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Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.
Clinicians urged to use CURE ID to report COVID-19 cases
in conjunction with ongoing clinical trial efforts.
“By utilizing the CURE ID platform now for COVID-19 case collection – in conjunction with data gathered from other registries, EHR systems, and clinical trials – data collected during an outbreak can be improved and coordinated,” Heather A. Stone, MPH, said during a June 9 webinar sponsored by the Food and Drug Administration. “This may allow us to find possible treatments to help ease this pandemic, and prepare us better to fight the next one.”
During the hour-long webinar, Ms. Stone, a health science policy analyst in the office of medical policy at the FDA’s Center for Drug Evaluation and Research, demonstrated CURE ID, an Internet-based data repository first developed in 2013 as a collaboration between the FDA and the National Center for Advancing Translational Sciences, a part of the National Institutes of Health (NCATS/NIH). It provides licensed clinicians worldwide with an opportunity to report novel uses of existing drugs for patients with difficult-to-treat infectious diseases, including COVID-19, through a website, a smartphone, or other mobile device. The app can be downloaded for free at http://cure.ncats.io. It can also be downloaded from the Apple app store or the Google Play store by searching “CURE ID.”
According to Ms. Stone, the platform’s three main goals are to enhance the understanding of new uses of approved medical products, to facilitate clinical trials and drug development, and to serve as a resource for physicians to share information where no FDA-approved product (which has been proven to be safe and effective) exists for the new use. CURE ID enables users to report their own cases as well as read cases of neglected infectious diseases with no sufficient approved therapies from other clinicians around the world. “It also enables clinicians to engage directly with communities of disease experts around the world, breaking down geographic and specialty silos,” Ms. Stone said. “It also enables them to access information on approved therapies for each disease and as well on active clinical trials.”
To date, CURE-ID contains information on 325 infectious diseases, including 1,580 case reports and 18,907 clinical trials. Initial pilot priority diseases include COVID-19, mycetoma, atypical mycobacteria, drug-resistant gonorrhea, rare and resistant fungal infections, as well as multidrug resistant gram-negative bacteria.
As of June 9, COVID-19-related data on the platform includes 151 case reports that have been extracted from the published literature or entered by clinician users, 80 discussion posts, and links to 694 clinical trials, 303 journal articles, 212 news articles, and 34 events. A total of 65 repurposed drugs have been identified as potential treatments for the virus, including 15 drugs with 10 or more cases.
“This facilitates clinicians reporting their real-world experiences treating COVID-19 patients, when patients are unable to be enrolled in a clinical trial,” Ms. Stone said. “It includes an updated case report form tailored to COVID-19 and data fields that have been harmonized with other real-world data and clinical trial platforms.” She pointed out that voluntary submission of cases to CURE ID is not a substitute for filing information with regulatory and public health authorities, where required. The platform also enables data to be entered and adverse events to be automatically shared with the FDA’s MedWatch Adverse Reporting System.
Ms. Stone concluded the webinar by announcing the formation of a new private-public partnership between the Critical Path Institute and the FDA and NCATS/NIH known as the CURE Drug Repurposing Collaboratory. The effort will begin with a pilot project focused on furthering drug development for COVID-19 through use of the CURE ID platform. “The Collaboratory will demonstrate how data shared from clinicians in real-time can be used to inform ongoing and future clinical trials, and potentially drug labeling,” Ms. Stone said. She reported having no financial disclosures.
in conjunction with ongoing clinical trial efforts.
“By utilizing the CURE ID platform now for COVID-19 case collection – in conjunction with data gathered from other registries, EHR systems, and clinical trials – data collected during an outbreak can be improved and coordinated,” Heather A. Stone, MPH, said during a June 9 webinar sponsored by the Food and Drug Administration. “This may allow us to find possible treatments to help ease this pandemic, and prepare us better to fight the next one.”
During the hour-long webinar, Ms. Stone, a health science policy analyst in the office of medical policy at the FDA’s Center for Drug Evaluation and Research, demonstrated CURE ID, an Internet-based data repository first developed in 2013 as a collaboration between the FDA and the National Center for Advancing Translational Sciences, a part of the National Institutes of Health (NCATS/NIH). It provides licensed clinicians worldwide with an opportunity to report novel uses of existing drugs for patients with difficult-to-treat infectious diseases, including COVID-19, through a website, a smartphone, or other mobile device. The app can be downloaded for free at http://cure.ncats.io. It can also be downloaded from the Apple app store or the Google Play store by searching “CURE ID.”
According to Ms. Stone, the platform’s three main goals are to enhance the understanding of new uses of approved medical products, to facilitate clinical trials and drug development, and to serve as a resource for physicians to share information where no FDA-approved product (which has been proven to be safe and effective) exists for the new use. CURE ID enables users to report their own cases as well as read cases of neglected infectious diseases with no sufficient approved therapies from other clinicians around the world. “It also enables clinicians to engage directly with communities of disease experts around the world, breaking down geographic and specialty silos,” Ms. Stone said. “It also enables them to access information on approved therapies for each disease and as well on active clinical trials.”
To date, CURE-ID contains information on 325 infectious diseases, including 1,580 case reports and 18,907 clinical trials. Initial pilot priority diseases include COVID-19, mycetoma, atypical mycobacteria, drug-resistant gonorrhea, rare and resistant fungal infections, as well as multidrug resistant gram-negative bacteria.
As of June 9, COVID-19-related data on the platform includes 151 case reports that have been extracted from the published literature or entered by clinician users, 80 discussion posts, and links to 694 clinical trials, 303 journal articles, 212 news articles, and 34 events. A total of 65 repurposed drugs have been identified as potential treatments for the virus, including 15 drugs with 10 or more cases.
“This facilitates clinicians reporting their real-world experiences treating COVID-19 patients, when patients are unable to be enrolled in a clinical trial,” Ms. Stone said. “It includes an updated case report form tailored to COVID-19 and data fields that have been harmonized with other real-world data and clinical trial platforms.” She pointed out that voluntary submission of cases to CURE ID is not a substitute for filing information with regulatory and public health authorities, where required. The platform also enables data to be entered and adverse events to be automatically shared with the FDA’s MedWatch Adverse Reporting System.
Ms. Stone concluded the webinar by announcing the formation of a new private-public partnership between the Critical Path Institute and the FDA and NCATS/NIH known as the CURE Drug Repurposing Collaboratory. The effort will begin with a pilot project focused on furthering drug development for COVID-19 through use of the CURE ID platform. “The Collaboratory will demonstrate how data shared from clinicians in real-time can be used to inform ongoing and future clinical trials, and potentially drug labeling,” Ms. Stone said. She reported having no financial disclosures.
in conjunction with ongoing clinical trial efforts.
“By utilizing the CURE ID platform now for COVID-19 case collection – in conjunction with data gathered from other registries, EHR systems, and clinical trials – data collected during an outbreak can be improved and coordinated,” Heather A. Stone, MPH, said during a June 9 webinar sponsored by the Food and Drug Administration. “This may allow us to find possible treatments to help ease this pandemic, and prepare us better to fight the next one.”
During the hour-long webinar, Ms. Stone, a health science policy analyst in the office of medical policy at the FDA’s Center for Drug Evaluation and Research, demonstrated CURE ID, an Internet-based data repository first developed in 2013 as a collaboration between the FDA and the National Center for Advancing Translational Sciences, a part of the National Institutes of Health (NCATS/NIH). It provides licensed clinicians worldwide with an opportunity to report novel uses of existing drugs for patients with difficult-to-treat infectious diseases, including COVID-19, through a website, a smartphone, or other mobile device. The app can be downloaded for free at http://cure.ncats.io. It can also be downloaded from the Apple app store or the Google Play store by searching “CURE ID.”
According to Ms. Stone, the platform’s three main goals are to enhance the understanding of new uses of approved medical products, to facilitate clinical trials and drug development, and to serve as a resource for physicians to share information where no FDA-approved product (which has been proven to be safe and effective) exists for the new use. CURE ID enables users to report their own cases as well as read cases of neglected infectious diseases with no sufficient approved therapies from other clinicians around the world. “It also enables clinicians to engage directly with communities of disease experts around the world, breaking down geographic and specialty silos,” Ms. Stone said. “It also enables them to access information on approved therapies for each disease and as well on active clinical trials.”
To date, CURE-ID contains information on 325 infectious diseases, including 1,580 case reports and 18,907 clinical trials. Initial pilot priority diseases include COVID-19, mycetoma, atypical mycobacteria, drug-resistant gonorrhea, rare and resistant fungal infections, as well as multidrug resistant gram-negative bacteria.
As of June 9, COVID-19-related data on the platform includes 151 case reports that have been extracted from the published literature or entered by clinician users, 80 discussion posts, and links to 694 clinical trials, 303 journal articles, 212 news articles, and 34 events. A total of 65 repurposed drugs have been identified as potential treatments for the virus, including 15 drugs with 10 or more cases.
“This facilitates clinicians reporting their real-world experiences treating COVID-19 patients, when patients are unable to be enrolled in a clinical trial,” Ms. Stone said. “It includes an updated case report form tailored to COVID-19 and data fields that have been harmonized with other real-world data and clinical trial platforms.” She pointed out that voluntary submission of cases to CURE ID is not a substitute for filing information with regulatory and public health authorities, where required. The platform also enables data to be entered and adverse events to be automatically shared with the FDA’s MedWatch Adverse Reporting System.
Ms. Stone concluded the webinar by announcing the formation of a new private-public partnership between the Critical Path Institute and the FDA and NCATS/NIH known as the CURE Drug Repurposing Collaboratory. The effort will begin with a pilot project focused on furthering drug development for COVID-19 through use of the CURE ID platform. “The Collaboratory will demonstrate how data shared from clinicians in real-time can be used to inform ongoing and future clinical trials, and potentially drug labeling,” Ms. Stone said. She reported having no financial disclosures.
Former smokers using e-cigarettes at risk for cigarette smoking relapse
The use of , results from a large longitudinal cohort study demonstrated.
“For the many clinicians treating former smokers who have successfully quit all nicotine products, the implications are that use of [electronic nicotine delivery systems] should be discouraged, just as use of all other tobacco products is discouraged,” researchers led by Colm D. Everard, PhD, reported in a study published in JAMA Network Open (2020 Jun 5. doi: 10.1001/jamanetworkopen.2020.4813).
Dr. Everard, of the National Institute on Drug Abuse, and colleagues based their comments on results from a survey of adult former smokers who participated in Waves 1-4 of the Population Assessment of Tobacco and Health (PATH) Study (2013-2018). They limited the analysis to 2,273 former cigarette smokers who self-reported reported no tobacco product use at Wave 1, and categorized them as recent former smokers (defined as having last smoked within the past 12 previous months) or as long-term former smokers (defined as having last smoked for longer ago than in the previous 12 months). The main outcome of interest was the self-reported current use of cigarettes at follow-up interviews, which was defined as every day or some days. Electronic nicotine delivery systems (ENDS) comprised e-cigarettes, e-cigars, e-pipes, and e-hookahs. Other tobacco products included cigars, pipe tobacco, hookahs, snus tobacco, other smokeless tobacco, and dissolvable tobacco.
Of the 2,273 adult former smokers, 52% were women, 60% were older than age 50, and 80% were non-Hispanic white. Adjusted hazard ratio (AHR) analysis revealed that the use of ENDS was associated with significant risk of cigarette smoking relapse among recent former smokers (AHR 1.63) and among long-term former smokers (AHR 3.79). The use of other tobacco products was associated with significant risk for cigarette smoking relapse among recent former smokers (AHR 1.97) and among long-term former smokers (AHR 3.82).
The authors acknowledged certain limitations of the study, including the fact that it did not assess different ENDS devices, different e-liquid nicotine levels, or frequency of ENDS use and their associations with cigarette smoking relapse. It also did not explore the mechanism by which ENDS use may lead to reestablishing or reinforcing nicotine-seeking behavior among former cigarette users. “Determining pharmacologic, behavioral, or some other explanation for these findings may require laboratory-based research,” they wrote.
The PATH Study is supported with federal funds from the National Institute on Drug Abuse, the National Institutes of Health, and the Food and Drug Administration and Department of Health and Human Services under a contract to Westat. One of the study authors, Wilson M. Compton, MD, reported having long-term stock holdings in General Electric, 3M, and Pfizer. The other authors reported having no financial disclosures.
The use of , results from a large longitudinal cohort study demonstrated.
“For the many clinicians treating former smokers who have successfully quit all nicotine products, the implications are that use of [electronic nicotine delivery systems] should be discouraged, just as use of all other tobacco products is discouraged,” researchers led by Colm D. Everard, PhD, reported in a study published in JAMA Network Open (2020 Jun 5. doi: 10.1001/jamanetworkopen.2020.4813).
Dr. Everard, of the National Institute on Drug Abuse, and colleagues based their comments on results from a survey of adult former smokers who participated in Waves 1-4 of the Population Assessment of Tobacco and Health (PATH) Study (2013-2018). They limited the analysis to 2,273 former cigarette smokers who self-reported reported no tobacco product use at Wave 1, and categorized them as recent former smokers (defined as having last smoked within the past 12 previous months) or as long-term former smokers (defined as having last smoked for longer ago than in the previous 12 months). The main outcome of interest was the self-reported current use of cigarettes at follow-up interviews, which was defined as every day or some days. Electronic nicotine delivery systems (ENDS) comprised e-cigarettes, e-cigars, e-pipes, and e-hookahs. Other tobacco products included cigars, pipe tobacco, hookahs, snus tobacco, other smokeless tobacco, and dissolvable tobacco.
Of the 2,273 adult former smokers, 52% were women, 60% were older than age 50, and 80% were non-Hispanic white. Adjusted hazard ratio (AHR) analysis revealed that the use of ENDS was associated with significant risk of cigarette smoking relapse among recent former smokers (AHR 1.63) and among long-term former smokers (AHR 3.79). The use of other tobacco products was associated with significant risk for cigarette smoking relapse among recent former smokers (AHR 1.97) and among long-term former smokers (AHR 3.82).
The authors acknowledged certain limitations of the study, including the fact that it did not assess different ENDS devices, different e-liquid nicotine levels, or frequency of ENDS use and their associations with cigarette smoking relapse. It also did not explore the mechanism by which ENDS use may lead to reestablishing or reinforcing nicotine-seeking behavior among former cigarette users. “Determining pharmacologic, behavioral, or some other explanation for these findings may require laboratory-based research,” they wrote.
The PATH Study is supported with federal funds from the National Institute on Drug Abuse, the National Institutes of Health, and the Food and Drug Administration and Department of Health and Human Services under a contract to Westat. One of the study authors, Wilson M. Compton, MD, reported having long-term stock holdings in General Electric, 3M, and Pfizer. The other authors reported having no financial disclosures.
The use of , results from a large longitudinal cohort study demonstrated.
“For the many clinicians treating former smokers who have successfully quit all nicotine products, the implications are that use of [electronic nicotine delivery systems] should be discouraged, just as use of all other tobacco products is discouraged,” researchers led by Colm D. Everard, PhD, reported in a study published in JAMA Network Open (2020 Jun 5. doi: 10.1001/jamanetworkopen.2020.4813).
Dr. Everard, of the National Institute on Drug Abuse, and colleagues based their comments on results from a survey of adult former smokers who participated in Waves 1-4 of the Population Assessment of Tobacco and Health (PATH) Study (2013-2018). They limited the analysis to 2,273 former cigarette smokers who self-reported reported no tobacco product use at Wave 1, and categorized them as recent former smokers (defined as having last smoked within the past 12 previous months) or as long-term former smokers (defined as having last smoked for longer ago than in the previous 12 months). The main outcome of interest was the self-reported current use of cigarettes at follow-up interviews, which was defined as every day or some days. Electronic nicotine delivery systems (ENDS) comprised e-cigarettes, e-cigars, e-pipes, and e-hookahs. Other tobacco products included cigars, pipe tobacco, hookahs, snus tobacco, other smokeless tobacco, and dissolvable tobacco.
Of the 2,273 adult former smokers, 52% were women, 60% were older than age 50, and 80% were non-Hispanic white. Adjusted hazard ratio (AHR) analysis revealed that the use of ENDS was associated with significant risk of cigarette smoking relapse among recent former smokers (AHR 1.63) and among long-term former smokers (AHR 3.79). The use of other tobacco products was associated with significant risk for cigarette smoking relapse among recent former smokers (AHR 1.97) and among long-term former smokers (AHR 3.82).
The authors acknowledged certain limitations of the study, including the fact that it did not assess different ENDS devices, different e-liquid nicotine levels, or frequency of ENDS use and their associations with cigarette smoking relapse. It also did not explore the mechanism by which ENDS use may lead to reestablishing or reinforcing nicotine-seeking behavior among former cigarette users. “Determining pharmacologic, behavioral, or some other explanation for these findings may require laboratory-based research,” they wrote.
The PATH Study is supported with federal funds from the National Institute on Drug Abuse, the National Institutes of Health, and the Food and Drug Administration and Department of Health and Human Services under a contract to Westat. One of the study authors, Wilson M. Compton, MD, reported having long-term stock holdings in General Electric, 3M, and Pfizer. The other authors reported having no financial disclosures.
FROM JAMA NETWORK OPEN
Low IgG levels in COPD patients linked to increased risk of hospitalization
Among patients with COPD, the presence of hypogammaglobulinemia confers a nearly 30% increased risk of hospitalization, results from a pooled analysis of four studies showed.
“Mechanistic studies are still warranted to better elucidate how IgG and other immunoglobulins, in particular IgA, may contribute to the local airway host defense,” researchers led by Fernando Sergio Leitao Filho, MD, PhD, wrote in a study published in Chest (2020 May 18. doi: 10.1016/j.chest.2020.04.058). “Nevertheless, our results raise the possibility that, in select COPD patients, IgG replacement therapy may be effective in reducing the risk of COPD hospitalizations. Given the growing rate of COPD hospitalization in the U.S. and elsewhere, there is a pressing need for a large well-designed trial to test this hypothesis.”
In an effort to evaluate the effect of IgG levels on the cumulative incidence of COPD hospitalizations, Dr. Leitao Filho, of the University of British Columbia, Vancouver, and colleagues drew from 2,259 patients who participated in four different trials: Azithromycin for Prevention of Exacerbations of COPD (MACRO), Simvastatin for the Prevention of Exacerbations in Moderate and Severe COPD (STATCOPE), the Long-Term Oxygen Treatment Trial (LOTT), and COPD Activity: Serotonin Transporter, Cytokines and Depression (CASCADE). The mean baseline age of study participants was 66 years, and 641 (28.4%) had hypogammaglobulinemia, which was defined as having a serum IgG levels of less than 7.0 g/L, while the remainder had normal IgG levels.
The pooled meta-analysis, which is believed to be the largest of its kind, revealed that the presence of hypogammaglobulinemia was associated with an incidence of COPD hospitalizations that was 1.29-fold higher than that observed among participants who had normal IgG levels (P = .01). The incidence was even higher among patients with prior COPD admissions (pooled subdistribution hazard ratio, 1.58; P < .01), yet the risk of COPD admissions was similar between IgG groups in patients with no prior hospitalizations (pooled SHR, 1.15; P = .34). Patients with hypogammaglobulinemia also showed significantly higher rates of COPD hospitalizations per person-year, compared with their counterparts who had normal IgG levels (0.48 vs. 0.29, respectively; P < .001.)
The authors acknowledged certain limitations of the study, including the fact that they measured serum IgG levels only at baseline “when participants were clinically stable; thus, the variability of IgG levels in a given individual over time and during the course of an AECOPD [severe acute exacerbation of COPD] is uncertain. Secondly, clinical data on corticosteroid use (formulations, dose, and length of use) were not readily available. However, systemic steroid use (one or more courses due to AECOPD prior to study entry) was accounted for in our analyses.”
The MACRO, STATCOPE, LOTT trials, and the CASCADE cohort were supported by the National Heart, Lung, and Blood Institute; National Institutes of Health; and Department of Health & Human Services. The current study was funded by the Canadian Institutes of Health Research and BC Lung Association. The authors reported having no relevant disclosures.
SOURCE: Leitao Filho SF et al. Chest. 2020 May 18. doi: 10.1016/j.chest.2020.04.058.
Among patients with COPD, the presence of hypogammaglobulinemia confers a nearly 30% increased risk of hospitalization, results from a pooled analysis of four studies showed.
“Mechanistic studies are still warranted to better elucidate how IgG and other immunoglobulins, in particular IgA, may contribute to the local airway host defense,” researchers led by Fernando Sergio Leitao Filho, MD, PhD, wrote in a study published in Chest (2020 May 18. doi: 10.1016/j.chest.2020.04.058). “Nevertheless, our results raise the possibility that, in select COPD patients, IgG replacement therapy may be effective in reducing the risk of COPD hospitalizations. Given the growing rate of COPD hospitalization in the U.S. and elsewhere, there is a pressing need for a large well-designed trial to test this hypothesis.”
