SAN DIEGO – In the opinion of Kimberly J. Butterwick, MD, there are at least three reasons why dermatologists should consider incorporating cosmeceuticals into their aesthetic practice

First, if you don’t, patients will buy products elsewhere. “There’s good data showing that 80% of patients will purchase a product within 24 hours of an office visit,” Dr. Butterwick said at the annual Masters of Aesthetics Symposium.

“You should be the one giving them unbiased advice, because patients waste a lot of money on products which aren’t that effective. Female patients spend an average of $2,000 per year on cosmetics. The average woman uses 15 different cosmetics per day,” according to Dr. Butterwick.

A second reason to consider selling cosmeceuticals is that patients visit dermatologists in order to have healthy, beautiful skin. “Patients want and need your expertise,” said Dr. Butterwick, one of five board-certified dermatologists who practices at the San Diego-based Cosmetic Laser Dermatology. “Patients who are educated and are given advice have better compliance and outcomes. You also want to care for patients for life, to show that you have an interest in treating them beyond what they come to see you for. That will make them come back to you. They’ll get refills and visits and more advice.”

A third reason to consider selling moisturizers, bleaching agents, and other cosmeceuticals is that it’s good for business. “It can be profitable, not just to you, but it’s an opportunity for employees to be creative and earn more with a product sales incentive,” Dr. Butterwick said. “Some of them are great sellers.” She and her colleagues at Cosmetic Laser Dermatology hit more than $1 million in gross revenue from cosmeceutical sales in 2016, 2017, and 2018. In 2018 alone, they sold 167 different products across 27 skin care lines. Six product lines brought in 84% of total sales: SkinMedica, Calecim, SkinCeuticals, Neocutis, Colorescience, and Topix. “Antiaging products are always going to be the number one seller,” she said, including antioxidants, peptides, growth factors, retinoids, hydroxyacids, botanicals, nutriceuticals, teeth-whitening agents, and supplements. New serums with solid science behind them, she continued, include Multi-Action Cream, a product from Calecim that contains a cytokine and growth factor blend from umbilical cord stem cells of red deer to stimulate collagen production and healing after procedures. In 2020, Dr. Butterwick said that SkinMedica’s TNS Essential Serum will contain human fibroblasts grown at low oxygen levels. These are designed to behave as embryonic fibroblasts with more effective growth factors, resulting in better collagen production.

“You want to take the high road when selling cosmeceuticals,” said Dr. Butterwick, who also was a co-founder of SkinMedica. “Provide guidance and education to steer your patients toward products that have proven efficacy, safety, are well tolerated, and are tested and approved by office staff and patients.”

Her tips for effective dispensing include selecting products that target your patient base and the climate in your area, and starting with a specific product line such as SkinMedica, Obagi, SkinCeuticals, Colorescience, Alastin, or Skin Better. “When you choose a company, make sure they have good return policies,” she said. “Get that in writing. Make sure they’ll educate your staff, and make sure they have some system in place to monitor unauthorized sales online. A lot of companies have this now. At trade shows, I’ve learned that some companies will dump expired products, which people buy at a discount and sell online. You don’t want to be competing with that kind of situation.”

She recommends setting aside a dedicated area in your office to display products, “whether it’s the checkout counter in your waiting room or a separate room that resembles a store,” she said. “For effective dispensing, physician-directed products are best. Explain the science: why you are recommending a product and why it is effective. Staff can review the regimen and try products with the patient. A written regimen assures compliance. You also want to offer patients discounts for multiple products or a featured brand of the month. Offer free shipping for refills, and consider linking products with procedures for a discount.”

Citing independent research conducted for a major cosmetics company, Dr. Butterwick said that patients are initially excited to purchase a cosmeceutical product, but once they get home compliance wanes. Only 30% buy the product a second time, and only 12% buy it a third time. “Reasons why so many drop off include that they find it inconvenient to buy, they forgot how to use the product, they become demotivated or distracted, or they shop around for a lower price,” she explained. “Remind your patients not to buy products online. Many of these products are expired or counterfeit. There’s so much information available online, but why not be a source of truth and tell them what’s really going to help? That’s going to assure your patient of the best outcome. It will also keep your patient loyal to you and your practice.”

In addition to co-founding SkinMedica, Dr. Butterwick disclosed that she has received grants/research support from Allergan, Galderma, and Histogen, and consulting fees from Allergan, Colorescience, Evolus, Galderma, Merz, and Sinclair. She is also a member of the speakers’ bureau for Allergan and Merz.

[email protected]

SAN DIEGO – In the opinion of Kimberly J. Butterwick, MD, there are at least three reasons why dermatologists should consider incorporating cosmeceuticals into their aesthetic practice

First, if you don’t, patients will buy products elsewhere. “There’s good data showing that 80% of patients will purchase a product within 24 hours of an office visit,” Dr. Butterwick said at the annual Masters of Aesthetics Symposium.

“You should be the one giving them unbiased advice, because patients waste a lot of money on products which aren’t that effective. Female patients spend an average of $2,000 per year on cosmetics. The average woman uses 15 different cosmetics per day,” according to Dr. Butterwick.

A second reason to consider selling cosmeceuticals is that patients visit dermatologists in order to have healthy, beautiful skin. “Patients want and need your expertise,” said Dr. Butterwick, one of five board-certified dermatologists who practices at the San Diego-based Cosmetic Laser Dermatology. “Patients who are educated and are given advice have better compliance and outcomes. You also want to care for patients for life, to show that you have an interest in treating them beyond what they come to see you for. That will make them come back to you. They’ll get refills and visits and more advice.”

A third reason to consider selling moisturizers, bleaching agents, and other cosmeceuticals is that it’s good for business. “It can be profitable, not just to you, but it’s an opportunity for employees to be creative and earn more with a product sales incentive,” Dr. Butterwick said. “Some of them are great sellers.” She and her colleagues at Cosmetic Laser Dermatology hit more than $1 million in gross revenue from cosmeceutical sales in 2016, 2017, and 2018. In 2018 alone, they sold 167 different products across 27 skin care lines. Six product lines brought in 84% of total sales: SkinMedica, Calecim, SkinCeuticals, Neocutis, Colorescience, and Topix. “Antiaging products are always going to be the number one seller,” she said, including antioxidants, peptides, growth factors, retinoids, hydroxyacids, botanicals, nutriceuticals, teeth-whitening agents, and supplements. New serums with solid science behind them, she continued, include Multi-Action Cream, a product from Calecim that contains a cytokine and growth factor blend from umbilical cord stem cells of red deer to stimulate collagen production and healing after procedures. In 2020, Dr. Butterwick said that SkinMedica’s TNS Essential Serum will contain human fibroblasts grown at low oxygen levels. These are designed to behave as embryonic fibroblasts with more effective growth factors, resulting in better collagen production.

“You want to take the high road when selling cosmeceuticals,” said Dr. Butterwick, who also was a co-founder of SkinMedica. “Provide guidance and education to steer your patients toward products that have proven efficacy, safety, are well tolerated, and are tested and approved by office staff and patients.”

Her tips for effective dispensing include selecting products that target your patient base and the climate in your area, and starting with a specific product line such as SkinMedica, Obagi, SkinCeuticals, Colorescience, Alastin, or Skin Better. “When you choose a company, make sure they have good return policies,” she said. “Get that in writing. Make sure they’ll educate your staff, and make sure they have some system in place to monitor unauthorized sales online. A lot of companies have this now. At trade shows, I’ve learned that some companies will dump expired products, which people buy at a discount and sell online. You don’t want to be competing with that kind of situation.”

She recommends setting aside a dedicated area in your office to display products, “whether it’s the checkout counter in your waiting room or a separate room that resembles a store,” she said. “For effective dispensing, physician-directed products are best. Explain the science: why you are recommending a product and why it is effective. Staff can review the regimen and try products with the patient. A written regimen assures compliance. You also want to offer patients discounts for multiple products or a featured brand of the month. Offer free shipping for refills, and consider linking products with procedures for a discount.”

Citing independent research conducted for a major cosmetics company, Dr. Butterwick said that patients are initially excited to purchase a cosmeceutical product, but once they get home compliance wanes. Only 30% buy the product a second time, and only 12% buy it a third time. “Reasons why so many drop off include that they find it inconvenient to buy, they forgot how to use the product, they become demotivated or distracted, or they shop around for a lower price,” she explained. “Remind your patients not to buy products online. Many of these products are expired or counterfeit. There’s so much information available online, but why not be a source of truth and tell them what’s really going to help? That’s going to assure your patient of the best outcome. It will also keep your patient loyal to you and your practice.”

In addition to co-founding SkinMedica, Dr. Butterwick disclosed that she has received grants/research support from Allergan, Galderma, and Histogen, and consulting fees from Allergan, Colorescience, Evolus, Galderma, Merz, and Sinclair. She is also a member of the speakers’ bureau for Allergan and Merz.

[email protected]

SAN DIEGO – In the opinion of Kimberly J. Butterwick, MD, there are at least three reasons why dermatologists should consider incorporating cosmeceuticals into their aesthetic practice

First, if you don’t, patients will buy products elsewhere. “There’s good data showing that 80% of patients will purchase a product within 24 hours of an office visit,” Dr. Butterwick said at the annual Masters of Aesthetics Symposium.

“You should be the one giving them unbiased advice, because patients waste a lot of money on products which aren’t that effective. Female patients spend an average of $2,000 per year on cosmetics. The average woman uses 15 different cosmetics per day,” according to Dr. Butterwick.

A second reason to consider selling cosmeceuticals is that patients visit dermatologists in order to have healthy, beautiful skin. “Patients want and need your expertise,” said Dr. Butterwick, one of five board-certified dermatologists who practices at the San Diego-based Cosmetic Laser Dermatology. “Patients who are educated and are given advice have better compliance and outcomes. You also want to care for patients for life, to show that you have an interest in treating them beyond what they come to see you for. That will make them come back to you. They’ll get refills and visits and more advice.”

A third reason to consider selling moisturizers, bleaching agents, and other cosmeceuticals is that it’s good for business. “It can be profitable, not just to you, but it’s an opportunity for employees to be creative and earn more with a product sales incentive,” Dr. Butterwick said. “Some of them are great sellers.” She and her colleagues at Cosmetic Laser Dermatology hit more than $1 million in gross revenue from cosmeceutical sales in 2016, 2017, and 2018. In 2018 alone, they sold 167 different products across 27 skin care lines. Six product lines brought in 84% of total sales: SkinMedica, Calecim, SkinCeuticals, Neocutis, Colorescience, and Topix. “Antiaging products are always going to be the number one seller,” she said, including antioxidants, peptides, growth factors, retinoids, hydroxyacids, botanicals, nutriceuticals, teeth-whitening agents, and supplements. New serums with solid science behind them, she continued, include Multi-Action Cream, a product from Calecim that contains a cytokine and growth factor blend from umbilical cord stem cells of red deer to stimulate collagen production and healing after procedures. In 2020, Dr. Butterwick said that SkinMedica’s TNS Essential Serum will contain human fibroblasts grown at low oxygen levels. These are designed to behave as embryonic fibroblasts with more effective growth factors, resulting in better collagen production.

“You want to take the high road when selling cosmeceuticals,” said Dr. Butterwick, who also was a co-founder of SkinMedica. “Provide guidance and education to steer your patients toward products that have proven efficacy, safety, are well tolerated, and are tested and approved by office staff and patients.”

Her tips for effective dispensing include selecting products that target your patient base and the climate in your area, and starting with a specific product line such as SkinMedica, Obagi, SkinCeuticals, Colorescience, Alastin, or Skin Better. “When you choose a company, make sure they have good return policies,” she said. “Get that in writing. Make sure they’ll educate your staff, and make sure they have some system in place to monitor unauthorized sales online. A lot of companies have this now. At trade shows, I’ve learned that some companies will dump expired products, which people buy at a discount and sell online. You don’t want to be competing with that kind of situation.”

She recommends setting aside a dedicated area in your office to display products, “whether it’s the checkout counter in your waiting room or a separate room that resembles a store,” she said. “For effective dispensing, physician-directed products are best. Explain the science: why you are recommending a product and why it is effective. Staff can review the regimen and try products with the patient. A written regimen assures compliance. You also want to offer patients discounts for multiple products or a featured brand of the month. Offer free shipping for refills, and consider linking products with procedures for a discount.”

