based on his decisions written while he sat on the Court of Appeals for the District of Columbia Circuit, it’s more likely that Justice Kavanaugh would attempt to narrow the instances in which state abortion restrictions are considered to impede a woman’s constitutional right to an abortion, according to Timothy S. Jost, a legal analyst and retired health law professor at Washington and Lee University in Lexington, Va.

In Garza v. Hargan for example, then-Judge Kavanaugh dissented from a majority decision which ultimately allowed a teenage immigrant in U.S. custody to have an abortion. Judge Kavanaugh argued that it was wrong for unlawful immigrant minors in U.S. detention to obtain “immediate abortion on demand.” However, his dissent was not as far-reaching as that of another judge who argued that a minor undocumented immigrant had no constitutional right to an abortion.

As the Supreme Court sits for its second session on Oct. 29, legal analysts question what impact its newest Associate Justice, Brett M. Kavanaugh, may have on health care cases that might come before the court.

Collection of the Supreme Court of the United States

The addition of Justice Kavanaugh cements a conservative majority on the high court, said Eric J. Segall, a constitutional law professor at Georgia State University in Atlanta.

“Where Justice Kennedy was moderate or liberal, Justice Kavanaugh will move the court dramatically to the right in most areas of law,” Mr. Segall said in an interview.

One area drawing considerable attention is abortion, with abortion rights advocates raising concerns that Justice Kavanaugh’s appointment may mean the reversal of Roe v. Wade. Legal analysts, however, say fall of the momentous ruling is not probable.

Based on his decisions written while he sat on the Court of Appeals for the District of Columbia Circuit, it’s more likely that Justice Kavanaugh would attempt to narrow the instances in which state abortion restrictions are considered to impede a woman’s constitutional right to an abortion, according to Timothy S. Jost, a legal analyst and retired health law professor at Washington and Lee University in Lexington, Va.

In Garza v. Hargan for example, then-Judge Kavanaugh dissented from a majority decision which ultimately allowed a teenage immigrant in U.S. custody to have an abortion. Judge Kavanaugh argued that it was wrong for unlawful immigrant minors in U.S. detention to obtain “immediate abortion on demand.” However, his dissent was not as far-reaching as that of another judge who argued that a minor undocumented immigrant had no constitutional right to an abortion.

As the Supreme Court sits for its second session on Oct. 29, legal analysts question what impact its newest Associate Justice, Brett M. Kavanaugh, may have on health care cases that might come before the court.

Collection of the Supreme Court of the United States

The addition of Justice Kavanaugh cements a conservative majority on the high court, said Eric J. Segall, a constitutional law professor at Georgia State University in Atlanta.

“Where Justice Kennedy was moderate or liberal, Justice Kavanaugh will move the court dramatically to the right in most areas of law,” Mr. Segall said in an interview.

One area drawing considerable attention is abortion, with abortion rights advocates raising concerns that Justice Kavanaugh’s appointment may mean the reversal of Roe v. Wade. Legal analysts, however, say fall of the momentous ruling is not probable.

Based on his decisions written while he sat on the Court of Appeals for the District of Columbia Circuit, it’s more likely that Justice Kavanaugh would attempt to narrow the instances in which state abortion restrictions are considered to impede a woman’s constitutional right to an abortion, according to Timothy S. Jost, a legal analyst and retired health law professor at Washington and Lee University in Lexington, Va.

In Garza v. Hargan for example, then-Judge Kavanaugh dissented from a majority decision which ultimately allowed a teenage immigrant in U.S. custody to have an abortion. Judge Kavanaugh argued that it was wrong for unlawful immigrant minors in U.S. detention to obtain “immediate abortion on demand.” However, his dissent was not as far-reaching as that of another judge who argued that a minor undocumented immigrant had no constitutional right to an abortion.

BARCELONA – Amyloid PET brain imaging changed clinical management in 60% of patients with a diagnosis of mild cognitive impairment or dementia and confirmed a presumptive Alzheimer’s diagnosis in 95% of those with positive scans.

