Video

Read the full Cutis article, “Quality of Life in Patients With Atopic Dermatitis.”

Read the full Cutis article, “Quality of Life in Patients With Atopic Dermatitis.”

Read the full Cutis article, “Quality of Life in Patients With Atopic Dermatitis.”

SAN DIEGO – A relatively new treatment approach called good psychiatric management (GPM) is available for patients with borderline personality disorder.

It’s a solid option for “environments where people may not have many resources and might not be able to deliver treatments that are more resource intensive, like dialectical behavioral therapy,” the standard intervention, said James Jenkins, MD, a psychiatrist affiliated with Massachusetts General Hospital, Boston, in a video interview at the annual Psych Congress.

“GPM is a treatment, not a psychotherapy, that’s maybe a little bit more easily adaptable to a variety of different contexts and situations,” he said.

It’s an atheoretical, pragmatic approach that focuses on helping people establish a life outside of therapy. Clinicians actively engage with patients, encouraging them to start working and building successful relationships with other people. The model emphasizes the value of educating people about the condition and giving them hope. Typically, patients participate in GPM once each week (Curr Opin Psychol. 2018 Jun;21:127-31).

Vidyard Video

For most people, it works just as well as dialectical behavioral therapy, and when it doesn’t, patients can transition to that or another more intensive approach. Training is less intensive and sometimes free. GPM is offered at McLean Hospital in Boston, where the intervention originated. McLean also is Dr. Jenkins’s former institution.

Dr. Jenkins reported that he had no disclosures.

[email protected]

SAN DIEGO – A relatively new treatment approach called good psychiatric management (GPM) is available for patients with borderline personality disorder.

It’s a solid option for “environments where people may not have many resources and might not be able to deliver treatments that are more resource intensive, like dialectical behavioral therapy,” the standard intervention, said James Jenkins, MD, a psychiatrist affiliated with Massachusetts General Hospital, Boston, in a video interview at the annual Psych Congress.

“GPM is a treatment, not a psychotherapy, that’s maybe a little bit more easily adaptable to a variety of different contexts and situations,” he said.

It’s an atheoretical, pragmatic approach that focuses on helping people establish a life outside of therapy. Clinicians actively engage with patients, encouraging them to start working and building successful relationships with other people. The model emphasizes the value of educating people about the condition and giving them hope. Typically, patients participate in GPM once each week (Curr Opin Psychol. 2018 Jun;21:127-31).

Vidyard Video

For most people, it works just as well as dialectical behavioral therapy, and when it doesn’t, patients can transition to that or another more intensive approach. Training is less intensive and sometimes free. GPM is offered at McLean Hospital in Boston, where the intervention originated. McLean also is Dr. Jenkins’s former institution.

Dr. Jenkins reported that he had no disclosures.

[email protected]

SAN DIEGO – A relatively new treatment approach called good psychiatric management (GPM) is available for patients with borderline personality disorder.

It’s a solid option for “environments where people may not have many resources and might not be able to deliver treatments that are more resource intensive, like dialectical behavioral therapy,” the standard intervention, said James Jenkins, MD, a psychiatrist affiliated with Massachusetts General Hospital, Boston, in a video interview at the annual Psych Congress.

“GPM is a treatment, not a psychotherapy, that’s maybe a little bit more easily adaptable to a variety of different contexts and situations,” he said.

It’s an atheoretical, pragmatic approach that focuses on helping people establish a life outside of therapy. Clinicians actively engage with patients, encouraging them to start working and building successful relationships with other people. The model emphasizes the value of educating people about the condition and giving them hope. Typically, patients participate in GPM once each week (Curr Opin Psychol. 2018 Jun;21:127-31).

Vidyard Video

For most people, it works just as well as dialectical behavioral therapy, and when it doesn’t, patients can transition to that or another more intensive approach. Training is less intensive and sometimes free. GPM is offered at McLean Hospital in Boston, where the intervention originated. McLean also is Dr. Jenkins’s former institution.

Dr. Jenkins reported that he had no disclosures.

[email protected]

WASHINGTON – Patients hospitalized for pyelonephritis and discharged after receiving intravenous antibiotic treatment who then received step-down treatment with an oral beta-lactam had 30-day outcomes that were noninferior to patients who received an oral fluoroquinolone or trimethoprim-sulfamethoxazole as their discharge regimen, in a retrospective study of 211 patients managed at either of two U.S. hospitals.

This was the largest comparison reported on oral beta-lactam drugs for postdischarge treatment of pyelonephritis relative to the standard oral agents, fluoroquinolones and trimethoprim-sulfamethoxazole (Bactrim), Athena Hobbs, PharmD, said at an annual scientific meeting on infectious diseases. The superiority of an oral fluoroquinolone or trimethoprim-sulfamethoxazole and inferiority of oral beta-lactam drugs were cited in 2010 guidelines for managing pyelonephritis from the Infectious Diseases Society of America (Clin Infect Dis. 2011 March 1;52 [5]: e103-20).

