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WASHINGTON – The top existential threats to health today are climate change and overpopulation, but third in this list is antimicrobial resistance, according to Helen Boucher, MD, of Tufts Medical Center, Boston. In her talk at an annual scientific meeting on infectious diseases, however, she focused on the last, presenting the hottest developments in the clinical science of treating and identifying disease-causing agents.

In particular, she discussed two of the most important developments in the area of rapid diagnostics: cell-free microbial DNA in plasma and the use of next-generation gene sequencing for determining disease etiology.

Using a meta-genomics test, cell-free microbial DNA can be identified in plasma from more than 1,000 relevant bacteria, DNA viruses, fungi, and parasites. Though importantly, RNA viruses are not detectable using this technology, she added. Although current sampling is of plasma, this might expand to the ability to use urine in the future. She discussed its particular use in sepsis, as outlined in a paper in Nature Microbiology (2019;4[4]:663-74). The researchers examined 350 suspected sepsis patients and they found a 93% sensitivity, compared with reference standards, using this new test. The main issue with the test was a high incidence of false positives.

Another test Dr. Boucher discussed was the use of meta-genomic next-generation sequencing. She referred to a 2019 paper in the New England Journal of Medicine, which discussed the use of clinical meta-genomic next-generation sequencing of cerebrospinal fluid for the diagnosis of meningitis and encephalitis (2019;380[27]:2327-40). Next-generation sequencing identified 13% of patients positive who were missed using standard screening. However, a number of patients were not diagnosed using the new test, showing that this technique was an improvement over current methods, but not 100% successful.

Dr. Boucher stressed the need for “diagnostic stewardship” to identify the correct microbial agent causing disease, allowing for the use of appropriate treatment rather than shotgun approaches to prevent the development of antibiotic resistance. This practice requires collaboration between the clinical laboratory, pharmacists, and infectious disease specialists.

Dr. Boucher then switched to the area of therapeutics, focusing on the introduction of new antibiotics and other innovations in disease treatment methodologies, especially in the field of transplant ID.

“We have new drugs. That is the good news,” with the goals of the 10 x ’20 initiative to develop 10 new systemic antibiotics by 2020, having “been met and then some,” said Dr. Boucher.

“We now have 13 new drugs, systemically available antibiotics, available by August 2019,” she added, discussing several of the new drugs.

In addition, she pointed out several studies that have indicated that shorter courses of antibiotics are better than longer, and that, in many cases, oral therapy is better than intravenous.

In the burgeoning area of transplant ID studies, Dr. Boucher discussed new research showing that vaccinations in transplanted patients can be advised in several instances, though may require higher dosing, and how the use of hepatitis C virus–positive organs for transplant is showing good results and increasing the availability of organs for transplant.

Dr. Boucher has served on data review committees for Actelion and Medtronix and has served as a consultant/advisor for Cerexa, Durata Therapeutics, Merck (adjudication committee), Rib-X, and Wyeth/Pfizer (data safety monitoring committee).

[email protected]

WASHINGTON – The top existential threats to health today are climate change and overpopulation, but third in this list is antimicrobial resistance, according to Helen Boucher, MD, of Tufts Medical Center, Boston. In her talk at an annual scientific meeting on infectious diseases, however, she focused on the last, presenting the hottest developments in the clinical science of treating and identifying disease-causing agents.

In particular, she discussed two of the most important developments in the area of rapid diagnostics: cell-free microbial DNA in plasma and the use of next-generation gene sequencing for determining disease etiology.

Using a meta-genomics test, cell-free microbial DNA can be identified in plasma from more than 1,000 relevant bacteria, DNA viruses, fungi, and parasites. Though importantly, RNA viruses are not detectable using this technology, she added. Although current sampling is of plasma, this might expand to the ability to use urine in the future. She discussed its particular use in sepsis, as outlined in a paper in Nature Microbiology (2019;4[4]:663-74). The researchers examined 350 suspected sepsis patients and they found a 93% sensitivity, compared with reference standards, using this new test. The main issue with the test was a high incidence of false positives.

Another test Dr. Boucher discussed was the use of meta-genomic next-generation sequencing. She referred to a 2019 paper in the New England Journal of Medicine, which discussed the use of clinical meta-genomic next-generation sequencing of cerebrospinal fluid for the diagnosis of meningitis and encephalitis (2019;380[27]:2327-40). Next-generation sequencing identified 13% of patients positive who were missed using standard screening. However, a number of patients were not diagnosed using the new test, showing that this technique was an improvement over current methods, but not 100% successful.

Dr. Boucher stressed the need for “diagnostic stewardship” to identify the correct microbial agent causing disease, allowing for the use of appropriate treatment rather than shotgun approaches to prevent the development of antibiotic resistance. This practice requires collaboration between the clinical laboratory, pharmacists, and infectious disease specialists.

Dr. Boucher then switched to the area of therapeutics, focusing on the introduction of new antibiotics and other innovations in disease treatment methodologies, especially in the field of transplant ID.

“We have new drugs. That is the good news,” with the goals of the 10 x ’20 initiative to develop 10 new systemic antibiotics by 2020, having “been met and then some,” said Dr. Boucher.

“We now have 13 new drugs, systemically available antibiotics, available by August 2019,” she added, discussing several of the new drugs.

In addition, she pointed out several studies that have indicated that shorter courses of antibiotics are better than longer, and that, in many cases, oral therapy is better than intravenous.

In the burgeoning area of transplant ID studies, Dr. Boucher discussed new research showing that vaccinations in transplanted patients can be advised in several instances, though may require higher dosing, and how the use of hepatitis C virus–positive organs for transplant is showing good results and increasing the availability of organs for transplant.

Dr. Boucher has served on data review committees for Actelion and Medtronix and has served as a consultant/advisor for Cerexa, Durata Therapeutics, Merck (adjudication committee), Rib-X, and Wyeth/Pfizer (data safety monitoring committee).

[email protected]

WASHINGTON – The top existential threats to health today are climate change and overpopulation, but third in this list is antimicrobial resistance, according to Helen Boucher, MD, of Tufts Medical Center, Boston. In her talk at an annual scientific meeting on infectious diseases, however, she focused on the last, presenting the hottest developments in the clinical science of treating and identifying disease-causing agents.

In particular, she discussed two of the most important developments in the area of rapid diagnostics: cell-free microbial DNA in plasma and the use of next-generation gene sequencing for determining disease etiology.

Using a meta-genomics test, cell-free microbial DNA can be identified in plasma from more than 1,000 relevant bacteria, DNA viruses, fungi, and parasites. Though importantly, RNA viruses are not detectable using this technology, she added. Although current sampling is of plasma, this might expand to the ability to use urine in the future. She discussed its particular use in sepsis, as outlined in a paper in Nature Microbiology (2019;4[4]:663-74). The researchers examined 350 suspected sepsis patients and they found a 93% sensitivity, compared with reference standards, using this new test. The main issue with the test was a high incidence of false positives.

Another test Dr. Boucher discussed was the use of meta-genomic next-generation sequencing. She referred to a 2019 paper in the New England Journal of Medicine, which discussed the use of clinical meta-genomic next-generation sequencing of cerebrospinal fluid for the diagnosis of meningitis and encephalitis (2019;380[27]:2327-40). Next-generation sequencing identified 13% of patients positive who were missed using standard screening. However, a number of patients were not diagnosed using the new test, showing that this technique was an improvement over current methods, but not 100% successful.

Dr. Boucher stressed the need for “diagnostic stewardship” to identify the correct microbial agent causing disease, allowing for the use of appropriate treatment rather than shotgun approaches to prevent the development of antibiotic resistance. This practice requires collaboration between the clinical laboratory, pharmacists, and infectious disease specialists.

Dr. Boucher then switched to the area of therapeutics, focusing on the introduction of new antibiotics and other innovations in disease treatment methodologies, especially in the field of transplant ID.

“We have new drugs. That is the good news,” with the goals of the 10 x ’20 initiative to develop 10 new systemic antibiotics by 2020, having “been met and then some,” said Dr. Boucher.

“We now have 13 new drugs, systemically available antibiotics, available by August 2019,” she added, discussing several of the new drugs.

In addition, she pointed out several studies that have indicated that shorter courses of antibiotics are better than longer, and that, in many cases, oral therapy is better than intravenous.

In the burgeoning area of transplant ID studies, Dr. Boucher discussed new research showing that vaccinations in transplanted patients can be advised in several instances, though may require higher dosing, and how the use of hepatitis C virus–positive organs for transplant is showing good results and increasing the availability of organs for transplant.

Dr. Boucher has served on data review committees for Actelion and Medtronix and has served as a consultant/advisor for Cerexa, Durata Therapeutics, Merck (adjudication committee), Rib-X, and Wyeth/Pfizer (data safety monitoring committee).

[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]

CHICAGO – A care model that uses hospitalists to comanage vascular surgery patients cut myocardial infarction rates by more than half and reduced hospital stays by about 12%, according to results of a study of the hospitalist comanagement model from Loyola University Chicago, Maywood, Ill., presented at the annual meeting of the Midwestern Vascular Surgery Society.

“Hospitalist comanagement was associated with decreased length of stay without affecting readmission for patients undergoing amputation, embolectomy, and infected graft,” said Kaavya Adam, a third-year medical student at Loyola University Chicago. “In the overall population, there was a reduction in cases of MI, 30-day readmissions, and overall length of stay.”

In 2014, Loyola implemented a program that used 11 hospitalists to rotate through the vascular surgery service. The hospitalists call on any patient who stays more than 24 hours on the non-ICU floors. Adam said hospitalist duties include evaluating patient comorbidities, adjusting medication, talking with family about medical management, seeing patients on the day of surgery, ordering preoperative labs, and meeting with the anesthesiology and vascular surgery teams.

The study compared outcomes in 866 patients admitted during 2007-2013, before the comanagement model was put into place, and 572 admitted during 2014-2017.

Rates of diabetes, hypertension, chronic kidney disease, coronary artery disease, hyperlipidemia, and malnutrition were similar between the groups. However, the pre-comanagement group had significantly higher rates of ischemic pain (27.8% vs. 10.7%), gangrene (21.3% vs. 13.6%) and ulceration (30.6% vs. 21.9%), while the comanaged group had significantly higher rates of claudication (34.3% vs. 13.2%). The statistical analysis accounted for these variations, Adam said.

“We did find significant results for the reduction in the odds of MI at 30 days; there was a 61% reduction,” he said.

