MDedge Emergency Medicine

Survivors of out-of-hospital cardiac arrest (OHCA) without ST-segment elevation who were transported to the nearest hospital emergency department had outcomes similar to those of patients transported to specialist cardiac arrest centers, in the ARREST trial.

Both groups had the same 30-day survival, the primary outcome, as well as 3-month survival and neurologic outcomes.

“The take-home message is that this trial does not support transporting cardiac arrest patients direct to a cardiac arrest center in London; they would fare better going to their nearest emergency department,” senior author Simon R. Redwood, MD, principal investigator of ARREST, from Guy’s and St. Thomas’ NHS Trust Hospitals and King’s College, London, said during a press briefing. “These results may allow better resource allocation elsewhere.”

Importantly, this study excluded patients who clearly had myocardial infarction (MI), he stressed. Cardiac arrest can result from cardiac causes or from other events, including trauma, overdose, drowning, or electrocution, he noted.

On the other hand, patients with MI “will benefit from going straight to a heart attack center and having an attempt at reopening the artery,” he emphasized.

Tiffany Patterson, PhD, clinical lead of ARREST, with the same affiliations as Dr. Redwood, presented the trial findings at the annual congress of the European Society of Cardiology in Amsterdam, on Aug. 27. The study was simultaneously published online in The Lancet.

Observational studies of registry data suggest that postarrest care for patients resuscitated after cardiac arrest, without ST-segment elevation, may be best delivered in a specialized center, she noted.

The International Liaison Committee on Resuscitation called for a randomized clinical trial of patients resuscitated after cardiac arrest without ST-segment elevation to clarify this.

In the ARREST trial, among 800 patients with return of spontaneous circulation following OHCA without ST-segment elevation who were randomly assigned to be transported to specialized centers or an emergency department, there was no survival benefit, she summarized.

ARREST was “not simply a negative trial, but a new evidence-based starting point,” according to the trial discussant Lia Crotti, MD, PhD, IRCCS Istituto Auxologico Italiano and University Milano-Bicocca, Italy. 

She drew attention to two findings: First, among the 862 patients who were enrolled, whom paramedics judged as being without an obvious noncardiac cause of the cardiac arrest, “only 60% ended up having a cardiac cause for their cardiac arrest and only around one quarter of the total had coronary artery disease.”

The small number of patients who could have benefited from early access to a catheterization laboratory probably contributed to the negative result obtained in this trial, with the loss of statistical power, she said.

Second, London is a dense urban area with high-quality acute care hospitals, so the standard of care in the nearest emergency department may be not so different from that in cardiac arrest centers, she noted. Furthermore, four of the seven cardiac arrest centers have an emergency department, and some of the standard care patients may have been transported there.

“If the clinical trial would be extended to the entire country, including rural areas, maybe the result would be different,” she said.

The study authors acknowledge that the main limitation of this study was that “it was done across London with a dense population in a small geographic area,” and “the London Ambulance Service has rapid response times and short transit times and delivers high quality prehospital care, which could limit generalizability.”

Asked during the press conference here why the results were so different from the registry study findings, Dr. Redwood said, “We’ve seen time and time again that registry data think they are telling us the answer. They’re actually not.”

The session cochairs, Rudolf de Boer, MD, PhD, of Erasmus University Medical Centre, Rotterdam, the Netherlands, and Faiez Zannad, MD, PhD, from University of Lorraine–Vandoeuvre-lès-Nancy, France, each congratulated the researchers on a well-done study.

Dr. de Boer wanted to know whether, for example, 100% of these resuscitated OHCA patients without ST-segment elevation  had a cardiac cause, “Would results differ? Or is this just real life?” he asked. Dr. Patterson replied that the paramedics excluded obvious noncardiac causes and the findings were based on current facilities.

“Does this trial provide a definitive answer?” Dr. de Boer asked. Dr. Patterson replied that for the moment, subgroup analysis did not identify any subgroup that might benefit from expedited transport to a cardiac arrest center.

Dr. Zannad wanted to know how informed consent was obtained. Dr. Patterson noted that they have an excellent ethical committee that allowed them to undertake this research in vulnerable patients. Written informed consent was obtained from the patient once the initial emergency had passed if they had regained capacity.
 

Rationale and trial findings

“It’s very well established that early bystander CPR [cardiopulmonary resuscitation], early defibrillation, and advanced in-hospital care improves survival,” Dr. Redwood noted. “Despite this, only 1 in 10 survive to leave the hospital.”

Therefore, “a cardiac arrest center has been proposed as a way of improving outcome.” These centers have a catheterization laboratory, open 24 hours a day, 7 days a week, advanced critical care including advanced ventilation, temperature management of the patient, hemodynamic support, and neuroprognostication and rehab “because often these patients will have brain injury.

“There’s quite overwhelming registry data to suggest that these cardiac arrest centers improve outcome,” he said, “but these are limited by bias.”

Between January 2018 and December 2022, London Ambulance paramedics randomly assigned 862 patients who were successfully resuscitated and without a confirmed MI to be transported the nearest hospital emergency department or the catheterization laboratory in a cardiac arrest center.

Data were available for 822 participants. They had a mean age of 63 years, and 68% were male.

The primary endpoint, 30-day mortality, occurred in 258 (63%) of 411 participants in the cardiac arrest center group and in 258 (63%) of 412 in the standard care group (unadjusted risk ratio for survival, 1.00; 95% confidence interval [CI], 0.90-1.11; P = 0.96).

Mortality at 3 months was similar in both groups: 64% in the standard care group and 65% in the cardiac arrest center group.

Neurologic outcomes at discharge and 3 months were similar in both groups.

Eight (2%) of 414 patients in the cardiac arrest center group and three (1%) of 413 in the standard care group had serious adverse events, none of which were deemed related to the trial intervention.

A cardiac cause of arrest was identified in roughly 60% of patients in each group, and of these, roughly 42% were coronary causes, 33% were arrhythmia, and 17% were cardiomyopathy.

The median time from cardiac arrest to hospital arrival was 84 minutes in the cardiac arrest center group and 77 minutes in the standard care group.
 

“Surprising and important RCT evidence”

In an accompanying editorial, Carolina Malta Hansen, MD, PhD, University of Copenhagen, and colleagues wrote that “this study provides randomized trial evidence that in urban settings such as London, there is no survival advantage of a strategy of transporting patients who have been resuscitated to centres with specialty expertise in care of cardiac arrest.
“This result is surprising and important, since this complex and critically ill population would be expected to benefit from centres with more expertise.”

However, “it would be a mistake to conclude that the trial results apply to regions where local hospitals provide a lower quality of care than those in this trial,” they cautioned.

“Where does this leave the medical community, researchers, and society in general?” they asked rhetorically. “Prioritising a minimum standard of care at local hospitals caring for this population is at least as important as ensuring high-quality care or advanced treatment at tertiary centres.

“This trial also calls for more focus on the basics, including efforts to increase bystander cardiopulmonary resuscitation and early defibrillation, aspects of care that are currently being assessed in two ongoing clinical trials (NCT04660526 and NCT03835403) and are most strongly associated with improved survival, when coupled with high-quality prehospital care with trained staff and short response times,” they concluded.

The study was fully funded by the British Heart Foundation. The authors reported that they have no relevant financial disclosures. The financial disclosures of the editorialists are listed with the editorial.

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

Survivors of out-of-hospital cardiac arrest (OHCA) without ST-segment elevation who were transported to the nearest hospital emergency department had outcomes similar to those of patients transported to specialist cardiac arrest centers, in the ARREST trial.

Both groups had the same 30-day survival, the primary outcome, as well as 3-month survival and neurologic outcomes.

“The take-home message is that this trial does not support transporting cardiac arrest patients direct to a cardiac arrest center in London; they would fare better going to their nearest emergency department,” senior author Simon R. Redwood, MD, principal investigator of ARREST, from Guy’s and St. Thomas’ NHS Trust Hospitals and King’s College, London, said during a press briefing. “These results may allow better resource allocation elsewhere.”

Importantly, this study excluded patients who clearly had myocardial infarction (MI), he stressed. Cardiac arrest can result from cardiac causes or from other events, including trauma, overdose, drowning, or electrocution, he noted.

On the other hand, patients with MI “will benefit from going straight to a heart attack center and having an attempt at reopening the artery,” he emphasized.

Tiffany Patterson, PhD, clinical lead of ARREST, with the same affiliations as Dr. Redwood, presented the trial findings at the annual congress of the European Society of Cardiology in Amsterdam, on Aug. 27. The study was simultaneously published online in The Lancet.

Observational studies of registry data suggest that postarrest care for patients resuscitated after cardiac arrest, without ST-segment elevation, may be best delivered in a specialized center, she noted.

The International Liaison Committee on Resuscitation called for a randomized clinical trial of patients resuscitated after cardiac arrest without ST-segment elevation to clarify this.

In the ARREST trial, among 800 patients with return of spontaneous circulation following OHCA without ST-segment elevation who were randomly assigned to be transported to specialized centers or an emergency department, there was no survival benefit, she summarized.

ARREST was “not simply a negative trial, but a new evidence-based starting point,” according to the trial discussant Lia Crotti, MD, PhD, IRCCS Istituto Auxologico Italiano and University Milano-Bicocca, Italy. 

She drew attention to two findings: First, among the 862 patients who were enrolled, whom paramedics judged as being without an obvious noncardiac cause of the cardiac arrest, “only 60% ended up having a cardiac cause for their cardiac arrest and only around one quarter of the total had coronary artery disease.”

The small number of patients who could have benefited from early access to a catheterization laboratory probably contributed to the negative result obtained in this trial, with the loss of statistical power, she said.

Second, London is a dense urban area with high-quality acute care hospitals, so the standard of care in the nearest emergency department may be not so different from that in cardiac arrest centers, she noted. Furthermore, four of the seven cardiac arrest centers have an emergency department, and some of the standard care patients may have been transported there.

“If the clinical trial would be extended to the entire country, including rural areas, maybe the result would be different,” she said.

The study authors acknowledge that the main limitation of this study was that “it was done across London with a dense population in a small geographic area,” and “the London Ambulance Service has rapid response times and short transit times and delivers high quality prehospital care, which could limit generalizability.”

Asked during the press conference here why the results were so different from the registry study findings, Dr. Redwood said, “We’ve seen time and time again that registry data think they are telling us the answer. They’re actually not.”

The session cochairs, Rudolf de Boer, MD, PhD, of Erasmus University Medical Centre, Rotterdam, the Netherlands, and Faiez Zannad, MD, PhD, from University of Lorraine–Vandoeuvre-lès-Nancy, France, each congratulated the researchers on a well-done study.

Dr. de Boer wanted to know whether, for example, 100% of these resuscitated OHCA patients without ST-segment elevation  had a cardiac cause, “Would results differ? Or is this just real life?” he asked. Dr. Patterson replied that the paramedics excluded obvious noncardiac causes and the findings were based on current facilities.

“Does this trial provide a definitive answer?” Dr. de Boer asked. Dr. Patterson replied that for the moment, subgroup analysis did not identify any subgroup that might benefit from expedited transport to a cardiac arrest center.

Dr. Zannad wanted to know how informed consent was obtained. Dr. Patterson noted that they have an excellent ethical committee that allowed them to undertake this research in vulnerable patients. Written informed consent was obtained from the patient once the initial emergency had passed if they had regained capacity.
 

Rationale and trial findings

“It’s very well established that early bystander CPR [cardiopulmonary resuscitation], early defibrillation, and advanced in-hospital care improves survival,” Dr. Redwood noted. “Despite this, only 1 in 10 survive to leave the hospital.”

Therefore, “a cardiac arrest center has been proposed as a way of improving outcome.” These centers have a catheterization laboratory, open 24 hours a day, 7 days a week, advanced critical care including advanced ventilation, temperature management of the patient, hemodynamic support, and neuroprognostication and rehab “because often these patients will have brain injury.

“There’s quite overwhelming registry data to suggest that these cardiac arrest centers improve outcome,” he said, “but these are limited by bias.”

Between January 2018 and December 2022, London Ambulance paramedics randomly assigned 862 patients who were successfully resuscitated and without a confirmed MI to be transported the nearest hospital emergency department or the catheterization laboratory in a cardiac arrest center.

Data were available for 822 participants. They had a mean age of 63 years, and 68% were male.

The primary endpoint, 30-day mortality, occurred in 258 (63%) of 411 participants in the cardiac arrest center group and in 258 (63%) of 412 in the standard care group (unadjusted risk ratio for survival, 1.00; 95% confidence interval [CI], 0.90-1.11; P = 0.96).

Mortality at 3 months was similar in both groups: 64% in the standard care group and 65% in the cardiac arrest center group.

Neurologic outcomes at discharge and 3 months were similar in both groups.

Eight (2%) of 414 patients in the cardiac arrest center group and three (1%) of 413 in the standard care group had serious adverse events, none of which were deemed related to the trial intervention.

A cardiac cause of arrest was identified in roughly 60% of patients in each group, and of these, roughly 42% were coronary causes, 33% were arrhythmia, and 17% were cardiomyopathy.

The median time from cardiac arrest to hospital arrival was 84 minutes in the cardiac arrest center group and 77 minutes in the standard care group.
 

“Surprising and important RCT evidence”

In an accompanying editorial, Carolina Malta Hansen, MD, PhD, University of Copenhagen, and colleagues wrote that “this study provides randomized trial evidence that in urban settings such as London, there is no survival advantage of a strategy of transporting patients who have been resuscitated to centres with specialty expertise in care of cardiac arrest.
“This result is surprising and important, since this complex and critically ill population would be expected to benefit from centres with more expertise.”

However, “it would be a mistake to conclude that the trial results apply to regions where local hospitals provide a lower quality of care than those in this trial,” they cautioned.

“Where does this leave the medical community, researchers, and society in general?” they asked rhetorically. “Prioritising a minimum standard of care at local hospitals caring for this population is at least as important as ensuring high-quality care or advanced treatment at tertiary centres.

“This trial also calls for more focus on the basics, including efforts to increase bystander cardiopulmonary resuscitation and early defibrillation, aspects of care that are currently being assessed in two ongoing clinical trials (NCT04660526 and NCT03835403) and are most strongly associated with improved survival, when coupled with high-quality prehospital care with trained staff and short response times,” they concluded.

The study was fully funded by the British Heart Foundation. The authors reported that they have no relevant financial disclosures. The financial disclosures of the editorialists are listed with the editorial.

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

Survivors of out-of-hospital cardiac arrest (OHCA) without ST-segment elevation who were transported to the nearest hospital emergency department had outcomes similar to those of patients transported to specialist cardiac arrest centers, in the ARREST trial.

Both groups had the same 30-day survival, the primary outcome, as well as 3-month survival and neurologic outcomes.

“The take-home message is that this trial does not support transporting cardiac arrest patients direct to a cardiac arrest center in London; they would fare better going to their nearest emergency department,” senior author Simon R. Redwood, MD, principal investigator of ARREST, from Guy’s and St. Thomas’ NHS Trust Hospitals and King’s College, London, said during a press briefing. “These results may allow better resource allocation elsewhere.”

Importantly, this study excluded patients who clearly had myocardial infarction (MI), he stressed. Cardiac arrest can result from cardiac causes or from other events, including trauma, overdose, drowning, or electrocution, he noted.

On the other hand, patients with MI “will benefit from going straight to a heart attack center and having an attempt at reopening the artery,” he emphasized.

Tiffany Patterson, PhD, clinical lead of ARREST, with the same affiliations as Dr. Redwood, presented the trial findings at the annual congress of the European Society of Cardiology in Amsterdam, on Aug. 27. The study was simultaneously published online in The Lancet.

Observational studies of registry data suggest that postarrest care for patients resuscitated after cardiac arrest, without ST-segment elevation, may be best delivered in a specialized center, she noted.

The International Liaison Committee on Resuscitation called for a randomized clinical trial of patients resuscitated after cardiac arrest without ST-segment elevation to clarify this.

In the ARREST trial, among 800 patients with return of spontaneous circulation following OHCA without ST-segment elevation who were randomly assigned to be transported to specialized centers or an emergency department, there was no survival benefit, she summarized.

ARREST was “not simply a negative trial, but a new evidence-based starting point,” according to the trial discussant Lia Crotti, MD, PhD, IRCCS Istituto Auxologico Italiano and University Milano-Bicocca, Italy. 

She drew attention to two findings: First, among the 862 patients who were enrolled, whom paramedics judged as being without an obvious noncardiac cause of the cardiac arrest, “only 60% ended up having a cardiac cause for their cardiac arrest and only around one quarter of the total had coronary artery disease.”

The small number of patients who could have benefited from early access to a catheterization laboratory probably contributed to the negative result obtained in this trial, with the loss of statistical power, she said.

Second, London is a dense urban area with high-quality acute care hospitals, so the standard of care in the nearest emergency department may be not so different from that in cardiac arrest centers, she noted. Furthermore, four of the seven cardiac arrest centers have an emergency department, and some of the standard care patients may have been transported there.

“If the clinical trial would be extended to the entire country, including rural areas, maybe the result would be different,” she said.

The study authors acknowledge that the main limitation of this study was that “it was done across London with a dense population in a small geographic area,” and “the London Ambulance Service has rapid response times and short transit times and delivers high quality prehospital care, which could limit generalizability.”