Citing independent research conducted for a major cosmetics company, Dr. Butterwick said that patients are initially excited to purchase a cosmeceutical product, but once they get home compliance wanes. Only 30% buy the product a second time, and only 12% buy it a third time. “Reasons why so many drop off include that they find it inconvenient to buy, they forgot how to use the product, they become demotivated or distracted, or they shop around for a lower price,” she explained. “Remind your patients not to buy products online. Many of these products are expired or counterfeit. There’s so much information available online, but why not be a source of truth and tell them what’s really going to help? That’s going to assure your patient of the best outcome. It will also keep your patient loyal to you and your practice.”

In addition to co-founding SkinMedica, Dr. Butterwick disclosed that she has received grants/research support from Allergan, Galderma, and Histogen, and consulting fees from Allergan, Colorescience, Evolus, Galderma, Merz, and Sinclair. She is also a member of the speakers’ bureau for Allergan and Merz.

[email protected]

SAN DIEGO – If the idea of marketing your aesthetic dermatology services to Millennials is an afterthought, Brian Biesman, MD, recommends that you reconsider that outlook. At the annual Masters of Aesthetics Symposium, Dr. Biesman told attendees that the age group dubbed as the “Me Me Me Generation” by Joel Stein of Time Magazine is slowly overtaking Baby Boomers as the largest shopping generation in history.

A large consumer survey conducted by Accenture found that by 2020, spending by Millennials will account for $1.4 trillion in U.S. retail sales. This segment of the population, which the Pew Research Center defines as those born from 1981 to 1996, also spends more online than any other generation. According to data from the consulting firm Bain & Company, 25% of luxury goods will be purchased online by 2025, up from 8% in 2016. “Millennials are going to be a huge economic driving force,” Dr. Biesman said.

Dr. Biesman, an oculofacial plastic surgeon who practices in Nashville, Tenn., said Millennials were born into a digital age. “They are very socially connected, sometimes to their detriment,” said Dr. Biesman, who is a past president of the American Society for Laser Medicine and Surgery. “They’re definitely in debt ... but they’re comfortable with that and don’t mind spending. Their priorities are different. They tend to put off marriage and having kids, and they’re driven by social media.

They also hold a strong interest in appearance, said Dr, Biesman, who noted that the average Millennial woman is more likely to be aware of beauty issues by a factor of 10 years younger than her mother’s generation. “At age 25, Millennial women are getting interested in aesthetics, whereas the older generation didn’t start until about 35,” he said. Millennials “are educated, and they use the Internet to read up on procedures.” In his clinical experience, Millennials seek aesthetic treatments to resolve specific issues such as acne scars, to try noninvasive aesthetic treatments for “prejuvenation,” to beautify or to address dissatisfaction with their appearance, and to keep up with the latest trends endorsed or promoted by the media or by celebrities. The most popular procedures include neuromodulators, fillers (especially in the lips and in the infraorbital hollow), minimally invasive laser hair removal, superficial laser resurfacing, and prescription skin care and cosmeceuticals.

According to a 2018 survey of 500 Millennials conducted by the aesthetics site Zalea, 32% were considering a cosmetic procedure and 6.6% had undergone one. Of the 149 Millennials who completed all of the survey questions, 65% indicated that they relied on Google search for information about cosmetic treatments, which was a higher proportion than for physicians (63%), friends and family (60%), and social networks such as Instagram, Facebook, and Twitter (25%). Dr. Biesman said that a paradigm shift is under way in aesthetic dermatology, in which the traditional means of achieving a strong reputation amongst patients by excellent training, publications, and research can be replaced by building a visible social media presence/personality.

“The social media influencer factor is a real phenomenon, and can carry tremendous weight due to their perceived relationship with their audience/followers,” Dr. Biesman said. “Some physicians are influencers, while others collaborate with influencers.” He emphasized that the decision to work with social media influencers depends on your preference, your comfort level/trust, the professionalism of the influencer, and your overall social media strategy. “The more you share about yourself, the more successful your social media account will be,” he said. “You need to determine your comfort zone, such as how much of your life you want to share.”

He advises aesthetic dermatologists to develop a strategy for reaching out to and incorporating Millennials into their practice. “Be deliberate in assessing the profile of your practice demographics, and determine which patient groups you want to serve, and to what extent,” he said. “If your practice is focused on minimally invasive aesthetics, it’s important to understand the Millennial mindset, because this is the largest group of consumers.”

Dr. Biesman reported having no relevant disclosures related to his presentation.

[email protected]

SAN DIEGO – If the idea of marketing your aesthetic dermatology services to Millennials is an afterthought, Brian Biesman, MD, recommends that you reconsider that outlook. At the annual Masters of Aesthetics Symposium, Dr. Biesman told attendees that the age group dubbed as the “Me Me Me Generation” by Joel Stein of Time Magazine is slowly overtaking Baby Boomers as the largest shopping generation in history.

A large consumer survey conducted by Accenture found that by 2020, spending by Millennials will account for $1.4 trillion in U.S. retail sales. This segment of the population, which the Pew Research Center defines as those born from 1981 to 1996, also spends more online than any other generation. According to data from the consulting firm Bain & Company, 25% of luxury goods will be purchased online by 2025, up from 8% in 2016. “Millennials are going to be a huge economic driving force,” Dr. Biesman said.

Dr. Biesman, an oculofacial plastic surgeon who practices in Nashville, Tenn., said Millennials were born into a digital age. “They are very socially connected, sometimes to their detriment,” said Dr. Biesman, who is a past president of the American Society for Laser Medicine and Surgery. “They’re definitely in debt ... but they’re comfortable with that and don’t mind spending. Their priorities are different. They tend to put off marriage and having kids, and they’re driven by social media.

They also hold a strong interest in appearance, said Dr, Biesman, who noted that the average Millennial woman is more likely to be aware of beauty issues by a factor of 10 years younger than her mother’s generation. “At age 25, Millennial women are getting interested in aesthetics, whereas the older generation didn’t start until about 35,” he said. Millennials “are educated, and they use the Internet to read up on procedures.” In his clinical experience, Millennials seek aesthetic treatments to resolve specific issues such as acne scars, to try noninvasive aesthetic treatments for “prejuvenation,” to beautify or to address dissatisfaction with their appearance, and to keep up with the latest trends endorsed or promoted by the media or by celebrities. The most popular procedures include neuromodulators, fillers (especially in the lips and in the infraorbital hollow), minimally invasive laser hair removal, superficial laser resurfacing, and prescription skin care and cosmeceuticals.

According to a 2018 survey of 500 Millennials conducted by the aesthetics site Zalea, 32% were considering a cosmetic procedure and 6.6% had undergone one. Of the 149 Millennials who completed all of the survey questions, 65% indicated that they relied on Google search for information about cosmetic treatments, which was a higher proportion than for physicians (63%), friends and family (60%), and social networks such as Instagram, Facebook, and Twitter (25%). Dr. Biesman said that a paradigm shift is under way in aesthetic dermatology, in which the traditional means of achieving a strong reputation amongst patients by excellent training, publications, and research can be replaced by building a visible social media presence/personality.

“The social media influencer factor is a real phenomenon, and can carry tremendous weight due to their perceived relationship with their audience/followers,” Dr. Biesman said. “Some physicians are influencers, while others collaborate with influencers.” He emphasized that the decision to work with social media influencers depends on your preference, your comfort level/trust, the professionalism of the influencer, and your overall social media strategy. “The more you share about yourself, the more successful your social media account will be,” he said. “You need to determine your comfort zone, such as how much of your life you want to share.”

He advises aesthetic dermatologists to develop a strategy for reaching out to and incorporating Millennials into their practice. “Be deliberate in assessing the profile of your practice demographics, and determine which patient groups you want to serve, and to what extent,” he said. “If your practice is focused on minimally invasive aesthetics, it’s important to understand the Millennial mindset, because this is the largest group of consumers.”

Dr. Biesman reported having no relevant disclosures related to his presentation.

[email protected]

SAN DIEGO – If the idea of marketing your aesthetic dermatology services to Millennials is an afterthought, Brian Biesman, MD, recommends that you reconsider that outlook. At the annual Masters of Aesthetics Symposium, Dr. Biesman told attendees that the age group dubbed as the “Me Me Me Generation” by Joel Stein of Time Magazine is slowly overtaking Baby Boomers as the largest shopping generation in history.

A large consumer survey conducted by Accenture found that by 2020, spending by Millennials will account for $1.4 trillion in U.S. retail sales. This segment of the population, which the Pew Research Center defines as those born from 1981 to 1996, also spends more online than any other generation. According to data from the consulting firm Bain & Company, 25% of luxury goods will be purchased online by 2025, up from 8% in 2016. “Millennials are going to be a huge economic driving force,” Dr. Biesman said.

Dr. Biesman, an oculofacial plastic surgeon who practices in Nashville, Tenn., said Millennials were born into a digital age. “They are very socially connected, sometimes to their detriment,” said Dr. Biesman, who is a past president of the American Society for Laser Medicine and Surgery. “They’re definitely in debt ... but they’re comfortable with that and don’t mind spending. Their priorities are different. They tend to put off marriage and having kids, and they’re driven by social media.

They also hold a strong interest in appearance, said Dr, Biesman, who noted that the average Millennial woman is more likely to be aware of beauty issues by a factor of 10 years younger than her mother’s generation. “At age 25, Millennial women are getting interested in aesthetics, whereas the older generation didn’t start until about 35,” he said. Millennials “are educated, and they use the Internet to read up on procedures.” In his clinical experience, Millennials seek aesthetic treatments to resolve specific issues such as acne scars, to try noninvasive aesthetic treatments for “prejuvenation,” to beautify or to address dissatisfaction with their appearance, and to keep up with the latest trends endorsed or promoted by the media or by celebrities. The most popular procedures include neuromodulators, fillers (especially in the lips and in the infraorbital hollow), minimally invasive laser hair removal, superficial laser resurfacing, and prescription skin care and cosmeceuticals.

According to a 2018 survey of 500 Millennials conducted by the aesthetics site Zalea, 32% were considering a cosmetic procedure and 6.6% had undergone one. Of the 149 Millennials who completed all of the survey questions, 65% indicated that they relied on Google search for information about cosmetic treatments, which was a higher proportion than for physicians (63%), friends and family (60%), and social networks such as Instagram, Facebook, and Twitter (25%). Dr. Biesman said that a paradigm shift is under way in aesthetic dermatology, in which the traditional means of achieving a strong reputation amongst patients by excellent training, publications, and research can be replaced by building a visible social media presence/personality.

“The social media influencer factor is a real phenomenon, and can carry tremendous weight due to their perceived relationship with their audience/followers,” Dr. Biesman said. “Some physicians are influencers, while others collaborate with influencers.” He emphasized that the decision to work with social media influencers depends on your preference, your comfort level/trust, the professionalism of the influencer, and your overall social media strategy. “The more you share about yourself, the more successful your social media account will be,” he said. “You need to determine your comfort zone, such as how much of your life you want to share.”

He advises aesthetic dermatologists to develop a strategy for reaching out to and incorporating Millennials into their practice. “Be deliberate in assessing the profile of your practice demographics, and determine which patient groups you want to serve, and to what extent,” he said. “If your practice is focused on minimally invasive aesthetics, it’s important to understand the Millennial mindset, because this is the largest group of consumers.”

Dr. Biesman reported having no relevant disclosures related to his presentation.

[email protected]

Background: With increased use of anticoagulants, the amount of related ADEs has also increased. ADEs may be preventable through improved communication during transitions of care. The key communication elements are not standardized.

The following items are the 15 RDEs that require documentation: (1) current anticoagulants; (2) indications; (3) new or previous user; (4) if new, start date, (5) short-term or long-term use; (6) if short term, intended duration; (7) last two doses given; (8) next dose due; (9) latest renal function; (10) provision of patient education materials; (11) assessment of patient/caregiver understanding; (12) future anticoagulation provider; and if warfarin, (13) the target range, (14) at least 2-3 consecutive international normalized ratio results, and (15) next INR level.

Bottom line: Standardized communication during transitions of care regarding anticoagulation may reduce anticoagulant ADEs. Objective evidence showing reduction of ADEs after implementation of the list is needed.

Citation: Triller D et al. Defining minimum necessary anticoagulation-related communication at discharge: Consensus of the Care Transitions Task Force of the New York State Anticoagulation Coalition. Jt Comm J Qual Patient Saf. 2018;44(11):630-40.

Dr. Vuong is an associate physician in the division of hospital medicine at the University of California, San Diego.

Background: With increased use of anticoagulants, the amount of related ADEs has also increased. ADEs may be preventable through improved communication during transitions of care. The key communication elements are not standardized.

