CHEST Physician

A group of leading medical journal editors is seeking to improve the completeness and transparency of financial disclosure reporting with a proposed new disclosure form that puts more onus on readers to decide whether relationships and activities should influence how they view published papers.

The proposed changes are described in an editorial published simultaneously today in the Annals of Internal Medicine, British Medical Journal, Journal of the American Medical Association, The Lancet, New England Journal of Medicine, and several other journals whose editors are members of the International Committee of Medical Journal Editors (ICMJE).

“While no approach to disclosure will be perfect or foolproof, we hope the changes we propose will help promote transparency and trust,” the editorial stated (Ann Intern Med. 2020 Jan 27. doi: 10.7326/M19-3933).

The ICMJE adopted its currently used electronic form – the “ICMJE Form for the Disclosure of Potential Conflicts of Interest” – 10 years ago in an effort to create some uniformity amidst a patchwork of differing disclosure requirements for authors.

It’s not known how many journals outside of the ICMJE’s member journals routinely use the disclosure form, but the organization’s website houses an extensive list of journals whose editors or publishers have requested to be listed as following the ICMJE’s recommendations for editing, reporting, and publishing, including those concerning disclosures. The ICMJE does not “certify” journals. The full set of recommendations was updated in December 2019.

Most authors are committed to transparent reporting, but “opinions differ over which relationships or activities to report,” the editorial stated.

An author might choose to omit an item that others deem important because of a difference in opinion regarding “relevance,” confusion over definitions, or a simple oversight. Some authors may be “concerned that readers will interpret the listing of any item as a ‘potential conflict of interest’ as indicative of problematic influence and wrongdoing,” the editorial stated.

The revised form, like the current one, asks authors to disclose relationships and activities that are directly related to the reported work, as well as those that are topically related (within the broadly defined field addressed in the work). But unlike the current form, the new version provides a checklist of relationships and activities and asks authors to check ‘yes’ or ‘no’ for each one (and to name them when the answer is ‘yes’).

Items in the checklist include grants, payments/honoraria for lectures, patents issued or planned, stock/stock options, and leadership or fiduciary roles in committees, boards, or societies.

The proposed new form makes no mention of “potential conflicts of interest” or “relevancy,” per say. Authors aren’t asked to determine what might be interpreted as a potential conflict of interest, but instead are asked for a “complete listing” of what readers may find “pertinent” to their work.

“We’re trying to move away from calling everything a [potential] ‘conflict,’ ” Darren B. Taichman, MD, PhD, secretary of ICMJE and executive editor of the Annals of Internal Medicine, said in an interview. “We want to remove for authors the concern or stigma, if you will, that anything listed on a form implies that there is something wrong, because that’s just not true. … We want readers to decide what relationships are important as they interpret the work.”

Dr. Taichman said in the interview that the ICMJE’s updating of the form was more a function of “good housekeeping” and continuous appreciation of disclosure as an important issue, rather than any one specific issue, such as concern over a “relevancy” approach to disclosures.

The ICMJE is seeking feedback about its proposed form, which is available with a link for providing comments, at www.icmje.org.

Broader national efforts

Editors and others have been increasingly moving, however, toward asking for more complete disclosures where authors aren’t asked to judge “relevancy” and where readers can make decisions on their own. The American Society of Clinical Oncology, which produces the Journal of Clinical Oncology (JCO) as well as practice guidelines and continuing medical education programs, moved about 5 years ago to a system of general disclosure that asks physicians and others to disclose all financial interests and industry relationships, with no qualifiers.

Earlier in January 2020, the Accreditation Council for Continuing Medical Education issued proposed revisions to its Standards for Integrity and Independence in Accredited Continuing Education. These revisions, which are open for comment, require CME providers to collect disclosure information about all financial relationships of speakers and presenters. It’s up to the CME provider to then determine which relationships are relevant, according to the proposed document.

More change is on the way, as disclosure issues are being deliberated nationally in the wake of a highly publicized disclosure failure at Memorial Sloan Kettering Cancer Center in 2018. Chief medical officer José Baselga, MD, PhD, failed to report millions of dollars of industry payments and ownership interests in journal articles he wrote or cowrote over several years.

In February 2019, leaders from journals, academia, medical societies, and other institutions gathered in Washington for a closed-door meeting to hash out various disclosure related issues.

Hosted by the Association of American Medical Colleges and cosponsored by Memorial Sloan Kettering Cancer Center, ASCO, JAMA, and the Council of Medical Specialty Societies, the meeting led to a series of working groups that are creating additional recommendations “due out soon in 2020,” Heather Pierce, senior director of science policy and regulatory counsel for the AAMC, said in an interview.

Among the questions being discussed: What disclosures should be verified and who should do so? How can disclosures be made more complete and easier for researchers? And, “most importantly,” said Ms. Pierce, how can policy requirements across each of these sectors be aligned so that there’s more coordination and oversight – and with it, public trust?

Some critics of current disclosure policies have called for more reporting of compensation amounts, and Ms. Pierce said that this has been part of cross-sector discussions.

The ICMJE’s proposed form invites, but does not require, authors to indicate what payments were made to them or their institutions. “Part of this is due to the fact that it’s hard to define, let alone agree on, what’s an important amount,” Dr. Taichman said.

A push for registries

The ICMJE is also aiming to make the disclosure process more efficient for authors – and to eliminate inconsistent and incomplete disclosures – by accepting disclosures from web-based repositories, according to the editorial. Repositories allow authors to maintain an inventory of their relationships and activities and then create electronic disclosures that are tailored to the requirements of the ICMJE, medical societies, and other entities.

The AAMC-run repository, called Convey, is consistent with ICMJE reporting requirements and other criteria (e.g., there are no fees for individuals to enter, store, or export their data), but the development of other repositories may be helpful “for meeting regional, linguistic, and regulatory needs” of authors across the world, the editorial stated.

The Annals of Internal Medicine and the New England Journal of Medicine are both currently collecting disclosures through Convey. The platform was born from discussions that followed a 2009 Institute of Medicine report on conflicts of interest.

Signers of the ICMJE editorial include representatives of the National Library of Medicine and the World Association of Medical Editors, in addition to editors in chief and other leaders of the ICMJE member journals.

A group of leading medical journal editors is seeking to improve the completeness and transparency of financial disclosure reporting with a proposed new disclosure form that puts more onus on readers to decide whether relationships and activities should influence how they view published papers.

The proposed changes are described in an editorial published simultaneously today in the Annals of Internal Medicine, British Medical Journal, Journal of the American Medical Association, The Lancet, New England Journal of Medicine, and several other journals whose editors are members of the International Committee of Medical Journal Editors (ICMJE).

“While no approach to disclosure will be perfect or foolproof, we hope the changes we propose will help promote transparency and trust,” the editorial stated (Ann Intern Med. 2020 Jan 27. doi: 10.7326/M19-3933).

The ICMJE adopted its currently used electronic form – the “ICMJE Form for the Disclosure of Potential Conflicts of Interest” – 10 years ago in an effort to create some uniformity amidst a patchwork of differing disclosure requirements for authors.

It’s not known how many journals outside of the ICMJE’s member journals routinely use the disclosure form, but the organization’s website houses an extensive list of journals whose editors or publishers have requested to be listed as following the ICMJE’s recommendations for editing, reporting, and publishing, including those concerning disclosures. The ICMJE does not “certify” journals. The full set of recommendations was updated in December 2019.

Most authors are committed to transparent reporting, but “opinions differ over which relationships or activities to report,” the editorial stated.

An author might choose to omit an item that others deem important because of a difference in opinion regarding “relevance,” confusion over definitions, or a simple oversight. Some authors may be “concerned that readers will interpret the listing of any item as a ‘potential conflict of interest’ as indicative of problematic influence and wrongdoing,” the editorial stated.

The revised form, like the current one, asks authors to disclose relationships and activities that are directly related to the reported work, as well as those that are topically related (within the broadly defined field addressed in the work). But unlike the current form, the new version provides a checklist of relationships and activities and asks authors to check ‘yes’ or ‘no’ for each one (and to name them when the answer is ‘yes’).

Items in the checklist include grants, payments/honoraria for lectures, patents issued or planned, stock/stock options, and leadership or fiduciary roles in committees, boards, or societies.

The proposed new form makes no mention of “potential conflicts of interest” or “relevancy,” per say. Authors aren’t asked to determine what might be interpreted as a potential conflict of interest, but instead are asked for a “complete listing” of what readers may find “pertinent” to their work.

“We’re trying to move away from calling everything a [potential] ‘conflict,’ ” Darren B. Taichman, MD, PhD, secretary of ICMJE and executive editor of the Annals of Internal Medicine, said in an interview. “We want to remove for authors the concern or stigma, if you will, that anything listed on a form implies that there is something wrong, because that’s just not true. … We want readers to decide what relationships are important as they interpret the work.”

Dr. Taichman said in the interview that the ICMJE’s updating of the form was more a function of “good housekeeping” and continuous appreciation of disclosure as an important issue, rather than any one specific issue, such as concern over a “relevancy” approach to disclosures.

The ICMJE is seeking feedback about its proposed form, which is available with a link for providing comments, at www.icmje.org.

Broader national efforts

Editors and others have been increasingly moving, however, toward asking for more complete disclosures where authors aren’t asked to judge “relevancy” and where readers can make decisions on their own. The American Society of Clinical Oncology, which produces the Journal of Clinical Oncology (JCO) as well as practice guidelines and continuing medical education programs, moved about 5 years ago to a system of general disclosure that asks physicians and others to disclose all financial interests and industry relationships, with no qualifiers.

Earlier in January 2020, the Accreditation Council for Continuing Medical Education issued proposed revisions to its Standards for Integrity and Independence in Accredited Continuing Education. These revisions, which are open for comment, require CME providers to collect disclosure information about all financial relationships of speakers and presenters. It’s up to the CME provider to then determine which relationships are relevant, according to the proposed document.

More change is on the way, as disclosure issues are being deliberated nationally in the wake of a highly publicized disclosure failure at Memorial Sloan Kettering Cancer Center in 2018. Chief medical officer José Baselga, MD, PhD, failed to report millions of dollars of industry payments and ownership interests in journal articles he wrote or cowrote over several years.

In February 2019, leaders from journals, academia, medical societies, and other institutions gathered in Washington for a closed-door meeting to hash out various disclosure related issues.

Hosted by the Association of American Medical Colleges and cosponsored by Memorial Sloan Kettering Cancer Center, ASCO, JAMA, and the Council of Medical Specialty Societies, the meeting led to a series of working groups that are creating additional recommendations “due out soon in 2020,” Heather Pierce, senior director of science policy and regulatory counsel for the AAMC, said in an interview.

Among the questions being discussed: What disclosures should be verified and who should do so? How can disclosures be made more complete and easier for researchers? And, “most importantly,” said Ms. Pierce, how can policy requirements across each of these sectors be aligned so that there’s more coordination and oversight – and with it, public trust?

Some critics of current disclosure policies have called for more reporting of compensation amounts, and Ms. Pierce said that this has been part of cross-sector discussions.

The ICMJE’s proposed form invites, but does not require, authors to indicate what payments were made to them or their institutions. “Part of this is due to the fact that it’s hard to define, let alone agree on, what’s an important amount,” Dr. Taichman said.

A push for registries

The ICMJE is also aiming to make the disclosure process more efficient for authors – and to eliminate inconsistent and incomplete disclosures – by accepting disclosures from web-based repositories, according to the editorial. Repositories allow authors to maintain an inventory of their relationships and activities and then create electronic disclosures that are tailored to the requirements of the ICMJE, medical societies, and other entities.

The AAMC-run repository, called Convey, is consistent with ICMJE reporting requirements and other criteria (e.g., there are no fees for individuals to enter, store, or export their data), but the development of other repositories may be helpful “for meeting regional, linguistic, and regulatory needs” of authors across the world, the editorial stated.

The Annals of Internal Medicine and the New England Journal of Medicine are both currently collecting disclosures through Convey. The platform was born from discussions that followed a 2009 Institute of Medicine report on conflicts of interest.

Signers of the ICMJE editorial include representatives of the National Library of Medicine and the World Association of Medical Editors, in addition to editors in chief and other leaders of the ICMJE member journals.

A group of leading medical journal editors is seeking to improve the completeness and transparency of financial disclosure reporting with a proposed new disclosure form that puts more onus on readers to decide whether relationships and activities should influence how they view published papers.

The proposed changes are described in an editorial published simultaneously today in the Annals of Internal Medicine, British Medical Journal, Journal of the American Medical Association, The Lancet, New England Journal of Medicine, and several other journals whose editors are members of the International Committee of Medical Journal Editors (ICMJE).

“While no approach to disclosure will be perfect or foolproof, we hope the changes we propose will help promote transparency and trust,” the editorial stated (Ann Intern Med. 2020 Jan 27. doi: 10.7326/M19-3933).

The ICMJE adopted its currently used electronic form – the “ICMJE Form for the Disclosure of Potential Conflicts of Interest” – 10 years ago in an effort to create some uniformity amidst a patchwork of differing disclosure requirements for authors.

It’s not known how many journals outside of the ICMJE’s member journals routinely use the disclosure form, but the organization’s website houses an extensive list of journals whose editors or publishers have requested to be listed as following the ICMJE’s recommendations for editing, reporting, and publishing, including those concerning disclosures. The ICMJE does not “certify” journals. The full set of recommendations was updated in December 2019.

Most authors are committed to transparent reporting, but “opinions differ over which relationships or activities to report,” the editorial stated.

An author might choose to omit an item that others deem important because of a difference in opinion regarding “relevance,” confusion over definitions, or a simple oversight. Some authors may be “concerned that readers will interpret the listing of any item as a ‘potential conflict of interest’ as indicative of problematic influence and wrongdoing,” the editorial stated.

The revised form, like the current one, asks authors to disclose relationships and activities that are directly related to the reported work, as well as those that are topically related (within the broadly defined field addressed in the work). But unlike the current form, the new version provides a checklist of relationships and activities and asks authors to check ‘yes’ or ‘no’ for each one (and to name them when the answer is ‘yes’).

Items in the checklist include grants, payments/honoraria for lectures, patents issued or planned, stock/stock options, and leadership or fiduciary roles in committees, boards, or societies.

The proposed new form makes no mention of “potential conflicts of interest” or “relevancy,” per say. Authors aren’t asked to determine what might be interpreted as a potential conflict of interest, but instead are asked for a “complete listing” of what readers may find “pertinent” to their work.

“We’re trying to move away from calling everything a [potential] ‘conflict,’ ” Darren B. Taichman, MD, PhD, secretary of ICMJE and executive editor of the Annals of Internal Medicine, said in an interview. “We want to remove for authors the concern or stigma, if you will, that anything listed on a form implies that there is something wrong, because that’s just not true. … We want readers to decide what relationships are important as they interpret the work.”

Dr. Taichman said in the interview that the ICMJE’s updating of the form was more a function of “good housekeeping” and continuous appreciation of disclosure as an important issue, rather than any one specific issue, such as concern over a “relevancy” approach to disclosures.

The ICMJE is seeking feedback about its proposed form, which is available with a link for providing comments, at www.icmje.org.

Broader national efforts

Editors and others have been increasingly moving, however, toward asking for more complete disclosures where authors aren’t asked to judge “relevancy” and where readers can make decisions on their own. The American Society of Clinical Oncology, which produces the Journal of Clinical Oncology (JCO) as well as practice guidelines and continuing medical education programs, moved about 5 years ago to a system of general disclosure that asks physicians and others to disclose all financial interests and industry relationships, with no qualifiers.