In an effort to evaluate the effect of IgG levels on the cumulative incidence of COPD hospitalizations, Dr. Leitao Filho, of the University of British Columbia, Vancouver, and colleagues drew from 2,259 patients who participated in four different trials: Azithromycin for Prevention of Exacerbations of COPD (MACRO), Simvastatin for the Prevention of Exacerbations in Moderate and Severe COPD (STATCOPE), the Long-Term Oxygen Treatment Trial (LOTT), and COPD Activity: Serotonin Transporter, Cytokines and Depression (CASCADE). The mean baseline age of study participants was 66 years, and 641 (28.4%) had hypogammaglobulinemia, which was defined as having a serum IgG levels of less than 7.0 g/L, while the remainder had normal IgG levels.
The pooled meta-analysis, which is believed to be the largest of its kind, revealed that the presence of hypogammaglobulinemia was associated with an incidence of COPD hospitalizations that was 1.29-fold higher than that observed among participants who had normal IgG levels (P = .01). The incidence was even higher among patients with prior COPD admissions (pooled subdistribution hazard ratio, 1.58; P < .01), yet the risk of COPD admissions was similar between IgG groups in patients with no prior hospitalizations (pooled SHR, 1.15; P = .34). Patients with hypogammaglobulinemia also showed significantly higher rates of COPD hospitalizations per person-year, compared with their counterparts who had normal IgG levels (0.48 vs. 0.29, respectively; P < .001.)
The authors acknowledged certain limitations of the study, including the fact that they measured serum IgG levels only at baseline “when participants were clinically stable; thus, the variability of IgG levels in a given individual over time and during the course of an AECOPD [severe acute exacerbation of COPD] is uncertain. Secondly, clinical data on corticosteroid use (formulations, dose, and length of use) were not readily available. However, systemic steroid use (one or more courses due to AECOPD prior to study entry) was accounted for in our analyses.”
The MACRO, STATCOPE, LOTT trials, and the CASCADE cohort were supported by the National Heart, Lung, and Blood Institute; National Institutes of Health; and Department of Health & Human Services. The current study was funded by the Canadian Institutes of Health Research and BC Lung Association. The authors reported having no relevant disclosures.
SOURCE: Leitao Filho SF et al. Chest. 2020 May 18. doi: 10.1016/j.chest.2020.04.058.
Among patients with COPD, the presence of hypogammaglobulinemia confers a nearly 30% increased risk of hospitalization, results from a pooled analysis of four studies showed.
“Mechanistic studies are still warranted to better elucidate how IgG and other immunoglobulins, in particular IgA, may contribute to the local airway host defense,” researchers led by Fernando Sergio Leitao Filho, MD, PhD, wrote in a study published in Chest (2020 May 18. doi: 10.1016/j.chest.2020.04.058). “Nevertheless, our results raise the possibility that, in select COPD patients, IgG replacement therapy may be effective in reducing the risk of COPD hospitalizations. Given the growing rate of COPD hospitalization in the U.S. and elsewhere, there is a pressing need for a large well-designed trial to test this hypothesis.”
In an effort to evaluate the effect of IgG levels on the cumulative incidence of COPD hospitalizations, Dr. Leitao Filho, of the University of British Columbia, Vancouver, and colleagues drew from 2,259 patients who participated in four different trials: Azithromycin for Prevention of Exacerbations of COPD (MACRO), Simvastatin for the Prevention of Exacerbations in Moderate and Severe COPD (STATCOPE), the Long-Term Oxygen Treatment Trial (LOTT), and COPD Activity: Serotonin Transporter, Cytokines and Depression (CASCADE). The mean baseline age of study participants was 66 years, and 641 (28.4%) had hypogammaglobulinemia, which was defined as having a serum IgG levels of less than 7.0 g/L, while the remainder had normal IgG levels.
The pooled meta-analysis, which is believed to be the largest of its kind, revealed that the presence of hypogammaglobulinemia was associated with an incidence of COPD hospitalizations that was 1.29-fold higher than that observed among participants who had normal IgG levels (P = .01). The incidence was even higher among patients with prior COPD admissions (pooled subdistribution hazard ratio, 1.58; P < .01), yet the risk of COPD admissions was similar between IgG groups in patients with no prior hospitalizations (pooled SHR, 1.15; P = .34). Patients with hypogammaglobulinemia also showed significantly higher rates of COPD hospitalizations per person-year, compared with their counterparts who had normal IgG levels (0.48 vs. 0.29, respectively; P < .001.)
The authors acknowledged certain limitations of the study, including the fact that they measured serum IgG levels only at baseline “when participants were clinically stable; thus, the variability of IgG levels in a given individual over time and during the course of an AECOPD [severe acute exacerbation of COPD] is uncertain. Secondly, clinical data on corticosteroid use (formulations, dose, and length of use) were not readily available. However, systemic steroid use (one or more courses due to AECOPD prior to study entry) was accounted for in our analyses.”
The MACRO, STATCOPE, LOTT trials, and the CASCADE cohort were supported by the National Heart, Lung, and Blood Institute; National Institutes of Health; and Department of Health & Human Services. The current study was funded by the Canadian Institutes of Health Research and BC Lung Association. The authors reported having no relevant disclosures.
SOURCE: Leitao Filho SF et al. Chest. 2020 May 18. doi: 10.1016/j.chest.2020.04.058.
FROM CHEST
Latest from ISCHEMIA: Worse outcomes in patients with intermediate left main disease on CCTA
Patients in the landmark ISCHEMIA trial with intermediate left main disease had a greater extent of coronary artery disease on invasive angiography, indicating greater atherosclerotic burden. They also had worse prognosis with a higher risk of cardiovascular events.
“Many times, we are looking at results as to whether patients have left main disease or not,” Sripal Bangalore, MD, said during the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “Here, we are showing that it’s not black and white; there are shades of gray. If a patient has intermediate left main disease, the prognosis is worse. That’s very important information we need to convey to our referrals also, because many times they may just look at the bottom line and say, ‘there is no left main disease.’ But here, we’re seeing that even having intermediate left main disease has significantly worse prognosis. We need to take that seriously.”
Prior studies show that patients with significant left main disease (LMD; defined as 50% or greater stenosis on coronary CT angiography [CCTA]) have a high risk of cardiovascular events and guidelines recommend revascularization to improve survival, said Dr. Bangalore, an interventional cardiologist at New York University Langone Health. However, the impact of intermediate LMD (defined as 25%-49% stenosis on CCTA) on outcomes is unclear.
Members of the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) research group randomized 5,179 participants to an initial invasive or conservative strategy. The main results showed that immediate revascularization in patients with stable ischemic heart disease provided no reduction in cardiovascular endpoints through 4 years of follow-up, compared with initial optimal medical therapy alone.
‘Discordance’ revealed in imaging modalities
For the current analysis, named the ISCHEMIA Intermediate LM Substudy, those who underwent coronary CCTA comprise the LMD substudy cohort. The objective was to evaluate clinical and quality of life outcomes in patients with and without intermediate left main disease on coronary CT and to evaluate the impact of treatment strategy on those outcomes across subgroups.
At baseline, these patients were categorized into those with and without intermediate LMD as determined by a core lab. Patients with LMD of 50% or greater, those with prior coronary artery bypass graft surgery, and those with nonevaluable or missing data on LM stenosis were excluded.
Among the 3,913 ISCHEMIA participants who underwent CCTA, 3,699 satisfied the inclusion criteria. Of these patients, 962 (26%) had intermediate LMD and 2,737 (74%) did not.
The researchers observed no significant differences in baseline characteristics between patients with and without LMD. However, patients with intermediate LMD tended to be older, and a greater proportion had hypertension and diabetes. Stress test characteristics were also similar between patients with and without LMD. However, patients with intermediate LMD tended toward a greater severity of severe ischemia.
This was also true for anatomic disease on CCTA. A higher proportion of patients with intermediate LMD had triple-vessel disease (61%-62%, compared with 36%-40% along those without intermediate LMD). In addition, a higher proportion of patients with intermediate LMD had stenosis in the proximal left anterior artery descending (LAD) artery (65% vs. 39% among those without intermediate LMD).
On analysis limited to 1,846 patients who underwent invasive angiography treatment in the main ISCHEMIA trial, 7% of those who were categorized into the intermediate LMD group were found to have LMD disease of 50% or greater, compared with 1.4% of patients who were categorized as not having intermediate LMD. “This goes to show this discordance between the two modalities [CCTA and coronary angiography], and I think we have to be careful,” said Dr. Bangalore, who also directs NYU Langone’s Cardiac Catheterization Laboratory. “There may be patients with left main disease, even if the CCTA says it’s not at 25%-29% [stenosis].”
The researchers found that, among patients who underwent invasive angiography, a greater proportion of those who were categorized into the LMD group had proximal LAD disease (43% vs. 33% among those who were categorized into the nonintermediate LMD group), triple-vessel disease (47% vs. 35%), a greater extent of coronary artery disease as denoted by a higher SYNTAX score (21 vs. 15), and a higher proportion underwent coronary artery bypass graft surgery (32% vs. 18%).
Intermediate LMD linked to worse outcomes
After the researchers adjusted for baseline differences between the two groups in overall substudy cohort, they found that intermediate LMD severity was an independent predictor of the primary composite endpoint of cardiovascular death, MI, hospitalization for unstable angina, heart failure, and resuscitated cardiac arrest (hazard ratio, 1.31; P = .0123); cardiovascular death/MI/stroke (HR, 1.30; P = .0143); procedural primary MI (HR, 1.64; P = .0487); heart failure (HR, 2.06; P = .0239); and stroke (HR, 1.82, P = .0362).
“We then looked to see if there is a treatment difference, a treatment effect based on whether patients had intermediate LMD,” Dr. Bangalore said. “Most of the P values were not significant. The results are very consistent with what we saw in the main analysis: not a significant difference between invasive and conservative strategy. We do see some differences, though. An invasive strategy was associated with a significantly higher risk of procedural MI [2.9% vs. 1.5%], but a significantly lower risk of nonprocedural MI [–6.4% vs. –2%].”
Dr. Bangalore added that there was significant benefit of the invasive strategy in reducing angina and improving quality of life based on the Seattle Angina Questionnaire-7. “This result was durable up to 48 months of follow-up, whether the patient had intermediate left main disease or not. These results were dependent on baseline angina status. The benefit of invasive strategy was mainly in patients who had daily, weekly, and monthly angina, and no benefit in patients with no angina; there was no interaction based on intermediate left main status.”
Dr. Bangalore emphasized that the original ISCHEMIA trial excluded patients with severe left main disease by design. “But patients with intermediate left main disease in ISCHEMIA tended to have a greater extent of coronary artery disease, indicating greater atherosclerotic burden. I don’t think that’s any surprise. They had a worse prognosis with higher risk of cardiovascular events but similar quality of life, including angina-specific quality of life.”
The key clinical message, he said, is that patients with intermediate LMD face an increased risk of cardiovascular events. “I think we have to be aggressive in trying to reduce their risk with medical therapy, etc.,” he said. “If they are symptomatic, ISCHEMIA tells us that patients have two options. They can choose an invasive strategy, because clearly there is a benefit. You have a significant benefit at making you feel better and potentially reducing the risk of spontaneous MI over a period of time. Or, you can try medical therapy first. If you do see some left main disease, it’s showing the general burden of atherosclerosis disease in those patients. I think that’s the critical message, that we have to be very aggressive with these patients.”
A call for more imaging studies
An invited panelist, Timothy D. Henry, MD, said that the results of the ISCHEMIA substudy should stimulate further research. “With an intermediate lesion, clearly the interventional group did better, and it wasn’t symptom related,” said Dr. Henry, medical director of the Carl and Edyth Lindner Center for Research and Education at the Christ Hospital in Cincinnati. “So even if you do medical therapy, you’re not going to really find it out. In my mind, this should stimulate us to do more imaging of the left main that are moderate lesions, and follow this up as an independent study. I think this is a really important finding.”
ISCHEMIA was supported by grants from the National Heart, Lung, and Blood Institute. Dr. Bangalore disclosed that he is a member of the advisory board and/or a board member for Meril, SMT, Pfizer, Amgen, Biotronik, and Abbott. He also is a consultant for Reata Pharmaceuticals.
SOURCE: Bangalore S et al. SCAI 2020, Abstract 11656.
Patients in the landmark ISCHEMIA trial with intermediate left main disease had a greater extent of coronary artery disease on invasive angiography, indicating greater atherosclerotic burden. They also had worse prognosis with a higher risk of cardiovascular events.
“Many times, we are looking at results as to whether patients have left main disease or not,” Sripal Bangalore, MD, said during the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “Here, we are showing that it’s not black and white; there are shades of gray. If a patient has intermediate left main disease, the prognosis is worse. That’s very important information we need to convey to our referrals also, because many times they may just look at the bottom line and say, ‘there is no left main disease.’ But here, we’re seeing that even having intermediate left main disease has significantly worse prognosis. We need to take that seriously.”
Prior studies show that patients with significant left main disease (LMD; defined as 50% or greater stenosis on coronary CT angiography [CCTA]) have a high risk of cardiovascular events and guidelines recommend revascularization to improve survival, said Dr. Bangalore, an interventional cardiologist at New York University Langone Health. However, the impact of intermediate LMD (defined as 25%-49% stenosis on CCTA) on outcomes is unclear.
Members of the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) research group randomized 5,179 participants to an initial invasive or conservative strategy. The main results showed that immediate revascularization in patients with stable ischemic heart disease provided no reduction in cardiovascular endpoints through 4 years of follow-up, compared with initial optimal medical therapy alone.
‘Discordance’ revealed in imaging modalities
For the current analysis, named the ISCHEMIA Intermediate LM Substudy, those who underwent coronary CCTA comprise the LMD substudy cohort. The objective was to evaluate clinical and quality of life outcomes in patients with and without intermediate left main disease on coronary CT and to evaluate the impact of treatment strategy on those outcomes across subgroups.
At baseline, these patients were categorized into those with and without intermediate LMD as determined by a core lab. Patients with LMD of 50% or greater, those with prior coronary artery bypass graft surgery, and those with nonevaluable or missing data on LM stenosis were excluded.
Among the 3,913 ISCHEMIA participants who underwent CCTA, 3,699 satisfied the inclusion criteria. Of these patients, 962 (26%) had intermediate LMD and 2,737 (74%) did not.
The researchers observed no significant differences in baseline characteristics between patients with and without LMD. However, patients with intermediate LMD tended to be older, and a greater proportion had hypertension and diabetes. Stress test characteristics were also similar between patients with and without LMD. However, patients with intermediate LMD tended toward a greater severity of severe ischemia.
This was also true for anatomic disease on CCTA. A higher proportion of patients with intermediate LMD had triple-vessel disease (61%-62%, compared with 36%-40% along those without intermediate LMD). In addition, a higher proportion of patients with intermediate LMD had stenosis in the proximal left anterior artery descending (LAD) artery (65% vs. 39% among those without intermediate LMD).
On analysis limited to 1,846 patients who underwent invasive angiography treatment in the main ISCHEMIA trial, 7% of those who were categorized into the intermediate LMD group were found to have LMD disease of 50% or greater, compared with 1.4% of patients who were categorized as not having intermediate LMD. “This goes to show this discordance between the two modalities [CCTA and coronary angiography], and I think we have to be careful,” said Dr. Bangalore, who also directs NYU Langone’s Cardiac Catheterization Laboratory. “There may be patients with left main disease, even if the CCTA says it’s not at 25%-29% [stenosis].”
The researchers found that, among patients who underwent invasive angiography, a greater proportion of those who were categorized into the LMD group had proximal LAD disease (43% vs. 33% among those who were categorized into the nonintermediate LMD group), triple-vessel disease (47% vs. 35%), a greater extent of coronary artery disease as denoted by a higher SYNTAX score (21 vs. 15), and a higher proportion underwent coronary artery bypass graft surgery (32% vs. 18%).
Intermediate LMD linked to worse outcomes
After the researchers adjusted for baseline differences between the two groups in overall substudy cohort, they found that intermediate LMD severity was an independent predictor of the primary composite endpoint of cardiovascular death, MI, hospitalization for unstable angina, heart failure, and resuscitated cardiac arrest (hazard ratio, 1.31; P = .0123); cardiovascular death/MI/stroke (HR, 1.30; P = .0143); procedural primary MI (HR, 1.64; P = .0487); heart failure (HR, 2.06; P = .0239); and stroke (HR, 1.82, P = .0362).
“We then looked to see if there is a treatment difference, a treatment effect based on whether patients had intermediate LMD,” Dr. Bangalore said. “Most of the P values were not significant. The results are very consistent with what we saw in the main analysis: not a significant difference between invasive and conservative strategy. We do see some differences, though. An invasive strategy was associated with a significantly higher risk of procedural MI [2.9% vs. 1.5%], but a significantly lower risk of nonprocedural MI [–6.4% vs. –2%].”
Dr. Bangalore added that there was significant benefit of the invasive strategy in reducing angina and improving quality of life based on the Seattle Angina Questionnaire-7. “This result was durable up to 48 months of follow-up, whether the patient had intermediate left main disease or not. These results were dependent on baseline angina status. The benefit of invasive strategy was mainly in patients who had daily, weekly, and monthly angina, and no benefit in patients with no angina; there was no interaction based on intermediate left main status.”
Dr. Bangalore emphasized that the original ISCHEMIA trial excluded patients with severe left main disease by design. “But patients with intermediate left main disease in ISCHEMIA tended to have a greater extent of coronary artery disease, indicating greater atherosclerotic burden. I don’t think that’s any surprise. They had a worse prognosis with higher risk of cardiovascular events but similar quality of life, including angina-specific quality of life.”
The key clinical message, he said, is that patients with intermediate LMD face an increased risk of cardiovascular events. “I think we have to be aggressive in trying to reduce their risk with medical therapy, etc.,” he said. “If they are symptomatic, ISCHEMIA tells us that patients have two options. They can choose an invasive strategy, because clearly there is a benefit. You have a significant benefit at making you feel better and potentially reducing the risk of spontaneous MI over a period of time. Or, you can try medical therapy first. If you do see some left main disease, it’s showing the general burden of atherosclerosis disease in those patients. I think that’s the critical message, that we have to be very aggressive with these patients.”
A call for more imaging studies
An invited panelist, Timothy D. Henry, MD, said that the results of the ISCHEMIA substudy should stimulate further research. “With an intermediate lesion, clearly the interventional group did better, and it wasn’t symptom related,” said Dr. Henry, medical director of the Carl and Edyth Lindner Center for Research and Education at the Christ Hospital in Cincinnati. “So even if you do medical therapy, you’re not going to really find it out. In my mind, this should stimulate us to do more imaging of the left main that are moderate lesions, and follow this up as an independent study. I think this is a really important finding.”
ISCHEMIA was supported by grants from the National Heart, Lung, and Blood Institute. Dr. Bangalore disclosed that he is a member of the advisory board and/or a board member for Meril, SMT, Pfizer, Amgen, Biotronik, and Abbott. He also is a consultant for Reata Pharmaceuticals.
SOURCE: Bangalore S et al. SCAI 2020, Abstract 11656.
Patients in the landmark ISCHEMIA trial with intermediate left main disease had a greater extent of coronary artery disease on invasive angiography, indicating greater atherosclerotic burden. They also had worse prognosis with a higher risk of cardiovascular events.
“Many times, we are looking at results as to whether patients have left main disease or not,” Sripal Bangalore, MD, said during the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “Here, we are showing that it’s not black and white; there are shades of gray. If a patient has intermediate left main disease, the prognosis is worse. That’s very important information we need to convey to our referrals also, because many times they may just look at the bottom line and say, ‘there is no left main disease.’ But here, we’re seeing that even having intermediate left main disease has significantly worse prognosis. We need to take that seriously.”
Prior studies show that patients with significant left main disease (LMD; defined as 50% or greater stenosis on coronary CT angiography [CCTA]) have a high risk of cardiovascular events and guidelines recommend revascularization to improve survival, said Dr. Bangalore, an interventional cardiologist at New York University Langone Health. However, the impact of intermediate LMD (defined as 25%-49% stenosis on CCTA) on outcomes is unclear.
Members of the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) research group randomized 5,179 participants to an initial invasive or conservative strategy. The main results showed that immediate revascularization in patients with stable ischemic heart disease provided no reduction in cardiovascular endpoints through 4 years of follow-up, compared with initial optimal medical therapy alone.
‘Discordance’ revealed in imaging modalities
For the current analysis, named the ISCHEMIA Intermediate LM Substudy, those who underwent coronary CCTA comprise the LMD substudy cohort. The objective was to evaluate clinical and quality of life outcomes in patients with and without intermediate left main disease on coronary CT and to evaluate the impact of treatment strategy on those outcomes across subgroups.