The reduction in hospital stay was even more pronounced for patients with complex cases, Adam said. In amputation, the length of stay was reduced by 3.77 days (P = .01); in embolectomy, by 7.35 (P = .004); and in infected graft, by 8.35 (P = .007).

Continuing research will evaluate the cost effectiveness of the hospitalist model and define a comanagement model that is most beneficial, Mr. Adam said. He had no relevant financial disclosures.

SOURCE: Adam K et al. Midwestern Vascular 2019, Abstract 14.

CHICAGO – A care model that uses hospitalists to comanage vascular surgery patients cut myocardial infarction rates by more than half and reduced hospital stays by about 12%, according to results of a study of the hospitalist comanagement model from Loyola University Chicago, Maywood, Ill., presented at the annual meeting of the Midwestern Vascular Surgery Society.

“Hospitalist comanagement was associated with decreased length of stay without affecting readmission for patients undergoing amputation, embolectomy, and infected graft,” said Kaavya Adam, a third-year medical student at Loyola University Chicago. “In the overall population, there was a reduction in cases of MI, 30-day readmissions, and overall length of stay.”

In 2014, Loyola implemented a program that used 11 hospitalists to rotate through the vascular surgery service. The hospitalists call on any patient who stays more than 24 hours on the non-ICU floors. Adam said hospitalist duties include evaluating patient comorbidities, adjusting medication, talking with family about medical management, seeing patients on the day of surgery, ordering preoperative labs, and meeting with the anesthesiology and vascular surgery teams.

The study compared outcomes in 866 patients admitted during 2007-2013, before the comanagement model was put into place, and 572 admitted during 2014-2017.

Rates of diabetes, hypertension, chronic kidney disease, coronary artery disease, hyperlipidemia, and malnutrition were similar between the groups. However, the pre-comanagement group had significantly higher rates of ischemic pain (27.8% vs. 10.7%), gangrene (21.3% vs. 13.6%) and ulceration (30.6% vs. 21.9%), while the comanaged group had significantly higher rates of claudication (34.3% vs. 13.2%). The statistical analysis accounted for these variations, Adam said.

“We did find significant results for the reduction in the odds of MI at 30 days; there was a 61% reduction,” he said.

The reduction in hospital stay was even more pronounced for patients with complex cases, Adam said. In amputation, the length of stay was reduced by 3.77 days (P = .01); in embolectomy, by 7.35 (P = .004); and in infected graft, by 8.35 (P = .007).

Continuing research will evaluate the cost effectiveness of the hospitalist model and define a comanagement model that is most beneficial, Mr. Adam said. He had no relevant financial disclosures.

SOURCE: Adam K et al. Midwestern Vascular 2019, Abstract 14.

CHICAGO – A care model that uses hospitalists to comanage vascular surgery patients cut myocardial infarction rates by more than half and reduced hospital stays by about 12%, according to results of a study of the hospitalist comanagement model from Loyola University Chicago, Maywood, Ill., presented at the annual meeting of the Midwestern Vascular Surgery Society.

“Hospitalist comanagement was associated with decreased length of stay without affecting readmission for patients undergoing amputation, embolectomy, and infected graft,” said Kaavya Adam, a third-year medical student at Loyola University Chicago. “In the overall population, there was a reduction in cases of MI, 30-day readmissions, and overall length of stay.”

In 2014, Loyola implemented a program that used 11 hospitalists to rotate through the vascular surgery service. The hospitalists call on any patient who stays more than 24 hours on the non-ICU floors. Adam said hospitalist duties include evaluating patient comorbidities, adjusting medication, talking with family about medical management, seeing patients on the day of surgery, ordering preoperative labs, and meeting with the anesthesiology and vascular surgery teams.

The study compared outcomes in 866 patients admitted during 2007-2013, before the comanagement model was put into place, and 572 admitted during 2014-2017.

Rates of diabetes, hypertension, chronic kidney disease, coronary artery disease, hyperlipidemia, and malnutrition were similar between the groups. However, the pre-comanagement group had significantly higher rates of ischemic pain (27.8% vs. 10.7%), gangrene (21.3% vs. 13.6%) and ulceration (30.6% vs. 21.9%), while the comanaged group had significantly higher rates of claudication (34.3% vs. 13.2%). The statistical analysis accounted for these variations, Adam said.

“We did find significant results for the reduction in the odds of MI at 30 days; there was a 61% reduction,” he said.

The reduction in hospital stay was even more pronounced for patients with complex cases, Adam said. In amputation, the length of stay was reduced by 3.77 days (P = .01); in embolectomy, by 7.35 (P = .004); and in infected graft, by 8.35 (P = .007).

Continuing research will evaluate the cost effectiveness of the hospitalist model and define a comanagement model that is most beneficial, Mr. Adam said. He had no relevant financial disclosures.

SOURCE: Adam K et al. Midwestern Vascular 2019, Abstract 14.

Vaping-associated lung injury is likely a form of airway-centered chemical pneumonitis, not exogenous lipoid pneumonia, according to Yasmeen M. Butt, MD, of the University of Texas Southwestern Medical Center, Dallas, and associates.

VlaDee/Getty Images

Dr. Butt and associates performed a review of lung biopsies from 17 patients (13 men; median age, 35 years) with a history of vaping and either suspected or confirmed vaping-associated lung injury. All cases showed patterns of acute lung injury, including acute fibrinous pneumonitis, diffuse alveolar damage, or organizing pneumonia, the authors noted in a letter to the editor published in the New England Journal of Medicine.

While no histologic findings were specific, foamy macrophages and pneumocyte vacuolization were seen in all cases, the authors added. Pigmented macrophages were occasionally present but not dominant, neutrophils were often prominent, eosinophils were rare, and granulomas were not seen. Two patients eventually died, despite treatment with glucocorticoids and maximum supportive care.

“None of our cases showed histologic evidence of exogenous lipoid pneumonia and no radiologic evidence thereof has been found; this calls into question the diagnostic utility of identifying lipid-laden macrophages or performing oil red O staining on bronchioloalveolar lavage fluid as a marker of vaping-associated lung injury, as has been proposed,” Dr. Butt and associates wrote.

No conflicts of interest were reported.

[email protected]

SOURCE: Butt YM et al. N Engl J Med. 2019 Oct 2. doi: 10.1056/NEJMc1913069.

Vaping-associated lung injury is likely a form of airway-centered chemical pneumonitis, not exogenous lipoid pneumonia, according to Yasmeen M. Butt, MD, of the University of Texas Southwestern Medical Center, Dallas, and associates.

VlaDee/Getty Images

Dr. Butt and associates performed a review of lung biopsies from 17 patients (13 men; median age, 35 years) with a history of vaping and either suspected or confirmed vaping-associated lung injury. All cases showed patterns of acute lung injury, including acute fibrinous pneumonitis, diffuse alveolar damage, or organizing pneumonia, the authors noted in a letter to the editor published in the New England Journal of Medicine.

While no histologic findings were specific, foamy macrophages and pneumocyte vacuolization were seen in all cases, the authors added. Pigmented macrophages were occasionally present but not dominant, neutrophils were often prominent, eosinophils were rare, and granulomas were not seen. Two patients eventually died, despite treatment with glucocorticoids and maximum supportive care.

“None of our cases showed histologic evidence of exogenous lipoid pneumonia and no radiologic evidence thereof has been found; this calls into question the diagnostic utility of identifying lipid-laden macrophages or performing oil red O staining on bronchioloalveolar lavage fluid as a marker of vaping-associated lung injury, as has been proposed,” Dr. Butt and associates wrote.

No conflicts of interest were reported.

[email protected]

SOURCE: Butt YM et al. N Engl J Med. 2019 Oct 2. doi: 10.1056/NEJMc1913069.

Vaping-associated lung injury is likely a form of airway-centered chemical pneumonitis, not exogenous lipoid pneumonia, according to Yasmeen M. Butt, MD, of the University of Texas Southwestern Medical Center, Dallas, and associates.

VlaDee/Getty Images

Dr. Butt and associates performed a review of lung biopsies from 17 patients (13 men; median age, 35 years) with a history of vaping and either suspected or confirmed vaping-associated lung injury. All cases showed patterns of acute lung injury, including acute fibrinous pneumonitis, diffuse alveolar damage, or organizing pneumonia, the authors noted in a letter to the editor published in the New England Journal of Medicine.

While no histologic findings were specific, foamy macrophages and pneumocyte vacuolization were seen in all cases, the authors added. Pigmented macrophages were occasionally present but not dominant, neutrophils were often prominent, eosinophils were rare, and granulomas were not seen. Two patients eventually died, despite treatment with glucocorticoids and maximum supportive care.

“None of our cases showed histologic evidence of exogenous lipoid pneumonia and no radiologic evidence thereof has been found; this calls into question the diagnostic utility of identifying lipid-laden macrophages or performing oil red O staining on bronchioloalveolar lavage fluid as a marker of vaping-associated lung injury, as has been proposed,” Dr. Butt and associates wrote.

No conflicts of interest were reported.

[email protected]

SOURCE: Butt YM et al. N Engl J Med. 2019 Oct 2. doi: 10.1056/NEJMc1913069.

A total of 1,249 measles cases were reported in the United States during Jan. 1–Oct.1, 2019, making it the most active year for the disease since 1992, according to investigators from the Centers for Disease Control and Prevention.

CDC/ Cynthia S. Goldsmith; William Bellini, Ph.D.

While 22 outbreaks were reported in 17 states during 2019, the majority of measles cases occurred in a pair of outbreaks that started in late 2018, one in New York City and the other in New York state. Theses two outbreaks, which occurred in underimmunized, close-knit communities, accounted for 934 (75%) of the 2019 total. An additional six outbreaks in similar communities accounted for nearly half of the remaining reported cases.

The overall median patient age was 6 years, with 31% being children aged 1-4 years, 27% being school-age children aged 5-17 years, and 29% were adults aged at least 18 years. However, when excluding the New York City (NYC) and New York state outbreaks, the median patient age was 19 years. Outbreak length also differed significantly between the NYC and New York state outbreaks, compared with all other outbreaks; the NYC outbreak lasted for 9.5 months, involving 702 patients from start to finish, the New York state outbreak lasted for 10.5 months and involved 412 cases.