Earlier in January 2020, the Accreditation Council for Continuing Medical Education issued proposed revisions to its Standards for Integrity and Independence in Accredited Continuing Education. These revisions, which are open for comment, require CME providers to collect disclosure information about all financial relationships of speakers and presenters. It’s up to the CME provider to then determine which relationships are relevant, according to the proposed document.

More change is on the way, as disclosure issues are being deliberated nationally in the wake of a highly publicized disclosure failure at Memorial Sloan Kettering Cancer Center in 2018. Chief medical officer José Baselga, MD, PhD, failed to report millions of dollars of industry payments and ownership interests in journal articles he wrote or cowrote over several years.

In February 2019, leaders from journals, academia, medical societies, and other institutions gathered in Washington for a closed-door meeting to hash out various disclosure related issues.

Hosted by the Association of American Medical Colleges and cosponsored by Memorial Sloan Kettering Cancer Center, ASCO, JAMA, and the Council of Medical Specialty Societies, the meeting led to a series of working groups that are creating additional recommendations “due out soon in 2020,” Heather Pierce, senior director of science policy and regulatory counsel for the AAMC, said in an interview.

Among the questions being discussed: What disclosures should be verified and who should do so? How can disclosures be made more complete and easier for researchers? And, “most importantly,” said Ms. Pierce, how can policy requirements across each of these sectors be aligned so that there’s more coordination and oversight – and with it, public trust?

Some critics of current disclosure policies have called for more reporting of compensation amounts, and Ms. Pierce said that this has been part of cross-sector discussions.

The ICMJE’s proposed form invites, but does not require, authors to indicate what payments were made to them or their institutions. “Part of this is due to the fact that it’s hard to define, let alone agree on, what’s an important amount,” Dr. Taichman said.

A push for registries

The ICMJE is also aiming to make the disclosure process more efficient for authors – and to eliminate inconsistent and incomplete disclosures – by accepting disclosures from web-based repositories, according to the editorial. Repositories allow authors to maintain an inventory of their relationships and activities and then create electronic disclosures that are tailored to the requirements of the ICMJE, medical societies, and other entities.

The AAMC-run repository, called Convey, is consistent with ICMJE reporting requirements and other criteria (e.g., there are no fees for individuals to enter, store, or export their data), but the development of other repositories may be helpful “for meeting regional, linguistic, and regulatory needs” of authors across the world, the editorial stated.

The Annals of Internal Medicine and the New England Journal of Medicine are both currently collecting disclosures through Convey. The platform was born from discussions that followed a 2009 Institute of Medicine report on conflicts of interest.

Signers of the ICMJE editorial include representatives of the National Library of Medicine and the World Association of Medical Editors, in addition to editors in chief and other leaders of the ICMJE member journals.

A Chinese man became ill from a novel coronavirus (2019-nCoV) 4 days after arriving in Vietnam to visit his 27-year-old son. Three days later the healthy young man was also stricken, according to a report published online Jan. 28 in the New England Journal of Medicine.

“This family cluster of 2019-nCoV infection that occurred outside China arouses concern regarding human-to-human transmission,” the authors wrote.

The father, age 65 years and with multiple comorbidities including hypertension, type 2 diabetes, coronary heart disease with stent placement, and lung cancer, flew to Hanoi with his wife on January 13; they traveled from the Wuchang district in Wuhan, China, where outbreaks of 2019-nCoV have been occurring.

On Jan. 17, the older man and his wife met their adult son in Ho Chi Minh City, Vietnam, and shared a hotel room with him for 3 days. The father developed a fever that same day and the son developed a dry cough, fever, diarrhea, and vomiting on Jan. 20. Both men went to a hospital ED on Jan. 22.

The authors say the timing of the son’s symptoms suggests the incubation period may have been 3 days or fewer.

Upon admission to the hospital, the father reported that he had not visited a “wet market” where live and dead animals are sold while he was in Wuhan. Throat swabs were positive for 2019-nCoV on real-time reverse-transcription–polymerase-chain-reaction assays.

The man was placed in isolation and “treated empirically with antiviral agents, broad-spectrum antibiotics, and supportive therapies,” wrote Lan T. Phan, PhD, from the Pasteur Institute Ho Chi Minh City and coauthors.

On admission, chest radiographs revealed an infiltrate in the upper lobe of his left lung; he developed worsening dyspnea with hypoxemia on Jan. 25 and required supplemental oxygen at 5 L/min by nasal cannula. Chest radiographs showed a progressive infiltrate and consolidation. His fever resolved on that day and he has progressively improved.

The man’s son had a fever of 39° C (102.2° F) when the two men arrived at the hospital on Jan. 22; hospital staff isolated the son, and chest radiographs and other laboratory tests were normal with the exception of an increased C-reactive protein level.

The son’s throat swab was positive for 2019-nCoV and he is believed to have been exposed from his father; however, the strains have not been ascertained.

“This family had traveled to four cities across Vietnam using various forms of transportation, including planes, trains, and taxis,” the authors wrote. A total of 28 close contacts were identified, none of whom have developed respiratory symptoms. The older man’s wife has been healthy as well.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A Chinese man became ill from a novel coronavirus (2019-nCoV) 4 days after arriving in Vietnam to visit his 27-year-old son. Three days later the healthy young man was also stricken, according to a report published online Jan. 28 in the New England Journal of Medicine.

“This family cluster of 2019-nCoV infection that occurred outside China arouses concern regarding human-to-human transmission,” the authors wrote.

The father, age 65 years and with multiple comorbidities including hypertension, type 2 diabetes, coronary heart disease with stent placement, and lung cancer, flew to Hanoi with his wife on January 13; they traveled from the Wuchang district in Wuhan, China, where outbreaks of 2019-nCoV have been occurring.

On Jan. 17, the older man and his wife met their adult son in Ho Chi Minh City, Vietnam, and shared a hotel room with him for 3 days. The father developed a fever that same day and the son developed a dry cough, fever, diarrhea, and vomiting on Jan. 20. Both men went to a hospital ED on Jan. 22.

The authors say the timing of the son’s symptoms suggests the incubation period may have been 3 days or fewer.

Upon admission to the hospital, the father reported that he had not visited a “wet market” where live and dead animals are sold while he was in Wuhan. Throat swabs were positive for 2019-nCoV on real-time reverse-transcription–polymerase-chain-reaction assays.

The man was placed in isolation and “treated empirically with antiviral agents, broad-spectrum antibiotics, and supportive therapies,” wrote Lan T. Phan, PhD, from the Pasteur Institute Ho Chi Minh City and coauthors.

On admission, chest radiographs revealed an infiltrate in the upper lobe of his left lung; he developed worsening dyspnea with hypoxemia on Jan. 25 and required supplemental oxygen at 5 L/min by nasal cannula. Chest radiographs showed a progressive infiltrate and consolidation. His fever resolved on that day and he has progressively improved.

The man’s son had a fever of 39° C (102.2° F) when the two men arrived at the hospital on Jan. 22; hospital staff isolated the son, and chest radiographs and other laboratory tests were normal with the exception of an increased C-reactive protein level.

The son’s throat swab was positive for 2019-nCoV and he is believed to have been exposed from his father; however, the strains have not been ascertained.

“This family had traveled to four cities across Vietnam using various forms of transportation, including planes, trains, and taxis,” the authors wrote. A total of 28 close contacts were identified, none of whom have developed respiratory symptoms. The older man’s wife has been healthy as well.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A Chinese man became ill from a novel coronavirus (2019-nCoV) 4 days after arriving in Vietnam to visit his 27-year-old son. Three days later the healthy young man was also stricken, according to a report published online Jan. 28 in the New England Journal of Medicine.

“This family cluster of 2019-nCoV infection that occurred outside China arouses concern regarding human-to-human transmission,” the authors wrote.

The father, age 65 years and with multiple comorbidities including hypertension, type 2 diabetes, coronary heart disease with stent placement, and lung cancer, flew to Hanoi with his wife on January 13; they traveled from the Wuchang district in Wuhan, China, where outbreaks of 2019-nCoV have been occurring.

On Jan. 17, the older man and his wife met their adult son in Ho Chi Minh City, Vietnam, and shared a hotel room with him for 3 days. The father developed a fever that same day and the son developed a dry cough, fever, diarrhea, and vomiting on Jan. 20. Both men went to a hospital ED on Jan. 22.

The authors say the timing of the son’s symptoms suggests the incubation period may have been 3 days or fewer.

Upon admission to the hospital, the father reported that he had not visited a “wet market” where live and dead animals are sold while he was in Wuhan. Throat swabs were positive for 2019-nCoV on real-time reverse-transcription–polymerase-chain-reaction assays.

The man was placed in isolation and “treated empirically with antiviral agents, broad-spectrum antibiotics, and supportive therapies,” wrote Lan T. Phan, PhD, from the Pasteur Institute Ho Chi Minh City and coauthors.

On admission, chest radiographs revealed an infiltrate in the upper lobe of his left lung; he developed worsening dyspnea with hypoxemia on Jan. 25 and required supplemental oxygen at 5 L/min by nasal cannula. Chest radiographs showed a progressive infiltrate and consolidation. His fever resolved on that day and he has progressively improved.

The man’s son had a fever of 39° C (102.2° F) when the two men arrived at the hospital on Jan. 22; hospital staff isolated the son, and chest radiographs and other laboratory tests were normal with the exception of an increased C-reactive protein level.

The son’s throat swab was positive for 2019-nCoV and he is believed to have been exposed from his father; however, the strains have not been ascertained.

“This family had traveled to four cities across Vietnam using various forms of transportation, including planes, trains, and taxis,” the authors wrote. A total of 28 close contacts were identified, none of whom have developed respiratory symptoms. The older man’s wife has been healthy as well.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

SNOWMASS, COLO. – A repeated theme threading through much of one prominent interventional cardiologist’s personal list of the top five coronary artery disease (CAD) trials of the past year is that aspirin is very often more trouble than it’s worth.

Bruce Jancin/MDedge News

“For some years I’ve been concerned that the only thing that aspirin does [in patients after percutaneous coronary intervention] is increase your risk of bleeding. It doesn’t really provide any additional ischemic protection,” Malcolm R. Bell, MBBS, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

“I’ll remind you that, when we go back to the early stent days, the combination of clopidogrel and aspirin was never compared in a proper trial to clopidogrel alone. We’ve just inherited this DAPT [dual-antiplatelet therapy] philosophy,” observed Dr. Bell, professor of medicine and vice chair of the department of cardiovascular medicine at the Mayo Clinic in Rochester, Minn.

Here are the key takeaway messages from his five most important randomized trials in CAD during the last year.
 

AUGUSTUS

For years, cardiologists have grappled with how to best manage high-cardiovascular-risk patients with atrial fibrillation who seem like they might benefit from triple-antithrombotic therapy. AUGUSTUS supplied the answer: Don’t do it. Skip the aspirin and turn instead to a P2Y12 inhibitor plus a non–vitamin K antagonist oral anticoagulant (NOAC), rather than warfarin.

“I would like you to think of triple therapy as a triple threat. That’s really what triple therapy is all about”– a three-pronged threat to patient safety, Dr. Bell commented.

In AUGUSTUS, 4,614 patients with atrial fibrillation and CAD with an acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI) in 33 countries were placed on a P2Y12 inhibitor – most often clopidogrel – and randomized double blind to either apixaban (Eliquis) or warfarin, and further to aspirin or placebo, for 6 months of antithrombotic therapy. The strategy of a P2Y12 inhibitor and apixaban without aspirin was the clear winner, resulting in significantly less major bleeding, mortality, and hospitalizations than treatment with a P2Y12 inhibitor and warfarin, with or without aspirin. Most importantly, ischemic event rates didn’t differ between the apixaban and warfarin groups. And patients randomized to aspirin had rates of ischemic events and death or hospitalization similar to placebo-treated controls, meaning aspirin accomplished nothing (N Engl J Med. 2019 Apr 18;380[16]:1509-24).

Dr. Bell noted that a meta-analysis of AUGUSTUS and three smaller randomized trials including more than 10,000 AUGUSTUS-type patients with atrial fibrillation concluded that a treatment strategy utilizing a NOAC and a P2Y12 inhibitor resulted in less bleeding than warfarin plus DAPT, and at no cost in terms of excess ischemic events. Moreover, regimens without aspirin resulted in less intracranial and other major bleeding without any difference in major adverse cardiovascular events (JAMA Cardiol. 2019 Jun 19. doi: 10.1001/jamacardio.2019.1880).

A key message of these four trials is that a NOAC is preferable to warfarin, so much so that, in high-risk patients who are already on warfarin, it’s worth considering a switch to a NOAC.

“And we should really be avoiding DAPT,” Dr. Bell added.

How soon after an ACS and/or PCI should patients with atrial fibrillation stop taking aspirin?

“In AUGUSTUS, randomization occurred at a median of 6 days, so we know that half the patients stopped their aspirin by then. In our own practice, we’re just dropping the aspirin for the most part before the patient leaves the hospital. I think if you leave them with instructions to stop the aspirin in a week’s time or a month’s time it just leads to confusion. And we should also remember that half of the major bleeding after PCI or ACS happens in the first 30 days, so it doesn’t make a lot of sense to say that we should continue it for a month and then drop it,” according to the cardiologist.
 

SMART-CHOICE and STOPDAPT-2

These two large multicenter studies demonstrate that DAPT can safely be stopped early if needed. SMART-CHOICE from South Korea and STOPDAPT-2 from Japan each randomized roughly 3,000 patients undergoing PCI to 12 months of DAPT or to DAPT for only 3 months or 1 month, respectively, at which point the aspirin was dropped and patients in the abbreviated DAPT arm continued on P2Y12 inhibitor monotherapy, mostly clopidogrel, for the remainder of the 12 months. In the Japanese STOPDAPT-2 trial, 1 month of DAPT proved superior to 12 months of DAPT for the primary composite endpoint of cardiovascular death, MI, stroke, definite stent thrombosis, or major or minor bleeding at 12 months (JAMA. 2019 Jun 25;321[24]:2414-27). In the South Korean SMART-CHOICE trial, 3 months of DAPT was noninferior to 12 months for major adverse cardiac and cerebrovascular events, and superior in terms of bleeding risk (JAMA. 2019 Jun 25;321[24]:2428-37). Of note, roughly half of patients in the two trials were lower-risk individuals undergoing PCI for stable angina.

Dr. Bell noted that, while the TWILIGHT trial (Ticagrelor With or Without Aspirin in High-Risk Patients After PCI) didn’t make his top-five list, it certainly fits well with the two East Asian studies. The TWILIGHT investigators randomized more than 7,000 patients to 12 months of DAPT or discontinuation of aspirin after 3 months. The result: a lower incidence of clinically relevant bleeding with ticagrelor monotherapy, and with no increased risk of death, MI, or stroke, compared with 12 months of DAPT (N Engl J Med. 2019 Nov 21;381[21]:2032-42).

“Again, I would just question what the added value of aspirin is here,” Dr. Bell commented. “Many interventional cardiologists are absolutely terrified of their patients having stent thrombosis, but with second-generation drug-eluting stents – the stents we’re putting in day in and day out – the risk of stent thrombosis is less than 1%. And in these two trials it was less than 0.5%. There’s more risk of having major bleeding events than there is of ischemia, so I think the balance is in favor of preventing bleeding. We know that major bleeding predicts short- and long-term mortality.”
 