At baseline, these patients were categorized into those with and without intermediate LMD as determined by a core lab. Patients with LMD of 50% or greater, those with prior coronary artery bypass graft surgery, and those with nonevaluable or missing data on LM stenosis were excluded.
Among the 3,913 ISCHEMIA participants who underwent CCTA, 3,699 satisfied the inclusion criteria. Of these patients, 962 (26%) had intermediate LMD and 2,737 (74%) did not.
The researchers observed no significant differences in baseline characteristics between patients with and without LMD. However, patients with intermediate LMD tended to be older, and a greater proportion had hypertension and diabetes. Stress test characteristics were also similar between patients with and without LMD. However, patients with intermediate LMD tended toward a greater severity of severe ischemia.
This was also true for anatomic disease on CCTA. A higher proportion of patients with intermediate LMD had triple-vessel disease (61%-62%, compared with 36%-40% along those without intermediate LMD). In addition, a higher proportion of patients with intermediate LMD had stenosis in the proximal left anterior artery descending (LAD) artery (65% vs. 39% among those without intermediate LMD).
On analysis limited to 1,846 patients who underwent invasive angiography treatment in the main ISCHEMIA trial, 7% of those who were categorized into the intermediate LMD group were found to have LMD disease of 50% or greater, compared with 1.4% of patients who were categorized as not having intermediate LMD. “This goes to show this discordance between the two modalities [CCTA and coronary angiography], and I think we have to be careful,” said Dr. Bangalore, who also directs NYU Langone’s Cardiac Catheterization Laboratory. “There may be patients with left main disease, even if the CCTA says it’s not at 25%-29% [stenosis].”
The researchers found that, among patients who underwent invasive angiography, a greater proportion of those who were categorized into the LMD group had proximal LAD disease (43% vs. 33% among those who were categorized into the nonintermediate LMD group), triple-vessel disease (47% vs. 35%), a greater extent of coronary artery disease as denoted by a higher SYNTAX score (21 vs. 15), and a higher proportion underwent coronary artery bypass graft surgery (32% vs. 18%).
Intermediate LMD linked to worse outcomes
After the researchers adjusted for baseline differences between the two groups in overall substudy cohort, they found that intermediate LMD severity was an independent predictor of the primary composite endpoint of cardiovascular death, MI, hospitalization for unstable angina, heart failure, and resuscitated cardiac arrest (hazard ratio, 1.31; P = .0123); cardiovascular death/MI/stroke (HR, 1.30; P = .0143); procedural primary MI (HR, 1.64; P = .0487); heart failure (HR, 2.06; P = .0239); and stroke (HR, 1.82, P = .0362).
“We then looked to see if there is a treatment difference, a treatment effect based on whether patients had intermediate LMD,” Dr. Bangalore said. “Most of the P values were not significant. The results are very consistent with what we saw in the main analysis: not a significant difference between invasive and conservative strategy. We do see some differences, though. An invasive strategy was associated with a significantly higher risk of procedural MI [2.9% vs. 1.5%], but a significantly lower risk of nonprocedural MI [–6.4% vs. –2%].”
Dr. Bangalore added that there was significant benefit of the invasive strategy in reducing angina and improving quality of life based on the Seattle Angina Questionnaire-7. “This result was durable up to 48 months of follow-up, whether the patient had intermediate left main disease or not. These results were dependent on baseline angina status. The benefit of invasive strategy was mainly in patients who had daily, weekly, and monthly angina, and no benefit in patients with no angina; there was no interaction based on intermediate left main status.”
Dr. Bangalore emphasized that the original ISCHEMIA trial excluded patients with severe left main disease by design. “But patients with intermediate left main disease in ISCHEMIA tended to have a greater extent of coronary artery disease, indicating greater atherosclerotic burden. I don’t think that’s any surprise. They had a worse prognosis with higher risk of cardiovascular events but similar quality of life, including angina-specific quality of life.”
The key clinical message, he said, is that patients with intermediate LMD face an increased risk of cardiovascular events. “I think we have to be aggressive in trying to reduce their risk with medical therapy, etc.,” he said. “If they are symptomatic, ISCHEMIA tells us that patients have two options. They can choose an invasive strategy, because clearly there is a benefit. You have a significant benefit at making you feel better and potentially reducing the risk of spontaneous MI over a period of time. Or, you can try medical therapy first. If you do see some left main disease, it’s showing the general burden of atherosclerosis disease in those patients. I think that’s the critical message, that we have to be very aggressive with these patients.”
A call for more imaging studies
An invited panelist, Timothy D. Henry, MD, said that the results of the ISCHEMIA substudy should stimulate further research. “With an intermediate lesion, clearly the interventional group did better, and it wasn’t symptom related,” said Dr. Henry, medical director of the Carl and Edyth Lindner Center for Research and Education at the Christ Hospital in Cincinnati. “So even if you do medical therapy, you’re not going to really find it out. In my mind, this should stimulate us to do more imaging of the left main that are moderate lesions, and follow this up as an independent study. I think this is a really important finding.”
ISCHEMIA was supported by grants from the National Heart, Lung, and Blood Institute. Dr. Bangalore disclosed that he is a member of the advisory board and/or a board member for Meril, SMT, Pfizer, Amgen, Biotronik, and Abbott. He also is a consultant for Reata Pharmaceuticals.
SOURCE: Bangalore S et al. SCAI 2020, Abstract 11656.
FROM SCAI 2020
Authors of picosecond laser review predict more widespread use of the technology
Ever since the first picosecond laser hit the market in 2012 as an option for treating unwanted tattoos and pigmented lesions, clinicians have used the technology to safely and effectively treat an expanding range of dermatologic conditions, from Nevus of Ota and melasma to rejuvenation.
. They called for further development of the technology and predicted that application of the devices will become more widespread.
“Future directions may include the development of even shorter pulse durations, improvements in fractionation method and delivery, and exploration of the utility of pulsing other laser wavelengths in the picosecond (or shorter) domain,” first author Douglas C. Wu, MD, PhD, of Cosmetic Laser Dermatology and colleagues wrote in the review. “The introduction of newer devices along with continued improvements in clinical technique and experience will drive the refinement and expansion of this technology.”
The authors evaluated medical literature on the topic published up to March 2020 and classified 78 studies into one of the following categories: discrete pigmented lesions, other nonmelasma pigmented conditions, rejuvenation, melasma, scar revision, and tattoo removal. They assessed the level of evidence for each indication according to modified criteria published by the Oxford Centre of Evidence-Based Medicine and proposed recommendations based on the medical literature in combination with the authors’ collective clinical experience with picosecond laser.
In the category of discrete pigmented lesions, the authors assigned level of evidence 1a to Nevus of Ota and Hori’s macules, level of evidence 2b to solar lentigines and freckles, level of evidence 3c to café au lait macules, and level of evidence 4 to all other benign pigmentary conditions. “Comparative studies utilizing clinical, histological, and microscopic endpoints further suggest that picosecond laser may be safer and more effective than nanosecond laser in some situations, with potentially reduced risk of inducing postinflammatory hyperpigmentation,” the authors wrote. “This increased safety level may be due to the reduction of non-specific photothermal damage of the melanocyte and dermal-epidermal junction,” they noted. They called for more robust clinical comparative data with a focus on shorter pulse durations and refined clinical endpoints “to further distinguish the differences between picosecond and nanosecond laser for the treatment of some benign pigmented lesions.”
Based on seven prospective open-label trials and three split-face comparison trials involving the use of picosecond lasers for photorejuvenation, the authors assigned a level of evidence 2a to this category. “The studies show a high level of safety associated with a moderate level of efficacy,” they wrote. “Indeed, when compared with traditional non-ablative fractional laser, fractionated picosecond laser may have an improved side effect profile without sacrificing treatment efficacy. This could be due to the unique mechanism of action of fractionated picosecond laser, which results in greater confinement of tissue injury to focal and precise points within the epidermis and papillary dermis.”
Clinical data on using picosecond lasers to treat melasma remains “mixed and unclear,” but it may have a role as an adjunctive treatment combined with rigorous photoprotection, topical melanin inhibitors, “and potentially other laser or systemic therapies as dictated by clinical circumstance,” the authors said. They do not recommend the picosecond laser as a monotherapy for melasma, and they assigned a level of evidence 2a to this category.
Although the fractionated picosecond laser is cleared by the Food and Drug Administration for the treatment of acne scars, Dr. Wu and his colleagues noted that rigorous clinical data on using the technology for this indication is limited. “Encouragingly, reports thus far seem to suggest that the risk of post-inflammatory pigmentary alteration is low when using fractionated picosecond laser, which has added significance due to the high prevalence of acne scarring in skin of color,” they wrote. They assigned a level of evidence 2b to this category. Meanwhile, clinical data on the use of picosecond lasers for non-acne scars are limited to cases series and retrospective reviews, reaching evidence level 3c. “Although the level of evidence is weak, there is likely an effective role for fractionated picosecond laser for the improvement of hyperpigmented scars given its more robust track record for the treatment of hyperpigmentation due to other causes such as benign pigmentary conditions and photodamage,” the authors wrote.
The manuscript concludes with a discussion of the picosecond laser’s role in tattoo removal, which represents the oldest and most established dermatologic indication for the technology. “The accumulated scientific and clinical evidence to date concludes that the shorter pulse duration confers a distinct advantage when other laser parameters remain equal,” the authors wrote. “The evidence also suggests that the shorter the pulse gets (within currently commercially available and tested devices), the greater becomes the efficacy for tattoo removal. There is no evidence to suggest that larger tattoo particles are more optimally targeted by longer nanosecond pulses.” They assigned a level of evidence 1a to this category and described using the picosecond laser for tattoo removal of almost any color as “the gold standard.”
In an interview, Arisa Ortiz, MD, described the manuscript as a thorough review of the clinical indications for picosecond lasers. “Overall, the review shows evidence for slightly better improvement of efficacy with picosecond lasers compared to nanosecond lasers,” said Dr. Ortiz, director of laser and cosmetic dermatology at the University of California, San Diego, who was not involved with the review. “They also show a slightly improved side effect profile with picosecond lasers [and] notably, less risk of postinflammatory hyperpigmentation in darker skin types compared to nanosecond lasers. One issue that was not addressed was the cost of picosecond lasers. The cost of a picosecond lasers remains substantially higher than the cost of a nanosecond laser. I am not sure that this extra cost justifies a slightly improved efficacy or slightly improved side effect profile.”
According to Eric F. Bernstein, MD, director of the Main Line Center for Laser Surgery in Ardmore, Penn., the versatility of picosecond lasers offers an advantage to dermatologists. “Most of them have three wavelengths at least,” said Dr. Bernstein, who was not involved with the systematic review. “That means you can treat skin types I-VI. I was never able to offer much for my patients with skin types V and VI for fractionated rejuvenation and treatment of acne scarring. But now, with these lasers, I have an option for them. That’s a huge advantage.”
He credited laser engineers as “the real heroes” in the success of picosecond lasers in dermatology. “They’re passionate, they’re brilliant, and they’re creative,” Dr. Bernstein said. “They’re the ones that build and produce these devices for multiple manufacturers. In our space, the innovation really comes from industry.”
The review authors and Dr. Ortiz reported having no relevant disclosures. Dr. Bernstein disclosed that he is head of Candela’s medical advisory board.
SOURCE: Wu DC et al. Lasers Surg Med. 2020. doi: 10.1002/lsm.23244.
Ever since the first picosecond laser hit the market in 2012 as an option for treating unwanted tattoos and pigmented lesions, clinicians have used the technology to safely and effectively treat an expanding range of dermatologic conditions, from Nevus of Ota and melasma to rejuvenation.
. They called for further development of the technology and predicted that application of the devices will become more widespread.
“Future directions may include the development of even shorter pulse durations, improvements in fractionation method and delivery, and exploration of the utility of pulsing other laser wavelengths in the picosecond (or shorter) domain,” first author Douglas C. Wu, MD, PhD, of Cosmetic Laser Dermatology and colleagues wrote in the review. “The introduction of newer devices along with continued improvements in clinical technique and experience will drive the refinement and expansion of this technology.”
The authors evaluated medical literature on the topic published up to March 2020 and classified 78 studies into one of the following categories: discrete pigmented lesions, other nonmelasma pigmented conditions, rejuvenation, melasma, scar revision, and tattoo removal. They assessed the level of evidence for each indication according to modified criteria published by the Oxford Centre of Evidence-Based Medicine and proposed recommendations based on the medical literature in combination with the authors’ collective clinical experience with picosecond laser.
In the category of discrete pigmented lesions, the authors assigned level of evidence 1a to Nevus of Ota and Hori’s macules, level of evidence 2b to solar lentigines and freckles, level of evidence 3c to café au lait macules, and level of evidence 4 to all other benign pigmentary conditions. “Comparative studies utilizing clinical, histological, and microscopic endpoints further suggest that picosecond laser may be safer and more effective than nanosecond laser in some situations, with potentially reduced risk of inducing postinflammatory hyperpigmentation,” the authors wrote. “This increased safety level may be due to the reduction of non-specific photothermal damage of the melanocyte and dermal-epidermal junction,” they noted. They called for more robust clinical comparative data with a focus on shorter pulse durations and refined clinical endpoints “to further distinguish the differences between picosecond and nanosecond laser for the treatment of some benign pigmented lesions.”
Based on seven prospective open-label trials and three split-face comparison trials involving the use of picosecond lasers for photorejuvenation, the authors assigned a level of evidence 2a to this category. “The studies show a high level of safety associated with a moderate level of efficacy,” they wrote. “Indeed, when compared with traditional non-ablative fractional laser, fractionated picosecond laser may have an improved side effect profile without sacrificing treatment efficacy. This could be due to the unique mechanism of action of fractionated picosecond laser, which results in greater confinement of tissue injury to focal and precise points within the epidermis and papillary dermis.”
Clinical data on using picosecond lasers to treat melasma remains “mixed and unclear,” but it may have a role as an adjunctive treatment combined with rigorous photoprotection, topical melanin inhibitors, “and potentially other laser or systemic therapies as dictated by clinical circumstance,” the authors said. They do not recommend the picosecond laser as a monotherapy for melasma, and they assigned a level of evidence 2a to this category.
Although the fractionated picosecond laser is cleared by the Food and Drug Administration for the treatment of acne scars, Dr. Wu and his colleagues noted that rigorous clinical data on using the technology for this indication is limited. “Encouragingly, reports thus far seem to suggest that the risk of post-inflammatory pigmentary alteration is low when using fractionated picosecond laser, which has added significance due to the high prevalence of acne scarring in skin of color,” they wrote. They assigned a level of evidence 2b to this category. Meanwhile, clinical data on the use of picosecond lasers for non-acne scars are limited to cases series and retrospective reviews, reaching evidence level 3c. “Although the level of evidence is weak, there is likely an effective role for fractionated picosecond laser for the improvement of hyperpigmented scars given its more robust track record for the treatment of hyperpigmentation due to other causes such as benign pigmentary conditions and photodamage,” the authors wrote.
The manuscript concludes with a discussion of the picosecond laser’s role in tattoo removal, which represents the oldest and most established dermatologic indication for the technology. “The accumulated scientific and clinical evidence to date concludes that the shorter pulse duration confers a distinct advantage when other laser parameters remain equal,” the authors wrote. “The evidence also suggests that the shorter the pulse gets (within currently commercially available and tested devices), the greater becomes the efficacy for tattoo removal. There is no evidence to suggest that larger tattoo particles are more optimally targeted by longer nanosecond pulses.” They assigned a level of evidence 1a to this category and described using the picosecond laser for tattoo removal of almost any color as “the gold standard.”
In an interview, Arisa Ortiz, MD, described the manuscript as a thorough review of the clinical indications for picosecond lasers. “Overall, the review shows evidence for slightly better improvement of efficacy with picosecond lasers compared to nanosecond lasers,” said Dr. Ortiz, director of laser and cosmetic dermatology at the University of California, San Diego, who was not involved with the review. “They also show a slightly improved side effect profile with picosecond lasers [and] notably, less risk of postinflammatory hyperpigmentation in darker skin types compared to nanosecond lasers. One issue that was not addressed was the cost of picosecond lasers. The cost of a picosecond lasers remains substantially higher than the cost of a nanosecond laser. I am not sure that this extra cost justifies a slightly improved efficacy or slightly improved side effect profile.”
According to Eric F. Bernstein, MD, director of the Main Line Center for Laser Surgery in Ardmore, Penn., the versatility of picosecond lasers offers an advantage to dermatologists. “Most of them have three wavelengths at least,” said Dr. Bernstein, who was not involved with the systematic review. “That means you can treat skin types I-VI. I was never able to offer much for my patients with skin types V and VI for fractionated rejuvenation and treatment of acne scarring. But now, with these lasers, I have an option for them. That’s a huge advantage.”
He credited laser engineers as “the real heroes” in the success of picosecond lasers in dermatology. “They’re passionate, they’re brilliant, and they’re creative,” Dr. Bernstein said. “They’re the ones that build and produce these devices for multiple manufacturers. In our space, the innovation really comes from industry.”
The review authors and Dr. Ortiz reported having no relevant disclosures. Dr. Bernstein disclosed that he is head of Candela’s medical advisory board.
SOURCE: Wu DC et al. Lasers Surg Med. 2020. doi: 10.1002/lsm.23244.
Ever since the first picosecond laser hit the market in 2012 as an option for treating unwanted tattoos and pigmented lesions, clinicians have used the technology to safely and effectively treat an expanding range of dermatologic conditions, from Nevus of Ota and melasma to rejuvenation.
. They called for further development of the technology and predicted that application of the devices will become more widespread.
“Future directions may include the development of even shorter pulse durations, improvements in fractionation method and delivery, and exploration of the utility of pulsing other laser wavelengths in the picosecond (or shorter) domain,” first author Douglas C. Wu, MD, PhD, of Cosmetic Laser Dermatology and colleagues wrote in the review. “The introduction of newer devices along with continued improvements in clinical technique and experience will drive the refinement and expansion of this technology.”
The authors evaluated medical literature on the topic published up to March 2020 and classified 78 studies into one of the following categories: discrete pigmented lesions, other nonmelasma pigmented conditions, rejuvenation, melasma, scar revision, and tattoo removal. They assessed the level of evidence for each indication according to modified criteria published by the Oxford Centre of Evidence-Based Medicine and proposed recommendations based on the medical literature in combination with the authors’ collective clinical experience with picosecond laser.
In the category of discrete pigmented lesions, the authors assigned level of evidence 1a to Nevus of Ota and Hori’s macules, level of evidence 2b to solar lentigines and freckles, level of evidence 3c to café au lait macules, and level of evidence 4 to all other benign pigmentary conditions. “Comparative studies utilizing clinical, histological, and microscopic endpoints further suggest that picosecond laser may be safer and more effective than nanosecond laser in some situations, with potentially reduced risk of inducing postinflammatory hyperpigmentation,” the authors wrote. “This increased safety level may be due to the reduction of non-specific photothermal damage of the melanocyte and dermal-epidermal junction,” they noted. They called for more robust clinical comparative data with a focus on shorter pulse durations and refined clinical endpoints “to further distinguish the differences between picosecond and nanosecond laser for the treatment of some benign pigmented lesions.”
Based on seven prospective open-label trials and three split-face comparison trials involving the use of picosecond lasers for photorejuvenation, the authors assigned a level of evidence 2a to this category. “The studies show a high level of safety associated with a moderate level of efficacy,” they wrote. “Indeed, when compared with traditional non-ablative fractional laser, fractionated picosecond laser may have an improved side effect profile without sacrificing treatment efficacy. This could be due to the unique mechanism of action of fractionated picosecond laser, which results in greater confinement of tissue injury to focal and precise points within the epidermis and papillary dermis.”
Clinical data on using picosecond lasers to treat melasma remains “mixed and unclear,” but it may have a role as an adjunctive treatment combined with rigorous photoprotection, topical melanin inhibitors, “and potentially other laser or systemic therapies as dictated by clinical circumstance,” the authors said. They do not recommend the picosecond laser as a monotherapy for melasma, and they assigned a level of evidence 2a to this category.
Although the fractionated picosecond laser is cleared by the Food and Drug Administration for the treatment of acne scars, Dr. Wu and his colleagues noted that rigorous clinical data on using the technology for this indication is limited. “Encouragingly, reports thus far seem to suggest that the risk of post-inflammatory pigmentary alteration is low when using fractionated picosecond laser, which has added significance due to the high prevalence of acne scarring in skin of color,” they wrote. They assigned a level of evidence 2b to this category. Meanwhile, clinical data on the use of picosecond lasers for non-acne scars are limited to cases series and retrospective reviews, reaching evidence level 3c. “Although the level of evidence is weak, there is likely an effective role for fractionated picosecond laser for the improvement of hyperpigmented scars given its more robust track record for the treatment of hyperpigmentation due to other causes such as benign pigmentary conditions and photodamage,” the authors wrote.