The following items are the 15 RDEs that require documentation: (1) current anticoagulants; (2) indications; (3) new or previous user; (4) if new, start date, (5) short-term or long-term use; (6) if short term, intended duration; (7) last two doses given; (8) next dose due; (9) latest renal function; (10) provision of patient education materials; (11) assessment of patient/caregiver understanding; (12) future anticoagulation provider; and if warfarin, (13) the target range, (14) at least 2-3 consecutive international normalized ratio results, and (15) next INR level.

Bottom line: Standardized communication during transitions of care regarding anticoagulation may reduce anticoagulant ADEs. Objective evidence showing reduction of ADEs after implementation of the list is needed.

Citation: Triller D et al. Defining minimum necessary anticoagulation-related communication at discharge: Consensus of the Care Transitions Task Force of the New York State Anticoagulation Coalition. Jt Comm J Qual Patient Saf. 2018;44(11):630-40.

Dr. Vuong is an associate physician in the division of hospital medicine at the University of California, San Diego.

Background: With increased use of anticoagulants, the amount of related ADEs has also increased. ADEs may be preventable through improved communication during transitions of care. The key communication elements are not standardized.

The following items are the 15 RDEs that require documentation: (1) current anticoagulants; (2) indications; (3) new or previous user; (4) if new, start date, (5) short-term or long-term use; (6) if short term, intended duration; (7) last two doses given; (8) next dose due; (9) latest renal function; (10) provision of patient education materials; (11) assessment of patient/caregiver understanding; (12) future anticoagulation provider; and if warfarin, (13) the target range, (14) at least 2-3 consecutive international normalized ratio results, and (15) next INR level.

Bottom line: Standardized communication during transitions of care regarding anticoagulation may reduce anticoagulant ADEs. Objective evidence showing reduction of ADEs after implementation of the list is needed.

Citation: Triller D et al. Defining minimum necessary anticoagulation-related communication at discharge: Consensus of the Care Transitions Task Force of the New York State Anticoagulation Coalition. Jt Comm J Qual Patient Saf. 2018;44(11):630-40.

Dr. Vuong is an associate physician in the division of hospital medicine at the University of California, San Diego.

A new study has reaffirmed that, as methicillin‐sensitive Staphylococcus aureus (MSSA) remains the most common skin infection in pediatric atopic dermatitis (AD) patients, first‐generation cephalosporins remain the appropriate empiric therapy.

“Clindamycin, tetracyclines, or TMP‐SMX can be considered in patients suspected to have, or with a history of, MRSA [methicillin‐resistant S. aureus] infection,” wrote Cristopher C. Briscoe, MD, of the Washington University School of Medicine in St. Louis, Missouri, and his coauthors. The study was published in Pediatric Dermatology.

To determine the optimal empiric antibiotic for pediatric AD patients with skin infections, the researchers analyzed skin cultures from 106 patients seen at Saint Louis Children’s Hospital (SLCH). The results were also compared to cultures from pediatric patients who presented at the SLCH emergency department (ED) with S. aureus skin abscesses.

Of the 170 cultures that grew S. aureus, 130 (77.8%) grew MSSA, and 37 (22.2%) grew MRSA. Three of the cultures grew both. The prevalence of MRSA in the cohort differed from the prevalence in the ED patients (44%). The prevalence of either infection did not differ significantly by age, sex or race, though the average number of cultures in African American patients topped the average for Caucasian patients (1.8 vs. 1.2, P less than .003).

All patients with MSSA – in both the cohort and the ED – proved 100% susceptible to cefazolin. Cohort patients with MSSA saw lower susceptibility to doxycycline compared to the ED patients (89.4% vs. 97%), as did MRSA cohort patients to trimethoprim‐sulfamethoxazole (92% vs. 98%).

“When a patient with AD walks into your office and looks like they have an infection of their eczema, your go-to antibiotic is going to be one that targets MSSA,” said coauthor Carrie Coughlin, MD, of the Washington University School of Medicine in an interview. “You’ll still do a culture to prove or disprove that assumption, but it gives you a guide to help make that patient better in the short term while you work things up.”

“Also, remember that MSSA is not ‘better’ to have than MRSA,” she added. “You can now see some of the virulence factors from MRSA strains in MSSA strains, so treating both of them is important.”

The authors acknowledged their study’s limitations, including the limited generalizability of a single-center design and a lack of information as to the body sites from which the cultures were obtained. They were also unable to reliably determine prior antibiotic exposure, noting that “future work could examine whether prior exposure differed significantly in the MRSA and MSSA groups.”

The study was funded by grants from the Agency for Healthcare Research and Quality. The authors reported no conflicts of interest.


SOURCE: Briscoe CC et al. Pediatr Dermatol. 2019 May 24. doi: 10.1111/pde.13867.

A new study has reaffirmed that, as methicillin‐sensitive Staphylococcus aureus (MSSA) remains the most common skin infection in pediatric atopic dermatitis (AD) patients, first‐generation cephalosporins remain the appropriate empiric therapy.

“Clindamycin, tetracyclines, or TMP‐SMX can be considered in patients suspected to have, or with a history of, MRSA [methicillin‐resistant S. aureus] infection,” wrote Cristopher C. Briscoe, MD, of the Washington University School of Medicine in St. Louis, Missouri, and his coauthors. The study was published in Pediatric Dermatology.

To determine the optimal empiric antibiotic for pediatric AD patients with skin infections, the researchers analyzed skin cultures from 106 patients seen at Saint Louis Children’s Hospital (SLCH). The results were also compared to cultures from pediatric patients who presented at the SLCH emergency department (ED) with S. aureus skin abscesses.

Of the 170 cultures that grew S. aureus, 130 (77.8%) grew MSSA, and 37 (22.2%) grew MRSA. Three of the cultures grew both. The prevalence of MRSA in the cohort differed from the prevalence in the ED patients (44%). The prevalence of either infection did not differ significantly by age, sex or race, though the average number of cultures in African American patients topped the average for Caucasian patients (1.8 vs. 1.2, P less than .003).

All patients with MSSA – in both the cohort and the ED – proved 100% susceptible to cefazolin. Cohort patients with MSSA saw lower susceptibility to doxycycline compared to the ED patients (89.4% vs. 97%), as did MRSA cohort patients to trimethoprim‐sulfamethoxazole (92% vs. 98%).

“When a patient with AD walks into your office and looks like they have an infection of their eczema, your go-to antibiotic is going to be one that targets MSSA,” said coauthor Carrie Coughlin, MD, of the Washington University School of Medicine in an interview. “You’ll still do a culture to prove or disprove that assumption, but it gives you a guide to help make that patient better in the short term while you work things up.”

“Also, remember that MSSA is not ‘better’ to have than MRSA,” she added. “You can now see some of the virulence factors from MRSA strains in MSSA strains, so treating both of them is important.”

The authors acknowledged their study’s limitations, including the limited generalizability of a single-center design and a lack of information as to the body sites from which the cultures were obtained. They were also unable to reliably determine prior antibiotic exposure, noting that “future work could examine whether prior exposure differed significantly in the MRSA and MSSA groups.”

The study was funded by grants from the Agency for Healthcare Research and Quality. The authors reported no conflicts of interest.


SOURCE: Briscoe CC et al. Pediatr Dermatol. 2019 May 24. doi: 10.1111/pde.13867.

A new study has reaffirmed that, as methicillin‐sensitive Staphylococcus aureus (MSSA) remains the most common skin infection in pediatric atopic dermatitis (AD) patients, first‐generation cephalosporins remain the appropriate empiric therapy.

“Clindamycin, tetracyclines, or TMP‐SMX can be considered in patients suspected to have, or with a history of, MRSA [methicillin‐resistant S. aureus] infection,” wrote Cristopher C. Briscoe, MD, of the Washington University School of Medicine in St. Louis, Missouri, and his coauthors. The study was published in Pediatric Dermatology.

To determine the optimal empiric antibiotic for pediatric AD patients with skin infections, the researchers analyzed skin cultures from 106 patients seen at Saint Louis Children’s Hospital (SLCH). The results were also compared to cultures from pediatric patients who presented at the SLCH emergency department (ED) with S. aureus skin abscesses.

Of the 170 cultures that grew S. aureus, 130 (77.8%) grew MSSA, and 37 (22.2%) grew MRSA. Three of the cultures grew both. The prevalence of MRSA in the cohort differed from the prevalence in the ED patients (44%). The prevalence of either infection did not differ significantly by age, sex or race, though the average number of cultures in African American patients topped the average for Caucasian patients (1.8 vs. 1.2, P less than .003).

All patients with MSSA – in both the cohort and the ED – proved 100% susceptible to cefazolin. Cohort patients with MSSA saw lower susceptibility to doxycycline compared to the ED patients (89.4% vs. 97%), as did MRSA cohort patients to trimethoprim‐sulfamethoxazole (92% vs. 98%).

“When a patient with AD walks into your office and looks like they have an infection of their eczema, your go-to antibiotic is going to be one that targets MSSA,” said coauthor Carrie Coughlin, MD, of the Washington University School of Medicine in an interview. “You’ll still do a culture to prove or disprove that assumption, but it gives you a guide to help make that patient better in the short term while you work things up.”

“Also, remember that MSSA is not ‘better’ to have than MRSA,” she added. “You can now see some of the virulence factors from MRSA strains in MSSA strains, so treating both of them is important.”

The authors acknowledged their study’s limitations, including the limited generalizability of a single-center design and a lack of information as to the body sites from which the cultures were obtained. They were also unable to reliably determine prior antibiotic exposure, noting that “future work could examine whether prior exposure differed significantly in the MRSA and MSSA groups.”

The study was funded by grants from the Agency for Healthcare Research and Quality. The authors reported no conflicts of interest.


SOURCE: Briscoe CC et al. Pediatr Dermatol. 2019 May 24. doi: 10.1111/pde.13867.

PARIS – Treatment with the SGLT2 inhibitor dapagliflozin produced a statistically significant 27% drop in cardiovascular death or heart failure events in patients with existing heart failure with reduced ejection fraction and no diabetes, results that in a stroke changed the status of dapagliflozin from fundamentally a drug that treats diabetes to a drug that treats heart failure.

Mitchel L. Zoler/MDedge News

“Dapagliflozin offers a new approach to the treatment of heart failure with reduced ejection fraction” (HFrEF), John McMurray, MD, said at the annual congress of the European Society of Cardiology.

The results he reported from the DAPA-HF (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure) trial showed statistically significant benefits when adding dapagliflozin to guideline-directed therapy for a list of outcomes that include a 17% drop in all-cause death compared with placebo, an 18% fall in cardiovascular death, and a 25% relative reduction in total heart failure hospitalizations plus cardiovascular deaths during a median follow-up of just over 18 months. The primary endpoint of the reduction in cardiovascular death, first heart failure hospitalization, or an urgent heart failure visit fell by 25% in the enrolled patients with diabetes (45% of the study population, all with type 2 diabetes), and by 27% in the remaining patients who had no diabetes, showing that the presence of diabetes had no impact on the heart failure benefit from dapagliflozin (Farxiga). The absolute reduction in the primary endpoint was about 5%, with a number needed to treat of 21 to prevent one primary endpoint during 18 months of treatment.

Dr. McMurray’s report of the primary endpoint as well as the finding that the drug was as effective in patients without diabetes as in those with diabetes were both met with loud applause by the packed congress audience.

The efficacy results also showed that 58% of patients on dapagliflozin had a clinically meaningful (5 point or greater) increase in their quality of life score on the Kansas City Cardiomyopathy Questionnaire after 8 months on treatment compared with a 51% rate in the placebo patients, a statistically significant difference.

The safety results showed no new signals for a drug that already has regulatory approval but was being used in a novel population. The rate of major hypoglycemia was virtually nonexistent, 0.2%, and identical in both treatment arms. All adverse events occurred at roughly equal rates in the dapagliflozin and placebo groups, with a 5% rate of adverse events leading to study discontinuation in both arms, and a serious adverse event rate of 38% in the dapaglifolzin patients and 42% in the placebo patients. The rate of worsening renal function was less than 2% in both arms and not statistically different.

“This is as close to a home run as you see in heart failure treatment,” commented Douglas L. Mann, MD, professor of medicine at Washington University, St. Louis, and a heart failure clinician and researcher.

DAPA-HF “is a landmark trial. It took a diabetes drug and used it in patients without diabetes, a concept that would have been considered outlandish 5 years ago. Scientifically it’s huge,” commented Deepak L. Bhatt, MD, professor of medicine at Harvard Medical School in Boston.

