If by now you have not had a patient ask, “Doctor, what sunscreen should I use NOW?” you will soon.

The US Food and Drug Administration (FDA) recently published a press release detailing a proposed rule on how manufacturers will be required to test and label sunscreens in the United States.^1,2 Although the press release was complicated and contained much information, the media specifically latched onto the FDA’s consideration of only 2 active sunscreen ingredients—zinc oxide and titanium dioxide—as generally recognized as safe and effective (GRASE). In response, some patients may assume that most sunscreens on the market are dangerous.

How did this new proposed rule come about? To understand the process, it takes some explanation of the history of the FDA’s regulation of sunscreens.

How are sunscreens regulated by the FDA?

The regulatory process for sunscreens in the United States is complicated. The FDA regulates sunscreens as over-the-counter (OTC) drugs rather than as cosmetics, which is how they are regulated in most of the rest of the world.

The US sunscreen regulation process began in 1978 with an advance notice of proposed rulemaking from the FDA that included recommendations from an advisory review panel on the safe and effective use of OTC sunscreen products.³ At that time, 21 active sunscreen ingredients and their maximum use concentrations were listed and determined to be safe, or GRASE. It also gave manufacturers guidance on how to test for efficacy with the methodology for determining the sun protection factor (SPF) as well as various labeling requirements. Over the years, the FDA has issued a number of other sunscreen guidelines, such as removing padimate A and adding avobenzone and zinc oxide to the list of GRASE ingredients in the 1990s.^4,5

In 1999, the FDA issued a final rule that listed 16 active sunscreen ingredients and concentrations as GRASE.⁶ There were some restrictions as to certain combinations of ingredients that could not be used in a finished product. Labeling requirements, including a maximum SPF of 30, also were put in place. This final rule established a final sunscreen monograph that was supposed to have been effective by 2002; however, in 2001 the agency delayed the effective date indefinitely because they had not yet established broad-spectrum (UVA) protection testing and labeling.⁷

The FDA published a proposed rule in 2007 as well as a final rule in 2011 that again listed the same 16 ingredients as GRASE and specified labeling and testing methods for establishing SPF, broad-spectrum protection, and water-resistance claims.^8,9 The final rule limited product labels to a maximum SPF of 50+; provided directions for use with regard to other labeling elements (eg, warnings); and identified specific claims that would not be allowed on product labels, such as “waterproof” and “all-day protection.”⁹

Nevertheless, an effective final OTC monograph for sunscreen products has not yet been published.

What is the Sunscreen Innovation Act?

In 2014, the US Congress enacted the Sunscreen Innovation Act¹⁰ primarily to mandate that the FDA develop a more efficient way to determine the safety and efficacy of new active sunscreen ingredients that were commonly used in Europe and other parts of the world at the time. Many of these agents were thought to be more protective in the UVA and/or UVB spectrum, and if added to the list of GRASE ingredients available to US manufacturers, they would lead to the development of products that would improve the protection offered by sunscreens marketed to US consumers. The time and extent application (TEA) was established, a method that allowed manufacturers to apply for FDA approval of specific agents. The TEA also suggested allowing data generated in other countries where these agents were already in use for years to be considered in the FDA’s evaluation of the agents as GRASE. In addition, Congress mandated that a final monograph on OTC sunscreens be published by the end of 2019. A number of manufacturers have submitted TEAs for new active sunscreen ingredients, and so far, all have been rejected.

Why is the FDA interested in more safety data?

Since then, the FDA has become concerned not only with the safety and efficacy of newly proposed agents through the TEA but also with the original 16 active sunscreen ingredients listed as GRASE in the 2011 final rule. In the 1970s and 1980s, sunscreen use was limited to beach vacations or outdoor sporting events, but sun-protective behaviors have changed dramatically since that time, with health care providers now becoming cognizant of the growing threats of skin cancer and melanoma as well as the cosmetic concerns of photoaging, thereby recommending daily sunscreen use to their patients. In addition, the science behind sunscreens with higher concentrations of active ingredients intended to achieve higher and higher SPFs and their respective penetration of the skin has evolved, leading to new concerns about systemic toxicity. Early limited research frequently touted by the lay media has suggested that some of these agents might lead to hormonal changes, reproductive toxicity, and carcinogenicity.

In November 2016, the FDA issued a guidance for manufacturers that outlined the safety data that would be required to establish an OTC sunscreen active ingredient as GRASE.¹¹ It also provided detailed information about both clinical and nonclinical safety testing, including human irritation and sensitization studies as well as human photosafety studies. In vitro dermal and systemic carcinogenicity studies and animal developmental and reproductive toxicity studies also were required as well studies regarding safety in children.

Many of these recommendations were already being utilized by manufacturers; however, one important change was the requirement for human absorption studies by a maximal usage trial, which more accurately addresses the absorption of sunscreen agents according to actual use. Such studies will be required at the highest allowable concentration of an agent in multiple vehicles and over large body surface areas for considerable exposure times.

This guidance to sunscreen manufacturers was announced to the public in a press release in May 2018.¹²

What are the new regulations?

All of this has culminated in the recent proposed rule, which includes several important proposals²:

• Of the 16 currently marketed active sunscreen ingredients, only 2—zinc oxide and titanium dioxide—are considered GRASE. Two ingredients—trolamine salicylate and para-aminobenzoic acid—are considered non-GRASE, but there is not enough information at this time to determine if the remaining 12 ingredients are GRASE. The FDA is working with manufacturers to obtain sufficient information to make this determination.

• Approved dosage formulations include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. Further information is needed regarding powders before they can be considered.

• The maximum SPF will be increased from 50+ to 60+.

• Sunscreens with an SPF of 15 or higher are required to provide broad-spectrum protection commensurate with the SPF, expanding on critical wavelength testing.

• There are new labeling changes, including a requirement that active ingredients be listed on the front of the packaging.
• Sunscreen products that contain insect repellents are considered non-GRASE.

What’s next?

The process for the proposed final rule has now entered a 90-day public comment period that will end on May 27, 2019; however, it is unlikely that a final monograph as mandated by Congress will be produced by the end of this year.

Sunscreen manufacturers currently are coordinating a response to the proposed rule through the Personal Care Products Council and the Consumer Healthcare Products Association Sunscreen Task Force. It is likely that the new required testing will be costly, with estimates exceeding tens or even hundreds of millions of dollars. In all likelihood, the number of active ingredients that the industry will agree to support with costly testing will be fewer than the 12 that are now on the list. It also is likely that this process will lead to fewer sunscreen products for consumers to choose from and almost certainly at a higher cost.

What do we tell patients in the meantime?

According to the FDA’s rules, it was necessary that this process was made public, but it will almost certainly concern our patients as to the safety of the sunscreen products they have been using. We should be concerned that some of our patients may limit their use of sunscreens because of safety concerns.

There is no question that, as physicians, we want to “first, do no harm,” so we should all be interested in assuring our patients that our sunscreen recommendations are safe and we support the FDA proposal for additional data. The good news is that when this process is completed, a large number of agents will likely be found to be GRASE. When the FDA finally gives its imprimatur to sunscreens, it will hopefully help to silence those naysayers who report that sunscreens are dangerous for consumers; however, it has been suggested by some in industry that the new testing required may take at least 5 years.

What should dermatologists do when we are asked, “What sunscreen should I use NOW?” For most patients, I would explain the regulatory process and assure them that the risk-benefit ratio at this point suggests they should continue using the same sunscreens that they are currently using. For special situations such as pregnant women and children, it may be best to suggest products that contain only the 2 GRASE inorganic agents.

If by now you have not had a patient ask, “Doctor, what sunscreen should I use NOW?” you will soon.

The US Food and Drug Administration (FDA) recently published a press release detailing a proposed rule on how manufacturers will be required to test and label sunscreens in the United States.^1,2 Although the press release was complicated and contained much information, the media specifically latched onto the FDA’s consideration of only 2 active sunscreen ingredients—zinc oxide and titanium dioxide—as generally recognized as safe and effective (GRASE). In response, some patients may assume that most sunscreens on the market are dangerous.

How did this new proposed rule come about? To understand the process, it takes some explanation of the history of the FDA’s regulation of sunscreens.

How are sunscreens regulated by the FDA?

The regulatory process for sunscreens in the United States is complicated. The FDA regulates sunscreens as over-the-counter (OTC) drugs rather than as cosmetics, which is how they are regulated in most of the rest of the world.

The US sunscreen regulation process began in 1978 with an advance notice of proposed rulemaking from the FDA that included recommendations from an advisory review panel on the safe and effective use of OTC sunscreen products.³ At that time, 21 active sunscreen ingredients and their maximum use concentrations were listed and determined to be safe, or GRASE. It also gave manufacturers guidance on how to test for efficacy with the methodology for determining the sun protection factor (SPF) as well as various labeling requirements. Over the years, the FDA has issued a number of other sunscreen guidelines, such as removing padimate A and adding avobenzone and zinc oxide to the list of GRASE ingredients in the 1990s.^4,5

In 1999, the FDA issued a final rule that listed 16 active sunscreen ingredients and concentrations as GRASE.⁶ There were some restrictions as to certain combinations of ingredients that could not be used in a finished product. Labeling requirements, including a maximum SPF of 30, also were put in place. This final rule established a final sunscreen monograph that was supposed to have been effective by 2002; however, in 2001 the agency delayed the effective date indefinitely because they had not yet established broad-spectrum (UVA) protection testing and labeling.⁷

The FDA published a proposed rule in 2007 as well as a final rule in 2011 that again listed the same 16 ingredients as GRASE and specified labeling and testing methods for establishing SPF, broad-spectrum protection, and water-resistance claims.^8,9 The final rule limited product labels to a maximum SPF of 50+; provided directions for use with regard to other labeling elements (eg, warnings); and identified specific claims that would not be allowed on product labels, such as “waterproof” and “all-day protection.”⁹

Nevertheless, an effective final OTC monograph for sunscreen products has not yet been published.