The manuscript concludes with a discussion of the picosecond laser’s role in tattoo removal, which represents the oldest and most established dermatologic indication for the technology. “The accumulated scientific and clinical evidence to date concludes that the shorter pulse duration confers a distinct advantage when other laser parameters remain equal,” the authors wrote. “The evidence also suggests that the shorter the pulse gets (within currently commercially available and tested devices), the greater becomes the efficacy for tattoo removal. There is no evidence to suggest that larger tattoo particles are more optimally targeted by longer nanosecond pulses.” They assigned a level of evidence 1a to this category and described using the picosecond laser for tattoo removal of almost any color as “the gold standard.”
In an interview, Arisa Ortiz, MD, described the manuscript as a thorough review of the clinical indications for picosecond lasers. “Overall, the review shows evidence for slightly better improvement of efficacy with picosecond lasers compared to nanosecond lasers,” said Dr. Ortiz, director of laser and cosmetic dermatology at the University of California, San Diego, who was not involved with the review. “They also show a slightly improved side effect profile with picosecond lasers [and] notably, less risk of postinflammatory hyperpigmentation in darker skin types compared to nanosecond lasers. One issue that was not addressed was the cost of picosecond lasers. The cost of a picosecond lasers remains substantially higher than the cost of a nanosecond laser. I am not sure that this extra cost justifies a slightly improved efficacy or slightly improved side effect profile.”
According to Eric F. Bernstein, MD, director of the Main Line Center for Laser Surgery in Ardmore, Penn., the versatility of picosecond lasers offers an advantage to dermatologists. “Most of them have three wavelengths at least,” said Dr. Bernstein, who was not involved with the systematic review. “That means you can treat skin types I-VI. I was never able to offer much for my patients with skin types V and VI for fractionated rejuvenation and treatment of acne scarring. But now, with these lasers, I have an option for them. That’s a huge advantage.”
He credited laser engineers as “the real heroes” in the success of picosecond lasers in dermatology. “They’re passionate, they’re brilliant, and they’re creative,” Dr. Bernstein said. “They’re the ones that build and produce these devices for multiple manufacturers. In our space, the innovation really comes from industry.”
The review authors and Dr. Ortiz reported having no relevant disclosures. Dr. Bernstein disclosed that he is head of Candela’s medical advisory board.
SOURCE: Wu DC et al. Lasers Surg Med. 2020. doi: 10.1002/lsm.23244.
FROM LASERS IN SURGERY AND MEDICINE
Immunotherapy, steroids had positive outcomes in COVID-19–associated multisystem inflammatory syndrome
According to study of a cluster of patients in France and Switzerland, children may experience an acute cardiac decompensation from the severe inflammatory state following SARS-CoV-2 infection, termed multisystem inflammatory syndrome in children (MIS-C). Treatment with immunoglobulin appears to be associated with recovery of left ventricular systolic function.
“The pediatric and cardiology communities should be acutely aware of this new disease probably related to SARS-CoV-2 infection (MIS-C), that shares similarities with Kawasaki disease but has specificities in its presentation,” researchers led by Zahra Belhadjer, MD, of Necker-Enfants Malades Hospital in Paris, wrote in a cases series report published online in Circulation “Early diagnosis and management appear to lead to favorable outcome using classical therapies. Elucidating the immune mechanisms of this disease will afford further insights for treatment and potential global prevention of severe forms.”
Over a 2-month period that coincided with the SARS-CoV-2 pandemic in France and Switzerland, the researchers retrospectively collected clinical, biological, therapeutic, and early-outcomes data in 35 children who were admitted to pediatric ICUs in 14 centers for cardiogenic shock, left ventricular dysfunction, and severe inflammatory state. Their median age was 10 years, all presented with a fever, 80% had gastrointestinal symptoms of abdominal pain, vomiting, or diarrhea, and 28% had comorbidities that included body mass index of greater than 25 kg/m2 (17%), asthma (9%), and lupus (3%), and overweight. Only 17% presented with chest pain. The researchers observed that left ventricular ejection fraction was less than 30% in 28% of patients, and 80% required inotropic support with 28% treated with extracorporeal membrane oxygenation (ECMO). All patients presented with a severe inflammatory state evidenced by elevated C-reactive protein and d-dimer. Interleukin 6 was elevated to a median of 135 pg/mL in 13 of the patients. Elevation of troponin I was constant but mild to moderate, and NT-proBNP or BNP elevation was present in all children.
Nearly all patients 35 (88%) patients tested positive for SARS-CoV-2 infection by polymerase chain reaction of nasopharyngeal swab or serology. Most patients (80%) received IV inotropic support, 71% received first-line IV immunoglobulin, 65% received anticoagulation with heparin, 34% received IV steroids having been considered high-risk patients with symptoms similar to an incomplete form of Kawasaki disease, and 8% received treatment with an interleukin-1 receptor antagonist because of a persistent severe inflammatory state. Left ventricular function was restored in 71% of those discharged from the intensive care unit. No patient died, and all patients treated with ECMO were successfully weaned after a median of 4.5 days.
“Some aspects of this emerging pediatric disease (MIS-C) are similar to those of Kawasaki disease: prolonged fever, multisystem inflammation with skin rash, lymphadenopathy, diarrhea, meningism, and high levels of inflammatory biomarkers,” the researchers wrote. “But differences are important and raise the question as to whether this syndrome is Kawasaki disease with SARS-CoV-2 as the triggering agent, or represents a different syndrome (MIS-C). Kawasaki disease predominantly affects young children younger than 5 years, whereas the median age in our series is 10 years. Incomplete forms of Kawasaki disease occur in infants who may have fever as the sole clinical finding, whereas older patients are more prone to exhibit the complete form.”
They went on to note that the overlapping features between MIS-C and Kawasaki disease “may be due to similar pathophysiology. The etiologic agent of Kawasaki disease is unknown but likely to be ubiquitous, causing asymptomatic childhood infection but triggering the immunologic cascade of Kawasaki disease in genetically susceptible individuals. Please note that infection with a novel RNA virus that enters through the upper respiratory tract has been proposed to be the cause of the disease (see PLoS One. 2008 Feb 13;3:e1582 and J Infect Dis. 2011 Apr 1;203:1021-30).”
Based on the work of authors, it appears that a high index of suspicion for MIS-C is important for children who develop Kawasaki-like symptoms, David J. Goldberg, MD, said in an interview. “Although children have largely been spared from the acute respiratory presentation of the SARS-CoV-2 pandemic, the recognition and understanding of what appears to be a postviral inflammatory response is a critical first step in developing treatment algorithms for this disease process,” said Dr. Goldberg, a board-certified attending cardiologist in the cardiac center and fetal heart program at Children’s Hospital of Philadelphia. “If inflammatory markers are elevated, particularly if there are accompanying gastrointestinal symptoms, the possibility of cardiac involvement suggests the utility of screening echocardiography. Given the potential need for inotropic or mechanical circulatory support, the presence of myocardial dysfunction dictates care in an intensive care unit capable of providing advanced therapies. While the evidence from Dr. Belhadjer’s cohort suggests that full recovery is probable, there is still much to be learned about this unique inflammatory syndrome and the alarm has rightly been sounded.”
The researchers and Dr. Goldberg reported having no disclosures.
SOURCE: Belhadjer Z et al. Circulation 2020 May 17; doi: 10.1161/circulationaha.120.048360.
According to study of a cluster of patients in France and Switzerland, children may experience an acute cardiac decompensation from the severe inflammatory state following SARS-CoV-2 infection, termed multisystem inflammatory syndrome in children (MIS-C). Treatment with immunoglobulin appears to be associated with recovery of left ventricular systolic function.
“The pediatric and cardiology communities should be acutely aware of this new disease probably related to SARS-CoV-2 infection (MIS-C), that shares similarities with Kawasaki disease but has specificities in its presentation,” researchers led by Zahra Belhadjer, MD, of Necker-Enfants Malades Hospital in Paris, wrote in a cases series report published online in Circulation “Early diagnosis and management appear to lead to favorable outcome using classical therapies. Elucidating the immune mechanisms of this disease will afford further insights for treatment and potential global prevention of severe forms.”
Over a 2-month period that coincided with the SARS-CoV-2 pandemic in France and Switzerland, the researchers retrospectively collected clinical, biological, therapeutic, and early-outcomes data in 35 children who were admitted to pediatric ICUs in 14 centers for cardiogenic shock, left ventricular dysfunction, and severe inflammatory state. Their median age was 10 years, all presented with a fever, 80% had gastrointestinal symptoms of abdominal pain, vomiting, or diarrhea, and 28% had comorbidities that included body mass index of greater than 25 kg/m2 (17%), asthma (9%), and lupus (3%), and overweight. Only 17% presented with chest pain. The researchers observed that left ventricular ejection fraction was less than 30% in 28% of patients, and 80% required inotropic support with 28% treated with extracorporeal membrane oxygenation (ECMO). All patients presented with a severe inflammatory state evidenced by elevated C-reactive protein and d-dimer. Interleukin 6 was elevated to a median of 135 pg/mL in 13 of the patients. Elevation of troponin I was constant but mild to moderate, and NT-proBNP or BNP elevation was present in all children.
Nearly all patients 35 (88%) patients tested positive for SARS-CoV-2 infection by polymerase chain reaction of nasopharyngeal swab or serology. Most patients (80%) received IV inotropic support, 71% received first-line IV immunoglobulin, 65% received anticoagulation with heparin, 34% received IV steroids having been considered high-risk patients with symptoms similar to an incomplete form of Kawasaki disease, and 8% received treatment with an interleukin-1 receptor antagonist because of a persistent severe inflammatory state. Left ventricular function was restored in 71% of those discharged from the intensive care unit. No patient died, and all patients treated with ECMO were successfully weaned after a median of 4.5 days.
“Some aspects of this emerging pediatric disease (MIS-C) are similar to those of Kawasaki disease: prolonged fever, multisystem inflammation with skin rash, lymphadenopathy, diarrhea, meningism, and high levels of inflammatory biomarkers,” the researchers wrote. “But differences are important and raise the question as to whether this syndrome is Kawasaki disease with SARS-CoV-2 as the triggering agent, or represents a different syndrome (MIS-C). Kawasaki disease predominantly affects young children younger than 5 years, whereas the median age in our series is 10 years. Incomplete forms of Kawasaki disease occur in infants who may have fever as the sole clinical finding, whereas older patients are more prone to exhibit the complete form.”
They went on to note that the overlapping features between MIS-C and Kawasaki disease “may be due to similar pathophysiology. The etiologic agent of Kawasaki disease is unknown but likely to be ubiquitous, causing asymptomatic childhood infection but triggering the immunologic cascade of Kawasaki disease in genetically susceptible individuals. Please note that infection with a novel RNA virus that enters through the upper respiratory tract has been proposed to be the cause of the disease (see PLoS One. 2008 Feb 13;3:e1582 and J Infect Dis. 2011 Apr 1;203:1021-30).”
Based on the work of authors, it appears that a high index of suspicion for MIS-C is important for children who develop Kawasaki-like symptoms, David J. Goldberg, MD, said in an interview. “Although children have largely been spared from the acute respiratory presentation of the SARS-CoV-2 pandemic, the recognition and understanding of what appears to be a postviral inflammatory response is a critical first step in developing treatment algorithms for this disease process,” said Dr. Goldberg, a board-certified attending cardiologist in the cardiac center and fetal heart program at Children’s Hospital of Philadelphia. “If inflammatory markers are elevated, particularly if there are accompanying gastrointestinal symptoms, the possibility of cardiac involvement suggests the utility of screening echocardiography. Given the potential need for inotropic or mechanical circulatory support, the presence of myocardial dysfunction dictates care in an intensive care unit capable of providing advanced therapies. While the evidence from Dr. Belhadjer’s cohort suggests that full recovery is probable, there is still much to be learned about this unique inflammatory syndrome and the alarm has rightly been sounded.”
The researchers and Dr. Goldberg reported having no disclosures.
SOURCE: Belhadjer Z et al. Circulation 2020 May 17; doi: 10.1161/circulationaha.120.048360.
According to study of a cluster of patients in France and Switzerland, children may experience an acute cardiac decompensation from the severe inflammatory state following SARS-CoV-2 infection, termed multisystem inflammatory syndrome in children (MIS-C). Treatment with immunoglobulin appears to be associated with recovery of left ventricular systolic function.
“The pediatric and cardiology communities should be acutely aware of this new disease probably related to SARS-CoV-2 infection (MIS-C), that shares similarities with Kawasaki disease but has specificities in its presentation,” researchers led by Zahra Belhadjer, MD, of Necker-Enfants Malades Hospital in Paris, wrote in a cases series report published online in Circulation “Early diagnosis and management appear to lead to favorable outcome using classical therapies. Elucidating the immune mechanisms of this disease will afford further insights for treatment and potential global prevention of severe forms.”
Over a 2-month period that coincided with the SARS-CoV-2 pandemic in France and Switzerland, the researchers retrospectively collected clinical, biological, therapeutic, and early-outcomes data in 35 children who were admitted to pediatric ICUs in 14 centers for cardiogenic shock, left ventricular dysfunction, and severe inflammatory state. Their median age was 10 years, all presented with a fever, 80% had gastrointestinal symptoms of abdominal pain, vomiting, or diarrhea, and 28% had comorbidities that included body mass index of greater than 25 kg/m2 (17%), asthma (9%), and lupus (3%), and overweight. Only 17% presented with chest pain. The researchers observed that left ventricular ejection fraction was less than 30% in 28% of patients, and 80% required inotropic support with 28% treated with extracorporeal membrane oxygenation (ECMO). All patients presented with a severe inflammatory state evidenced by elevated C-reactive protein and d-dimer. Interleukin 6 was elevated to a median of 135 pg/mL in 13 of the patients. Elevation of troponin I was constant but mild to moderate, and NT-proBNP or BNP elevation was present in all children.
Nearly all patients 35 (88%) patients tested positive for SARS-CoV-2 infection by polymerase chain reaction of nasopharyngeal swab or serology. Most patients (80%) received IV inotropic support, 71% received first-line IV immunoglobulin, 65% received anticoagulation with heparin, 34% received IV steroids having been considered high-risk patients with symptoms similar to an incomplete form of Kawasaki disease, and 8% received treatment with an interleukin-1 receptor antagonist because of a persistent severe inflammatory state. Left ventricular function was restored in 71% of those discharged from the intensive care unit. No patient died, and all patients treated with ECMO were successfully weaned after a median of 4.5 days.
“Some aspects of this emerging pediatric disease (MIS-C) are similar to those of Kawasaki disease: prolonged fever, multisystem inflammation with skin rash, lymphadenopathy, diarrhea, meningism, and high levels of inflammatory biomarkers,” the researchers wrote. “But differences are important and raise the question as to whether this syndrome is Kawasaki disease with SARS-CoV-2 as the triggering agent, or represents a different syndrome (MIS-C). Kawasaki disease predominantly affects young children younger than 5 years, whereas the median age in our series is 10 years. Incomplete forms of Kawasaki disease occur in infants who may have fever as the sole clinical finding, whereas older patients are more prone to exhibit the complete form.”
They went on to note that the overlapping features between MIS-C and Kawasaki disease “may be due to similar pathophysiology. The etiologic agent of Kawasaki disease is unknown but likely to be ubiquitous, causing asymptomatic childhood infection but triggering the immunologic cascade of Kawasaki disease in genetically susceptible individuals. Please note that infection with a novel RNA virus that enters through the upper respiratory tract has been proposed to be the cause of the disease (see PLoS One. 2008 Feb 13;3:e1582 and J Infect Dis. 2011 Apr 1;203:1021-30).”
Based on the work of authors, it appears that a high index of suspicion for MIS-C is important for children who develop Kawasaki-like symptoms, David J. Goldberg, MD, said in an interview. “Although children have largely been spared from the acute respiratory presentation of the SARS-CoV-2 pandemic, the recognition and understanding of what appears to be a postviral inflammatory response is a critical first step in developing treatment algorithms for this disease process,” said Dr. Goldberg, a board-certified attending cardiologist in the cardiac center and fetal heart program at Children’s Hospital of Philadelphia. “If inflammatory markers are elevated, particularly if there are accompanying gastrointestinal symptoms, the possibility of cardiac involvement suggests the utility of screening echocardiography. Given the potential need for inotropic or mechanical circulatory support, the presence of myocardial dysfunction dictates care in an intensive care unit capable of providing advanced therapies. While the evidence from Dr. Belhadjer’s cohort suggests that full recovery is probable, there is still much to be learned about this unique inflammatory syndrome and the alarm has rightly been sounded.”
The researchers and Dr. Goldberg reported having no disclosures.
SOURCE: Belhadjer Z et al. Circulation 2020 May 17; doi: 10.1161/circulationaha.120.048360.
FROM CIRCULATION
To fast or not to fast before elective cardiac catheterization
No restriction of oral food intake prior to nonemergent cardiac catheterization is as safe as the current traditional NPO [nothing by mouth] strategy, results from a large, single-center, randomized controlled trial showed.
According to lead investigator Abhishek Mishra, MD, NPO after midnight has been a standard practice before major surgery requiring general anesthesia since Mendelson Syndrome was first described in 1946. “The rational for keeping NPO after midnight has been to keep the stomach empty, to reduce gastric contents and acidity – which would reduce emesis – and eventually reduce the risk of aspiration,” Dr. Mishra, a cardiologist at the Heart and Vascular Institute at Vidant Health in Greenville, N.C., said at the at the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “The rationale of NPO in the setting of cardiac catheterization is to reduce the risk of aspiration, and more so, of a patient needing emergent cardiac surgery.” The clinical question was, do we really need to keep our patients NPO prior to elective cardiac catheterization? So far, no large randomized study has been done to answer this question.”
To find out, Dr. Mishra and colleagues carried out CHOW NOW (Can We Safely Have Our Patients Eat With Cardiac Catheterization – Nix or Allow), a single-center, prospective, randomized, single-blinded study that compared the safety of a nonfasting strategy with the current fasting protocol strategies in 599 patients who underwent nonemergent cardiac catheterization at The Guthrie Clinic/Robert Packer Hospital in Sayre, Pa.
Patients in the fasting group were instructed to be NPO after midnight, but could have clear liquids up to 2 hours prior to the procedure, while those in the nonfasting group had no restriction of oral intake, irrespective of time of cardiac catheterization. The primary outcome was a composite of aspiration pneumonia, preprocedural hypertension, preprocedural hypoglycemia or hyperglycemia, incidence of nausea/vomiting, and contrast-induced neuropathy. Secondary outcomes included total cost of the index hospitalization, patient satisfaction via a questionnaire containing seven questions, and in-hospital mortality.
Of the 599 patients, 306 were assigned to the standard fasting group and the remaining 293 to the nonfasting group. Their mean age was 67 years, 45% were on a proton pump inhibitor or H2 blockers, and 33% had diabetes. In addition, 40% had acute coronary syndrome, and 23% underwent percutaneous intervention.
The researchers observed no statistically significant difference in the primary or secondary outcomes between the study groups. In the nonfasting group, 11.3% of patients met the primary endpoint, compared with 9.8% of the patients in the standard fasting group (P = .65). In addition, the nonfasting strategy was found to be noninferior to the standard fasting strategy for the primary outcome at a noninferiority margin threshold of 0.059.
Dr. Mishra and colleagues observed no differences between the standard fasting and nonfasting groups with respect to in-hospital mortality (0.3% vs. 0.7%, respectively; P = .616), patient satisfaction score (a mean of 4.4 vs. a mean of 4.5; P = .257), and mean total cost of hospitalization ($8,446 vs. $6,960; P = .654).
“In this randomized, controlled trial, we found that there was no significant difference in the rate of overall adverse events with an approach of unrestricted oral intake prior to cardiac catheterization compared to strict fasting, and it was associated with better patient satisfaction and lower cost of care, especially for hospitalized patients,” concluded Dr. Mishra, who conducted the research during his fellowship at The Guthrie Clinic.
He acknowledged certain limitations of the trial, including the fact that results are applicable only to cardiac catheterization procedures, including coronary angiographies, percutaneous coronary interventions, and left heart catheterizations. “These results are not applicable to certain high-risk coronary procedures that required the use of a large-bore access or any valve procedures,” he said.
One of the session’s invited panelists, Cindy L. Grines, MD,, said that she and other interventional cardiologists have “gone around and around” on the issue of NPO prior to nonemergent cardiac catheterization. “I actually let my patients get fluids up until the time they’re put on the cath lab table,” said Dr. Grines, chief scientific officer of the Northside Cardiovascular Institute in Atlanta. “I haven’t been giving them solid food like this, though.”
Another panelist, Timothy D. Henry, MD, said that in his clinical experience, “patients don’t like being NPO, and I think we’ve all seen cases where patients are actually volume-depleted in the morning.” Dr. Henry, medical director of The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati, pointed out that most NPO policy “is not dictated by us as interventional cardiologists; it’s dictated by hospital policies or by anesthesiologists. Will [the results of this study] change what we do?”