The DAPA-HF results were another step in the remarkable journey toward heart failure intervention taken by the SGLT2 (sodium glucose cotransport 2) inhibitor class of drugs that includes dapagliflozin as well as canagliflozin (Invokana) and empagliflozin(Jardiance), a path that began 4 years ago with the report of empagliflozin’s unexpected efficacy for reducing cardiovascular death and heart failure hospitalizations in a large cardiovascular-safety study, EMPA-REG OUTCOME (N Engl J Med. 2015 Nov 26;373[22]:2117-28). Subsequent reports showed similar effects benefiting heart failure and survival for canagliflozin and dapagliflozin, and now with DAPA-HF the evidence extended the benefit to heart failure patients regardless of whether they have diabetes. Additional studies now in progress are exploring the same question for empagliflozin and canagliflozin.

The results from DAPA-HF are likely a class effect for all these SGLT2 inhibitors, suggested Dr. McMurray in a video interview, a view shared by several other experts. He cautioned clinicians against using dapagliflozin to treat patients with heart failure with reduced ejection fraction (HFrEF) but without diabetes until this indication receives regulatory approval, and even then using dapagliflozin or other SGLT2 inhibitors this way may take some getting used to on the part of cardiologists and other clinicians.

“The results put dapagliflozin in the same league as [standard HFrEF drugs], but using it will require a shift in thinking. Most physicians will initially say “aren’t SGLT2 inhibitors used for treating diabetes?” Dr. Bhatt said.

“I’m sure most cardiologists are not familiar with the SGLT2 inhibitors; we’ll have to educate them,” conceded Dr. McMurray, professor of medical cardiology at the University of Glasgow. However, other aspects of dapagliflozin and this drug class in general may make the SGLT2 inhibitors particularly attractive and spur their use once labeling changes.

[email protected]

PARIS – Treatment with the SGLT2 inhibitor dapagliflozin produced a statistically significant 27% drop in cardiovascular death or heart failure events in patients with existing heart failure with reduced ejection fraction and no diabetes, results that in a stroke changed the status of dapagliflozin from fundamentally a drug that treats diabetes to a drug that treats heart failure.

Mitchel L. Zoler/MDedge News

“Dapagliflozin offers a new approach to the treatment of heart failure with reduced ejection fraction” (HFrEF), John McMurray, MD, said at the annual congress of the European Society of Cardiology.

The results he reported from the DAPA-HF (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure) trial showed statistically significant benefits when adding dapagliflozin to guideline-directed therapy for a list of outcomes that include a 17% drop in all-cause death compared with placebo, an 18% fall in cardiovascular death, and a 25% relative reduction in total heart failure hospitalizations plus cardiovascular deaths during a median follow-up of just over 18 months. The primary endpoint of the reduction in cardiovascular death, first heart failure hospitalization, or an urgent heart failure visit fell by 25% in the enrolled patients with diabetes (45% of the study population, all with type 2 diabetes), and by 27% in the remaining patients who had no diabetes, showing that the presence of diabetes had no impact on the heart failure benefit from dapagliflozin (Farxiga). The absolute reduction in the primary endpoint was about 5%, with a number needed to treat of 21 to prevent one primary endpoint during 18 months of treatment.

Dr. McMurray’s report of the primary endpoint as well as the finding that the drug was as effective in patients without diabetes as in those with diabetes were both met with loud applause by the packed congress audience.

The efficacy results also showed that 58% of patients on dapagliflozin had a clinically meaningful (5 point or greater) increase in their quality of life score on the Kansas City Cardiomyopathy Questionnaire after 8 months on treatment compared with a 51% rate in the placebo patients, a statistically significant difference.

The safety results showed no new signals for a drug that already has regulatory approval but was being used in a novel population. The rate of major hypoglycemia was virtually nonexistent, 0.2%, and identical in both treatment arms. All adverse events occurred at roughly equal rates in the dapagliflozin and placebo groups, with a 5% rate of adverse events leading to study discontinuation in both arms, and a serious adverse event rate of 38% in the dapaglifolzin patients and 42% in the placebo patients. The rate of worsening renal function was less than 2% in both arms and not statistically different.

“This is as close to a home run as you see in heart failure treatment,” commented Douglas L. Mann, MD, professor of medicine at Washington University, St. Louis, and a heart failure clinician and researcher.

DAPA-HF “is a landmark trial. It took a diabetes drug and used it in patients without diabetes, a concept that would have been considered outlandish 5 years ago. Scientifically it’s huge,” commented Deepak L. Bhatt, MD, professor of medicine at Harvard Medical School in Boston.

The DAPA-HF results were another step in the remarkable journey toward heart failure intervention taken by the SGLT2 (sodium glucose cotransport 2) inhibitor class of drugs that includes dapagliflozin as well as canagliflozin (Invokana) and empagliflozin(Jardiance), a path that began 4 years ago with the report of empagliflozin’s unexpected efficacy for reducing cardiovascular death and heart failure hospitalizations in a large cardiovascular-safety study, EMPA-REG OUTCOME (N Engl J Med. 2015 Nov 26;373[22]:2117-28). Subsequent reports showed similar effects benefiting heart failure and survival for canagliflozin and dapagliflozin, and now with DAPA-HF the evidence extended the benefit to heart failure patients regardless of whether they have diabetes. Additional studies now in progress are exploring the same question for empagliflozin and canagliflozin.

The results from DAPA-HF are likely a class effect for all these SGLT2 inhibitors, suggested Dr. McMurray in a video interview, a view shared by several other experts. He cautioned clinicians against using dapagliflozin to treat patients with heart failure with reduced ejection fraction (HFrEF) but without diabetes until this indication receives regulatory approval, and even then using dapagliflozin or other SGLT2 inhibitors this way may take some getting used to on the part of cardiologists and other clinicians.

“The results put dapagliflozin in the same league as [standard HFrEF drugs], but using it will require a shift in thinking. Most physicians will initially say “aren’t SGLT2 inhibitors used for treating diabetes?” Dr. Bhatt said.

“I’m sure most cardiologists are not familiar with the SGLT2 inhibitors; we’ll have to educate them,” conceded Dr. McMurray, professor of medical cardiology at the University of Glasgow. However, other aspects of dapagliflozin and this drug class in general may make the SGLT2 inhibitors particularly attractive and spur their use once labeling changes.

[email protected]

PARIS – Treatment with the SGLT2 inhibitor dapagliflozin produced a statistically significant 27% drop in cardiovascular death or heart failure events in patients with existing heart failure with reduced ejection fraction and no diabetes, results that in a stroke changed the status of dapagliflozin from fundamentally a drug that treats diabetes to a drug that treats heart failure.

Mitchel L. Zoler/MDedge News

“Dapagliflozin offers a new approach to the treatment of heart failure with reduced ejection fraction” (HFrEF), John McMurray, MD, said at the annual congress of the European Society of Cardiology.

The results he reported from the DAPA-HF (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure) trial showed statistically significant benefits when adding dapagliflozin to guideline-directed therapy for a list of outcomes that include a 17% drop in all-cause death compared with placebo, an 18% fall in cardiovascular death, and a 25% relative reduction in total heart failure hospitalizations plus cardiovascular deaths during a median follow-up of just over 18 months. The primary endpoint of the reduction in cardiovascular death, first heart failure hospitalization, or an urgent heart failure visit fell by 25% in the enrolled patients with diabetes (45% of the study population, all with type 2 diabetes), and by 27% in the remaining patients who had no diabetes, showing that the presence of diabetes had no impact on the heart failure benefit from dapagliflozin (Farxiga). The absolute reduction in the primary endpoint was about 5%, with a number needed to treat of 21 to prevent one primary endpoint during 18 months of treatment.

Dr. McMurray’s report of the primary endpoint as well as the finding that the drug was as effective in patients without diabetes as in those with diabetes were both met with loud applause by the packed congress audience.

The efficacy results also showed that 58% of patients on dapagliflozin had a clinically meaningful (5 point or greater) increase in their quality of life score on the Kansas City Cardiomyopathy Questionnaire after 8 months on treatment compared with a 51% rate in the placebo patients, a statistically significant difference.

The safety results showed no new signals for a drug that already has regulatory approval but was being used in a novel population. The rate of major hypoglycemia was virtually nonexistent, 0.2%, and identical in both treatment arms. All adverse events occurred at roughly equal rates in the dapagliflozin and placebo groups, with a 5% rate of adverse events leading to study discontinuation in both arms, and a serious adverse event rate of 38% in the dapaglifolzin patients and 42% in the placebo patients. The rate of worsening renal function was less than 2% in both arms and not statistically different.

“This is as close to a home run as you see in heart failure treatment,” commented Douglas L. Mann, MD, professor of medicine at Washington University, St. Louis, and a heart failure clinician and researcher.

DAPA-HF “is a landmark trial. It took a diabetes drug and used it in patients without diabetes, a concept that would have been considered outlandish 5 years ago. Scientifically it’s huge,” commented Deepak L. Bhatt, MD, professor of medicine at Harvard Medical School in Boston.

The DAPA-HF results were another step in the remarkable journey toward heart failure intervention taken by the SGLT2 (sodium glucose cotransport 2) inhibitor class of drugs that includes dapagliflozin as well as canagliflozin (Invokana) and empagliflozin(Jardiance), a path that began 4 years ago with the report of empagliflozin’s unexpected efficacy for reducing cardiovascular death and heart failure hospitalizations in a large cardiovascular-safety study, EMPA-REG OUTCOME (N Engl J Med. 2015 Nov 26;373[22]:2117-28). Subsequent reports showed similar effects benefiting heart failure and survival for canagliflozin and dapagliflozin, and now with DAPA-HF the evidence extended the benefit to heart failure patients regardless of whether they have diabetes. Additional studies now in progress are exploring the same question for empagliflozin and canagliflozin.

The results from DAPA-HF are likely a class effect for all these SGLT2 inhibitors, suggested Dr. McMurray in a video interview, a view shared by several other experts. He cautioned clinicians against using dapagliflozin to treat patients with heart failure with reduced ejection fraction (HFrEF) but without diabetes until this indication receives regulatory approval, and even then using dapagliflozin or other SGLT2 inhibitors this way may take some getting used to on the part of cardiologists and other clinicians.

“The results put dapagliflozin in the same league as [standard HFrEF drugs], but using it will require a shift in thinking. Most physicians will initially say “aren’t SGLT2 inhibitors used for treating diabetes?” Dr. Bhatt said.

“I’m sure most cardiologists are not familiar with the SGLT2 inhibitors; we’ll have to educate them,” conceded Dr. McMurray, professor of medical cardiology at the University of Glasgow. However, other aspects of dapagliflozin and this drug class in general may make the SGLT2 inhibitors particularly attractive and spur their use once labeling changes.

[email protected]

The first signs are always vague. Katie (not her real name) was 33 years old and loved to spend her weekends hiking. First, it was fatigue when doing elevation. Then fatigue even while walking across flat ground. One day she just sat in bed and noticed her heart racing.

One blood test, and her primary care doctor called her at home with the results. Go to the emergency room, she said. Katie’s red blood cells were dangerously low. She would need a blood transfusion.

Something was wrong, but the list of possibilities remained broad. Someone in the emergency room tossed out the word “leukemia.” Katie froze. She liked the resident who tossed out “internal bleeding” better.

This was the start of the ups and downs; the good news and bad news; the branch points that opened and closed her future.

The hematologist-oncologist came by. You need to be admitted to the hospital, and we need to do a bone marrow biopsy, she told Katie. It could be – and then the word was said again – this time by a specialist, making it all the more real: leukemia.

Katie had a few days to sit with this. The bone marrow biopsy was done. Now, what type of leukemia? She read on her computer. She knew there were lots of kinds, some better than others. Now, she was praying for a “good” cancer.

It was one of the bad ones. But.

We sent off additional molecular and genetics testing from your bone marrow, the doctor explained. This type of leukemia can be divided into three groups: high risk, standard risk, and low risk. All the signs so far point to low risk. This is good news, Katie thought.

Six days later. The final cytogenetics came back. Actually, Katie had a rare mutation that automatically put her in the high risk category. It meant she would definitely need a bone marrow transplant to be cured. Bad.

And so she underwent induction chemotherapy. The nurse posted a big calendar on her wall and filled it with her daily blood counts. The counts are dropping, Katie noted. This is good, right? It means the leukemia is responding to chemo? Yes. Good news.

Four days later. The blast count in her blood crept up. It could be anything. It could be reactive. It doesn’t necessarily mean refractory leukemia. But. It’s bad news.