COLCOT

This double-blind trial randomized 4,745 patients within 30 days post MI to low-dose colchicine or placebo on top of excellent rates of background guideline-directed medical therapy. The goal was to see if this anti-inflammatory agent could reduce cardiovascular events independent of any lipid-lowering effect, as was earlier seen with canakinumab in the CANTOS trial. It did so to a statistically significant but relatively modest degree, with a 5.5% rate of the composite cardiovascular events endpoint in the colchicine group and 7.1% in placebo-treated controls (N Engl J Med. 2019 Dec 26;381[26]:2497-505). But Dr. Bell was unimpressed.

“All-cause mortality was identical at 1.8% in both groups. So colchicine is not saving lives. In fact, the only real differences were in stroke – but the study wasn’t powered to look at stroke – and in urgent hospitalization for angina leading to revascularization, which is a soft endpoint,” he observed.

Plus, 2.5% of patients were lost to follow-up, which Dr. Bell considers “a little concerning” in a trial conducted in the current era.

“In my opinion, the evidence that colchicine is effective is weak, and I don’t think really supports the drug’s routine use post MI. We already send these patients out on numerous medications. We have to think about cost/benefit, and if a patient asks me: ‘Is this going to prevent another heart attack or make me live longer?’ I think the unequivocal answer is no,” he said.

These days colchicine is no longer an inexpensive drug, either, at an average cost of $300-$400 per month, the cardiologist added.
 

COMPLETE

This study randomized more than 4,000 patients with ST-segment elevation MI (STEMI) and multivessel disease to primary PCI of the culprit lesion only or to staged complete revascularization via PCI of all angiographically significant nonculprit lesions. Complete revascularization proved to be the superior strategy, with a 26% reduction in the risk of the composite of cardiovascular death or MI at a median of 3 years (N Engl J Med. 2019 Oct 10;381[15]:1411-21).

The optimal timing of the staged procedure remains unclear, since the study didn’t specify a protocol.

“I’m still a bit uncomfortable doing multivessel PCI at 2 o’clock in the morning in the setting of STEMI in someone I’ve never met before. I don’t think there’s a rush to do anything then. Often in this middle-of-the-night stuff, we miss things or we overinterpret things. I think it’s better to let the patient cool down, get to know them,” according to Dr. Bell.
 

EXCEL

Publication of the 5-year outcomes of the largest-ever randomized trial of PCI versus coronary artery bypass grafting (CABG) for left main coronary disease has led to furious controversy, with a few of the surgeons involved in the study opting to publically broadcast allegations of misbehavior on the part of the interventional cardiologist study leadership, charges that have been strongly denied.

The actual results are in line with findings reported from smaller randomized trials. At 5 years in EXCEL, there was no significant difference between the PCI and CABG groups in the primary composite endpoint of death, cerebrovascular accident, or MI (N Engl J Med. 2019 Nov 7;381[19]:1820-30). The all-cause mortality rate was 13% in the PCI arm and 9.9% with CABG, but this finding comes with a caveat.

“I’ll emphasize this trial was never powered to look at mortality. Neither were any of the other randomized trials. On the other hand, I don’t think you can necessarily ignore the finding of an absolute 3.1% difference,” Dr. Bell said.

PCI and CABG are both very good, mature therapies for left main disease, in his view. In the setting of more-complex coronary disease in younger patients, he often views the complete revascularization offered by surgery as the preferred option. On the other hand, in an 80-year-old with severe comorbidities, clearly PCI is attractive.

He considers the highly public nature of this interspecialty spat a regrettable black eye for the entire field of cardiovascular medicine. And he predicted that an ongoing outside neutral-party review of the study data and procedures will conclude, as he has, “there was no malfeasance at all in the trial.”

Dr. Bell reported having no financial conflicts regarding his presentation.

[email protected]

SNOWMASS, COLO. – A repeated theme threading through much of one prominent interventional cardiologist’s personal list of the top five coronary artery disease (CAD) trials of the past year is that aspirin is very often more trouble than it’s worth.

Bruce Jancin/MDedge News

“For some years I’ve been concerned that the only thing that aspirin does [in patients after percutaneous coronary intervention] is increase your risk of bleeding. It doesn’t really provide any additional ischemic protection,” Malcolm R. Bell, MBBS, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

“I’ll remind you that, when we go back to the early stent days, the combination of clopidogrel and aspirin was never compared in a proper trial to clopidogrel alone. We’ve just inherited this DAPT [dual-antiplatelet therapy] philosophy,” observed Dr. Bell, professor of medicine and vice chair of the department of cardiovascular medicine at the Mayo Clinic in Rochester, Minn.

Here are the key takeaway messages from his five most important randomized trials in CAD during the last year.
 

AUGUSTUS

For years, cardiologists have grappled with how to best manage high-cardiovascular-risk patients with atrial fibrillation who seem like they might benefit from triple-antithrombotic therapy. AUGUSTUS supplied the answer: Don’t do it. Skip the aspirin and turn instead to a P2Y12 inhibitor plus a non–vitamin K antagonist oral anticoagulant (NOAC), rather than warfarin.

“I would like you to think of triple therapy as a triple threat. That’s really what triple therapy is all about”– a three-pronged threat to patient safety, Dr. Bell commented.

In AUGUSTUS, 4,614 patients with atrial fibrillation and CAD with an acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI) in 33 countries were placed on a P2Y12 inhibitor – most often clopidogrel – and randomized double blind to either apixaban (Eliquis) or warfarin, and further to aspirin or placebo, for 6 months of antithrombotic therapy. The strategy of a P2Y12 inhibitor and apixaban without aspirin was the clear winner, resulting in significantly less major bleeding, mortality, and hospitalizations than treatment with a P2Y12 inhibitor and warfarin, with or without aspirin. Most importantly, ischemic event rates didn’t differ between the apixaban and warfarin groups. And patients randomized to aspirin had rates of ischemic events and death or hospitalization similar to placebo-treated controls, meaning aspirin accomplished nothing (N Engl J Med. 2019 Apr 18;380[16]:1509-24).

Dr. Bell noted that a meta-analysis of AUGUSTUS and three smaller randomized trials including more than 10,000 AUGUSTUS-type patients with atrial fibrillation concluded that a treatment strategy utilizing a NOAC and a P2Y12 inhibitor resulted in less bleeding than warfarin plus DAPT, and at no cost in terms of excess ischemic events. Moreover, regimens without aspirin resulted in less intracranial and other major bleeding without any difference in major adverse cardiovascular events (JAMA Cardiol. 2019 Jun 19. doi: 10.1001/jamacardio.2019.1880).

A key message of these four trials is that a NOAC is preferable to warfarin, so much so that, in high-risk patients who are already on warfarin, it’s worth considering a switch to a NOAC.

“And we should really be avoiding DAPT,” Dr. Bell added.

How soon after an ACS and/or PCI should patients with atrial fibrillation stop taking aspirin?

“In AUGUSTUS, randomization occurred at a median of 6 days, so we know that half the patients stopped their aspirin by then. In our own practice, we’re just dropping the aspirin for the most part before the patient leaves the hospital. I think if you leave them with instructions to stop the aspirin in a week’s time or a month’s time it just leads to confusion. And we should also remember that half of the major bleeding after PCI or ACS happens in the first 30 days, so it doesn’t make a lot of sense to say that we should continue it for a month and then drop it,” according to the cardiologist.
 

SMART-CHOICE and STOPDAPT-2

These two large multicenter studies demonstrate that DAPT can safely be stopped early if needed. SMART-CHOICE from South Korea and STOPDAPT-2 from Japan each randomized roughly 3,000 patients undergoing PCI to 12 months of DAPT or to DAPT for only 3 months or 1 month, respectively, at which point the aspirin was dropped and patients in the abbreviated DAPT arm continued on P2Y12 inhibitor monotherapy, mostly clopidogrel, for the remainder of the 12 months. In the Japanese STOPDAPT-2 trial, 1 month of DAPT proved superior to 12 months of DAPT for the primary composite endpoint of cardiovascular death, MI, stroke, definite stent thrombosis, or major or minor bleeding at 12 months (JAMA. 2019 Jun 25;321[24]:2414-27). In the South Korean SMART-CHOICE trial, 3 months of DAPT was noninferior to 12 months for major adverse cardiac and cerebrovascular events, and superior in terms of bleeding risk (JAMA. 2019 Jun 25;321[24]:2428-37). Of note, roughly half of patients in the two trials were lower-risk individuals undergoing PCI for stable angina.

Dr. Bell noted that, while the TWILIGHT trial (Ticagrelor With or Without Aspirin in High-Risk Patients After PCI) didn’t make his top-five list, it certainly fits well with the two East Asian studies. The TWILIGHT investigators randomized more than 7,000 patients to 12 months of DAPT or discontinuation of aspirin after 3 months. The result: a lower incidence of clinically relevant bleeding with ticagrelor monotherapy, and with no increased risk of death, MI, or stroke, compared with 12 months of DAPT (N Engl J Med. 2019 Nov 21;381[21]:2032-42).

“Again, I would just question what the added value of aspirin is here,” Dr. Bell commented. “Many interventional cardiologists are absolutely terrified of their patients having stent thrombosis, but with second-generation drug-eluting stents – the stents we’re putting in day in and day out – the risk of stent thrombosis is less than 1%. And in these two trials it was less than 0.5%. There’s more risk of having major bleeding events than there is of ischemia, so I think the balance is in favor of preventing bleeding. We know that major bleeding predicts short- and long-term mortality.”
 

COLCOT

This double-blind trial randomized 4,745 patients within 30 days post MI to low-dose colchicine or placebo on top of excellent rates of background guideline-directed medical therapy. The goal was to see if this anti-inflammatory agent could reduce cardiovascular events independent of any lipid-lowering effect, as was earlier seen with canakinumab in the CANTOS trial. It did so to a statistically significant but relatively modest degree, with a 5.5% rate of the composite cardiovascular events endpoint in the colchicine group and 7.1% in placebo-treated controls (N Engl J Med. 2019 Dec 26;381[26]:2497-505). But Dr. Bell was unimpressed.

“All-cause mortality was identical at 1.8% in both groups. So colchicine is not saving lives. In fact, the only real differences were in stroke – but the study wasn’t powered to look at stroke – and in urgent hospitalization for angina leading to revascularization, which is a soft endpoint,” he observed.

Plus, 2.5% of patients were lost to follow-up, which Dr. Bell considers “a little concerning” in a trial conducted in the current era.

“In my opinion, the evidence that colchicine is effective is weak, and I don’t think really supports the drug’s routine use post MI. We already send these patients out on numerous medications. We have to think about cost/benefit, and if a patient asks me: ‘Is this going to prevent another heart attack or make me live longer?’ I think the unequivocal answer is no,” he said.

These days colchicine is no longer an inexpensive drug, either, at an average cost of $300-$400 per month, the cardiologist added.
 

COMPLETE

This study randomized more than 4,000 patients with ST-segment elevation MI (STEMI) and multivessel disease to primary PCI of the culprit lesion only or to staged complete revascularization via PCI of all angiographically significant nonculprit lesions. Complete revascularization proved to be the superior strategy, with a 26% reduction in the risk of the composite of cardiovascular death or MI at a median of 3 years (N Engl J Med. 2019 Oct 10;381[15]:1411-21).

The optimal timing of the staged procedure remains unclear, since the study didn’t specify a protocol.

“I’m still a bit uncomfortable doing multivessel PCI at 2 o’clock in the morning in the setting of STEMI in someone I’ve never met before. I don’t think there’s a rush to do anything then. Often in this middle-of-the-night stuff, we miss things or we overinterpret things. I think it’s better to let the patient cool down, get to know them,” according to Dr. Bell.
 

EXCEL

Publication of the 5-year outcomes of the largest-ever randomized trial of PCI versus coronary artery bypass grafting (CABG) for left main coronary disease has led to furious controversy, with a few of the surgeons involved in the study opting to publically broadcast allegations of misbehavior on the part of the interventional cardiologist study leadership, charges that have been strongly denied.

The actual results are in line with findings reported from smaller randomized trials. At 5 years in EXCEL, there was no significant difference between the PCI and CABG groups in the primary composite endpoint of death, cerebrovascular accident, or MI (N Engl J Med. 2019 Nov 7;381[19]:1820-30). The all-cause mortality rate was 13% in the PCI arm and 9.9% with CABG, but this finding comes with a caveat.

“I’ll emphasize this trial was never powered to look at mortality. Neither were any of the other randomized trials. On the other hand, I don’t think you can necessarily ignore the finding of an absolute 3.1% difference,” Dr. Bell said.

PCI and CABG are both very good, mature therapies for left main disease, in his view. In the setting of more-complex coronary disease in younger patients, he often views the complete revascularization offered by surgery as the preferred option. On the other hand, in an 80-year-old with severe comorbidities, clearly PCI is attractive.

He considers the highly public nature of this interspecialty spat a regrettable black eye for the entire field of cardiovascular medicine. And he predicted that an ongoing outside neutral-party review of the study data and procedures will conclude, as he has, “there was no malfeasance at all in the trial.”

Dr. Bell reported having no financial conflicts regarding his presentation.

[email protected]

SNOWMASS, COLO. – A repeated theme threading through much of one prominent interventional cardiologist’s personal list of the top five coronary artery disease (CAD) trials of the past year is that aspirin is very often more trouble than it’s worth.

Bruce Jancin/MDedge News

“For some years I’ve been concerned that the only thing that aspirin does [in patients after percutaneous coronary intervention] is increase your risk of bleeding. It doesn’t really provide any additional ischemic protection,” Malcolm R. Bell, MBBS, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

“I’ll remind you that, when we go back to the early stent days, the combination of clopidogrel and aspirin was never compared in a proper trial to clopidogrel alone. We’ve just inherited this DAPT [dual-antiplatelet therapy] philosophy,” observed Dr. Bell, professor of medicine and vice chair of the department of cardiovascular medicine at the Mayo Clinic in Rochester, Minn.

Here are the key takeaway messages from his five most important randomized trials in CAD during the last year.
 

AUGUSTUS

For years, cardiologists have grappled with how to best manage high-cardiovascular-risk patients with atrial fibrillation who seem like they might benefit from triple-antithrombotic therapy. AUGUSTUS supplied the answer: Don’t do it. Skip the aspirin and turn instead to a P2Y12 inhibitor plus a non–vitamin K antagonist oral anticoagulant (NOAC), rather than warfarin.

“I would like you to think of triple therapy as a triple threat. That’s really what triple therapy is all about”– a three-pronged threat to patient safety, Dr. Bell commented.

In AUGUSTUS, 4,614 patients with atrial fibrillation and CAD with an acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI) in 33 countries were placed on a P2Y12 inhibitor – most often clopidogrel – and randomized double blind to either apixaban (Eliquis) or warfarin, and further to aspirin or placebo, for 6 months of antithrombotic therapy. The strategy of a P2Y12 inhibitor and apixaban without aspirin was the clear winner, resulting in significantly less major bleeding, mortality, and hospitalizations than treatment with a P2Y12 inhibitor and warfarin, with or without aspirin. Most importantly, ischemic event rates didn’t differ between the apixaban and warfarin groups. And patients randomized to aspirin had rates of ischemic events and death or hospitalization similar to placebo-treated controls, meaning aspirin accomplished nothing (N Engl J Med. 2019 Apr 18;380[16]:1509-24).

Dr. Bell noted that a meta-analysis of AUGUSTUS and three smaller randomized trials including more than 10,000 AUGUSTUS-type patients with atrial fibrillation concluded that a treatment strategy utilizing a NOAC and a P2Y12 inhibitor resulted in less bleeding than warfarin plus DAPT, and at no cost in terms of excess ischemic events. Moreover, regimens without aspirin resulted in less intracranial and other major bleeding without any difference in major adverse cardiovascular events (JAMA Cardiol. 2019 Jun 19. doi: 10.1001/jamacardio.2019.1880).