The Donald Guthrie Research Foundation funded the study. Daniel P. Sporn, MD, FACC, was the study’s principal investigator. Dr. Mishra reported having no financial disclosures.
SOURCE: Mishra A et al., SCAI 2020, abstract 11758.
No restriction of oral food intake prior to nonemergent cardiac catheterization is as safe as the current traditional NPO [nothing by mouth] strategy, results from a large, single-center, randomized controlled trial showed.
According to lead investigator Abhishek Mishra, MD, NPO after midnight has been a standard practice before major surgery requiring general anesthesia since Mendelson Syndrome was first described in 1946. “The rational for keeping NPO after midnight has been to keep the stomach empty, to reduce gastric contents and acidity – which would reduce emesis – and eventually reduce the risk of aspiration,” Dr. Mishra, a cardiologist at the Heart and Vascular Institute at Vidant Health in Greenville, N.C., said at the at the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “The rationale of NPO in the setting of cardiac catheterization is to reduce the risk of aspiration, and more so, of a patient needing emergent cardiac surgery.” The clinical question was, do we really need to keep our patients NPO prior to elective cardiac catheterization? So far, no large randomized study has been done to answer this question.”
To find out, Dr. Mishra and colleagues carried out CHOW NOW (Can We Safely Have Our Patients Eat With Cardiac Catheterization – Nix or Allow), a single-center, prospective, randomized, single-blinded study that compared the safety of a nonfasting strategy with the current fasting protocol strategies in 599 patients who underwent nonemergent cardiac catheterization at The Guthrie Clinic/Robert Packer Hospital in Sayre, Pa.
Patients in the fasting group were instructed to be NPO after midnight, but could have clear liquids up to 2 hours prior to the procedure, while those in the nonfasting group had no restriction of oral intake, irrespective of time of cardiac catheterization. The primary outcome was a composite of aspiration pneumonia, preprocedural hypertension, preprocedural hypoglycemia or hyperglycemia, incidence of nausea/vomiting, and contrast-induced neuropathy. Secondary outcomes included total cost of the index hospitalization, patient satisfaction via a questionnaire containing seven questions, and in-hospital mortality.
Of the 599 patients, 306 were assigned to the standard fasting group and the remaining 293 to the nonfasting group. Their mean age was 67 years, 45% were on a proton pump inhibitor or H2 blockers, and 33% had diabetes. In addition, 40% had acute coronary syndrome, and 23% underwent percutaneous intervention.
The researchers observed no statistically significant difference in the primary or secondary outcomes between the study groups. In the nonfasting group, 11.3% of patients met the primary endpoint, compared with 9.8% of the patients in the standard fasting group (P = .65). In addition, the nonfasting strategy was found to be noninferior to the standard fasting strategy for the primary outcome at a noninferiority margin threshold of 0.059.
Dr. Mishra and colleagues observed no differences between the standard fasting and nonfasting groups with respect to in-hospital mortality (0.3% vs. 0.7%, respectively; P = .616), patient satisfaction score (a mean of 4.4 vs. a mean of 4.5; P = .257), and mean total cost of hospitalization ($8,446 vs. $6,960; P = .654).
“In this randomized, controlled trial, we found that there was no significant difference in the rate of overall adverse events with an approach of unrestricted oral intake prior to cardiac catheterization compared to strict fasting, and it was associated with better patient satisfaction and lower cost of care, especially for hospitalized patients,” concluded Dr. Mishra, who conducted the research during his fellowship at The Guthrie Clinic.
He acknowledged certain limitations of the trial, including the fact that results are applicable only to cardiac catheterization procedures, including coronary angiographies, percutaneous coronary interventions, and left heart catheterizations. “These results are not applicable to certain high-risk coronary procedures that required the use of a large-bore access or any valve procedures,” he said.
One of the session’s invited panelists, Cindy L. Grines, MD,, said that she and other interventional cardiologists have “gone around and around” on the issue of NPO prior to nonemergent cardiac catheterization. “I actually let my patients get fluids up until the time they’re put on the cath lab table,” said Dr. Grines, chief scientific officer of the Northside Cardiovascular Institute in Atlanta. “I haven’t been giving them solid food like this, though.”
Another panelist, Timothy D. Henry, MD, said that in his clinical experience, “patients don’t like being NPO, and I think we’ve all seen cases where patients are actually volume-depleted in the morning.” Dr. Henry, medical director of The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati, pointed out that most NPO policy “is not dictated by us as interventional cardiologists; it’s dictated by hospital policies or by anesthesiologists. Will [the results of this study] change what we do?”
The Donald Guthrie Research Foundation funded the study. Daniel P. Sporn, MD, FACC, was the study’s principal investigator. Dr. Mishra reported having no financial disclosures.
SOURCE: Mishra A et al., SCAI 2020, abstract 11758.
No restriction of oral food intake prior to nonemergent cardiac catheterization is as safe as the current traditional NPO [nothing by mouth] strategy, results from a large, single-center, randomized controlled trial showed.
According to lead investigator Abhishek Mishra, MD, NPO after midnight has been a standard practice before major surgery requiring general anesthesia since Mendelson Syndrome was first described in 1946. “The rational for keeping NPO after midnight has been to keep the stomach empty, to reduce gastric contents and acidity – which would reduce emesis – and eventually reduce the risk of aspiration,” Dr. Mishra, a cardiologist at the Heart and Vascular Institute at Vidant Health in Greenville, N.C., said at the at the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “The rationale of NPO in the setting of cardiac catheterization is to reduce the risk of aspiration, and more so, of a patient needing emergent cardiac surgery.” The clinical question was, do we really need to keep our patients NPO prior to elective cardiac catheterization? So far, no large randomized study has been done to answer this question.”
To find out, Dr. Mishra and colleagues carried out CHOW NOW (Can We Safely Have Our Patients Eat With Cardiac Catheterization – Nix or Allow), a single-center, prospective, randomized, single-blinded study that compared the safety of a nonfasting strategy with the current fasting protocol strategies in 599 patients who underwent nonemergent cardiac catheterization at The Guthrie Clinic/Robert Packer Hospital in Sayre, Pa.
Patients in the fasting group were instructed to be NPO after midnight, but could have clear liquids up to 2 hours prior to the procedure, while those in the nonfasting group had no restriction of oral intake, irrespective of time of cardiac catheterization. The primary outcome was a composite of aspiration pneumonia, preprocedural hypertension, preprocedural hypoglycemia or hyperglycemia, incidence of nausea/vomiting, and contrast-induced neuropathy. Secondary outcomes included total cost of the index hospitalization, patient satisfaction via a questionnaire containing seven questions, and in-hospital mortality.
Of the 599 patients, 306 were assigned to the standard fasting group and the remaining 293 to the nonfasting group. Their mean age was 67 years, 45% were on a proton pump inhibitor or H2 blockers, and 33% had diabetes. In addition, 40% had acute coronary syndrome, and 23% underwent percutaneous intervention.
The researchers observed no statistically significant difference in the primary or secondary outcomes between the study groups. In the nonfasting group, 11.3% of patients met the primary endpoint, compared with 9.8% of the patients in the standard fasting group (P = .65). In addition, the nonfasting strategy was found to be noninferior to the standard fasting strategy for the primary outcome at a noninferiority margin threshold of 0.059.
Dr. Mishra and colleagues observed no differences between the standard fasting and nonfasting groups with respect to in-hospital mortality (0.3% vs. 0.7%, respectively; P = .616), patient satisfaction score (a mean of 4.4 vs. a mean of 4.5; P = .257), and mean total cost of hospitalization ($8,446 vs. $6,960; P = .654).
“In this randomized, controlled trial, we found that there was no significant difference in the rate of overall adverse events with an approach of unrestricted oral intake prior to cardiac catheterization compared to strict fasting, and it was associated with better patient satisfaction and lower cost of care, especially for hospitalized patients,” concluded Dr. Mishra, who conducted the research during his fellowship at The Guthrie Clinic.
He acknowledged certain limitations of the trial, including the fact that results are applicable only to cardiac catheterization procedures, including coronary angiographies, percutaneous coronary interventions, and left heart catheterizations. “These results are not applicable to certain high-risk coronary procedures that required the use of a large-bore access or any valve procedures,” he said.
One of the session’s invited panelists, Cindy L. Grines, MD,, said that she and other interventional cardiologists have “gone around and around” on the issue of NPO prior to nonemergent cardiac catheterization. “I actually let my patients get fluids up until the time they’re put on the cath lab table,” said Dr. Grines, chief scientific officer of the Northside Cardiovascular Institute in Atlanta. “I haven’t been giving them solid food like this, though.”
Another panelist, Timothy D. Henry, MD, said that in his clinical experience, “patients don’t like being NPO, and I think we’ve all seen cases where patients are actually volume-depleted in the morning.” Dr. Henry, medical director of The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati, pointed out that most NPO policy “is not dictated by us as interventional cardiologists; it’s dictated by hospital policies or by anesthesiologists. Will [the results of this study] change what we do?”
The Donald Guthrie Research Foundation funded the study. Daniel P. Sporn, MD, FACC, was the study’s principal investigator. Dr. Mishra reported having no financial disclosures.
SOURCE: Mishra A et al., SCAI 2020, abstract 11758.
REPORTING FROM SCAI 2020
With massive reach, telemedicine transforms STEMI care in Latin America
A novel telemedicine approach to remotely guide ST-segment elevation myocardial infarction treatment in four Latin American countries screened more than 780,000 patients and resulted in a mortality rate of 5.2%, results from a 1-year, prospective, observational study showed.
“We have created a modality where the care of acute MI can be remotely guided,” lead investigator Sameer Mehta, MD, MBA, said during a press briefing at the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “This flattens the disparity between the developed and the developing countries, particularly in the poorer parts of Africa, the Middle East, and Southeast Asia.”
Dr. Mehta, chairman of the Lumen Foundation in Miami, and colleagues developed a “hub and spoke” platform to expand STEMI access to more than 100 million people in Brazil, Colombia, Mexico, and Argentina. For the effort, known as the Latin America Telemedicine Infarct Network (LATIN), “spokes” consisted of small clinics and primary health care centers in remote locations, while the “hubs” were medical centers that provided percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery. There were 313 spokes, 47 hubs, and more than 2,000 health care professionals who participated in the endeavor, including about 600 physicians.
The study, which is the largest of its kind, implemented a 3T strategy: telemedicine, triage, and transport, “which was the hardest part,” Dr. Mehta said. “In some cases, the spokes were located up to 300 miles away from the hubs. Up to 11% of these spokes in the remote areas did not even have a physician. Some had nurses who were triaging the patients.”
Patients who presented at spoke sites were enrolled into LATIN and data were collected through a form that included patient demographics, previous medical history, and an ECG. This information was sent through an app to one of three telemedicine diagnosis centers with 24/7 access to a cardiologist: one in Colombia, one in Brazil, one in Argentina. Once STEMI was identified by ECG, the STEMI protocol was activated, sending alerts to both designated hub and spoke sites and triggering ambulance dispatch. At the spoke sites, thrombolysis, a pharmaco-invasive strategy, or a primary PCI was performed, depending on case and treatment availability. Patients with successful thrombolysis were stabilized for up to 24 hours before transferral to a hub. Patients for whom reperfusion failed were transferred immediately to a hub for rescue PCI.
Dr. Mehta reported findings from 780,234 telemedicine encounters that occurred in the LATIN network in 2018. Telemedicine experts diagnosed 8,395 patients (1%) with STEMI, of which 3,872 (46%) were urgently treated at 47 hubs. A total of 3,015 (78%) were reperfused with PCI. Time-to-telemedicine diagnosis averaged 3.5 minutes. “It used to take us 11 minutes of time to make a diagnosis by telemedicine,” Dr. Mehta said. “By the time we were done with the trial, the time to diagnosis was brought down to 3.5 minutes.” Average door-to-balloon time was 48 minutes and the STEMI mortality was 5.2%. This represents a 55% reduction in STEMI mortality from when LATIN began as a pilot project in 2013, Dr. Mehta said.
Hypertension was the most prevalent underlying disease (59%), followed by smoking (30%) and diabetes (29%), and the male to female STEMI diagnosis ratio was 1.71. The chief reason for nontreatment was coverage denial from insurance carriers (71%). “Getting payers onboard is extremely difficult, because being located here in Miami, is it very hard for me to convince them about the importance of supporting these people,” Dr. Mehta said. “However, as time has passed [and with] coverage of LATIN by the media, the program has become better known. We have been able to work mainly through the health secretaries [in these four countries], but is difficult from there onward.”
LATIN investigators faced other hurdles, which were unique in each of the four countries. “In Colombia, we were facing all sorts of geographical challenges; Brazil was challenging because of its size of the country and [difficulty establishing relationships with] some of the inner-city hospitals,” he said. “Mexico and Argentina were unique from the telemedicine point of view.” The fact that the care of LATIN patients was navigated from one of three telemedicine diagnosis centers “demonstrates the ability of telemedicine,” he said. “If I am able to guide a patient in Mexico from Bogotá, Colombia, it should be easy to guide a patient from Miami who’s presenting in Zambia.”
Dealing with the lack of ambulance services in Brazil, Colombia, Mexico, and Argentina has also been a hitch to the effort. “There is either a complete lack of ambulances or there is no central ambulance system,” he said. “In one of the earlier cities where we started the program in Colombia, 84% of patients used to self-transport. At the moment, 79% are being transported by ambulance. So, the halo effect of how LATIN has helped MI management has been impressive.”
Despite the lack of a comparator study as robust as LATIN, the program was estimated to reach between $39.6 million and $119 million USD total savings during the study period. This includes the cost of tele-emergency encounters, avoided transfers, and the cost of transportation. The investigators project that by the year 2026, 5 million patients could be triaged by this telemedicine pathway, saving $249 million. “As we are getting excited about the developments and the possibilities of telemedicine in the COVID-19 era, I think the work of LATIN becomes all the more relevant,” Dr. Mehta said during his main presentation.
During the press briefing, Timothy D. Henry, MD, praised the success of LATIN in reaching an underserved population. “The majority of these patients 10 years ago were not being treated with any reperfusion therapy at all,” said Dr. Henry, medical director of The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati. “With rapid diagnosis and the process of putting [LATIN] in place, that has increased to the point where 78% are now getting primary PCI. That is remarkable.”
LATIN was supported by an educational grant from the Medtronic Foundation. Dr. Mehta and Dr. Henry both reported having no financial disclosures.
A novel telemedicine approach to remotely guide ST-segment elevation myocardial infarction treatment in four Latin American countries screened more than 780,000 patients and resulted in a mortality rate of 5.2%, results from a 1-year, prospective, observational study showed.
“We have created a modality where the care of acute MI can be remotely guided,” lead investigator Sameer Mehta, MD, MBA, said during a press briefing at the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “This flattens the disparity between the developed and the developing countries, particularly in the poorer parts of Africa, the Middle East, and Southeast Asia.”
Dr. Mehta, chairman of the Lumen Foundation in Miami, and colleagues developed a “hub and spoke” platform to expand STEMI access to more than 100 million people in Brazil, Colombia, Mexico, and Argentina. For the effort, known as the Latin America Telemedicine Infarct Network (LATIN), “spokes” consisted of small clinics and primary health care centers in remote locations, while the “hubs” were medical centers that provided percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery. There were 313 spokes, 47 hubs, and more than 2,000 health care professionals who participated in the endeavor, including about 600 physicians.
The study, which is the largest of its kind, implemented a 3T strategy: telemedicine, triage, and transport, “which was the hardest part,” Dr. Mehta said. “In some cases, the spokes were located up to 300 miles away from the hubs. Up to 11% of these spokes in the remote areas did not even have a physician. Some had nurses who were triaging the patients.”
Patients who presented at spoke sites were enrolled into LATIN and data were collected through a form that included patient demographics, previous medical history, and an ECG. This information was sent through an app to one of three telemedicine diagnosis centers with 24/7 access to a cardiologist: one in Colombia, one in Brazil, one in Argentina. Once STEMI was identified by ECG, the STEMI protocol was activated, sending alerts to both designated hub and spoke sites and triggering ambulance dispatch. At the spoke sites, thrombolysis, a pharmaco-invasive strategy, or a primary PCI was performed, depending on case and treatment availability. Patients with successful thrombolysis were stabilized for up to 24 hours before transferral to a hub. Patients for whom reperfusion failed were transferred immediately to a hub for rescue PCI.
Dr. Mehta reported findings from 780,234 telemedicine encounters that occurred in the LATIN network in 2018. Telemedicine experts diagnosed 8,395 patients (1%) with STEMI, of which 3,872 (46%) were urgently treated at 47 hubs. A total of 3,015 (78%) were reperfused with PCI. Time-to-telemedicine diagnosis averaged 3.5 minutes. “It used to take us 11 minutes of time to make a diagnosis by telemedicine,” Dr. Mehta said. “By the time we were done with the trial, the time to diagnosis was brought down to 3.5 minutes.” Average door-to-balloon time was 48 minutes and the STEMI mortality was 5.2%. This represents a 55% reduction in STEMI mortality from when LATIN began as a pilot project in 2013, Dr. Mehta said.
Hypertension was the most prevalent underlying disease (59%), followed by smoking (30%) and diabetes (29%), and the male to female STEMI diagnosis ratio was 1.71. The chief reason for nontreatment was coverage denial from insurance carriers (71%). “Getting payers onboard is extremely difficult, because being located here in Miami, is it very hard for me to convince them about the importance of supporting these people,” Dr. Mehta said. “However, as time has passed [and with] coverage of LATIN by the media, the program has become better known. We have been able to work mainly through the health secretaries [in these four countries], but is difficult from there onward.”
LATIN investigators faced other hurdles, which were unique in each of the four countries. “In Colombia, we were facing all sorts of geographical challenges; Brazil was challenging because of its size of the country and [difficulty establishing relationships with] some of the inner-city hospitals,” he said. “Mexico and Argentina were unique from the telemedicine point of view.” The fact that the care of LATIN patients was navigated from one of three telemedicine diagnosis centers “demonstrates the ability of telemedicine,” he said. “If I am able to guide a patient in Mexico from Bogotá, Colombia, it should be easy to guide a patient from Miami who’s presenting in Zambia.”
Dealing with the lack of ambulance services in Brazil, Colombia, Mexico, and Argentina has also been a hitch to the effort. “There is either a complete lack of ambulances or there is no central ambulance system,” he said. “In one of the earlier cities where we started the program in Colombia, 84% of patients used to self-transport. At the moment, 79% are being transported by ambulance. So, the halo effect of how LATIN has helped MI management has been impressive.”
Despite the lack of a comparator study as robust as LATIN, the program was estimated to reach between $39.6 million and $119 million USD total savings during the study period. This includes the cost of tele-emergency encounters, avoided transfers, and the cost of transportation. The investigators project that by the year 2026, 5 million patients could be triaged by this telemedicine pathway, saving $249 million. “As we are getting excited about the developments and the possibilities of telemedicine in the COVID-19 era, I think the work of LATIN becomes all the more relevant,” Dr. Mehta said during his main presentation.
During the press briefing, Timothy D. Henry, MD, praised the success of LATIN in reaching an underserved population. “The majority of these patients 10 years ago were not being treated with any reperfusion therapy at all,” said Dr. Henry, medical director of The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati. “With rapid diagnosis and the process of putting [LATIN] in place, that has increased to the point where 78% are now getting primary PCI. That is remarkable.”
LATIN was supported by an educational grant from the Medtronic Foundation. Dr. Mehta and Dr. Henry both reported having no financial disclosures.
A novel telemedicine approach to remotely guide ST-segment elevation myocardial infarction treatment in four Latin American countries screened more than 780,000 patients and resulted in a mortality rate of 5.2%, results from a 1-year, prospective, observational study showed.
“We have created a modality where the care of acute MI can be remotely guided,” lead investigator Sameer Mehta, MD, MBA, said during a press briefing at the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “This flattens the disparity between the developed and the developing countries, particularly in the poorer parts of Africa, the Middle East, and Southeast Asia.”
Dr. Mehta, chairman of the Lumen Foundation in Miami, and colleagues developed a “hub and spoke” platform to expand STEMI access to more than 100 million people in Brazil, Colombia, Mexico, and Argentina. For the effort, known as the Latin America Telemedicine Infarct Network (LATIN), “spokes” consisted of small clinics and primary health care centers in remote locations, while the “hubs” were medical centers that provided percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery. There were 313 spokes, 47 hubs, and more than 2,000 health care professionals who participated in the endeavor, including about 600 physicians.
The study, which is the largest of its kind, implemented a 3T strategy: telemedicine, triage, and transport, “which was the hardest part,” Dr. Mehta said. “In some cases, the spokes were located up to 300 miles away from the hubs. Up to 11% of these spokes in the remote areas did not even have a physician. Some had nurses who were triaging the patients.”