What is the Sunscreen Innovation Act?

In 2014, the US Congress enacted the Sunscreen Innovation Act¹⁰ primarily to mandate that the FDA develop a more efficient way to determine the safety and efficacy of new active sunscreen ingredients that were commonly used in Europe and other parts of the world at the time. Many of these agents were thought to be more protective in the UVA and/or UVB spectrum, and if added to the list of GRASE ingredients available to US manufacturers, they would lead to the development of products that would improve the protection offered by sunscreens marketed to US consumers. The time and extent application (TEA) was established, a method that allowed manufacturers to apply for FDA approval of specific agents. The TEA also suggested allowing data generated in other countries where these agents were already in use for years to be considered in the FDA’s evaluation of the agents as GRASE. In addition, Congress mandated that a final monograph on OTC sunscreens be published by the end of 2019. A number of manufacturers have submitted TEAs for new active sunscreen ingredients, and so far, all have been rejected.

Why is the FDA interested in more safety data?

Since then, the FDA has become concerned not only with the safety and efficacy of newly proposed agents through the TEA but also with the original 16 active sunscreen ingredients listed as GRASE in the 2011 final rule. In the 1970s and 1980s, sunscreen use was limited to beach vacations or outdoor sporting events, but sun-protective behaviors have changed dramatically since that time, with health care providers now becoming cognizant of the growing threats of skin cancer and melanoma as well as the cosmetic concerns of photoaging, thereby recommending daily sunscreen use to their patients. In addition, the science behind sunscreens with higher concentrations of active ingredients intended to achieve higher and higher SPFs and their respective penetration of the skin has evolved, leading to new concerns about systemic toxicity. Early limited research frequently touted by the lay media has suggested that some of these agents might lead to hormonal changes, reproductive toxicity, and carcinogenicity.

In November 2016, the FDA issued a guidance for manufacturers that outlined the safety data that would be required to establish an OTC sunscreen active ingredient as GRASE.¹¹ It also provided detailed information about both clinical and nonclinical safety testing, including human irritation and sensitization studies as well as human photosafety studies. In vitro dermal and systemic carcinogenicity studies and animal developmental and reproductive toxicity studies also were required as well studies regarding safety in children.

Many of these recommendations were already being utilized by manufacturers; however, one important change was the requirement for human absorption studies by a maximal usage trial, which more accurately addresses the absorption of sunscreen agents according to actual use. Such studies will be required at the highest allowable concentration of an agent in multiple vehicles and over large body surface areas for considerable exposure times.

This guidance to sunscreen manufacturers was announced to the public in a press release in May 2018.¹²

What are the new regulations?

All of this has culminated in the recent proposed rule, which includes several important proposals²:

• Of the 16 currently marketed active sunscreen ingredients, only 2—zinc oxide and titanium dioxide—are considered GRASE. Two ingredients—trolamine salicylate and para-aminobenzoic acid—are considered non-GRASE, but there is not enough information at this time to determine if the remaining 12 ingredients are GRASE. The FDA is working with manufacturers to obtain sufficient information to make this determination.

• Approved dosage formulations include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. Further information is needed regarding powders before they can be considered.

• The maximum SPF will be increased from 50+ to 60+.

• Sunscreens with an SPF of 15 or higher are required to provide broad-spectrum protection commensurate with the SPF, expanding on critical wavelength testing.

• There are new labeling changes, including a requirement that active ingredients be listed on the front of the packaging.
• Sunscreen products that contain insect repellents are considered non-GRASE.

What’s next?

The process for the proposed final rule has now entered a 90-day public comment period that will end on May 27, 2019; however, it is unlikely that a final monograph as mandated by Congress will be produced by the end of this year.

Sunscreen manufacturers currently are coordinating a response to the proposed rule through the Personal Care Products Council and the Consumer Healthcare Products Association Sunscreen Task Force. It is likely that the new required testing will be costly, with estimates exceeding tens or even hundreds of millions of dollars. In all likelihood, the number of active ingredients that the industry will agree to support with costly testing will be fewer than the 12 that are now on the list. It also is likely that this process will lead to fewer sunscreen products for consumers to choose from and almost certainly at a higher cost.

What do we tell patients in the meantime?

According to the FDA’s rules, it was necessary that this process was made public, but it will almost certainly concern our patients as to the safety of the sunscreen products they have been using. We should be concerned that some of our patients may limit their use of sunscreens because of safety concerns.

There is no question that, as physicians, we want to “first, do no harm,” so we should all be interested in assuring our patients that our sunscreen recommendations are safe and we support the FDA proposal for additional data. The good news is that when this process is completed, a large number of agents will likely be found to be GRASE. When the FDA finally gives its imprimatur to sunscreens, it will hopefully help to silence those naysayers who report that sunscreens are dangerous for consumers; however, it has been suggested by some in industry that the new testing required may take at least 5 years.

What should dermatologists do when we are asked, “What sunscreen should I use NOW?” For most patients, I would explain the regulatory process and assure them that the risk-benefit ratio at this point suggests they should continue using the same sunscreens that they are currently using. For special situations such as pregnant women and children, it may be best to suggest products that contain only the 2 GRASE inorganic agents.

If by now you have not had a patient ask, “Doctor, what sunscreen should I use NOW?” you will soon.

The US Food and Drug Administration (FDA) recently published a press release detailing a proposed rule on how manufacturers will be required to test and label sunscreens in the United States.^1,2 Although the press release was complicated and contained much information, the media specifically latched onto the FDA’s consideration of only 2 active sunscreen ingredients—zinc oxide and titanium dioxide—as generally recognized as safe and effective (GRASE). In response, some patients may assume that most sunscreens on the market are dangerous.

How did this new proposed rule come about? To understand the process, it takes some explanation of the history of the FDA’s regulation of sunscreens.

How are sunscreens regulated by the FDA?

The regulatory process for sunscreens in the United States is complicated. The FDA regulates sunscreens as over-the-counter (OTC) drugs rather than as cosmetics, which is how they are regulated in most of the rest of the world.

The US sunscreen regulation process began in 1978 with an advance notice of proposed rulemaking from the FDA that included recommendations from an advisory review panel on the safe and effective use of OTC sunscreen products.³ At that time, 21 active sunscreen ingredients and their maximum use concentrations were listed and determined to be safe, or GRASE. It also gave manufacturers guidance on how to test for efficacy with the methodology for determining the sun protection factor (SPF) as well as various labeling requirements. Over the years, the FDA has issued a number of other sunscreen guidelines, such as removing padimate A and adding avobenzone and zinc oxide to the list of GRASE ingredients in the 1990s.^4,5

In 1999, the FDA issued a final rule that listed 16 active sunscreen ingredients and concentrations as GRASE.⁶ There were some restrictions as to certain combinations of ingredients that could not be used in a finished product. Labeling requirements, including a maximum SPF of 30, also were put in place. This final rule established a final sunscreen monograph that was supposed to have been effective by 2002; however, in 2001 the agency delayed the effective date indefinitely because they had not yet established broad-spectrum (UVA) protection testing and labeling.⁷

The FDA published a proposed rule in 2007 as well as a final rule in 2011 that again listed the same 16 ingredients as GRASE and specified labeling and testing methods for establishing SPF, broad-spectrum protection, and water-resistance claims.^8,9 The final rule limited product labels to a maximum SPF of 50+; provided directions for use with regard to other labeling elements (eg, warnings); and identified specific claims that would not be allowed on product labels, such as “waterproof” and “all-day protection.”⁹

Nevertheless, an effective final OTC monograph for sunscreen products has not yet been published.

What is the Sunscreen Innovation Act?

In 2014, the US Congress enacted the Sunscreen Innovation Act¹⁰ primarily to mandate that the FDA develop a more efficient way to determine the safety and efficacy of new active sunscreen ingredients that were commonly used in Europe and other parts of the world at the time. Many of these agents were thought to be more protective in the UVA and/or UVB spectrum, and if added to the list of GRASE ingredients available to US manufacturers, they would lead to the development of products that would improve the protection offered by sunscreens marketed to US consumers. The time and extent application (TEA) was established, a method that allowed manufacturers to apply for FDA approval of specific agents. The TEA also suggested allowing data generated in other countries where these agents were already in use for years to be considered in the FDA’s evaluation of the agents as GRASE. In addition, Congress mandated that a final monograph on OTC sunscreens be published by the end of 2019. A number of manufacturers have submitted TEAs for new active sunscreen ingredients, and so far, all have been rejected.

Why is the FDA interested in more safety data?

Since then, the FDA has become concerned not only with the safety and efficacy of newly proposed agents through the TEA but also with the original 16 active sunscreen ingredients listed as GRASE in the 2011 final rule. In the 1970s and 1980s, sunscreen use was limited to beach vacations or outdoor sporting events, but sun-protective behaviors have changed dramatically since that time, with health care providers now becoming cognizant of the growing threats of skin cancer and melanoma as well as the cosmetic concerns of photoaging, thereby recommending daily sunscreen use to their patients. In addition, the science behind sunscreens with higher concentrations of active ingredients intended to achieve higher and higher SPFs and their respective penetration of the skin has evolved, leading to new concerns about systemic toxicity. Early limited research frequently touted by the lay media has suggested that some of these agents might lead to hormonal changes, reproductive toxicity, and carcinogenicity.

In November 2016, the FDA issued a guidance for manufacturers that outlined the safety data that would be required to establish an OTC sunscreen active ingredient as GRASE.¹¹ It also provided detailed information about both clinical and nonclinical safety testing, including human irritation and sensitization studies as well as human photosafety studies. In vitro dermal and systemic carcinogenicity studies and animal developmental and reproductive toxicity studies also were required as well studies regarding safety in children.