The rate of patients who were either unvaccinated or had unknown vaccination status was similar in the New York outbreaks and in the other U.S. outbreaks, ranging from 87% to 91%. A total of 119 patients were hospitalized, 20% of whom were younger than 1 year; no deaths were reported. A total of 81 cases were internationally imported; the rate of patients who were unvaccinated or had unknown status in this group was 90%.

While most outbreaks in 2019 were similar to those previously seen, the outbreaks in NYC and New York state were more sustained for three reasons, the CDC investigators said: pockets of low vaccination coverage and variable vaccine acceptance, relatively high population density and closed social nature of the community, and repeated importations of measles cases among unvaccinated persons traveling internationally and returning to or visiting the affected communities.

“Public health authorities need to identify pockets of undervaccinated persons to prevent these outbreaks, which require substantial resources to control. A preventive strategy to build vaccine confidence is important, especially one that uses culturally appropriate communication strategies to offset misinformation and disseminate accurate information about the safety and importance of vaccination in advance of outbreaks,” the CDC investigators concluded.

The CDC investigators reported that they had no conflicts of interest.
 

[email protected]

SOURCE: Patel M et al. MMWR Morb Mortal Wkly Rep. 2019 Oct 4. doi: 10.15585/mmwr.mm6840e2.

A total of 1,249 measles cases were reported in the United States during Jan. 1–Oct.1, 2019, making it the most active year for the disease since 1992, according to investigators from the Centers for Disease Control and Prevention.

CDC/ Cynthia S. Goldsmith; William Bellini, Ph.D.

While 22 outbreaks were reported in 17 states during 2019, the majority of measles cases occurred in a pair of outbreaks that started in late 2018, one in New York City and the other in New York state. Theses two outbreaks, which occurred in underimmunized, close-knit communities, accounted for 934 (75%) of the 2019 total. An additional six outbreaks in similar communities accounted for nearly half of the remaining reported cases.

The overall median patient age was 6 years, with 31% being children aged 1-4 years, 27% being school-age children aged 5-17 years, and 29% were adults aged at least 18 years. However, when excluding the New York City (NYC) and New York state outbreaks, the median patient age was 19 years. Outbreak length also differed significantly between the NYC and New York state outbreaks, compared with all other outbreaks; the NYC outbreak lasted for 9.5 months, involving 702 patients from start to finish, the New York state outbreak lasted for 10.5 months and involved 412 cases.

The rate of patients who were either unvaccinated or had unknown vaccination status was similar in the New York outbreaks and in the other U.S. outbreaks, ranging from 87% to 91%. A total of 119 patients were hospitalized, 20% of whom were younger than 1 year; no deaths were reported. A total of 81 cases were internationally imported; the rate of patients who were unvaccinated or had unknown status in this group was 90%.

While most outbreaks in 2019 were similar to those previously seen, the outbreaks in NYC and New York state were more sustained for three reasons, the CDC investigators said: pockets of low vaccination coverage and variable vaccine acceptance, relatively high population density and closed social nature of the community, and repeated importations of measles cases among unvaccinated persons traveling internationally and returning to or visiting the affected communities.

“Public health authorities need to identify pockets of undervaccinated persons to prevent these outbreaks, which require substantial resources to control. A preventive strategy to build vaccine confidence is important, especially one that uses culturally appropriate communication strategies to offset misinformation and disseminate accurate information about the safety and importance of vaccination in advance of outbreaks,” the CDC investigators concluded.

The CDC investigators reported that they had no conflicts of interest.
 

[email protected]

SOURCE: Patel M et al. MMWR Morb Mortal Wkly Rep. 2019 Oct 4. doi: 10.15585/mmwr.mm6840e2.

A total of 1,249 measles cases were reported in the United States during Jan. 1–Oct.1, 2019, making it the most active year for the disease since 1992, according to investigators from the Centers for Disease Control and Prevention.

CDC/ Cynthia S. Goldsmith; William Bellini, Ph.D.

While 22 outbreaks were reported in 17 states during 2019, the majority of measles cases occurred in a pair of outbreaks that started in late 2018, one in New York City and the other in New York state. Theses two outbreaks, which occurred in underimmunized, close-knit communities, accounted for 934 (75%) of the 2019 total. An additional six outbreaks in similar communities accounted for nearly half of the remaining reported cases.

The overall median patient age was 6 years, with 31% being children aged 1-4 years, 27% being school-age children aged 5-17 years, and 29% were adults aged at least 18 years. However, when excluding the New York City (NYC) and New York state outbreaks, the median patient age was 19 years. Outbreak length also differed significantly between the NYC and New York state outbreaks, compared with all other outbreaks; the NYC outbreak lasted for 9.5 months, involving 702 patients from start to finish, the New York state outbreak lasted for 10.5 months and involved 412 cases.

The rate of patients who were either unvaccinated or had unknown vaccination status was similar in the New York outbreaks and in the other U.S. outbreaks, ranging from 87% to 91%. A total of 119 patients were hospitalized, 20% of whom were younger than 1 year; no deaths were reported. A total of 81 cases were internationally imported; the rate of patients who were unvaccinated or had unknown status in this group was 90%.

While most outbreaks in 2019 were similar to those previously seen, the outbreaks in NYC and New York state were more sustained for three reasons, the CDC investigators said: pockets of low vaccination coverage and variable vaccine acceptance, relatively high population density and closed social nature of the community, and repeated importations of measles cases among unvaccinated persons traveling internationally and returning to or visiting the affected communities.

“Public health authorities need to identify pockets of undervaccinated persons to prevent these outbreaks, which require substantial resources to control. A preventive strategy to build vaccine confidence is important, especially one that uses culturally appropriate communication strategies to offset misinformation and disseminate accurate information about the safety and importance of vaccination in advance of outbreaks,” the CDC investigators concluded.

The CDC investigators reported that they had no conflicts of interest.
 

[email protected]

SOURCE: Patel M et al. MMWR Morb Mortal Wkly Rep. 2019 Oct 4. doi: 10.15585/mmwr.mm6840e2.

In June 2019, a 5-hour preconference seminar at the annual Integrating Quality Conference of the Association of American Medical Colleges (AAMC) in Minneapolis highlighted the emergence of a new concept, and a new community, within the larger field of hospital medicine.

“Bridging leaders” are clinician-educators with a foot in two worlds: leading quality and safety initiatives within their teaching hospitals – with the hospitalist’s customary participation in a broad spectrum of quality improvement (QI) efforts in the hospital – while helping to train future and current physicians. “Bridging” also extends to the third piece of the quality puzzle, the hospital and/or health system’s senior administrators.

“About 8 years ago, another hospitalist and I found ourselves in this role, bridging graduate medical education with hospital quality and safety,” said Jennifer S. Myers, MD, FHM, director of quality and safety education in the department of medicine at the University of Pennsylvania, Philadelphia. “The role has since begun to proliferate, in teaching settings large and small, and about 30-50 of us with somewhat similar job responsibilities have been trying to create a community.”

Following the lead of the American College of Graduate Medical Education¹ and its standards for clinical learning environments that include integration of patient safety and quality improvement, these have become graduate medical education (GME) priorities. Students need to learn the theory and practice of safety and quality improvement on the job as part of their professional development. Residency program directors and other trainers thus need to find opportunities for them to practice these techniques in the clinical practice environment.

At the same time, mobilizing those eager medical learners to plan and conduct quality improvement projects can enhance a hospital’s ability to advance its mission in the new health care environment of accountable care and population health.
 

New concept arises

Is bridging leaders a real thing? The short answer is yes, said Thomas Ciesielski, MD, GME medical director for patient safety, quality education, and clinical learning environment review program development at Washington University in St. Louis. “This is a new trend, but it’s still in the process of defining itself. Every bridging leader has their own identity based on their institution. Some play a bridging role for the entire institution; others play similar roles but only within a specific department or division. There’s a lot of learning going on in our community,” he said.

The first Bridging Leaders track was held last year at AAMC’s 2018 Integrating Quality Conference, an event which has been held annually for the past decade. The concept was also highlighted in a 2017 article in the Journal of Graduate Medical Education² by bridging leaders, including many of the faculty at the subsequent AAMC sessions, highlighting their roles and programs at six academic medical centers.

One of those coauthors, hospitalist Vineet Arora, MD, MAPP, MHM, was recently appointed to a new position at University of Chicago Medicine: associate chief medical officer for the clinical learning environment – which pulls together many of the threads of the bridging leaders movement into a single job title. Dr. Arora said her job builds on her prior work in GME and improves the clinical learning environment for residents and fellows by integrating them into the health system’s institutional quality, safety, and value missions. It also expands on that work to include faculty and allied health professionals. “I just happen to come from the health system side,” she said.
 

Natural bridges: From clinical to educational

As with the early days of the hospitalist movement, bridging leaders are trying to build a community of peers with common interests.

“We’re just at the beginning,” Dr. Arora said. “Hospitalists have been the natural torch bearers for quality and safety in their hospitals, and also play roles in the education of residents and medical students, working alongside residency program directors. They are well-versed in quality and in education. So, they are the natural bridges between education and clinical care,” she said. “We also know this is a young group that comes to our meetings. One-third of them have been doing this for only the past 2 years or less – so they are early in their career paths.”

Front-line clinical providers, such as residents, often have good ideas, and bridging leaders can bring these ideas to the health system’s leaders, Dr. Arora said. “Bridging at the leadership level also involves thinking about the larger priorities of the system.” There are trust issues that these leaders can help to bridge, as well as internal communication barriers. “We also realize that health systems have to move quickly in response to a rapidly changing environment,” she noted.

“You don’t want a hundred quality improvement projects being done by students that are unaligned with the organization’s priorities. That leads to waste, and highlights the need for greater alignment,” Dr. Arora added. “Think about using front-line staff as agents of change, of engaging with learners as a win/win – as a way to actually solve the problems we are facing.”

A bridging leader occupies a role in which they can influence and affect these two parts of the mission of health care, somebody whose leadership responsibilities sit at the intersection of these two areas, said Darlene Tad-y, MD, director of GME quality and safety programs at the University of Colorado, Aurora. “Once, these people were mostly in academic medical centers, but that’s not so true anymore. A director of quality for a hospital medicine group is responsible for developing the group’s quality strategy, but at the same time responsible for teaching members of the group – not only doing QI but teaching others how to do it,” she said.

“Hospitalists make terrific bridging leaders. We really are in that sweet spot, and we can and should step into these leadership roles,” Dr. Tad-y said. “Because of our role in the hospital, we know the ins and outs of how processes work or don’t work. We have an insider’s view of the system’s dysfunction, which puts us in a great place to lead these efforts.”