Patients who presented at spoke sites were enrolled into LATIN and data were collected through a form that included patient demographics, previous medical history, and an ECG. This information was sent through an app to one of three telemedicine diagnosis centers with 24/7 access to a cardiologist: one in Colombia, one in Brazil, one in Argentina. Once STEMI was identified by ECG, the STEMI protocol was activated, sending alerts to both designated hub and spoke sites and triggering ambulance dispatch. At the spoke sites, thrombolysis, a pharmaco-invasive strategy, or a primary PCI was performed, depending on case and treatment availability. Patients with successful thrombolysis were stabilized for up to 24 hours before transferral to a hub. Patients for whom reperfusion failed were transferred immediately to a hub for rescue PCI.
Dr. Mehta reported findings from 780,234 telemedicine encounters that occurred in the LATIN network in 2018. Telemedicine experts diagnosed 8,395 patients (1%) with STEMI, of which 3,872 (46%) were urgently treated at 47 hubs. A total of 3,015 (78%) were reperfused with PCI. Time-to-telemedicine diagnosis averaged 3.5 minutes. “It used to take us 11 minutes of time to make a diagnosis by telemedicine,” Dr. Mehta said. “By the time we were done with the trial, the time to diagnosis was brought down to 3.5 minutes.” Average door-to-balloon time was 48 minutes and the STEMI mortality was 5.2%. This represents a 55% reduction in STEMI mortality from when LATIN began as a pilot project in 2013, Dr. Mehta said.
Hypertension was the most prevalent underlying disease (59%), followed by smoking (30%) and diabetes (29%), and the male to female STEMI diagnosis ratio was 1.71. The chief reason for nontreatment was coverage denial from insurance carriers (71%). “Getting payers onboard is extremely difficult, because being located here in Miami, is it very hard for me to convince them about the importance of supporting these people,” Dr. Mehta said. “However, as time has passed [and with] coverage of LATIN by the media, the program has become better known. We have been able to work mainly through the health secretaries [in these four countries], but is difficult from there onward.”
LATIN investigators faced other hurdles, which were unique in each of the four countries. “In Colombia, we were facing all sorts of geographical challenges; Brazil was challenging because of its size of the country and [difficulty establishing relationships with] some of the inner-city hospitals,” he said. “Mexico and Argentina were unique from the telemedicine point of view.” The fact that the care of LATIN patients was navigated from one of three telemedicine diagnosis centers “demonstrates the ability of telemedicine,” he said. “If I am able to guide a patient in Mexico from Bogotá, Colombia, it should be easy to guide a patient from Miami who’s presenting in Zambia.”
Dealing with the lack of ambulance services in Brazil, Colombia, Mexico, and Argentina has also been a hitch to the effort. “There is either a complete lack of ambulances or there is no central ambulance system,” he said. “In one of the earlier cities where we started the program in Colombia, 84% of patients used to self-transport. At the moment, 79% are being transported by ambulance. So, the halo effect of how LATIN has helped MI management has been impressive.”
Despite the lack of a comparator study as robust as LATIN, the program was estimated to reach between $39.6 million and $119 million USD total savings during the study period. This includes the cost of tele-emergency encounters, avoided transfers, and the cost of transportation. The investigators project that by the year 2026, 5 million patients could be triaged by this telemedicine pathway, saving $249 million. “As we are getting excited about the developments and the possibilities of telemedicine in the COVID-19 era, I think the work of LATIN becomes all the more relevant,” Dr. Mehta said during his main presentation.
During the press briefing, Timothy D. Henry, MD, praised the success of LATIN in reaching an underserved population. “The majority of these patients 10 years ago were not being treated with any reperfusion therapy at all,” said Dr. Henry, medical director of The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati. “With rapid diagnosis and the process of putting [LATIN] in place, that has increased to the point where 78% are now getting primary PCI. That is remarkable.”
LATIN was supported by an educational grant from the Medtronic Foundation. Dr. Mehta and Dr. Henry both reported having no financial disclosures.
REPORTING FROM SCAI 2020
Experts recommend slow, steady approach to reopening laser and cosmetic surgery practices
“People talk about reinventing the wheel,” Jeffrey S. Dover, MD, codirector of SkinCare Physicians in Chestnut Hill, Mass., said during an hour-long webinar on May 5 sponsored by the American Society for Laser Medicine and Surgery. “In this case, we’re inventing the wheel; no one’s ever done this before – not in our lifetimes. The last pandemic was over 100 years ago, when there wasn’t aesthetic medicine.”
Dr. Dover joined a panel of four other experts from around the country to discuss how to reopen practices safely and effectively. Paul M. Friedman, MD, director of the Houston Cosmetic Dermatology & Laser Center, moderated the event.
In Florida, which reopened certain businesses on May 4, 2020, Jill S. Waibel, MD, plans to start at 25% capacity at Miami Dermatology and Laser Institute, and build from there. “We’re trying to take care of skin cancer patients first,” said Dr. Waibel, a dermatologist who owns the practice. “Then we’re going to start doing less aggressive cosmetic procedures like injectables, nonablative procedures. We’ll move into the more aggressive procedures as we ease back into it. We really want to see what’s going to happen 2-3 weeks down the line now that things are starting to open up.”
In Maryland, where state officials announced on May 6 that guidelines would be issued to allow for nonmedical procedures, Elizabeth L. Tanzi, MD, founder and director of Capital Laser & Skin Care in Chevy Chase, expects things to “look very different” once her practice reopens. “We are taking it very slowly,” she said. “Teledermatology for acne and other follow-ups is not something we did before, but it is certainly something that we’ll continue.”
The way she sees it, having the proper personal protective equipment is a key part of any reopening discussion. “I am not going near anyone’s face without an N95 mask that fits well, and without a face shield,” she said. “If you’re delegating these procedures to people that you don’t trust to be wearing the PPE correctly, then you shouldn’t be delegating them, because a key is the PPE. You have to assume that everyone has the virus at every time.”
In Ardmore, Pa., the Main Line Center for Laser Surgery remains closed because of current state regulations. When practice director Eric F. Bernstein, MD, gets the green light to reopen, patients will undergo a consultation by phone or videoconference and pay their bill before they set foot in the office. “We’re on the second floor, so patients can take a stairwell and avoid the elevator,” Dr. Bernstein said. “They’ll come in, not check in at the desk; go right to the room. There will be one treater and one assistant. If the patient doesn’t come in with a mask, we’ll supply one. It’s going to be a very different process. People are setting their hours longer because they’re going to be seeing fewer people. There will be no sitting in the waiting room.”
In the COVID-19 epicenter, Roy G. Geronemus, MD, director of the Laser & Skin Surgery Center of New York, has been performing Mohs procedures and treating children with vascular malformations, but everything else is on hold. “Once the governor [Andrew Cuomo] lifts the stay-at-home restrictions, we’ll ease into things,” he said. “The issue of performing more invasive procedures – like ablative fractional resurfacing – is something that we are concerned about. I’m concerned about any laser that has environmental plume. For example, with our tattoo-removal procedures, I intend to treat every patient through a gel for the short term, and perhaps even for the long term. One can do that safely, and that eliminates the plume altogether.”
At the center, Dr. Geronemus added, “we do a fair amount of ablative fractional resurfacing and some fully ablative resurfacing. I intend to use large facial shields with these patients. We do use vacuum in each room as it stands right now, not only with electrosurgery, but we’ll be adding that to laser procedures as well. That will be helpful.”
In Chestnut Hill, Mass., Dr. Dover and his colleagues plan to practice what he termed “universal COVID precaution” by wearing a face mask, goggles, or a face shield, gloves, and protective clothing when necessary. “We are not going to do any ablative procedures, no procedures with plume, and we’re going to try and eliminate risk as much as we can,” he said. “We will have no waiting room; the patients will walk right to an exam room. They’ll be prescreened on the phone. The only thing they’ll have done when they first come in is to have their temperature taken, and they’ll be checked in and out with the doctor and the nurse in the room, and that’s it. There will be no other extraneous people to help to eliminate risk. We’re cutting our schedules down by 75% so that we can socially distance within our practice,” Dr. Dover said.
Dr. Dover served as lead author on “A path to resume aesthetic care: Executive summary of Project AesCert guidance supplement – practical considerations for aesthetic medicine professionals supporting clinic preparedness in response to the SARS-CoV-2 outbreak,” which was published online in Facial Plastic Surgery & Aesthetic Medicine (2002 May 5. doi: 10.1089/fpsam.2020.0239). His coauthors included a facial plastic surgeon and three infectious disease experts.
Dr. Dover said, “We took the advice of these experts in infectious diseases, who said, ‘we don’t know all the right answers [to resuming aesthetic care]. We can mitigate risk, but we cannot eliminate risk. You have to treat every patient in your office as if they’re COVID-19 positive. If you do that, you’ll have a safe office. It’ll be the safest place in your world, safer than a grocery store, where you have no idea who you’re standing beside.’ ”
“The problem with this virus, compared to, say, SARS-CoV-1, is that these patients are positive and shedding virus 2-3 days before they get a fever,” he added. “With SARS-CoV-1, they had a fever first and then they shed virus. What I learned was, treat everybody with universal precautions.” The document includes tips for communicating with patient about expectations for office visits, clinic schedule management, cleaning procedures, PPE, treatment room set-up, and employee health screening and training.
During the webinar, an ASLMS member posed a question to the panelists about their comfort level in performing mechanical microneedling and radiofrequency (RF) microneedling procedures as aesthetic practices begin to reopen. “Generally, there’s no plume with microneedling with or without RF,” Dr. Geronemus said. “Depending upon the procedure that you’re doing, some of the microneedling procedures are very bloody; that may carry a risk unto itself. Other procedures where you’re using a thermal component have less bleeding. I’m more inclined to proceed with an RF with microneedling procedure and less inclined to proceed with a bloody, more aggressive microneedling procedure.”
Dr. Waibel emphasized the importance of disinfecting the microneedling device between uses. “If you have disposable needle cartridges, I think it’s a lot safer than if you have to clean [them],” she said. “We know that COVID-19 can live up to 3 hours, at least in a lab scenario, so you don’t want to transmit it from patient to patient. If someone has COVID-19 on their nose, and you microneedle over it, and that’s not completely disinfected, you could spread it to the next patient. We have really amped up our cleaning in between rooms. We have a whole crew that cleans every surface with [disinfectant wipes] and 90% alcohol.”
With reported shortages of N95 in many health care settings, some panelists said that they plan to reuse masks until the supply chain improves. Dr. Dover said that one option is to “use a mask, label it, number it, drop it in into a paper bag or into a [sealed plastic food container] upside down without touching the front of it,” he said. “If it sits for a week and you see patients 5 days a week, that mask will be dried out and highly effective a week later. That’s what we’re going to do until there is a big supply of them.”
The pandemic has also thrown a monkey wrench into aesthetic and medical dermatology clinical research efforts. According to Dr. Dover, many aesthetic studies have been shut down, “and most companies are giving us little guidance,” he said. “As they figure things out, they ask us to do things over and over again. So, I hope that clinical research will improve because of COVID-19 in the long term, but in the short term, it’s been a bit of a nightmare.”
Dr. Geronemus added that, in order to fulfill criteria for most studies, clinicians are required to see patients in a certain number of days. “We’re out of protocol in many different studies, so we’re requesting that protocols be amended and that the FDA [Food and Drug Administration] and the sponsors will consider opportunities to make those changes,” he said. “We’ll do as much as we can virtually, but if you’re studying an acne scar, you really need to see the patient [in person].”
Strict social distancing measures are also disrupting agreements that dermatologists may have had with trainees and fellows before the pandemic hit. “We’ve had to send letters and e-mails to people who were planning visits and preceptorships,” Dr. Dover said. “Even with our fellows, we’re going to have to figure out a way to practice so as not to complicate the issue in the room. The more people in the room, the more risk there is for transmitting disease. It’s really an issue.”
Dr. Tanzi limits everyone in the room during procedures. “We’re screening patients beforehand and telling them no family members, unless there’s a disability; no kids, unless it’s a kid coming in for acne treatment and they have to bring their parent; no drivers – they can wait outside,” she said.
Another ASLMS member asked the panelists if they plan to incorporate an informed consent form for COVID-19 risk into their practices, similar to the one developed by the American Society of Plastic Surgeons. “That’s a tough one,” Dr. Waibel said. “Before patients enter our practice, we take their temperature and ask them several COVID-related symptoms and contact questions – which they validate as true.”
Dr. Geronemus said that he will consider the idea. “The downside is logistical,” he said. “Patients sign so many forms already; they’re complaining that it takes so long to get into see me, and my hand is tired from signing so many forms.’”
Dr. Dover said that he and his colleagues are planning to use a COVID-19 risk consent form. “I’d err on the side of yes rather than on the side of no, because you’re better off overdoing it than underdoing it,” he said. “This is not the time for shortcuts.”
[email protected]
“People talk about reinventing the wheel,” Jeffrey S. Dover, MD, codirector of SkinCare Physicians in Chestnut Hill, Mass., said during an hour-long webinar on May 5 sponsored by the American Society for Laser Medicine and Surgery. “In this case, we’re inventing the wheel; no one’s ever done this before – not in our lifetimes. The last pandemic was over 100 years ago, when there wasn’t aesthetic medicine.”
Dr. Dover joined a panel of four other experts from around the country to discuss how to reopen practices safely and effectively. Paul M. Friedman, MD, director of the Houston Cosmetic Dermatology & Laser Center, moderated the event.
In Florida, which reopened certain businesses on May 4, 2020, Jill S. Waibel, MD, plans to start at 25% capacity at Miami Dermatology and Laser Institute, and build from there. “We’re trying to take care of skin cancer patients first,” said Dr. Waibel, a dermatologist who owns the practice. “Then we’re going to start doing less aggressive cosmetic procedures like injectables, nonablative procedures. We’ll move into the more aggressive procedures as we ease back into it. We really want to see what’s going to happen 2-3 weeks down the line now that things are starting to open up.”
In Maryland, where state officials announced on May 6 that guidelines would be issued to allow for nonmedical procedures, Elizabeth L. Tanzi, MD, founder and director of Capital Laser & Skin Care in Chevy Chase, expects things to “look very different” once her practice reopens. “We are taking it very slowly,” she said. “Teledermatology for acne and other follow-ups is not something we did before, but it is certainly something that we’ll continue.”
The way she sees it, having the proper personal protective equipment is a key part of any reopening discussion. “I am not going near anyone’s face without an N95 mask that fits well, and without a face shield,” she said. “If you’re delegating these procedures to people that you don’t trust to be wearing the PPE correctly, then you shouldn’t be delegating them, because a key is the PPE. You have to assume that everyone has the virus at every time.”
In Ardmore, Pa., the Main Line Center for Laser Surgery remains closed because of current state regulations. When practice director Eric F. Bernstein, MD, gets the green light to reopen, patients will undergo a consultation by phone or videoconference and pay their bill before they set foot in the office. “We’re on the second floor, so patients can take a stairwell and avoid the elevator,” Dr. Bernstein said. “They’ll come in, not check in at the desk; go right to the room. There will be one treater and one assistant. If the patient doesn’t come in with a mask, we’ll supply one. It’s going to be a very different process. People are setting their hours longer because they’re going to be seeing fewer people. There will be no sitting in the waiting room.”
In the COVID-19 epicenter, Roy G. Geronemus, MD, director of the Laser & Skin Surgery Center of New York, has been performing Mohs procedures and treating children with vascular malformations, but everything else is on hold. “Once the governor [Andrew Cuomo] lifts the stay-at-home restrictions, we’ll ease into things,” he said. “The issue of performing more invasive procedures – like ablative fractional resurfacing – is something that we are concerned about. I’m concerned about any laser that has environmental plume. For example, with our tattoo-removal procedures, I intend to treat every patient through a gel for the short term, and perhaps even for the long term. One can do that safely, and that eliminates the plume altogether.”
At the center, Dr. Geronemus added, “we do a fair amount of ablative fractional resurfacing and some fully ablative resurfacing. I intend to use large facial shields with these patients. We do use vacuum in each room as it stands right now, not only with electrosurgery, but we’ll be adding that to laser procedures as well. That will be helpful.”
In Chestnut Hill, Mass., Dr. Dover and his colleagues plan to practice what he termed “universal COVID precaution” by wearing a face mask, goggles, or a face shield, gloves, and protective clothing when necessary. “We are not going to do any ablative procedures, no procedures with plume, and we’re going to try and eliminate risk as much as we can,” he said. “We will have no waiting room; the patients will walk right to an exam room. They’ll be prescreened on the phone. The only thing they’ll have done when they first come in is to have their temperature taken, and they’ll be checked in and out with the doctor and the nurse in the room, and that’s it. There will be no other extraneous people to help to eliminate risk. We’re cutting our schedules down by 75% so that we can socially distance within our practice,” Dr. Dover said.
Dr. Dover served as lead author on “A path to resume aesthetic care: Executive summary of Project AesCert guidance supplement – practical considerations for aesthetic medicine professionals supporting clinic preparedness in response to the SARS-CoV-2 outbreak,” which was published online in Facial Plastic Surgery & Aesthetic Medicine (2002 May 5. doi: 10.1089/fpsam.2020.0239). His coauthors included a facial plastic surgeon and three infectious disease experts.
Dr. Dover said, “We took the advice of these experts in infectious diseases, who said, ‘we don’t know all the right answers [to resuming aesthetic care]. We can mitigate risk, but we cannot eliminate risk. You have to treat every patient in your office as if they’re COVID-19 positive. If you do that, you’ll have a safe office. It’ll be the safest place in your world, safer than a grocery store, where you have no idea who you’re standing beside.’ ”
“The problem with this virus, compared to, say, SARS-CoV-1, is that these patients are positive and shedding virus 2-3 days before they get a fever,” he added. “With SARS-CoV-1, they had a fever first and then they shed virus. What I learned was, treat everybody with universal precautions.” The document includes tips for communicating with patient about expectations for office visits, clinic schedule management, cleaning procedures, PPE, treatment room set-up, and employee health screening and training.
During the webinar, an ASLMS member posed a question to the panelists about their comfort level in performing mechanical microneedling and radiofrequency (RF) microneedling procedures as aesthetic practices begin to reopen. “Generally, there’s no plume with microneedling with or without RF,” Dr. Geronemus said. “Depending upon the procedure that you’re doing, some of the microneedling procedures are very bloody; that may carry a risk unto itself. Other procedures where you’re using a thermal component have less bleeding. I’m more inclined to proceed with an RF with microneedling procedure and less inclined to proceed with a bloody, more aggressive microneedling procedure.”
Dr. Waibel emphasized the importance of disinfecting the microneedling device between uses. “If you have disposable needle cartridges, I think it’s a lot safer than if you have to clean [them],” she said. “We know that COVID-19 can live up to 3 hours, at least in a lab scenario, so you don’t want to transmit it from patient to patient. If someone has COVID-19 on their nose, and you microneedle over it, and that’s not completely disinfected, you could spread it to the next patient. We have really amped up our cleaning in between rooms. We have a whole crew that cleans every surface with [disinfectant wipes] and 90% alcohol.”
With reported shortages of N95 in many health care settings, some panelists said that they plan to reuse masks until the supply chain improves. Dr. Dover said that one option is to “use a mask, label it, number it, drop it in into a paper bag or into a [sealed plastic food container] upside down without touching the front of it,” he said. “If it sits for a week and you see patients 5 days a week, that mask will be dried out and highly effective a week later. That’s what we’re going to do until there is a big supply of them.”
The pandemic has also thrown a monkey wrench into aesthetic and medical dermatology clinical research efforts. According to Dr. Dover, many aesthetic studies have been shut down, “and most companies are giving us little guidance,” he said. “As they figure things out, they ask us to do things over and over again. So, I hope that clinical research will improve because of COVID-19 in the long term, but in the short term, it’s been a bit of a nightmare.”
Dr. Geronemus added that, in order to fulfill criteria for most studies, clinicians are required to see patients in a certain number of days. “We’re out of protocol in many different studies, so we’re requesting that protocols be amended and that the FDA [Food and Drug Administration] and the sponsors will consider opportunities to make those changes,” he said. “We’ll do as much as we can virtually, but if you’re studying an acne scar, you really need to see the patient [in person].”
Strict social distancing measures are also disrupting agreements that dermatologists may have had with trainees and fellows before the pandemic hit. “We’ve had to send letters and e-mails to people who were planning visits and preceptorships,” Dr. Dover said. “Even with our fellows, we’re going to have to figure out a way to practice so as not to complicate the issue in the room. The more people in the room, the more risk there is for transmitting disease. It’s really an issue.”
Dr. Tanzi limits everyone in the room during procedures. “We’re screening patients beforehand and telling them no family members, unless there’s a disability; no kids, unless it’s a kid coming in for acne treatment and they have to bring their parent; no drivers – they can wait outside,” she said.