Although limited as a nonrandomized, retrospective comparison, the finding of at least similar efficacy by beta-lactam agents “opens new treatment options” that avoid issues with drug resistance and adverse effects from treatment with fluoroquinolones or trimethoprim-sulfamethoxazole, Dr. Hobbs said in a video interview. Beta-lactams have already been embraced for this indication by some hospitalists, demonstrated by their use of beta-lactam antibiotics for 122 (58%) of the 211 patients included in the study. Among the 89 patients discharged on a non–beta-lactam, 69 (78%) had fluoroquinolone treatment and the remaining 20 patients went home taking trimethoprim-sulfamethoxazole. The new finding “confirms that we are not doing harm to patients,” with this existing practice of mostly prescribing an oral beta-lactam drug, noted Dr. Hobbs, an infectious diseases pharmacy specialist at Baptist Memorial Hospital in Memphis.

The study included patients aged 18-89 years hospitalized during 2014-2017 for a primary diagnosis of pyelonephritis at Baptist or at a second Hospital in Austin, Tex. The study excluded patients in intensive care, with a urologic abnormality, pregnant women, and patients treated with an intravenous antibiotic other than a beta-lactam for more than 24 hours. The most commonly used intravenous drugs were cefazolin and ceftriaxone. The enrolled patients averaged just over 40 years old, and more than 90% were women.

The study’s primary outcome was the 30-day rate of either hospital readmission or an ED visit for pyelonephritis or a urinary tract infection. This occurred in 4.9% of the patients discharged on an oral course of a beta-lactam drug, and in 5.6% of those discharged on either a fluoroquinolone or trimethoprim-sulfamethoxazole, a difference that was not statistically significant and that met the prespecified criteria for noninferiority, Dr. Hobbs reported. The most commonly prescribed oral beta-lactam was cefuroxime in about half the patients, followed by cephalexin or cefadroxil in about a quarter of patients, and amoxicillin with clavulanate in 19%. The two arms of the study also showed no significant difference in infection recurrences during 90-day follow-up.

The study received no commercial funding. Dr. Hobbs had no relevant disclosures.

[email protected]

WASHINGTON – Patients hospitalized for pyelonephritis and discharged after receiving intravenous antibiotic treatment who then received step-down treatment with an oral beta-lactam had 30-day outcomes that were noninferior to patients who received an oral fluoroquinolone or trimethoprim-sulfamethoxazole as their discharge regimen, in a retrospective study of 211 patients managed at either of two U.S. hospitals.

This was the largest comparison reported on oral beta-lactam drugs for postdischarge treatment of pyelonephritis relative to the standard oral agents, fluoroquinolones and trimethoprim-sulfamethoxazole (Bactrim), Athena Hobbs, PharmD, said at an annual scientific meeting on infectious diseases. The superiority of an oral fluoroquinolone or trimethoprim-sulfamethoxazole and inferiority of oral beta-lactam drugs were cited in 2010 guidelines for managing pyelonephritis from the Infectious Diseases Society of America (Clin Infect Dis. 2011 March 1;52 [5]: e103-20).

Although limited as a nonrandomized, retrospective comparison, the finding of at least similar efficacy by beta-lactam agents “opens new treatment options” that avoid issues with drug resistance and adverse effects from treatment with fluoroquinolones or trimethoprim-sulfamethoxazole, Dr. Hobbs said in a video interview. Beta-lactams have already been embraced for this indication by some hospitalists, demonstrated by their use of beta-lactam antibiotics for 122 (58%) of the 211 patients included in the study. Among the 89 patients discharged on a non–beta-lactam, 69 (78%) had fluoroquinolone treatment and the remaining 20 patients went home taking trimethoprim-sulfamethoxazole. The new finding “confirms that we are not doing harm to patients,” with this existing practice of mostly prescribing an oral beta-lactam drug, noted Dr. Hobbs, an infectious diseases pharmacy specialist at Baptist Memorial Hospital in Memphis.

The study included patients aged 18-89 years hospitalized during 2014-2017 for a primary diagnosis of pyelonephritis at Baptist or at a second Hospital in Austin, Tex. The study excluded patients in intensive care, with a urologic abnormality, pregnant women, and patients treated with an intravenous antibiotic other than a beta-lactam for more than 24 hours. The most commonly used intravenous drugs were cefazolin and ceftriaxone. The enrolled patients averaged just over 40 years old, and more than 90% were women.