Asked during the press conference here why the results were so different from the registry study findings, Dr. Redwood said, “We’ve seen time and time again that registry data think they are telling us the answer. They’re actually not.”

The session cochairs, Rudolf de Boer, MD, PhD, of Erasmus University Medical Centre, Rotterdam, the Netherlands, and Faiez Zannad, MD, PhD, from University of Lorraine–Vandoeuvre-lès-Nancy, France, each congratulated the researchers on a well-done study.

Dr. de Boer wanted to know whether, for example, 100% of these resuscitated OHCA patients without ST-segment elevation  had a cardiac cause, “Would results differ? Or is this just real life?” he asked. Dr. Patterson replied that the paramedics excluded obvious noncardiac causes and the findings were based on current facilities.

“Does this trial provide a definitive answer?” Dr. de Boer asked. Dr. Patterson replied that for the moment, subgroup analysis did not identify any subgroup that might benefit from expedited transport to a cardiac arrest center.

Dr. Zannad wanted to know how informed consent was obtained. Dr. Patterson noted that they have an excellent ethical committee that allowed them to undertake this research in vulnerable patients. Written informed consent was obtained from the patient once the initial emergency had passed if they had regained capacity.
 

Rationale and trial findings

“It’s very well established that early bystander CPR [cardiopulmonary resuscitation], early defibrillation, and advanced in-hospital care improves survival,” Dr. Redwood noted. “Despite this, only 1 in 10 survive to leave the hospital.”

Therefore, “a cardiac arrest center has been proposed as a way of improving outcome.” These centers have a catheterization laboratory, open 24 hours a day, 7 days a week, advanced critical care including advanced ventilation, temperature management of the patient, hemodynamic support, and neuroprognostication and rehab “because often these patients will have brain injury.

“There’s quite overwhelming registry data to suggest that these cardiac arrest centers improve outcome,” he said, “but these are limited by bias.”

Between January 2018 and December 2022, London Ambulance paramedics randomly assigned 862 patients who were successfully resuscitated and without a confirmed MI to be transported the nearest hospital emergency department or the catheterization laboratory in a cardiac arrest center.

Data were available for 822 participants. They had a mean age of 63 years, and 68% were male.

The primary endpoint, 30-day mortality, occurred in 258 (63%) of 411 participants in the cardiac arrest center group and in 258 (63%) of 412 in the standard care group (unadjusted risk ratio for survival, 1.00; 95% confidence interval [CI], 0.90-1.11; P = 0.96).

Mortality at 3 months was similar in both groups: 64% in the standard care group and 65% in the cardiac arrest center group.

Neurologic outcomes at discharge and 3 months were similar in both groups.

Eight (2%) of 414 patients in the cardiac arrest center group and three (1%) of 413 in the standard care group had serious adverse events, none of which were deemed related to the trial intervention.

A cardiac cause of arrest was identified in roughly 60% of patients in each group, and of these, roughly 42% were coronary causes, 33% were arrhythmia, and 17% were cardiomyopathy.

The median time from cardiac arrest to hospital arrival was 84 minutes in the cardiac arrest center group and 77 minutes in the standard care group.
 

“Surprising and important RCT evidence”

In an accompanying editorial, Carolina Malta Hansen, MD, PhD, University of Copenhagen, and colleagues wrote that “this study provides randomized trial evidence that in urban settings such as London, there is no survival advantage of a strategy of transporting patients who have been resuscitated to centres with specialty expertise in care of cardiac arrest.
“This result is surprising and important, since this complex and critically ill population would be expected to benefit from centres with more expertise.”

However, “it would be a mistake to conclude that the trial results apply to regions where local hospitals provide a lower quality of care than those in this trial,” they cautioned.

“Where does this leave the medical community, researchers, and society in general?” they asked rhetorically. “Prioritising a minimum standard of care at local hospitals caring for this population is at least as important as ensuring high-quality care or advanced treatment at tertiary centres.

“This trial also calls for more focus on the basics, including efforts to increase bystander cardiopulmonary resuscitation and early defibrillation, aspects of care that are currently being assessed in two ongoing clinical trials (NCT04660526 and NCT03835403) and are most strongly associated with improved survival, when coupled with high-quality prehospital care with trained staff and short response times,” they concluded.

The study was fully funded by the British Heart Foundation. The authors reported that they have no relevant financial disclosures. The financial disclosures of the editorialists are listed with the editorial.

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

Patients with acute myocardial infarction (MI) and shock are often put on extracorporeal membrane oxygenation (ECMO) support before heading to the catheterization laboratory. But the practice, done routinely, doesn’t have much backing from randomized trials. Now it’s being challenged by one of the largest such studies to explore the issue.

In a new multicenter trial, there was no survival advantage at 30 days to early use of ECMO in such patients with cardiogenic shock, compared with a usual-care medical approach. ECMO-managed patients, moreover, had sharply increased risks for moderate and severe bleeding and vascular complications.
 

A challenge to common practice

The results undercut guidelines that promote mechanical circulatory support in MI-related cardiogenic shock primarily based on observational data, and they argue against what’s become common practice, said Holger Thiele, MD, Heart Center Leipzig, University of Leipzig, Germany.

Such use of ECMO could well offer some type of advantage in MI-related shock, but the data so far don’t show it, Dr. Thiele said at a press conference on the new study, called ECLS-SHOCK, at the annual congress of the European Society of Cardiology in Amsterdam. He formally presented the trial at the meeting and is lead author on its simultaneous publication in The New England Journal of Medicine.

Almost half of the trial’s patients died, whether or not they had been put on ECMO. All-cause mortality at 30 days, the primary endpoint, was about the same, at 47.8% and 49.0% for the ECMO and usual-care groups, respectively.

Meanwhile, Dr. Thiele reported, risks for moderate or severe bleeding more than doubled and serious peripheral vascular complications almost tripled with addition of ECMO support.

The findings, he noted, are consistent with a new meta-analysis of trials testing ECMO in MI-related shock that also showed increases in bleeding with survival gains using the devices. Dr. Thiele is senior author on that report, published in The Lancet to coincide with his ECLS-SHOCK presentation.
 

Would any subgroups benefit?

Importantly, he said in an interview, ECMO’s failure to improve 30-day survival in the trial probably applies across the spectrum of patients with MI-related shock. Subgroup analyses in both ECLS-SHOCK and the meta-analysis didn’t identify any groups that benefit, Dr. Thiele observed.

For example, there were no significant differences for the primary outcome by age, sex, whether the MI was ST-segment elevation MI or non–ST-segment elevation MI or anterior or nonanterior, or whether the patient had diabetes.

If there is a subgroup in MI-related shock that is likely to benefit from the intervention with lower mortality, he said, “it’s less than 1%, if you ask me.”

An accompanying editorial essentially agreed, arguing that ECLS-SHOCK contests the intervention’s broad application in MI-related shock without shedding light on any selective benefits.

“Will the results of the ECLS-SHOCK trial change current clinical practice? If the goal of [ECMO] is to improve 30-day mortality, these data should steer interventional and critical care cardiologists away from its early routine implementation for all or even most patients with myocardial infarction and cardiogenic shock,” the editorialists say.

“There will be some patients in this population for whom [ECMO] is necessary and lifesaving, but the results of the ECLS-SHOCK trial do not tell us which ones,” write Jane A. Leopold, MD, Brigham and Women’s Hospital, Boston, and Darren B. Taichman, MD, PhD, Penn Presbyterian Medical Center, Philadelphia.

“For now, the best course may be to reserve the early initiation of [ECMO] for those patients with infarct-related cardiogenic shock in whom the likely benefits more clearly outweigh the potential harms. We need further studies to tell us who they are,” write Dr. Leopold and Dr. Taichman, who are deputy editors with The New England Journal of Medicine.

ECLS-SHOCK randomly assigned 420 patients with acute MI complicated by shock and slated for coronary revascularization to receive standard care with or without early ECMO at 44 centers in Germany and Slovenia. Their median age was 63 years, and about 81% were men.

The relative risk for death from any cause, ECMO vs. usual care, was flatly nonsignificant at 0.98 (95% confidence interval, 0.80-1.19; P = .81).

ECMO came at the cost of significantly more cases of the primary safety endpoint, moderate or severe bleeding by Bleeding Academic Research Consortium criteria. That endpoint was met by 23.4% of ECMO patients and 9.6% of the control group, for an RR of 2.44 (95% CI, 1.50-3.95).

Rates of stroke or systemic embolization were nonsignificantly different at 3.8% and 2.9%, respectively (RR, 1.33; 95% CI, 0.47-3.76).

Speaking with this news organization, Sripal Bangalore, MD, MHA, pointed out that only 5.8% of the ECMO group but about 32% of those managed with usual care received some form of left ventricular (LV) unloading therapy.

Such measures can include atrial septostomy or the addition of an intra-aortic balloon pump or percutaneous LV-assist pump.

Given that ECMO increases afterload, “which is physiologically detrimental in patients with an ongoing MI, one is left to wonder if the results would have been different with greater use of LV unloading,” said Dr. Bangalore, of NYU Langone Health, New York, who isn’t associated with ECLS-SHOCK.

Also, he pointed out, about 78% of the trial’s patients had experienced some degree of cardiopulmonary resuscitation despite exclusion of anyone who had undergone it for more than 45 minutes. That may make the study more generalizable but also harder to show a benefit from ECMO. “The overall prognosis of that subset of patients despite heroic efforts is bleak at best.”

Dr. Thiele had no disclosures; statements for the other authors can be found at nejm.org. Dr. Bangalore has previously disclosed financial relationships with Abbott Vascular, Amgen, Biotronik, Inari, Pfizer, Reata, and Truvic. Dr. Leopold reports grants from Astellas and personal fees from United Therapeutics, Abbott Vascular, and North America Thrombosis Forum. Dr. Leopold and Dr. Taichman both report employment by The New England Journal of Medicine.

A version of this article appeared on Medscape.com.

Patients with acute myocardial infarction (MI) and shock are often put on extracorporeal membrane oxygenation (ECMO) support before heading to the catheterization laboratory. But the practice, done routinely, doesn’t have much backing from randomized trials. Now it’s being challenged by one of the largest such studies to explore the issue.

In a new multicenter trial, there was no survival advantage at 30 days to early use of ECMO in such patients with cardiogenic shock, compared with a usual-care medical approach. ECMO-managed patients, moreover, had sharply increased risks for moderate and severe bleeding and vascular complications.
 

A challenge to common practice

The results undercut guidelines that promote mechanical circulatory support in MI-related cardiogenic shock primarily based on observational data, and they argue against what’s become common practice, said Holger Thiele, MD, Heart Center Leipzig, University of Leipzig, Germany.

Such use of ECMO could well offer some type of advantage in MI-related shock, but the data so far don’t show it, Dr. Thiele said at a press conference on the new study, called ECLS-SHOCK, at the annual congress of the European Society of Cardiology in Amsterdam. He formally presented the trial at the meeting and is lead author on its simultaneous publication in The New England Journal of Medicine.

Almost half of the trial’s patients died, whether or not they had been put on ECMO. All-cause mortality at 30 days, the primary endpoint, was about the same, at 47.8% and 49.0% for the ECMO and usual-care groups, respectively.

Meanwhile, Dr. Thiele reported, risks for moderate or severe bleeding more than doubled and serious peripheral vascular complications almost tripled with addition of ECMO support.

The findings, he noted, are consistent with a new meta-analysis of trials testing ECMO in MI-related shock that also showed increases in bleeding with survival gains using the devices. Dr. Thiele is senior author on that report, published in The Lancet to coincide with his ECLS-SHOCK presentation.
 

Would any subgroups benefit?

Importantly, he said in an interview, ECMO’s failure to improve 30-day survival in the trial probably applies across the spectrum of patients with MI-related shock. Subgroup analyses in both ECLS-SHOCK and the meta-analysis didn’t identify any groups that benefit, Dr. Thiele observed.

For example, there were no significant differences for the primary outcome by age, sex, whether the MI was ST-segment elevation MI or non–ST-segment elevation MI or anterior or nonanterior, or whether the patient had diabetes.

If there is a subgroup in MI-related shock that is likely to benefit from the intervention with lower mortality, he said, “it’s less than 1%, if you ask me.”

An accompanying editorial essentially agreed, arguing that ECLS-SHOCK contests the intervention’s broad application in MI-related shock without shedding light on any selective benefits.

“Will the results of the ECLS-SHOCK trial change current clinical practice? If the goal of [ECMO] is to improve 30-day mortality, these data should steer interventional and critical care cardiologists away from its early routine implementation for all or even most patients with myocardial infarction and cardiogenic shock,” the editorialists say.

“There will be some patients in this population for whom [ECMO] is necessary and lifesaving, but the results of the ECLS-SHOCK trial do not tell us which ones,” write Jane A. Leopold, MD, Brigham and Women’s Hospital, Boston, and Darren B. Taichman, MD, PhD, Penn Presbyterian Medical Center, Philadelphia.

“For now, the best course may be to reserve the early initiation of [ECMO] for those patients with infarct-related cardiogenic shock in whom the likely benefits more clearly outweigh the potential harms. We need further studies to tell us who they are,” write Dr. Leopold and Dr. Taichman, who are deputy editors with The New England Journal of Medicine.

ECLS-SHOCK randomly assigned 420 patients with acute MI complicated by shock and slated for coronary revascularization to receive standard care with or without early ECMO at 44 centers in Germany and Slovenia. Their median age was 63 years, and about 81% were men.

The relative risk for death from any cause, ECMO vs. usual care, was flatly nonsignificant at 0.98 (95% confidence interval, 0.80-1.19; P = .81).

ECMO came at the cost of significantly more cases of the primary safety endpoint, moderate or severe bleeding by Bleeding Academic Research Consortium criteria. That endpoint was met by 23.4% of ECMO patients and 9.6% of the control group, for an RR of 2.44 (95% CI, 1.50-3.95).

Rates of stroke or systemic embolization were nonsignificantly different at 3.8% and 2.9%, respectively (RR, 1.33; 95% CI, 0.47-3.76).

Speaking with this news organization, Sripal Bangalore, MD, MHA, pointed out that only 5.8% of the ECMO group but about 32% of those managed with usual care received some form of left ventricular (LV) unloading therapy.

Such measures can include atrial septostomy or the addition of an intra-aortic balloon pump or percutaneous LV-assist pump.

Given that ECMO increases afterload, “which is physiologically detrimental in patients with an ongoing MI, one is left to wonder if the results would have been different with greater use of LV unloading,” said Dr. Bangalore, of NYU Langone Health, New York, who isn’t associated with ECLS-SHOCK.

Also, he pointed out, about 78% of the trial’s patients had experienced some degree of cardiopulmonary resuscitation despite exclusion of anyone who had undergone it for more than 45 minutes. That may make the study more generalizable but also harder to show a benefit from ECMO. “The overall prognosis of that subset of patients despite heroic efforts is bleak at best.”

Dr. Thiele had no disclosures; statements for the other authors can be found at nejm.org. Dr. Bangalore has previously disclosed financial relationships with Abbott Vascular, Amgen, Biotronik, Inari, Pfizer, Reata, and Truvic. Dr. Leopold reports grants from Astellas and personal fees from United Therapeutics, Abbott Vascular, and North America Thrombosis Forum. Dr. Leopold and Dr. Taichman both report employment by The New England Journal of Medicine.

A version of this article appeared on Medscape.com.

Patients with acute myocardial infarction (MI) and shock are often put on extracorporeal membrane oxygenation (ECMO) support before heading to the catheterization laboratory. But the practice, done routinely, doesn’t have much backing from randomized trials. Now it’s being challenged by one of the largest such studies to explore the issue.

In a new multicenter trial, there was no survival advantage at 30 days to early use of ECMO in such patients with cardiogenic shock, compared with a usual-care medical approach. ECMO-managed patients, moreover, had sharply increased risks for moderate and severe bleeding and vascular complications.
 

A challenge to common practice

The results undercut guidelines that promote mechanical circulatory support in MI-related cardiogenic shock primarily based on observational data, and they argue against what’s become common practice, said Holger Thiele, MD, Heart Center Leipzig, University of Leipzig, Germany.

Such use of ECMO could well offer some type of advantage in MI-related shock, but the data so far don’t show it, Dr. Thiele said at a press conference on the new study, called ECLS-SHOCK, at the annual congress of the European Society of Cardiology in Amsterdam. He formally presented the trial at the meeting and is lead author on its simultaneous publication in The New England Journal of Medicine.

Almost half of the trial’s patients died, whether or not they had been put on ECMO. All-cause mortality at 30 days, the primary endpoint, was about the same, at 47.8% and 49.0% for the ECMO and usual-care groups, respectively.

Meanwhile, Dr. Thiele reported, risks for moderate or severe bleeding more than doubled and serious peripheral vascular complications almost tripled with addition of ECMO support.

The findings, he noted, are consistent with a new meta-analysis of trials testing ECMO in MI-related shock that also showed increases in bleeding with survival gains using the devices. Dr. Thiele is senior author on that report, published in The Lancet to coincide with his ECLS-SHOCK presentation.
 

Would any subgroups benefit?

Importantly, he said in an interview, ECMO’s failure to improve 30-day survival in the trial probably applies across the spectrum of patients with MI-related shock. Subgroup analyses in both ECLS-SHOCK and the meta-analysis didn’t identify any groups that benefit, Dr. Thiele observed.