In the interim, some more testing came back. You have one sister, right? Sharon? Yes, Katie confirmed. Looks like Sharon is a perfect match for a bone marrow transplant. Katie cried. Such good news.

Two weeks later the next bone marrow biopsy was done. This shows how you responded to the chemotherapy, the doctors explained. Will it be in remission? Will it be refractory? It’s in remission. Wow, good news.

But the window to transplant is small. In the few weeks to get there, another test came back. Even though the cancer is technically in remission, you have something called minimal residual disease. Meaning there are small amounts of leukemia left over. We should bridge with more chemo before transplant.

Was this good news? Bad news? Who knew anymore?

It’s well known in the hematology and oncology world that – even with advanced disease and poor prognoses – patients with blood cancers are less likely to see palliative care than patients with solid tumors. At conferences and in academic journals, leaders in the field expound on why this may be. One reason is the inability for most hospice agencies to offer blood transfusions. That’s certainly a big piece.

Then there’s Katie. When Katie was diagnosed, she asked me what stage her cancer was. It’s a question I hear a lot. With leukemia, I explained, we don’t think about staging the same way we do for conditions like breast cancer or prostate cancer. Since it’s in the blood, it’s stage 4 by definition, I said, but that doesn’t mean anything about prognosis. Our model of thinking is fundamentally different.

With a solid stage 4 cancer, there is generally no chance for cure. The goal is stabilization: We want to keep the cancer where it is for as long as possible. A stable CT scan, in which the disease burden is identical to 3 months before, is a success. The difference between good news and bad news is in lifespan. Receiving bad news is the difference between projecting 2 years and 6 months to live.

With a stage 4 blood cancer like Katie’s leukemia, there is generally a chance for cure. The goal is to make the cancer disappear completely and have someone live a normal lifespan. The outcomes are binary. The difference between good news and bad news is not a difference in lifespan, but a difference in probability of cure. Receiving bad news is the difference between an 80% chance of cure and a 20% chance.

Whenever I order chemotherapy, the electronic record prompts me for my intent: Is this palliative or curative intent? I always type curative intent. The intent is curative until we choose to stop pursuing cure.

Grappling with uncertainty is an enormous challenge for anyone after a diagnosis of cancer. Not knowing whether cure is even possible makes it that much more complex. The outcomes are as diverse as can be. The next branch point can literally be the difference between no more cancer and no more options.

Which raises the question, at what point – if any – should we have asked palliative care to see Katie? I wish we would have done it sooner, not because patients like Katie won’t be cured, but to help them sit with the toughest of uncertainties; prepare for it; live in it as best as possible.

As I write this, Katie is undergoing a bone marrow transplant from her sister, the match. In a few weeks she will face her next branch point – whether the transplant worked. It will move her closer or further from a cure.
 

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz and listen to her each week on the Blood & Cancer podcast.

The first signs are always vague. Katie (not her real name) was 33 years old and loved to spend her weekends hiking. First, it was fatigue when doing elevation. Then fatigue even while walking across flat ground. One day she just sat in bed and noticed her heart racing.

One blood test, and her primary care doctor called her at home with the results. Go to the emergency room, she said. Katie’s red blood cells were dangerously low. She would need a blood transfusion.

Something was wrong, but the list of possibilities remained broad. Someone in the emergency room tossed out the word “leukemia.” Katie froze. She liked the resident who tossed out “internal bleeding” better.

This was the start of the ups and downs; the good news and bad news; the branch points that opened and closed her future.

The hematologist-oncologist came by. You need to be admitted to the hospital, and we need to do a bone marrow biopsy, she told Katie. It could be – and then the word was said again – this time by a specialist, making it all the more real: leukemia.

Katie had a few days to sit with this. The bone marrow biopsy was done. Now, what type of leukemia? She read on her computer. She knew there were lots of kinds, some better than others. Now, she was praying for a “good” cancer.

It was one of the bad ones. But.

We sent off additional molecular and genetics testing from your bone marrow, the doctor explained. This type of leukemia can be divided into three groups: high risk, standard risk, and low risk. All the signs so far point to low risk. This is good news, Katie thought.

Six days later. The final cytogenetics came back. Actually, Katie had a rare mutation that automatically put her in the high risk category. It meant she would definitely need a bone marrow transplant to be cured. Bad.

And so she underwent induction chemotherapy. The nurse posted a big calendar on her wall and filled it with her daily blood counts. The counts are dropping, Katie noted. This is good, right? It means the leukemia is responding to chemo? Yes. Good news.

Four days later. The blast count in her blood crept up. It could be anything. It could be reactive. It doesn’t necessarily mean refractory leukemia. But. It’s bad news.

In the interim, some more testing came back. You have one sister, right? Sharon? Yes, Katie confirmed. Looks like Sharon is a perfect match for a bone marrow transplant. Katie cried. Such good news.

Two weeks later the next bone marrow biopsy was done. This shows how you responded to the chemotherapy, the doctors explained. Will it be in remission? Will it be refractory? It’s in remission. Wow, good news.

But the window to transplant is small. In the few weeks to get there, another test came back. Even though the cancer is technically in remission, you have something called minimal residual disease. Meaning there are small amounts of leukemia left over. We should bridge with more chemo before transplant.

Was this good news? Bad news? Who knew anymore?

It’s well known in the hematology and oncology world that – even with advanced disease and poor prognoses – patients with blood cancers are less likely to see palliative care than patients with solid tumors. At conferences and in academic journals, leaders in the field expound on why this may be. One reason is the inability for most hospice agencies to offer blood transfusions. That’s certainly a big piece.

Then there’s Katie. When Katie was diagnosed, she asked me what stage her cancer was. It’s a question I hear a lot. With leukemia, I explained, we don’t think about staging the same way we do for conditions like breast cancer or prostate cancer. Since it’s in the blood, it’s stage 4 by definition, I said, but that doesn’t mean anything about prognosis. Our model of thinking is fundamentally different.

With a solid stage 4 cancer, there is generally no chance for cure. The goal is stabilization: We want to keep the cancer where it is for as long as possible. A stable CT scan, in which the disease burden is identical to 3 months before, is a success. The difference between good news and bad news is in lifespan. Receiving bad news is the difference between projecting 2 years and 6 months to live.

With a stage 4 blood cancer like Katie’s leukemia, there is generally a chance for cure. The goal is to make the cancer disappear completely and have someone live a normal lifespan. The outcomes are binary. The difference between good news and bad news is not a difference in lifespan, but a difference in probability of cure. Receiving bad news is the difference between an 80% chance of cure and a 20% chance.

Whenever I order chemotherapy, the electronic record prompts me for my intent: Is this palliative or curative intent? I always type curative intent. The intent is curative until we choose to stop pursuing cure.

Grappling with uncertainty is an enormous challenge for anyone after a diagnosis of cancer. Not knowing whether cure is even possible makes it that much more complex. The outcomes are as diverse as can be. The next branch point can literally be the difference between no more cancer and no more options.

Which raises the question, at what point – if any – should we have asked palliative care to see Katie? I wish we would have done it sooner, not because patients like Katie won’t be cured, but to help them sit with the toughest of uncertainties; prepare for it; live in it as best as possible.

As I write this, Katie is undergoing a bone marrow transplant from her sister, the match. In a few weeks she will face her next branch point – whether the transplant worked. It will move her closer or further from a cure.
 

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz and listen to her each week on the Blood & Cancer podcast.

The first signs are always vague. Katie (not her real name) was 33 years old and loved to spend her weekends hiking. First, it was fatigue when doing elevation. Then fatigue even while walking across flat ground. One day she just sat in bed and noticed her heart racing.

One blood test, and her primary care doctor called her at home with the results. Go to the emergency room, she said. Katie’s red blood cells were dangerously low. She would need a blood transfusion.

Something was wrong, but the list of possibilities remained broad. Someone in the emergency room tossed out the word “leukemia.” Katie froze. She liked the resident who tossed out “internal bleeding” better.

This was the start of the ups and downs; the good news and bad news; the branch points that opened and closed her future.

The hematologist-oncologist came by. You need to be admitted to the hospital, and we need to do a bone marrow biopsy, she told Katie. It could be – and then the word was said again – this time by a specialist, making it all the more real: leukemia.

Katie had a few days to sit with this. The bone marrow biopsy was done. Now, what type of leukemia? She read on her computer. She knew there were lots of kinds, some better than others. Now, she was praying for a “good” cancer.

It was one of the bad ones. But.

We sent off additional molecular and genetics testing from your bone marrow, the doctor explained. This type of leukemia can be divided into three groups: high risk, standard risk, and low risk. All the signs so far point to low risk. This is good news, Katie thought.

Six days later. The final cytogenetics came back. Actually, Katie had a rare mutation that automatically put her in the high risk category. It meant she would definitely need a bone marrow transplant to be cured. Bad.

And so she underwent induction chemotherapy. The nurse posted a big calendar on her wall and filled it with her daily blood counts. The counts are dropping, Katie noted. This is good, right? It means the leukemia is responding to chemo? Yes. Good news.

Four days later. The blast count in her blood crept up. It could be anything. It could be reactive. It doesn’t necessarily mean refractory leukemia. But. It’s bad news.

In the interim, some more testing came back. You have one sister, right? Sharon? Yes, Katie confirmed. Looks like Sharon is a perfect match for a bone marrow transplant. Katie cried. Such good news.

Two weeks later the next bone marrow biopsy was done. This shows how you responded to the chemotherapy, the doctors explained. Will it be in remission? Will it be refractory? It’s in remission. Wow, good news.

But the window to transplant is small. In the few weeks to get there, another test came back. Even though the cancer is technically in remission, you have something called minimal residual disease. Meaning there are small amounts of leukemia left over. We should bridge with more chemo before transplant.

Was this good news? Bad news? Who knew anymore?

It’s well known in the hematology and oncology world that – even with advanced disease and poor prognoses – patients with blood cancers are less likely to see palliative care than patients with solid tumors. At conferences and in academic journals, leaders in the field expound on why this may be. One reason is the inability for most hospice agencies to offer blood transfusions. That’s certainly a big piece.

Then there’s Katie. When Katie was diagnosed, she asked me what stage her cancer was. It’s a question I hear a lot. With leukemia, I explained, we don’t think about staging the same way we do for conditions like breast cancer or prostate cancer. Since it’s in the blood, it’s stage 4 by definition, I said, but that doesn’t mean anything about prognosis. Our model of thinking is fundamentally different.

With a solid stage 4 cancer, there is generally no chance for cure. The goal is stabilization: We want to keep the cancer where it is for as long as possible. A stable CT scan, in which the disease burden is identical to 3 months before, is a success. The difference between good news and bad news is in lifespan. Receiving bad news is the difference between projecting 2 years and 6 months to live.

With a stage 4 blood cancer like Katie’s leukemia, there is generally a chance for cure. The goal is to make the cancer disappear completely and have someone live a normal lifespan. The outcomes are binary. The difference between good news and bad news is not a difference in lifespan, but a difference in probability of cure. Receiving bad news is the difference between an 80% chance of cure and a 20% chance.

Whenever I order chemotherapy, the electronic record prompts me for my intent: Is this palliative or curative intent? I always type curative intent. The intent is curative until we choose to stop pursuing cure.

Grappling with uncertainty is an enormous challenge for anyone after a diagnosis of cancer. Not knowing whether cure is even possible makes it that much more complex. The outcomes are as diverse as can be. The next branch point can literally be the difference between no more cancer and no more options.

Which raises the question, at what point – if any – should we have asked palliative care to see Katie? I wish we would have done it sooner, not because patients like Katie won’t be cured, but to help them sit with the toughest of uncertainties; prepare for it; live in it as best as possible.

As I write this, Katie is undergoing a bone marrow transplant from her sister, the match. In a few weeks she will face her next branch point – whether the transplant worked. It will move her closer or further from a cure.
 

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz and listen to her each week on the Blood & Cancer podcast.

A community-based care model to control hypertension led by nonphysician health care workers significantly reduced cardiovascular disease risk over 12 months, data from a cluster-controlled randomized study has shown.

Hypertension remains the most common risk factor for cardiovascular disease, but fewer than 20% of individuals with hypertension have their blood pressure controlled, wrote Jon-David Schwalm, MD, of McMaster University in Hamilton, Ont., and colleagues. To help control hypertension in underserved populations, the researchers tested a care model involving nonphysician health workers (NPHWs), primary care physicians, and family members.