A key message of these four trials is that a NOAC is preferable to warfarin, so much so that, in high-risk patients who are already on warfarin, it’s worth considering a switch to a NOAC.

“And we should really be avoiding DAPT,” Dr. Bell added.

How soon after an ACS and/or PCI should patients with atrial fibrillation stop taking aspirin?

“In AUGUSTUS, randomization occurred at a median of 6 days, so we know that half the patients stopped their aspirin by then. In our own practice, we’re just dropping the aspirin for the most part before the patient leaves the hospital. I think if you leave them with instructions to stop the aspirin in a week’s time or a month’s time it just leads to confusion. And we should also remember that half of the major bleeding after PCI or ACS happens in the first 30 days, so it doesn’t make a lot of sense to say that we should continue it for a month and then drop it,” according to the cardiologist.
 

SMART-CHOICE and STOPDAPT-2

These two large multicenter studies demonstrate that DAPT can safely be stopped early if needed. SMART-CHOICE from South Korea and STOPDAPT-2 from Japan each randomized roughly 3,000 patients undergoing PCI to 12 months of DAPT or to DAPT for only 3 months or 1 month, respectively, at which point the aspirin was dropped and patients in the abbreviated DAPT arm continued on P2Y12 inhibitor monotherapy, mostly clopidogrel, for the remainder of the 12 months. In the Japanese STOPDAPT-2 trial, 1 month of DAPT proved superior to 12 months of DAPT for the primary composite endpoint of cardiovascular death, MI, stroke, definite stent thrombosis, or major or minor bleeding at 12 months (JAMA. 2019 Jun 25;321[24]:2414-27). In the South Korean SMART-CHOICE trial, 3 months of DAPT was noninferior to 12 months for major adverse cardiac and cerebrovascular events, and superior in terms of bleeding risk (JAMA. 2019 Jun 25;321[24]:2428-37). Of note, roughly half of patients in the two trials were lower-risk individuals undergoing PCI for stable angina.

Dr. Bell noted that, while the TWILIGHT trial (Ticagrelor With or Without Aspirin in High-Risk Patients After PCI) didn’t make his top-five list, it certainly fits well with the two East Asian studies. The TWILIGHT investigators randomized more than 7,000 patients to 12 months of DAPT or discontinuation of aspirin after 3 months. The result: a lower incidence of clinically relevant bleeding with ticagrelor monotherapy, and with no increased risk of death, MI, or stroke, compared with 12 months of DAPT (N Engl J Med. 2019 Nov 21;381[21]:2032-42).

“Again, I would just question what the added value of aspirin is here,” Dr. Bell commented. “Many interventional cardiologists are absolutely terrified of their patients having stent thrombosis, but with second-generation drug-eluting stents – the stents we’re putting in day in and day out – the risk of stent thrombosis is less than 1%. And in these two trials it was less than 0.5%. There’s more risk of having major bleeding events than there is of ischemia, so I think the balance is in favor of preventing bleeding. We know that major bleeding predicts short- and long-term mortality.”
 

COLCOT

This double-blind trial randomized 4,745 patients within 30 days post MI to low-dose colchicine or placebo on top of excellent rates of background guideline-directed medical therapy. The goal was to see if this anti-inflammatory agent could reduce cardiovascular events independent of any lipid-lowering effect, as was earlier seen with canakinumab in the CANTOS trial. It did so to a statistically significant but relatively modest degree, with a 5.5% rate of the composite cardiovascular events endpoint in the colchicine group and 7.1% in placebo-treated controls (N Engl J Med. 2019 Dec 26;381[26]:2497-505). But Dr. Bell was unimpressed.

“All-cause mortality was identical at 1.8% in both groups. So colchicine is not saving lives. In fact, the only real differences were in stroke – but the study wasn’t powered to look at stroke – and in urgent hospitalization for angina leading to revascularization, which is a soft endpoint,” he observed.

Plus, 2.5% of patients were lost to follow-up, which Dr. Bell considers “a little concerning” in a trial conducted in the current era.

“In my opinion, the evidence that colchicine is effective is weak, and I don’t think really supports the drug’s routine use post MI. We already send these patients out on numerous medications. We have to think about cost/benefit, and if a patient asks me: ‘Is this going to prevent another heart attack or make me live longer?’ I think the unequivocal answer is no,” he said.

These days colchicine is no longer an inexpensive drug, either, at an average cost of $300-$400 per month, the cardiologist added.
 

COMPLETE

This study randomized more than 4,000 patients with ST-segment elevation MI (STEMI) and multivessel disease to primary PCI of the culprit lesion only or to staged complete revascularization via PCI of all angiographically significant nonculprit lesions. Complete revascularization proved to be the superior strategy, with a 26% reduction in the risk of the composite of cardiovascular death or MI at a median of 3 years (N Engl J Med. 2019 Oct 10;381[15]:1411-21).

The optimal timing of the staged procedure remains unclear, since the study didn’t specify a protocol.

“I’m still a bit uncomfortable doing multivessel PCI at 2 o’clock in the morning in the setting of STEMI in someone I’ve never met before. I don’t think there’s a rush to do anything then. Often in this middle-of-the-night stuff, we miss things or we overinterpret things. I think it’s better to let the patient cool down, get to know them,” according to Dr. Bell.
 

EXCEL

Publication of the 5-year outcomes of the largest-ever randomized trial of PCI versus coronary artery bypass grafting (CABG) for left main coronary disease has led to furious controversy, with a few of the surgeons involved in the study opting to publically broadcast allegations of misbehavior on the part of the interventional cardiologist study leadership, charges that have been strongly denied.

The actual results are in line with findings reported from smaller randomized trials. At 5 years in EXCEL, there was no significant difference between the PCI and CABG groups in the primary composite endpoint of death, cerebrovascular accident, or MI (N Engl J Med. 2019 Nov 7;381[19]:1820-30). The all-cause mortality rate was 13% in the PCI arm and 9.9% with CABG, but this finding comes with a caveat.

“I’ll emphasize this trial was never powered to look at mortality. Neither were any of the other randomized trials. On the other hand, I don’t think you can necessarily ignore the finding of an absolute 3.1% difference,” Dr. Bell said.

PCI and CABG are both very good, mature therapies for left main disease, in his view. In the setting of more-complex coronary disease in younger patients, he often views the complete revascularization offered by surgery as the preferred option. On the other hand, in an 80-year-old with severe comorbidities, clearly PCI is attractive.

He considers the highly public nature of this interspecialty spat a regrettable black eye for the entire field of cardiovascular medicine. And he predicted that an ongoing outside neutral-party review of the study data and procedures will conclude, as he has, “there was no malfeasance at all in the trial.”

Dr. Bell reported having no financial conflicts regarding his presentation.

[email protected]

U.S. public health officials attempted to stymie concerns about the coronavirus during a press conference on Tuesday, emphasizing that most Americans are not in danger of contracting the illness and urging citizens not to take extreme measures in response to the low-risk virus.

“Right now, there is no spread of this virus in our communities here at home,” Centers for Disease Control and Prevention director Robert Redfield, MD, said during the Jan. 28 press conference. “This is why our current assessment is that the immediate health risk of this new virus to the general public is low in our nation. The coming days and weeks are likely to bring more confirmed cases here and around the world, including the possibility of some person-to-person spreading, but our goal of the ongoing U.S. public health response is to contain this outbreak and prevent sustained spread of the virus in our country.”

During the press conference, Department Health & Human Services Secretary Alex M. Azar II, reiterated there have been only five confirmed U.S. cases of the coronavirus thus far and all were associated with travel to Wuhan, China, where the virus first appeared. The number of confirmed cases in China, meanwhile, has risen to more than 4,500 with about 100 associated deaths.

U.S. health providers should be on the lookout for any patient who has traveled to China recently, particularly to Hubei province, and they should pay close attention to any relevant symptoms, Secretary Azar said during the press conference.

He defended the decision not to declare a public health emergency at this time, stressing that such a move is based on standards and requirements not yet met by the coronavirus.

“It’s important to remember where we are right now; we have five cases in the United States, each of those individuals with direct contact to Wuhan and no person-to-person transmission in the United States,” Secretary Azar said. “I won’t hesitate at all to invoke any authorities that I need to ensure that we’re taking all the steps to protect the American people, but I’ll do it when it’s appropriate under the standards that we have and the authorities that I need.”

In the meantime, a number of efforts are underway by U.S. agencies to assess the nation’s emergency preparedness stockpile, to assist American families in China with evacuation, and to pursue research into diagnostics and a potential vaccine for the virus, Secretary Azar said.

HHS.gov

U.S. public health officials attempted to stymie concerns about the coronavirus during a press conference on Tuesday, emphasizing that most Americans are not in danger of contracting the illness and urging citizens not to take extreme measures in response to the low-risk virus.

“Right now, there is no spread of this virus in our communities here at home,” Centers for Disease Control and Prevention director Robert Redfield, MD, said during the Jan. 28 press conference. “This is why our current assessment is that the immediate health risk of this new virus to the general public is low in our nation. The coming days and weeks are likely to bring more confirmed cases here and around the world, including the possibility of some person-to-person spreading, but our goal of the ongoing U.S. public health response is to contain this outbreak and prevent sustained spread of the virus in our country.”

During the press conference, Department Health & Human Services Secretary Alex M. Azar II, reiterated there have been only five confirmed U.S. cases of the coronavirus thus far and all were associated with travel to Wuhan, China, where the virus first appeared. The number of confirmed cases in China, meanwhile, has risen to more than 4,500 with about 100 associated deaths.

U.S. health providers should be on the lookout for any patient who has traveled to China recently, particularly to Hubei province, and they should pay close attention to any relevant symptoms, Secretary Azar said during the press conference.

He defended the decision not to declare a public health emergency at this time, stressing that such a move is based on standards and requirements not yet met by the coronavirus.

“It’s important to remember where we are right now; we have five cases in the United States, each of those individuals with direct contact to Wuhan and no person-to-person transmission in the United States,” Secretary Azar said. “I won’t hesitate at all to invoke any authorities that I need to ensure that we’re taking all the steps to protect the American people, but I’ll do it when it’s appropriate under the standards that we have and the authorities that I need.”

In the meantime, a number of efforts are underway by U.S. agencies to assess the nation’s emergency preparedness stockpile, to assist American families in China with evacuation, and to pursue research into diagnostics and a potential vaccine for the virus, Secretary Azar said.

HHS.gov

U.S. public health officials attempted to stymie concerns about the coronavirus during a press conference on Tuesday, emphasizing that most Americans are not in danger of contracting the illness and urging citizens not to take extreme measures in response to the low-risk virus.

“Right now, there is no spread of this virus in our communities here at home,” Centers for Disease Control and Prevention director Robert Redfield, MD, said during the Jan. 28 press conference. “This is why our current assessment is that the immediate health risk of this new virus to the general public is low in our nation. The coming days and weeks are likely to bring more confirmed cases here and around the world, including the possibility of some person-to-person spreading, but our goal of the ongoing U.S. public health response is to contain this outbreak and prevent sustained spread of the virus in our country.”

During the press conference, Department Health & Human Services Secretary Alex M. Azar II, reiterated there have been only five confirmed U.S. cases of the coronavirus thus far and all were associated with travel to Wuhan, China, where the virus first appeared. The number of confirmed cases in China, meanwhile, has risen to more than 4,500 with about 100 associated deaths.

U.S. health providers should be on the lookout for any patient who has traveled to China recently, particularly to Hubei province, and they should pay close attention to any relevant symptoms, Secretary Azar said during the press conference.

He defended the decision not to declare a public health emergency at this time, stressing that such a move is based on standards and requirements not yet met by the coronavirus.

“It’s important to remember where we are right now; we have five cases in the United States, each of those individuals with direct contact to Wuhan and no person-to-person transmission in the United States,” Secretary Azar said. “I won’t hesitate at all to invoke any authorities that I need to ensure that we’re taking all the steps to protect the American people, but I’ll do it when it’s appropriate under the standards that we have and the authorities that I need.”

In the meantime, a number of efforts are underway by U.S. agencies to assess the nation’s emergency preparedness stockpile, to assist American families in China with evacuation, and to pursue research into diagnostics and a potential vaccine for the virus, Secretary Azar said.

HHS.gov

The current outbreak of severe respiratory infections caused by the 2019 novel coronarvirus (2019-nCoV) has a clinical presentation resembling the Severe Acute Respiratory Syndrome coronavirus (SARS-CoV) outbreak that began in 2002, Chinese investigators caution.

By Jan. 2, 2020, 41 patients with confirmed 2019-nCoV had been admitted to a designated hospital in the city of Wuhan, Hubei Province, in central China. Thirteen required ICU admission and six died, reported Chaolin Huang, MD, from Jin Yin-tan Hospital in Wuhan, and colleagues.

“2019-nCoV still needs to be studied deeply in case it becomes a global health threat. Reliable quick pathogen tests and feasible differential diagnosis based on clinical description are crucial for clinicians in their first contact with suspected patients. Because of the pandemic potential of 2019-nCoV, careful surveillance is essential to monitor its future host adaption, viral evolution, infectivity, transmissibility, and pathogenicity,” they wrote in a review published online by The Lancet.

According to the U.S. Centers for Disease Control and Prevention, as of Jan. 28, 2020, the total number of 2019-nCoV cases reported in the United States stood at five, but further cases of the infection – which Chinese health officials have confirmed can be transmitted person-to-person – are expected.

Dr. Huang and colleagues note that although most human coronavirus infections are mild, SARS-CoV and the Middle East respiratory syndrome coronavirus (MERS-CoV) were responsible for more than 10,000 infections, with mortality rates ranging from 10% with SARS to 37% with MERS. To date, 2019-nCoV has “caused clusters of fatal pneumonia greatly resembling SARS-CoV,” they write.

The authors studied the epidemiological, clinical, laboratory, and radiological characteristics as well as treatments and clinical outcomes of 41 patients admitted or transferred to the Jin Yin-tan Hospital with laboratory-confirmed 2019-nCoV infections.

The median patient age was 49 years. Thirty of the 41 patients (73%) were male. Comorbid conditions included diabetes in 13 of the 41 patients (32%), hypertension in 6 (15%), and cardiovascular disease in 6.

In all 27 of the 41 patients had been exposed to the Huanan seafood market in Wuhan, the suspected epicenter of the outbreak that was shut down by health authorities on Jan. 1 of this year.

The most common symptoms at the onset of the illness were fever in all but one of the 41 patients, cough in 31, and myalgia or fatigue in 18. Other, less frequent symptoms included sputum production in 11, headache in three, hemoptysis in two, and diarrhea in one.

“In this cohort, most patients presented with fever, dry cough, dyspnoea, and bilateral ground-glass opacities on chest CT scans. These features of 2019-nCoV infection bear some resemblance to SARS-CoV and MERS-CoV infections. However, few patients with 2019-nCoV infection had prominent upper respiratory tract signs and symptoms (e.g., rhinorrhoea, sneezing, or sore throat), indicating that the target cells might be located in the lower airway. Furthermore, 2019-nCoV patients rarely developed intestinal signs and symptoms (e.g., diarrhoea), whereas about 20%-25% of patients with MERS-CoV or SARS-CoV infection had diarrhoea.”