For example, there were no significant differences for the primary outcome by age, sex, whether the MI was ST-segment elevation MI or non–ST-segment elevation MI or anterior or nonanterior, or whether the patient had diabetes.

If there is a subgroup in MI-related shock that is likely to benefit from the intervention with lower mortality, he said, “it’s less than 1%, if you ask me.”

An accompanying editorial essentially agreed, arguing that ECLS-SHOCK contests the intervention’s broad application in MI-related shock without shedding light on any selective benefits.

“Will the results of the ECLS-SHOCK trial change current clinical practice? If the goal of [ECMO] is to improve 30-day mortality, these data should steer interventional and critical care cardiologists away from its early routine implementation for all or even most patients with myocardial infarction and cardiogenic shock,” the editorialists say.

“There will be some patients in this population for whom [ECMO] is necessary and lifesaving, but the results of the ECLS-SHOCK trial do not tell us which ones,” write Jane A. Leopold, MD, Brigham and Women’s Hospital, Boston, and Darren B. Taichman, MD, PhD, Penn Presbyterian Medical Center, Philadelphia.

“For now, the best course may be to reserve the early initiation of [ECMO] for those patients with infarct-related cardiogenic shock in whom the likely benefits more clearly outweigh the potential harms. We need further studies to tell us who they are,” write Dr. Leopold and Dr. Taichman, who are deputy editors with The New England Journal of Medicine.

ECLS-SHOCK randomly assigned 420 patients with acute MI complicated by shock and slated for coronary revascularization to receive standard care with or without early ECMO at 44 centers in Germany and Slovenia. Their median age was 63 years, and about 81% were men.

The relative risk for death from any cause, ECMO vs. usual care, was flatly nonsignificant at 0.98 (95% confidence interval, 0.80-1.19; P = .81).

ECMO came at the cost of significantly more cases of the primary safety endpoint, moderate or severe bleeding by Bleeding Academic Research Consortium criteria. That endpoint was met by 23.4% of ECMO patients and 9.6% of the control group, for an RR of 2.44 (95% CI, 1.50-3.95).

Rates of stroke or systemic embolization were nonsignificantly different at 3.8% and 2.9%, respectively (RR, 1.33; 95% CI, 0.47-3.76).

Speaking with this news organization, Sripal Bangalore, MD, MHA, pointed out that only 5.8% of the ECMO group but about 32% of those managed with usual care received some form of left ventricular (LV) unloading therapy.

Such measures can include atrial septostomy or the addition of an intra-aortic balloon pump or percutaneous LV-assist pump.

Given that ECMO increases afterload, “which is physiologically detrimental in patients with an ongoing MI, one is left to wonder if the results would have been different with greater use of LV unloading,” said Dr. Bangalore, of NYU Langone Health, New York, who isn’t associated with ECLS-SHOCK.

Also, he pointed out, about 78% of the trial’s patients had experienced some degree of cardiopulmonary resuscitation despite exclusion of anyone who had undergone it for more than 45 minutes. That may make the study more generalizable but also harder to show a benefit from ECMO. “The overall prognosis of that subset of patients despite heroic efforts is bleak at best.”

Dr. Thiele had no disclosures; statements for the other authors can be found at nejm.org. Dr. Bangalore has previously disclosed financial relationships with Abbott Vascular, Amgen, Biotronik, Inari, Pfizer, Reata, and Truvic. Dr. Leopold reports grants from Astellas and personal fees from United Therapeutics, Abbott Vascular, and North America Thrombosis Forum. Dr. Leopold and Dr. Taichman both report employment by The New England Journal of Medicine.

A version of this article appeared on Medscape.com.

People may get more protection against COVID-19 if they get their vaccinations and boosters in the same arm, a new study says.

Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.

Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.

The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.

“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.

William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.

There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.

The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.

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

People may get more protection against COVID-19 if they get their vaccinations and boosters in the same arm, a new study says.

Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.

Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.

The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.

“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.

William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.

There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.

The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.

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

People may get more protection against COVID-19 if they get their vaccinations and boosters in the same arm, a new study says.

Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.

Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.

The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.

“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.

William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.

There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.

The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.

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

Any parent might naturally assume that their newborn is at little risk from respiratory syncytial virus (RSV), which in healthy infants has been thought to cause mild symptoms similar to having a cold. But a new study challenges the assumption that only infirm children are at risk for the worst outcomes from RSV, finding that more than 80% of infants hospitalized with the infection were otherwise healthy before they developed the lung disease.

The researchers, who published their study in JAMA Network Open, said the results reinforce the importance of a new preventive injection that can lower the risk for severe RSV infection in babies.

“RSV is the number one cause of hospitalizations in young infants,” said Natasha Halasa, MD, MPH, an infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn., and the lead author of the new study. But “the vast majority of kids didn’t have underlying medical conditions” when they got sick.

Every infant in the study was in an intensive care unit for at least 24 hours, Dr. Halasa said, and most babies gave no prior indication that RSV would affect them so profoundly.

“Two to three of every 100 babies in the United States will be hospitalized for RSV in their first year of life,” added study author Angela Campbell, MD, MPH, of the Coronavirus and Other Respiratory Viruses Division of the Centers for Disease Control and Prevention in Atlanta. 

Until recently, only one treatment was available for children up to age 2 at high risk for RSV, the monoclonal antibody palivizumab (Synagis). Palivizumab is reserved for children who are born prematurely, are immunocompromised, or have chronic heart or lung disease. The injection is given monthly during the 5-month peak of RSV season, from fall to spring.

In July, the Food and Drug Administration approved, and the CDC has since recommended, a new monoclonal antibody called nirsevimab (Beyfortus) to prevent the worst effects of RSV. Nirsevimab is intended for all newborns under age 8 months who were born during the RSV season, or babies who will be entering that season before reaching 8 months. The injection is given only once and can act for 150 days. The FDA and CDC actions came following a clinical trial showing that nirsevimab lowers the risk for hospitalization from RSV among infants by more than 75%.

“We’re very excited that this product exists now,” Dr. Campbell said.
 

Chart reviews during the ‘tripledemic’

In fall 2022 the United States experienced a “tripledemic” of elevated hospitalizations for COVID-19, influenza, and RSV. For the new study, Dr. Halasa and her colleagues examined the medical records of 600 infants (under age 1; average age, 2.6 months) admitted to U.S. ICUs for lower respiratory tract infections caused by RSV from October to December 2022, during the height of the tripledemic. 

More than 60% of admissions, 361, were boys; 44% were White, 23% were Hispanic, 16% were Black, 10% were unknown race, 5% were multiple race, and 2% were Asian. 

Of the 600 infants, 572 (95.3%) required oxygen at the hospital and 487 (81.2%) had no underlying medical conditions linked to higher risk from RSV. The other infants had at least one ailment, such as a cardiac or lung condition, that could result in more severe RSV outcomes.

The 169 preemies in the study population were more likely to be intubated in the ICU than were those born at term. But 90 of the 143 total recorded intubations happened among full-term infants. Two children in the study group died.

Christopher Horvat, MD, MHA, who works in the pediatric ICU at the University of Pittsburgh Medical Center, called the new study “important,” adding that it shows “the RSV burden is substantial for children who are otherwise healthy.” Dr. Horvat, who was not involved in the work, said the new data highlight the value of preventive measures to prevent any repeat of the tripledemic.

On the same day the new study was published, the American Academy of Pediatrics (AAP) released a statement calling for widespread access to nirsevimab.

“The American Academy of Pediatrics recommends that all infants – and especially those at high risk – receive the new preventive antibody, nirsevimab, to protect against severe disease caused by respiratory syncytial virus (RSV), which is common, highly contagious, and sometimes deadly,” the organization said in a statement.

The AAP called for the CDC and the Centers for Medicaid & Medicare Services to work together to ensure that any parent in America can obtain nirsevimab for their children if needed. Anyone who cannot access nirsevimab this year, the AAP said, should rely on the older treatment palivizumab instead.

The sources in this story reported no relevant financial relationships.
 

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

Any parent might naturally assume that their newborn is at little risk from respiratory syncytial virus (RSV), which in healthy infants has been thought to cause mild symptoms similar to having a cold. But a new study challenges the assumption that only infirm children are at risk for the worst outcomes from RSV, finding that more than 80% of infants hospitalized with the infection were otherwise healthy before they developed the lung disease.

The researchers, who published their study in JAMA Network Open, said the results reinforce the importance of a new preventive injection that can lower the risk for severe RSV infection in babies.

“RSV is the number one cause of hospitalizations in young infants,” said Natasha Halasa, MD, MPH, an infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn., and the lead author of the new study. But “the vast majority of kids didn’t have underlying medical conditions” when they got sick.

Every infant in the study was in an intensive care unit for at least 24 hours, Dr. Halasa said, and most babies gave no prior indication that RSV would affect them so profoundly.

“Two to three of every 100 babies in the United States will be hospitalized for RSV in their first year of life,” added study author Angela Campbell, MD, MPH, of the Coronavirus and Other Respiratory Viruses Division of the Centers for Disease Control and Prevention in Atlanta. 

Until recently, only one treatment was available for children up to age 2 at high risk for RSV, the monoclonal antibody palivizumab (Synagis). Palivizumab is reserved for children who are born prematurely, are immunocompromised, or have chronic heart or lung disease. The injection is given monthly during the 5-month peak of RSV season, from fall to spring.

In July, the Food and Drug Administration approved, and the CDC has since recommended, a new monoclonal antibody called nirsevimab (Beyfortus) to prevent the worst effects of RSV. Nirsevimab is intended for all newborns under age 8 months who were born during the RSV season, or babies who will be entering that season before reaching 8 months. The injection is given only once and can act for 150 days. The FDA and CDC actions came following a clinical trial showing that nirsevimab lowers the risk for hospitalization from RSV among infants by more than 75%.

“We’re very excited that this product exists now,” Dr. Campbell said.
 

Chart reviews during the ‘tripledemic’

In fall 2022 the United States experienced a “tripledemic” of elevated hospitalizations for COVID-19, influenza, and RSV. For the new study, Dr. Halasa and her colleagues examined the medical records of 600 infants (under age 1; average age, 2.6 months) admitted to U.S. ICUs for lower respiratory tract infections caused by RSV from October to December 2022, during the height of the tripledemic. 

More than 60% of admissions, 361, were boys; 44% were White, 23% were Hispanic, 16% were Black, 10% were unknown race, 5% were multiple race, and 2% were Asian. 

Of the 600 infants, 572 (95.3%) required oxygen at the hospital and 487 (81.2%) had no underlying medical conditions linked to higher risk from RSV. The other infants had at least one ailment, such as a cardiac or lung condition, that could result in more severe RSV outcomes.

The 169 preemies in the study population were more likely to be intubated in the ICU than were those born at term. But 90 of the 143 total recorded intubations happened among full-term infants. Two children in the study group died.

Christopher Horvat, MD, MHA, who works in the pediatric ICU at the University of Pittsburgh Medical Center, called the new study “important,” adding that it shows “the RSV burden is substantial for children who are otherwise healthy.” Dr. Horvat, who was not involved in the work, said the new data highlight the value of preventive measures to prevent any repeat of the tripledemic.

On the same day the new study was published, the American Academy of Pediatrics (AAP) released a statement calling for widespread access to nirsevimab.

“The American Academy of Pediatrics recommends that all infants – and especially those at high risk – receive the new preventive antibody, nirsevimab, to protect against severe disease caused by respiratory syncytial virus (RSV), which is common, highly contagious, and sometimes deadly,” the organization said in a statement.

The AAP called for the CDC and the Centers for Medicaid & Medicare Services to work together to ensure that any parent in America can obtain nirsevimab for their children if needed. Anyone who cannot access nirsevimab this year, the AAP said, should rely on the older treatment palivizumab instead.

The sources in this story reported no relevant financial relationships.
 

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

Any parent might naturally assume that their newborn is at little risk from respiratory syncytial virus (RSV), which in healthy infants has been thought to cause mild symptoms similar to having a cold. But a new study challenges the assumption that only infirm children are at risk for the worst outcomes from RSV, finding that more than 80% of infants hospitalized with the infection were otherwise healthy before they developed the lung disease.

The researchers, who published their study in JAMA Network Open, said the results reinforce the importance of a new preventive injection that can lower the risk for severe RSV infection in babies.

“RSV is the number one cause of hospitalizations in young infants,” said Natasha Halasa, MD, MPH, an infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn., and the lead author of the new study. But “the vast majority of kids didn’t have underlying medical conditions” when they got sick.

Every infant in the study was in an intensive care unit for at least 24 hours, Dr. Halasa said, and most babies gave no prior indication that RSV would affect them so profoundly.

“Two to three of every 100 babies in the United States will be hospitalized for RSV in their first year of life,” added study author Angela Campbell, MD, MPH, of the Coronavirus and Other Respiratory Viruses Division of the Centers for Disease Control and Prevention in Atlanta. 

Until recently, only one treatment was available for children up to age 2 at high risk for RSV, the monoclonal antibody palivizumab (Synagis). Palivizumab is reserved for children who are born prematurely, are immunocompromised, or have chronic heart or lung disease. The injection is given monthly during the 5-month peak of RSV season, from fall to spring.

In July, the Food and Drug Administration approved, and the CDC has since recommended, a new monoclonal antibody called nirsevimab (Beyfortus) to prevent the worst effects of RSV. Nirsevimab is intended for all newborns under age 8 months who were born during the RSV season, or babies who will be entering that season before reaching 8 months. The injection is given only once and can act for 150 days. The FDA and CDC actions came following a clinical trial showing that nirsevimab lowers the risk for hospitalization from RSV among infants by more than 75%.

“We’re very excited that this product exists now,” Dr. Campbell said.
 

Chart reviews during the ‘tripledemic’

In fall 2022 the United States experienced a “tripledemic” of elevated hospitalizations for COVID-19, influenza, and RSV. For the new study, Dr. Halasa and her colleagues examined the medical records of 600 infants (under age 1; average age, 2.6 months) admitted to U.S. ICUs for lower respiratory tract infections caused by RSV from October to December 2022, during the height of the tripledemic. 

More than 60% of admissions, 361, were boys; 44% were White, 23% were Hispanic, 16% were Black, 10% were unknown race, 5% were multiple race, and 2% were Asian. 

Of the 600 infants, 572 (95.3%) required oxygen at the hospital and 487 (81.2%) had no underlying medical conditions linked to higher risk from RSV. The other infants had at least one ailment, such as a cardiac or lung condition, that could result in more severe RSV outcomes.

The 169 preemies in the study population were more likely to be intubated in the ICU than were those born at term. But 90 of the 143 total recorded intubations happened among full-term infants. Two children in the study group died.

Christopher Horvat, MD, MHA, who works in the pediatric ICU at the University of Pittsburgh Medical Center, called the new study “important,” adding that it shows “the RSV burden is substantial for children who are otherwise healthy.” Dr. Horvat, who was not involved in the work, said the new data highlight the value of preventive measures to prevent any repeat of the tripledemic.

On the same day the new study was published, the American Academy of Pediatrics (AAP) released a statement calling for widespread access to nirsevimab.

“The American Academy of Pediatrics recommends that all infants – and especially those at high risk – receive the new preventive antibody, nirsevimab, to protect against severe disease caused by respiratory syncytial virus (RSV), which is common, highly contagious, and sometimes deadly,” the organization said in a statement.

The AAP called for the CDC and the Centers for Medicaid & Medicare Services to work together to ensure that any parent in America can obtain nirsevimab for their children if needed. Anyone who cannot access nirsevimab this year, the AAP said, should rely on the older treatment palivizumab instead.

The sources in this story reported no relevant financial relationships.
 

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

Sunday night. Las Vegas. Jason Aldean had just started playing.

My wife and I were at the 2017 Route 91 Harvest Festival with three other couples; two of them were our close friends. We were sitting in the VIP section, a tented area right next to the stage. We started hearing what I was convinced were fireworks.

I’ve been in the Army for 20 some years. I’ve been deployed and shot at multiple times. But these shots were far away. And you don’t expect people to be shooting at you at a concert.

I was on the edge of the VIP area, so I could see around the corner of the tent. I looked up at the Mandalay Bay and saw the muzzle flash in the hotel window. That’s when I knew.

I screamed: “Somebody’s shooting at us! Everybody get down!”

It took a while for people to realize what was going on. When the first couple volleys sprayed into the crowd, nobody understood. But once enough people had been hit and dropped, everyone knew, and it was just mass exodus.

People screamed and ran everywhere. Some of them tried to jump over the front barrier so they could get underneath the stage. Others were trying to pick up loved ones who’d been shot.

The next 15 minutes are a little foggy. I was helping my wife and the people around us to get down. Funny things come back to you afterward. One of my friends was carrying a 16-ounce beer in his hand. Somebody’s shooting at him and he’s walking around with his beer like he’s afraid to put it down. It was so surreal.

We got everybody underneath the tent, and then we just sat there. There would be shooting and then a pause. You’d think it was over. And then there would be more shooting and another pause. It felt like it never was going to stop.

After a short period of time, somebody came in with an official badge, maybe FBI, who knows. They said: “Okay, everybody up. We’ve got to get you out of here.” So, we all got up and headed across the stage. The gate they were taking us to was in full view of the shooter, so it wasn’t very safe.

As I got up, I looked out at the field. Bodies were scattered everywhere. I’m a trauma surgeon by trade. I couldn’t just leave.