The bridging leaders movement has been a grass-roots development, Dr. Tad-y explained. “It’s not like people started with the job title. But because all of this work was needed, a few people started doing it – and they began seeking each other out. Then they found that there were more than a few of us. We just hadn’t known what it was called.”
 

What is being bridged?

There has long been a relationship between individuals who lead in the clinical environment and those who lead in education, such as the program directors of residency programs, said Janis Orlowski, MD, chief health care officer for AAMC, which represents 154 MD-granting medical schools and their associated teaching hospitals.

“Our association’s three missions of research, education, and patient care really come together around the bridging leaders concept. So, this movement is well aligned. And as bridging leaders started to develop as a group, they found a home in AAMC and at our Integrating Quality Conference,” she said.

“Where we see this integration is in the teaching of residents and medical students in the clinical environment,” Dr. Orlowski said. “It’s not just their knowledge of disease or treatments or procedural skills that needs to be taught. They also need to understand the safe and effective clinical environment, and the role of learners in patient safety, quality improvement, and efficient and cost-effective hospital care. They need to understand value.” A new field of health systems science is emerging and quality improvement is evolving to incorporate population health. But traditional medical faculty may not be that comfortable teaching it.

Any physician who sees that they have a role in the clinical, administrative, and educational worlds can do the bridging, Dr. Orlowski said. “It could be any environment in which care is provided and learning takes place. I mentioned QI and patient safety, but among the other essential skills for the doctor of tomorrow are teamwork, inter-professional training in how to work with, for example, the pharmacist and dietitian, and understanding the value they bring.”

Whenever quality improvement projects are undertaken as part of post-graduate medical education, they should be aligned with the institution’s quality improvement plan and with the priorities of the health system, said Rob Dressler, MD, MBA, quality and safety officer at Christiana Health Care System in Newark, Del., and president of the Alliance of Independent Academic Medical Centers (AIAMC), which represents 80 hospital and health systems active in the emerging movement for bridging leaders.

“GME needs to keep the C-suite aware of its front-line efforts to improve quality and safety, so the institution’s return on investment can be recognized,” he said. “The AIAMC has consistently advocated for the building of bridges between GME leaders and their C-suites at our member hospitals. If you are doing process improvement, you need to be aligned with the organization and its priorities, or you’ll be less successful.”

AIAMC convenes the National Initiative – a multi-institutional collaborative in which residents lead multi-disciplinary teams in quality improvement projects. A total of 64 hospitals and health systems have participated since the program started in 2007. “We need to train our clinicians to solve the problems of tomorrow,” Dr. Dressler said.
 

Bridging leaders in action

The leaders contacted for this article offered some examples of bridging in action. Dr. Arora has used “crowd sourcing” – a technique employed extensively in her work with Costs of Care, a global nonprofit trying to drive better health care at lower cost – to implement a local program for front-line clinicians to generate ideas on how to improve value and reduce unnecessary treatment.

“We created our local ‘Choosing Wisely’ challenge for residents and staff at the University of Chicago – with the understanding that the winner would get analytic and time support to pursue their project,” she said. A resident winner was a finalist in the RIV (Research, Innovations and Clinical Vignettes) competition at a recent SHM Annual Conference.

At the University of Colorado, there is an associate program director who is responsible for the quality improvement curriculum for residents, Dr. Tad-y said. Because teaching QI means doing QI, the associate program director had to start implementing QI in the hospital, learning how to choose appropriate QI projects for the residents. That meant looking at quality priorities for the hospital – including VTE prophylaxis, fall prevention, and rates of central line–associated bloodstream infections and catheter-associated urinary tract infections. “A critical priority was to align the learners’ QI projects with what the hospital is already working on,” she explained.

“In our practice, all fellows need education and training in patient safety, how to recognize medical errors and close calls, and how to use our errors reporting system,” Dr. Myers said. “They also need to participate in errors analysis discussions. But we have struggled to get residents to attend those meetings. There’s not enough time in their schedules, and here at Penn, we have 1,500 residents and fellows, and maybe only 20 of these formal medical errors conferences per year,” she said.

Dr. Myers worked with the hospital’s patient safety officer and head of GME to design a simulated approach to fill the gap, a simulation of the root cause analysis process – how it works, the various roles played by different individuals, and what happens after it is done. “In my role, I trained one faculty member in each large residency program in how to identify a case and how to use the simulation,” she said. “They can now teach their own learners and make it more relevant to their specialty.”

Penn also has a blueprint for quality – a road map for how the organization socializes health care quality, safety, and value, Dr. Myers said. “Every 3 or 4 years our CEO looks at the road map and tries to get feedback on its direction from payers and insurers, quality leaders, academic department heads – and residents. I was in a good position to organize a session for a representative group of residents to get together and talk about where they see the quality and safety gaps in their everyday work.”

The role of the bridging leader is a viable career path or target for many hospitalists, Dr. Arora said. “But even if it’s not a career path for you, knowing that hospitalists are at the forefront of the bridging leaders movement could help you energize your health system. If you are seeing gaps in quality and safety, this is an issue you can bring before the system.”

These days doctors are wearing a lot of hats and filling roles that weren’t seen as much before, said Dr. Orlowski. “Bridging leaders are not an exclusive group but open to anyone who finds their passion in teaching quality and safety. Maybe you’re doing quality and safety, but not education, but you recognize its importance, or vice versa. First of all, look to see what this bridging leaders thing really is, and how it might apply to you. You might say: ‘That accurately describes what I’m doing now. I have the interest; I want to learn more.’”
 

References

1. Accreditation Council for Graduate Medical Education. CLER pathways to excellence.

2. Myers JS et al. Bridging leadership roles in quality and patient safety: Experience of 6 U.S. Academic Medical Centers. J Grad Med Educ. 2017 Feb;9(1): 9-13.
 

In June 2019, a 5-hour preconference seminar at the annual Integrating Quality Conference of the Association of American Medical Colleges (AAMC) in Minneapolis highlighted the emergence of a new concept, and a new community, within the larger field of hospital medicine.

“Bridging leaders” are clinician-educators with a foot in two worlds: leading quality and safety initiatives within their teaching hospitals – with the hospitalist’s customary participation in a broad spectrum of quality improvement (QI) efforts in the hospital – while helping to train future and current physicians. “Bridging” also extends to the third piece of the quality puzzle, the hospital and/or health system’s senior administrators.

“About 8 years ago, another hospitalist and I found ourselves in this role, bridging graduate medical education with hospital quality and safety,” said Jennifer S. Myers, MD, FHM, director of quality and safety education in the department of medicine at the University of Pennsylvania, Philadelphia. “The role has since begun to proliferate, in teaching settings large and small, and about 30-50 of us with somewhat similar job responsibilities have been trying to create a community.”

Following the lead of the American College of Graduate Medical Education¹ and its standards for clinical learning environments that include integration of patient safety and quality improvement, these have become graduate medical education (GME) priorities. Students need to learn the theory and practice of safety and quality improvement on the job as part of their professional development. Residency program directors and other trainers thus need to find opportunities for them to practice these techniques in the clinical practice environment.

At the same time, mobilizing those eager medical learners to plan and conduct quality improvement projects can enhance a hospital’s ability to advance its mission in the new health care environment of accountable care and population health.
 

New concept arises

Is bridging leaders a real thing? The short answer is yes, said Thomas Ciesielski, MD, GME medical director for patient safety, quality education, and clinical learning environment review program development at Washington University in St. Louis. “This is a new trend, but it’s still in the process of defining itself. Every bridging leader has their own identity based on their institution. Some play a bridging role for the entire institution; others play similar roles but only within a specific department or division. There’s a lot of learning going on in our community,” he said.

The first Bridging Leaders track was held last year at AAMC’s 2018 Integrating Quality Conference, an event which has been held annually for the past decade. The concept was also highlighted in a 2017 article in the Journal of Graduate Medical Education² by bridging leaders, including many of the faculty at the subsequent AAMC sessions, highlighting their roles and programs at six academic medical centers.

One of those coauthors, hospitalist Vineet Arora, MD, MAPP, MHM, was recently appointed to a new position at University of Chicago Medicine: associate chief medical officer for the clinical learning environment – which pulls together many of the threads of the bridging leaders movement into a single job title. Dr. Arora said her job builds on her prior work in GME and improves the clinical learning environment for residents and fellows by integrating them into the health system’s institutional quality, safety, and value missions. It also expands on that work to include faculty and allied health professionals. “I just happen to come from the health system side,” she said.
 

Natural bridges: From clinical to educational

As with the early days of the hospitalist movement, bridging leaders are trying to build a community of peers with common interests.

“We’re just at the beginning,” Dr. Arora said. “Hospitalists have been the natural torch bearers for quality and safety in their hospitals, and also play roles in the education of residents and medical students, working alongside residency program directors. They are well-versed in quality and in education. So, they are the natural bridges between education and clinical care,” she said. “We also know this is a young group that comes to our meetings. One-third of them have been doing this for only the past 2 years or less – so they are early in their career paths.”

Front-line clinical providers, such as residents, often have good ideas, and bridging leaders can bring these ideas to the health system’s leaders, Dr. Arora said. “Bridging at the leadership level also involves thinking about the larger priorities of the system.” There are trust issues that these leaders can help to bridge, as well as internal communication barriers. “We also realize that health systems have to move quickly in response to a rapidly changing environment,” she noted.

“You don’t want a hundred quality improvement projects being done by students that are unaligned with the organization’s priorities. That leads to waste, and highlights the need for greater alignment,” Dr. Arora added. “Think about using front-line staff as agents of change, of engaging with learners as a win/win – as a way to actually solve the problems we are facing.”

A bridging leader occupies a role in which they can influence and affect these two parts of the mission of health care, somebody whose leadership responsibilities sit at the intersection of these two areas, said Darlene Tad-y, MD, director of GME quality and safety programs at the University of Colorado, Aurora. “Once, these people were mostly in academic medical centers, but that’s not so true anymore. A director of quality for a hospital medicine group is responsible for developing the group’s quality strategy, but at the same time responsible for teaching members of the group – not only doing QI but teaching others how to do it,” she said.

“Hospitalists make terrific bridging leaders. We really are in that sweet spot, and we can and should step into these leadership roles,” Dr. Tad-y said. “Because of our role in the hospital, we know the ins and outs of how processes work or don’t work. We have an insider’s view of the system’s dysfunction, which puts us in a great place to lead these efforts.”