Another ASLMS member asked the panelists if they plan to incorporate an informed consent form for COVID-19 risk into their practices, similar to the one developed by the American Society of Plastic Surgeons. “That’s a tough one,” Dr. Waibel said. “Before patients enter our practice, we take their temperature and ask them several COVID-related symptoms and contact questions – which they validate as true.”
Dr. Geronemus said that he will consider the idea. “The downside is logistical,” he said. “Patients sign so many forms already; they’re complaining that it takes so long to get into see me, and my hand is tired from signing so many forms.’”
Dr. Dover said that he and his colleagues are planning to use a COVID-19 risk consent form. “I’d err on the side of yes rather than on the side of no, because you’re better off overdoing it than underdoing it,” he said. “This is not the time for shortcuts.”
[email protected]
“People talk about reinventing the wheel,” Jeffrey S. Dover, MD, codirector of SkinCare Physicians in Chestnut Hill, Mass., said during an hour-long webinar on May 5 sponsored by the American Society for Laser Medicine and Surgery. “In this case, we’re inventing the wheel; no one’s ever done this before – not in our lifetimes. The last pandemic was over 100 years ago, when there wasn’t aesthetic medicine.”
Dr. Dover joined a panel of four other experts from around the country to discuss how to reopen practices safely and effectively. Paul M. Friedman, MD, director of the Houston Cosmetic Dermatology & Laser Center, moderated the event.
In Florida, which reopened certain businesses on May 4, 2020, Jill S. Waibel, MD, plans to start at 25% capacity at Miami Dermatology and Laser Institute, and build from there. “We’re trying to take care of skin cancer patients first,” said Dr. Waibel, a dermatologist who owns the practice. “Then we’re going to start doing less aggressive cosmetic procedures like injectables, nonablative procedures. We’ll move into the more aggressive procedures as we ease back into it. We really want to see what’s going to happen 2-3 weeks down the line now that things are starting to open up.”
In Maryland, where state officials announced on May 6 that guidelines would be issued to allow for nonmedical procedures, Elizabeth L. Tanzi, MD, founder and director of Capital Laser & Skin Care in Chevy Chase, expects things to “look very different” once her practice reopens. “We are taking it very slowly,” she said. “Teledermatology for acne and other follow-ups is not something we did before, but it is certainly something that we’ll continue.”
The way she sees it, having the proper personal protective equipment is a key part of any reopening discussion. “I am not going near anyone’s face without an N95 mask that fits well, and without a face shield,” she said. “If you’re delegating these procedures to people that you don’t trust to be wearing the PPE correctly, then you shouldn’t be delegating them, because a key is the PPE. You have to assume that everyone has the virus at every time.”
In Ardmore, Pa., the Main Line Center for Laser Surgery remains closed because of current state regulations. When practice director Eric F. Bernstein, MD, gets the green light to reopen, patients will undergo a consultation by phone or videoconference and pay their bill before they set foot in the office. “We’re on the second floor, so patients can take a stairwell and avoid the elevator,” Dr. Bernstein said. “They’ll come in, not check in at the desk; go right to the room. There will be one treater and one assistant. If the patient doesn’t come in with a mask, we’ll supply one. It’s going to be a very different process. People are setting their hours longer because they’re going to be seeing fewer people. There will be no sitting in the waiting room.”
In the COVID-19 epicenter, Roy G. Geronemus, MD, director of the Laser & Skin Surgery Center of New York, has been performing Mohs procedures and treating children with vascular malformations, but everything else is on hold. “Once the governor [Andrew Cuomo] lifts the stay-at-home restrictions, we’ll ease into things,” he said. “The issue of performing more invasive procedures – like ablative fractional resurfacing – is something that we are concerned about. I’m concerned about any laser that has environmental plume. For example, with our tattoo-removal procedures, I intend to treat every patient through a gel for the short term, and perhaps even for the long term. One can do that safely, and that eliminates the plume altogether.”
At the center, Dr. Geronemus added, “we do a fair amount of ablative fractional resurfacing and some fully ablative resurfacing. I intend to use large facial shields with these patients. We do use vacuum in each room as it stands right now, not only with electrosurgery, but we’ll be adding that to laser procedures as well. That will be helpful.”
In Chestnut Hill, Mass., Dr. Dover and his colleagues plan to practice what he termed “universal COVID precaution” by wearing a face mask, goggles, or a face shield, gloves, and protective clothing when necessary. “We are not going to do any ablative procedures, no procedures with plume, and we’re going to try and eliminate risk as much as we can,” he said. “We will have no waiting room; the patients will walk right to an exam room. They’ll be prescreened on the phone. The only thing they’ll have done when they first come in is to have their temperature taken, and they’ll be checked in and out with the doctor and the nurse in the room, and that’s it. There will be no other extraneous people to help to eliminate risk. We’re cutting our schedules down by 75% so that we can socially distance within our practice,” Dr. Dover said.
Dr. Dover served as lead author on “A path to resume aesthetic care: Executive summary of Project AesCert guidance supplement – practical considerations for aesthetic medicine professionals supporting clinic preparedness in response to the SARS-CoV-2 outbreak,” which was published online in Facial Plastic Surgery & Aesthetic Medicine (2002 May 5. doi: 10.1089/fpsam.2020.0239). His coauthors included a facial plastic surgeon and three infectious disease experts.
Dr. Dover said, “We took the advice of these experts in infectious diseases, who said, ‘we don’t know all the right answers [to resuming aesthetic care]. We can mitigate risk, but we cannot eliminate risk. You have to treat every patient in your office as if they’re COVID-19 positive. If you do that, you’ll have a safe office. It’ll be the safest place in your world, safer than a grocery store, where you have no idea who you’re standing beside.’ ”
“The problem with this virus, compared to, say, SARS-CoV-1, is that these patients are positive and shedding virus 2-3 days before they get a fever,” he added. “With SARS-CoV-1, they had a fever first and then they shed virus. What I learned was, treat everybody with universal precautions.” The document includes tips for communicating with patient about expectations for office visits, clinic schedule management, cleaning procedures, PPE, treatment room set-up, and employee health screening and training.
During the webinar, an ASLMS member posed a question to the panelists about their comfort level in performing mechanical microneedling and radiofrequency (RF) microneedling procedures as aesthetic practices begin to reopen. “Generally, there’s no plume with microneedling with or without RF,” Dr. Geronemus said. “Depending upon the procedure that you’re doing, some of the microneedling procedures are very bloody; that may carry a risk unto itself. Other procedures where you’re using a thermal component have less bleeding. I’m more inclined to proceed with an RF with microneedling procedure and less inclined to proceed with a bloody, more aggressive microneedling procedure.”
Dr. Waibel emphasized the importance of disinfecting the microneedling device between uses. “If you have disposable needle cartridges, I think it’s a lot safer than if you have to clean [them],” she said. “We know that COVID-19 can live up to 3 hours, at least in a lab scenario, so you don’t want to transmit it from patient to patient. If someone has COVID-19 on their nose, and you microneedle over it, and that’s not completely disinfected, you could spread it to the next patient. We have really amped up our cleaning in between rooms. We have a whole crew that cleans every surface with [disinfectant wipes] and 90% alcohol.”
With reported shortages of N95 in many health care settings, some panelists said that they plan to reuse masks until the supply chain improves. Dr. Dover said that one option is to “use a mask, label it, number it, drop it in into a paper bag or into a [sealed plastic food container] upside down without touching the front of it,” he said. “If it sits for a week and you see patients 5 days a week, that mask will be dried out and highly effective a week later. That’s what we’re going to do until there is a big supply of them.”
The pandemic has also thrown a monkey wrench into aesthetic and medical dermatology clinical research efforts. According to Dr. Dover, many aesthetic studies have been shut down, “and most companies are giving us little guidance,” he said. “As they figure things out, they ask us to do things over and over again. So, I hope that clinical research will improve because of COVID-19 in the long term, but in the short term, it’s been a bit of a nightmare.”
Dr. Geronemus added that, in order to fulfill criteria for most studies, clinicians are required to see patients in a certain number of days. “We’re out of protocol in many different studies, so we’re requesting that protocols be amended and that the FDA [Food and Drug Administration] and the sponsors will consider opportunities to make those changes,” he said. “We’ll do as much as we can virtually, but if you’re studying an acne scar, you really need to see the patient [in person].”
Strict social distancing measures are also disrupting agreements that dermatologists may have had with trainees and fellows before the pandemic hit. “We’ve had to send letters and e-mails to people who were planning visits and preceptorships,” Dr. Dover said. “Even with our fellows, we’re going to have to figure out a way to practice so as not to complicate the issue in the room. The more people in the room, the more risk there is for transmitting disease. It’s really an issue.”
Dr. Tanzi limits everyone in the room during procedures. “We’re screening patients beforehand and telling them no family members, unless there’s a disability; no kids, unless it’s a kid coming in for acne treatment and they have to bring their parent; no drivers – they can wait outside,” she said.
Another ASLMS member asked the panelists if they plan to incorporate an informed consent form for COVID-19 risk into their practices, similar to the one developed by the American Society of Plastic Surgeons. “That’s a tough one,” Dr. Waibel said. “Before patients enter our practice, we take their temperature and ask them several COVID-related symptoms and contact questions – which they validate as true.”
Dr. Geronemus said that he will consider the idea. “The downside is logistical,” he said. “Patients sign so many forms already; they’re complaining that it takes so long to get into see me, and my hand is tired from signing so many forms.’”
Dr. Dover said that he and his colleagues are planning to use a COVID-19 risk consent form. “I’d err on the side of yes rather than on the side of no, because you’re better off overdoing it than underdoing it,” he said. “This is not the time for shortcuts.”
[email protected]
With life in the balance, a pediatric palliative care program expands its work to adults
In late March of 2020, when it became clear that hospitals in the greater New York City area would face a capacity crisis in caring for seriously ill patients with COVID-19, members of the leadership team at the Children’s Hospital at Montefiore (CHAM) in the Bronx, N.Y., convened to draft a response plan.
The recommendations put into action that day included moving the hospital’s emergency department from the lower level to the fourth floor, increasing the age limit for patients seen in the ED from 21 years of age to 30 and freeing up an entire hospital floor and a half to accommodate the anticipated surge of patients with COVID-19 admitted to Montefiore’s interconnected adult hospital, according to Sarah E. Norris, MD.
“We made multiple moves all at once,” said Dr. Norris, director of pediatric palliative care at CHAM. “It struck everyone as logical that palliative care had to be expanded, because all of the news we had received as the surge came to New York from around the world was full of death and uncertainty, and would require thoughtful conversations about end-of-life wishes at critical times and how to really respect the person and understand their values.”
When Dr. Norris left the leadership team meeting, she returned to her office, put her face in her hands, and sobbed as she began to process the gravity of what was ahead. “I cried because I knew that so many families were going to suffer a heartbreak, no matter how much we could do,” she said.
Stitching the QUILT
Over the next few days, Dr. Norris began recruiting colleagues from the large Montefiore Health System – most of whom she did not know – who met criteria for work deployment to expand CHAM’s palliative care program of clinician to 27 clinicians consisting of pediatricians, nurse practitioners, and psychologists, to meet the projected needs of COVID-19 patients and their families.
Some candidates for the effort, known as the Quality in Life Team (QUILT), were 65 years of age or older, considered at high risk for developing COVID-19-related complications themselves. Others were immunocompromised or had medical conditions that would not allow them to have direct contact with COVID-19 patients. “There were also clinicians in other parts of our health system whose practice hours were going to be severely reduced,” said Dr. Norris, who is board-certified in general pediatrics and in hospice and palliative care medicine.
Once she assembled QUILT, members participated in a 1-day rapid training webinar covering the basics of palliative care and grief, and readied themselves for one of three roles: physicians to provide face-to-face palliative care in CHAM; supportive callers to provide support to patients with COVID-19 and their families between 12:00-8:00 p.m. each day; and bereavement callers to reach out to families who lost loved ones to COVID-19 and provide grief counseling for 3 weeks.
“This allows families to have at least two contacts a day from the hospital: one from the medical team that’s giving them technical, medical information, and another from members of the QUILT team,” Dr. Norris said. “We provide support for the worry, anxiety, and fear that we know creeps in when you’re separated from your family member, especially during a pandemic when you watch TV and there’s a death count rising.”
During her early meetings with QUILT members via Zoom or on the phone, Dr. Norris encouraged them to stretch their skill sets and mindsets as they shifted from caring for children and adolescents to mostly adults. “Pediatricians are all about family; that’s why we get into this,” she said. “We’re used to treating your kids, but then, suddenly, the parent becomes our patient, like in COVID-19, or the grandparent becomes our patient. We treat you all the same; you’re part of our family. There has been no adult who has died ‘within our house’ that has died alone. There has either been a staff member at their bedside, or when possible, a family member. We are witnessing life until the last breath here.”
‘They have no loved ones with them’
One day, members of CHAM’s medical team contacted Dr. Norris about a patient with COVID-19 who’d been cared for by Montefiore clinicians all of his young life. The boy’s mother, who did not speak English, was at his bedside in the ICU, and the clinicians asked Dr. Norris to speak with her by cell phone while they prepared him for intubation.
“We were looking at each other through a glass window wall in our ICU,” Dr. Norris recalled. “I talked to her the entire time the team worked to put him on the breathing machine, through an interpreter. I asked her to tell me about her son and about her family, and she did. We developed a warm relationship. After that, every day I would see her son through the glass window wall. Every couple of days, I would have the privilege of talking to his mother by phone. At one point, she asked me, ‘Dr. Norris, do you think his lungs will heal?’ I had to tell her no. Almost selfishly, I was relieved we were on the phone, because she cried, and so did I. When he died, she was able to be by his side.”
Frederick J. Kaskel, MD, PhD, joined QUILT as a supportive caller after being asked to go home during his on-call shift on St. Patrick’s Day at CHAM, where he serves as chief emeritus of nephrology. “I was told that I was deemed to be at high risk because of my age,” the 75-year-old said. “The next day, a junior person took over for me, and 2 days later she got sick with COVID-19. She’s fine but she was home for 3 weeks sick as a dog. It was scary.”
In his role as a supportive caller, Dr. Kaskel found himself engaged in his share of detective work, trying to find phone numbers of next of kin for patients hospitalized with COVID-19. “When they come into the ER, they may not have been with a loved one or a family member; they may have been brought in by an EMT,” he said. “Some of them speak little English and others have little documentation with them. It takes a lot of work to get phone numbers.”
Once Dr. Kaskel reaches a loved one by phone, he introduces himself as a member of the QUILT team. “I tell them I’m not calling to update the medical status but just to talk to them about their loved one,” he said. “Then I usually ask, ‘So, how are you doing with this? The stress is enormous, the uncertainties.’ Then they open up and express their fears. I’ve had a lot of people say, ‘we have no money, and I don’t know how we’re going to pay rent for the apartment. We have to line up for food.’ I also ask what they do to alleviate stress. One guy said, ‘I drink a lot, but I’m careful.’ ”
Dr. Kaskel, who is also a past president of the American Society of Pediatric Nephrology, applies that same personable approach in daily conversations with adult patients hospitalized at CHAM with COVID-19, the majority of whom are African Americans in their 30s, 40s, and 50s. “Invariably, they ask, ‘Has my loved one been updated as to my status?’ ” he said. “The second thing they often say is, ‘I’m worried about infecting other people, but I also worry if I’m going to get through this. I’m really afraid I’m going to die.’ I say, ‘You have a wonderful team keeping track of you. They’re seeing you all the time and making changes to your medicines.’ ”
When patients express their fear of dying from the virus, Dr. Kaskel asks them how they’re coping with that fear. Most tell him that they pray.
“If they don’t answer, I ask if they have any hobbies, like ‘Are you watching TV? Are you reading? Do you have your cell phone?’ ” he said. “Then they open up and say things like, ‘I’m listening to music on the cell phone,’ or ‘I’m FaceTiming with my loved ones.’ The use of FaceTime is crucial, because they are in a hospital, critically ill, potentially dying alone with strangers. This really hit me on the first day [of this work]. They have no loved ones with them. They have strangers: the CHAM nurses, the medical residents, the social workers, and the doctors.”
No hospital cheeseburgers
QUILT began its work on April 6, and at one time provided palliative care services for a peak of 92 mostly adult patients with COVID-19. The supportive callers made 249 individual connections with patients and family members by phone from April 6-13, 162 connections from April 13-19, and 130 connections from April 20-26, according to Dr. Norris. As of April 28, the CHAM inpatient census of patients aged 18 years and over with COVID-19 was 42, “and we’re making 130 connections by phone to patients and family members each day,” she said.
QUILT bereavement callers are following 30 families, providing 3 weeks of acute grief counseling from the date of death. “A sad truth is that, here in New York, our entire funeral, burial, cremation system is overwhelmed in volume,” Dr. Norris said. “Only half of the patients we’re following 3 weeks out have been able to have their family member buried or cremated; many are still waiting. What strikes me here is that pediatricians are often partners in care. With time, we’re partners in care in heartbreak, and in the occasional victory. We mourn patients who have died. We’ve had colleagues who died from COVID-19 right here at our hospital. But we stand together like a family.”
Dr. Norris recalled an older woman who came into CHAM’s ICU on a ventilator, critically ill from COVID-19. She called her husband at home every day with updates. “I got to know her husband, and I got to know her through him,” Dr. Norris said. “We talked every single day and she was able to graduate off of the breathing tube and out of the ICU, which was amazing.” The woman was moved to a floor in the adult hospital, but Dr. Norris continues to visit her and to provide her husband with updates, “because I’m devoted to them,” she said.
Recently, physicians in the adult hospital consulted with Dr. Norris about the woman. “They were trying to figure out what to do with her next,” she said. “Could she go home, or did she need rehab? They said, ‘We called you, Dr. Norris, because her husband thinks he can take her home.’ We know that COVID-19 really weakens people, so I went over to see her myself. I thought, ‘No single person could take care of an adult so weak at home.’ So, I called her husband and said, ‘I’m here with your wife, and I have to tell you; if she were my mother, I couldn’t take her home today. I need you to trust me.’ He said, ‘OK. We trust you and know that you have her best interest at heart.’ ”
Dr. Kaskel relayed the story of an older patient who was slowly recovering from COVID-19. During a phone call, he asked the man if there was anything he wanted at that moment.
“He said, ‘I’d love to see my wife and my children and my grandkids. I know I’m going to see them again, but right now, doc, if you could get me a cheeseburger with lettuce and tomato and ketchup and French fries from outside of the hospital, I’d be the happiest man in the world.’
I said, ‘What’s the matter with the cheeseburger made at the hospital?’
He said, ‘No! They can’t make the cheeseburger I want.’
I promised him I’d relay that message to the social worker responsible for the patient. I told her please, if you buy this for him, I’ll pay you back.”
Self-care and the next chapter
Twice each week, QUILT members gather in front of their computer monitors for mandatory Zoom meetings facilitated by two psychologists to share challenges, best practices, and to discuss the difficult work they’re doing. “We meet, because you cannot help someone if you cannot help yourself,” Dr. Norris said. “We have been encouraged each and every meeting to practice self-compassion, and to recognize that things happen during a pandemic – some will be the best you can do.”
She described organizing and serving on QUILT as a grounding experience with important lessons for the delivery of health care after the pandemic subsides and the team members return to their respective practices. “I think we’ve all gained a greater sense of humility, and we understand that the badge I wear every day does not protect me from becoming a patient, or from having my own family fall ill,” she said. “Here, we think about it very simply: ‘I’m going to treat you like you’re part of my own family.’ ”
Dr. Kaskel said that serving on QUILT as a supportive caller is an experience he won’t soon forget.
“The human bond is so accessible if you accept it,” he said. “If someone is an introvert that might not be able to draw out a stranger on the phone, then [he or she] shouldn’t do this [work]. But the fact that you can make a bond with someone that you’re not even seeing in person and know that both sides of this phone call are getting good vibes, that’s a remarkable feeling that I never really knew before, because I’ve never really had to do that before. It brings up feelings like I had after 9/11 – a unified approach to surviving this as people, as a community, the idea that ‘we will get through this,’ even though it’s totally different than anything before. The idea that there’s still hope. Those are things you can’t put a price on.”
An article about how CHAM transformed to provide care to adult COVID-19 patients was published online May 4, 2020, in the Journal of Pediatrics: doi: 10.1016/j.jpeds.2020.04.060.
In late March of 2020, when it became clear that hospitals in the greater New York City area would face a capacity crisis in caring for seriously ill patients with COVID-19, members of the leadership team at the Children’s Hospital at Montefiore (CHAM) in the Bronx, N.Y., convened to draft a response plan.
The recommendations put into action that day included moving the hospital’s emergency department from the lower level to the fourth floor, increasing the age limit for patients seen in the ED from 21 years of age to 30 and freeing up an entire hospital floor and a half to accommodate the anticipated surge of patients with COVID-19 admitted to Montefiore’s interconnected adult hospital, according to Sarah E. Norris, MD.