In all, 22 patients developed dyspnea, with a median time from illness onset to dyspnea of 8 days. The median time from illness onset to admission was 7 days, median time to shortness of breath was 8 days, median time to acute respiratory distress syndrome (ARDS) was 9 days, and median time to both mechanical ventilation and ICU admission was 10.5 days.

All of the patients developed pneumonia with abnormal findings on chest CT scan. In addition, 12 patients developed ARDS, six had RNAaemia, five developed acute cardiac injury, and four developed a secondary infection. As noted before, 13 of the 14 patients were admitted to an ICU, and six died. RNAaemia is a positive result for real-time polymerase chain reaction in plasma samples. Patients admitted to the ICU had higher initial concentrations of multiple inflammatory cytokines than patients who did not need ICU care, “suggesting that the cytokine storm was associated with disease severity.”

All of the patients received empirical antibiotics, 38 were treated with oseltamivir (Tamiflu), and 9 received systemic corticosteroids.

The investigators have initiated a randomized controlled trial of the antiviral agents lopinavir and ritonavir for patients hospitalized with 2019-nCoV infection.

The study was funded by the Chinese Ministry of Science and Technology, Chinese Academy of Medical Sciences, National Natural Science Foundation of China, and Beijing Municipal Science and Technology Commission. All authors declared having no competing interests.

SOURCE: Huang C et al. Lancet. 2020 Jan 24. doi: 10.1016/S0140-6736(20)30183-5.

The current outbreak of severe respiratory infections caused by the 2019 novel coronarvirus (2019-nCoV) has a clinical presentation resembling the Severe Acute Respiratory Syndrome coronavirus (SARS-CoV) outbreak that began in 2002, Chinese investigators caution.

By Jan. 2, 2020, 41 patients with confirmed 2019-nCoV had been admitted to a designated hospital in the city of Wuhan, Hubei Province, in central China. Thirteen required ICU admission and six died, reported Chaolin Huang, MD, from Jin Yin-tan Hospital in Wuhan, and colleagues.

“2019-nCoV still needs to be studied deeply in case it becomes a global health threat. Reliable quick pathogen tests and feasible differential diagnosis based on clinical description are crucial for clinicians in their first contact with suspected patients. Because of the pandemic potential of 2019-nCoV, careful surveillance is essential to monitor its future host adaption, viral evolution, infectivity, transmissibility, and pathogenicity,” they wrote in a review published online by The Lancet.

According to the U.S. Centers for Disease Control and Prevention, as of Jan. 28, 2020, the total number of 2019-nCoV cases reported in the United States stood at five, but further cases of the infection – which Chinese health officials have confirmed can be transmitted person-to-person – are expected.

Dr. Huang and colleagues note that although most human coronavirus infections are mild, SARS-CoV and the Middle East respiratory syndrome coronavirus (MERS-CoV) were responsible for more than 10,000 infections, with mortality rates ranging from 10% with SARS to 37% with MERS. To date, 2019-nCoV has “caused clusters of fatal pneumonia greatly resembling SARS-CoV,” they write.

The authors studied the epidemiological, clinical, laboratory, and radiological characteristics as well as treatments and clinical outcomes of 41 patients admitted or transferred to the Jin Yin-tan Hospital with laboratory-confirmed 2019-nCoV infections.

The median patient age was 49 years. Thirty of the 41 patients (73%) were male. Comorbid conditions included diabetes in 13 of the 41 patients (32%), hypertension in 6 (15%), and cardiovascular disease in 6.

In all 27 of the 41 patients had been exposed to the Huanan seafood market in Wuhan, the suspected epicenter of the outbreak that was shut down by health authorities on Jan. 1 of this year.

The most common symptoms at the onset of the illness were fever in all but one of the 41 patients, cough in 31, and myalgia or fatigue in 18. Other, less frequent symptoms included sputum production in 11, headache in three, hemoptysis in two, and diarrhea in one.

“In this cohort, most patients presented with fever, dry cough, dyspnoea, and bilateral ground-glass opacities on chest CT scans. These features of 2019-nCoV infection bear some resemblance to SARS-CoV and MERS-CoV infections. However, few patients with 2019-nCoV infection had prominent upper respiratory tract signs and symptoms (e.g., rhinorrhoea, sneezing, or sore throat), indicating that the target cells might be located in the lower airway. Furthermore, 2019-nCoV patients rarely developed intestinal signs and symptoms (e.g., diarrhoea), whereas about 20%-25% of patients with MERS-CoV or SARS-CoV infection had diarrhoea.”

In all, 22 patients developed dyspnea, with a median time from illness onset to dyspnea of 8 days. The median time from illness onset to admission was 7 days, median time to shortness of breath was 8 days, median time to acute respiratory distress syndrome (ARDS) was 9 days, and median time to both mechanical ventilation and ICU admission was 10.5 days.

All of the patients developed pneumonia with abnormal findings on chest CT scan. In addition, 12 patients developed ARDS, six had RNAaemia, five developed acute cardiac injury, and four developed a secondary infection. As noted before, 13 of the 14 patients were admitted to an ICU, and six died. RNAaemia is a positive result for real-time polymerase chain reaction in plasma samples. Patients admitted to the ICU had higher initial concentrations of multiple inflammatory cytokines than patients who did not need ICU care, “suggesting that the cytokine storm was associated with disease severity.”

All of the patients received empirical antibiotics, 38 were treated with oseltamivir (Tamiflu), and 9 received systemic corticosteroids.

The investigators have initiated a randomized controlled trial of the antiviral agents lopinavir and ritonavir for patients hospitalized with 2019-nCoV infection.

The study was funded by the Chinese Ministry of Science and Technology, Chinese Academy of Medical Sciences, National Natural Science Foundation of China, and Beijing Municipal Science and Technology Commission. All authors declared having no competing interests.

SOURCE: Huang C et al. Lancet. 2020 Jan 24. doi: 10.1016/S0140-6736(20)30183-5.

The current outbreak of severe respiratory infections caused by the 2019 novel coronarvirus (2019-nCoV) has a clinical presentation resembling the Severe Acute Respiratory Syndrome coronavirus (SARS-CoV) outbreak that began in 2002, Chinese investigators caution.

By Jan. 2, 2020, 41 patients with confirmed 2019-nCoV had been admitted to a designated hospital in the city of Wuhan, Hubei Province, in central China. Thirteen required ICU admission and six died, reported Chaolin Huang, MD, from Jin Yin-tan Hospital in Wuhan, and colleagues.

“2019-nCoV still needs to be studied deeply in case it becomes a global health threat. Reliable quick pathogen tests and feasible differential diagnosis based on clinical description are crucial for clinicians in their first contact with suspected patients. Because of the pandemic potential of 2019-nCoV, careful surveillance is essential to monitor its future host adaption, viral evolution, infectivity, transmissibility, and pathogenicity,” they wrote in a review published online by The Lancet.

According to the U.S. Centers for Disease Control and Prevention, as of Jan. 28, 2020, the total number of 2019-nCoV cases reported in the United States stood at five, but further cases of the infection – which Chinese health officials have confirmed can be transmitted person-to-person – are expected.

Dr. Huang and colleagues note that although most human coronavirus infections are mild, SARS-CoV and the Middle East respiratory syndrome coronavirus (MERS-CoV) were responsible for more than 10,000 infections, with mortality rates ranging from 10% with SARS to 37% with MERS. To date, 2019-nCoV has “caused clusters of fatal pneumonia greatly resembling SARS-CoV,” they write.

The authors studied the epidemiological, clinical, laboratory, and radiological characteristics as well as treatments and clinical outcomes of 41 patients admitted or transferred to the Jin Yin-tan Hospital with laboratory-confirmed 2019-nCoV infections.

The median patient age was 49 years. Thirty of the 41 patients (73%) were male. Comorbid conditions included diabetes in 13 of the 41 patients (32%), hypertension in 6 (15%), and cardiovascular disease in 6.

In all 27 of the 41 patients had been exposed to the Huanan seafood market in Wuhan, the suspected epicenter of the outbreak that was shut down by health authorities on Jan. 1 of this year.

The most common symptoms at the onset of the illness were fever in all but one of the 41 patients, cough in 31, and myalgia or fatigue in 18. Other, less frequent symptoms included sputum production in 11, headache in three, hemoptysis in two, and diarrhea in one.

“In this cohort, most patients presented with fever, dry cough, dyspnoea, and bilateral ground-glass opacities on chest CT scans. These features of 2019-nCoV infection bear some resemblance to SARS-CoV and MERS-CoV infections. However, few patients with 2019-nCoV infection had prominent upper respiratory tract signs and symptoms (e.g., rhinorrhoea, sneezing, or sore throat), indicating that the target cells might be located in the lower airway. Furthermore, 2019-nCoV patients rarely developed intestinal signs and symptoms (e.g., diarrhoea), whereas about 20%-25% of patients with MERS-CoV or SARS-CoV infection had diarrhoea.”

In all, 22 patients developed dyspnea, with a median time from illness onset to dyspnea of 8 days. The median time from illness onset to admission was 7 days, median time to shortness of breath was 8 days, median time to acute respiratory distress syndrome (ARDS) was 9 days, and median time to both mechanical ventilation and ICU admission was 10.5 days.

All of the patients developed pneumonia with abnormal findings on chest CT scan. In addition, 12 patients developed ARDS, six had RNAaemia, five developed acute cardiac injury, and four developed a secondary infection. As noted before, 13 of the 14 patients were admitted to an ICU, and six died. RNAaemia is a positive result for real-time polymerase chain reaction in plasma samples. Patients admitted to the ICU had higher initial concentrations of multiple inflammatory cytokines than patients who did not need ICU care, “suggesting that the cytokine storm was associated with disease severity.”

All of the patients received empirical antibiotics, 38 were treated with oseltamivir (Tamiflu), and 9 received systemic corticosteroids.

The investigators have initiated a randomized controlled trial of the antiviral agents lopinavir and ritonavir for patients hospitalized with 2019-nCoV infection.

The study was funded by the Chinese Ministry of Science and Technology, Chinese Academy of Medical Sciences, National Natural Science Foundation of China, and Beijing Municipal Science and Technology Commission. All authors declared having no competing interests.

SOURCE: Huang C et al. Lancet. 2020 Jan 24. doi: 10.1016/S0140-6736(20)30183-5.

SNOWMASS, COLO. – The tragic opioid epidemic has “one small bright spot”: an expanding pool of eligible donor hearts for transplantation, Akshay S. Desai, MD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

For decades, the annual volume of heart transplantations performed in the U.S. was static because of the huge mismatch between donor organ supply and demand. But heart transplant volume has increased steadily in the last few years – a result of the opioid epidemic.

Data from the U.S. Organ Procurement and Transplantation Network show that the proportion of donor hearts obtained from individuals who died from drug intoxication climbed from a mere 1.5% in 1999 to 17.6% in 2017, the most recent year for which data are available. Meanwhile, the size of the heart transplant waiting list, which rose year after year in 2009-2015, has since declined (N Engl J Med. 2019 Feb 7;380[6]:597-9).

“What’s amazing is that, even though these patients might have historically been considered high risk in general, the organs recovered from these patients – and particularly the hearts – don’t seem to be any worse in terms of allograft survival than the organs recovered from patients who died from other causes, which are the traditional sources, like blunt head trauma, gunshot wounds, or stroke, that lead to brain death. In general, these organs are useful and do quite well,” according to Dr. Desai, medical director of the cardiomyopathy and heart failure program at Brigham and Women’s Hospital, Boston.

He highlighted several other recent developments in the field of cardiac transplantation that promise to further expand the donor heart pool, including acceptance of hepatitis C–infected donors and organ donation after circulatory rather than brain death. Dr. Desai also drew attention to the unintended perverse consequences of a recent redesign of the U.S. donor heart allocation system and discussed the impressive improvement in clinical outcomes with mechanical circulatory support. He noted that, while relatively few cardiologists practice in the highly specialized centers where heart transplants take place, virtually all cardiologists are affected by advances in heart transplantation since hundreds of thousands of the estimated 7 million Americans with heart failure have advanced disease.

Heart transplantation, he emphasized, is becoming increasingly complex. Recipients are on average older, sicker, and have more comorbidities than in times past. As a result, there is greater need for dual organ transplants: heart/lung, heart/liver, or heart/kidney. Plus, more patients come to transplantation after prior cardiac surgery for implantation of a ventricular assist device, so sensitization to blood products is a growing issue. And, of course, the pool of transplant candidates has expanded.

“We’re now forced to take patients previously considered to have contraindications to transplant; for example, diabetes was a contraindication to transplant in the early years, but now it’s the rule in 35%-40% of our patients who present with advanced heart failure,” the cardiologist noted.
 

Transplants from HCV-infected donors to uninfected recipients

Hearts and lungs from donors with hepatitis C viremia were traditionally deemed unsuitable for transplant. That’s all changed in the current era of highly effective direct-acting antiviral agents for the treatment of HCV infection.

In the DONATE HCV trial, Dr. Desai’s colleagues at Brigham and Women’s Hospital showed that giving HCV-uninfected recipients of hearts or lungs from HCV-viremic donors a shortened 4-week course of treatment with sofosbuvir-velpatasvir (Epclusa) beginning within a few hours after transplantation uniformly blocked viral replication. Six months after transplantation, none of the study participants had a detectable HCV viral load, and all had excellent graft function (N Engl J Med. 2019 Apr 25;380[17]:1606-17).

“This is effective prevention of HCV infection by aggressive upfront therapy,” Dr. Desai explained. “We can now take organs from HCV-viremic patients and use them in solid organ transplantation. This has led to a skyrocketing increase in donors with HCV infection, and those donations have helped us clear the waiting list.”
 

Donation after circulatory death

Australian transplant physicians have pioneered the use of donor hearts obtained after circulatory death in individuals with devastating neurologic injury who didn’t quite meet the criteria for brain death, which is the traditional prerequisite. In the new scenario, withdrawal of life-supporting therapy is followed by circulatory death, then the donor heart is procured and preserved via extracorporeal perfusion until transplantation.

The Australians report excellent outcomes, with rates of overall survival and rejection episodes similar to outcomes from brain-dead donors (J Am Coll Cardiol. 2019 Apr 2;73[12]:1447-59). The first U.S. heart transplant involving donation after circulatory death took place at Duke University in Durham, North Carolina. A multicenter U.S. clinical trial of this practice is underway.

If the results are positive and the practice of donation after circulatory death becomes widely implemented, the U.S. heart donor pool could increase by 30%.
 

Recent overhaul of donor heart allocation system may have backfired

The U.S. donor heart allocation system was redesigned in the fall of 2018 in an effort to reduce waiting times. One of the biggest changes involved breaking down the category with the highest urgency status into three new subcategories based upon sickness. Now, the highest-urgency category is for patients in cardiogenic shock who are supported by extracorporeal membrane oxygenation (ECMO) or other temporary mechanical circulatory support devices.

But an analysis of United Network for Organ Sharing (UNOS) data suggests this change has unintended adverse consequences for clinical outcomes.

Indeed, the investigators reported that the use of ECMO support is fourfold greater in the new system, the use of durable left ventricular assist devices (LVADs) as a bridge to transplant is down, and outcomes are worse. The 180-day rate of freedom from death or retransplantation was 77.9%, down significantly from 93.4% in the former system. In a multivariate analysis, patients transplanted in the new system had an adjusted 2.1-fold increased risk of death or retransplantation (J Heart Lung Transplant. 2020 Jan;39[1]:1-4).