The bridging leaders movement has been a grass-roots development, Dr. Tad-y explained. “It’s not like people started with the job title. But because all of this work was needed, a few people started doing it – and they began seeking each other out. Then they found that there were more than a few of us. We just hadn’t known what it was called.”
 

What is being bridged?

There has long been a relationship between individuals who lead in the clinical environment and those who lead in education, such as the program directors of residency programs, said Janis Orlowski, MD, chief health care officer for AAMC, which represents 154 MD-granting medical schools and their associated teaching hospitals.

“Our association’s three missions of research, education, and patient care really come together around the bridging leaders concept. So, this movement is well aligned. And as bridging leaders started to develop as a group, they found a home in AAMC and at our Integrating Quality Conference,” she said.

“Where we see this integration is in the teaching of residents and medical students in the clinical environment,” Dr. Orlowski said. “It’s not just their knowledge of disease or treatments or procedural skills that needs to be taught. They also need to understand the safe and effective clinical environment, and the role of learners in patient safety, quality improvement, and efficient and cost-effective hospital care. They need to understand value.” A new field of health systems science is emerging and quality improvement is evolving to incorporate population health. But traditional medical faculty may not be that comfortable teaching it.

Any physician who sees that they have a role in the clinical, administrative, and educational worlds can do the bridging, Dr. Orlowski said. “It could be any environment in which care is provided and learning takes place. I mentioned QI and patient safety, but among the other essential skills for the doctor of tomorrow are teamwork, inter-professional training in how to work with, for example, the pharmacist and dietitian, and understanding the value they bring.”

Whenever quality improvement projects are undertaken as part of post-graduate medical education, they should be aligned with the institution’s quality improvement plan and with the priorities of the health system, said Rob Dressler, MD, MBA, quality and safety officer at Christiana Health Care System in Newark, Del., and president of the Alliance of Independent Academic Medical Centers (AIAMC), which represents 80 hospital and health systems active in the emerging movement for bridging leaders.

“GME needs to keep the C-suite aware of its front-line efforts to improve quality and safety, so the institution’s return on investment can be recognized,” he said. “The AIAMC has consistently advocated for the building of bridges between GME leaders and their C-suites at our member hospitals. If you are doing process improvement, you need to be aligned with the organization and its priorities, or you’ll be less successful.”

AIAMC convenes the National Initiative – a multi-institutional collaborative in which residents lead multi-disciplinary teams in quality improvement projects. A total of 64 hospitals and health systems have participated since the program started in 2007. “We need to train our clinicians to solve the problems of tomorrow,” Dr. Dressler said.
 

Bridging leaders in action

The leaders contacted for this article offered some examples of bridging in action. Dr. Arora has used “crowd sourcing” – a technique employed extensively in her work with Costs of Care, a global nonprofit trying to drive better health care at lower cost – to implement a local program for front-line clinicians to generate ideas on how to improve value and reduce unnecessary treatment.

“We created our local ‘Choosing Wisely’ challenge for residents and staff at the University of Chicago – with the understanding that the winner would get analytic and time support to pursue their project,” she said. A resident winner was a finalist in the RIV (Research, Innovations and Clinical Vignettes) competition at a recent SHM Annual Conference.

At the University of Colorado, there is an associate program director who is responsible for the quality improvement curriculum for residents, Dr. Tad-y said. Because teaching QI means doing QI, the associate program director had to start implementing QI in the hospital, learning how to choose appropriate QI projects for the residents. That meant looking at quality priorities for the hospital – including VTE prophylaxis, fall prevention, and rates of central line–associated bloodstream infections and catheter-associated urinary tract infections. “A critical priority was to align the learners’ QI projects with what the hospital is already working on,” she explained.

“In our practice, all fellows need education and training in patient safety, how to recognize medical errors and close calls, and how to use our errors reporting system,” Dr. Myers said. “They also need to participate in errors analysis discussions. But we have struggled to get residents to attend those meetings. There’s not enough time in their schedules, and here at Penn, we have 1,500 residents and fellows, and maybe only 20 of these formal medical errors conferences per year,” she said.

Dr. Myers worked with the hospital’s patient safety officer and head of GME to design a simulated approach to fill the gap, a simulation of the root cause analysis process – how it works, the various roles played by different individuals, and what happens after it is done. “In my role, I trained one faculty member in each large residency program in how to identify a case and how to use the simulation,” she said. “They can now teach their own learners and make it more relevant to their specialty.”

Penn also has a blueprint for quality – a road map for how the organization socializes health care quality, safety, and value, Dr. Myers said. “Every 3 or 4 years our CEO looks at the road map and tries to get feedback on its direction from payers and insurers, quality leaders, academic department heads – and residents. I was in a good position to organize a session for a representative group of residents to get together and talk about where they see the quality and safety gaps in their everyday work.”

The role of the bridging leader is a viable career path or target for many hospitalists, Dr. Arora said. “But even if it’s not a career path for you, knowing that hospitalists are at the forefront of the bridging leaders movement could help you energize your health system. If you are seeing gaps in quality and safety, this is an issue you can bring before the system.”

These days doctors are wearing a lot of hats and filling roles that weren’t seen as much before, said Dr. Orlowski. “Bridging leaders are not an exclusive group but open to anyone who finds their passion in teaching quality and safety. Maybe you’re doing quality and safety, but not education, but you recognize its importance, or vice versa. First of all, look to see what this bridging leaders thing really is, and how it might apply to you. You might say: ‘That accurately describes what I’m doing now. I have the interest; I want to learn more.’”
 

References

1. Accreditation Council for Graduate Medical Education. CLER pathways to excellence.

2. Myers JS et al. Bridging leadership roles in quality and patient safety: Experience of 6 U.S. Academic Medical Centers. J Grad Med Educ. 2017 Feb;9(1): 9-13.
 

In June 2019, a 5-hour preconference seminar at the annual Integrating Quality Conference of the Association of American Medical Colleges (AAMC) in Minneapolis highlighted the emergence of a new concept, and a new community, within the larger field of hospital medicine.

“Bridging leaders” are clinician-educators with a foot in two worlds: leading quality and safety initiatives within their teaching hospitals – with the hospitalist’s customary participation in a broad spectrum of quality improvement (QI) efforts in the hospital – while helping to train future and current physicians. “Bridging” also extends to the third piece of the quality puzzle, the hospital and/or health system’s senior administrators.

“About 8 years ago, another hospitalist and I found ourselves in this role, bridging graduate medical education with hospital quality and safety,” said Jennifer S. Myers, MD, FHM, director of quality and safety education in the department of medicine at the University of Pennsylvania, Philadelphia. “The role has since begun to proliferate, in teaching settings large and small, and about 30-50 of us with somewhat similar job responsibilities have been trying to create a community.”

Following the lead of the American College of Graduate Medical Education¹ and its standards for clinical learning environments that include integration of patient safety and quality improvement, these have become graduate medical education (GME) priorities. Students need to learn the theory and practice of safety and quality improvement on the job as part of their professional development. Residency program directors and other trainers thus need to find opportunities for them to practice these techniques in the clinical practice environment.

At the same time, mobilizing those eager medical learners to plan and conduct quality improvement projects can enhance a hospital’s ability to advance its mission in the new health care environment of accountable care and population health.
 

New concept arises

Is bridging leaders a real thing? The short answer is yes, said Thomas Ciesielski, MD, GME medical director for patient safety, quality education, and clinical learning environment review program development at Washington University in St. Louis. “This is a new trend, but it’s still in the process of defining itself. Every bridging leader has their own identity based on their institution. Some play a bridging role for the entire institution; others play similar roles but only within a specific department or division. There’s a lot of learning going on in our community,” he said.

The first Bridging Leaders track was held last year at AAMC’s 2018 Integrating Quality Conference, an event which has been held annually for the past decade. The concept was also highlighted in a 2017 article in the Journal of Graduate Medical Education² by bridging leaders, including many of the faculty at the subsequent AAMC sessions, highlighting their roles and programs at six academic medical centers.

One of those coauthors, hospitalist Vineet Arora, MD, MAPP, MHM, was recently appointed to a new position at University of Chicago Medicine: associate chief medical officer for the clinical learning environment – which pulls together many of the threads of the bridging leaders movement into a single job title. Dr. Arora said her job builds on her prior work in GME and improves the clinical learning environment for residents and fellows by integrating them into the health system’s institutional quality, safety, and value missions. It also expands on that work to include faculty and allied health professionals. “I just happen to come from the health system side,” she said.
 

Natural bridges: From clinical to educational

As with the early days of the hospitalist movement, bridging leaders are trying to build a community of peers with common interests.

“We’re just at the beginning,” Dr. Arora said. “Hospitalists have been the natural torch bearers for quality and safety in their hospitals, and also play roles in the education of residents and medical students, working alongside residency program directors. They are well-versed in quality and in education. So, they are the natural bridges between education and clinical care,” she said. “We also know this is a young group that comes to our meetings. One-third of them have been doing this for only the past 2 years or less – so they are early in their career paths.”

Front-line clinical providers, such as residents, often have good ideas, and bridging leaders can bring these ideas to the health system’s leaders, Dr. Arora said. “Bridging at the leadership level also involves thinking about the larger priorities of the system.” There are trust issues that these leaders can help to bridge, as well as internal communication barriers. “We also realize that health systems have to move quickly in response to a rapidly changing environment,” she noted.

“You don’t want a hundred quality improvement projects being done by students that are unaligned with the organization’s priorities. That leads to waste, and highlights the need for greater alignment,” Dr. Arora added. “Think about using front-line staff as agents of change, of engaging with learners as a win/win – as a way to actually solve the problems we are facing.”

A bridging leader occupies a role in which they can influence and affect these two parts of the mission of health care, somebody whose leadership responsibilities sit at the intersection of these two areas, said Darlene Tad-y, MD, director of GME quality and safety programs at the University of Colorado, Aurora. “Once, these people were mostly in academic medical centers, but that’s not so true anymore. A director of quality for a hospital medicine group is responsible for developing the group’s quality strategy, but at the same time responsible for teaching members of the group – not only doing QI but teaching others how to do it,” she said.

“Hospitalists make terrific bridging leaders. We really are in that sweet spot, and we can and should step into these leadership roles,” Dr. Tad-y said. “Because of our role in the hospital, we know the ins and outs of how processes work or don’t work. We have an insider’s view of the system’s dysfunction, which puts us in a great place to lead these efforts.”