The study’s primary outcome was the 30-day rate of either hospital readmission or an ED visit for pyelonephritis or a urinary tract infection. This occurred in 4.9% of the patients discharged on an oral course of a beta-lactam drug, and in 5.6% of those discharged on either a fluoroquinolone or trimethoprim-sulfamethoxazole, a difference that was not statistically significant and that met the prespecified criteria for noninferiority, Dr. Hobbs reported. The most commonly prescribed oral beta-lactam was cefuroxime in about half the patients, followed by cephalexin or cefadroxil in about a quarter of patients, and amoxicillin with clavulanate in 19%. The two arms of the study also showed no significant difference in infection recurrences during 90-day follow-up.

The study received no commercial funding. Dr. Hobbs had no relevant disclosures.

[email protected]

WASHINGTON – Patients hospitalized for pyelonephritis and discharged after receiving intravenous antibiotic treatment who then received step-down treatment with an oral beta-lactam had 30-day outcomes that were noninferior to patients who received an oral fluoroquinolone or trimethoprim-sulfamethoxazole as their discharge regimen, in a retrospective study of 211 patients managed at either of two U.S. hospitals.

This was the largest comparison reported on oral beta-lactam drugs for postdischarge treatment of pyelonephritis relative to the standard oral agents, fluoroquinolones and trimethoprim-sulfamethoxazole (Bactrim), Athena Hobbs, PharmD, said at an annual scientific meeting on infectious diseases. The superiority of an oral fluoroquinolone or trimethoprim-sulfamethoxazole and inferiority of oral beta-lactam drugs were cited in 2010 guidelines for managing pyelonephritis from the Infectious Diseases Society of America (Clin Infect Dis. 2011 March 1;52 [5]: e103-20).

Although limited as a nonrandomized, retrospective comparison, the finding of at least similar efficacy by beta-lactam agents “opens new treatment options” that avoid issues with drug resistance and adverse effects from treatment with fluoroquinolones or trimethoprim-sulfamethoxazole, Dr. Hobbs said in a video interview. Beta-lactams have already been embraced for this indication by some hospitalists, demonstrated by their use of beta-lactam antibiotics for 122 (58%) of the 211 patients included in the study. Among the 89 patients discharged on a non–beta-lactam, 69 (78%) had fluoroquinolone treatment and the remaining 20 patients went home taking trimethoprim-sulfamethoxazole. The new finding “confirms that we are not doing harm to patients,” with this existing practice of mostly prescribing an oral beta-lactam drug, noted Dr. Hobbs, an infectious diseases pharmacy specialist at Baptist Memorial Hospital in Memphis.

The study included patients aged 18-89 years hospitalized during 2014-2017 for a primary diagnosis of pyelonephritis at Baptist or at a second Hospital in Austin, Tex. The study excluded patients in intensive care, with a urologic abnormality, pregnant women, and patients treated with an intravenous antibiotic other than a beta-lactam for more than 24 hours. The most commonly used intravenous drugs were cefazolin and ceftriaxone. The enrolled patients averaged just over 40 years old, and more than 90% were women.

The study’s primary outcome was the 30-day rate of either hospital readmission or an ED visit for pyelonephritis or a urinary tract infection. This occurred in 4.9% of the patients discharged on an oral course of a beta-lactam drug, and in 5.6% of those discharged on either a fluoroquinolone or trimethoprim-sulfamethoxazole, a difference that was not statistically significant and that met the prespecified criteria for noninferiority, Dr. Hobbs reported. The most commonly prescribed oral beta-lactam was cefuroxime in about half the patients, followed by cephalexin or cefadroxil in about a quarter of patients, and amoxicillin with clavulanate in 19%. The two arms of the study also showed no significant difference in infection recurrences during 90-day follow-up.

The study received no commercial funding. Dr. Hobbs had no relevant disclosures.

[email protected]

SAN DIEGO – You don’t have to stop prescribing lithium when patients go on ACE inhibitors or angiotensin-receptor blockers (ARBs) for blood pressure treatment.

Some might opt to do that, but there’s no need to worry. In fact, the reason both classes are known to protect the kidneys is that they were tested with lithium; it was used to measure the drug’s effects on renal clearance, according to Stephen R. Saklad, PharmD, director of psychiatric pharmacy and clinical professor at the University of Texas at Austin.

There is interaction, but “lithium is not toxic in the presence of an ACE or an RB. You just have to adjust the dose,” he said at the annual Psych Congress.

Dr. Saklad shared lithium drug interaction pearls during a video interview at the meeting, including also using lithium with diuretics and NSAIDs. “The worst offender is probably my favorite of the NSAIDs, which is ibuprofen,” he said.

Most of the time with lithium, all that’s needed is a dose adjustment up or down of either it or the coadministered medication.