Many of these recommendations were already being utilized by manufacturers; however, one important change was the requirement for human absorption studies by a maximal usage trial, which more accurately addresses the absorption of sunscreen agents according to actual use. Such studies will be required at the highest allowable concentration of an agent in multiple vehicles and over large body surface areas for considerable exposure times.

This guidance to sunscreen manufacturers was announced to the public in a press release in May 2018.¹²

What are the new regulations?

All of this has culminated in the recent proposed rule, which includes several important proposals²:

• Of the 16 currently marketed active sunscreen ingredients, only 2—zinc oxide and titanium dioxide—are considered GRASE. Two ingredients—trolamine salicylate and para-aminobenzoic acid—are considered non-GRASE, but there is not enough information at this time to determine if the remaining 12 ingredients are GRASE. The FDA is working with manufacturers to obtain sufficient information to make this determination.

• Approved dosage formulations include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. Further information is needed regarding powders before they can be considered.

• The maximum SPF will be increased from 50+ to 60+.

• Sunscreens with an SPF of 15 or higher are required to provide broad-spectrum protection commensurate with the SPF, expanding on critical wavelength testing.

• There are new labeling changes, including a requirement that active ingredients be listed on the front of the packaging.
• Sunscreen products that contain insect repellents are considered non-GRASE.

What’s next?

The process for the proposed final rule has now entered a 90-day public comment period that will end on May 27, 2019; however, it is unlikely that a final monograph as mandated by Congress will be produced by the end of this year.

Sunscreen manufacturers currently are coordinating a response to the proposed rule through the Personal Care Products Council and the Consumer Healthcare Products Association Sunscreen Task Force. It is likely that the new required testing will be costly, with estimates exceeding tens or even hundreds of millions of dollars. In all likelihood, the number of active ingredients that the industry will agree to support with costly testing will be fewer than the 12 that are now on the list. It also is likely that this process will lead to fewer sunscreen products for consumers to choose from and almost certainly at a higher cost.

What do we tell patients in the meantime?

According to the FDA’s rules, it was necessary that this process was made public, but it will almost certainly concern our patients as to the safety of the sunscreen products they have been using. We should be concerned that some of our patients may limit their use of sunscreens because of safety concerns.

There is no question that, as physicians, we want to “first, do no harm,” so we should all be interested in assuring our patients that our sunscreen recommendations are safe and we support the FDA proposal for additional data. The good news is that when this process is completed, a large number of agents will likely be found to be GRASE. When the FDA finally gives its imprimatur to sunscreens, it will hopefully help to silence those naysayers who report that sunscreens are dangerous for consumers; however, it has been suggested by some in industry that the new testing required may take at least 5 years.

What should dermatologists do when we are asked, “What sunscreen should I use NOW?” For most patients, I would explain the regulatory process and assure them that the risk-benefit ratio at this point suggests they should continue using the same sunscreens that they are currently using. For special situations such as pregnant women and children, it may be best to suggest products that contain only the 2 GRASE inorganic agents.

Filamentous bacteriophage (Pf phage) may contribute to Pseudomonas aeruginosa infections in cystic fibrosis (CF) patients, according to a study of the prevalence and clinical relevance of Pf phage in two patient cohorts.

CDC/ Janice Haney Carr

“Our data from both the Stanford and Danish CF cohorts together suggest that either patients with CF acquire Pf phage–producing strains of P. aeruginosa or the Pf phage–negative P. aeruginosa become infected with Pf phage as patients age and their disease progresses,” wrote Elizabeth B. Burgener, MD, of Stanford (Calif.) University, and her coauthors. The study was published in Science Translational Medicine.The study analyzed a previous Danish longitudinal cohort of 34 patients and a prospective cross-sectional cohort of 76 patients at Stanford, 58 of which had P. aeruginosa. The researchers also reviewed a collection of genetic sequences called the Pseudomonas Genome Database to determine the prevalence of Pf phage, finding evidence in 1,159 of 2,226 P. aeruginosa sequences (52.1%).

In the Danish cohort, 21 of the 34 CF patients (61.8%; 95% confidence interval, 43.6%-77.8%) had at least one P. aeruginosa isolate containing Pf phage; 9 (26.5%) of the patients were found to be consistently positive for Pf phage. Those who were consistently positive were also older than those who never had Pf phage detected (19.1 years vs. 13.9 years; P = .046), suggesting that “there may be a tendency for P. aeruginosa strains that produce Pf phage to dominate in the sputum of individual patients with CF over time.”

In the Stanford cohort, the prevalence of Pf phage was 36.2% (21 of 58; 95% CI, 24.0%-49.9%) in patients with P. aeruginosa infection and 27.6% (21 of 76; 95% CI, 18.0%-39.1%) in all patients. No Pf phage was detected in any P. aeruginosa–negative samples. Patients positive for Pf phage in this cohort were also older than patients who were negative.

The authors acknowledged their study’s limitations, describing the methods used to collect and sequence the analyzed samples as “highly heterogeneous.” In addition, the two cohorts were CF specific while the Genome Database is not. Finally, the CF cohorts only had a single dominant strain sampled, though multiple P. aeruginosa lineages are often present in CF patients.

One author reported receiving grants from the Cystic Fibrosis Foundation, clinical trial support, and consulting fees from industry. Two other authors are inventors on a patent application that covers the development of a vaccine that targets Pf phage. The others reported no conflicts of interest.

SOURCE: Burgener EB et al. Sci Transl Med. 2019 Apr 17. doi: 10.1126/scitranslmed.aau9748.

Filamentous bacteriophage (Pf phage) may contribute to Pseudomonas aeruginosa infections in cystic fibrosis (CF) patients, according to a study of the prevalence and clinical relevance of Pf phage in two patient cohorts.

CDC/ Janice Haney Carr

“Our data from both the Stanford and Danish CF cohorts together suggest that either patients with CF acquire Pf phage–producing strains of P. aeruginosa or the Pf phage–negative P. aeruginosa become infected with Pf phage as patients age and their disease progresses,” wrote Elizabeth B. Burgener, MD, of Stanford (Calif.) University, and her coauthors. The study was published in Science Translational Medicine.The study analyzed a previous Danish longitudinal cohort of 34 patients and a prospective cross-sectional cohort of 76 patients at Stanford, 58 of which had P. aeruginosa. The researchers also reviewed a collection of genetic sequences called the Pseudomonas Genome Database to determine the prevalence of Pf phage, finding evidence in 1,159 of 2,226 P. aeruginosa sequences (52.1%).

In the Danish cohort, 21 of the 34 CF patients (61.8%; 95% confidence interval, 43.6%-77.8%) had at least one P. aeruginosa isolate containing Pf phage; 9 (26.5%) of the patients were found to be consistently positive for Pf phage. Those who were consistently positive were also older than those who never had Pf phage detected (19.1 years vs. 13.9 years; P = .046), suggesting that “there may be a tendency for P. aeruginosa strains that produce Pf phage to dominate in the sputum of individual patients with CF over time.”

In the Stanford cohort, the prevalence of Pf phage was 36.2% (21 of 58; 95% CI, 24.0%-49.9%) in patients with P. aeruginosa infection and 27.6% (21 of 76; 95% CI, 18.0%-39.1%) in all patients. No Pf phage was detected in any P. aeruginosa–negative samples. Patients positive for Pf phage in this cohort were also older than patients who were negative.

The authors acknowledged their study’s limitations, describing the methods used to collect and sequence the analyzed samples as “highly heterogeneous.” In addition, the two cohorts were CF specific while the Genome Database is not. Finally, the CF cohorts only had a single dominant strain sampled, though multiple P. aeruginosa lineages are often present in CF patients.

One author reported receiving grants from the Cystic Fibrosis Foundation, clinical trial support, and consulting fees from industry. Two other authors are inventors on a patent application that covers the development of a vaccine that targets Pf phage. The others reported no conflicts of interest.

SOURCE: Burgener EB et al. Sci Transl Med. 2019 Apr 17. doi: 10.1126/scitranslmed.aau9748.

Filamentous bacteriophage (Pf phage) may contribute to Pseudomonas aeruginosa infections in cystic fibrosis (CF) patients, according to a study of the prevalence and clinical relevance of Pf phage in two patient cohorts.

CDC/ Janice Haney Carr

“Our data from both the Stanford and Danish CF cohorts together suggest that either patients with CF acquire Pf phage–producing strains of P. aeruginosa or the Pf phage–negative P. aeruginosa become infected with Pf phage as patients age and their disease progresses,” wrote Elizabeth B. Burgener, MD, of Stanford (Calif.) University, and her coauthors. The study was published in Science Translational Medicine.The study analyzed a previous Danish longitudinal cohort of 34 patients and a prospective cross-sectional cohort of 76 patients at Stanford, 58 of which had P. aeruginosa. The researchers also reviewed a collection of genetic sequences called the Pseudomonas Genome Database to determine the prevalence of Pf phage, finding evidence in 1,159 of 2,226 P. aeruginosa sequences (52.1%).

In the Danish cohort, 21 of the 34 CF patients (61.8%; 95% confidence interval, 43.6%-77.8%) had at least one P. aeruginosa isolate containing Pf phage; 9 (26.5%) of the patients were found to be consistently positive for Pf phage. Those who were consistently positive were also older than those who never had Pf phage detected (19.1 years vs. 13.9 years; P = .046), suggesting that “there may be a tendency for P. aeruginosa strains that produce Pf phage to dominate in the sputum of individual patients with CF over time.”

In the Stanford cohort, the prevalence of Pf phage was 36.2% (21 of 58; 95% CI, 24.0%-49.9%) in patients with P. aeruginosa infection and 27.6% (21 of 76; 95% CI, 18.0%-39.1%) in all patients. No Pf phage was detected in any P. aeruginosa–negative samples. Patients positive for Pf phage in this cohort were also older than patients who were negative.