I told my two best friends to take my wife with them. My wife lost her mind at that point. She didn’t want me to run out on the field. But I had to. I saw the injured and they needed help. Another buddy and I jumped over the fence and started taking care of people.

The feeling of being out on the field was one of complete frustration. I was in sandals, shorts, and a t-shirt. We had no stretchers, no medical supplies, no nothing. I didn’t have a belt to use as a tourniquet. I didn’t even have a bandage.

Worse: We were seeing high-velocity gunshot wounds that I’ve seen for 20 years in the Army. I know how to take care of them. I know how to fix them. But there wasn’t a single thing I could do.

We had to get people off the field, so we started gathering up as many as we could. We didn’t know if we were going to get shot at again, so we were trying to hide behind things as we ran. Our main objective was just to get people to a place of safety.

A lot of it is a blur. But a few patients stick out in my mind.

A father and son. The father had been shot through the abdomen, exited out through his back. He was in severe pain and couldn’t walk.

A young girl shot in the arm. Her parents carrying her.

A group of people doing CPR on a young lady. She had a gunshot wound to the head or neck. She was obviously dead. But they were still doing chest compressions in the middle of the field. I had to say to them: “She’s dead. You can’t save her. You need to get off the field.” But they wouldn’t stop. We picked her up and took her out while they continued to do CPR.

Later, I realized I knew that woman. She was part of a group of friends that we would see at the festival. I hadn’t recognized her. I also didn’t know that my friend Marco was there. A month or 2 later, we figured out that he was one of the people doing CPR. And I was the guy who came up and said his friend was dead.

Some people were so badly injured we couldn’t lift them. We started tearing apart the fencing used to separate the crowd and slid sections of the barricades under the wounded to carry them. We also carried off a bunch of people who were dead.

We were moving patients to a covered bar area where we thought they would be safer. What we didn’t know was there was an ambulance rally point at the very far end of the field. Unfortunately, we had no idea it was there.

I saw a lot of other first responders out there, people from the fire department, corpsmen from the Navy, medics. I ran into an anesthesia provider and a series of nurses.

When we got everybody off the field, we started moving them into vehicles. People were bringing their trucks up. One guy even stole a truck so he could drive people to the ED. There wasn’t a lot of triage. We were just stacking whoever we could into the backs of these pickups.

I tried to help a nurse taking care of a lady who had been shot in the neck. She was sitting sort of half upright with the patient lying in her arms. When I reached to help her, she said: “You can’t move her.”

“We need to get her to the hospital,” I replied.

“This is the only position that this lady has an airway,” she said. “You’re going to have to move both of us together. If I move at all, she loses her airway.”

So, a group of us managed to slide something underneath and lift them into the back of a truck.

Loading the wounded went on for a while. And then, just like that, everybody was gone.

I walked back out onto this field which not too long ago held 30,000 people. It was as if aliens had just suddenly beamed everyone out.

There was stuff on the ground everywhere – blankets, clothing, single boots, wallets, purses. I walked past a food stand with food still cooking on the grill. There was a beer tap still running. It was the weirdest feeling I’d ever had in my life.

After that, things got a little crazy again. There had been a report of a second shooter, and no one knew if it was real or not. The police started herding a group of us across the street to the Tropicana. We were still trying to take cover as we walked there. We went past a big lion statue in front of one of the casinos. I have a picture from two years earlier of me sitting on the back of that lion. I remember thinking: Now I’m hunkered down behind the same lion hiding from a shooter. Times change.

They brought about 50 of us into a food court, which was closed. They wouldn’t tell us what was going on. And they wouldn’t let us leave. This went on for hours. Meanwhile, I had dropped my cell phone on the field, so my wife couldn’t get hold of me, and later she told me she assumed I’d been shot. I was just hoping that she was safe.

People were huddled together, crying, holding each other. Most were wearing Western concert–going stuff, which for a lot of them wasn’t very much clothing. The hotel eventually brought some blankets.

I was covered in blood. My shirt, shorts, and sandals were soaked. It was running down my legs. I couldn’t find anything to eat or drink. At one point, I sat down at a slot machine, put a hundred dollars in, and started playing slots. I didn’t know what else to do. It didn’t take me very long to lose it all.

Finally, I started looking for a way to get out. I checked all the exits, but there were security and police there. Then I ran into a guy who said he had found a fire exit. When we opened the fire door, there was a big security guard there, and he said: “You can’t leave.”

We said: “Try to stop us. We’re out of here.”

Another thing I’ll always remember – after I broke out of the Tropicana, I was low crawling through the bushes along the Strip toward my hotel. I got a block away and stood up to cross the street. I pushed the crosswalk button and waited. There were no cars, no people. I’ve just broken all the rules, violated police orders, and now I’m standing there waiting for a blinking light to allow me to cross the street!

I made it back to my hotel room around 3:30 or 4:00 in the morning. My wife was hysterical because I hadn’t been answering my cell phone. I came in, and she gave me a big hug, and I got in the shower. Our plane was leaving in a few hours, so we laid down, but didn’t sleep.

As we were getting ready to leave, my wife’s phone rang, and it was my number. A guy at the same hotel had found my phone on the field and called the “in case of emergency” number. So, I got my phone back.

It wasn’t easy to deal with the aftermath. It really affected everybody’s life. To this day, I’m particular about where we sit at concerts. My wife isn’t comfortable if she can’t see an exit. I now have a med bag in my car with tourniquets, pressure dressings, airway masks for CPR.

I’ll never forget that feeling of absolute frustration. That lady without an airway – I could’ve put a trach in her very quickly and made a difference. Were they able to keep her airway? Did she live?

The father and son – did the father make it? I have no idea what happened to any of them. Later, I went through and looked at the pictures of all the people who had died, but I couldn’t recognize anybody.

The hardest part was being there with my wife. I’ve been in places where people are shooting at you, in vehicles that are getting bombed. I’ve always believed that when it’s your time, it’s your time. If I get shot, well, okay, that happens. But if she got shot or my friends ... that would be really tough.

A year later, I gave a talk about it at a conference. I thought I had worked through everything. But all of those feelings, all of that helplessness, that anger, everything came roaring back to the surface again. They asked me how I deal with it, and I said: “Well ... poorly.” I’m the guy who sticks it in a box in the back of his brain, tucks it in and buries it with a bunch of other boxes, and hopes it never comes out again. But every once in a while, it does.

There were all kinds of people out on that field, some with medical training, some without, all determined to help, trying to get those injured people where they needed to be. In retrospect, it does make you feel good. Somebody was shooting at us, but people were still willing to stand up and risk their lives to help others.

We still talk with our friends about what happened that night. Over the years, it’s become less and less. But there’s still a text sent out every year on that day: “Today is the anniversary. Glad we’re all alive. Thanks for being our friends.”

Dr. Sebesta is a bariatric surgeon with MultiCare Health System in Tacoma, Wash.

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

Sunday night. Las Vegas. Jason Aldean had just started playing.

My wife and I were at the 2017 Route 91 Harvest Festival with three other couples; two of them were our close friends. We were sitting in the VIP section, a tented area right next to the stage. We started hearing what I was convinced were fireworks.

I’ve been in the Army for 20 some years. I’ve been deployed and shot at multiple times. But these shots were far away. And you don’t expect people to be shooting at you at a concert.

I was on the edge of the VIP area, so I could see around the corner of the tent. I looked up at the Mandalay Bay and saw the muzzle flash in the hotel window. That’s when I knew.

I screamed: “Somebody’s shooting at us! Everybody get down!”

It took a while for people to realize what was going on. When the first couple volleys sprayed into the crowd, nobody understood. But once enough people had been hit and dropped, everyone knew, and it was just mass exodus.

People screamed and ran everywhere. Some of them tried to jump over the front barrier so they could get underneath the stage. Others were trying to pick up loved ones who’d been shot.

The next 15 minutes are a little foggy. I was helping my wife and the people around us to get down. Funny things come back to you afterward. One of my friends was carrying a 16-ounce beer in his hand. Somebody’s shooting at him and he’s walking around with his beer like he’s afraid to put it down. It was so surreal.

We got everybody underneath the tent, and then we just sat there. There would be shooting and then a pause. You’d think it was over. And then there would be more shooting and another pause. It felt like it never was going to stop.

After a short period of time, somebody came in with an official badge, maybe FBI, who knows. They said: “Okay, everybody up. We’ve got to get you out of here.” So, we all got up and headed across the stage. The gate they were taking us to was in full view of the shooter, so it wasn’t very safe.

As I got up, I looked out at the field. Bodies were scattered everywhere. I’m a trauma surgeon by trade. I couldn’t just leave.

I told my two best friends to take my wife with them. My wife lost her mind at that point. She didn’t want me to run out on the field. But I had to. I saw the injured and they needed help. Another buddy and I jumped over the fence and started taking care of people.

The feeling of being out on the field was one of complete frustration. I was in sandals, shorts, and a t-shirt. We had no stretchers, no medical supplies, no nothing. I didn’t have a belt to use as a tourniquet. I didn’t even have a bandage.

Worse: We were seeing high-velocity gunshot wounds that I’ve seen for 20 years in the Army. I know how to take care of them. I know how to fix them. But there wasn’t a single thing I could do.

We had to get people off the field, so we started gathering up as many as we could. We didn’t know if we were going to get shot at again, so we were trying to hide behind things as we ran. Our main objective was just to get people to a place of safety.

A lot of it is a blur. But a few patients stick out in my mind.

A father and son. The father had been shot through the abdomen, exited out through his back. He was in severe pain and couldn’t walk.

A young girl shot in the arm. Her parents carrying her.

A group of people doing CPR on a young lady. She had a gunshot wound to the head or neck. She was obviously dead. But they were still doing chest compressions in the middle of the field. I had to say to them: “She’s dead. You can’t save her. You need to get off the field.” But they wouldn’t stop. We picked her up and took her out while they continued to do CPR.

Later, I realized I knew that woman. She was part of a group of friends that we would see at the festival. I hadn’t recognized her. I also didn’t know that my friend Marco was there. A month or 2 later, we figured out that he was one of the people doing CPR. And I was the guy who came up and said his friend was dead.

Some people were so badly injured we couldn’t lift them. We started tearing apart the fencing used to separate the crowd and slid sections of the barricades under the wounded to carry them. We also carried off a bunch of people who were dead.

We were moving patients to a covered bar area where we thought they would be safer. What we didn’t know was there was an ambulance rally point at the very far end of the field. Unfortunately, we had no idea it was there.

I saw a lot of other first responders out there, people from the fire department, corpsmen from the Navy, medics. I ran into an anesthesia provider and a series of nurses.

When we got everybody off the field, we started moving them into vehicles. People were bringing their trucks up. One guy even stole a truck so he could drive people to the ED. There wasn’t a lot of triage. We were just stacking whoever we could into the backs of these pickups.

I tried to help a nurse taking care of a lady who had been shot in the neck. She was sitting sort of half upright with the patient lying in her arms. When I reached to help her, she said: “You can’t move her.”

“We need to get her to the hospital,” I replied.

“This is the only position that this lady has an airway,” she said. “You’re going to have to move both of us together. If I move at all, she loses her airway.”

So, a group of us managed to slide something underneath and lift them into the back of a truck.

Loading the wounded went on for a while. And then, just like that, everybody was gone.

I walked back out onto this field which not too long ago held 30,000 people. It was as if aliens had just suddenly beamed everyone out.

There was stuff on the ground everywhere – blankets, clothing, single boots, wallets, purses. I walked past a food stand with food still cooking on the grill. There was a beer tap still running. It was the weirdest feeling I’d ever had in my life.

After that, things got a little crazy again. There had been a report of a second shooter, and no one knew if it was real or not. The police started herding a group of us across the street to the Tropicana. We were still trying to take cover as we walked there. We went past a big lion statue in front of one of the casinos. I have a picture from two years earlier of me sitting on the back of that lion. I remember thinking: Now I’m hunkered down behind the same lion hiding from a shooter. Times change.

They brought about 50 of us into a food court, which was closed. They wouldn’t tell us what was going on. And they wouldn’t let us leave. This went on for hours. Meanwhile, I had dropped my cell phone on the field, so my wife couldn’t get hold of me, and later she told me she assumed I’d been shot. I was just hoping that she was safe.

People were huddled together, crying, holding each other. Most were wearing Western concert–going stuff, which for a lot of them wasn’t very much clothing. The hotel eventually brought some blankets.

I was covered in blood. My shirt, shorts, and sandals were soaked. It was running down my legs. I couldn’t find anything to eat or drink. At one point, I sat down at a slot machine, put a hundred dollars in, and started playing slots. I didn’t know what else to do. It didn’t take me very long to lose it all.

Finally, I started looking for a way to get out. I checked all the exits, but there were security and police there. Then I ran into a guy who said he had found a fire exit. When we opened the fire door, there was a big security guard there, and he said: “You can’t leave.”

We said: “Try to stop us. We’re out of here.”

Another thing I’ll always remember – after I broke out of the Tropicana, I was low crawling through the bushes along the Strip toward my hotel. I got a block away and stood up to cross the street. I pushed the crosswalk button and waited. There were no cars, no people. I’ve just broken all the rules, violated police orders, and now I’m standing there waiting for a blinking light to allow me to cross the street!

I made it back to my hotel room around 3:30 or 4:00 in the morning. My wife was hysterical because I hadn’t been answering my cell phone. I came in, and she gave me a big hug, and I got in the shower. Our plane was leaving in a few hours, so we laid down, but didn’t sleep.

As we were getting ready to leave, my wife’s phone rang, and it was my number. A guy at the same hotel had found my phone on the field and called the “in case of emergency” number. So, I got my phone back.

It wasn’t easy to deal with the aftermath. It really affected everybody’s life. To this day, I’m particular about where we sit at concerts. My wife isn’t comfortable if she can’t see an exit. I now have a med bag in my car with tourniquets, pressure dressings, airway masks for CPR.

I’ll never forget that feeling of absolute frustration. That lady without an airway – I could’ve put a trach in her very quickly and made a difference. Were they able to keep her airway? Did she live?

The father and son – did the father make it? I have no idea what happened to any of them. Later, I went through and looked at the pictures of all the people who had died, but I couldn’t recognize anybody.

The hardest part was being there with my wife. I’ve been in places where people are shooting at you, in vehicles that are getting bombed. I’ve always believed that when it’s your time, it’s your time. If I get shot, well, okay, that happens. But if she got shot or my friends ... that would be really tough.

A year later, I gave a talk about it at a conference. I thought I had worked through everything. But all of those feelings, all of that helplessness, that anger, everything came roaring back to the surface again. They asked me how I deal with it, and I said: “Well ... poorly.” I’m the guy who sticks it in a box in the back of his brain, tucks it in and buries it with a bunch of other boxes, and hopes it never comes out again. But every once in a while, it does.

There were all kinds of people out on that field, some with medical training, some without, all determined to help, trying to get those injured people where they needed to be. In retrospect, it does make you feel good. Somebody was shooting at us, but people were still willing to stand up and risk their lives to help others.

We still talk with our friends about what happened that night. Over the years, it’s become less and less. But there’s still a text sent out every year on that day: “Today is the anniversary. Glad we’re all alive. Thanks for being our friends.”

Dr. Sebesta is a bariatric surgeon with MultiCare Health System in Tacoma, Wash.

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

Sunday night. Las Vegas. Jason Aldean had just started playing.

My wife and I were at the 2017 Route 91 Harvest Festival with three other couples; two of them were our close friends. We were sitting in the VIP section, a tented area right next to the stage. We started hearing what I was convinced were fireworks.

I’ve been in the Army for 20 some years. I’ve been deployed and shot at multiple times. But these shots were far away. And you don’t expect people to be shooting at you at a concert.

I was on the edge of the VIP area, so I could see around the corner of the tent. I looked up at the Mandalay Bay and saw the muzzle flash in the hotel window. That’s when I knew.

I screamed: “Somebody’s shooting at us! Everybody get down!”

It took a while for people to realize what was going on. When the first couple volleys sprayed into the crowd, nobody understood. But once enough people had been hit and dropped, everyone knew, and it was just mass exodus.

People screamed and ran everywhere. Some of them tried to jump over the front barrier so they could get underneath the stage. Others were trying to pick up loved ones who’d been shot.

The next 15 minutes are a little foggy. I was helping my wife and the people around us to get down. Funny things come back to you afterward. One of my friends was carrying a 16-ounce beer in his hand. Somebody’s shooting at him and he’s walking around with his beer like he’s afraid to put it down. It was so surreal.

We got everybody underneath the tent, and then we just sat there. There would be shooting and then a pause. You’d think it was over. And then there would be more shooting and another pause. It felt like it never was going to stop.

After a short period of time, somebody came in with an official badge, maybe FBI, who knows. They said: “Okay, everybody up. We’ve got to get you out of here.” So, we all got up and headed across the stage. The gate they were taking us to was in full view of the shooter, so it wasn’t very safe.

As I got up, I looked out at the field. Bodies were scattered everywhere. I’m a trauma surgeon by trade. I couldn’t just leave.

I told my two best friends to take my wife with them. My wife lost her mind at that point. She didn’t want me to run out on the field. But I had to. I saw the injured and they needed help. Another buddy and I jumped over the fence and started taking care of people.