The overall guiding principle, he said, is that “lithium follows sodium. Anything that alters sodium in the body is going to alter sodium.”

[email protected]

SAN DIEGO – You don’t have to stop prescribing lithium when patients go on ACE inhibitors or angiotensin-receptor blockers (ARBs) for blood pressure treatment.

Some might opt to do that, but there’s no need to worry. In fact, the reason both classes are known to protect the kidneys is that they were tested with lithium; it was used to measure the drug’s effects on renal clearance, according to Stephen R. Saklad, PharmD, director of psychiatric pharmacy and clinical professor at the University of Texas at Austin.

There is interaction, but “lithium is not toxic in the presence of an ACE or an RB. You just have to adjust the dose,” he said at the annual Psych Congress.

Dr. Saklad shared lithium drug interaction pearls during a video interview at the meeting, including also using lithium with diuretics and NSAIDs. “The worst offender is probably my favorite of the NSAIDs, which is ibuprofen,” he said.

Most of the time with lithium, all that’s needed is a dose adjustment up or down of either it or the coadministered medication.

The overall guiding principle, he said, is that “lithium follows sodium. Anything that alters sodium in the body is going to alter sodium.”

[email protected]

SAN DIEGO – You don’t have to stop prescribing lithium when patients go on ACE inhibitors or angiotensin-receptor blockers (ARBs) for blood pressure treatment.

Some might opt to do that, but there’s no need to worry. In fact, the reason both classes are known to protect the kidneys is that they were tested with lithium; it was used to measure the drug’s effects on renal clearance, according to Stephen R. Saklad, PharmD, director of psychiatric pharmacy and clinical professor at the University of Texas at Austin.

There is interaction, but “lithium is not toxic in the presence of an ACE or an RB. You just have to adjust the dose,” he said at the annual Psych Congress.

Dr. Saklad shared lithium drug interaction pearls during a video interview at the meeting, including also using lithium with diuretics and NSAIDs. “The worst offender is probably my favorite of the NSAIDs, which is ibuprofen,” he said.

Most of the time with lithium, all that’s needed is a dose adjustment up or down of either it or the coadministered medication.

The overall guiding principle, he said, is that “lithium follows sodium. Anything that alters sodium in the body is going to alter sodium.”

[email protected]

SAN DIEGO – Lofexidine (Lucemyra), the new kid on the block in the United States for opioid withdrawal, can help patients get through the process in a few days, instead of a week or more, according to Thomas Kosten, MD, a psychiatry professor and director of the division of addictions at Baylor College of Medicine, Houston.

Lofexidine relieves symptom withdrawal and has significant advantages over clonidine, a similar drug, including easier dosing and no orthostatic hypertension.

In a video interview at the annual Psych Congress, Dr. Kosten went into the nuts and bolts of how to use lofexidine with buprenorphine and naltrexone – plus benzodiazepines when needed – to help people safely go through withdrawal and in just a few days.

Once chronic pain patients are off opioids, the next question is what to do for their pain. In a presentation before the interview, Dr. Kosten said he favors tricyclic antidepressants, especially desipramine because it has the fewest side effects. The effect size with tricyclic antidepressants is larger than with gabapentin and other options. They take a few weeks to kick in, however, so he’s thinking about a unique approach: using ketamine – either infusions or the new nasal spray esketamine (Spravato) – to tide people over in the meantime. It’s becoming well known that ketamine works amazingly fast for depression and suicidality, and there is emerging support that it might do the same for chronic pain. Dr. Kosten is a consultant for US Worldmeds, maker of lofexidine.

[email protected]

SAN DIEGO – Lofexidine (Lucemyra), the new kid on the block in the United States for opioid withdrawal, can help patients get through the process in a few days, instead of a week or more, according to Thomas Kosten, MD, a psychiatry professor and director of the division of addictions at Baylor College of Medicine, Houston.

Lofexidine relieves symptom withdrawal and has significant advantages over clonidine, a similar drug, including easier dosing and no orthostatic hypertension.

In a video interview at the annual Psych Congress, Dr. Kosten went into the nuts and bolts of how to use lofexidine with buprenorphine and naltrexone – plus benzodiazepines when needed – to help people safely go through withdrawal and in just a few days.

Once chronic pain patients are off opioids, the next question is what to do for their pain. In a presentation before the interview, Dr. Kosten said he favors tricyclic antidepressants, especially desipramine because it has the fewest side effects. The effect size with tricyclic antidepressants is larger than with gabapentin and other options. They take a few weeks to kick in, however, so he’s thinking about a unique approach: using ketamine – either infusions or the new nasal spray esketamine (Spravato) – to tide people over in the meantime. It’s becoming well known that ketamine works amazingly fast for depression and suicidality, and there is emerging support that it might do the same for chronic pain. Dr. Kosten is a consultant for US Worldmeds, maker of lofexidine.