But the scans also benefited amyloid-negative patients, Gil Rabinovici, MD, said at the Clinical Trials on Alzheimer’s Disease conference. Before the test, 71% carried an Alzheimer’s disease (AD) diagnosis; after the test, just 10% did, opening the way for an accurate diagnosis and more effective treatment.

“These patients were saved from unnecessary treatment for Alzheimer’s,” said Dr. Rabinovici, the Edward Fein and Pearl Landrith Endowed Professor in Memory & Aging at the University of California, San Francisco. They received more suitable care plans because of the confirmation.

He presented final results of aim one of the IDEAS (Imaging Dementia–Evidence for Amyloid Scanning) study, which seeks to prove that amyloid imaging changes clinical management and improves health outcomes in Medicare beneficiaries who have been diagnosed with mild cognitive impairment (MCI) or dementia of uncertain cause. Its two aims are to show that amyloid PET imaging affects a patient’s care plan within 3 months of the scan and that this impacts major medical outcomes 12 months later. In diagnostically uncertain cases, investigators theorized, amyloid PET imaging would lead to significant changes in patient management, which would then translate into improved medical outcomes.

Ultimately, investigators hope the U.S.-wide, open-label study will prove the clinical value of amyloid PET scanning and convince the Centers for Medicare & Medicaid Services to make the test a fully covered service.

So far, IDEAS has accrued data on 11,409 patients and is quickly closing in on the 18,000-patient target. The patients reported on at CTAD were aged a mean of 75 years and were largely white; only 4% were black and 4% Hispanic. The mean Mini-Mental Scale Exam score was 26. AD was the leading suspect pathology in 73% of the 6,905 with MCI and in 83% of those with dementia of uncertain etiology. Overall, 44% were taking AD medications at baseline.

Scans were positive in 55% of those with MCI and in 70% of those with dementia. Overall, the scans changed clinical management in 61% (7,018), including 60% of those with MCI and 63% of those with dementia.

“We also asked physicians how much the scan results contributed to these changes, and 86.7% replied that they ‘contributed significantly,’ ” Dr. Rabinovici said.

Most changes involved adjustments to medication. AD drugs were started in 44% of MCI patients and in 45% of dementia patients, and non-AD drugs started in 22% and 25%, respectively. About a fifth of the patients received counseling in wake of the scan results.

Medication adjustments also varied by scan result. Among amyloid-positive MCI patients, AD drug use increased from 40% before imaging to 81% after; among amyloid-negative MCI patients, drug use decreased slightly from 27% to 24%. Among amyloid-positive dementia patients, AD drug use increased from 63% to 91%, and among amyloid-negative patients, it dropped from 50% to 44%. All these changes were statistically significant.

The primary diagnosis changed from AD to non-AD in 25%, and from non-AD to AD in 10%. Among amyloid-positive patients, the diagnosis prevalence jumped from 80.0% to 95.5%; among amyloid-negative patients, it dropped from 71% to just 10%.

“IDEAS now provides the strongest data we have supporting the beneficial impact of amyloid PET on patient management,” said Dr. Rabinovici. “Aim two, which is the 12-month health outcomes, we expect to be completed by the end of next year.”

The IDEAS team is also looking at a furthering the investigation with a study called, aptly, “NEW IDEAS.” That would reach out to recruit the minorities that were so underrepresented in the main study and include patients with early-onset MCI or dementia. Building up a library of DNA and blood plasma samples might also fit into the new project.

IDEAS is a funding collaboration of the CMS, the Alzheimer’s Association, Avid Radiopharmaceuticals/Eli Lilly, General Electric Healthcare, Piramal Imaging, and the American College of Radiology. Dr. Rabinovici had no financial disclosures.