The authors acknowledged their study’s limitations, describing the methods used to collect and sequence the analyzed samples as “highly heterogeneous.” In addition, the two cohorts were CF specific while the Genome Database is not. Finally, the CF cohorts only had a single dominant strain sampled, though multiple P. aeruginosa lineages are often present in CF patients.

One author reported receiving grants from the Cystic Fibrosis Foundation, clinical trial support, and consulting fees from industry. Two other authors are inventors on a patent application that covers the development of a vaccine that targets Pf phage. The others reported no conflicts of interest.

SOURCE: Burgener EB et al. Sci Transl Med. 2019 Apr 17. doi: 10.1126/scitranslmed.aau9748.

A novel antifungal successfully eradicated Candida auris in two critically ill patients with fungemia, according to data presented in a poster session at the European Congress of Clinical Microbiology & Infectious Diseases.

CDC/MMWR

The case reports, drawn from the phase 3 CARES study of the oral formulation of ibrexafungerp, demonstrated complete response to the glucan synthase inhibitor, according to Deven Juneja, MD, and his coauthors of the Max Super Specialty Hospital, New Delhi.

The first patient was an Asian male, aged 58 years, who had a previous history of diabetes and experienced a protracted ICU stay after acute ischemic stroke. He developed septic shock after aspiration pneumonia, and also experienced a popliteal thrombosis and liver, spleen, and kidney infarcts.

The patient had received empiric antibiotics with the addition of fluconazole; the antifungal was later switched to micafungin after C. auris was identified from blood cultures. Despite clinical improvement on micafungin, blood cultures remained positive for C. auris, so ibrexafungerp was started and continued for 17 days. Blood cultures became negative by day 3 of ibrexafungerp and remained negative for the follow-up period. The patient later developed Klebsiella pneumonia and died.

The second patient, an Asian female, aged 64 years, presented with a lower respiratory tract infection accompanied by fever and hypotension. She had a previous history of diabetes, hypertension, and chronic kidney disease with maintenance hemodialysis. Her fever also persisted despite antibiotics, and C. auris was isolated from her blood cultures with the subsequent initiation of ibrexafungerp. Her blood cultures were still positive at day 3 of ibrexafungerp, but negative at day 9 and 21. She completed 22 days of ibrexafungerp therapy and was asymptomatic with no evidence of C. auris recurrence at a 6-week follow-up visit.

The male patient experienced 2 days of loose stools soon after initiating ibrexafungerp; the female patient had no adverse events.

“These cases provide initial evidence of efficacy and safety of ibrexafungerp in the treatment of candidemia caused by C. auris, including in patients who failed previous therapies,” wrote Dr. Juneja and his coauthors in the late-breaking poster.

Ibrexafungerp belongs to a novel class of glucan synthase inhibitors called triterpenoids. Scynexis funded the CARES study and also is evaluating it alone or in combination with other antifungals for treatment of vulvovaginal candidiasis, invasive pulmonary aspergillosis, and refractory invasive and/or severe fungal disease.

[email protected]

SOURCE: Juneja D et al. ECCMID 2019, Poster L0028.

A novel antifungal successfully eradicated Candida auris in two critically ill patients with fungemia, according to data presented in a poster session at the European Congress of Clinical Microbiology & Infectious Diseases.

CDC/MMWR

The case reports, drawn from the phase 3 CARES study of the oral formulation of ibrexafungerp, demonstrated complete response to the glucan synthase inhibitor, according to Deven Juneja, MD, and his coauthors of the Max Super Specialty Hospital, New Delhi.

The first patient was an Asian male, aged 58 years, who had a previous history of diabetes and experienced a protracted ICU stay after acute ischemic stroke. He developed septic shock after aspiration pneumonia, and also experienced a popliteal thrombosis and liver, spleen, and kidney infarcts.

The patient had received empiric antibiotics with the addition of fluconazole; the antifungal was later switched to micafungin after C. auris was identified from blood cultures. Despite clinical improvement on micafungin, blood cultures remained positive for C. auris, so ibrexafungerp was started and continued for 17 days. Blood cultures became negative by day 3 of ibrexafungerp and remained negative for the follow-up period. The patient later developed Klebsiella pneumonia and died.

The second patient, an Asian female, aged 64 years, presented with a lower respiratory tract infection accompanied by fever and hypotension. She had a previous history of diabetes, hypertension, and chronic kidney disease with maintenance hemodialysis. Her fever also persisted despite antibiotics, and C. auris was isolated from her blood cultures with the subsequent initiation of ibrexafungerp. Her blood cultures were still positive at day 3 of ibrexafungerp, but negative at day 9 and 21. She completed 22 days of ibrexafungerp therapy and was asymptomatic with no evidence of C. auris recurrence at a 6-week follow-up visit.

The male patient experienced 2 days of loose stools soon after initiating ibrexafungerp; the female patient had no adverse events.

“These cases provide initial evidence of efficacy and safety of ibrexafungerp in the treatment of candidemia caused by C. auris, including in patients who failed previous therapies,” wrote Dr. Juneja and his coauthors in the late-breaking poster.

Ibrexafungerp belongs to a novel class of glucan synthase inhibitors called triterpenoids. Scynexis funded the CARES study and also is evaluating it alone or in combination with other antifungals for treatment of vulvovaginal candidiasis, invasive pulmonary aspergillosis, and refractory invasive and/or severe fungal disease.

[email protected]

SOURCE: Juneja D et al. ECCMID 2019, Poster L0028.

A novel antifungal successfully eradicated Candida auris in two critically ill patients with fungemia, according to data presented in a poster session at the European Congress of Clinical Microbiology & Infectious Diseases.

CDC/MMWR

The case reports, drawn from the phase 3 CARES study of the oral formulation of ibrexafungerp, demonstrated complete response to the glucan synthase inhibitor, according to Deven Juneja, MD, and his coauthors of the Max Super Specialty Hospital, New Delhi.

The first patient was an Asian male, aged 58 years, who had a previous history of diabetes and experienced a protracted ICU stay after acute ischemic stroke. He developed septic shock after aspiration pneumonia, and also experienced a popliteal thrombosis and liver, spleen, and kidney infarcts.

The patient had received empiric antibiotics with the addition of fluconazole; the antifungal was later switched to micafungin after C. auris was identified from blood cultures. Despite clinical improvement on micafungin, blood cultures remained positive for C. auris, so ibrexafungerp was started and continued for 17 days. Blood cultures became negative by day 3 of ibrexafungerp and remained negative for the follow-up period. The patient later developed Klebsiella pneumonia and died.

The second patient, an Asian female, aged 64 years, presented with a lower respiratory tract infection accompanied by fever and hypotension. She had a previous history of diabetes, hypertension, and chronic kidney disease with maintenance hemodialysis. Her fever also persisted despite antibiotics, and C. auris was isolated from her blood cultures with the subsequent initiation of ibrexafungerp. Her blood cultures were still positive at day 3 of ibrexafungerp, but negative at day 9 and 21. She completed 22 days of ibrexafungerp therapy and was asymptomatic with no evidence of C. auris recurrence at a 6-week follow-up visit.

The male patient experienced 2 days of loose stools soon after initiating ibrexafungerp; the female patient had no adverse events.

“These cases provide initial evidence of efficacy and safety of ibrexafungerp in the treatment of candidemia caused by C. auris, including in patients who failed previous therapies,” wrote Dr. Juneja and his coauthors in the late-breaking poster.

Ibrexafungerp belongs to a novel class of glucan synthase inhibitors called triterpenoids. Scynexis funded the CARES study and also is evaluating it alone or in combination with other antifungals for treatment of vulvovaginal candidiasis, invasive pulmonary aspergillosis, and refractory invasive and/or severe fungal disease.

[email protected]

SOURCE: Juneja D et al. ECCMID 2019, Poster L0028.

Sticking it to the (junk-food) man

Fight the power – the power, in this case, being Ronald McDonald and his brethren.

wundervisuals/E+

In a new effort to convince teens to reject junk food and make healthier choices, researchers found that one surefire way to achieve this was to play on the natural teen desire to reject authority and rebel. Parents of teens across the country don’t know whether to rejoice or groan.

The study, published this week, found that an effective way to combat junk food marketing was to frame companies as corporate overlords and figures of authority who take advantage of vulnerable populations (so, the truth). The teens, who value social justice and autonomy from adults, responded well to this reframing. Instead of snacking on Doritos at lunch, the study subjects chose to really stick it to the man and make healthy food choices instead.

Researchers reported that boys in particular responded positively to the idea of rejecting authority. Which will surprise no one who has ever known a teenage boy.
 

I heart 3-D printing

Fifty-two years ago, a South African surgeon named Dr. Christiaan Barnard took a heart from one (deceased) human and successfully transplanted it into another (live) human. Now, Israeli researchers could relegate Dr. Barnard’s recycled-cardiac-parts approach to the medical history museum’s hall of obsolete approaches, next to the leeches and the wax barber-surgeon.

Scharfsinn86/iStock/Getty Images Plus

In a claimed first, Tel Aviv University scientists have “printed” a fully vascularized, engineered human heart. The organ is crafted from a cellular slurry of a patient’s own fat cells turned into pluripotent stem cells. With collagen and glycoproteins as structural printing “ink,” the researchers mixed in the stem cells and printed their 3-D heart. The cells differentiated into cardiac and endothelial cells, complete with a medical first: vascularized and perfusable heart tissue.

Unlike Barnard’s allogeneic approach, building from a patient’s own cellular material can eliminate the risk of organ rejection, the heart’s creators say.

Next on the heart-printers’ punch list: getting the cells to contract in unison to form a pumping unit. Then testing it in animals. Oh, and creating something a bit larger than their initial rabbit-sized heart.

And then? Who knows? Perhaps even Dorothy’s friend the Tin Man can finally get an autologous, printed replacement for that allogeneic, heart-shaped clock.
 