The HOPE4 study, presented at the annual congress of the European Society of Cardiology and published simultaneously in the Lancet, included 1,371 adults aged 50 years and older with new or poorly controlled hypertension from 30 communities in Colombia and Malaysia. Sixteen communities were randomized to usual care and 14 to an intervention. The intervention included community screening and treatment of cardiovascular disease risk factors by NPHWs, free medications recommended by NPHWs under physician supervision, and family support for treatment adherence.

After 12 months, the Framingham Risk Scores for 10-year cardiovascular disease risk were significantly lower in the intervention group, compared with the control group (–11.17% vs. –6.40%). In addition, the intervention group showed a significant 11.45 mm Hg greater reduction in systolic blood pressure and a significant 0.41 mmol/L reduction in LDL cholesterol, compared with controls (P less than .0001 for both measures).

Baseline characteristics were similar between the two groups. Approximately 74% of the participants had a history of poorly controlled hypertension, while the remaining patients had new hypertension diagnoses.

“NPHWs were found to be consistently accurate in their ability to identify cardiovascular risk (patient identified by NPHWs as having poorly controlled blood pressure and medication was indicated) and recommend appropriate therapies (antihypertensives and statin as per the study algorithm) when compared with the assessment by local primary care physicians,” the researchers wrote. The study shows how effectively NPHWs can help reduce cardiovascular disease risk at the community level with proper training, effective community outreach, and task sharing with physicians and family members, they noted.

The findings were limited by the inability to assess the safety of specific medications, but no differences in adverse events were reported between the intervention and control groups. Other limitations included the screening of controls for cardiovascular disease risk at baseline, which meant that controls may have modified their behavior as a result, the researchers noted. In addition, the study was not blinded and surrogate outcomes were used because of the short study duration and relatively small sample size, they said.

However, the results support the use of a comprehensive, NPHW-led model, and “the HOPE 4 strategy could help to attain the UN General Assembly Action Plan for a one-third reduction in premature mortality from cardiovascular disease” by 2030, the researchers concluded.

The study was supported by the Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, World Health Organization; and the Population Health Research Institute. Lead author Dr. Schwalm and several coauthors disclosed grants to their institutions for this study from the Canadian Institutes of Health Research, Ontario Ministry of Health and Long-Term Care, Boehringer Ingelheim, and the Department of Management of Non-Communicable Diseases, WHO.

SOURCE: Schwalm J-D et al. Lancet. 2019 Sept 2. doi: http://dx.doi.org/10.1016/ S0140-6736(19)31949-X.

A community-based care model to control hypertension led by nonphysician health care workers significantly reduced cardiovascular disease risk over 12 months, data from a cluster-controlled randomized study has shown.

Hypertension remains the most common risk factor for cardiovascular disease, but fewer than 20% of individuals with hypertension have their blood pressure controlled, wrote Jon-David Schwalm, MD, of McMaster University in Hamilton, Ont., and colleagues. To help control hypertension in underserved populations, the researchers tested a care model involving nonphysician health workers (NPHWs), primary care physicians, and family members.

The HOPE4 study, presented at the annual congress of the European Society of Cardiology and published simultaneously in the Lancet, included 1,371 adults aged 50 years and older with new or poorly controlled hypertension from 30 communities in Colombia and Malaysia. Sixteen communities were randomized to usual care and 14 to an intervention. The intervention included community screening and treatment of cardiovascular disease risk factors by NPHWs, free medications recommended by NPHWs under physician supervision, and family support for treatment adherence.

After 12 months, the Framingham Risk Scores for 10-year cardiovascular disease risk were significantly lower in the intervention group, compared with the control group (–11.17% vs. –6.40%). In addition, the intervention group showed a significant 11.45 mm Hg greater reduction in systolic blood pressure and a significant 0.41 mmol/L reduction in LDL cholesterol, compared with controls (P less than .0001 for both measures).

Baseline characteristics were similar between the two groups. Approximately 74% of the participants had a history of poorly controlled hypertension, while the remaining patients had new hypertension diagnoses.

“NPHWs were found to be consistently accurate in their ability to identify cardiovascular risk (patient identified by NPHWs as having poorly controlled blood pressure and medication was indicated) and recommend appropriate therapies (antihypertensives and statin as per the study algorithm) when compared with the assessment by local primary care physicians,” the researchers wrote. The study shows how effectively NPHWs can help reduce cardiovascular disease risk at the community level with proper training, effective community outreach, and task sharing with physicians and family members, they noted.

The findings were limited by the inability to assess the safety of specific medications, but no differences in adverse events were reported between the intervention and control groups. Other limitations included the screening of controls for cardiovascular disease risk at baseline, which meant that controls may have modified their behavior as a result, the researchers noted. In addition, the study was not blinded and surrogate outcomes were used because of the short study duration and relatively small sample size, they said.

However, the results support the use of a comprehensive, NPHW-led model, and “the HOPE 4 strategy could help to attain the UN General Assembly Action Plan for a one-third reduction in premature mortality from cardiovascular disease” by 2030, the researchers concluded.

The study was supported by the Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, World Health Organization; and the Population Health Research Institute. Lead author Dr. Schwalm and several coauthors disclosed grants to their institutions for this study from the Canadian Institutes of Health Research, Ontario Ministry of Health and Long-Term Care, Boehringer Ingelheim, and the Department of Management of Non-Communicable Diseases, WHO.

SOURCE: Schwalm J-D et al. Lancet. 2019 Sept 2. doi: http://dx.doi.org/10.1016/ S0140-6736(19)31949-X.

A community-based care model to control hypertension led by nonphysician health care workers significantly reduced cardiovascular disease risk over 12 months, data from a cluster-controlled randomized study has shown.

Hypertension remains the most common risk factor for cardiovascular disease, but fewer than 20% of individuals with hypertension have their blood pressure controlled, wrote Jon-David Schwalm, MD, of McMaster University in Hamilton, Ont., and colleagues. To help control hypertension in underserved populations, the researchers tested a care model involving nonphysician health workers (NPHWs), primary care physicians, and family members.

The HOPE4 study, presented at the annual congress of the European Society of Cardiology and published simultaneously in the Lancet, included 1,371 adults aged 50 years and older with new or poorly controlled hypertension from 30 communities in Colombia and Malaysia. Sixteen communities were randomized to usual care and 14 to an intervention. The intervention included community screening and treatment of cardiovascular disease risk factors by NPHWs, free medications recommended by NPHWs under physician supervision, and family support for treatment adherence.

After 12 months, the Framingham Risk Scores for 10-year cardiovascular disease risk were significantly lower in the intervention group, compared with the control group (–11.17% vs. –6.40%). In addition, the intervention group showed a significant 11.45 mm Hg greater reduction in systolic blood pressure and a significant 0.41 mmol/L reduction in LDL cholesterol, compared with controls (P less than .0001 for both measures).

Baseline characteristics were similar between the two groups. Approximately 74% of the participants had a history of poorly controlled hypertension, while the remaining patients had new hypertension diagnoses.

“NPHWs were found to be consistently accurate in their ability to identify cardiovascular risk (patient identified by NPHWs as having poorly controlled blood pressure and medication was indicated) and recommend appropriate therapies (antihypertensives and statin as per the study algorithm) when compared with the assessment by local primary care physicians,” the researchers wrote. The study shows how effectively NPHWs can help reduce cardiovascular disease risk at the community level with proper training, effective community outreach, and task sharing with physicians and family members, they noted.

The findings were limited by the inability to assess the safety of specific medications, but no differences in adverse events were reported between the intervention and control groups. Other limitations included the screening of controls for cardiovascular disease risk at baseline, which meant that controls may have modified their behavior as a result, the researchers noted. In addition, the study was not blinded and surrogate outcomes were used because of the short study duration and relatively small sample size, they said.

However, the results support the use of a comprehensive, NPHW-led model, and “the HOPE 4 strategy could help to attain the UN General Assembly Action Plan for a one-third reduction in premature mortality from cardiovascular disease” by 2030, the researchers concluded.

The study was supported by the Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, World Health Organization; and the Population Health Research Institute. Lead author Dr. Schwalm and several coauthors disclosed grants to their institutions for this study from the Canadian Institutes of Health Research, Ontario Ministry of Health and Long-Term Care, Boehringer Ingelheim, and the Department of Management of Non-Communicable Diseases, WHO.

SOURCE: Schwalm J-D et al. Lancet. 2019 Sept 2. doi: http://dx.doi.org/10.1016/ S0140-6736(19)31949-X.

PARIS –A study of the angiotensin receptor-neprilysin inhibitor sacubitril-valsartan supports updated guidelines that encourage ARNI substitution for traditional therapies in lower-risk heart failure patients, although the study found sacubitril-valsartan does not significantly reduce central aortic stiffness, compared with enalapril therapy, according results reported here at the annual congress of the European Society of Cardiology. The study was published simultaneously in JAMA.

“The study findings may provide insight into mechanisms underlying the effects of sacubitril-valsartan in heart failure and reduced ejection fraction,” lead author Akshay S. Desai, MD, of Brigham and Women’s Hospital, Boston, and co-authors wrote.

The study set out to determine the pathophysiologic mechanisms behind the clinical effects of sacubitril-valsartan, compared with enalapril in patients with heart failure and reduced ejection fraction (HFrEF). The EVALUATE-HF trial evaluated 464 patients age 50 years and older with multiple cardiovascular symptoms, including chronic heart failure with ejection fraction of less than 40%. Aortic characteristic impedance, a measure of central aortic stiffness, was evaluated with two-dimensional echocardiography at screening, then at four, 12 and 24 weeks. The primary endpoint was change in aortic characteristic impedance between the two treatment groups at 12 weeks.

Aortic characteristic impedance at baseline to 12 weeks decreased from 223.8 to 218.9 dyne x s/cm ⁵ in the sacubitril-valsartan treatment group and increased from 213.2 to 214.4 dyne x s/cm ⁵ in the enalapril group. “There was no statistically significant difference between groups in the change from baseline,” the investigators wrote. The between-group difference factored out to -2.2 dyne x s/cm ⁵ , ranging from -17.6 to 13.2 dyne x s/cm ⁵ . This was despite a reduction in brachial systolic blood pressure (6.5 and 1.6 mm Hg) and central systolic blood pressure (4.9 and 2.3 mm Hg), respectively.

The sacubitril-valsartan group showed greater reductions in left ventricular end-diastolic volume index, left ventricular end-systolic volume index, left atrial volume index and mitral E/e ′ ratio. “Although ejection fraction increased modestly by 1.9% in the sacubitril-valsartan group and by 1.3% in the enalapril group, we observed no significant between-group differences in change from baseline to 12 weeks in left ventricular ejection fraction or in other measured parameters,” the investigators wrote. Those other parameters include global longitudinal strain, mitral e ′ velocity or arterial elastance:ventricular elastance ratio. Rates of hypertension, hyperkalemia, and worsening renal function were similar in both groups.

Another secondary outcome was change from baseline in the overall 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ). A post-hoc analysis evaluated patients who achieved a statistically significant 5-points-or-greater change in KCCQ score, finding the score improved by 8.9 points in the sacubitril-valsartan group and 4.3 points in the enalapril group, a difference wider than 8-month results from the PARADIGM-HF trial ( Circ Heart Fail. 2017;10:e003430). “These data suggest that clinical benefits of sacubitril-valsartan compared with enalapril in patients with HFrEF are likely unrelated to changes in central aortic stiffness or pulsatile load, despite favorable effects of neprilysin inhibition on myocardial remodeling and wall stress,” the investigators wrote.

The data support the current guidelines for substituting ARNI for angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers therapy, “even in the face of apparent clinical stability,” Dr. Desai and co-authors said. In an invited commentary, Mark H. Drazner, MD , of Texas Southwestern Medical Center in Dallas, said the EVALUATE-HF trial, along with the observational PROVE-HF trial data also reported at the ESC meeting (JAMA. 2019 Sept 2. doi:10.1001/jama.2019.12821), “strongly suggest” ARNI therapy can promote cardiac reverse remodeling in patients with HFrEF. “As with beta-blockers and ACE inhibitors, it thus appears that the benefits of ARNI therapy on clinical outcomes in patients with HFrEF are mediated, at least in part, by their favorable effects on the adverse cardiac remodeling that characterizes the condition,” Dr. Desai and co-authors wrote.

The EVALUATE-HF trial was sponsored by Novartis. Dr. Desai disclosed financial relationships with Alnylam, AstraZeneca, Novartis, Abbott, Biofourmis, Boehringer Ingelheim, Boston Scientific, DalCor Pharma and Regeneron. Dr. Drazner has no financial relationships to disclose.