The feeling of being out on the field was one of complete frustration. I was in sandals, shorts, and a t-shirt. We had no stretchers, no medical supplies, no nothing. I didn’t have a belt to use as a tourniquet. I didn’t even have a bandage.

Worse: We were seeing high-velocity gunshot wounds that I’ve seen for 20 years in the Army. I know how to take care of them. I know how to fix them. But there wasn’t a single thing I could do.

We had to get people off the field, so we started gathering up as many as we could. We didn’t know if we were going to get shot at again, so we were trying to hide behind things as we ran. Our main objective was just to get people to a place of safety.

A lot of it is a blur. But a few patients stick out in my mind.

A father and son. The father had been shot through the abdomen, exited out through his back. He was in severe pain and couldn’t walk.

A young girl shot in the arm. Her parents carrying her.

A group of people doing CPR on a young lady. She had a gunshot wound to the head or neck. She was obviously dead. But they were still doing chest compressions in the middle of the field. I had to say to them: “She’s dead. You can’t save her. You need to get off the field.” But they wouldn’t stop. We picked her up and took her out while they continued to do CPR.

Later, I realized I knew that woman. She was part of a group of friends that we would see at the festival. I hadn’t recognized her. I also didn’t know that my friend Marco was there. A month or 2 later, we figured out that he was one of the people doing CPR. And I was the guy who came up and said his friend was dead.

Some people were so badly injured we couldn’t lift them. We started tearing apart the fencing used to separate the crowd and slid sections of the barricades under the wounded to carry them. We also carried off a bunch of people who were dead.

We were moving patients to a covered bar area where we thought they would be safer. What we didn’t know was there was an ambulance rally point at the very far end of the field. Unfortunately, we had no idea it was there.

I saw a lot of other first responders out there, people from the fire department, corpsmen from the Navy, medics. I ran into an anesthesia provider and a series of nurses.

When we got everybody off the field, we started moving them into vehicles. People were bringing their trucks up. One guy even stole a truck so he could drive people to the ED. There wasn’t a lot of triage. We were just stacking whoever we could into the backs of these pickups.

I tried to help a nurse taking care of a lady who had been shot in the neck. She was sitting sort of half upright with the patient lying in her arms. When I reached to help her, she said: “You can’t move her.”

“We need to get her to the hospital,” I replied.

“This is the only position that this lady has an airway,” she said. “You’re going to have to move both of us together. If I move at all, she loses her airway.”

So, a group of us managed to slide something underneath and lift them into the back of a truck.

Loading the wounded went on for a while. And then, just like that, everybody was gone.

I walked back out onto this field which not too long ago held 30,000 people. It was as if aliens had just suddenly beamed everyone out.

There was stuff on the ground everywhere – blankets, clothing, single boots, wallets, purses. I walked past a food stand with food still cooking on the grill. There was a beer tap still running. It was the weirdest feeling I’d ever had in my life.

After that, things got a little crazy again. There had been a report of a second shooter, and no one knew if it was real or not. The police started herding a group of us across the street to the Tropicana. We were still trying to take cover as we walked there. We went past a big lion statue in front of one of the casinos. I have a picture from two years earlier of me sitting on the back of that lion. I remember thinking: Now I’m hunkered down behind the same lion hiding from a shooter. Times change.

They brought about 50 of us into a food court, which was closed. They wouldn’t tell us what was going on. And they wouldn’t let us leave. This went on for hours. Meanwhile, I had dropped my cell phone on the field, so my wife couldn’t get hold of me, and later she told me she assumed I’d been shot. I was just hoping that she was safe.

People were huddled together, crying, holding each other. Most were wearing Western concert–going stuff, which for a lot of them wasn’t very much clothing. The hotel eventually brought some blankets.

I was covered in blood. My shirt, shorts, and sandals were soaked. It was running down my legs. I couldn’t find anything to eat or drink. At one point, I sat down at a slot machine, put a hundred dollars in, and started playing slots. I didn’t know what else to do. It didn’t take me very long to lose it all.

Finally, I started looking for a way to get out. I checked all the exits, but there were security and police there. Then I ran into a guy who said he had found a fire exit. When we opened the fire door, there was a big security guard there, and he said: “You can’t leave.”

We said: “Try to stop us. We’re out of here.”

Another thing I’ll always remember – after I broke out of the Tropicana, I was low crawling through the bushes along the Strip toward my hotel. I got a block away and stood up to cross the street. I pushed the crosswalk button and waited. There were no cars, no people. I’ve just broken all the rules, violated police orders, and now I’m standing there waiting for a blinking light to allow me to cross the street!

I made it back to my hotel room around 3:30 or 4:00 in the morning. My wife was hysterical because I hadn’t been answering my cell phone. I came in, and she gave me a big hug, and I got in the shower. Our plane was leaving in a few hours, so we laid down, but didn’t sleep.

As we were getting ready to leave, my wife’s phone rang, and it was my number. A guy at the same hotel had found my phone on the field and called the “in case of emergency” number. So, I got my phone back.

It wasn’t easy to deal with the aftermath. It really affected everybody’s life. To this day, I’m particular about where we sit at concerts. My wife isn’t comfortable if she can’t see an exit. I now have a med bag in my car with tourniquets, pressure dressings, airway masks for CPR.

I’ll never forget that feeling of absolute frustration. That lady without an airway – I could’ve put a trach in her very quickly and made a difference. Were they able to keep her airway? Did she live?

The father and son – did the father make it? I have no idea what happened to any of them. Later, I went through and looked at the pictures of all the people who had died, but I couldn’t recognize anybody.

The hardest part was being there with my wife. I’ve been in places where people are shooting at you, in vehicles that are getting bombed. I’ve always believed that when it’s your time, it’s your time. If I get shot, well, okay, that happens. But if she got shot or my friends ... that would be really tough.

A year later, I gave a talk about it at a conference. I thought I had worked through everything. But all of those feelings, all of that helplessness, that anger, everything came roaring back to the surface again. They asked me how I deal with it, and I said: “Well ... poorly.” I’m the guy who sticks it in a box in the back of his brain, tucks it in and buries it with a bunch of other boxes, and hopes it never comes out again. But every once in a while, it does.

There were all kinds of people out on that field, some with medical training, some without, all determined to help, trying to get those injured people where they needed to be. In retrospect, it does make you feel good. Somebody was shooting at us, but people were still willing to stand up and risk their lives to help others.

We still talk with our friends about what happened that night. Over the years, it’s become less and less. But there’s still a text sent out every year on that day: “Today is the anniversary. Glad we’re all alive. Thanks for being our friends.”

Dr. Sebesta is a bariatric surgeon with MultiCare Health System in Tacoma, Wash.

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

Among military veterans who die by suicide, those who experience a traumatic brain injury (TBI) during service take their lives 21% sooner after deployment than those without a TBI history, a new study shows.

Investigators also found that increases in new mental health diagnoses are significantly higher in soldiers with a history of TBI – in some cases, strikingly higher. For example, cases of substance use disorder rose by 100% among veterans with TBI compared to just 14.5% in those with no brain injury.

Veterans Health Administration

“We had had pieces of these findings for a long time but to be able to lay out this longitudinal story over time is the part that’s new and important to really switch the focus to people’s whole lives and things that happen over time, both psychological and physical,” lead author Lisa Brenner, PhD, director of the Veterans Health Administration (VHA) Rocky Mountain Mental Illness Research Education and Clinical Center, Aurora, Colo., said in an interview.

“If we take that life-course view, it’s a very different way about thinking about conceptualizing exposures and conceptualizing risk and it’s a different way of thinking about treatment and prevention,” added Dr. Brenner, professor of physical medicine and rehabilitation, psychiatry, and neurology at the University of Colorado, Aurora. “I think that definitely applies to civilian populations.”

The findings were published online in JAMA Network Open.
 

Largest, longest study to date

Researchers have long suspected that TBI and a higher rate of new mental illness and a shorter time to suicide are all somehow linked. But this study examined all three components longitudinally, in what is thought to be the largest and longest study on the topic to date, including more than 860,000 people who were followed for up to a decade.

Investigators studied health data from the Substance Use and Psychological Injury Combat Study database on 860,892 U.S. Army soldiers who returned from deployment in Iraq or Afghanistan between 2008 and 2014 and were 18-24 years old at the end of that deployment. They then examined new mental health diagnoses and suicide trends over time.

Nearly 109,000 (12.6%) experienced a TBI during deployment, and 2,695 had died by suicide through the end of 2018.

New-onset diagnoses of anxiety, mood disorders, posttraumatic stress disorder, alcohol use, and substance use disorder (SUD) after deployment were all more common in soldiers who experienced PTSD while serving compared with those with no history of TBI.

There was a 67.7% increase in mood disorders in participants with TBI compared with a 37.5% increase in those without TBI. The increase in new cases of alcohol use disorder was also greater in the TBI group (a 31.9% increase vs. a 10.3% increase).

But the sharpest difference was the increase in substance use disorder among those with TBI, which rose 100% compared with a 14.5% increase in solders with no history of TBI.
 

Sharp differences in time to suicide

Death by suicide was only slightly more common in those with TBI compared with those without (0.4% vs. 0.3%, respectively). But those with a brain injury committed suicide 21.3% sooner than did those without a head injury, after the researchers controlled for sex, age, race, ethnicity, and fiscal year of return from deployment.

Time to suicide was faster in those with a TBI and two or more new mental health diagnoses and fastest among those with TBI and a new SUD diagnosis, who took their own lives 62.8% faster than did those without a TBI.

The findings offer an important message to medical professionals in many different specialties, Dr. Brenner said.

“Folks in mental health probably have a lot of patients who have brain injury in their practice, and they don’t know it and that’s an important thing to know,” she said, adding that “neurologists should screen for depression and other mental health conditions and make sure those people have evidence-based treatments for those mental health conditions while they’re addressing the TBI-related symptoms.”
 

Applicable to civilians?

“The complex interplay between TBI, its potential effects on mental health, and risk of suicide remains a vexing focus of ongoing investigations and academic inquiry,” Ross Zafonte, DO, president of Spaulding Rehabilitation Hospital Network and professor and chair of physical medicine and rehabilitation at Harvard Medical School, Boston, and colleagues, wrote in an accompanying editorial.

The study builds on earlier work, they added, and praised the study’s longitudinal design and large cohort as key to the findings. The data on increased rates of new-onset substance use disorder, which was also associated with a faster time to suicide in the TBI group, were of particular interest.

“In this work, Brenner and colleagues identified substance use disorder as a key factor in faster time to suicide for active-duty service members with a history of TBI compared with those without TBI and theorized that a multiple stress or exposure burden may enhance risk,” they wrote. “This theory is reasonable and has been postulated among individuals with medical sequelae linked to TBI.”

However, the authors caution against applying these findings in military veterans to civilians.

“While this work is critical in the military population, caution should be given to avoid direct generalization to other populations, such as athletes, for whom the linkage to suicidal ideation is less understood,” they wrote.

The study was funded by National Institute of Mental Health and Office of the Director at National Institutes of Health. Dr. Brenner has received personal fees from Wolters Kluwer, Rand, American Psychological Association, and Oxford University Press and serves as a consultant to sports leagues via her university affiliation. Dr. Zafonte reported receiving royalties from Springer/Demos; serving as a member of the editorial boards of Journal of Neurotrauma and Frontiers in Neurology and scientific advisory boards of Myomo, Nanodiagnostics, Onecare.ai, and Kisbee; and evaluating patients in the MGH Brain and Body-TRUST Program, which is funded by the National Football League Players Association.
 

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

Among military veterans who die by suicide, those who experience a traumatic brain injury (TBI) during service take their lives 21% sooner after deployment than those without a TBI history, a new study shows.

Investigators also found that increases in new mental health diagnoses are significantly higher in soldiers with a history of TBI – in some cases, strikingly higher. For example, cases of substance use disorder rose by 100% among veterans with TBI compared to just 14.5% in those with no brain injury.

Veterans Health Administration

“We had had pieces of these findings for a long time but to be able to lay out this longitudinal story over time is the part that’s new and important to really switch the focus to people’s whole lives and things that happen over time, both psychological and physical,” lead author Lisa Brenner, PhD, director of the Veterans Health Administration (VHA) Rocky Mountain Mental Illness Research Education and Clinical Center, Aurora, Colo., said in an interview.

“If we take that life-course view, it’s a very different way about thinking about conceptualizing exposures and conceptualizing risk and it’s a different way of thinking about treatment and prevention,” added Dr. Brenner, professor of physical medicine and rehabilitation, psychiatry, and neurology at the University of Colorado, Aurora. “I think that definitely applies to civilian populations.”

The findings were published online in JAMA Network Open.
 

Largest, longest study to date

Researchers have long suspected that TBI and a higher rate of new mental illness and a shorter time to suicide are all somehow linked. But this study examined all three components longitudinally, in what is thought to be the largest and longest study on the topic to date, including more than 860,000 people who were followed for up to a decade.

Investigators studied health data from the Substance Use and Psychological Injury Combat Study database on 860,892 U.S. Army soldiers who returned from deployment in Iraq or Afghanistan between 2008 and 2014 and were 18-24 years old at the end of that deployment. They then examined new mental health diagnoses and suicide trends over time.

Nearly 109,000 (12.6%) experienced a TBI during deployment, and 2,695 had died by suicide through the end of 2018.

New-onset diagnoses of anxiety, mood disorders, posttraumatic stress disorder, alcohol use, and substance use disorder (SUD) after deployment were all more common in soldiers who experienced PTSD while serving compared with those with no history of TBI.

There was a 67.7% increase in mood disorders in participants with TBI compared with a 37.5% increase in those without TBI. The increase in new cases of alcohol use disorder was also greater in the TBI group (a 31.9% increase vs. a 10.3% increase).

But the sharpest difference was the increase in substance use disorder among those with TBI, which rose 100% compared with a 14.5% increase in solders with no history of TBI.
 

Sharp differences in time to suicide

Death by suicide was only slightly more common in those with TBI compared with those without (0.4% vs. 0.3%, respectively). But those with a brain injury committed suicide 21.3% sooner than did those without a head injury, after the researchers controlled for sex, age, race, ethnicity, and fiscal year of return from deployment.

Time to suicide was faster in those with a TBI and two or more new mental health diagnoses and fastest among those with TBI and a new SUD diagnosis, who took their own lives 62.8% faster than did those without a TBI.

The findings offer an important message to medical professionals in many different specialties, Dr. Brenner said.

“Folks in mental health probably have a lot of patients who have brain injury in their practice, and they don’t know it and that’s an important thing to know,” she said, adding that “neurologists should screen for depression and other mental health conditions and make sure those people have evidence-based treatments for those mental health conditions while they’re addressing the TBI-related symptoms.”
 

Applicable to civilians?

“The complex interplay between TBI, its potential effects on mental health, and risk of suicide remains a vexing focus of ongoing investigations and academic inquiry,” Ross Zafonte, DO, president of Spaulding Rehabilitation Hospital Network and professor and chair of physical medicine and rehabilitation at Harvard Medical School, Boston, and colleagues, wrote in an accompanying editorial.

The study builds on earlier work, they added, and praised the study’s longitudinal design and large cohort as key to the findings. The data on increased rates of new-onset substance use disorder, which was also associated with a faster time to suicide in the TBI group, were of particular interest.

“In this work, Brenner and colleagues identified substance use disorder as a key factor in faster time to suicide for active-duty service members with a history of TBI compared with those without TBI and theorized that a multiple stress or exposure burden may enhance risk,” they wrote. “This theory is reasonable and has been postulated among individuals with medical sequelae linked to TBI.”

However, the authors caution against applying these findings in military veterans to civilians.

“While this work is critical in the military population, caution should be given to avoid direct generalization to other populations, such as athletes, for whom the linkage to suicidal ideation is less understood,” they wrote.

The study was funded by National Institute of Mental Health and Office of the Director at National Institutes of Health. Dr. Brenner has received personal fees from Wolters Kluwer, Rand, American Psychological Association, and Oxford University Press and serves as a consultant to sports leagues via her university affiliation. Dr. Zafonte reported receiving royalties from Springer/Demos; serving as a member of the editorial boards of Journal of Neurotrauma and Frontiers in Neurology and scientific advisory boards of Myomo, Nanodiagnostics, Onecare.ai, and Kisbee; and evaluating patients in the MGH Brain and Body-TRUST Program, which is funded by the National Football League Players Association.
 

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

Among military veterans who die by suicide, those who experience a traumatic brain injury (TBI) during service take their lives 21% sooner after deployment than those without a TBI history, a new study shows.

Investigators also found that increases in new mental health diagnoses are significantly higher in soldiers with a history of TBI – in some cases, strikingly higher. For example, cases of substance use disorder rose by 100% among veterans with TBI compared to just 14.5% in those with no brain injury.

Veterans Health Administration

“We had had pieces of these findings for a long time but to be able to lay out this longitudinal story over time is the part that’s new and important to really switch the focus to people’s whole lives and things that happen over time, both psychological and physical,” lead author Lisa Brenner, PhD, director of the Veterans Health Administration (VHA) Rocky Mountain Mental Illness Research Education and Clinical Center, Aurora, Colo., said in an interview.

“If we take that life-course view, it’s a very different way about thinking about conceptualizing exposures and conceptualizing risk and it’s a different way of thinking about treatment and prevention,” added Dr. Brenner, professor of physical medicine and rehabilitation, psychiatry, and neurology at the University of Colorado, Aurora. “I think that definitely applies to civilian populations.”