[email protected]

SAN DIEGO – Lofexidine (Lucemyra), the new kid on the block in the United States for opioid withdrawal, can help patients get through the process in a few days, instead of a week or more, according to Thomas Kosten, MD, a psychiatry professor and director of the division of addictions at Baylor College of Medicine, Houston.

Lofexidine relieves symptom withdrawal and has significant advantages over clonidine, a similar drug, including easier dosing and no orthostatic hypertension.

In a video interview at the annual Psych Congress, Dr. Kosten went into the nuts and bolts of how to use lofexidine with buprenorphine and naltrexone – plus benzodiazepines when needed – to help people safely go through withdrawal and in just a few days.

Once chronic pain patients are off opioids, the next question is what to do for their pain. In a presentation before the interview, Dr. Kosten said he favors tricyclic antidepressants, especially desipramine because it has the fewest side effects. The effect size with tricyclic antidepressants is larger than with gabapentin and other options. They take a few weeks to kick in, however, so he’s thinking about a unique approach: using ketamine – either infusions or the new nasal spray esketamine (Spravato) – to tide people over in the meantime. It’s becoming well known that ketamine works amazingly fast for depression and suicidality, and there is emerging support that it might do the same for chronic pain. Dr. Kosten is a consultant for US Worldmeds, maker of lofexidine.

[email protected]

PARIS – An accelerated rule-out pathway, reliant upon a single high-sensitivity cardiac troponin test upon presentation to the ED with suspected acute coronary syndrome, reduced length of stay and hospital admission rates without increasing cardiac events at 30 days or 1 year in a major Scottish study.

“We conclude that implementation of this early rule-out pathway is both effective and safe, and adoption of this pathway will have major benefits for patients and health care systems,” Nicholas L. Mills, MBChB, PhD, said in presenting the results of the HiSTORIC (High-Sensitivity Cardiac Troponin at Presentation to Rule Out Myocardial Infarction) trial at the annual congress of the European Society of Cardiology.

Indeed, in the Unites States, where more than 20 million people per year present to EDs with suspected ACS, the 3.3-hour reduction in length of stay achieved in the HiSTORIC trial by implementing the accelerated rule-out pathway would add up to a $3.6 billion annual savings in bed occupancy alone, according to Dr. Mills, who is chair of cardiology at the University of Edinburgh.

The HiSTORIC pathway incorporates separate thresholds for risk stratification and diagnosis. This strategy is based on an accumulation of persuasive evidence that the major advantage of high-sensitivity cardiac troponin testing is to rule out MI, rather than to rule it in, Dr. Mills explained.

HiSTORIC was a 2-year, prospective, stepped-wedge, cluster-randomized, controlled trial including 31,492 consecutive patients with suspected ACS who presented to seven participating hospitals in Scotland. Patients were randomized, at the hospital level, to one of two management pathways. The control group got a standard guideline-recommended strategy involving high-sensitivity cardiac troponin I testing upon presentation and again 6-12 hours later, with MI being ruled out if the troponin levels were not above the 99th percentile.

In contrast, the novel early rule-out strategy worked as follows: If the patient presented with at least 2 hours of symptoms and the initial troponin I level was below 5 ng/L, then MI was ruled out and the patient was triaged straightaway for outpatient management. If the level was above the 99th percentile, the patient was admitted for serial testing to be done 6-12 hours after symptom onset. And for an intermediate test result – that is, a troponin level between 5 ng/L and the 99th percentile – patients remained in the ED for retesting 3 hours from the time of presentation, and were subsequently admitted only if their troponin level was rising.

Using the accelerated rule-out strategy, two-thirds of patients were quickly discharged from the ED on the basis of a troponin level below 5 ng/mL, and another 7% were ruled out for MI and discharged from the ED after a 3-hour stay on the basis of their second test.

The primary efficacy outcome was length of stay from initial presentation to the ED to discharge. The duration was 10.1 hours with the guideline-recommended pathway and 6.8 hours with the accelerated rule-out pathway, for a statistically significant and clinically meaningful 3.3-hour difference. Moreover, the proportion of patients discharged directly from the ED without hospital admission increased from 53% to 74%, a 57% jump.

The primary safety outcome was the rate of MI or cardiac death post discharge. The rates at 30 days and 1 year were 0.4% and 2.6%, respectively, in the standard-pathway group, compared with 0.3% and 1.8% with the early rule-out pathway. Those between-group differences favoring the accelerated rule-out pathway weren’t statistically significant, but they provided reassurance that the novel pathway was safe.