The bridging leaders movement has been a grass-roots development, Dr. Tad-y explained. “It’s not like people started with the job title. But because all of this work was needed, a few people started doing it – and they began seeking each other out. Then they found that there were more than a few of us. We just hadn’t known what it was called.”
 

What is being bridged?

There has long been a relationship between individuals who lead in the clinical environment and those who lead in education, such as the program directors of residency programs, said Janis Orlowski, MD, chief health care officer for AAMC, which represents 154 MD-granting medical schools and their associated teaching hospitals.

“Our association’s three missions of research, education, and patient care really come together around the bridging leaders concept. So, this movement is well aligned. And as bridging leaders started to develop as a group, they found a home in AAMC and at our Integrating Quality Conference,” she said.

“Where we see this integration is in the teaching of residents and medical students in the clinical environment,” Dr. Orlowski said. “It’s not just their knowledge of disease or treatments or procedural skills that needs to be taught. They also need to understand the safe and effective clinical environment, and the role of learners in patient safety, quality improvement, and efficient and cost-effective hospital care. They need to understand value.” A new field of health systems science is emerging and quality improvement is evolving to incorporate population health. But traditional medical faculty may not be that comfortable teaching it.

Any physician who sees that they have a role in the clinical, administrative, and educational worlds can do the bridging, Dr. Orlowski said. “It could be any environment in which care is provided and learning takes place. I mentioned QI and patient safety, but among the other essential skills for the doctor of tomorrow are teamwork, inter-professional training in how to work with, for example, the pharmacist and dietitian, and understanding the value they bring.”

Whenever quality improvement projects are undertaken as part of post-graduate medical education, they should be aligned with the institution’s quality improvement plan and with the priorities of the health system, said Rob Dressler, MD, MBA, quality and safety officer at Christiana Health Care System in Newark, Del., and president of the Alliance of Independent Academic Medical Centers (AIAMC), which represents 80 hospital and health systems active in the emerging movement for bridging leaders.

“GME needs to keep the C-suite aware of its front-line efforts to improve quality and safety, so the institution’s return on investment can be recognized,” he said. “The AIAMC has consistently advocated for the building of bridges between GME leaders and their C-suites at our member hospitals. If you are doing process improvement, you need to be aligned with the organization and its priorities, or you’ll be less successful.”

AIAMC convenes the National Initiative – a multi-institutional collaborative in which residents lead multi-disciplinary teams in quality improvement projects. A total of 64 hospitals and health systems have participated since the program started in 2007. “We need to train our clinicians to solve the problems of tomorrow,” Dr. Dressler said.
 

Bridging leaders in action

The leaders contacted for this article offered some examples of bridging in action. Dr. Arora has used “crowd sourcing” – a technique employed extensively in her work with Costs of Care, a global nonprofit trying to drive better health care at lower cost – to implement a local program for front-line clinicians to generate ideas on how to improve value and reduce unnecessary treatment.

“We created our local ‘Choosing Wisely’ challenge for residents and staff at the University of Chicago – with the understanding that the winner would get analytic and time support to pursue their project,” she said. A resident winner was a finalist in the RIV (Research, Innovations and Clinical Vignettes) competition at a recent SHM Annual Conference.

At the University of Colorado, there is an associate program director who is responsible for the quality improvement curriculum for residents, Dr. Tad-y said. Because teaching QI means doing QI, the associate program director had to start implementing QI in the hospital, learning how to choose appropriate QI projects for the residents. That meant looking at quality priorities for the hospital – including VTE prophylaxis, fall prevention, and rates of central line–associated bloodstream infections and catheter-associated urinary tract infections. “A critical priority was to align the learners’ QI projects with what the hospital is already working on,” she explained.

“In our practice, all fellows need education and training in patient safety, how to recognize medical errors and close calls, and how to use our errors reporting system,” Dr. Myers said. “They also need to participate in errors analysis discussions. But we have struggled to get residents to attend those meetings. There’s not enough time in their schedules, and here at Penn, we have 1,500 residents and fellows, and maybe only 20 of these formal medical errors conferences per year,” she said.

Dr. Myers worked with the hospital’s patient safety officer and head of GME to design a simulated approach to fill the gap, a simulation of the root cause analysis process – how it works, the various roles played by different individuals, and what happens after it is done. “In my role, I trained one faculty member in each large residency program in how to identify a case and how to use the simulation,” she said. “They can now teach their own learners and make it more relevant to their specialty.”

Penn also has a blueprint for quality – a road map for how the organization socializes health care quality, safety, and value, Dr. Myers said. “Every 3 or 4 years our CEO looks at the road map and tries to get feedback on its direction from payers and insurers, quality leaders, academic department heads – and residents. I was in a good position to organize a session for a representative group of residents to get together and talk about where they see the quality and safety gaps in their everyday work.”

The role of the bridging leader is a viable career path or target for many hospitalists, Dr. Arora said. “But even if it’s not a career path for you, knowing that hospitalists are at the forefront of the bridging leaders movement could help you energize your health system. If you are seeing gaps in quality and safety, this is an issue you can bring before the system.”

These days doctors are wearing a lot of hats and filling roles that weren’t seen as much before, said Dr. Orlowski. “Bridging leaders are not an exclusive group but open to anyone who finds their passion in teaching quality and safety. Maybe you’re doing quality and safety, but not education, but you recognize its importance, or vice versa. First of all, look to see what this bridging leaders thing really is, and how it might apply to you. You might say: ‘That accurately describes what I’m doing now. I have the interest; I want to learn more.’”
 

References

1. Accreditation Council for Graduate Medical Education. CLER pathways to excellence.

2. Myers JS et al. Bridging leadership roles in quality and patient safety: Experience of 6 U.S. Academic Medical Centers. J Grad Med Educ. 2017 Feb;9(1): 9-13.
 

More than 1,000 cases of vaping-associated lung injury have been reported in 48 states and the U.S. Virgin Islands, according to a telebriefing by the Centers for Disease Control and Prevention.

vchal/Getty Images

As of Oct. 1, there have been 1,080 confirmed and probable cases of lung injury associated with the use of e-cigarettes, or vaping, said Anne Schuchat, MD, principal deputy director of the CDC. The latest figures were also reported in a statement issued by the CDC.

Dr. Schuchat said 18 related deaths in 15 states have been confirmed, and additional deaths are under investigation.

“As we have continued to get data for additional cases, the trends we reported last week persist,” Dr. Schuchat said (MMWR. 2019 Sep 27;68[39];860-4).

“Most patients reported a history of using THC [tetrahydrocannabinol]-containing products, and most patients are male and young people.” Of the 1,080 cases identified, approximately 70% are male, roughly 80% are younger than 35 years of age, and 37% are under 21 years of age. The patients’ median age is 23 years (range, 13-75 years). Among patients who have died, the median age is 50 years (range, 27-71 years).

The CDC now has information from 578 patients on the substances used in vaping products in the 90 days before symptom onset. About 78% of these patients reported using THC-containing products, and 37% reported exclusive use of THC-containing products. Roughly 58% of patients reported using nicotine-containing products, and 17% reported exclusive use of nicotine-containing products.

“I wish we had more answers regarding the specific harmful products or components that are causing these illnesses,” Dr. Schuchat said. She noted that THC-containing products appear to be the most commonly used, but these products don’t appear to be the only culprit. Additionally, in a report released recently in the New England Journal of Medicine (2019 Sep 9. doi: 10.1056/NEJMoa1911614), THC-containing products bought “off the street” were commonly used by patients with lung injuries. However, the CDC can’t say for certain if it’s safer for consumers to buy THC-containing products from a licensed dispensary.

The CDC has deployed staff to several states to help investigate the lung injuries, reached out to the clinical community to increase awareness of the injuries, and worked with clinicians and medical examiners to review assessments of patients who have developed these injuries, including those who have died. The CDC has also convened clinical professional societies to “help strengthen the detection, reporting, and management of cases,” Dr. Schuchat said.

In addition, the CDC has joined with the Food and Drug Administration and other public health partners to develop a laboratory plan for “continued testing of products, aerosol testing of substances produced by the products, and clinical pathology lung specimens from patients,” Dr. Schuchat said.

The FDA is also working to gather more information about vaping-associated lung injuries. The FDA is trying to obtain “critical details” about the specific products or substances that may be involved, said Judy McMeekin, PharmD, deputy associate commissioner for regulatory affairs at the FDA.

“There does not currently appear to be one product or substance involved in all of the cases,” Dr. McMeekin said. “We are leaving no stone unturned and following all potential leads regarding any particular product, constituent, or compound that may be at issue.”

The FDA has collected more than 440 samples of vaping devices and products from 18 states. The agency is still analyzing these samples, but a preliminary analysis has shown that some products contain THC concentrations ranging from 14% to 76%, and some products contain a combination of THC and vitamin E acetate ranging from 31% to 88%.

For information about the collection of vaping products for possible testing by the FDA, email [email protected]. For information about collection and submission of clinical specimens for possible testing by the CDC, see the Healthcare Provider webpage.

Clinicians and health officials who have questions about this outbreak can email [email protected]. All others with questions about this outbreak can contact CDC-INFO at 800-232-4636 or submit information at the Contact CDC-INFO page.

[email protected]

More than 1,000 cases of vaping-associated lung injury have been reported in 48 states and the U.S. Virgin Islands, according to a telebriefing by the Centers for Disease Control and Prevention.

vchal/Getty Images

As of Oct. 1, there have been 1,080 confirmed and probable cases of lung injury associated with the use of e-cigarettes, or vaping, said Anne Schuchat, MD, principal deputy director of the CDC. The latest figures were also reported in a statement issued by the CDC.

Dr. Schuchat said 18 related deaths in 15 states have been confirmed, and additional deaths are under investigation.

“As we have continued to get data for additional cases, the trends we reported last week persist,” Dr. Schuchat said (MMWR. 2019 Sep 27;68[39];860-4).

“Most patients reported a history of using THC [tetrahydrocannabinol]-containing products, and most patients are male and young people.” Of the 1,080 cases identified, approximately 70% are male, roughly 80% are younger than 35 years of age, and 37% are under 21 years of age. The patients’ median age is 23 years (range, 13-75 years). Among patients who have died, the median age is 50 years (range, 27-71 years).