The findings were published online in JAMA Network Open.
 

Largest, longest study to date

Researchers have long suspected that TBI and a higher rate of new mental illness and a shorter time to suicide are all somehow linked. But this study examined all three components longitudinally, in what is thought to be the largest and longest study on the topic to date, including more than 860,000 people who were followed for up to a decade.

Investigators studied health data from the Substance Use and Psychological Injury Combat Study database on 860,892 U.S. Army soldiers who returned from deployment in Iraq or Afghanistan between 2008 and 2014 and were 18-24 years old at the end of that deployment. They then examined new mental health diagnoses and suicide trends over time.

Nearly 109,000 (12.6%) experienced a TBI during deployment, and 2,695 had died by suicide through the end of 2018.

New-onset diagnoses of anxiety, mood disorders, posttraumatic stress disorder, alcohol use, and substance use disorder (SUD) after deployment were all more common in soldiers who experienced PTSD while serving compared with those with no history of TBI.

There was a 67.7% increase in mood disorders in participants with TBI compared with a 37.5% increase in those without TBI. The increase in new cases of alcohol use disorder was also greater in the TBI group (a 31.9% increase vs. a 10.3% increase).

But the sharpest difference was the increase in substance use disorder among those with TBI, which rose 100% compared with a 14.5% increase in solders with no history of TBI.
 

Sharp differences in time to suicide

Death by suicide was only slightly more common in those with TBI compared with those without (0.4% vs. 0.3%, respectively). But those with a brain injury committed suicide 21.3% sooner than did those without a head injury, after the researchers controlled for sex, age, race, ethnicity, and fiscal year of return from deployment.

Time to suicide was faster in those with a TBI and two or more new mental health diagnoses and fastest among those with TBI and a new SUD diagnosis, who took their own lives 62.8% faster than did those without a TBI.

The findings offer an important message to medical professionals in many different specialties, Dr. Brenner said.

“Folks in mental health probably have a lot of patients who have brain injury in their practice, and they don’t know it and that’s an important thing to know,” she said, adding that “neurologists should screen for depression and other mental health conditions and make sure those people have evidence-based treatments for those mental health conditions while they’re addressing the TBI-related symptoms.”
 

Applicable to civilians?

“The complex interplay between TBI, its potential effects on mental health, and risk of suicide remains a vexing focus of ongoing investigations and academic inquiry,” Ross Zafonte, DO, president of Spaulding Rehabilitation Hospital Network and professor and chair of physical medicine and rehabilitation at Harvard Medical School, Boston, and colleagues, wrote in an accompanying editorial.

The study builds on earlier work, they added, and praised the study’s longitudinal design and large cohort as key to the findings. The data on increased rates of new-onset substance use disorder, which was also associated with a faster time to suicide in the TBI group, were of particular interest.

“In this work, Brenner and colleagues identified substance use disorder as a key factor in faster time to suicide for active-duty service members with a history of TBI compared with those without TBI and theorized that a multiple stress or exposure burden may enhance risk,” they wrote. “This theory is reasonable and has been postulated among individuals with medical sequelae linked to TBI.”

However, the authors caution against applying these findings in military veterans to civilians.

“While this work is critical in the military population, caution should be given to avoid direct generalization to other populations, such as athletes, for whom the linkage to suicidal ideation is less understood,” they wrote.

The study was funded by National Institute of Mental Health and Office of the Director at National Institutes of Health. Dr. Brenner has received personal fees from Wolters Kluwer, Rand, American Psychological Association, and Oxford University Press and serves as a consultant to sports leagues via her university affiliation. Dr. Zafonte reported receiving royalties from Springer/Demos; serving as a member of the editorial boards of Journal of Neurotrauma and Frontiers in Neurology and scientific advisory boards of Myomo, Nanodiagnostics, Onecare.ai, and Kisbee; and evaluating patients in the MGH Brain and Body-TRUST Program, which is funded by the National Football League Players Association.
 

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

A woman’s quest to become pregnant resulted in lead poisoning from an Ayurvedic treatment. The case triggered the seizure of pills from an Ontario natural-products clinic and the issuance of government warnings about the risks of products from this business, according to a new report.

The case highlights the need for collaboration between clinicians and public health authorities to address the potential health risks of supplements, including the presence of lead and other metals in Ayurvedic products, according to the report.

“When consumer products may be contaminated with lead, or when lead exposure is linked to sources in the community, involving public health can facilitate broader actions to reduce and prevent exposures to other people at risk,” wrote report author Julian Gitelman, MD, MPH, a resident physician at the University of Toronto Dalla Lana School of Public Health, and colleagues.

Their case study was published in the Canadian Medical Association Journal.

The researchers detailed what happened after a 39-year-old woman sought medical care for abdominal pain, constipation, nausea, and vomiting. The woman underwent a series of tests, including colonoscopy, laparoscopy, and biopsies of bone marrow and ovarian cysts.

Only later did clinicians home in on the cause of her ailments: the Ayurvedic medications that the patient had been taking daily for more than a year for infertility. Her daily regimen had varied, ranging from a few pills to a dozen pills.

Heavy metals are sometimes intentionally added to Ayurvedic supplements for perceived healing properties, wrote the authors. They cited a previous study of a sample of Ayurvedic pills bought on the Internet from manufacturers based in the United States and India that showed that 21% contained lead, mercury, or arsenic.

A case report published last year in German Medical Weekly raised the same issue.
 

Melatonin gummies

Regulators in many countries struggle to help consumers understand the risks of natural health supplements, and the challenge extends well beyond Ayurvedic products.

There has been a “huge and very troubling increase” in U.S. poison control calls associated with gummy-bear products containing melatonin, said Canadian Senator Stan Kutcher, MD, at a May 11 meeting of Canada’s Standing Senate Committee on Social Affairs, Science, and Technology.

In April, JAMA published a U.S. analysis of melatonin gummy products, Dr. Kutcher noted. In this research letter, investigators reported that one product did not contain detectable levels of melatonin but did contain 31.3 mg of cannabidiol.

In other products, the quantity of melatonin ranged from 74% to 347% of the labeled quantity. A previous Canadian study of 16 melatonin brands found that the actual dose of melatonin ranged from 17% to 478% of the declared quantity, the letter noted.

The May 11 Senate meeting provided a forum for many of the recurring debates about supplements, which also are known as natural health products.

Barry Power, PharmD, editor in chief for the Canadian Pharmacists Association, said that his group was disappointed when Canada excluded natural health products from Vanessa’s Law, which was passed in 2014. This law sought to improve the reporting of adverse reactions to drugs.

“We’re glad this is being revisited now,” Dr. Power told the Senate committee. “Although natural health products are often seen as low risk, we need to keep in mind that ‘low risk’ does not mean ‘no risk,’ and ‘natural’ does not mean ‘safe.’ ”

In contrast, Aaron Skelton, chief executive of the Canadian Health Food Association, spoke against this bid to expand the reach of Vanessa’s Law into natural health products. Canadian lawmakers attached provisions regarding increased oversight of natural health products to a budget package instead of considering them as part of a stand-alone bill.

“Our concern is that the powers that are being discussed have not been reviewed and debated,” Mr. Skelton told Dr. Kutcher. “The potential for overreach and unnecessary regulation is significant, and that deserves debate.”

“Profits should not trump Canadians’ health,” answered Dr. Kutcher, who earlier served as head of the psychiatry department at Dalhousie University in Halifax, N.S.

By June, Vanessa’s Law had been expanded with provisions that address natural health products, including the reporting of products that present a serious risk to consumers.
 

Educating consumers

Many consumers overestimate the level of government regulation of supplements, said Pieter A. Cohen, MD, leader of the Supplement Research Program at Cambridge Health Alliance in Massachusetts. Dr. Cohen was the lead author of the JAMA research letter about melatonin products.

Supplements often share shelves in pharmacies with medicines that are subject to more strict regulation, which causes confusion.

“It’s really hard to wrap your brain around [the fact] that a health product is being sold in pharmacies in the United States and it’s not being vetted by the FDA [U.S. Food and Drug Administration]”, Dr. Cohen said in an interview

The confusion extends across borders. Many consumers in other countries will assume that the FDA performed premarket screening of U.S.-made supplements, but that is not the case, he said.

People who want to take supplements should look for reputable sources of information about them, such as the website of the National Institutes of Health’s Office of Dietary Supplements, Dr. Cohen said. But patients often forget or fail to do this, which can create medical puzzles, such as the case of the woman in the Ontario case study, said Peter Lurie, MD, MPH, executive director of the nonprofit Center for Science in the Public Interest, which has pressed for increased regulation of supplements.

Clinicians need to keep in mind that patients may need prodding to reveal what supplements they are taking, he said.

“They just think of them as different, somehow not the province of the doctor,” Dr. Lurie said. “For others, they are concerned that the doctors will disapprove. So, they hide it.”

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

A woman’s quest to become pregnant resulted in lead poisoning from an Ayurvedic treatment. The case triggered the seizure of pills from an Ontario natural-products clinic and the issuance of government warnings about the risks of products from this business, according to a new report.

The case highlights the need for collaboration between clinicians and public health authorities to address the potential health risks of supplements, including the presence of lead and other metals in Ayurvedic products, according to the report.

“When consumer products may be contaminated with lead, or when lead exposure is linked to sources in the community, involving public health can facilitate broader actions to reduce and prevent exposures to other people at risk,” wrote report author Julian Gitelman, MD, MPH, a resident physician at the University of Toronto Dalla Lana School of Public Health, and colleagues.

Their case study was published in the Canadian Medical Association Journal.

The researchers detailed what happened after a 39-year-old woman sought medical care for abdominal pain, constipation, nausea, and vomiting. The woman underwent a series of tests, including colonoscopy, laparoscopy, and biopsies of bone marrow and ovarian cysts.

Only later did clinicians home in on the cause of her ailments: the Ayurvedic medications that the patient had been taking daily for more than a year for infertility. Her daily regimen had varied, ranging from a few pills to a dozen pills.

Heavy metals are sometimes intentionally added to Ayurvedic supplements for perceived healing properties, wrote the authors. They cited a previous study of a sample of Ayurvedic pills bought on the Internet from manufacturers based in the United States and India that showed that 21% contained lead, mercury, or arsenic.

A case report published last year in German Medical Weekly raised the same issue.
 

Melatonin gummies

Regulators in many countries struggle to help consumers understand the risks of natural health supplements, and the challenge extends well beyond Ayurvedic products.

There has been a “huge and very troubling increase” in U.S. poison control calls associated with gummy-bear products containing melatonin, said Canadian Senator Stan Kutcher, MD, at a May 11 meeting of Canada’s Standing Senate Committee on Social Affairs, Science, and Technology.

In April, JAMA published a U.S. analysis of melatonin gummy products, Dr. Kutcher noted. In this research letter, investigators reported that one product did not contain detectable levels of melatonin but did contain 31.3 mg of cannabidiol.

In other products, the quantity of melatonin ranged from 74% to 347% of the labeled quantity. A previous Canadian study of 16 melatonin brands found that the actual dose of melatonin ranged from 17% to 478% of the declared quantity, the letter noted.

The May 11 Senate meeting provided a forum for many of the recurring debates about supplements, which also are known as natural health products.

Barry Power, PharmD, editor in chief for the Canadian Pharmacists Association, said that his group was disappointed when Canada excluded natural health products from Vanessa’s Law, which was passed in 2014. This law sought to improve the reporting of adverse reactions to drugs.

“We’re glad this is being revisited now,” Dr. Power told the Senate committee. “Although natural health products are often seen as low risk, we need to keep in mind that ‘low risk’ does not mean ‘no risk,’ and ‘natural’ does not mean ‘safe.’ ”

In contrast, Aaron Skelton, chief executive of the Canadian Health Food Association, spoke against this bid to expand the reach of Vanessa’s Law into natural health products. Canadian lawmakers attached provisions regarding increased oversight of natural health products to a budget package instead of considering them as part of a stand-alone bill.

“Our concern is that the powers that are being discussed have not been reviewed and debated,” Mr. Skelton told Dr. Kutcher. “The potential for overreach and unnecessary regulation is significant, and that deserves debate.”

“Profits should not trump Canadians’ health,” answered Dr. Kutcher, who earlier served as head of the psychiatry department at Dalhousie University in Halifax, N.S.

By June, Vanessa’s Law had been expanded with provisions that address natural health products, including the reporting of products that present a serious risk to consumers.
 

Educating consumers

Many consumers overestimate the level of government regulation of supplements, said Pieter A. Cohen, MD, leader of the Supplement Research Program at Cambridge Health Alliance in Massachusetts. Dr. Cohen was the lead author of the JAMA research letter about melatonin products.

Supplements often share shelves in pharmacies with medicines that are subject to more strict regulation, which causes confusion.

“It’s really hard to wrap your brain around [the fact] that a health product is being sold in pharmacies in the United States and it’s not being vetted by the FDA [U.S. Food and Drug Administration]”, Dr. Cohen said in an interview

The confusion extends across borders. Many consumers in other countries will assume that the FDA performed premarket screening of U.S.-made supplements, but that is not the case, he said.

People who want to take supplements should look for reputable sources of information about them, such as the website of the National Institutes of Health’s Office of Dietary Supplements, Dr. Cohen said. But patients often forget or fail to do this, which can create medical puzzles, such as the case of the woman in the Ontario case study, said Peter Lurie, MD, MPH, executive director of the nonprofit Center for Science in the Public Interest, which has pressed for increased regulation of supplements.

Clinicians need to keep in mind that patients may need prodding to reveal what supplements they are taking, he said.

“They just think of them as different, somehow not the province of the doctor,” Dr. Lurie said. “For others, they are concerned that the doctors will disapprove. So, they hide it.”

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

A woman’s quest to become pregnant resulted in lead poisoning from an Ayurvedic treatment. The case triggered the seizure of pills from an Ontario natural-products clinic and the issuance of government warnings about the risks of products from this business, according to a new report.

The case highlights the need for collaboration between clinicians and public health authorities to address the potential health risks of supplements, including the presence of lead and other metals in Ayurvedic products, according to the report.

“When consumer products may be contaminated with lead, or when lead exposure is linked to sources in the community, involving public health can facilitate broader actions to reduce and prevent exposures to other people at risk,” wrote report author Julian Gitelman, MD, MPH, a resident physician at the University of Toronto Dalla Lana School of Public Health, and colleagues.

Their case study was published in the Canadian Medical Association Journal.

The researchers detailed what happened after a 39-year-old woman sought medical care for abdominal pain, constipation, nausea, and vomiting. The woman underwent a series of tests, including colonoscopy, laparoscopy, and biopsies of bone marrow and ovarian cysts.

Only later did clinicians home in on the cause of her ailments: the Ayurvedic medications that the patient had been taking daily for more than a year for infertility. Her daily regimen had varied, ranging from a few pills to a dozen pills.

Heavy metals are sometimes intentionally added to Ayurvedic supplements for perceived healing properties, wrote the authors. They cited a previous study of a sample of Ayurvedic pills bought on the Internet from manufacturers based in the United States and India that showed that 21% contained lead, mercury, or arsenic.

A case report published last year in German Medical Weekly raised the same issue.
 

Melatonin gummies

Regulators in many countries struggle to help consumers understand the risks of natural health supplements, and the challenge extends well beyond Ayurvedic products.

There has been a “huge and very troubling increase” in U.S. poison control calls associated with gummy-bear products containing melatonin, said Canadian Senator Stan Kutcher, MD, at a May 11 meeting of Canada’s Standing Senate Committee on Social Affairs, Science, and Technology.

In April, JAMA published a U.S. analysis of melatonin gummy products, Dr. Kutcher noted. In this research letter, investigators reported that one product did not contain detectable levels of melatonin but did contain 31.3 mg of cannabidiol.

In other products, the quantity of melatonin ranged from 74% to 347% of the labeled quantity. A previous Canadian study of 16 melatonin brands found that the actual dose of melatonin ranged from 17% to 478% of the declared quantity, the letter noted.

The May 11 Senate meeting provided a forum for many of the recurring debates about supplements, which also are known as natural health products.

Barry Power, PharmD, editor in chief for the Canadian Pharmacists Association, said that his group was disappointed when Canada excluded natural health products from Vanessa’s Law, which was passed in 2014. This law sought to improve the reporting of adverse reactions to drugs.

“We’re glad this is being revisited now,” Dr. Power told the Senate committee. “Although natural health products are often seen as low risk, we need to keep in mind that ‘low risk’ does not mean ‘no risk,’ and ‘natural’ does not mean ‘safe.’ ”

In contrast, Aaron Skelton, chief executive of the Canadian Health Food Association, spoke against this bid to expand the reach of Vanessa’s Law into natural health products. Canadian lawmakers attached provisions regarding increased oversight of natural health products to a budget package instead of considering them as part of a stand-alone bill.

“Our concern is that the powers that are being discussed have not been reviewed and debated,” Mr. Skelton told Dr. Kutcher. “The potential for overreach and unnecessary regulation is significant, and that deserves debate.”

“Profits should not trump Canadians’ health,” answered Dr. Kutcher, who earlier served as head of the psychiatry department at Dalhousie University in Halifax, N.S.

By June, Vanessa’s Law had been expanded with provisions that address natural health products, including the reporting of products that present a serious risk to consumers.
 