Of note, this was the first-ever randomized trial to evaluate the safety and efficacy of an early rule-out pathway. Other rapid diagnostic pathways are largely based on observational experience and expert opinion, Dr. Mills said.

The assay utilized in the HiSTORIC trial was the Abbott Diagnostics Architect high sensitivity assay. The 5-ng/L threshold for early rule-out was chosen for the trial because an earlier study by Dr. Mills and coinvestigators showed that a level below that cutoff had a 99.6% negative predictive value for MI (Lancet. 2015 Dec 19;386[10012]:2481-8)

The early rule-out pathway was deliberately designed to be simple and pragmatic, according to the cardiologist. “One of the most remarkable observations in this trial was the adherence to the pathway. We prespecified three criteria to evaluate this and demonstrated adherence rates of 86%-92% for each of these criteria. This was despite the pathway being implemented in all consecutive patients at seven different hospitals and used by many hundreds of different clinicians.”

Discussant Hugo A. Katus, MD, called the HiSTORIC study “a really urgently needed and very well-conducted trial.”

Bruce Jancin/MDedge News

“There were very consistently low MI and cardiac death rates at 30 days and 1 year. So this really works,” commented Dr. Katus, who is chief of internal medicine and director of the department of cardiovascular medicine at Heidelberg (Germany) University.

“Accelerated rule-out high-sensitivity cardiac troponin protocols are here to stay,” he declared.

However, Dr. Katus voiced a concern: “By early discharge as rule out, are other life-threatening conditions ignored?”

He raised this issue because of what he views as the substantial 1-year all-cause mortality and return-to-hospital rates of 5.8% and 39.2% in the standard-pathway group and 5.2% and 38.9% in the accelerated rule-out patients in HiSTORIC. An accelerated rule-out strategy should not prohibit a careful clinical work-up, he emphasized.

Dr. Mills discussed the results in a video interview.

The HiSTORIC trial was funded by the British Heart Foundation. Dr. Mills reported receiving research grants from Abbott Diagnostics and Siemens.

Simultaneous with Dr. Mills’ presentation of the HiSTORIC trial results at the ESC congress, an earlier study that formed the scientific basis for the investigators’ decision to employ distinct risk stratification and diagnostic thresholds for cardiac troponin testing was published online (Circulation. 2019 Sep 1. doi: 10.1161/CIRCULATIONAHA.119.042866). The actual HiSTORIC trial results will be published later.

Dr. Katus reported holding a patent for a cardiac troponin T test and serving as a consultant to AstraZeneca, Bayer, Boehringer Ingelheim, and Novo Nordisk.

[email protected]

PARIS – An accelerated rule-out pathway, reliant upon a single high-sensitivity cardiac troponin test upon presentation to the ED with suspected acute coronary syndrome, reduced length of stay and hospital admission rates without increasing cardiac events at 30 days or 1 year in a major Scottish study.

“We conclude that implementation of this early rule-out pathway is both effective and safe, and adoption of this pathway will have major benefits for patients and health care systems,” Nicholas L. Mills, MBChB, PhD, said in presenting the results of the HiSTORIC (High-Sensitivity Cardiac Troponin at Presentation to Rule Out Myocardial Infarction) trial at the annual congress of the European Society of Cardiology.

Indeed, in the Unites States, where more than 20 million people per year present to EDs with suspected ACS, the 3.3-hour reduction in length of stay achieved in the HiSTORIC trial by implementing the accelerated rule-out pathway would add up to a $3.6 billion annual savings in bed occupancy alone, according to Dr. Mills, who is chair of cardiology at the University of Edinburgh.

The HiSTORIC pathway incorporates separate thresholds for risk stratification and diagnosis. This strategy is based on an accumulation of persuasive evidence that the major advantage of high-sensitivity cardiac troponin testing is to rule out MI, rather than to rule it in, Dr. Mills explained.

HiSTORIC was a 2-year, prospective, stepped-wedge, cluster-randomized, controlled trial including 31,492 consecutive patients with suspected ACS who presented to seven participating hospitals in Scotland. Patients were randomized, at the hospital level, to one of two management pathways. The control group got a standard guideline-recommended strategy involving high-sensitivity cardiac troponin I testing upon presentation and again 6-12 hours later, with MI being ruled out if the troponin levels were not above the 99th percentile.

In contrast, the novel early rule-out strategy worked as follows: If the patient presented with at least 2 hours of symptoms and the initial troponin I level was below 5 ng/L, then MI was ruled out and the patient was triaged straightaway for outpatient management. If the level was above the 99th percentile, the patient was admitted for serial testing to be done 6-12 hours after symptom onset. And for an intermediate test result – that is, a troponin level between 5 ng/L and the 99th percentile – patients remained in the ED for retesting 3 hours from the time of presentation, and were subsequently admitted only if their troponin level was rising.