SOURCE: Desai AS et al. JAMA. 2019 Sept 2. doi:10.1001/jama.2019.12843.

PARIS –A study of the angiotensin receptor-neprilysin inhibitor sacubitril-valsartan supports updated guidelines that encourage ARNI substitution for traditional therapies in lower-risk heart failure patients, although the study found sacubitril-valsartan does not significantly reduce central aortic stiffness, compared with enalapril therapy, according results reported here at the annual congress of the European Society of Cardiology. The study was published simultaneously in JAMA.

“The study findings may provide insight into mechanisms underlying the effects of sacubitril-valsartan in heart failure and reduced ejection fraction,” lead author Akshay S. Desai, MD, of Brigham and Women’s Hospital, Boston, and co-authors wrote.

The study set out to determine the pathophysiologic mechanisms behind the clinical effects of sacubitril-valsartan, compared with enalapril in patients with heart failure and reduced ejection fraction (HFrEF). The EVALUATE-HF trial evaluated 464 patients age 50 years and older with multiple cardiovascular symptoms, including chronic heart failure with ejection fraction of less than 40%. Aortic characteristic impedance, a measure of central aortic stiffness, was evaluated with two-dimensional echocardiography at screening, then at four, 12 and 24 weeks. The primary endpoint was change in aortic characteristic impedance between the two treatment groups at 12 weeks.

Aortic characteristic impedance at baseline to 12 weeks decreased from 223.8 to 218.9 dyne x s/cm ⁵ in the sacubitril-valsartan treatment group and increased from 213.2 to 214.4 dyne x s/cm ⁵ in the enalapril group. “There was no statistically significant difference between groups in the change from baseline,” the investigators wrote. The between-group difference factored out to -2.2 dyne x s/cm ⁵ , ranging from -17.6 to 13.2 dyne x s/cm ⁵ . This was despite a reduction in brachial systolic blood pressure (6.5 and 1.6 mm Hg) and central systolic blood pressure (4.9 and 2.3 mm Hg), respectively.

The sacubitril-valsartan group showed greater reductions in left ventricular end-diastolic volume index, left ventricular end-systolic volume index, left atrial volume index and mitral E/e ′ ratio. “Although ejection fraction increased modestly by 1.9% in the sacubitril-valsartan group and by 1.3% in the enalapril group, we observed no significant between-group differences in change from baseline to 12 weeks in left ventricular ejection fraction or in other measured parameters,” the investigators wrote. Those other parameters include global longitudinal strain, mitral e ′ velocity or arterial elastance:ventricular elastance ratio. Rates of hypertension, hyperkalemia, and worsening renal function were similar in both groups.

Another secondary outcome was change from baseline in the overall 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ). A post-hoc analysis evaluated patients who achieved a statistically significant 5-points-or-greater change in KCCQ score, finding the score improved by 8.9 points in the sacubitril-valsartan group and 4.3 points in the enalapril group, a difference wider than 8-month results from the PARADIGM-HF trial ( Circ Heart Fail. 2017;10:e003430). “These data suggest that clinical benefits of sacubitril-valsartan compared with enalapril in patients with HFrEF are likely unrelated to changes in central aortic stiffness or pulsatile load, despite favorable effects of neprilysin inhibition on myocardial remodeling and wall stress,” the investigators wrote.

The data support the current guidelines for substituting ARNI for angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers therapy, “even in the face of apparent clinical stability,” Dr. Desai and co-authors said. In an invited commentary, Mark H. Drazner, MD , of Texas Southwestern Medical Center in Dallas, said the EVALUATE-HF trial, along with the observational PROVE-HF trial data also reported at the ESC meeting (JAMA. 2019 Sept 2. doi:10.1001/jama.2019.12821), “strongly suggest” ARNI therapy can promote cardiac reverse remodeling in patients with HFrEF. “As with beta-blockers and ACE inhibitors, it thus appears that the benefits of ARNI therapy on clinical outcomes in patients with HFrEF are mediated, at least in part, by their favorable effects on the adverse cardiac remodeling that characterizes the condition,” Dr. Desai and co-authors wrote.

The EVALUATE-HF trial was sponsored by Novartis. Dr. Desai disclosed financial relationships with Alnylam, AstraZeneca, Novartis, Abbott, Biofourmis, Boehringer Ingelheim, Boston Scientific, DalCor Pharma and Regeneron. Dr. Drazner has no financial relationships to disclose.

SOURCE: Desai AS et al. JAMA. 2019 Sept 2. doi:10.1001/jama.2019.12843.

PARIS –A study of the angiotensin receptor-neprilysin inhibitor sacubitril-valsartan supports updated guidelines that encourage ARNI substitution for traditional therapies in lower-risk heart failure patients, although the study found sacubitril-valsartan does not significantly reduce central aortic stiffness, compared with enalapril therapy, according results reported here at the annual congress of the European Society of Cardiology. The study was published simultaneously in JAMA.

“The study findings may provide insight into mechanisms underlying the effects of sacubitril-valsartan in heart failure and reduced ejection fraction,” lead author Akshay S. Desai, MD, of Brigham and Women’s Hospital, Boston, and co-authors wrote.

The study set out to determine the pathophysiologic mechanisms behind the clinical effects of sacubitril-valsartan, compared with enalapril in patients with heart failure and reduced ejection fraction (HFrEF). The EVALUATE-HF trial evaluated 464 patients age 50 years and older with multiple cardiovascular symptoms, including chronic heart failure with ejection fraction of less than 40%. Aortic characteristic impedance, a measure of central aortic stiffness, was evaluated with two-dimensional echocardiography at screening, then at four, 12 and 24 weeks. The primary endpoint was change in aortic characteristic impedance between the two treatment groups at 12 weeks.

Aortic characteristic impedance at baseline to 12 weeks decreased from 223.8 to 218.9 dyne x s/cm ⁵ in the sacubitril-valsartan treatment group and increased from 213.2 to 214.4 dyne x s/cm ⁵ in the enalapril group. “There was no statistically significant difference between groups in the change from baseline,” the investigators wrote. The between-group difference factored out to -2.2 dyne x s/cm ⁵ , ranging from -17.6 to 13.2 dyne x s/cm ⁵ . This was despite a reduction in brachial systolic blood pressure (6.5 and 1.6 mm Hg) and central systolic blood pressure (4.9 and 2.3 mm Hg), respectively.

The sacubitril-valsartan group showed greater reductions in left ventricular end-diastolic volume index, left ventricular end-systolic volume index, left atrial volume index and mitral E/e ′ ratio. “Although ejection fraction increased modestly by 1.9% in the sacubitril-valsartan group and by 1.3% in the enalapril group, we observed no significant between-group differences in change from baseline to 12 weeks in left ventricular ejection fraction or in other measured parameters,” the investigators wrote. Those other parameters include global longitudinal strain, mitral e ′ velocity or arterial elastance:ventricular elastance ratio. Rates of hypertension, hyperkalemia, and worsening renal function were similar in both groups.

Another secondary outcome was change from baseline in the overall 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ). A post-hoc analysis evaluated patients who achieved a statistically significant 5-points-or-greater change in KCCQ score, finding the score improved by 8.9 points in the sacubitril-valsartan group and 4.3 points in the enalapril group, a difference wider than 8-month results from the PARADIGM-HF trial ( Circ Heart Fail. 2017;10:e003430). “These data suggest that clinical benefits of sacubitril-valsartan compared with enalapril in patients with HFrEF are likely unrelated to changes in central aortic stiffness or pulsatile load, despite favorable effects of neprilysin inhibition on myocardial remodeling and wall stress,” the investigators wrote.

The data support the current guidelines for substituting ARNI for angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers therapy, “even in the face of apparent clinical stability,” Dr. Desai and co-authors said. In an invited commentary, Mark H. Drazner, MD , of Texas Southwestern Medical Center in Dallas, said the EVALUATE-HF trial, along with the observational PROVE-HF trial data also reported at the ESC meeting (JAMA. 2019 Sept 2. doi:10.1001/jama.2019.12821), “strongly suggest” ARNI therapy can promote cardiac reverse remodeling in patients with HFrEF. “As with beta-blockers and ACE inhibitors, it thus appears that the benefits of ARNI therapy on clinical outcomes in patients with HFrEF are mediated, at least in part, by their favorable effects on the adverse cardiac remodeling that characterizes the condition,” Dr. Desai and co-authors wrote.

The EVALUATE-HF trial was sponsored by Novartis. Dr. Desai disclosed financial relationships with Alnylam, AstraZeneca, Novartis, Abbott, Biofourmis, Boehringer Ingelheim, Boston Scientific, DalCor Pharma and Regeneron. Dr. Drazner has no financial relationships to disclose.

SOURCE: Desai AS et al. JAMA. 2019 Sept 2. doi:10.1001/jama.2019.12843.

Weight-loss surgery in people with type 2 diabetes and obesity is associated with significant reductions in major adverse cardiovascular events, compared with nonsurgical management, according to data presented at the annual congress of the European Society of Cardiology.

The retrospective cohort study, simultaneously published in JAMA, looked at outcomes in 13,722 individuals with type 2 diabetes and obesity, 2,287 of whom underwent metabolic surgery and the rest of the matched cohort receiving usual care.

At 8 years of follow-up, the cumulative incidence of the primary endpoint – a composite of first occurrence of all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation – was 30.8% in the weight loss–surgery group and 47.7% in the nonsurgical-control group, representing a 39% lower risk with weight loss surgery (P less than .001).

The analysis failed to find any interaction with sex, age, body mass index (BMI), HbA_1c level, estimated glomerular filtration rate, or use of insulin, sulfonylureas, or lipid-lowering medications.

Metabolic surgery was also associated with a significantly lower cumulative incidence of myocardial infarction, ischemic stroke and mortality than usual care (17% vs. 27.6%).

In particular, researchers saw a significant 41% reduction in the risk of death at eight years in the surgical group compared to usual care (10% vs. 17.8%), a 62% reduction in the risk of heart failure, a 31% reduction in the risk of coronary artery disease, and a 60% reduction in nephropathy risk. Metabolic surgery was also associated with a 33% reduction in cerebrovascular disease risk, and a 22% lower risk of atrial fibrillation.

In the group that underwent metabolic surgery, mean bodyweight at 8 years was reduced by 29.1 kg, compared with 8.7 kg in the control group. At baseline, 75% of the metabolic surgery group had a BMI of 40 kg/m² or above, 20% had a BMI between 35-39.9, and 5% had a BMI between 30-34.9.

The surgery was also associated with significantly greater reductions in HbA_1c, and in the use of noninsulin diabetes medications, insulin, antihypertensive medications, lipid-lowering therapies, and aspirin.

The most common surgical weight loss procedure was Roux-en-Y gastric bypass (63%), followed by sleeve gastrectomy (32%), and adjustable gastric banding (5%). Five patients underwent duodenal switch.

In the 90 days after surgery, 3% of patients experienced bleeding that required transfusion, 2.5% experienced pulmonary adverse events, 1% experienced venous thromboembolism, 0.7% experienced cardiac events, and 0.2% experienced renal failure that required dialysis. There were also 15 deaths (0.7%) in the surgical group, and 4.8% of patients required abdominal surgical intervention.

“We speculate that the lower rate of [major adverse cardiovascular events] after metabolic surgery observed in this study may be related to substantial and sustained weight loss with subsequent improvement in metabolic, structural, hemodynamic, and neurohormonal abnormalities,” wrote Ali Aminian, MD, of the Bariatric and Metabolic Institute at the Cleveland Clinic, and coauthors.

“Although large and sustained surgically induced weight loss has profound physiologic effects, a growing body of evidence indicates that some of the beneficial metabolic and neurohormonal changes that occur after metabolic surgical procedures are related to anatomical changes in the gastrointestinal tract that are partially independent of weight loss,” they wrote.

The authors, however, were also keen to point out that their study was observational, and should therefore be considered “hypothesis generating.” While the two study groups were matched on 37 baseline covariates, those in the surgical group did have a higher body weight, higher BMI, higher rates of dyslipidemia, and higher rates of hypertension.

“The findings from this observational study must be confirmed in randomized clinical trials,” they noted.

The study was partly funded by Medtronic, and one author was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Five authors declared funding and support from private industry, including from Medtronic, and one author declared institutional grants.

SOURCE: Aminian A et al. JAMA 2019, Sept 2. DOI: 10.1001/jama.2019.14231.

Weight-loss surgery in people with type 2 diabetes and obesity is associated with significant reductions in major adverse cardiovascular events, compared with nonsurgical management, according to data presented at the annual congress of the European Society of Cardiology.