Larger portions of food for thought

In the world of nutrition science, there’s a concept known as self-regulation, which suggests that people have an innate ability to consume only as many calories as they need. Studies have shown that, in adults anyway, self-regulation can be circumvented by something known as the portion-size effect, which is the tendency to eat more when larger portions are served.

Fertnig/E+

But is the same thing true for small children? Let’s find out.

Researchers provided a group of 3- to 5-year-old children with all their meals and snacks for two 5-day periods. During one of the periods, the portions were 50% larger than the other period. The children were allowed to eat as much of each meal/snack as they wanted, and any leftovers were weighed to determine actual calorie intake.

The data showed that the children ate 16% more food and consumed 18% more calories when they were given the larger portions.

So, we already knew that if you give adults more food, they’ll eat more. And now we know that if you give children more food, they’ll eat more. Could this be the end of self-regulation?

Maybe it would work if you gave the little tykes something besides food. Maybe you could give them … money. Round up a few hundred children, put them together in a big room, and throw money at them.

Oh, right, that experiment is already underway. It’s called Congress.
 

It’s the end of the world as we ... zzzzz

Of all the countries to take refuge in during an apocalypse, Switzerland has to be at the top of the list. Its mountainous terrain is a natural barrier to any zombie horde that’s heard that Swiss brains are as delicious as their chocolate. Not only that, the Swiss government stockpiles essential resources to sustain its people during times of war or emergency.

Visual_Intermezzo/iStock/Getty Images Plus

All in all, it’s a pretty good deal.

Well, it’s a good deal so long as you don’t require a morning cup of coffee to stay fresh as you fight off armies of the undead, as the Swiss government has decreed that coffee is nonessential for life and will stop stockpiling it.

According to the Federal Office for National Economic Supply, “Coffee is not vital. ... that is, coffee contains almost no calories and therefore does not make any contribution to food security from a nutritional point of view.” Harsh words for a beverage that the Swiss consume at a rate of 9 kg per year, three times more than the British and twice that of Americans.

If the recommendation passes, the 3-month emergency supply, an amount topping 15,000 tons, would be returned to the corresponding manufacturers, who would pass the corresponding savings back to the consumer.

So, there’s some good news as the zombies breach your defenses because your guards fell asleep: At least the coffee was cheaper before the world ended.

[email protected]

Sticking it to the (junk-food) man

Fight the power – the power, in this case, being Ronald McDonald and his brethren.

wundervisuals/E+

In a new effort to convince teens to reject junk food and make healthier choices, researchers found that one surefire way to achieve this was to play on the natural teen desire to reject authority and rebel. Parents of teens across the country don’t know whether to rejoice or groan.

The study, published this week, found that an effective way to combat junk food marketing was to frame companies as corporate overlords and figures of authority who take advantage of vulnerable populations (so, the truth). The teens, who value social justice and autonomy from adults, responded well to this reframing. Instead of snacking on Doritos at lunch, the study subjects chose to really stick it to the man and make healthy food choices instead.

Researchers reported that boys in particular responded positively to the idea of rejecting authority. Which will surprise no one who has ever known a teenage boy.
 

I heart 3-D printing

Fifty-two years ago, a South African surgeon named Dr. Christiaan Barnard took a heart from one (deceased) human and successfully transplanted it into another (live) human. Now, Israeli researchers could relegate Dr. Barnard’s recycled-cardiac-parts approach to the medical history museum’s hall of obsolete approaches, next to the leeches and the wax barber-surgeon.

Scharfsinn86/iStock/Getty Images Plus

In a claimed first, Tel Aviv University scientists have “printed” a fully vascularized, engineered human heart. The organ is crafted from a cellular slurry of a patient’s own fat cells turned into pluripotent stem cells. With collagen and glycoproteins as structural printing “ink,” the researchers mixed in the stem cells and printed their 3-D heart. The cells differentiated into cardiac and endothelial cells, complete with a medical first: vascularized and perfusable heart tissue.

Unlike Barnard’s allogeneic approach, building from a patient’s own cellular material can eliminate the risk of organ rejection, the heart’s creators say.

Next on the heart-printers’ punch list: getting the cells to contract in unison to form a pumping unit. Then testing it in animals. Oh, and creating something a bit larger than their initial rabbit-sized heart.

And then? Who knows? Perhaps even Dorothy’s friend the Tin Man can finally get an autologous, printed replacement for that allogeneic, heart-shaped clock.
 

Larger portions of food for thought

In the world of nutrition science, there’s a concept known as self-regulation, which suggests that people have an innate ability to consume only as many calories as they need. Studies have shown that, in adults anyway, self-regulation can be circumvented by something known as the portion-size effect, which is the tendency to eat more when larger portions are served.

Fertnig/E+

But is the same thing true for small children? Let’s find out.

Researchers provided a group of 3- to 5-year-old children with all their meals and snacks for two 5-day periods. During one of the periods, the portions were 50% larger than the other period. The children were allowed to eat as much of each meal/snack as they wanted, and any leftovers were weighed to determine actual calorie intake.

The data showed that the children ate 16% more food and consumed 18% more calories when they were given the larger portions.

So, we already knew that if you give adults more food, they’ll eat more. And now we know that if you give children more food, they’ll eat more. Could this be the end of self-regulation?

Maybe it would work if you gave the little tykes something besides food. Maybe you could give them … money. Round up a few hundred children, put them together in a big room, and throw money at them.

Oh, right, that experiment is already underway. It’s called Congress.
 

It’s the end of the world as we ... zzzzz

Of all the countries to take refuge in during an apocalypse, Switzerland has to be at the top of the list. Its mountainous terrain is a natural barrier to any zombie horde that’s heard that Swiss brains are as delicious as their chocolate. Not only that, the Swiss government stockpiles essential resources to sustain its people during times of war or emergency.

Visual_Intermezzo/iStock/Getty Images Plus

All in all, it’s a pretty good deal.

Well, it’s a good deal so long as you don’t require a morning cup of coffee to stay fresh as you fight off armies of the undead, as the Swiss government has decreed that coffee is nonessential for life and will stop stockpiling it.

According to the Federal Office for National Economic Supply, “Coffee is not vital. ... that is, coffee contains almost no calories and therefore does not make any contribution to food security from a nutritional point of view.” Harsh words for a beverage that the Swiss consume at a rate of 9 kg per year, three times more than the British and twice that of Americans.

If the recommendation passes, the 3-month emergency supply, an amount topping 15,000 tons, would be returned to the corresponding manufacturers, who would pass the corresponding savings back to the consumer.

So, there’s some good news as the zombies breach your defenses because your guards fell asleep: At least the coffee was cheaper before the world ended.

[email protected]

Sticking it to the (junk-food) man

Fight the power – the power, in this case, being Ronald McDonald and his brethren.

wundervisuals/E+

In a new effort to convince teens to reject junk food and make healthier choices, researchers found that one surefire way to achieve this was to play on the natural teen desire to reject authority and rebel. Parents of teens across the country don’t know whether to rejoice or groan.

The study, published this week, found that an effective way to combat junk food marketing was to frame companies as corporate overlords and figures of authority who take advantage of vulnerable populations (so, the truth). The teens, who value social justice and autonomy from adults, responded well to this reframing. Instead of snacking on Doritos at lunch, the study subjects chose to really stick it to the man and make healthy food choices instead.

Researchers reported that boys in particular responded positively to the idea of rejecting authority. Which will surprise no one who has ever known a teenage boy.
 

I heart 3-D printing

Fifty-two years ago, a South African surgeon named Dr. Christiaan Barnard took a heart from one (deceased) human and successfully transplanted it into another (live) human. Now, Israeli researchers could relegate Dr. Barnard’s recycled-cardiac-parts approach to the medical history museum’s hall of obsolete approaches, next to the leeches and the wax barber-surgeon.

Scharfsinn86/iStock/Getty Images Plus

In a claimed first, Tel Aviv University scientists have “printed” a fully vascularized, engineered human heart. The organ is crafted from a cellular slurry of a patient’s own fat cells turned into pluripotent stem cells. With collagen and glycoproteins as structural printing “ink,” the researchers mixed in the stem cells and printed their 3-D heart. The cells differentiated into cardiac and endothelial cells, complete with a medical first: vascularized and perfusable heart tissue.

Unlike Barnard’s allogeneic approach, building from a patient’s own cellular material can eliminate the risk of organ rejection, the heart’s creators say.

Next on the heart-printers’ punch list: getting the cells to contract in unison to form a pumping unit. Then testing it in animals. Oh, and creating something a bit larger than their initial rabbit-sized heart.

And then? Who knows? Perhaps even Dorothy’s friend the Tin Man can finally get an autologous, printed replacement for that allogeneic, heart-shaped clock.
 

Larger portions of food for thought

In the world of nutrition science, there’s a concept known as self-regulation, which suggests that people have an innate ability to consume only as many calories as they need. Studies have shown that, in adults anyway, self-regulation can be circumvented by something known as the portion-size effect, which is the tendency to eat more when larger portions are served.

Fertnig/E+

But is the same thing true for small children? Let’s find out.

Researchers provided a group of 3- to 5-year-old children with all their meals and snacks for two 5-day periods. During one of the periods, the portions were 50% larger than the other period. The children were allowed to eat as much of each meal/snack as they wanted, and any leftovers were weighed to determine actual calorie intake.

The data showed that the children ate 16% more food and consumed 18% more calories when they were given the larger portions.

So, we already knew that if you give adults more food, they’ll eat more. And now we know that if you give children more food, they’ll eat more. Could this be the end of self-regulation?

Maybe it would work if you gave the little tykes something besides food. Maybe you could give them … money. Round up a few hundred children, put them together in a big room, and throw money at them.

Oh, right, that experiment is already underway. It’s called Congress.
 