The CDC now has information from 578 patients on the substances used in vaping products in the 90 days before symptom onset. About 78% of these patients reported using THC-containing products, and 37% reported exclusive use of THC-containing products. Roughly 58% of patients reported using nicotine-containing products, and 17% reported exclusive use of nicotine-containing products.

“I wish we had more answers regarding the specific harmful products or components that are causing these illnesses,” Dr. Schuchat said. She noted that THC-containing products appear to be the most commonly used, but these products don’t appear to be the only culprit. Additionally, in a report released recently in the New England Journal of Medicine (2019 Sep 9. doi: 10.1056/NEJMoa1911614), THC-containing products bought “off the street” were commonly used by patients with lung injuries. However, the CDC can’t say for certain if it’s safer for consumers to buy THC-containing products from a licensed dispensary.

The CDC has deployed staff to several states to help investigate the lung injuries, reached out to the clinical community to increase awareness of the injuries, and worked with clinicians and medical examiners to review assessments of patients who have developed these injuries, including those who have died. The CDC has also convened clinical professional societies to “help strengthen the detection, reporting, and management of cases,” Dr. Schuchat said.

In addition, the CDC has joined with the Food and Drug Administration and other public health partners to develop a laboratory plan for “continued testing of products, aerosol testing of substances produced by the products, and clinical pathology lung specimens from patients,” Dr. Schuchat said.

The FDA is also working to gather more information about vaping-associated lung injuries. The FDA is trying to obtain “critical details” about the specific products or substances that may be involved, said Judy McMeekin, PharmD, deputy associate commissioner for regulatory affairs at the FDA.

“There does not currently appear to be one product or substance involved in all of the cases,” Dr. McMeekin said. “We are leaving no stone unturned and following all potential leads regarding any particular product, constituent, or compound that may be at issue.”

The FDA has collected more than 440 samples of vaping devices and products from 18 states. The agency is still analyzing these samples, but a preliminary analysis has shown that some products contain THC concentrations ranging from 14% to 76%, and some products contain a combination of THC and vitamin E acetate ranging from 31% to 88%.

For information about the collection of vaping products for possible testing by the FDA, email [email protected]. For information about collection and submission of clinical specimens for possible testing by the CDC, see the Healthcare Provider webpage.

Clinicians and health officials who have questions about this outbreak can email [email protected]. All others with questions about this outbreak can contact CDC-INFO at 800-232-4636 or submit information at the Contact CDC-INFO page.

[email protected]

More than 1,000 cases of vaping-associated lung injury have been reported in 48 states and the U.S. Virgin Islands, according to a telebriefing by the Centers for Disease Control and Prevention.

vchal/Getty Images

As of Oct. 1, there have been 1,080 confirmed and probable cases of lung injury associated with the use of e-cigarettes, or vaping, said Anne Schuchat, MD, principal deputy director of the CDC. The latest figures were also reported in a statement issued by the CDC.

Dr. Schuchat said 18 related deaths in 15 states have been confirmed, and additional deaths are under investigation.

“As we have continued to get data for additional cases, the trends we reported last week persist,” Dr. Schuchat said (MMWR. 2019 Sep 27;68[39];860-4).

“Most patients reported a history of using THC [tetrahydrocannabinol]-containing products, and most patients are male and young people.” Of the 1,080 cases identified, approximately 70% are male, roughly 80% are younger than 35 years of age, and 37% are under 21 years of age. The patients’ median age is 23 years (range, 13-75 years). Among patients who have died, the median age is 50 years (range, 27-71 years).

The CDC now has information from 578 patients on the substances used in vaping products in the 90 days before symptom onset. About 78% of these patients reported using THC-containing products, and 37% reported exclusive use of THC-containing products. Roughly 58% of patients reported using nicotine-containing products, and 17% reported exclusive use of nicotine-containing products.

“I wish we had more answers regarding the specific harmful products or components that are causing these illnesses,” Dr. Schuchat said. She noted that THC-containing products appear to be the most commonly used, but these products don’t appear to be the only culprit. Additionally, in a report released recently in the New England Journal of Medicine (2019 Sep 9. doi: 10.1056/NEJMoa1911614), THC-containing products bought “off the street” were commonly used by patients with lung injuries. However, the CDC can’t say for certain if it’s safer for consumers to buy THC-containing products from a licensed dispensary.

The CDC has deployed staff to several states to help investigate the lung injuries, reached out to the clinical community to increase awareness of the injuries, and worked with clinicians and medical examiners to review assessments of patients who have developed these injuries, including those who have died. The CDC has also convened clinical professional societies to “help strengthen the detection, reporting, and management of cases,” Dr. Schuchat said.

In addition, the CDC has joined with the Food and Drug Administration and other public health partners to develop a laboratory plan for “continued testing of products, aerosol testing of substances produced by the products, and clinical pathology lung specimens from patients,” Dr. Schuchat said.

The FDA is also working to gather more information about vaping-associated lung injuries. The FDA is trying to obtain “critical details” about the specific products or substances that may be involved, said Judy McMeekin, PharmD, deputy associate commissioner for regulatory affairs at the FDA.

“There does not currently appear to be one product or substance involved in all of the cases,” Dr. McMeekin said. “We are leaving no stone unturned and following all potential leads regarding any particular product, constituent, or compound that may be at issue.”

The FDA has collected more than 440 samples of vaping devices and products from 18 states. The agency is still analyzing these samples, but a preliminary analysis has shown that some products contain THC concentrations ranging from 14% to 76%, and some products contain a combination of THC and vitamin E acetate ranging from 31% to 88%.

For information about the collection of vaping products for possible testing by the FDA, email [email protected]. For information about collection and submission of clinical specimens for possible testing by the CDC, see the Healthcare Provider webpage.

Clinicians and health officials who have questions about this outbreak can email [email protected]. All others with questions about this outbreak can contact CDC-INFO at 800-232-4636 or submit information at the Contact CDC-INFO page.

[email protected]

AFM cases continue to rise

Cases of Acute Flaccid Myelitis (AFM) are on the rise, with 210 confirmed cases of AFM in 40 states in 2018, up from 35 confirmed cases in 2017. AFM is a rare but serious condition that usually affects children, causing polio-like symptoms – focal extremity weakness, hyporeflexia, and sometimes cranial nerve dysfunction. The Centers for Disease Control and Prevention encourage all health care providers to contact their local health departments with any suspected cases of AFM.

Citation: Centers for Disease Control and Prevention. AFM Investigation. 2019 Jan. https://www.cdc.gov/acute-flaccid-myelitis/afm-surveillance.html.

HHS recommends prescribing naloxone to patients at high risk for opioid overdose

The U.S. Department of Health & Human Services recommends clinicians strongly consider prescribing or coprescribing naloxone to patients at high risk of opioid overdose. This includes patients who are on relatively high doses of opioids, take other medications which enhance opioid complications, or have underlying health conditions. Clinicians are also advised to educate patients and those likely to respond to an overdose on when and how to use naloxone in its variety of forms.

Citation: U.S. Department of Health & Human Services. HHS recommends prescribing or co-prescribing naloxone to patients at high risk for an opioid overdose. 2018 Dec 18. https://www.hhs.gov/about/news/2018/12/19/hhs-recommends-prescribing-or-co-prescribing-naloxone-to-patients-at-high-risk-for-an-opioid-overdose.html.

Fentanyl tops the list of opioid overdose drugs

The total number of drug overdose deaths per year in the United States increased 54%, from 41,340 deaths in 2011 to 63,632 deaths in 2016. Among opioids, mention of fentanyl increased during 2011-2016; that drug took the lead in 2016 with 29% of all drug overdose deaths. Among the drug overdose deaths involving fentanyl, 69% also involved one or more other drugs.

Citation: Hedegaard H et al. Drugs most frequently involved in drug overdose deaths: United States, 2011–2016. Natl Vital Stat Rep. 2018 Dec;67(9):1-14.

AFM cases continue to rise

Cases of Acute Flaccid Myelitis (AFM) are on the rise, with 210 confirmed cases of AFM in 40 states in 2018, up from 35 confirmed cases in 2017. AFM is a rare but serious condition that usually affects children, causing polio-like symptoms – focal extremity weakness, hyporeflexia, and sometimes cranial nerve dysfunction. The Centers for Disease Control and Prevention encourage all health care providers to contact their local health departments with any suspected cases of AFM.

Citation: Centers for Disease Control and Prevention. AFM Investigation. 2019 Jan. https://www.cdc.gov/acute-flaccid-myelitis/afm-surveillance.html.

HHS recommends prescribing naloxone to patients at high risk for opioid overdose

The U.S. Department of Health & Human Services recommends clinicians strongly consider prescribing or coprescribing naloxone to patients at high risk of opioid overdose. This includes patients who are on relatively high doses of opioids, take other medications which enhance opioid complications, or have underlying health conditions. Clinicians are also advised to educate patients and those likely to respond to an overdose on when and how to use naloxone in its variety of forms.

Citation: U.S. Department of Health & Human Services. HHS recommends prescribing or co-prescribing naloxone to patients at high risk for an opioid overdose. 2018 Dec 18. https://www.hhs.gov/about/news/2018/12/19/hhs-recommends-prescribing-or-co-prescribing-naloxone-to-patients-at-high-risk-for-an-opioid-overdose.html.

Fentanyl tops the list of opioid overdose drugs

The total number of drug overdose deaths per year in the United States increased 54%, from 41,340 deaths in 2011 to 63,632 deaths in 2016. Among opioids, mention of fentanyl increased during 2011-2016; that drug took the lead in 2016 with 29% of all drug overdose deaths. Among the drug overdose deaths involving fentanyl, 69% also involved one or more other drugs.

Citation: Hedegaard H et al. Drugs most frequently involved in drug overdose deaths: United States, 2011–2016. Natl Vital Stat Rep. 2018 Dec;67(9):1-14.

AFM cases continue to rise

Cases of Acute Flaccid Myelitis (AFM) are on the rise, with 210 confirmed cases of AFM in 40 states in 2018, up from 35 confirmed cases in 2017. AFM is a rare but serious condition that usually affects children, causing polio-like symptoms – focal extremity weakness, hyporeflexia, and sometimes cranial nerve dysfunction. The Centers for Disease Control and Prevention encourage all health care providers to contact their local health departments with any suspected cases of AFM.

Citation: Centers for Disease Control and Prevention. AFM Investigation. 2019 Jan. https://www.cdc.gov/acute-flaccid-myelitis/afm-surveillance.html.