[email protected]

BARCELONA – Amyloid PET brain imaging changed clinical management in 60% of patients with a diagnosis of mild cognitive impairment or dementia and confirmed a presumptive Alzheimer’s diagnosis in 95% of those with positive scans.

But the scans also benefited amyloid-negative patients, Gil Rabinovici, MD, said at the Clinical Trials on Alzheimer’s Disease conference. Before the test, 71% carried an Alzheimer’s disease (AD) diagnosis; after the test, just 10% did, opening the way for an accurate diagnosis and more effective treatment.

“These patients were saved from unnecessary treatment for Alzheimer’s,” said Dr. Rabinovici, the Edward Fein and Pearl Landrith Endowed Professor in Memory & Aging at the University of California, San Francisco. They received more suitable care plans because of the confirmation.

He presented final results of aim one of the IDEAS (Imaging Dementia–Evidence for Amyloid Scanning) study, which seeks to prove that amyloid imaging changes clinical management and improves health outcomes in Medicare beneficiaries who have been diagnosed with mild cognitive impairment (MCI) or dementia of uncertain cause. Its two aims are to show that amyloid PET imaging affects a patient’s care plan within 3 months of the scan and that this impacts major medical outcomes 12 months later. In diagnostically uncertain cases, investigators theorized, amyloid PET imaging would lead to significant changes in patient management, which would then translate into improved medical outcomes.

Ultimately, investigators hope the U.S.-wide, open-label study will prove the clinical value of amyloid PET scanning and convince the Centers for Medicare & Medicaid Services to make the test a fully covered service.

So far, IDEAS has accrued data on 11,409 patients and is quickly closing in on the 18,000-patient target. The patients reported on at CTAD were aged a mean of 75 years and were largely white; only 4% were black and 4% Hispanic. The mean Mini-Mental Scale Exam score was 26. AD was the leading suspect pathology in 73% of the 6,905 with MCI and in 83% of those with dementia of uncertain etiology. Overall, 44% were taking AD medications at baseline.

Scans were positive in 55% of those with MCI and in 70% of those with dementia. Overall, the scans changed clinical management in 61% (7,018), including 60% of those with MCI and 63% of those with dementia.

“We also asked physicians how much the scan results contributed to these changes, and 86.7% replied that they ‘contributed significantly,’ ” Dr. Rabinovici said.

Most changes involved adjustments to medication. AD drugs were started in 44% of MCI patients and in 45% of dementia patients, and non-AD drugs started in 22% and 25%, respectively. About a fifth of the patients received counseling in wake of the scan results.

Medication adjustments also varied by scan result. Among amyloid-positive MCI patients, AD drug use increased from 40% before imaging to 81% after; among amyloid-negative MCI patients, drug use decreased slightly from 27% to 24%. Among amyloid-positive dementia patients, AD drug use increased from 63% to 91%, and among amyloid-negative patients, it dropped from 50% to 44%. All these changes were statistically significant.

The primary diagnosis changed from AD to non-AD in 25%, and from non-AD to AD in 10%. Among amyloid-positive patients, the diagnosis prevalence jumped from 80.0% to 95.5%; among amyloid-negative patients, it dropped from 71% to just 10%.

“IDEAS now provides the strongest data we have supporting the beneficial impact of amyloid PET on patient management,” said Dr. Rabinovici. “Aim two, which is the 12-month health outcomes, we expect to be completed by the end of next year.”

The IDEAS team is also looking at a furthering the investigation with a study called, aptly, “NEW IDEAS.” That would reach out to recruit the minorities that were so underrepresented in the main study and include patients with early-onset MCI or dementia. Building up a library of DNA and blood plasma samples might also fit into the new project.

IDEAS is a funding collaboration of the CMS, the Alzheimer’s Association, Avid Radiopharmaceuticals/Eli Lilly, General Electric Healthcare, Piramal Imaging, and the American College of Radiology. Dr. Rabinovici had no financial disclosures.