“When you create a new listing system, you create new incentives, and people start to manage patients differently,” Dr. Desai observed. “Increasingly now, the path direct to transplant is through temporary mechanical circulatory support rather than durable mechanical circulatory support. Is that a good idea? We don’t know, but if you look at the best data, those on ECMO or percutaneous VADs have the worst outcomes. So the question of whether we should take the sickest of sick patients directly to transplant as a standard strategy has come under scrutiny.”
 

Improved durable LVAD technology brings impressive clinical outcomes

Results of the landmark MOMENTUM 3 randomized trial showed that 2-year clinical outcomes with the magnetically levitated centrifugal-flow HeartMate 3 LVAD now rival those of percutaneous mitral valve repair using the MitraClip device. Two-year all-cause mortality in the LVAD recipients was 22% versus 29.1% with the MitraClip in the COAPT trial and 34.9% in the MITRA-FR trial. The HeartMate 3 reduces the hemocompatibility issues that plagued earlier-generation durable LVADs, with resultant lower rates of pump thrombosis, stroke, and GI bleeding. Indeed, the outcomes in MOMENTUM 3 were so good – and so similar – with the HeartMate 3, regardless of whether the intended treatment goal was as a bridge to transplant or as lifelong destination therapy, that the investigators have recently proposed doing away with those distinctions.

“It is possible that use of arbitrary categorizations based on current or future transplant eligibility should be clinically abandoned in favor of a single preimplant strategy: to extend the survival and improve the quality of life of patients with medically refractory heart failure,” according to the investigators (JAMA Cardiol. 2020 Jan 15. doi: 10.1001/jamacardio.2019.5323).

The next step forward in LVAD technology is already on the horizon: a fully implantable device that eliminates the transcutaneous drive-line for the power supply, which is prone to infection and diminishes overall quality of life. This investigational device utilizes wireless coplanar energy transfer, with a coil ring placed around the lung and fixed to the chest wall. The implanted battery provides more than 6 hours of power without a recharge (J Heart Lung Transplant. 2019 Apr;38[4]:339-43).

“The first LVAD patient has gone swimming in Kazakhstan,” according to Dr. Desai.

Myocardial recovery in LVAD recipients remains elusive

The initial hope for LVADs was that they would not only be able to serve as a bridge to transplantation or as lifetime therapy, but that the prolonged unloading of the ventricle would enable potent medical therapy to rescue myocardial function so that the device could eventually be explanted. That does happen, but only rarely. In a large registry study, myocardial recovery occurred in only about 1% of patients on mechanical circulatory support. Attempts to enhance the process by add-on stem cell therapy have thus far been ineffective.

“For the moment, recovery is still a hope, not a reality,” the cardiologist said.

He reported serving as a consultant to more than a dozen pharmaceutical or medical device companies and receiving research grants from Alnylam, AstraZeneca, Bayer Healthcare, MyoKardia, and Novartis.

[email protected]
 

SNOWMASS, COLO. – The tragic opioid epidemic has “one small bright spot”: an expanding pool of eligible donor hearts for transplantation, Akshay S. Desai, MD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

For decades, the annual volume of heart transplantations performed in the U.S. was static because of the huge mismatch between donor organ supply and demand. But heart transplant volume has increased steadily in the last few years – a result of the opioid epidemic.

Data from the U.S. Organ Procurement and Transplantation Network show that the proportion of donor hearts obtained from individuals who died from drug intoxication climbed from a mere 1.5% in 1999 to 17.6% in 2017, the most recent year for which data are available. Meanwhile, the size of the heart transplant waiting list, which rose year after year in 2009-2015, has since declined (N Engl J Med. 2019 Feb 7;380[6]:597-9).

“What’s amazing is that, even though these patients might have historically been considered high risk in general, the organs recovered from these patients – and particularly the hearts – don’t seem to be any worse in terms of allograft survival than the organs recovered from patients who died from other causes, which are the traditional sources, like blunt head trauma, gunshot wounds, or stroke, that lead to brain death. In general, these organs are useful and do quite well,” according to Dr. Desai, medical director of the cardiomyopathy and heart failure program at Brigham and Women’s Hospital, Boston.

He highlighted several other recent developments in the field of cardiac transplantation that promise to further expand the donor heart pool, including acceptance of hepatitis C–infected donors and organ donation after circulatory rather than brain death. Dr. Desai also drew attention to the unintended perverse consequences of a recent redesign of the U.S. donor heart allocation system and discussed the impressive improvement in clinical outcomes with mechanical circulatory support. He noted that, while relatively few cardiologists practice in the highly specialized centers where heart transplants take place, virtually all cardiologists are affected by advances in heart transplantation since hundreds of thousands of the estimated 7 million Americans with heart failure have advanced disease.

Heart transplantation, he emphasized, is becoming increasingly complex. Recipients are on average older, sicker, and have more comorbidities than in times past. As a result, there is greater need for dual organ transplants: heart/lung, heart/liver, or heart/kidney. Plus, more patients come to transplantation after prior cardiac surgery for implantation of a ventricular assist device, so sensitization to blood products is a growing issue. And, of course, the pool of transplant candidates has expanded.

“We’re now forced to take patients previously considered to have contraindications to transplant; for example, diabetes was a contraindication to transplant in the early years, but now it’s the rule in 35%-40% of our patients who present with advanced heart failure,” the cardiologist noted.
 

Transplants from HCV-infected donors to uninfected recipients

Hearts and lungs from donors with hepatitis C viremia were traditionally deemed unsuitable for transplant. That’s all changed in the current era of highly effective direct-acting antiviral agents for the treatment of HCV infection.

In the DONATE HCV trial, Dr. Desai’s colleagues at Brigham and Women’s Hospital showed that giving HCV-uninfected recipients of hearts or lungs from HCV-viremic donors a shortened 4-week course of treatment with sofosbuvir-velpatasvir (Epclusa) beginning within a few hours after transplantation uniformly blocked viral replication. Six months after transplantation, none of the study participants had a detectable HCV viral load, and all had excellent graft function (N Engl J Med. 2019 Apr 25;380[17]:1606-17).

“This is effective prevention of HCV infection by aggressive upfront therapy,” Dr. Desai explained. “We can now take organs from HCV-viremic patients and use them in solid organ transplantation. This has led to a skyrocketing increase in donors with HCV infection, and those donations have helped us clear the waiting list.”
 

Donation after circulatory death

Australian transplant physicians have pioneered the use of donor hearts obtained after circulatory death in individuals with devastating neurologic injury who didn’t quite meet the criteria for brain death, which is the traditional prerequisite. In the new scenario, withdrawal of life-supporting therapy is followed by circulatory death, then the donor heart is procured and preserved via extracorporeal perfusion until transplantation.

The Australians report excellent outcomes, with rates of overall survival and rejection episodes similar to outcomes from brain-dead donors (J Am Coll Cardiol. 2019 Apr 2;73[12]:1447-59). The first U.S. heart transplant involving donation after circulatory death took place at Duke University in Durham, North Carolina. A multicenter U.S. clinical trial of this practice is underway.

If the results are positive and the practice of donation after circulatory death becomes widely implemented, the U.S. heart donor pool could increase by 30%.
 

Recent overhaul of donor heart allocation system may have backfired

The U.S. donor heart allocation system was redesigned in the fall of 2018 in an effort to reduce waiting times. One of the biggest changes involved breaking down the category with the highest urgency status into three new subcategories based upon sickness. Now, the highest-urgency category is for patients in cardiogenic shock who are supported by extracorporeal membrane oxygenation (ECMO) or other temporary mechanical circulatory support devices.

But an analysis of United Network for Organ Sharing (UNOS) data suggests this change has unintended adverse consequences for clinical outcomes.

Indeed, the investigators reported that the use of ECMO support is fourfold greater in the new system, the use of durable left ventricular assist devices (LVADs) as a bridge to transplant is down, and outcomes are worse. The 180-day rate of freedom from death or retransplantation was 77.9%, down significantly from 93.4% in the former system. In a multivariate analysis, patients transplanted in the new system had an adjusted 2.1-fold increased risk of death or retransplantation (J Heart Lung Transplant. 2020 Jan;39[1]:1-4).

“When you create a new listing system, you create new incentives, and people start to manage patients differently,” Dr. Desai observed. “Increasingly now, the path direct to transplant is through temporary mechanical circulatory support rather than durable mechanical circulatory support. Is that a good idea? We don’t know, but if you look at the best data, those on ECMO or percutaneous VADs have the worst outcomes. So the question of whether we should take the sickest of sick patients directly to transplant as a standard strategy has come under scrutiny.”
 

Improved durable LVAD technology brings impressive clinical outcomes

Results of the landmark MOMENTUM 3 randomized trial showed that 2-year clinical outcomes with the magnetically levitated centrifugal-flow HeartMate 3 LVAD now rival those of percutaneous mitral valve repair using the MitraClip device. Two-year all-cause mortality in the LVAD recipients was 22% versus 29.1% with the MitraClip in the COAPT trial and 34.9% in the MITRA-FR trial. The HeartMate 3 reduces the hemocompatibility issues that plagued earlier-generation durable LVADs, with resultant lower rates of pump thrombosis, stroke, and GI bleeding. Indeed, the outcomes in MOMENTUM 3 were so good – and so similar – with the HeartMate 3, regardless of whether the intended treatment goal was as a bridge to transplant or as lifelong destination therapy, that the investigators have recently proposed doing away with those distinctions.

“It is possible that use of arbitrary categorizations based on current or future transplant eligibility should be clinically abandoned in favor of a single preimplant strategy: to extend the survival and improve the quality of life of patients with medically refractory heart failure,” according to the investigators (JAMA Cardiol. 2020 Jan 15. doi: 10.1001/jamacardio.2019.5323).

The next step forward in LVAD technology is already on the horizon: a fully implantable device that eliminates the transcutaneous drive-line for the power supply, which is prone to infection and diminishes overall quality of life. This investigational device utilizes wireless coplanar energy transfer, with a coil ring placed around the lung and fixed to the chest wall. The implanted battery provides more than 6 hours of power without a recharge (J Heart Lung Transplant. 2019 Apr;38[4]:339-43).

“The first LVAD patient has gone swimming in Kazakhstan,” according to Dr. Desai.

Myocardial recovery in LVAD recipients remains elusive

The initial hope for LVADs was that they would not only be able to serve as a bridge to transplantation or as lifetime therapy, but that the prolonged unloading of the ventricle would enable potent medical therapy to rescue myocardial function so that the device could eventually be explanted. That does happen, but only rarely. In a large registry study, myocardial recovery occurred in only about 1% of patients on mechanical circulatory support. Attempts to enhance the process by add-on stem cell therapy have thus far been ineffective.

“For the moment, recovery is still a hope, not a reality,” the cardiologist said.

He reported serving as a consultant to more than a dozen pharmaceutical or medical device companies and receiving research grants from Alnylam, AstraZeneca, Bayer Healthcare, MyoKardia, and Novartis.

[email protected]
 

SNOWMASS, COLO. – The tragic opioid epidemic has “one small bright spot”: an expanding pool of eligible donor hearts for transplantation, Akshay S. Desai, MD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

For decades, the annual volume of heart transplantations performed in the U.S. was static because of the huge mismatch between donor organ supply and demand. But heart transplant volume has increased steadily in the last few years – a result of the opioid epidemic.

Data from the U.S. Organ Procurement and Transplantation Network show that the proportion of donor hearts obtained from individuals who died from drug intoxication climbed from a mere 1.5% in 1999 to 17.6% in 2017, the most recent year for which data are available. Meanwhile, the size of the heart transplant waiting list, which rose year after year in 2009-2015, has since declined (N Engl J Med. 2019 Feb 7;380[6]:597-9).

“What’s amazing is that, even though these patients might have historically been considered high risk in general, the organs recovered from these patients – and particularly the hearts – don’t seem to be any worse in terms of allograft survival than the organs recovered from patients who died from other causes, which are the traditional sources, like blunt head trauma, gunshot wounds, or stroke, that lead to brain death. In general, these organs are useful and do quite well,” according to Dr. Desai, medical director of the cardiomyopathy and heart failure program at Brigham and Women’s Hospital, Boston.

He highlighted several other recent developments in the field of cardiac transplantation that promise to further expand the donor heart pool, including acceptance of hepatitis C–infected donors and organ donation after circulatory rather than brain death. Dr. Desai also drew attention to the unintended perverse consequences of a recent redesign of the U.S. donor heart allocation system and discussed the impressive improvement in clinical outcomes with mechanical circulatory support. He noted that, while relatively few cardiologists practice in the highly specialized centers where heart transplants take place, virtually all cardiologists are affected by advances in heart transplantation since hundreds of thousands of the estimated 7 million Americans with heart failure have advanced disease.

Heart transplantation, he emphasized, is becoming increasingly complex. Recipients are on average older, sicker, and have more comorbidities than in times past. As a result, there is greater need for dual organ transplants: heart/lung, heart/liver, or heart/kidney. Plus, more patients come to transplantation after prior cardiac surgery for implantation of a ventricular assist device, so sensitization to blood products is a growing issue. And, of course, the pool of transplant candidates has expanded.

“We’re now forced to take patients previously considered to have contraindications to transplant; for example, diabetes was a contraindication to transplant in the early years, but now it’s the rule in 35%-40% of our patients who present with advanced heart failure,” the cardiologist noted.
 

Transplants from HCV-infected donors to uninfected recipients

Hearts and lungs from donors with hepatitis C viremia were traditionally deemed unsuitable for transplant. That’s all changed in the current era of highly effective direct-acting antiviral agents for the treatment of HCV infection.

In the DONATE HCV trial, Dr. Desai’s colleagues at Brigham and Women’s Hospital showed that giving HCV-uninfected recipients of hearts or lungs from HCV-viremic donors a shortened 4-week course of treatment with sofosbuvir-velpatasvir (Epclusa) beginning within a few hours after transplantation uniformly blocked viral replication. Six months after transplantation, none of the study participants had a detectable HCV viral load, and all had excellent graft function (N Engl J Med. 2019 Apr 25;380[17]:1606-17).

“This is effective prevention of HCV infection by aggressive upfront therapy,” Dr. Desai explained. “We can now take organs from HCV-viremic patients and use them in solid organ transplantation. This has led to a skyrocketing increase in donors with HCV infection, and those donations have helped us clear the waiting list.”
 

Donation after circulatory death

Australian transplant physicians have pioneered the use of donor hearts obtained after circulatory death in individuals with devastating neurologic injury who didn’t quite meet the criteria for brain death, which is the traditional prerequisite. In the new scenario, withdrawal of life-supporting therapy is followed by circulatory death, then the donor heart is procured and preserved via extracorporeal perfusion until transplantation.

The Australians report excellent outcomes, with rates of overall survival and rejection episodes similar to outcomes from brain-dead donors (J Am Coll Cardiol. 2019 Apr 2;73[12]:1447-59). The first U.S. heart transplant involving donation after circulatory death took place at Duke University in Durham, North Carolina. A multicenter U.S. clinical trial of this practice is underway.

If the results are positive and the practice of donation after circulatory death becomes widely implemented, the U.S. heart donor pool could increase by 30%.
 

Recent overhaul of donor heart allocation system may have backfired

The U.S. donor heart allocation system was redesigned in the fall of 2018 in an effort to reduce waiting times. One of the biggest changes involved breaking down the category with the highest urgency status into three new subcategories based upon sickness. Now, the highest-urgency category is for patients in cardiogenic shock who are supported by extracorporeal membrane oxygenation (ECMO) or other temporary mechanical circulatory support devices.

But an analysis of United Network for Organ Sharing (UNOS) data suggests this change has unintended adverse consequences for clinical outcomes.