Using the accelerated rule-out strategy, two-thirds of patients were quickly discharged from the ED on the basis of a troponin level below 5 ng/mL, and another 7% were ruled out for MI and discharged from the ED after a 3-hour stay on the basis of their second test.

The primary efficacy outcome was length of stay from initial presentation to the ED to discharge. The duration was 10.1 hours with the guideline-recommended pathway and 6.8 hours with the accelerated rule-out pathway, for a statistically significant and clinically meaningful 3.3-hour difference. Moreover, the proportion of patients discharged directly from the ED without hospital admission increased from 53% to 74%, a 57% jump.

The primary safety outcome was the rate of MI or cardiac death post discharge. The rates at 30 days and 1 year were 0.4% and 2.6%, respectively, in the standard-pathway group, compared with 0.3% and 1.8% with the early rule-out pathway. Those between-group differences favoring the accelerated rule-out pathway weren’t statistically significant, but they provided reassurance that the novel pathway was safe.

Of note, this was the first-ever randomized trial to evaluate the safety and efficacy of an early rule-out pathway. Other rapid diagnostic pathways are largely based on observational experience and expert opinion, Dr. Mills said.

The assay utilized in the HiSTORIC trial was the Abbott Diagnostics Architect high sensitivity assay. The 5-ng/L threshold for early rule-out was chosen for the trial because an earlier study by Dr. Mills and coinvestigators showed that a level below that cutoff had a 99.6% negative predictive value for MI (Lancet. 2015 Dec 19;386[10012]:2481-8)

The early rule-out pathway was deliberately designed to be simple and pragmatic, according to the cardiologist. “One of the most remarkable observations in this trial was the adherence to the pathway. We prespecified three criteria to evaluate this and demonstrated adherence rates of 86%-92% for each of these criteria. This was despite the pathway being implemented in all consecutive patients at seven different hospitals and used by many hundreds of different clinicians.”

Discussant Hugo A. Katus, MD, called the HiSTORIC study “a really urgently needed and very well-conducted trial.”

Bruce Jancin/MDedge News

“There were very consistently low MI and cardiac death rates at 30 days and 1 year. So this really works,” commented Dr. Katus, who is chief of internal medicine and director of the department of cardiovascular medicine at Heidelberg (Germany) University.

“Accelerated rule-out high-sensitivity cardiac troponin protocols are here to stay,” he declared.

However, Dr. Katus voiced a concern: “By early discharge as rule out, are other life-threatening conditions ignored?”

He raised this issue because of what he views as the substantial 1-year all-cause mortality and return-to-hospital rates of 5.8% and 39.2% in the standard-pathway group and 5.2% and 38.9% in the accelerated rule-out patients in HiSTORIC. An accelerated rule-out strategy should not prohibit a careful clinical work-up, he emphasized.

Dr. Mills discussed the results in a video interview.

The HiSTORIC trial was funded by the British Heart Foundation. Dr. Mills reported receiving research grants from Abbott Diagnostics and Siemens.

Simultaneous with Dr. Mills’ presentation of the HiSTORIC trial results at the ESC congress, an earlier study that formed the scientific basis for the investigators’ decision to employ distinct risk stratification and diagnostic thresholds for cardiac troponin testing was published online (Circulation. 2019 Sep 1. doi: 10.1161/CIRCULATIONAHA.119.042866). The actual HiSTORIC trial results will be published later.

Dr. Katus reported holding a patent for a cardiac troponin T test and serving as a consultant to AstraZeneca, Bayer, Boehringer Ingelheim, and Novo Nordisk.

[email protected]

PARIS – An accelerated rule-out pathway, reliant upon a single high-sensitivity cardiac troponin test upon presentation to the ED with suspected acute coronary syndrome, reduced length of stay and hospital admission rates without increasing cardiac events at 30 days or 1 year in a major Scottish study.

“We conclude that implementation of this early rule-out pathway is both effective and safe, and adoption of this pathway will have major benefits for patients and health care systems,” Nicholas L. Mills, MBChB, PhD, said in presenting the results of the HiSTORIC (High-Sensitivity Cardiac Troponin at Presentation to Rule Out Myocardial Infarction) trial at the annual congress of the European Society of Cardiology.

Indeed, in the Unites States, where more than 20 million people per year present to EDs with suspected ACS, the 3.3-hour reduction in length of stay achieved in the HiSTORIC trial by implementing the accelerated rule-out pathway would add up to a $3.6 billion annual savings in bed occupancy alone, according to Dr. Mills, who is chair of cardiology at the University of Edinburgh.