[email protected]

BARCELONA – Amyloid PET brain imaging changed clinical management in 60% of patients with a diagnosis of mild cognitive impairment or dementia and confirmed a presumptive Alzheimer’s diagnosis in 95% of those with positive scans.

But the scans also benefited amyloid-negative patients, Gil Rabinovici, MD, said at the Clinical Trials on Alzheimer’s Disease conference. Before the test, 71% carried an Alzheimer’s disease (AD) diagnosis; after the test, just 10% did, opening the way for an accurate diagnosis and more effective treatment.

“These patients were saved from unnecessary treatment for Alzheimer’s,” said Dr. Rabinovici, the Edward Fein and Pearl Landrith Endowed Professor in Memory & Aging at the University of California, San Francisco. They received more suitable care plans because of the confirmation.

He presented final results of aim one of the IDEAS (Imaging Dementia–Evidence for Amyloid Scanning) study, which seeks to prove that amyloid imaging changes clinical management and improves health outcomes in Medicare beneficiaries who have been diagnosed with mild cognitive impairment (MCI) or dementia of uncertain cause. Its two aims are to show that amyloid PET imaging affects a patient’s care plan within 3 months of the scan and that this impacts major medical outcomes 12 months later. In diagnostically uncertain cases, investigators theorized, amyloid PET imaging would lead to significant changes in patient management, which would then translate into improved medical outcomes.

Ultimately, investigators hope the U.S.-wide, open-label study will prove the clinical value of amyloid PET scanning and convince the Centers for Medicare & Medicaid Services to make the test a fully covered service.

So far, IDEAS has accrued data on 11,409 patients and is quickly closing in on the 18,000-patient target. The patients reported on at CTAD were aged a mean of 75 years and were largely white; only 4% were black and 4% Hispanic. The mean Mini-Mental Scale Exam score was 26. AD was the leading suspect pathology in 73% of the 6,905 with MCI and in 83% of those with dementia of uncertain etiology. Overall, 44% were taking AD medications at baseline.

Scans were positive in 55% of those with MCI and in 70% of those with dementia. Overall, the scans changed clinical management in 61% (7,018), including 60% of those with MCI and 63% of those with dementia.

“We also asked physicians how much the scan results contributed to these changes, and 86.7% replied that they ‘contributed significantly,’ ” Dr. Rabinovici said.

Most changes involved adjustments to medication. AD drugs were started in 44% of MCI patients and in 45% of dementia patients, and non-AD drugs started in 22% and 25%, respectively. About a fifth of the patients received counseling in wake of the scan results.

Medication adjustments also varied by scan result. Among amyloid-positive MCI patients, AD drug use increased from 40% before imaging to 81% after; among amyloid-negative MCI patients, drug use decreased slightly from 27% to 24%. Among amyloid-positive dementia patients, AD drug use increased from 63% to 91%, and among amyloid-negative patients, it dropped from 50% to 44%. All these changes were statistically significant.

The primary diagnosis changed from AD to non-AD in 25%, and from non-AD to AD in 10%. Among amyloid-positive patients, the diagnosis prevalence jumped from 80.0% to 95.5%; among amyloid-negative patients, it dropped from 71% to just 10%.

“IDEAS now provides the strongest data we have supporting the beneficial impact of amyloid PET on patient management,” said Dr. Rabinovici. “Aim two, which is the 12-month health outcomes, we expect to be completed by the end of next year.”

The IDEAS team is also looking at a furthering the investigation with a study called, aptly, “NEW IDEAS.” That would reach out to recruit the minorities that were so underrepresented in the main study and include patients with early-onset MCI or dementia. Building up a library of DNA and blood plasma samples might also fit into the new project.

IDEAS is a funding collaboration of the CMS, the Alzheimer’s Association, Avid Radiopharmaceuticals/Eli Lilly, General Electric Healthcare, Piramal Imaging, and the American College of Radiology. Dr. Rabinovici had no financial disclosures.

[email protected]