Educating consumers

Many consumers overestimate the level of government regulation of supplements, said Pieter A. Cohen, MD, leader of the Supplement Research Program at Cambridge Health Alliance in Massachusetts. Dr. Cohen was the lead author of the JAMA research letter about melatonin products.

Supplements often share shelves in pharmacies with medicines that are subject to more strict regulation, which causes confusion.

“It’s really hard to wrap your brain around [the fact] that a health product is being sold in pharmacies in the United States and it’s not being vetted by the FDA [U.S. Food and Drug Administration]”, Dr. Cohen said in an interview

The confusion extends across borders. Many consumers in other countries will assume that the FDA performed premarket screening of U.S.-made supplements, but that is not the case, he said.

People who want to take supplements should look for reputable sources of information about them, such as the website of the National Institutes of Health’s Office of Dietary Supplements, Dr. Cohen said. But patients often forget or fail to do this, which can create medical puzzles, such as the case of the woman in the Ontario case study, said Peter Lurie, MD, MPH, executive director of the nonprofit Center for Science in the Public Interest, which has pressed for increased regulation of supplements.

Clinicians need to keep in mind that patients may need prodding to reveal what supplements they are taking, he said.

“They just think of them as different, somehow not the province of the doctor,” Dr. Lurie said. “For others, they are concerned that the doctors will disapprove. So, they hide it.”

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

Thousands of children are being exposed to the dangers of liquid nicotine in e-cigarettes each year, and the number of exposures reported reached an all-time high last year.

Doctors say a 2016 law aimed at lowering the risk contained a big flaw, NBC News reported. The Child Nicotine Poisoning Prevention Act required child-resistant packaging on vaping liquid – but not on the vaping devices themselves.

Contact with the vaping liquid, or liquid nicotine, can cause children to get dizzy, pass out, and suffer drops in blood pressure. A few drops of the liquid can be fatal for a toddler.

Last year, 6,731 cases of vaping-related nicotine exposure were reported, according to Poison Help. “As of June 30, 2023, poison centers have managed 3,863 exposure cases about e-cigarette devices and liquid nicotine,” the organization said.

“Poison centers began receiving calls about e-cigarettes and liquid nicotine products in 2011, which coincides with the initial period where these products reached the U.S. market,” according to Poison Help.

“These products often contain a greater concentration of nicotine, a stimulant, than other nicotine/tobacco products on the market. Some children and toddlers who come in contact with e-cigarette devices or liquid nicotine have become very ill; some even requiring emergency department visits with nausea and vomiting being the most significant symptoms.”

Toxicologist Ryan Marino, MD, told NBC that refillable vapes are designed to hold liquid nicotine in a central reservoir, making them dangerous to children.

“Even vapes that appear more child-resistant – because their nicotine is sealed inside a removable cartridge – present a risk, because the cartridges can be pried open,” NBC said. “And some disposable e-cigarettes, now the top-selling type on the market, allow users to take thousands of ‘puffs’ and contain as much nicotine as multiple packs of cigarettes.”

A spokesperson for the vaping industry said all e-liquid bottles made in this country conform to U.S. law.

“Not only are the caps child-resistant, but the flow of liquid is restricted so that only small amounts can be dispensed,” said April Meyers of the Smoke-Free Alternatives Trade Association, which represents the vaping industry.
 

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

Thousands of children are being exposed to the dangers of liquid nicotine in e-cigarettes each year, and the number of exposures reported reached an all-time high last year.

Doctors say a 2016 law aimed at lowering the risk contained a big flaw, NBC News reported. The Child Nicotine Poisoning Prevention Act required child-resistant packaging on vaping liquid – but not on the vaping devices themselves.

Contact with the vaping liquid, or liquid nicotine, can cause children to get dizzy, pass out, and suffer drops in blood pressure. A few drops of the liquid can be fatal for a toddler.

Last year, 6,731 cases of vaping-related nicotine exposure were reported, according to Poison Help. “As of June 30, 2023, poison centers have managed 3,863 exposure cases about e-cigarette devices and liquid nicotine,” the organization said.

“Poison centers began receiving calls about e-cigarettes and liquid nicotine products in 2011, which coincides with the initial period where these products reached the U.S. market,” according to Poison Help.

“These products often contain a greater concentration of nicotine, a stimulant, than other nicotine/tobacco products on the market. Some children and toddlers who come in contact with e-cigarette devices or liquid nicotine have become very ill; some even requiring emergency department visits with nausea and vomiting being the most significant symptoms.”

Toxicologist Ryan Marino, MD, told NBC that refillable vapes are designed to hold liquid nicotine in a central reservoir, making them dangerous to children.

“Even vapes that appear more child-resistant – because their nicotine is sealed inside a removable cartridge – present a risk, because the cartridges can be pried open,” NBC said. “And some disposable e-cigarettes, now the top-selling type on the market, allow users to take thousands of ‘puffs’ and contain as much nicotine as multiple packs of cigarettes.”

A spokesperson for the vaping industry said all e-liquid bottles made in this country conform to U.S. law.

“Not only are the caps child-resistant, but the flow of liquid is restricted so that only small amounts can be dispensed,” said April Meyers of the Smoke-Free Alternatives Trade Association, which represents the vaping industry.
 

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

Thousands of children are being exposed to the dangers of liquid nicotine in e-cigarettes each year, and the number of exposures reported reached an all-time high last year.

Doctors say a 2016 law aimed at lowering the risk contained a big flaw, NBC News reported. The Child Nicotine Poisoning Prevention Act required child-resistant packaging on vaping liquid – but not on the vaping devices themselves.

Contact with the vaping liquid, or liquid nicotine, can cause children to get dizzy, pass out, and suffer drops in blood pressure. A few drops of the liquid can be fatal for a toddler.

Last year, 6,731 cases of vaping-related nicotine exposure were reported, according to Poison Help. “As of June 30, 2023, poison centers have managed 3,863 exposure cases about e-cigarette devices and liquid nicotine,” the organization said.

“Poison centers began receiving calls about e-cigarettes and liquid nicotine products in 2011, which coincides with the initial period where these products reached the U.S. market,” according to Poison Help.

“These products often contain a greater concentration of nicotine, a stimulant, than other nicotine/tobacco products on the market. Some children and toddlers who come in contact with e-cigarette devices or liquid nicotine have become very ill; some even requiring emergency department visits with nausea and vomiting being the most significant symptoms.”

Toxicologist Ryan Marino, MD, told NBC that refillable vapes are designed to hold liquid nicotine in a central reservoir, making them dangerous to children.

“Even vapes that appear more child-resistant – because their nicotine is sealed inside a removable cartridge – present a risk, because the cartridges can be pried open,” NBC said. “And some disposable e-cigarettes, now the top-selling type on the market, allow users to take thousands of ‘puffs’ and contain as much nicotine as multiple packs of cigarettes.”

A spokesperson for the vaping industry said all e-liquid bottles made in this country conform to U.S. law.

“Not only are the caps child-resistant, but the flow of liquid is restricted so that only small amounts can be dispensed,” said April Meyers of the Smoke-Free Alternatives Trade Association, which represents the vaping industry.
 

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

For children with stroke from large vessel occlusion, thrombectomy may result in better outcomes than medical management alone.

A matched case-control study followed 52 patients in Canada and Australia with acute stroke and assessed functional outcomes at 3 months for those who received thrombectomy, compared with those who did not. Patients receiving the procedure had significantly improved clinical outcomes (odds ratio [OR], 3.76). The procedure is the standard of care for adults with large vessel occlusion (LVO) stroke, but limited data exist for children.  

“In the absence of a randomized trial, this case-control study demonstrates better clinical outcomes with thrombectomy than medical management for pediatric patients aged 2 to 18 years with anterior circulation LVO stroke,” the authors concluded. The study was published in JAMA Neurology.
 

Improved results

Untreated LVO stroke is associated with poor outcomes, indicated in this study with scoring based on the modified Rankin Scale. Based on this scoring, 53.8% of patients who were managed conservatively had poor outcomes (moderate disability or greater) at 3 months, confirming previous findings. The data were drawn from five hospitals in Australia and Canada between January 2011 and April 2022.

Removing blood clots with mechanical thrombectomy resulted in improved outcomes 3 months after stroke for the patients included in the study, compared with the neuroprotective measures of medical therapy alone. The improved outcomes persisted in the final available follow-up (OR, 3.65).

In adults, thrombectomy has previously been demonstrated to be a safe and effective treatment for LVO stroke and is currently the standard of care. This study sought to expand the data for pediatric patients, for whom stroke is rarer and difficult to diagnose.

The authors cautioned, however, that the outcomes are from hospitals with pediatric neurology expertise and should not be generalized to settings without specialists.
 

Case-control study

While previous population-based studies of children with LVO stroke found that conservative treatment was associated with poor outcomes, these studies may include significant selection bias. The investigators chose to conduct the case-control study as an alternative to a randomized control trial, which would require withholding treatment from some patients and would not be considered ethical.

The study included 26 patients in each cohort, either receiving mechanical thrombectomy or medical treatment alone. The investigators matched patients by site and side of occlusion, age, and sex. Cases that could not be matched by site of occlusion, the primary criterion, were excluded.

With this methodology, the investigators reduced the impact of selection bias with the aim of providing “the next highest level of comparative evidence,” they stated in the study. However, they also noted that, without randomization, there is likely still some selection bias present.

The two cohorts were not significantly different based on factors such as sex or age. All patients in the study presented within 24 hours of symptom onset, with most eligible for thrombectomy by adult standards. There was a difference between the two cohorts in the timing of arrival to a dedicated hospital and imaging. “Our triage, imaging, and decision-making pathways require streamlining,” the authors concluded, regarding the difference.
 

‘A heterogeneous condition’

In a comment, Ratika Srivastava, MD, a pediatric neurologist at the University of Alberta, Edmonton, said she was glad to see a well-designed study dedicated to pediatric stroke. Neurologists have traditionally extrapolated from research on adult stroke due to the rarity of pediatric stroke and difficulty of diagnosis.

While physicians have previously relied on findings in adults, stroke presents differently in children. “The challenge is that it’s such a heterogeneous condition,” said Dr. Srivastava, who was not involved in the study. In children, stroke may have several different etiologies, such as a lesion in the heart or arterial disease. “Sometimes it’s amenable to taking the clot out and sometimes it’s not. So you have to figure out: Are they a good candidate for thrombectomy?” This study helps demonstrate that thrombectomy is a good option for some children with LVO stroke, she said.

The study was independently supported. Dr. Srivastava reported no relevant financial relationships.

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

For children with stroke from large vessel occlusion, thrombectomy may result in better outcomes than medical management alone.

A matched case-control study followed 52 patients in Canada and Australia with acute stroke and assessed functional outcomes at 3 months for those who received thrombectomy, compared with those who did not. Patients receiving the procedure had significantly improved clinical outcomes (odds ratio [OR], 3.76). The procedure is the standard of care for adults with large vessel occlusion (LVO) stroke, but limited data exist for children.  

“In the absence of a randomized trial, this case-control study demonstrates better clinical outcomes with thrombectomy than medical management for pediatric patients aged 2 to 18 years with anterior circulation LVO stroke,” the authors concluded. The study was published in JAMA Neurology.
 

Improved results

Untreated LVO stroke is associated with poor outcomes, indicated in this study with scoring based on the modified Rankin Scale. Based on this scoring, 53.8% of patients who were managed conservatively had poor outcomes (moderate disability or greater) at 3 months, confirming previous findings. The data were drawn from five hospitals in Australia and Canada between January 2011 and April 2022.

Removing blood clots with mechanical thrombectomy resulted in improved outcomes 3 months after stroke for the patients included in the study, compared with the neuroprotective measures of medical therapy alone. The improved outcomes persisted in the final available follow-up (OR, 3.65).

In adults, thrombectomy has previously been demonstrated to be a safe and effective treatment for LVO stroke and is currently the standard of care. This study sought to expand the data for pediatric patients, for whom stroke is rarer and difficult to diagnose.

The authors cautioned, however, that the outcomes are from hospitals with pediatric neurology expertise and should not be generalized to settings without specialists.
 

Case-control study

While previous population-based studies of children with LVO stroke found that conservative treatment was associated with poor outcomes, these studies may include significant selection bias. The investigators chose to conduct the case-control study as an alternative to a randomized control trial, which would require withholding treatment from some patients and would not be considered ethical.

The study included 26 patients in each cohort, either receiving mechanical thrombectomy or medical treatment alone. The investigators matched patients by site and side of occlusion, age, and sex. Cases that could not be matched by site of occlusion, the primary criterion, were excluded.

With this methodology, the investigators reduced the impact of selection bias with the aim of providing “the next highest level of comparative evidence,” they stated in the study. However, they also noted that, without randomization, there is likely still some selection bias present.

The two cohorts were not significantly different based on factors such as sex or age. All patients in the study presented within 24 hours of symptom onset, with most eligible for thrombectomy by adult standards. There was a difference between the two cohorts in the timing of arrival to a dedicated hospital and imaging. “Our triage, imaging, and decision-making pathways require streamlining,” the authors concluded, regarding the difference.
 

‘A heterogeneous condition’

In a comment, Ratika Srivastava, MD, a pediatric neurologist at the University of Alberta, Edmonton, said she was glad to see a well-designed study dedicated to pediatric stroke. Neurologists have traditionally extrapolated from research on adult stroke due to the rarity of pediatric stroke and difficulty of diagnosis.

While physicians have previously relied on findings in adults, stroke presents differently in children. “The challenge is that it’s such a heterogeneous condition,” said Dr. Srivastava, who was not involved in the study. In children, stroke may have several different etiologies, such as a lesion in the heart or arterial disease. “Sometimes it’s amenable to taking the clot out and sometimes it’s not. So you have to figure out: Are they a good candidate for thrombectomy?” This study helps demonstrate that thrombectomy is a good option for some children with LVO stroke, she said.

The study was independently supported. Dr. Srivastava reported no relevant financial relationships.

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

For children with stroke from large vessel occlusion, thrombectomy may result in better outcomes than medical management alone.

A matched case-control study followed 52 patients in Canada and Australia with acute stroke and assessed functional outcomes at 3 months for those who received thrombectomy, compared with those who did not. Patients receiving the procedure had significantly improved clinical outcomes (odds ratio [OR], 3.76). The procedure is the standard of care for adults with large vessel occlusion (LVO) stroke, but limited data exist for children.  

“In the absence of a randomized trial, this case-control study demonstrates better clinical outcomes with thrombectomy than medical management for pediatric patients aged 2 to 18 years with anterior circulation LVO stroke,” the authors concluded. The study was published in JAMA Neurology.
 

Improved results

Untreated LVO stroke is associated with poor outcomes, indicated in this study with scoring based on the modified Rankin Scale. Based on this scoring, 53.8% of patients who were managed conservatively had poor outcomes (moderate disability or greater) at 3 months, confirming previous findings. The data were drawn from five hospitals in Australia and Canada between January 2011 and April 2022.

Removing blood clots with mechanical thrombectomy resulted in improved outcomes 3 months after stroke for the patients included in the study, compared with the neuroprotective measures of medical therapy alone. The improved outcomes persisted in the final available follow-up (OR, 3.65).

In adults, thrombectomy has previously been demonstrated to be a safe and effective treatment for LVO stroke and is currently the standard of care. This study sought to expand the data for pediatric patients, for whom stroke is rarer and difficult to diagnose.

The authors cautioned, however, that the outcomes are from hospitals with pediatric neurology expertise and should not be generalized to settings without specialists.
 

Case-control study

While previous population-based studies of children with LVO stroke found that conservative treatment was associated with poor outcomes, these studies may include significant selection bias. The investigators chose to conduct the case-control study as an alternative to a randomized control trial, which would require withholding treatment from some patients and would not be considered ethical.

The study included 26 patients in each cohort, either receiving mechanical thrombectomy or medical treatment alone. The investigators matched patients by site and side of occlusion, age, and sex. Cases that could not be matched by site of occlusion, the primary criterion, were excluded.

With this methodology, the investigators reduced the impact of selection bias with the aim of providing “the next highest level of comparative evidence,” they stated in the study. However, they also noted that, without randomization, there is likely still some selection bias present.

The two cohorts were not significantly different based on factors such as sex or age. All patients in the study presented within 24 hours of symptom onset, with most eligible for thrombectomy by adult standards. There was a difference between the two cohorts in the timing of arrival to a dedicated hospital and imaging. “Our triage, imaging, and decision-making pathways require streamlining,” the authors concluded, regarding the difference.
 

‘A heterogeneous condition’

In a comment, Ratika Srivastava, MD, a pediatric neurologist at the University of Alberta, Edmonton, said she was glad to see a well-designed study dedicated to pediatric stroke. Neurologists have traditionally extrapolated from research on adult stroke due to the rarity of pediatric stroke and difficulty of diagnosis.

While physicians have previously relied on findings in adults, stroke presents differently in children. “The challenge is that it’s such a heterogeneous condition,” said Dr. Srivastava, who was not involved in the study. In children, stroke may have several different etiologies, such as a lesion in the heart or arterial disease. “Sometimes it’s amenable to taking the clot out and sometimes it’s not. So you have to figure out: Are they a good candidate for thrombectomy?” This study helps demonstrate that thrombectomy is a good option for some children with LVO stroke, she said.