It’s the end of the world as we ... zzzzz

Of all the countries to take refuge in during an apocalypse, Switzerland has to be at the top of the list. Its mountainous terrain is a natural barrier to any zombie horde that’s heard that Swiss brains are as delicious as their chocolate. Not only that, the Swiss government stockpiles essential resources to sustain its people during times of war or emergency.

Visual_Intermezzo/iStock/Getty Images Plus

All in all, it’s a pretty good deal.

Well, it’s a good deal so long as you don’t require a morning cup of coffee to stay fresh as you fight off armies of the undead, as the Swiss government has decreed that coffee is nonessential for life and will stop stockpiling it.

According to the Federal Office for National Economic Supply, “Coffee is not vital. ... that is, coffee contains almost no calories and therefore does not make any contribution to food security from a nutritional point of view.” Harsh words for a beverage that the Swiss consume at a rate of 9 kg per year, three times more than the British and twice that of Americans.

If the recommendation passes, the 3-month emergency supply, an amount topping 15,000 tons, would be returned to the corresponding manufacturers, who would pass the corresponding savings back to the consumer.

So, there’s some good news as the zombies breach your defenses because your guards fell asleep: At least the coffee was cheaper before the world ended.

[email protected]

Critical care units and long-term care facilities are on alert for cases of Candida auris, a novel fungal infection that is both dangerous to vulnerable patients and difficult to eradicate. The increased profile of C. auris is not a welcome development but is no surprise to critical care physicians.

This pathogen was first identified in 2009 and has since been found in increasing numbers of patients all over the world. As expected, cases of C. auris are on the rise in the United States.

The Centers for Disease Control and Prevention stated “Candida auris is an emerging fungus that presents a serious global health threat.” This is an opportunistic pathogen that hits critically ill patients and those with compromised immunity.

On March 29, 2019, CDC reported that confirmed clinical cases of C. auris in the United States have more than doubled over the past year, from 257 cases in 2018 to 587 cases with an additional 1,056 colonized patients identified as of February 2019. “Most C. auris cases in the United States have been detected in the New York City area, New Jersey, and the Chicago area. Strains of C. auris in the United States have been linked to other parts of the world. U.S. C. auris cases are a result of inadvertent introduction into the United States from a patient who recently received health care in a country where C. auris has been reported or a result of local spread after such an introduction.”

Case reports have found a mortality rate of up to 50% in patients with C. auris candidemia. The total number of cases is still small, but the trajectory is clear. The hunt is on in labs all over the world for optimal treatments and processes to handle outbreaks.

Jeniel Nett, MD, an infectious disease specialist, and a team of investigators at the University of Wisconsin, Madison, have focused their research on the characteristics of C. auris and its progression in patients and in medical facilities.

According to Dr. Nett, it’s not clear why this emerging threat has cropped up in multiple locations globally. “Candida auris was first recognized in 2009, in Japan, and relatively quickly we saw emergence of this species in relatively distant locations,” she said, adding that independent clades in these locations ruled out transmission as the source of the multiple outbreaks. Antifungal resistance is an epidemiologic area of concern and increased antifungal use may be a contributor, she said.

Kari Oakes/MDedge News

Once established, the organism is persistent: “It is found on mattresses, on bedsheets, IV poles, and a lot of reusable equipment,” said Dr. Nett in an interview. “It appears to persist in the environment for weeks – maybe longer.” In addition, “it seems to behave differently than a lot of the Candida species that we see; it readily colonizes the skin” to a much greater extent than does other Candida species, she said. “This allows it to be transmitted readily person to person, particularly in the hospitalized setting.” However, it can also colonize both the urinary and respiratory tracts, she said.

Which patients are susceptible to C. auris candidemia? “Many of these patients have undergone multiple procedures; they may have undergone mechanical ventilation as well as different surgical procedures,” said Dr. Nett. Affected patients often have received many rounds of antibiotic and antifungal treatment as well, she said, and may have an underlying illness like diabetes or malignancy.

Studies of C. auris outbreaks have begun to appear in the literature and give clinicians some perspective on the progression of an outbreak and potential strategies for containment. A prospective cohort study of a large outbreak of C. auris was conducted by Alba Ruiz-Gaitán, MD, and her colleagues at La Fe University and Polytechnic Hospital, Valencia, Spain (Expert Rev Anti Infect Ther. 2019 Apr;17[4]:295-305). The researchers followed 114 patients who were colonized with C. auris or had C. auris candidemia. The patients were compared with 114 case-matched controls within the hospital’s adult surgical and medical intensive care units over an 11-month period during the hospital’s protracted outbreak.

The investigators found a crude mortality rate of 58.5% at 30 days for patients with C. auris candidemia. All isolates in the study were completely resistant to fluconazole and had reduced susceptibility to voriconazole.

In critical care units at Hospital La Fe, investigators found C. auris on 25% of blood pressure cuffs, 10% of patient tables and keyboards, and 8% of infusion pumps.

Among the patients at Hospital La Fe, multivariable analysis revealed that those most likely to develop C. auris colonization or candidemia were individuals with polytrauma, cardiovascular disease, and cancer.

Patients receiving parenteral nutrition (odds ratio, 3.49), mechanical ventilation (OR, 2.43), and especially those having indwelling central venous catheters (OR, 13.48) were more likely to be colonized or have candidemia as well, according to Dr. Ruiz-Gaitán and her coauthors.

Once identified, how should C. auris be treated? “The majority of strains – upward of 90% – are resistant to fluconazole,” said Dr. Nett. “Moreover, 30%-50% of them are resistant to another antifungal, often amphotericin B. The isolates that we see in the United States are most often susceptible to an echinocandin, and echinocandins remain the choice for treatment of Candida auris pending susceptibility tests.”

However, in Valencia, “The susceptibility to echinocandins presented interesting features. These antifungals were not fungicidal against C. auris,” wrote Dr. Ruiz-Gaitán and her colleagues. They found that for caspofungin, “most isolates presented a clear paradoxical growth after 24 hours of incubation.” Additionally, fungal growth was inhibited at lower caspofungin concentrations, but rebounded at higher levels. Similar patterns were seen for anidulafungin and micafungin, they said.

These findings meant that Hospital La Fe patients received initial treatment with echinocandins, with the addition of liposomal amphotericin B or isavuconazole if candidemia persisted or clinical response was not seen, wrote the investigators.

Patient presentation is similar to other forms of candidiasis, said Dr. Nett. “Patients often have fever, chills, leukocytosis, and this persists despite antibacterial therapy… If Candida auris is suspected, the first course of action would be to place the patient in isolation, and laboratory staff should be alerted regarding the diagnosis.”

Most large clinical laboratories, she said, can now detect C. auris. Matrix-assisted laser desorption/ionization–time of flight is the identification technique of choice, provided that the databases are updated.

Smaller laboratories that use phenotypic tests may misidentify C. auris as another Candida species, or even as Saccharomyces cerevisiae – common beer yeast. Facilities without matrix-assisted laser desorption/ionization can find guidance for interpretation of phenotypic testing on the CDC website as well, said Dr. Nett.

After experiencing what they believe to be the largest C. auris outbreak at a single European hospital, Dr. Ruiz-Gaitán and her colleagues offered best-practice tips for treatment of patients with C. auris candidemia. These include removing mechanical devices as early as is safely practical; performing ophthalmologic examinations for endophthalmitis, a known C. auris complication; obtaining blood cultures every other day to track antimicrobial therapy to the point of sterilization; and searching for metastatic foci if blood cultures remain positive.

All instances of C. auris laboratory identification should be reported to the CDC at [email protected], and to local and state health agencies. The CDC recommends strict isolation and cleaning protocols, similar to those used for the spore-forming Clostridium difficile.

Dr. Nett reported funding support from the National Institutes of Health, the Burroughs Wellcome Fund, and the Doris Duke Charitable Foundation. She reported no conflicts of interest. Dr. Ruiz-Gaitán and her collaborators reported funding from Instituto de Salud Carlos III, Spain, and the Spanish Ministry of Science and University. They reported no conflicts of interest.

[email protected]

Critical care units and long-term care facilities are on alert for cases of Candida auris, a novel fungal infection that is both dangerous to vulnerable patients and difficult to eradicate. The increased profile of C. auris is not a welcome development but is no surprise to critical care physicians.

This pathogen was first identified in 2009 and has since been found in increasing numbers of patients all over the world. As expected, cases of C. auris are on the rise in the United States.

The Centers for Disease Control and Prevention stated “Candida auris is an emerging fungus that presents a serious global health threat.” This is an opportunistic pathogen that hits critically ill patients and those with compromised immunity.

On March 29, 2019, CDC reported that confirmed clinical cases of C. auris in the United States have more than doubled over the past year, from 257 cases in 2018 to 587 cases with an additional 1,056 colonized patients identified as of February 2019. “Most C. auris cases in the United States have been detected in the New York City area, New Jersey, and the Chicago area. Strains of C. auris in the United States have been linked to other parts of the world. U.S. C. auris cases are a result of inadvertent introduction into the United States from a patient who recently received health care in a country where C. auris has been reported or a result of local spread after such an introduction.”

Case reports have found a mortality rate of up to 50% in patients with C. auris candidemia. The total number of cases is still small, but the trajectory is clear. The hunt is on in labs all over the world for optimal treatments and processes to handle outbreaks.

Jeniel Nett, MD, an infectious disease specialist, and a team of investigators at the University of Wisconsin, Madison, have focused their research on the characteristics of C. auris and its progression in patients and in medical facilities.

According to Dr. Nett, it’s not clear why this emerging threat has cropped up in multiple locations globally. “Candida auris was first recognized in 2009, in Japan, and relatively quickly we saw emergence of this species in relatively distant locations,” she said, adding that independent clades in these locations ruled out transmission as the source of the multiple outbreaks. Antifungal resistance is an epidemiologic area of concern and increased antifungal use may be a contributor, she said.