“We made multiple moves all at once,” said Dr. Norris, director of pediatric palliative care at CHAM. “It struck everyone as logical that palliative care had to be expanded, because all of the news we had received as the surge came to New York from around the world was full of death and uncertainty, and would require thoughtful conversations about end-of-life wishes at critical times and how to really respect the person and understand their values.”
When Dr. Norris left the leadership team meeting, she returned to her office, put her face in her hands, and sobbed as she began to process the gravity of what was ahead. “I cried because I knew that so many families were going to suffer a heartbreak, no matter how much we could do,” she said.
Stitching the QUILT
Over the next few days, Dr. Norris began recruiting colleagues from the large Montefiore Health System – most of whom she did not know – who met criteria for work deployment to expand CHAM’s palliative care program of clinician to 27 clinicians consisting of pediatricians, nurse practitioners, and psychologists, to meet the projected needs of COVID-19 patients and their families.
Some candidates for the effort, known as the Quality in Life Team (QUILT), were 65 years of age or older, considered at high risk for developing COVID-19-related complications themselves. Others were immunocompromised or had medical conditions that would not allow them to have direct contact with COVID-19 patients. “There were also clinicians in other parts of our health system whose practice hours were going to be severely reduced,” said Dr. Norris, who is board-certified in general pediatrics and in hospice and palliative care medicine.
Once she assembled QUILT, members participated in a 1-day rapid training webinar covering the basics of palliative care and grief, and readied themselves for one of three roles: physicians to provide face-to-face palliative care in CHAM; supportive callers to provide support to patients with COVID-19 and their families between 12:00-8:00 p.m. each day; and bereavement callers to reach out to families who lost loved ones to COVID-19 and provide grief counseling for 3 weeks.
“This allows families to have at least two contacts a day from the hospital: one from the medical team that’s giving them technical, medical information, and another from members of the QUILT team,” Dr. Norris said. “We provide support for the worry, anxiety, and fear that we know creeps in when you’re separated from your family member, especially during a pandemic when you watch TV and there’s a death count rising.”
During her early meetings with QUILT members via Zoom or on the phone, Dr. Norris encouraged them to stretch their skill sets and mindsets as they shifted from caring for children and adolescents to mostly adults. “Pediatricians are all about family; that’s why we get into this,” she said. “We’re used to treating your kids, but then, suddenly, the parent becomes our patient, like in COVID-19, or the grandparent becomes our patient. We treat you all the same; you’re part of our family. There has been no adult who has died ‘within our house’ that has died alone. There has either been a staff member at their bedside, or when possible, a family member. We are witnessing life until the last breath here.”
‘They have no loved ones with them’
One day, members of CHAM’s medical team contacted Dr. Norris about a patient with COVID-19 who’d been cared for by Montefiore clinicians all of his young life. The boy’s mother, who did not speak English, was at his bedside in the ICU, and the clinicians asked Dr. Norris to speak with her by cell phone while they prepared him for intubation.
“We were looking at each other through a glass window wall in our ICU,” Dr. Norris recalled. “I talked to her the entire time the team worked to put him on the breathing machine, through an interpreter. I asked her to tell me about her son and about her family, and she did. We developed a warm relationship. After that, every day I would see her son through the glass window wall. Every couple of days, I would have the privilege of talking to his mother by phone. At one point, she asked me, ‘Dr. Norris, do you think his lungs will heal?’ I had to tell her no. Almost selfishly, I was relieved we were on the phone, because she cried, and so did I. When he died, she was able to be by his side.”
Frederick J. Kaskel, MD, PhD, joined QUILT as a supportive caller after being asked to go home during his on-call shift on St. Patrick’s Day at CHAM, where he serves as chief emeritus of nephrology. “I was told that I was deemed to be at high risk because of my age,” the 75-year-old said. “The next day, a junior person took over for me, and 2 days later she got sick with COVID-19. She’s fine but she was home for 3 weeks sick as a dog. It was scary.”
In his role as a supportive caller, Dr. Kaskel found himself engaged in his share of detective work, trying to find phone numbers of next of kin for patients hospitalized with COVID-19. “When they come into the ER, they may not have been with a loved one or a family member; they may have been brought in by an EMT,” he said. “Some of them speak little English and others have little documentation with them. It takes a lot of work to get phone numbers.”
Once Dr. Kaskel reaches a loved one by phone, he introduces himself as a member of the QUILT team. “I tell them I’m not calling to update the medical status but just to talk to them about their loved one,” he said. “Then I usually ask, ‘So, how are you doing with this? The stress is enormous, the uncertainties.’ Then they open up and express their fears. I’ve had a lot of people say, ‘we have no money, and I don’t know how we’re going to pay rent for the apartment. We have to line up for food.’ I also ask what they do to alleviate stress. One guy said, ‘I drink a lot, but I’m careful.’ ”
Dr. Kaskel, who is also a past president of the American Society of Pediatric Nephrology, applies that same personable approach in daily conversations with adult patients hospitalized at CHAM with COVID-19, the majority of whom are African Americans in their 30s, 40s, and 50s. “Invariably, they ask, ‘Has my loved one been updated as to my status?’ ” he said. “The second thing they often say is, ‘I’m worried about infecting other people, but I also worry if I’m going to get through this. I’m really afraid I’m going to die.’ I say, ‘You have a wonderful team keeping track of you. They’re seeing you all the time and making changes to your medicines.’ ”
When patients express their fear of dying from the virus, Dr. Kaskel asks them how they’re coping with that fear. Most tell him that they pray.
“If they don’t answer, I ask if they have any hobbies, like ‘Are you watching TV? Are you reading? Do you have your cell phone?’ ” he said. “Then they open up and say things like, ‘I’m listening to music on the cell phone,’ or ‘I’m FaceTiming with my loved ones.’ The use of FaceTime is crucial, because they are in a hospital, critically ill, potentially dying alone with strangers. This really hit me on the first day [of this work]. They have no loved ones with them. They have strangers: the CHAM nurses, the medical residents, the social workers, and the doctors.”
No hospital cheeseburgers
QUILT began its work on April 6, and at one time provided palliative care services for a peak of 92 mostly adult patients with COVID-19. The supportive callers made 249 individual connections with patients and family members by phone from April 6-13, 162 connections from April 13-19, and 130 connections from April 20-26, according to Dr. Norris. As of April 28, the CHAM inpatient census of patients aged 18 years and over with COVID-19 was 42, “and we’re making 130 connections by phone to patients and family members each day,” she said.
QUILT bereavement callers are following 30 families, providing 3 weeks of acute grief counseling from the date of death. “A sad truth is that, here in New York, our entire funeral, burial, cremation system is overwhelmed in volume,” Dr. Norris said. “Only half of the patients we’re following 3 weeks out have been able to have their family member buried or cremated; many are still waiting. What strikes me here is that pediatricians are often partners in care. With time, we’re partners in care in heartbreak, and in the occasional victory. We mourn patients who have died. We’ve had colleagues who died from COVID-19 right here at our hospital. But we stand together like a family.”
Dr. Norris recalled an older woman who came into CHAM’s ICU on a ventilator, critically ill from COVID-19. She called her husband at home every day with updates. “I got to know her husband, and I got to know her through him,” Dr. Norris said. “We talked every single day and she was able to graduate off of the breathing tube and out of the ICU, which was amazing.” The woman was moved to a floor in the adult hospital, but Dr. Norris continues to visit her and to provide her husband with updates, “because I’m devoted to them,” she said.
Recently, physicians in the adult hospital consulted with Dr. Norris about the woman. “They were trying to figure out what to do with her next,” she said. “Could she go home, or did she need rehab? They said, ‘We called you, Dr. Norris, because her husband thinks he can take her home.’ We know that COVID-19 really weakens people, so I went over to see her myself. I thought, ‘No single person could take care of an adult so weak at home.’ So, I called her husband and said, ‘I’m here with your wife, and I have to tell you; if she were my mother, I couldn’t take her home today. I need you to trust me.’ He said, ‘OK. We trust you and know that you have her best interest at heart.’ ”
Dr. Kaskel relayed the story of an older patient who was slowly recovering from COVID-19. During a phone call, he asked the man if there was anything he wanted at that moment.
“He said, ‘I’d love to see my wife and my children and my grandkids. I know I’m going to see them again, but right now, doc, if you could get me a cheeseburger with lettuce and tomato and ketchup and French fries from outside of the hospital, I’d be the happiest man in the world.’
I said, ‘What’s the matter with the cheeseburger made at the hospital?’
He said, ‘No! They can’t make the cheeseburger I want.’
I promised him I’d relay that message to the social worker responsible for the patient. I told her please, if you buy this for him, I’ll pay you back.”
Self-care and the next chapter
Twice each week, QUILT members gather in front of their computer monitors for mandatory Zoom meetings facilitated by two psychologists to share challenges, best practices, and to discuss the difficult work they’re doing. “We meet, because you cannot help someone if you cannot help yourself,” Dr. Norris said. “We have been encouraged each and every meeting to practice self-compassion, and to recognize that things happen during a pandemic – some will be the best you can do.”
She described organizing and serving on QUILT as a grounding experience with important lessons for the delivery of health care after the pandemic subsides and the team members return to their respective practices. “I think we’ve all gained a greater sense of humility, and we understand that the badge I wear every day does not protect me from becoming a patient, or from having my own family fall ill,” she said. “Here, we think about it very simply: ‘I’m going to treat you like you’re part of my own family.’ ”
Dr. Kaskel said that serving on QUILT as a supportive caller is an experience he won’t soon forget.
“The human bond is so accessible if you accept it,” he said. “If someone is an introvert that might not be able to draw out a stranger on the phone, then [he or she] shouldn’t do this [work]. But the fact that you can make a bond with someone that you’re not even seeing in person and know that both sides of this phone call are getting good vibes, that’s a remarkable feeling that I never really knew before, because I’ve never really had to do that before. It brings up feelings like I had after 9/11 – a unified approach to surviving this as people, as a community, the idea that ‘we will get through this,’ even though it’s totally different than anything before. The idea that there’s still hope. Those are things you can’t put a price on.”
An article about how CHAM transformed to provide care to adult COVID-19 patients was published online May 4, 2020, in the Journal of Pediatrics: doi: 10.1016/j.jpeds.2020.04.060.
In late March of 2020, when it became clear that hospitals in the greater New York City area would face a capacity crisis in caring for seriously ill patients with COVID-19, members of the leadership team at the Children’s Hospital at Montefiore (CHAM) in the Bronx, N.Y., convened to draft a response plan.
The recommendations put into action that day included moving the hospital’s emergency department from the lower level to the fourth floor, increasing the age limit for patients seen in the ED from 21 years of age to 30 and freeing up an entire hospital floor and a half to accommodate the anticipated surge of patients with COVID-19 admitted to Montefiore’s interconnected adult hospital, according to Sarah E. Norris, MD.
“We made multiple moves all at once,” said Dr. Norris, director of pediatric palliative care at CHAM. “It struck everyone as logical that palliative care had to be expanded, because all of the news we had received as the surge came to New York from around the world was full of death and uncertainty, and would require thoughtful conversations about end-of-life wishes at critical times and how to really respect the person and understand their values.”
When Dr. Norris left the leadership team meeting, she returned to her office, put her face in her hands, and sobbed as she began to process the gravity of what was ahead. “I cried because I knew that so many families were going to suffer a heartbreak, no matter how much we could do,” she said.
Stitching the QUILT
Over the next few days, Dr. Norris began recruiting colleagues from the large Montefiore Health System – most of whom she did not know – who met criteria for work deployment to expand CHAM’s palliative care program of clinician to 27 clinicians consisting of pediatricians, nurse practitioners, and psychologists, to meet the projected needs of COVID-19 patients and their families.
Some candidates for the effort, known as the Quality in Life Team (QUILT), were 65 years of age or older, considered at high risk for developing COVID-19-related complications themselves. Others were immunocompromised or had medical conditions that would not allow them to have direct contact with COVID-19 patients. “There were also clinicians in other parts of our health system whose practice hours were going to be severely reduced,” said Dr. Norris, who is board-certified in general pediatrics and in hospice and palliative care medicine.
Once she assembled QUILT, members participated in a 1-day rapid training webinar covering the basics of palliative care and grief, and readied themselves for one of three roles: physicians to provide face-to-face palliative care in CHAM; supportive callers to provide support to patients with COVID-19 and their families between 12:00-8:00 p.m. each day; and bereavement callers to reach out to families who lost loved ones to COVID-19 and provide grief counseling for 3 weeks.
“This allows families to have at least two contacts a day from the hospital: one from the medical team that’s giving them technical, medical information, and another from members of the QUILT team,” Dr. Norris said. “We provide support for the worry, anxiety, and fear that we know creeps in when you’re separated from your family member, especially during a pandemic when you watch TV and there’s a death count rising.”
During her early meetings with QUILT members via Zoom or on the phone, Dr. Norris encouraged them to stretch their skill sets and mindsets as they shifted from caring for children and adolescents to mostly adults. “Pediatricians are all about family; that’s why we get into this,” she said. “We’re used to treating your kids, but then, suddenly, the parent becomes our patient, like in COVID-19, or the grandparent becomes our patient. We treat you all the same; you’re part of our family. There has been no adult who has died ‘within our house’ that has died alone. There has either been a staff member at their bedside, or when possible, a family member. We are witnessing life until the last breath here.”
‘They have no loved ones with them’
One day, members of CHAM’s medical team contacted Dr. Norris about a patient with COVID-19 who’d been cared for by Montefiore clinicians all of his young life. The boy’s mother, who did not speak English, was at his bedside in the ICU, and the clinicians asked Dr. Norris to speak with her by cell phone while they prepared him for intubation.
“We were looking at each other through a glass window wall in our ICU,” Dr. Norris recalled. “I talked to her the entire time the team worked to put him on the breathing machine, through an interpreter. I asked her to tell me about her son and about her family, and she did. We developed a warm relationship. After that, every day I would see her son through the glass window wall. Every couple of days, I would have the privilege of talking to his mother by phone. At one point, she asked me, ‘Dr. Norris, do you think his lungs will heal?’ I had to tell her no. Almost selfishly, I was relieved we were on the phone, because she cried, and so did I. When he died, she was able to be by his side.”
Frederick J. Kaskel, MD, PhD, joined QUILT as a supportive caller after being asked to go home during his on-call shift on St. Patrick’s Day at CHAM, where he serves as chief emeritus of nephrology. “I was told that I was deemed to be at high risk because of my age,” the 75-year-old said. “The next day, a junior person took over for me, and 2 days later she got sick with COVID-19. She’s fine but she was home for 3 weeks sick as a dog. It was scary.”
In his role as a supportive caller, Dr. Kaskel found himself engaged in his share of detective work, trying to find phone numbers of next of kin for patients hospitalized with COVID-19. “When they come into the ER, they may not have been with a loved one or a family member; they may have been brought in by an EMT,” he said. “Some of them speak little English and others have little documentation with them. It takes a lot of work to get phone numbers.”
Once Dr. Kaskel reaches a loved one by phone, he introduces himself as a member of the QUILT team. “I tell them I’m not calling to update the medical status but just to talk to them about their loved one,” he said. “Then I usually ask, ‘So, how are you doing with this? The stress is enormous, the uncertainties.’ Then they open up and express their fears. I’ve had a lot of people say, ‘we have no money, and I don’t know how we’re going to pay rent for the apartment. We have to line up for food.’ I also ask what they do to alleviate stress. One guy said, ‘I drink a lot, but I’m careful.’ ”
Dr. Kaskel, who is also a past president of the American Society of Pediatric Nephrology, applies that same personable approach in daily conversations with adult patients hospitalized at CHAM with COVID-19, the majority of whom are African Americans in their 30s, 40s, and 50s. “Invariably, they ask, ‘Has my loved one been updated as to my status?’ ” he said. “The second thing they often say is, ‘I’m worried about infecting other people, but I also worry if I’m going to get through this. I’m really afraid I’m going to die.’ I say, ‘You have a wonderful team keeping track of you. They’re seeing you all the time and making changes to your medicines.’ ”
When patients express their fear of dying from the virus, Dr. Kaskel asks them how they’re coping with that fear. Most tell him that they pray.
“If they don’t answer, I ask if they have any hobbies, like ‘Are you watching TV? Are you reading? Do you have your cell phone?’ ” he said. “Then they open up and say things like, ‘I’m listening to music on the cell phone,’ or ‘I’m FaceTiming with my loved ones.’ The use of FaceTime is crucial, because they are in a hospital, critically ill, potentially dying alone with strangers. This really hit me on the first day [of this work]. They have no loved ones with them. They have strangers: the CHAM nurses, the medical residents, the social workers, and the doctors.”
No hospital cheeseburgers
QUILT began its work on April 6, and at one time provided palliative care services for a peak of 92 mostly adult patients with COVID-19. The supportive callers made 249 individual connections with patients and family members by phone from April 6-13, 162 connections from April 13-19, and 130 connections from April 20-26, according to Dr. Norris. As of April 28, the CHAM inpatient census of patients aged 18 years and over with COVID-19 was 42, “and we’re making 130 connections by phone to patients and family members each day,” she said.
QUILT bereavement callers are following 30 families, providing 3 weeks of acute grief counseling from the date of death. “A sad truth is that, here in New York, our entire funeral, burial, cremation system is overwhelmed in volume,” Dr. Norris said. “Only half of the patients we’re following 3 weeks out have been able to have their family member buried or cremated; many are still waiting. What strikes me here is that pediatricians are often partners in care. With time, we’re partners in care in heartbreak, and in the occasional victory. We mourn patients who have died. We’ve had colleagues who died from COVID-19 right here at our hospital. But we stand together like a family.”
Dr. Norris recalled an older woman who came into CHAM’s ICU on a ventilator, critically ill from COVID-19. She called her husband at home every day with updates. “I got to know her husband, and I got to know her through him,” Dr. Norris said. “We talked every single day and she was able to graduate off of the breathing tube and out of the ICU, which was amazing.” The woman was moved to a floor in the adult hospital, but Dr. Norris continues to visit her and to provide her husband with updates, “because I’m devoted to them,” she said.
Recently, physicians in the adult hospital consulted with Dr. Norris about the woman. “They were trying to figure out what to do with her next,” she said. “Could she go home, or did she need rehab? They said, ‘We called you, Dr. Norris, because her husband thinks he can take her home.’ We know that COVID-19 really weakens people, so I went over to see her myself. I thought, ‘No single person could take care of an adult so weak at home.’ So, I called her husband and said, ‘I’m here with your wife, and I have to tell you; if she were my mother, I couldn’t take her home today. I need you to trust me.’ He said, ‘OK. We trust you and know that you have her best interest at heart.’ ”
Dr. Kaskel relayed the story of an older patient who was slowly recovering from COVID-19. During a phone call, he asked the man if there was anything he wanted at that moment.
“He said, ‘I’d love to see my wife and my children and my grandkids. I know I’m going to see them again, but right now, doc, if you could get me a cheeseburger with lettuce and tomato and ketchup and French fries from outside of the hospital, I’d be the happiest man in the world.’
I said, ‘What’s the matter with the cheeseburger made at the hospital?’
He said, ‘No! They can’t make the cheeseburger I want.’
I promised him I’d relay that message to the social worker responsible for the patient. I told her please, if you buy this for him, I’ll pay you back.”
Self-care and the next chapter
Twice each week, QUILT members gather in front of their computer monitors for mandatory Zoom meetings facilitated by two psychologists to share challenges, best practices, and to discuss the difficult work they’re doing. “We meet, because you cannot help someone if you cannot help yourself,” Dr. Norris said. “We have been encouraged each and every meeting to practice self-compassion, and to recognize that things happen during a pandemic – some will be the best you can do.”
She described organizing and serving on QUILT as a grounding experience with important lessons for the delivery of health care after the pandemic subsides and the team members return to their respective practices. “I think we’ve all gained a greater sense of humility, and we understand that the badge I wear every day does not protect me from becoming a patient, or from having my own family fall ill,” she said. “Here, we think about it very simply: ‘I’m going to treat you like you’re part of my own family.’ ”
Dr. Kaskel said that serving on QUILT as a supportive caller is an experience he won’t soon forget.
“The human bond is so accessible if you accept it,” he said. “If someone is an introvert that might not be able to draw out a stranger on the phone, then [he or she] shouldn’t do this [work]. But the fact that you can make a bond with someone that you’re not even seeing in person and know that both sides of this phone call are getting good vibes, that’s a remarkable feeling that I never really knew before, because I’ve never really had to do that before. It brings up feelings like I had after 9/11 – a unified approach to surviving this as people, as a community, the idea that ‘we will get through this,’ even though it’s totally different than anything before. The idea that there’s still hope. Those are things you can’t put a price on.”
An article about how CHAM transformed to provide care to adult COVID-19 patients was published online May 4, 2020, in the Journal of Pediatrics: doi: 10.1016/j.jpeds.2020.04.060.