The HiSTORIC pathway incorporates separate thresholds for risk stratification and diagnosis. This strategy is based on an accumulation of persuasive evidence that the major advantage of high-sensitivity cardiac troponin testing is to rule out MI, rather than to rule it in, Dr. Mills explained.

HiSTORIC was a 2-year, prospective, stepped-wedge, cluster-randomized, controlled trial including 31,492 consecutive patients with suspected ACS who presented to seven participating hospitals in Scotland. Patients were randomized, at the hospital level, to one of two management pathways. The control group got a standard guideline-recommended strategy involving high-sensitivity cardiac troponin I testing upon presentation and again 6-12 hours later, with MI being ruled out if the troponin levels were not above the 99th percentile.

In contrast, the novel early rule-out strategy worked as follows: If the patient presented with at least 2 hours of symptoms and the initial troponin I level was below 5 ng/L, then MI was ruled out and the patient was triaged straightaway for outpatient management. If the level was above the 99th percentile, the patient was admitted for serial testing to be done 6-12 hours after symptom onset. And for an intermediate test result – that is, a troponin level between 5 ng/L and the 99th percentile – patients remained in the ED for retesting 3 hours from the time of presentation, and were subsequently admitted only if their troponin level was rising.

Using the accelerated rule-out strategy, two-thirds of patients were quickly discharged from the ED on the basis of a troponin level below 5 ng/mL, and another 7% were ruled out for MI and discharged from the ED after a 3-hour stay on the basis of their second test.

The primary efficacy outcome was length of stay from initial presentation to the ED to discharge. The duration was 10.1 hours with the guideline-recommended pathway and 6.8 hours with the accelerated rule-out pathway, for a statistically significant and clinically meaningful 3.3-hour difference. Moreover, the proportion of patients discharged directly from the ED without hospital admission increased from 53% to 74%, a 57% jump.

The primary safety outcome was the rate of MI or cardiac death post discharge. The rates at 30 days and 1 year were 0.4% and 2.6%, respectively, in the standard-pathway group, compared with 0.3% and 1.8% with the early rule-out pathway. Those between-group differences favoring the accelerated rule-out pathway weren’t statistically significant, but they provided reassurance that the novel pathway was safe.

Of note, this was the first-ever randomized trial to evaluate the safety and efficacy of an early rule-out pathway. Other rapid diagnostic pathways are largely based on observational experience and expert opinion, Dr. Mills said.

The assay utilized in the HiSTORIC trial was the Abbott Diagnostics Architect high sensitivity assay. The 5-ng/L threshold for early rule-out was chosen for the trial because an earlier study by Dr. Mills and coinvestigators showed that a level below that cutoff had a 99.6% negative predictive value for MI (Lancet. 2015 Dec 19;386[10012]:2481-8)

The early rule-out pathway was deliberately designed to be simple and pragmatic, according to the cardiologist. “One of the most remarkable observations in this trial was the adherence to the pathway. We prespecified three criteria to evaluate this and demonstrated adherence rates of 86%-92% for each of these criteria. This was despite the pathway being implemented in all consecutive patients at seven different hospitals and used by many hundreds of different clinicians.”

Discussant Hugo A. Katus, MD, called the HiSTORIC study “a really urgently needed and very well-conducted trial.”

Bruce Jancin/MDedge News

“There were very consistently low MI and cardiac death rates at 30 days and 1 year. So this really works,” commented Dr. Katus, who is chief of internal medicine and director of the department of cardiovascular medicine at Heidelberg (Germany) University.

“Accelerated rule-out high-sensitivity cardiac troponin protocols are here to stay,” he declared.

However, Dr. Katus voiced a concern: “By early discharge as rule out, are other life-threatening conditions ignored?”

He raised this issue because of what he views as the substantial 1-year all-cause mortality and return-to-hospital rates of 5.8% and 39.2% in the standard-pathway group and 5.2% and 38.9% in the accelerated rule-out patients in HiSTORIC. An accelerated rule-out strategy should not prohibit a careful clinical work-up, he emphasized.

Dr. Mills discussed the results in a video interview.

The HiSTORIC trial was funded by the British Heart Foundation. Dr. Mills reported receiving research grants from Abbott Diagnostics and Siemens.

Simultaneous with Dr. Mills’ presentation of the HiSTORIC trial results at the ESC congress, an earlier study that formed the scientific basis for the investigators’ decision to employ distinct risk stratification and diagnostic thresholds for cardiac troponin testing was published online (Circulation. 2019 Sep 1. doi: 10.1161/CIRCULATIONAHA.119.042866). The actual HiSTORIC trial results will be published later.

Dr. Katus reported holding a patent for a cardiac troponin T test and serving as a consultant to AstraZeneca, Bayer, Boehringer Ingelheim, and Novo Nordisk.

[email protected]