Kari Oakes/MDedge News

Once established, the organism is persistent: “It is found on mattresses, on bedsheets, IV poles, and a lot of reusable equipment,” said Dr. Nett in an interview. “It appears to persist in the environment for weeks – maybe longer.” In addition, “it seems to behave differently than a lot of the Candida species that we see; it readily colonizes the skin” to a much greater extent than does other Candida species, she said. “This allows it to be transmitted readily person to person, particularly in the hospitalized setting.” However, it can also colonize both the urinary and respiratory tracts, she said.

Which patients are susceptible to C. auris candidemia? “Many of these patients have undergone multiple procedures; they may have undergone mechanical ventilation as well as different surgical procedures,” said Dr. Nett. Affected patients often have received many rounds of antibiotic and antifungal treatment as well, she said, and may have an underlying illness like diabetes or malignancy.

Studies of C. auris outbreaks have begun to appear in the literature and give clinicians some perspective on the progression of an outbreak and potential strategies for containment. A prospective cohort study of a large outbreak of C. auris was conducted by Alba Ruiz-Gaitán, MD, and her colleagues at La Fe University and Polytechnic Hospital, Valencia, Spain (Expert Rev Anti Infect Ther. 2019 Apr;17[4]:295-305). The researchers followed 114 patients who were colonized with C. auris or had C. auris candidemia. The patients were compared with 114 case-matched controls within the hospital’s adult surgical and medical intensive care units over an 11-month period during the hospital’s protracted outbreak.

The investigators found a crude mortality rate of 58.5% at 30 days for patients with C. auris candidemia. All isolates in the study were completely resistant to fluconazole and had reduced susceptibility to voriconazole.

In critical care units at Hospital La Fe, investigators found C. auris on 25% of blood pressure cuffs, 10% of patient tables and keyboards, and 8% of infusion pumps.

Among the patients at Hospital La Fe, multivariable analysis revealed that those most likely to develop C. auris colonization or candidemia were individuals with polytrauma, cardiovascular disease, and cancer.

Patients receiving parenteral nutrition (odds ratio, 3.49), mechanical ventilation (OR, 2.43), and especially those having indwelling central venous catheters (OR, 13.48) were more likely to be colonized or have candidemia as well, according to Dr. Ruiz-Gaitán and her coauthors.

Once identified, how should C. auris be treated? “The majority of strains – upward of 90% – are resistant to fluconazole,” said Dr. Nett. “Moreover, 30%-50% of them are resistant to another antifungal, often amphotericin B. The isolates that we see in the United States are most often susceptible to an echinocandin, and echinocandins remain the choice for treatment of Candida auris pending susceptibility tests.”

However, in Valencia, “The susceptibility to echinocandins presented interesting features. These antifungals were not fungicidal against C. auris,” wrote Dr. Ruiz-Gaitán and her colleagues. They found that for caspofungin, “most isolates presented a clear paradoxical growth after 24 hours of incubation.” Additionally, fungal growth was inhibited at lower caspofungin concentrations, but rebounded at higher levels. Similar patterns were seen for anidulafungin and micafungin, they said.

These findings meant that Hospital La Fe patients received initial treatment with echinocandins, with the addition of liposomal amphotericin B or isavuconazole if candidemia persisted or clinical response was not seen, wrote the investigators.

Patient presentation is similar to other forms of candidiasis, said Dr. Nett. “Patients often have fever, chills, leukocytosis, and this persists despite antibacterial therapy… If Candida auris is suspected, the first course of action would be to place the patient in isolation, and laboratory staff should be alerted regarding the diagnosis.”

Most large clinical laboratories, she said, can now detect C. auris. Matrix-assisted laser desorption/ionization–time of flight is the identification technique of choice, provided that the databases are updated.

Smaller laboratories that use phenotypic tests may misidentify C. auris as another Candida species, or even as Saccharomyces cerevisiae – common beer yeast. Facilities without matrix-assisted laser desorption/ionization can find guidance for interpretation of phenotypic testing on the CDC website as well, said Dr. Nett.

After experiencing what they believe to be the largest C. auris outbreak at a single European hospital, Dr. Ruiz-Gaitán and her colleagues offered best-practice tips for treatment of patients with C. auris candidemia. These include removing mechanical devices as early as is safely practical; performing ophthalmologic examinations for endophthalmitis, a known C. auris complication; obtaining blood cultures every other day to track antimicrobial therapy to the point of sterilization; and searching for metastatic foci if blood cultures remain positive.

All instances of C. auris laboratory identification should be reported to the CDC at [email protected], and to local and state health agencies. The CDC recommends strict isolation and cleaning protocols, similar to those used for the spore-forming Clostridium difficile.

Dr. Nett reported funding support from the National Institutes of Health, the Burroughs Wellcome Fund, and the Doris Duke Charitable Foundation. She reported no conflicts of interest. Dr. Ruiz-Gaitán and her collaborators reported funding from Instituto de Salud Carlos III, Spain, and the Spanish Ministry of Science and University. They reported no conflicts of interest.

[email protected]

Critical care units and long-term care facilities are on alert for cases of Candida auris, a novel fungal infection that is both dangerous to vulnerable patients and difficult to eradicate. The increased profile of C. auris is not a welcome development but is no surprise to critical care physicians.

This pathogen was first identified in 2009 and has since been found in increasing numbers of patients all over the world. As expected, cases of C. auris are on the rise in the United States.

The Centers for Disease Control and Prevention stated “Candida auris is an emerging fungus that presents a serious global health threat.” This is an opportunistic pathogen that hits critically ill patients and those with compromised immunity.

On March 29, 2019, CDC reported that confirmed clinical cases of C. auris in the United States have more than doubled over the past year, from 257 cases in 2018 to 587 cases with an additional 1,056 colonized patients identified as of February 2019. “Most C. auris cases in the United States have been detected in the New York City area, New Jersey, and the Chicago area. Strains of C. auris in the United States have been linked to other parts of the world. U.S. C. auris cases are a result of inadvertent introduction into the United States from a patient who recently received health care in a country where C. auris has been reported or a result of local spread after such an introduction.”

Case reports have found a mortality rate of up to 50% in patients with C. auris candidemia. The total number of cases is still small, but the trajectory is clear. The hunt is on in labs all over the world for optimal treatments and processes to handle outbreaks.

Jeniel Nett, MD, an infectious disease specialist, and a team of investigators at the University of Wisconsin, Madison, have focused their research on the characteristics of C. auris and its progression in patients and in medical facilities.

According to Dr. Nett, it’s not clear why this emerging threat has cropped up in multiple locations globally. “Candida auris was first recognized in 2009, in Japan, and relatively quickly we saw emergence of this species in relatively distant locations,” she said, adding that independent clades in these locations ruled out transmission as the source of the multiple outbreaks. Antifungal resistance is an epidemiologic area of concern and increased antifungal use may be a contributor, she said.

Kari Oakes/MDedge News

Once established, the organism is persistent: “It is found on mattresses, on bedsheets, IV poles, and a lot of reusable equipment,” said Dr. Nett in an interview. “It appears to persist in the environment for weeks – maybe longer.” In addition, “it seems to behave differently than a lot of the Candida species that we see; it readily colonizes the skin” to a much greater extent than does other Candida species, she said. “This allows it to be transmitted readily person to person, particularly in the hospitalized setting.” However, it can also colonize both the urinary and respiratory tracts, she said.

Which patients are susceptible to C. auris candidemia? “Many of these patients have undergone multiple procedures; they may have undergone mechanical ventilation as well as different surgical procedures,” said Dr. Nett. Affected patients often have received many rounds of antibiotic and antifungal treatment as well, she said, and may have an underlying illness like diabetes or malignancy.

Studies of C. auris outbreaks have begun to appear in the literature and give clinicians some perspective on the progression of an outbreak and potential strategies for containment. A prospective cohort study of a large outbreak of C. auris was conducted by Alba Ruiz-Gaitán, MD, and her colleagues at La Fe University and Polytechnic Hospital, Valencia, Spain (Expert Rev Anti Infect Ther. 2019 Apr;17[4]:295-305). The researchers followed 114 patients who were colonized with C. auris or had C. auris candidemia. The patients were compared with 114 case-matched controls within the hospital’s adult surgical and medical intensive care units over an 11-month period during the hospital’s protracted outbreak.

The investigators found a crude mortality rate of 58.5% at 30 days for patients with C. auris candidemia. All isolates in the study were completely resistant to fluconazole and had reduced susceptibility to voriconazole.

In critical care units at Hospital La Fe, investigators found C. auris on 25% of blood pressure cuffs, 10% of patient tables and keyboards, and 8% of infusion pumps.

Among the patients at Hospital La Fe, multivariable analysis revealed that those most likely to develop C. auris colonization or candidemia were individuals with polytrauma, cardiovascular disease, and cancer.

Patients receiving parenteral nutrition (odds ratio, 3.49), mechanical ventilation (OR, 2.43), and especially those having indwelling central venous catheters (OR, 13.48) were more likely to be colonized or have candidemia as well, according to Dr. Ruiz-Gaitán and her coauthors.

Once identified, how should C. auris be treated? “The majority of strains – upward of 90% – are resistant to fluconazole,” said Dr. Nett. “Moreover, 30%-50% of them are resistant to another antifungal, often amphotericin B. The isolates that we see in the United States are most often susceptible to an echinocandin, and echinocandins remain the choice for treatment of Candida auris pending susceptibility tests.”

However, in Valencia, “The susceptibility to echinocandins presented interesting features. These antifungals were not fungicidal against C. auris,” wrote Dr. Ruiz-Gaitán and her colleagues. They found that for caspofungin, “most isolates presented a clear paradoxical growth after 24 hours of incubation.” Additionally, fungal growth was inhibited at lower caspofungin concentrations, but rebounded at higher levels. Similar patterns were seen for anidulafungin and micafungin, they said.

These findings meant that Hospital La Fe patients received initial treatment with echinocandins, with the addition of liposomal amphotericin B or isavuconazole if candidemia persisted or clinical response was not seen, wrote the investigators.