Indeed, the investigators reported that the use of ECMO support is fourfold greater in the new system, the use of durable left ventricular assist devices (LVADs) as a bridge to transplant is down, and outcomes are worse. The 180-day rate of freedom from death or retransplantation was 77.9%, down significantly from 93.4% in the former system. In a multivariate analysis, patients transplanted in the new system had an adjusted 2.1-fold increased risk of death or retransplantation (J Heart Lung Transplant. 2020 Jan;39[1]:1-4).

“When you create a new listing system, you create new incentives, and people start to manage patients differently,” Dr. Desai observed. “Increasingly now, the path direct to transplant is through temporary mechanical circulatory support rather than durable mechanical circulatory support. Is that a good idea? We don’t know, but if you look at the best data, those on ECMO or percutaneous VADs have the worst outcomes. So the question of whether we should take the sickest of sick patients directly to transplant as a standard strategy has come under scrutiny.”
 

Improved durable LVAD technology brings impressive clinical outcomes

Results of the landmark MOMENTUM 3 randomized trial showed that 2-year clinical outcomes with the magnetically levitated centrifugal-flow HeartMate 3 LVAD now rival those of percutaneous mitral valve repair using the MitraClip device. Two-year all-cause mortality in the LVAD recipients was 22% versus 29.1% with the MitraClip in the COAPT trial and 34.9% in the MITRA-FR trial. The HeartMate 3 reduces the hemocompatibility issues that plagued earlier-generation durable LVADs, with resultant lower rates of pump thrombosis, stroke, and GI bleeding. Indeed, the outcomes in MOMENTUM 3 were so good – and so similar – with the HeartMate 3, regardless of whether the intended treatment goal was as a bridge to transplant or as lifelong destination therapy, that the investigators have recently proposed doing away with those distinctions.

“It is possible that use of arbitrary categorizations based on current or future transplant eligibility should be clinically abandoned in favor of a single preimplant strategy: to extend the survival and improve the quality of life of patients with medically refractory heart failure,” according to the investigators (JAMA Cardiol. 2020 Jan 15. doi: 10.1001/jamacardio.2019.5323).

The next step forward in LVAD technology is already on the horizon: a fully implantable device that eliminates the transcutaneous drive-line for the power supply, which is prone to infection and diminishes overall quality of life. This investigational device utilizes wireless coplanar energy transfer, with a coil ring placed around the lung and fixed to the chest wall. The implanted battery provides more than 6 hours of power without a recharge (J Heart Lung Transplant. 2019 Apr;38[4]:339-43).

“The first LVAD patient has gone swimming in Kazakhstan,” according to Dr. Desai.

Myocardial recovery in LVAD recipients remains elusive

The initial hope for LVADs was that they would not only be able to serve as a bridge to transplantation or as lifetime therapy, but that the prolonged unloading of the ventricle would enable potent medical therapy to rescue myocardial function so that the device could eventually be explanted. That does happen, but only rarely. In a large registry study, myocardial recovery occurred in only about 1% of patients on mechanical circulatory support. Attempts to enhance the process by add-on stem cell therapy have thus far been ineffective.

“For the moment, recovery is still a hope, not a reality,” the cardiologist said.

He reported serving as a consultant to more than a dozen pharmaceutical or medical device companies and receiving research grants from Alnylam, AstraZeneca, Bayer Healthcare, MyoKardia, and Novartis.

[email protected]
 

Five cases of the new infectious coronavirus, 2019-nCoV, have been confirmed in the United States, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, said during a Jan. 27 press briefing.

A total of 110 individuals are under investigation in 26 states, she said. While five cases have been confirmed positive for the virus, 32 cases were confirmed negative. There have been no new cases overnight.

Last week, CDC scientists developed a real-time polymerase chain reaction (PCR) test that can diagnose the virus in respiratory and serum samples from clinical specimens. On Jan. 24, the protocol for this test was publicly posted. “This is essentially a blueprint to make the test,” Dr. Messonnier explained. “Currently, we are refining the use of the test so that it can provide optimal guidance to states and labs on how to use it. We are working on a plan so that priority states get these test kits as soon as possible. In the coming weeks, we will share these tests with domestic and international partners so they can test for this virus themselves.”

The CDC uploaded the entire genome of the virus from the first two cases in the United States to GenBank. It was similar to the one that China had previously posted. “Right now, based on CDC’s analysis of the available data, it doesn’t look like the virus has mutated,” she said. “And we are growing the virus in cell culture, which is necessary for further studies, including the additional genetic characterization.”

As of today, 16 international locations, including the United States, have identified cases of the virus. CDC officials are continuing to screen passengers from Wuhan, China, at five designated airports. “This serves two purposes: first to detect the illness and rapidly respond to [affected] people entering the country,” Dr. Messonnier said. “The second purpose is to educate travelers about the symptoms of this new virus, and what to do if they develop symptoms. I expect that in the coming days, our travel recommendations will change. Risk depends on exposure. Right now, we have an handful of new patients with this new virus here in the U.S. However, at this time in the U.S., this virus is not spreading in the community. For that reason, we believe that the immediate health risk of the new virus to the general American public is low.”

The CDC is asking its clinical lab partners to send virus samples to the CDC to ensure that results are analyzed as accurately as possible.

[email protected]

Five cases of the new infectious coronavirus, 2019-nCoV, have been confirmed in the United States, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, said during a Jan. 27 press briefing.

A total of 110 individuals are under investigation in 26 states, she said. While five cases have been confirmed positive for the virus, 32 cases were confirmed negative. There have been no new cases overnight.

Last week, CDC scientists developed a real-time polymerase chain reaction (PCR) test that can diagnose the virus in respiratory and serum samples from clinical specimens. On Jan. 24, the protocol for this test was publicly posted. “This is essentially a blueprint to make the test,” Dr. Messonnier explained. “Currently, we are refining the use of the test so that it can provide optimal guidance to states and labs on how to use it. We are working on a plan so that priority states get these test kits as soon as possible. In the coming weeks, we will share these tests with domestic and international partners so they can test for this virus themselves.”

The CDC uploaded the entire genome of the virus from the first two cases in the United States to GenBank. It was similar to the one that China had previously posted. “Right now, based on CDC’s analysis of the available data, it doesn’t look like the virus has mutated,” she said. “And we are growing the virus in cell culture, which is necessary for further studies, including the additional genetic characterization.”

As of today, 16 international locations, including the United States, have identified cases of the virus. CDC officials are continuing to screen passengers from Wuhan, China, at five designated airports. “This serves two purposes: first to detect the illness and rapidly respond to [affected] people entering the country,” Dr. Messonnier said. “The second purpose is to educate travelers about the symptoms of this new virus, and what to do if they develop symptoms. I expect that in the coming days, our travel recommendations will change. Risk depends on exposure. Right now, we have an handful of new patients with this new virus here in the U.S. However, at this time in the U.S., this virus is not spreading in the community. For that reason, we believe that the immediate health risk of the new virus to the general American public is low.”

The CDC is asking its clinical lab partners to send virus samples to the CDC to ensure that results are analyzed as accurately as possible.

[email protected]

Five cases of the new infectious coronavirus, 2019-nCoV, have been confirmed in the United States, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, said during a Jan. 27 press briefing.

A total of 110 individuals are under investigation in 26 states, she said. While five cases have been confirmed positive for the virus, 32 cases were confirmed negative. There have been no new cases overnight.

Last week, CDC scientists developed a real-time polymerase chain reaction (PCR) test that can diagnose the virus in respiratory and serum samples from clinical specimens. On Jan. 24, the protocol for this test was publicly posted. “This is essentially a blueprint to make the test,” Dr. Messonnier explained. “Currently, we are refining the use of the test so that it can provide optimal guidance to states and labs on how to use it. We are working on a plan so that priority states get these test kits as soon as possible. In the coming weeks, we will share these tests with domestic and international partners so they can test for this virus themselves.”

The CDC uploaded the entire genome of the virus from the first two cases in the United States to GenBank. It was similar to the one that China had previously posted. “Right now, based on CDC’s analysis of the available data, it doesn’t look like the virus has mutated,” she said. “And we are growing the virus in cell culture, which is necessary for further studies, including the additional genetic characterization.”

As of today, 16 international locations, including the United States, have identified cases of the virus. CDC officials are continuing to screen passengers from Wuhan, China, at five designated airports. “This serves two purposes: first to detect the illness and rapidly respond to [affected] people entering the country,” Dr. Messonnier said. “The second purpose is to educate travelers about the symptoms of this new virus, and what to do if they develop symptoms. I expect that in the coming days, our travel recommendations will change. Risk depends on exposure. Right now, we have an handful of new patients with this new virus here in the U.S. However, at this time in the U.S., this virus is not spreading in the community. For that reason, we believe that the immediate health risk of the new virus to the general American public is low.”

The CDC is asking its clinical lab partners to send virus samples to the CDC to ensure that results are analyzed as accurately as possible.

[email protected]

Patients suffering from chronic pain who take medicinal cannabis to initiate and maintain sleep appear to experience short-term benefit, but long-term use may ultimately disrupt slumber, new research shows.

Investigators found whole-plant medical cannabis use was associated with fewer problems with respect to waking up at night, but they also found that frequent medical cannabis use was associated with more problems initiating and maintaining sleep.

LPETTET/Getty Images

A common problem

Estimates suggest chronic pain affects up to 37% of adults in the developed world. Individuals who suffer chronic pain often experience comorbid insomnia, which includes difficulty initiating sleep, sleep disruption, and early morning wakening.

For its part, medical cannabis to treat chronic pain symptoms and manage sleep problems has been widely reported as a prime motivation for medical cannabis use. Indeed, previous studies have concluded that the endocannabinoid system plays a role in sleep regulation, including sleep promotion and maintenance.

In recent years, investigators have reported the beneficial effects of medical cannabis for sleep. Nevertheless, some preclinical research has also concluded that chronic administration of tetrahydrocannabinol may result in tolerance to the sleep-enhancing effects of cannabis.

With that in mind, the researchers set out to examine the potential impact of whole-plant medicinal cannabis on sleep problems experienced by middle-aged patients suffering from chronic pain.

“People are self-reporting that they’re using cannabis for sleep and that it helps, but as we know, just because people are reporting that it works doesn’t mean that it will hold up in research,” Dr. Sznitman said.

The study included 128 individuals (mean age, 61±6 years; 51% females) with chronic neuropathic pain: 66 were medical cannabis users and 62 were not.

Three indicators of insomnia were measured using the 7-point Likert scale to assess issues with sleep initiation and maintenance.

In addition, investigators collected sociodemographic information, as well as data on daily consumption of tobacco, frequency of alcohol use, and pain severity. Finally, they collected patient data on the use of sleep-aid medications during the past month as well as tricyclic antidepressant use.
 

Frequent use, more sleep problems?

On average, medical cannabis users were 3 years younger than their nonusing counterparts (mean age, 60±6 vs. 63±6 years, respectively, P = .003) and more likely to be male (58% vs 40%, respectively, P = .038). Otherwise, the two groups were comparable.

Medical cannabis users reported taking the drug for an average of 4 years, at an average quantity of 31 g per month. The primary mode of administration was smoking (68.6%), followed by oil extracts (21.4%) and vaporization (20%).

Results showed that, of the total sample, 24.1% reported always waking up early and not falling back to sleep, 20.2% reported always having difficulty falling asleep, and 27.2% reported always waking up during the night.

After adjusting for patient age, sex, pain level, and use of sleep medications and antidepressants, medical cannabis use was associated with fewer problems with waking up at night, compared with nonmedical cannabis use. No differences were found between groups with respect to problems falling asleep or waking up early without being able to fall back to sleep, Dr. Sznitman and associates reported.

The final analysis of a subsample of patients that only included medical cannabis users showed frequency of medical cannabis use was associated with sleep problems, they said.

Specifically, more frequent cannabis use was associated with more problems related to waking up at night, as well as problems falling asleep.

Sleep problems associated with frequent medical cannabis use may signal the development of tolerance to the agent. However, frequent users of medical cannabis also maybsuffer pain or other comorbidities, which, in turn, may be linked to more sleep problems.

Either way, Dr. Sznitman said the study might open the door to another treatment option for patients suffering from chronic pain who struggle with sleep.

“If future research shows that the effect of medical cannabis on sleep is a consistent one, then we may be adding a new therapy for sleep problems, which are huge in society and especially in chronic pain patients,” she said.
 

Early days

Commenting on the findings in an interview, Ryan G. Vandrey, PhD, who was not involved in the study, said the findings are in line with previous research.

“I think the results make sense with respect to the data I’ve collected and from what I’ve seen,” said Dr. Vandrey, associate professor of psychiatry and behavioral sciences at Johns Hopkins Medicine in Baltimore.

“We typically only want to use sleep medications for short periods of time,” he continued. “When you think about recommended prescribing practices for any hypnotic medication, it’s usually short term, 2 weeks or less. Longer-term use often leads to tolerance, dependence, and withdrawal symptoms when the medication is stopped, which leads to an exacerbation of disordered sleep,” Dr. Vandrey said.

Nevertheless, he urged caution when interpreting the results.

“I think the study warrants caution about long-term daily use of cannabinoids with respect to sleep,” he said. “But we need more detailed evaluations, as the trial wasn’t testing a defined product, specific dose, or dose regimen.

“In addition, this was all done in the context of people with chronic pain and not treating disordered sleep or insomnia, but the study highlights the importance of recognizing that long-term chronic use of cannabis is not likely to fully resolve sleep problems.”

Dr. Sznitman agreed that the research is still in its very early stages.

“We’re still far from saying we have the evidence to support the use of medical cannabis for sleep,” she said. “For in the end it was just a cross-sectional, observational study, so we cannot say anything about cause and effect. But if these results pan out, they could be far-reaching and exciting.”

The study was funded by the University of Haifa and Rambam Hospital in Israel, and by the Evelyn Lipper Foundation. Dr. Sznitman and Dr. Vandrey have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.
 

Patients suffering from chronic pain who take medicinal cannabis to initiate and maintain sleep appear to experience short-term benefit, but long-term use may ultimately disrupt slumber, new research shows.

Investigators found whole-plant medical cannabis use was associated with fewer problems with respect to waking up at night, but they also found that frequent medical cannabis use was associated with more problems initiating and maintaining sleep.

LPETTET/Getty Images

A common problem

Estimates suggest chronic pain affects up to 37% of adults in the developed world. Individuals who suffer chronic pain often experience comorbid insomnia, which includes difficulty initiating sleep, sleep disruption, and early morning wakening.

For its part, medical cannabis to treat chronic pain symptoms and manage sleep problems has been widely reported as a prime motivation for medical cannabis use. Indeed, previous studies have concluded that the endocannabinoid system plays a role in sleep regulation, including sleep promotion and maintenance.

In recent years, investigators have reported the beneficial effects of medical cannabis for sleep. Nevertheless, some preclinical research has also concluded that chronic administration of tetrahydrocannabinol may result in tolerance to the sleep-enhancing effects of cannabis.

With that in mind, the researchers set out to examine the potential impact of whole-plant medicinal cannabis on sleep problems experienced by middle-aged patients suffering from chronic pain.

“People are self-reporting that they’re using cannabis for sleep and that it helps, but as we know, just because people are reporting that it works doesn’t mean that it will hold up in research,” Dr. Sznitman said.

The study included 128 individuals (mean age, 61±6 years; 51% females) with chronic neuropathic pain: 66 were medical cannabis users and 62 were not.

Three indicators of insomnia were measured using the 7-point Likert scale to assess issues with sleep initiation and maintenance.