HHS recommends prescribing naloxone to patients at high risk for opioid overdose

The U.S. Department of Health & Human Services recommends clinicians strongly consider prescribing or coprescribing naloxone to patients at high risk of opioid overdose. This includes patients who are on relatively high doses of opioids, take other medications which enhance opioid complications, or have underlying health conditions. Clinicians are also advised to educate patients and those likely to respond to an overdose on when and how to use naloxone in its variety of forms.

Citation: U.S. Department of Health & Human Services. HHS recommends prescribing or co-prescribing naloxone to patients at high risk for an opioid overdose. 2018 Dec 18. https://www.hhs.gov/about/news/2018/12/19/hhs-recommends-prescribing-or-co-prescribing-naloxone-to-patients-at-high-risk-for-an-opioid-overdose.html.

Fentanyl tops the list of opioid overdose drugs

The total number of drug overdose deaths per year in the United States increased 54%, from 41,340 deaths in 2011 to 63,632 deaths in 2016. Among opioids, mention of fentanyl increased during 2011-2016; that drug took the lead in 2016 with 29% of all drug overdose deaths. Among the drug overdose deaths involving fentanyl, 69% also involved one or more other drugs.

Citation: Hedegaard H et al. Drugs most frequently involved in drug overdose deaths: United States, 2011–2016. Natl Vital Stat Rep. 2018 Dec;67(9):1-14.

PARIS – The risk of infective endocarditis following transcatheter aortic valve replacement (TAVR) for the treatment of severe aortic stenosis proved to be the same as after surgical replacement in a French national propensity score–matched study.

This finding from what is believed to be the largest-ever study of infective endocarditis following TAVR will come as a surprise to many physicians. It’s easy to mistakenly assume the risk of this feared complication is lower – and perhaps even negligible – in TAVR patients since the procedure doesn’t involve a significant surgical wound, it’s briefer, the hospital length of stay is shorter, and recovery time is markedly less than with surgical aortic valve replacement (SAVR).

Not so, Laurent Fauchier, MD, PhD, said in presenting the study findings at the annual congress of the European Society of Cardiology.

“Do not think there is a lower risk of infective endocarditis. Be aware, be careful, and provide appropriate antibiotic prophylaxis, just as surgeons do in SAVR. Don’t think, as I did, that with TAVR with no pacemaker implantation there is no risk of infective endocarditis. The TAVR valve is a device, it’s a prosthesis, and the risk is very similar to that of surgery,” advised Dr. Fauchier, a cardiologist at Francois Rabelais University in Tours, France.

He presented a study of all of the nearly 108,000 patients who underwent isolated TAVR or SAVR in France during 2010-2018. The data source was the French national administrative hospital discharge record system. Since the TAVR patients were overall markedly older and sicker than the SAVR patients, especially during the first years of the study, he and his coinvestigators performed propensity score matching using 30 variables, which enabled them to narrow the field of inquiry down to a carefully selected study population of 16,291 TAVR patients and an equal number of closely similar SAVR patients.

A total of 1,070 cases of infective endocarditis occurred during a mean follow-up of just over 2 years. The rate of hospital admission for this complication was 1.89% per year in the TAVR group and similar at 1.71% per year in the SAVR cohort.

Of note, all-cause mortality in TAVR patients who developed infective endocarditis was 1.32-fold greater than it was in SAVR patients with infective endocarditis, a statistically significant difference. The explanation for the increased mortality risk in the TAVR group probably has to do at least in part with an inability on the part of the investigators to fully capture and control for the TAVR group’s greater frailty, according to the cardiologist.

Risk factors for infective endocarditis shared in common by TAVR and SAVR patients included male gender, a higher Charlson Comorbidity Index score, and a greater frailty index. The main predictors unique to the TAVR patients were atrial fibrillation, anemia, and tricuspid regurgitation. And although pacemaker and defibrillator implantation were risk factors for infective endocarditis in the SAVR patients, it wasn’t predictive of increased risk in the TAVR population. Dr. Fauchier called this finding “quite reassuring” given that roughly 20% of the TAVR group received a pacemaker.

The causative microorganisms for infective endocarditis were essentially the same in the TAVR and SAVR groups, simplifying antimicrobial prophylaxis decision making.

Dr. Fauchier reported having no financial conflicts regarding the study, conducted free of commercial support. He serves as a consultant to and/or on speakers’ bureaus for Bayer, BMS Pfizer, Boehringer Ingelheim, Medtronic, and Novartis.

[email protected]

PARIS – The risk of infective endocarditis following transcatheter aortic valve replacement (TAVR) for the treatment of severe aortic stenosis proved to be the same as after surgical replacement in a French national propensity score–matched study.

This finding from what is believed to be the largest-ever study of infective endocarditis following TAVR will come as a surprise to many physicians. It’s easy to mistakenly assume the risk of this feared complication is lower – and perhaps even negligible – in TAVR patients since the procedure doesn’t involve a significant surgical wound, it’s briefer, the hospital length of stay is shorter, and recovery time is markedly less than with surgical aortic valve replacement (SAVR).

Not so, Laurent Fauchier, MD, PhD, said in presenting the study findings at the annual congress of the European Society of Cardiology.

“Do not think there is a lower risk of infective endocarditis. Be aware, be careful, and provide appropriate antibiotic prophylaxis, just as surgeons do in SAVR. Don’t think, as I did, that with TAVR with no pacemaker implantation there is no risk of infective endocarditis. The TAVR valve is a device, it’s a prosthesis, and the risk is very similar to that of surgery,” advised Dr. Fauchier, a cardiologist at Francois Rabelais University in Tours, France.

He presented a study of all of the nearly 108,000 patients who underwent isolated TAVR or SAVR in France during 2010-2018. The data source was the French national administrative hospital discharge record system. Since the TAVR patients were overall markedly older and sicker than the SAVR patients, especially during the first years of the study, he and his coinvestigators performed propensity score matching using 30 variables, which enabled them to narrow the field of inquiry down to a carefully selected study population of 16,291 TAVR patients and an equal number of closely similar SAVR patients.

A total of 1,070 cases of infective endocarditis occurred during a mean follow-up of just over 2 years. The rate of hospital admission for this complication was 1.89% per year in the TAVR group and similar at 1.71% per year in the SAVR cohort.

Of note, all-cause mortality in TAVR patients who developed infective endocarditis was 1.32-fold greater than it was in SAVR patients with infective endocarditis, a statistically significant difference. The explanation for the increased mortality risk in the TAVR group probably has to do at least in part with an inability on the part of the investigators to fully capture and control for the TAVR group’s greater frailty, according to the cardiologist.

Risk factors for infective endocarditis shared in common by TAVR and SAVR patients included male gender, a higher Charlson Comorbidity Index score, and a greater frailty index. The main predictors unique to the TAVR patients were atrial fibrillation, anemia, and tricuspid regurgitation. And although pacemaker and defibrillator implantation were risk factors for infective endocarditis in the SAVR patients, it wasn’t predictive of increased risk in the TAVR population. Dr. Fauchier called this finding “quite reassuring” given that roughly 20% of the TAVR group received a pacemaker.

The causative microorganisms for infective endocarditis were essentially the same in the TAVR and SAVR groups, simplifying antimicrobial prophylaxis decision making.

Dr. Fauchier reported having no financial conflicts regarding the study, conducted free of commercial support. He serves as a consultant to and/or on speakers’ bureaus for Bayer, BMS Pfizer, Boehringer Ingelheim, Medtronic, and Novartis.

[email protected]

PARIS – The risk of infective endocarditis following transcatheter aortic valve replacement (TAVR) for the treatment of severe aortic stenosis proved to be the same as after surgical replacement in a French national propensity score–matched study.

This finding from what is believed to be the largest-ever study of infective endocarditis following TAVR will come as a surprise to many physicians. It’s easy to mistakenly assume the risk of this feared complication is lower – and perhaps even negligible – in TAVR patients since the procedure doesn’t involve a significant surgical wound, it’s briefer, the hospital length of stay is shorter, and recovery time is markedly less than with surgical aortic valve replacement (SAVR).

Not so, Laurent Fauchier, MD, PhD, said in presenting the study findings at the annual congress of the European Society of Cardiology.

“Do not think there is a lower risk of infective endocarditis. Be aware, be careful, and provide appropriate antibiotic prophylaxis, just as surgeons do in SAVR. Don’t think, as I did, that with TAVR with no pacemaker implantation there is no risk of infective endocarditis. The TAVR valve is a device, it’s a prosthesis, and the risk is very similar to that of surgery,” advised Dr. Fauchier, a cardiologist at Francois Rabelais University in Tours, France.

He presented a study of all of the nearly 108,000 patients who underwent isolated TAVR or SAVR in France during 2010-2018. The data source was the French national administrative hospital discharge record system. Since the TAVR patients were overall markedly older and sicker than the SAVR patients, especially during the first years of the study, he and his coinvestigators performed propensity score matching using 30 variables, which enabled them to narrow the field of inquiry down to a carefully selected study population of 16,291 TAVR patients and an equal number of closely similar SAVR patients.

A total of 1,070 cases of infective endocarditis occurred during a mean follow-up of just over 2 years. The rate of hospital admission for this complication was 1.89% per year in the TAVR group and similar at 1.71% per year in the SAVR cohort.

Of note, all-cause mortality in TAVR patients who developed infective endocarditis was 1.32-fold greater than it was in SAVR patients with infective endocarditis, a statistically significant difference. The explanation for the increased mortality risk in the TAVR group probably has to do at least in part with an inability on the part of the investigators to fully capture and control for the TAVR group’s greater frailty, according to the cardiologist.

Risk factors for infective endocarditis shared in common by TAVR and SAVR patients included male gender, a higher Charlson Comorbidity Index score, and a greater frailty index. The main predictors unique to the TAVR patients were atrial fibrillation, anemia, and tricuspid regurgitation. And although pacemaker and defibrillator implantation were risk factors for infective endocarditis in the SAVR patients, it wasn’t predictive of increased risk in the TAVR population. Dr. Fauchier called this finding “quite reassuring” given that roughly 20% of the TAVR group received a pacemaker.

The causative microorganisms for infective endocarditis were essentially the same in the TAVR and SAVR groups, simplifying antimicrobial prophylaxis decision making.

Dr. Fauchier reported having no financial conflicts regarding the study, conducted free of commercial support. He serves as a consultant to and/or on speakers’ bureaus for Bayer, BMS Pfizer, Boehringer Ingelheim, Medtronic, and Novartis.

[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]