Patient presentation is similar to other forms of candidiasis, said Dr. Nett. “Patients often have fever, chills, leukocytosis, and this persists despite antibacterial therapy… If Candida auris is suspected, the first course of action would be to place the patient in isolation, and laboratory staff should be alerted regarding the diagnosis.”

Most large clinical laboratories, she said, can now detect C. auris. Matrix-assisted laser desorption/ionization–time of flight is the identification technique of choice, provided that the databases are updated.

Smaller laboratories that use phenotypic tests may misidentify C. auris as another Candida species, or even as Saccharomyces cerevisiae – common beer yeast. Facilities without matrix-assisted laser desorption/ionization can find guidance for interpretation of phenotypic testing on the CDC website as well, said Dr. Nett.

After experiencing what they believe to be the largest C. auris outbreak at a single European hospital, Dr. Ruiz-Gaitán and her colleagues offered best-practice tips for treatment of patients with C. auris candidemia. These include removing mechanical devices as early as is safely practical; performing ophthalmologic examinations for endophthalmitis, a known C. auris complication; obtaining blood cultures every other day to track antimicrobial therapy to the point of sterilization; and searching for metastatic foci if blood cultures remain positive.

All instances of C. auris laboratory identification should be reported to the CDC at [email protected], and to local and state health agencies. The CDC recommends strict isolation and cleaning protocols, similar to those used for the spore-forming Clostridium difficile.

Dr. Nett reported funding support from the National Institutes of Health, the Burroughs Wellcome Fund, and the Doris Duke Charitable Foundation. She reported no conflicts of interest. Dr. Ruiz-Gaitán and her collaborators reported funding from Instituto de Salud Carlos III, Spain, and the Spanish Ministry of Science and University. They reported no conflicts of interest.

[email protected]

A study of > 450,000 adults has “confirmed the long-held notion” that flu and heart failure are connected. The Atherosclerosis Risk in Communities study (ARIC), led by a VA researcher, found influenza significantly increased the risk of hospitalization for heart failure.

Every flu season about 36,000 people die, and > 200,000 are hospitalized due to flu, which is known to be associated with a higher risk of cardiovascular events. Several mechanisms likely contribute: Some form of immunocompromise is thought to be a key link. But few studies, the researchers note, have explored the temporal association between influenza activity and hospitalizations, particularly those caused by heart failure.

In ARIC, the researchers analyzed hospitalization data for adults aged 35 to 84 years between 2010 and 2014 in geographically diverse communities in Mississippi, Minnesota, North Carolina, and Maryland. They correlated those data with reports of influenza activity from the CDC Surveillance Network.

A 5% monthly increase in influenza activity was associated with a 24% relative increase in heart failure hospitalization rates. Myocardial infarction hospitalizations did not rise significantly. The most pneumonia and influenza-associated deaths were during the 2012-2013 season, when influenza-like illness (ILI) activity was highest, and the fewest deaths occurred during 2011-2012, when ILI activity was lowest. The model suggests that in a month with high influenza activity, about 19% of hospitalizations could be attributable to influenza, the researchers say.

“The study’s findings support VA’s aggressive effort every year to provide veterans with influenza vaccine,” said VA Secretary Robert Wilkie. Although the flu season is winding down, he added, it is not too late for veterans—and others—to get vaccinated.

A study of > 450,000 adults has “confirmed the long-held notion” that flu and heart failure are connected. The Atherosclerosis Risk in Communities study (ARIC), led by a VA researcher, found influenza significantly increased the risk of hospitalization for heart failure.

Every flu season about 36,000 people die, and > 200,000 are hospitalized due to flu, which is known to be associated with a higher risk of cardiovascular events. Several mechanisms likely contribute: Some form of immunocompromise is thought to be a key link. But few studies, the researchers note, have explored the temporal association between influenza activity and hospitalizations, particularly those caused by heart failure.

In ARIC, the researchers analyzed hospitalization data for adults aged 35 to 84 years between 2010 and 2014 in geographically diverse communities in Mississippi, Minnesota, North Carolina, and Maryland. They correlated those data with reports of influenza activity from the CDC Surveillance Network.

A 5% monthly increase in influenza activity was associated with a 24% relative increase in heart failure hospitalization rates. Myocardial infarction hospitalizations did not rise significantly. The most pneumonia and influenza-associated deaths were during the 2012-2013 season, when influenza-like illness (ILI) activity was highest, and the fewest deaths occurred during 2011-2012, when ILI activity was lowest. The model suggests that in a month with high influenza activity, about 19% of hospitalizations could be attributable to influenza, the researchers say.

“The study’s findings support VA’s aggressive effort every year to provide veterans with influenza vaccine,” said VA Secretary Robert Wilkie. Although the flu season is winding down, he added, it is not too late for veterans—and others—to get vaccinated.

A study of > 450,000 adults has “confirmed the long-held notion” that flu and heart failure are connected. The Atherosclerosis Risk in Communities study (ARIC), led by a VA researcher, found influenza significantly increased the risk of hospitalization for heart failure.

Every flu season about 36,000 people die, and > 200,000 are hospitalized due to flu, which is known to be associated with a higher risk of cardiovascular events. Several mechanisms likely contribute: Some form of immunocompromise is thought to be a key link. But few studies, the researchers note, have explored the temporal association between influenza activity and hospitalizations, particularly those caused by heart failure.

In ARIC, the researchers analyzed hospitalization data for adults aged 35 to 84 years between 2010 and 2014 in geographically diverse communities in Mississippi, Minnesota, North Carolina, and Maryland. They correlated those data with reports of influenza activity from the CDC Surveillance Network.

A 5% monthly increase in influenza activity was associated with a 24% relative increase in heart failure hospitalization rates. Myocardial infarction hospitalizations did not rise significantly. The most pneumonia and influenza-associated deaths were during the 2012-2013 season, when influenza-like illness (ILI) activity was highest, and the fewest deaths occurred during 2011-2012, when ILI activity was lowest. The model suggests that in a month with high influenza activity, about 19% of hospitalizations could be attributable to influenza, the researchers say.

“The study’s findings support VA’s aggressive effort every year to provide veterans with influenza vaccine,” said VA Secretary Robert Wilkie. Although the flu season is winding down, he added, it is not too late for veterans—and others—to get vaccinated.

ANSWER

The correct interpretation includes normal sinus rhythm, biatrial enlargement, and right-axis deviation. Other findings include a prolonged QT interval and ST-T wave abnormalities in inferior and anterior distributions.

A P wave for every QRS complex and a QRS complex for every P wave, with a consistent PR interval and a rate > 60 and < 100 beats/min, indicates normal sinus rhythm. Biatrial enlargement is evidenced by a notched P wave in lead I, a tall P wave in lead II, and a biphasic P wave in V1. Right-axis deviation is defined by an R-wave axis between 90° and 180°. Biatrial enlargement and right-axis deviation suggest a pulmonary disease pattern.

A normal QTc interval is generally 350 to 440 ms; the patient’s QTc interval (477 ms) meets the criteria for prolonged QT. There are ST- and T-wave inversions in leads II, III, and aVF, consistent with inferior ischemia, with ST depressions in leads V3 and V4, which could suggest anterior ischemia. Such findings are also seen in a pulmonary disease pattern.

Further workup included a chest x-ray, laboratory testing, and an echocardiogram. The last revealed right lower lobe consolidation and a diffuse, dilated cardiomyopathy with mild mitral and tricuspid regurgitation.

ANSWER

The correct interpretation includes normal sinus rhythm, biatrial enlargement, and right-axis deviation. Other findings include a prolonged QT interval and ST-T wave abnormalities in inferior and anterior distributions.

A P wave for every QRS complex and a QRS complex for every P wave, with a consistent PR interval and a rate > 60 and < 100 beats/min, indicates normal sinus rhythm. Biatrial enlargement is evidenced by a notched P wave in lead I, a tall P wave in lead II, and a biphasic P wave in V1. Right-axis deviation is defined by an R-wave axis between 90° and 180°. Biatrial enlargement and right-axis deviation suggest a pulmonary disease pattern.

A normal QTc interval is generally 350 to 440 ms; the patient’s QTc interval (477 ms) meets the criteria for prolonged QT. There are ST- and T-wave inversions in leads II, III, and aVF, consistent with inferior ischemia, with ST depressions in leads V3 and V4, which could suggest anterior ischemia. Such findings are also seen in a pulmonary disease pattern.

Further workup included a chest x-ray, laboratory testing, and an echocardiogram. The last revealed right lower lobe consolidation and a diffuse, dilated cardiomyopathy with mild mitral and tricuspid regurgitation.

ANSWER

The correct interpretation includes normal sinus rhythm, biatrial enlargement, and right-axis deviation. Other findings include a prolonged QT interval and ST-T wave abnormalities in inferior and anterior distributions.

A P wave for every QRS complex and a QRS complex for every P wave, with a consistent PR interval and a rate > 60 and < 100 beats/min, indicates normal sinus rhythm. Biatrial enlargement is evidenced by a notched P wave in lead I, a tall P wave in lead II, and a biphasic P wave in V1. Right-axis deviation is defined by an R-wave axis between 90° and 180°. Biatrial enlargement and right-axis deviation suggest a pulmonary disease pattern.

A normal QTc interval is generally 350 to 440 ms; the patient’s QTc interval (477 ms) meets the criteria for prolonged QT. There are ST- and T-wave inversions in leads II, III, and aVF, consistent with inferior ischemia, with ST depressions in leads V3 and V4, which could suggest anterior ischemia. Such findings are also seen in a pulmonary disease pattern.

Further workup included a chest x-ray, laboratory testing, and an echocardiogram. The last revealed right lower lobe consolidation and a diffuse, dilated cardiomyopathy with mild mitral and tricuspid regurgitation.