In addition, investigators collected sociodemographic information, as well as data on daily consumption of tobacco, frequency of alcohol use, and pain severity. Finally, they collected patient data on the use of sleep-aid medications during the past month as well as tricyclic antidepressant use.
 

Frequent use, more sleep problems?

On average, medical cannabis users were 3 years younger than their nonusing counterparts (mean age, 60±6 vs. 63±6 years, respectively, P = .003) and more likely to be male (58% vs 40%, respectively, P = .038). Otherwise, the two groups were comparable.

Medical cannabis users reported taking the drug for an average of 4 years, at an average quantity of 31 g per month. The primary mode of administration was smoking (68.6%), followed by oil extracts (21.4%) and vaporization (20%).

Results showed that, of the total sample, 24.1% reported always waking up early and not falling back to sleep, 20.2% reported always having difficulty falling asleep, and 27.2% reported always waking up during the night.

After adjusting for patient age, sex, pain level, and use of sleep medications and antidepressants, medical cannabis use was associated with fewer problems with waking up at night, compared with nonmedical cannabis use. No differences were found between groups with respect to problems falling asleep or waking up early without being able to fall back to sleep, Dr. Sznitman and associates reported.

The final analysis of a subsample of patients that only included medical cannabis users showed frequency of medical cannabis use was associated with sleep problems, they said.

Specifically, more frequent cannabis use was associated with more problems related to waking up at night, as well as problems falling asleep.

Sleep problems associated with frequent medical cannabis use may signal the development of tolerance to the agent. However, frequent users of medical cannabis also maybsuffer pain or other comorbidities, which, in turn, may be linked to more sleep problems.

Either way, Dr. Sznitman said the study might open the door to another treatment option for patients suffering from chronic pain who struggle with sleep.

“If future research shows that the effect of medical cannabis on sleep is a consistent one, then we may be adding a new therapy for sleep problems, which are huge in society and especially in chronic pain patients,” she said.
 

Early days

Commenting on the findings in an interview, Ryan G. Vandrey, PhD, who was not involved in the study, said the findings are in line with previous research.

“I think the results make sense with respect to the data I’ve collected and from what I’ve seen,” said Dr. Vandrey, associate professor of psychiatry and behavioral sciences at Johns Hopkins Medicine in Baltimore.

“We typically only want to use sleep medications for short periods of time,” he continued. “When you think about recommended prescribing practices for any hypnotic medication, it’s usually short term, 2 weeks or less. Longer-term use often leads to tolerance, dependence, and withdrawal symptoms when the medication is stopped, which leads to an exacerbation of disordered sleep,” Dr. Vandrey said.

Nevertheless, he urged caution when interpreting the results.

“I think the study warrants caution about long-term daily use of cannabinoids with respect to sleep,” he said. “But we need more detailed evaluations, as the trial wasn’t testing a defined product, specific dose, or dose regimen.

“In addition, this was all done in the context of people with chronic pain and not treating disordered sleep or insomnia, but the study highlights the importance of recognizing that long-term chronic use of cannabis is not likely to fully resolve sleep problems.”

Dr. Sznitman agreed that the research is still in its very early stages.

“We’re still far from saying we have the evidence to support the use of medical cannabis for sleep,” she said. “For in the end it was just a cross-sectional, observational study, so we cannot say anything about cause and effect. But if these results pan out, they could be far-reaching and exciting.”

The study was funded by the University of Haifa and Rambam Hospital in Israel, and by the Evelyn Lipper Foundation. Dr. Sznitman and Dr. Vandrey have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.
 

Patients suffering from chronic pain who take medicinal cannabis to initiate and maintain sleep appear to experience short-term benefit, but long-term use may ultimately disrupt slumber, new research shows.

Investigators found whole-plant medical cannabis use was associated with fewer problems with respect to waking up at night, but they also found that frequent medical cannabis use was associated with more problems initiating and maintaining sleep.

LPETTET/Getty Images

A common problem

Estimates suggest chronic pain affects up to 37% of adults in the developed world. Individuals who suffer chronic pain often experience comorbid insomnia, which includes difficulty initiating sleep, sleep disruption, and early morning wakening.

For its part, medical cannabis to treat chronic pain symptoms and manage sleep problems has been widely reported as a prime motivation for medical cannabis use. Indeed, previous studies have concluded that the endocannabinoid system plays a role in sleep regulation, including sleep promotion and maintenance.

In recent years, investigators have reported the beneficial effects of medical cannabis for sleep. Nevertheless, some preclinical research has also concluded that chronic administration of tetrahydrocannabinol may result in tolerance to the sleep-enhancing effects of cannabis.

With that in mind, the researchers set out to examine the potential impact of whole-plant medicinal cannabis on sleep problems experienced by middle-aged patients suffering from chronic pain.

“People are self-reporting that they’re using cannabis for sleep and that it helps, but as we know, just because people are reporting that it works doesn’t mean that it will hold up in research,” Dr. Sznitman said.

The study included 128 individuals (mean age, 61±6 years; 51% females) with chronic neuropathic pain: 66 were medical cannabis users and 62 were not.

Three indicators of insomnia were measured using the 7-point Likert scale to assess issues with sleep initiation and maintenance.

In addition, investigators collected sociodemographic information, as well as data on daily consumption of tobacco, frequency of alcohol use, and pain severity. Finally, they collected patient data on the use of sleep-aid medications during the past month as well as tricyclic antidepressant use.
 

Frequent use, more sleep problems?

On average, medical cannabis users were 3 years younger than their nonusing counterparts (mean age, 60±6 vs. 63±6 years, respectively, P = .003) and more likely to be male (58% vs 40%, respectively, P = .038). Otherwise, the two groups were comparable.

Medical cannabis users reported taking the drug for an average of 4 years, at an average quantity of 31 g per month. The primary mode of administration was smoking (68.6%), followed by oil extracts (21.4%) and vaporization (20%).

Results showed that, of the total sample, 24.1% reported always waking up early and not falling back to sleep, 20.2% reported always having difficulty falling asleep, and 27.2% reported always waking up during the night.

After adjusting for patient age, sex, pain level, and use of sleep medications and antidepressants, medical cannabis use was associated with fewer problems with waking up at night, compared with nonmedical cannabis use. No differences were found between groups with respect to problems falling asleep or waking up early without being able to fall back to sleep, Dr. Sznitman and associates reported.

The final analysis of a subsample of patients that only included medical cannabis users showed frequency of medical cannabis use was associated with sleep problems, they said.

Specifically, more frequent cannabis use was associated with more problems related to waking up at night, as well as problems falling asleep.

Sleep problems associated with frequent medical cannabis use may signal the development of tolerance to the agent. However, frequent users of medical cannabis also maybsuffer pain or other comorbidities, which, in turn, may be linked to more sleep problems.

Either way, Dr. Sznitman said the study might open the door to another treatment option for patients suffering from chronic pain who struggle with sleep.

“If future research shows that the effect of medical cannabis on sleep is a consistent one, then we may be adding a new therapy for sleep problems, which are huge in society and especially in chronic pain patients,” she said.
 

Early days

Commenting on the findings in an interview, Ryan G. Vandrey, PhD, who was not involved in the study, said the findings are in line with previous research.

“I think the results make sense with respect to the data I’ve collected and from what I’ve seen,” said Dr. Vandrey, associate professor of psychiatry and behavioral sciences at Johns Hopkins Medicine in Baltimore.

“We typically only want to use sleep medications for short periods of time,” he continued. “When you think about recommended prescribing practices for any hypnotic medication, it’s usually short term, 2 weeks or less. Longer-term use often leads to tolerance, dependence, and withdrawal symptoms when the medication is stopped, which leads to an exacerbation of disordered sleep,” Dr. Vandrey said.

Nevertheless, he urged caution when interpreting the results.

“I think the study warrants caution about long-term daily use of cannabinoids with respect to sleep,” he said. “But we need more detailed evaluations, as the trial wasn’t testing a defined product, specific dose, or dose regimen.

“In addition, this was all done in the context of people with chronic pain and not treating disordered sleep or insomnia, but the study highlights the importance of recognizing that long-term chronic use of cannabis is not likely to fully resolve sleep problems.”

Dr. Sznitman agreed that the research is still in its very early stages.

“We’re still far from saying we have the evidence to support the use of medical cannabis for sleep,” she said. “For in the end it was just a cross-sectional, observational study, so we cannot say anything about cause and effect. But if these results pan out, they could be far-reaching and exciting.”

The study was funded by the University of Haifa and Rambam Hospital in Israel, and by the Evelyn Lipper Foundation. Dr. Sznitman and Dr. Vandrey have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.
 

As the Wuhan coronavirus story unfolds, the most important thing for clinicians in the United States to do is ask patients who appear to have the flu if they, or someone they have been in contact with, recently returned from China, according to infectious disease experts.

China News Service/CC BY 3.0

“We are asking that of everyone with fever and respiratory symptoms who comes to our clinics, hospital, or emergency room. It’s a powerful screening tool,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.

In addition to fever, common signs of infection include cough, shortness of breath, and breathing difficulties. Some patients have had diarrhea, vomiting, and other gastrointestinal symptoms. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and death. The incubation period appears to be up to 2 weeks, according to the World Health Organization (WHO).

If patients exhibit symptoms and either they or a close contact has returned from China recently, take standard airborne precautions and send specimens – a serum sample, oral and nasal pharyngeal swabs, and lower respiratory tract specimens if available – to the local health department, which will forward them to the Centers for Disease Control and Prevention (CDC) for testing. Turnaround time is 24-48 hours.

Plan and rehearse

The first step to prepare is to use the CDC’s Interim Guidance for Healthcare Professionals to make a written plan specific to your practice to respond to a potential case. The plan must include notifying the local health department, the CDC liaison for testing, and tracking down patient contacts.

“It’s not good enough to just download CDC’s guidance; use it to make your own local plan and know what to do 24/7,” said Daniel Lucey, MD, an infectious disease expert at Georgetown University Medical Center, Washington, D.C.

“Know who is on call at the health department on weekends and nights,” he said. Know where the patient is going to be isolated; figure out what to do if there’s more than one, and tests come back positive. Have masks on hand, and rehearse the response. “Make a coronavirus team, and absolutely have the nurses involved,” as well as other providers who may come into contact with a case, he added.

Fatality rates

The focus right now is China. The outbreak has spread beyond Wuhan to other parts of the country, and there’s evidence of fourth-generation spread.

SARS: Lessons learned

In general, the world is much better equipped for coronavirus outbreaks than when SARS, in particular, emerged in 2003.

[email protected]

This article was updated with new case numbers on 1/26/20.

As the Wuhan coronavirus story unfolds, the most important thing for clinicians in the United States to do is ask patients who appear to have the flu if they, or someone they have been in contact with, recently returned from China, according to infectious disease experts.

China News Service/CC BY 3.0

“We are asking that of everyone with fever and respiratory symptoms who comes to our clinics, hospital, or emergency room. It’s a powerful screening tool,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.

In addition to fever, common signs of infection include cough, shortness of breath, and breathing difficulties. Some patients have had diarrhea, vomiting, and other gastrointestinal symptoms. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and death. The incubation period appears to be up to 2 weeks, according to the World Health Organization (WHO).

If patients exhibit symptoms and either they or a close contact has returned from China recently, take standard airborne precautions and send specimens – a serum sample, oral and nasal pharyngeal swabs, and lower respiratory tract specimens if available – to the local health department, which will forward them to the Centers for Disease Control and Prevention (CDC) for testing. Turnaround time is 24-48 hours.

Plan and rehearse

The first step to prepare is to use the CDC’s Interim Guidance for Healthcare Professionals to make a written plan specific to your practice to respond to a potential case. The plan must include notifying the local health department, the CDC liaison for testing, and tracking down patient contacts.

“It’s not good enough to just download CDC’s guidance; use it to make your own local plan and know what to do 24/7,” said Daniel Lucey, MD, an infectious disease expert at Georgetown University Medical Center, Washington, D.C.

“Know who is on call at the health department on weekends and nights,” he said. Know where the patient is going to be isolated; figure out what to do if there’s more than one, and tests come back positive. Have masks on hand, and rehearse the response. “Make a coronavirus team, and absolutely have the nurses involved,” as well as other providers who may come into contact with a case, he added.

Fatality rates

The focus right now is China. The outbreak has spread beyond Wuhan to other parts of the country, and there’s evidence of fourth-generation spread.

SARS: Lessons learned

In general, the world is much better equipped for coronavirus outbreaks than when SARS, in particular, emerged in 2003.

[email protected]

This article was updated with new case numbers on 1/26/20.

As the Wuhan coronavirus story unfolds, the most important thing for clinicians in the United States to do is ask patients who appear to have the flu if they, or someone they have been in contact with, recently returned from China, according to infectious disease experts.

China News Service/CC BY 3.0

“We are asking that of everyone with fever and respiratory symptoms who comes to our clinics, hospital, or emergency room. It’s a powerful screening tool,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.

In addition to fever, common signs of infection include cough, shortness of breath, and breathing difficulties. Some patients have had diarrhea, vomiting, and other gastrointestinal symptoms. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and death. The incubation period appears to be up to 2 weeks, according to the World Health Organization (WHO).

If patients exhibit symptoms and either they or a close contact has returned from China recently, take standard airborne precautions and send specimens – a serum sample, oral and nasal pharyngeal swabs, and lower respiratory tract specimens if available – to the local health department, which will forward them to the Centers for Disease Control and Prevention (CDC) for testing. Turnaround time is 24-48 hours.

Plan and rehearse

The first step to prepare is to use the CDC’s Interim Guidance for Healthcare Professionals to make a written plan specific to your practice to respond to a potential case. The plan must include notifying the local health department, the CDC liaison for testing, and tracking down patient contacts.

“It’s not good enough to just download CDC’s guidance; use it to make your own local plan and know what to do 24/7,” said Daniel Lucey, MD, an infectious disease expert at Georgetown University Medical Center, Washington, D.C.

“Know who is on call at the health department on weekends and nights,” he said. Know where the patient is going to be isolated; figure out what to do if there’s more than one, and tests come back positive. Have masks on hand, and rehearse the response. “Make a coronavirus team, and absolutely have the nurses involved,” as well as other providers who may come into contact with a case, he added.

Fatality rates

The focus right now is China. The outbreak has spread beyond Wuhan to other parts of the country, and there’s evidence of fourth-generation spread.

SARS: Lessons learned

In general, the world is much better equipped for coronavirus outbreaks than when SARS, in particular, emerged in 2003.

[email protected]

This article was updated with new case numbers on 1/26/20.

A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).

ArminStautBerlin/Thinkstock

Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.

“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.

Of the 82% of patients who reported using a THC-containing e-cigarette or vaping product, 33% reported only THC-containing product use. In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.

Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.

The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.

The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.

Nicotine-only vaping products

In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.

A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.

In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).

Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.

The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.

In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.

The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.

SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.

A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).

ArminStautBerlin/Thinkstock

Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.

“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.

Of the 82% of patients who reported using a THC-containing e-cigarette or vaping product, 33% reported only THC-containing product use. In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.

Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.

The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.

The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.

Nicotine-only vaping products

In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.

A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.

In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).

Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.

The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.

In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.

The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.

SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.

A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).

ArminStautBerlin/Thinkstock

Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.

“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.

Of the 82% of patients who reported using a THC-containing e-cigarette or vaping product, 33% reported only THC-containing product use. In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.

Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.

The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.

The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.

Nicotine-only vaping products

In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.

A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.

In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).

Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.

The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.

In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.

The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.

SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.