The study was independently supported. Dr. Srivastava reported no relevant financial relationships.

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

It seemed like a typical kind of day. I was out the door by 6:00 a.m., heading into work for a shift on I-35 West, my daily commute. It was still dark out. A little bit colder that morning, but nothing us Texans aren’t used to.

I was cruising down the tollway, which is separated from the main highway by a barrier. That stretch has a slight hill and turns to the left. You can’t see anything beyond the hill when you’re at the bottom.

As I made my way up, I spotted brake lights about 400 yards ahead. I eased on my brake, and next thing I knew, I was sliding.

I realized, I’m on black ice.

I was driving a 2011 Toyota FJ Cruiser and I had it all beefed up – lift tires, winch bumpers front and back. I had never had any sort of issue like that.

My ABS brakes kicked in. I slowed, but not fast enough. I saw a wall of crashed cars in front of me.

I was in the left-hand lane, so I turned my steering wheel into the center median. I could hear the whole side of my vehicle scraping against it. I managed to slow down enough to just tap the vehicle in front of me.

I looked in my passenger side-view mirror and saw headlights coming in the right lane. But this car couldn’t slow down. It crashed into the wreckage to my right.

That’s when it sunk in: There was going to be a car coming in my lane, and it might not be able to stop.

I looked in my rear-view mirror and saw headlights. Sparks flying off that center median.

I didn’t know at the time, but it was a fully loaded semi-truck traveling about 60 miles an hour.

I had a split second to think: This is it. This is how it ends. I closed my eyes.

It was the most violent impact I’ve ever experienced in my life.

I had no idea until afterward, but I had slammed into the vehicle in front of me and my SUV did a kind of 360° barrel roll over the median into the northbound lanes, landing wheels down on top of my sheared off roof rack.

Everything stopped. I opened my eyes. All my airbags had deployed. I gently tried moving my arms and legs, and they worked. I couldn’t move my left foot. It was wedged underneath the brake pedal. But I wasn’t in any pain, just very confused and disoriented. I knew I needed to get out of the vehicle.

My door was wedged shut, so I crawled out of the broken window, slipping on the black ice. I realized I had hit a Fort Worth police cruiser, now all smashed up. The driver couldn’t open his door. So, I helped him force it open, got him out of the vehicle, and checked on him. He was fine.

I had no idea how many vehicles and people were involved. I was in so much shock that the only thing I could do was immediately revert back to my training. I was the only first responder there. No ambulances on scene yet, no fire. So, I did what I know how to do – except without any tools. I tried to triage as many people as I could.

I was helping people with lacerations, back and neck issues from the violent impacts. When you’re involved in a mass casualty incident like that, you have to assess which patients will be the most viable and need the most immediate attention. You have greens, yellows, reds, and then blacks – the deceased. Someone who doesn’t have a pulse and isn’t breathing, you can’t necessarily do CPR because you don’t have enough resources. You have to use your best judgment.

Meanwhile, the crashes kept coming. I found out later I was roughly vehicle No. 50 in the pileup; 83 more would follow. I heard them over and over – a crash and then screams from people in their vehicles. Each time a car hit, the entire pileup would move a couple of inches, getting more and more compacted. With that going on, I couldn’t go in there to pull people out. That scene was absolutely unsafe.

It felt like forever, but about 10 minutes later, an ambulance showed up, and I walked over to them. Because I was in my work uniform, they thought I was there on a call.

A couple fire crews came, and a firefighter yelled, “Hey, we need a backboard!” So, I grabbed a backboard from their unit and helped load up a patient. Then I heard somebody screaming, “This patient needs a stretcher!” A woman was having lumbar pain that seemed excruciating. I helped move her from the wreckage and carry her over to the stretcher. I started trying to get as many people as I could out of their cars.

Around this time, one of my supervisors showed up. He thought I was there working. But then he asked me, “Why is your face bleeding? Why do you have blood coming from your nose?” I pointed to my vehicle, and his jaw just dropped. He said, “Okay, you’re done. Go sit in my vehicle over there.”

He put a stop to my helping out, which was probably for the best. Because I actually had a concussion, a bone contusion in my foot, and a severely sprained ankle. The next day, I felt like I had gotten hit by a truck. (I had!) But when you have so much adrenaline pumping, you don’t feel pain or emotion. You don’t really feel anything.

While I was sitting in that vehicle, I called my mom to let her know I was okay. My parents were watching the news, and there was an aerial view of the accident. It was massive – a giant pile of metal stretching 200 or 300 yards. Six people had perished, more than 60 were hurt.

That night, our public information officer reached out to me about doing an interview with NBC. So, I told my story about what happened. Because of the concussion, a lot of it was a blur.

A day later, I got a call on my cell phone and someone said, “This is Tyler from Toyota. We saw the NBC interview. We wanted to let you know, don’t worry about getting a new vehicle. Just tell us what color 4Runner you want.”

My first thought was: Okay, this can’t be real. This doesn’t happen to people like me. But it turned out that it was, and they put me in a brand new vehicle.

Toyota started sending me to events like NASCAR races, putting me up in VIP suites. It was a cool experience. But it’s just surface stuff – it’s never going to erase what happened. The experience left a mark. It took me 6 months to a year to get rid of that feeling of the impact. Every time I tried to fall asleep, the whole scenario would replay in my head.

In EMS, we have a saying: “Every patient is practice for the next one.” That pileup – you can’t train for something like that. We all learned from it, so we can better prepare if anything like that happens again.

Since then, I’ve seen people die in motor vehicle collisions from a lot less than what happened to me. I’m not religious or spiritual, but I believe there must be a reason why I’m still here.

Now I see patients in traffic accidents who are very distraught even though they’re going to be okay. I tell them, “I’m sorry this happened to you. But remember, this is not the end. You are alive. And I’m going to do everything I can to make sure that doesn’t change while you’re with me.”
 

Trey McDaniel is a paramedic with MedStar Mobile Healthcare in Fort Worth, Tex.

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

It seemed like a typical kind of day. I was out the door by 6:00 a.m., heading into work for a shift on I-35 West, my daily commute. It was still dark out. A little bit colder that morning, but nothing us Texans aren’t used to.

I was cruising down the tollway, which is separated from the main highway by a barrier. That stretch has a slight hill and turns to the left. You can’t see anything beyond the hill when you’re at the bottom.

As I made my way up, I spotted brake lights about 400 yards ahead. I eased on my brake, and next thing I knew, I was sliding.

I realized, I’m on black ice.

I was driving a 2011 Toyota FJ Cruiser and I had it all beefed up – lift tires, winch bumpers front and back. I had never had any sort of issue like that.

My ABS brakes kicked in. I slowed, but not fast enough. I saw a wall of crashed cars in front of me.

I was in the left-hand lane, so I turned my steering wheel into the center median. I could hear the whole side of my vehicle scraping against it. I managed to slow down enough to just tap the vehicle in front of me.

I looked in my passenger side-view mirror and saw headlights coming in the right lane. But this car couldn’t slow down. It crashed into the wreckage to my right.

That’s when it sunk in: There was going to be a car coming in my lane, and it might not be able to stop.

I looked in my rear-view mirror and saw headlights. Sparks flying off that center median.

I didn’t know at the time, but it was a fully loaded semi-truck traveling about 60 miles an hour.

I had a split second to think: This is it. This is how it ends. I closed my eyes.

It was the most violent impact I’ve ever experienced in my life.

I had no idea until afterward, but I had slammed into the vehicle in front of me and my SUV did a kind of 360° barrel roll over the median into the northbound lanes, landing wheels down on top of my sheared off roof rack.

Everything stopped. I opened my eyes. All my airbags had deployed. I gently tried moving my arms and legs, and they worked. I couldn’t move my left foot. It was wedged underneath the brake pedal. But I wasn’t in any pain, just very confused and disoriented. I knew I needed to get out of the vehicle.

My door was wedged shut, so I crawled out of the broken window, slipping on the black ice. I realized I had hit a Fort Worth police cruiser, now all smashed up. The driver couldn’t open his door. So, I helped him force it open, got him out of the vehicle, and checked on him. He was fine.

I had no idea how many vehicles and people were involved. I was in so much shock that the only thing I could do was immediately revert back to my training. I was the only first responder there. No ambulances on scene yet, no fire. So, I did what I know how to do – except without any tools. I tried to triage as many people as I could.

I was helping people with lacerations, back and neck issues from the violent impacts. When you’re involved in a mass casualty incident like that, you have to assess which patients will be the most viable and need the most immediate attention. You have greens, yellows, reds, and then blacks – the deceased. Someone who doesn’t have a pulse and isn’t breathing, you can’t necessarily do CPR because you don’t have enough resources. You have to use your best judgment.

Meanwhile, the crashes kept coming. I found out later I was roughly vehicle No. 50 in the pileup; 83 more would follow. I heard them over and over – a crash and then screams from people in their vehicles. Each time a car hit, the entire pileup would move a couple of inches, getting more and more compacted. With that going on, I couldn’t go in there to pull people out. That scene was absolutely unsafe.

It felt like forever, but about 10 minutes later, an ambulance showed up, and I walked over to them. Because I was in my work uniform, they thought I was there on a call.

A couple fire crews came, and a firefighter yelled, “Hey, we need a backboard!” So, I grabbed a backboard from their unit and helped load up a patient. Then I heard somebody screaming, “This patient needs a stretcher!” A woman was having lumbar pain that seemed excruciating. I helped move her from the wreckage and carry her over to the stretcher. I started trying to get as many people as I could out of their cars.

Around this time, one of my supervisors showed up. He thought I was there working. But then he asked me, “Why is your face bleeding? Why do you have blood coming from your nose?” I pointed to my vehicle, and his jaw just dropped. He said, “Okay, you’re done. Go sit in my vehicle over there.”

He put a stop to my helping out, which was probably for the best. Because I actually had a concussion, a bone contusion in my foot, and a severely sprained ankle. The next day, I felt like I had gotten hit by a truck. (I had!) But when you have so much adrenaline pumping, you don’t feel pain or emotion. You don’t really feel anything.

While I was sitting in that vehicle, I called my mom to let her know I was okay. My parents were watching the news, and there was an aerial view of the accident. It was massive – a giant pile of metal stretching 200 or 300 yards. Six people had perished, more than 60 were hurt.

That night, our public information officer reached out to me about doing an interview with NBC. So, I told my story about what happened. Because of the concussion, a lot of it was a blur.

A day later, I got a call on my cell phone and someone said, “This is Tyler from Toyota. We saw the NBC interview. We wanted to let you know, don’t worry about getting a new vehicle. Just tell us what color 4Runner you want.”

My first thought was: Okay, this can’t be real. This doesn’t happen to people like me. But it turned out that it was, and they put me in a brand new vehicle.

Toyota started sending me to events like NASCAR races, putting me up in VIP suites. It was a cool experience. But it’s just surface stuff – it’s never going to erase what happened. The experience left a mark. It took me 6 months to a year to get rid of that feeling of the impact. Every time I tried to fall asleep, the whole scenario would replay in my head.

In EMS, we have a saying: “Every patient is practice for the next one.” That pileup – you can’t train for something like that. We all learned from it, so we can better prepare if anything like that happens again.

Since then, I’ve seen people die in motor vehicle collisions from a lot less than what happened to me. I’m not religious or spiritual, but I believe there must be a reason why I’m still here.

Now I see patients in traffic accidents who are very distraught even though they’re going to be okay. I tell them, “I’m sorry this happened to you. But remember, this is not the end. You are alive. And I’m going to do everything I can to make sure that doesn’t change while you’re with me.”
 

Trey McDaniel is a paramedic with MedStar Mobile Healthcare in Fort Worth, Tex.

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

It seemed like a typical kind of day. I was out the door by 6:00 a.m., heading into work for a shift on I-35 West, my daily commute. It was still dark out. A little bit colder that morning, but nothing us Texans aren’t used to.

I was cruising down the tollway, which is separated from the main highway by a barrier. That stretch has a slight hill and turns to the left. You can’t see anything beyond the hill when you’re at the bottom.

As I made my way up, I spotted brake lights about 400 yards ahead. I eased on my brake, and next thing I knew, I was sliding.

I realized, I’m on black ice.

I was driving a 2011 Toyota FJ Cruiser and I had it all beefed up – lift tires, winch bumpers front and back. I had never had any sort of issue like that.

My ABS brakes kicked in. I slowed, but not fast enough. I saw a wall of crashed cars in front of me.

I was in the left-hand lane, so I turned my steering wheel into the center median. I could hear the whole side of my vehicle scraping against it. I managed to slow down enough to just tap the vehicle in front of me.

I looked in my passenger side-view mirror and saw headlights coming in the right lane. But this car couldn’t slow down. It crashed into the wreckage to my right.

That’s when it sunk in: There was going to be a car coming in my lane, and it might not be able to stop.

I looked in my rear-view mirror and saw headlights. Sparks flying off that center median.

I didn’t know at the time, but it was a fully loaded semi-truck traveling about 60 miles an hour.

I had a split second to think: This is it. This is how it ends. I closed my eyes.

It was the most violent impact I’ve ever experienced in my life.

I had no idea until afterward, but I had slammed into the vehicle in front of me and my SUV did a kind of 360° barrel roll over the median into the northbound lanes, landing wheels down on top of my sheared off roof rack.

Everything stopped. I opened my eyes. All my airbags had deployed. I gently tried moving my arms and legs, and they worked. I couldn’t move my left foot. It was wedged underneath the brake pedal. But I wasn’t in any pain, just very confused and disoriented. I knew I needed to get out of the vehicle.

My door was wedged shut, so I crawled out of the broken window, slipping on the black ice. I realized I had hit a Fort Worth police cruiser, now all smashed up. The driver couldn’t open his door. So, I helped him force it open, got him out of the vehicle, and checked on him. He was fine.

I had no idea how many vehicles and people were involved. I was in so much shock that the only thing I could do was immediately revert back to my training. I was the only first responder there. No ambulances on scene yet, no fire. So, I did what I know how to do – except without any tools. I tried to triage as many people as I could.

I was helping people with lacerations, back and neck issues from the violent impacts. When you’re involved in a mass casualty incident like that, you have to assess which patients will be the most viable and need the most immediate attention. You have greens, yellows, reds, and then blacks – the deceased. Someone who doesn’t have a pulse and isn’t breathing, you can’t necessarily do CPR because you don’t have enough resources. You have to use your best judgment.

Meanwhile, the crashes kept coming. I found out later I was roughly vehicle No. 50 in the pileup; 83 more would follow. I heard them over and over – a crash and then screams from people in their vehicles. Each time a car hit, the entire pileup would move a couple of inches, getting more and more compacted. With that going on, I couldn’t go in there to pull people out. That scene was absolutely unsafe.

It felt like forever, but about 10 minutes later, an ambulance showed up, and I walked over to them. Because I was in my work uniform, they thought I was there on a call.

A couple fire crews came, and a firefighter yelled, “Hey, we need a backboard!” So, I grabbed a backboard from their unit and helped load up a patient. Then I heard somebody screaming, “This patient needs a stretcher!” A woman was having lumbar pain that seemed excruciating. I helped move her from the wreckage and carry her over to the stretcher. I started trying to get as many people as I could out of their cars.

Around this time, one of my supervisors showed up. He thought I was there working. But then he asked me, “Why is your face bleeding? Why do you have blood coming from your nose?” I pointed to my vehicle, and his jaw just dropped. He said, “Okay, you’re done. Go sit in my vehicle over there.”

He put a stop to my helping out, which was probably for the best. Because I actually had a concussion, a bone contusion in my foot, and a severely sprained ankle. The next day, I felt like I had gotten hit by a truck. (I had!) But when you have so much adrenaline pumping, you don’t feel pain or emotion. You don’t really feel anything.

While I was sitting in that vehicle, I called my mom to let her know I was okay. My parents were watching the news, and there was an aerial view of the accident. It was massive – a giant pile of metal stretching 200 or 300 yards. Six people had perished, more than 60 were hurt.

That night, our public information officer reached out to me about doing an interview with NBC. So, I told my story about what happened. Because of the concussion, a lot of it was a blur.

A day later, I got a call on my cell phone and someone said, “This is Tyler from Toyota. We saw the NBC interview. We wanted to let you know, don’t worry about getting a new vehicle. Just tell us what color 4Runner you want.”

My first thought was: Okay, this can’t be real. This doesn’t happen to people like me. But it turned out that it was, and they put me in a brand new vehicle.

Toyota started sending me to events like NASCAR races, putting me up in VIP suites. It was a cool experience. But it’s just surface stuff – it’s never going to erase what happened. The experience left a mark. It took me 6 months to a year to get rid of that feeling of the impact. Every time I tried to fall asleep, the whole scenario would replay in my head.

In EMS, we have a saying: “Every patient is practice for the next one.” That pileup – you can’t train for something like that. We all learned from it, so we can better prepare if anything like that happens again.

Since then, I’ve seen people die in motor vehicle collisions from a lot less than what happened to me. I’m not religious or spiritual, but I believe there must be a reason why I’m still here.

Now I see patients in traffic accidents who are very distraught even though they’re going to be okay. I tell them, “I’m sorry this happened to you. But remember, this is not the end. You are alive. And I’m going to do everything I can to make sure that doesn’t change while you’re with me.”
 

Trey McDaniel is a paramedic with MedStar Mobile Healthcare in Fort Worth, Tex.

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