The retrospective cohort study, simultaneously published in JAMA, looked at outcomes in 13,722 individuals with type 2 diabetes and obesity, 2,287 of whom underwent metabolic surgery and the rest of the matched cohort receiving usual care.

At 8 years of follow-up, the cumulative incidence of the primary endpoint – a composite of first occurrence of all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation – was 30.8% in the weight loss–surgery group and 47.7% in the nonsurgical-control group, representing a 39% lower risk with weight loss surgery (P less than .001).

The analysis failed to find any interaction with sex, age, body mass index (BMI), HbA_1c level, estimated glomerular filtration rate, or use of insulin, sulfonylureas, or lipid-lowering medications.

Metabolic surgery was also associated with a significantly lower cumulative incidence of myocardial infarction, ischemic stroke and mortality than usual care (17% vs. 27.6%).

In particular, researchers saw a significant 41% reduction in the risk of death at eight years in the surgical group compared to usual care (10% vs. 17.8%), a 62% reduction in the risk of heart failure, a 31% reduction in the risk of coronary artery disease, and a 60% reduction in nephropathy risk. Metabolic surgery was also associated with a 33% reduction in cerebrovascular disease risk, and a 22% lower risk of atrial fibrillation.

In the group that underwent metabolic surgery, mean bodyweight at 8 years was reduced by 29.1 kg, compared with 8.7 kg in the control group. At baseline, 75% of the metabolic surgery group had a BMI of 40 kg/m² or above, 20% had a BMI between 35-39.9, and 5% had a BMI between 30-34.9.

The surgery was also associated with significantly greater reductions in HbA_1c, and in the use of noninsulin diabetes medications, insulin, antihypertensive medications, lipid-lowering therapies, and aspirin.

The most common surgical weight loss procedure was Roux-en-Y gastric bypass (63%), followed by sleeve gastrectomy (32%), and adjustable gastric banding (5%). Five patients underwent duodenal switch.

In the 90 days after surgery, 3% of patients experienced bleeding that required transfusion, 2.5% experienced pulmonary adverse events, 1% experienced venous thromboembolism, 0.7% experienced cardiac events, and 0.2% experienced renal failure that required dialysis. There were also 15 deaths (0.7%) in the surgical group, and 4.8% of patients required abdominal surgical intervention.

“We speculate that the lower rate of [major adverse cardiovascular events] after metabolic surgery observed in this study may be related to substantial and sustained weight loss with subsequent improvement in metabolic, structural, hemodynamic, and neurohormonal abnormalities,” wrote Ali Aminian, MD, of the Bariatric and Metabolic Institute at the Cleveland Clinic, and coauthors.

“Although large and sustained surgically induced weight loss has profound physiologic effects, a growing body of evidence indicates that some of the beneficial metabolic and neurohormonal changes that occur after metabolic surgical procedures are related to anatomical changes in the gastrointestinal tract that are partially independent of weight loss,” they wrote.

The authors, however, were also keen to point out that their study was observational, and should therefore be considered “hypothesis generating.” While the two study groups were matched on 37 baseline covariates, those in the surgical group did have a higher body weight, higher BMI, higher rates of dyslipidemia, and higher rates of hypertension.

“The findings from this observational study must be confirmed in randomized clinical trials,” they noted.

The study was partly funded by Medtronic, and one author was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Five authors declared funding and support from private industry, including from Medtronic, and one author declared institutional grants.

SOURCE: Aminian A et al. JAMA 2019, Sept 2. DOI: 10.1001/jama.2019.14231.

Weight-loss surgery in people with type 2 diabetes and obesity is associated with significant reductions in major adverse cardiovascular events, compared with nonsurgical management, according to data presented at the annual congress of the European Society of Cardiology.

The retrospective cohort study, simultaneously published in JAMA, looked at outcomes in 13,722 individuals with type 2 diabetes and obesity, 2,287 of whom underwent metabolic surgery and the rest of the matched cohort receiving usual care.

At 8 years of follow-up, the cumulative incidence of the primary endpoint – a composite of first occurrence of all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation – was 30.8% in the weight loss–surgery group and 47.7% in the nonsurgical-control group, representing a 39% lower risk with weight loss surgery (P less than .001).

The analysis failed to find any interaction with sex, age, body mass index (BMI), HbA_1c level, estimated glomerular filtration rate, or use of insulin, sulfonylureas, or lipid-lowering medications.

Metabolic surgery was also associated with a significantly lower cumulative incidence of myocardial infarction, ischemic stroke and mortality than usual care (17% vs. 27.6%).

In particular, researchers saw a significant 41% reduction in the risk of death at eight years in the surgical group compared to usual care (10% vs. 17.8%), a 62% reduction in the risk of heart failure, a 31% reduction in the risk of coronary artery disease, and a 60% reduction in nephropathy risk. Metabolic surgery was also associated with a 33% reduction in cerebrovascular disease risk, and a 22% lower risk of atrial fibrillation.

In the group that underwent metabolic surgery, mean bodyweight at 8 years was reduced by 29.1 kg, compared with 8.7 kg in the control group. At baseline, 75% of the metabolic surgery group had a BMI of 40 kg/m² or above, 20% had a BMI between 35-39.9, and 5% had a BMI between 30-34.9.

The surgery was also associated with significantly greater reductions in HbA_1c, and in the use of noninsulin diabetes medications, insulin, antihypertensive medications, lipid-lowering therapies, and aspirin.

The most common surgical weight loss procedure was Roux-en-Y gastric bypass (63%), followed by sleeve gastrectomy (32%), and adjustable gastric banding (5%). Five patients underwent duodenal switch.

In the 90 days after surgery, 3% of patients experienced bleeding that required transfusion, 2.5% experienced pulmonary adverse events, 1% experienced venous thromboembolism, 0.7% experienced cardiac events, and 0.2% experienced renal failure that required dialysis. There were also 15 deaths (0.7%) in the surgical group, and 4.8% of patients required abdominal surgical intervention.

“We speculate that the lower rate of [major adverse cardiovascular events] after metabolic surgery observed in this study may be related to substantial and sustained weight loss with subsequent improvement in metabolic, structural, hemodynamic, and neurohormonal abnormalities,” wrote Ali Aminian, MD, of the Bariatric and Metabolic Institute at the Cleveland Clinic, and coauthors.

“Although large and sustained surgically induced weight loss has profound physiologic effects, a growing body of evidence indicates that some of the beneficial metabolic and neurohormonal changes that occur after metabolic surgical procedures are related to anatomical changes in the gastrointestinal tract that are partially independent of weight loss,” they wrote.

The authors, however, were also keen to point out that their study was observational, and should therefore be considered “hypothesis generating.” While the two study groups were matched on 37 baseline covariates, those in the surgical group did have a higher body weight, higher BMI, higher rates of dyslipidemia, and higher rates of hypertension.

“The findings from this observational study must be confirmed in randomized clinical trials,” they noted.

The study was partly funded by Medtronic, and one author was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Five authors declared funding and support from private industry, including from Medtronic, and one author declared institutional grants.

SOURCE: Aminian A et al. JAMA 2019, Sept 2. DOI: 10.1001/jama.2019.14231.

A novel marker of repolarization may identify patients with cardiomyopathy who would benefit from an implanted cardioverter defibrillator, according to a European research study presented at the annual congress of the European Society of Cardiology and published simultaneously in The Lancet.

High periodic repolarization dynamics were linked to substantial reductions in mortality in a prespecified substudy of the EU-CERT-ICD (European Comparative Effectiveness Research to Assess the Use of Primary Prophylactic Implantable Cardioverter Defibrillators).

The degree of periodic repolarization dynamics correlated with reductions in mortality in the 1,371 patients, 968 of whom had ICD implantation and 403 of whom were treated conservatively, in the prospective, nonrandomized controlled cohort study conducted at 44 centers in 15 countries within the European Union. At a median follow-up of 2-7 years, the ICD group had a mortality rate of 14%; at a follow-up of 1-2 years, the control group had a mortality rate of 16%, resulting in a 43% overall reduction in mortality for the ICD group.

Low periodic repolarization dynamics were associated with a low reduction in ICD-related death, whereas high periodic repolarization dynamics were linked to substantial reductions in mortality. In 199 patients with periodic repolarization dynamics of 7.5% or higher, ICD implantation resulted in a 75% reduction in death, compared with controls. Periodic repolarization dynamics also served as reliable predictors of appropriate shocks in patients with ICDs as well as death in controls.

Because of the link between high periodic repolarization dynamics and greater benefits, cardiologists may be able to use the measure as a marker to individualize treatment decisions about the use of ICDs, said Axel Bauer, MD, director of University Hospital for Internal Medicine III, Cardiology and Angiology at Medical University Innsbruck, Austria, and coauthors. “Better patient selection could lead to a reduced number of devices needing to be implanted to save a life.

“Our results should help patients to make decisions about their treatment that take into account individual circumstances and preferences,” the researchers noted.

SOURCE: Bauer A et al. Lancet. 2019 Sep 2. doi: 10.1016/S0140-6736(19)31996-8.

A novel marker of repolarization may identify patients with cardiomyopathy who would benefit from an implanted cardioverter defibrillator, according to a European research study presented at the annual congress of the European Society of Cardiology and published simultaneously in The Lancet.

High periodic repolarization dynamics were linked to substantial reductions in mortality in a prespecified substudy of the EU-CERT-ICD (European Comparative Effectiveness Research to Assess the Use of Primary Prophylactic Implantable Cardioverter Defibrillators).

The degree of periodic repolarization dynamics correlated with reductions in mortality in the 1,371 patients, 968 of whom had ICD implantation and 403 of whom were treated conservatively, in the prospective, nonrandomized controlled cohort study conducted at 44 centers in 15 countries within the European Union. At a median follow-up of 2-7 years, the ICD group had a mortality rate of 14%; at a follow-up of 1-2 years, the control group had a mortality rate of 16%, resulting in a 43% overall reduction in mortality for the ICD group.

Low periodic repolarization dynamics were associated with a low reduction in ICD-related death, whereas high periodic repolarization dynamics were linked to substantial reductions in mortality. In 199 patients with periodic repolarization dynamics of 7.5% or higher, ICD implantation resulted in a 75% reduction in death, compared with controls. Periodic repolarization dynamics also served as reliable predictors of appropriate shocks in patients with ICDs as well as death in controls.

Because of the link between high periodic repolarization dynamics and greater benefits, cardiologists may be able to use the measure as a marker to individualize treatment decisions about the use of ICDs, said Axel Bauer, MD, director of University Hospital for Internal Medicine III, Cardiology and Angiology at Medical University Innsbruck, Austria, and coauthors. “Better patient selection could lead to a reduced number of devices needing to be implanted to save a life.

“Our results should help patients to make decisions about their treatment that take into account individual circumstances and preferences,” the researchers noted.

SOURCE: Bauer A et al. Lancet. 2019 Sep 2. doi: 10.1016/S0140-6736(19)31996-8.

A novel marker of repolarization may identify patients with cardiomyopathy who would benefit from an implanted cardioverter defibrillator, according to a European research study presented at the annual congress of the European Society of Cardiology and published simultaneously in The Lancet.

High periodic repolarization dynamics were linked to substantial reductions in mortality in a prespecified substudy of the EU-CERT-ICD (European Comparative Effectiveness Research to Assess the Use of Primary Prophylactic Implantable Cardioverter Defibrillators).

The degree of periodic repolarization dynamics correlated with reductions in mortality in the 1,371 patients, 968 of whom had ICD implantation and 403 of whom were treated conservatively, in the prospective, nonrandomized controlled cohort study conducted at 44 centers in 15 countries within the European Union. At a median follow-up of 2-7 years, the ICD group had a mortality rate of 14%; at a follow-up of 1-2 years, the control group had a mortality rate of 16%, resulting in a 43% overall reduction in mortality for the ICD group.

Low periodic repolarization dynamics were associated with a low reduction in ICD-related death, whereas high periodic repolarization dynamics were linked to substantial reductions in mortality. In 199 patients with periodic repolarization dynamics of 7.5% or higher, ICD implantation resulted in a 75% reduction in death, compared with controls. Periodic repolarization dynamics also served as reliable predictors of appropriate shocks in patients with ICDs as well as death in controls.

Because of the link between high periodic repolarization dynamics and greater benefits, cardiologists may be able to use the measure as a marker to individualize treatment decisions about the use of ICDs, said Axel Bauer, MD, director of University Hospital for Internal Medicine III, Cardiology and Angiology at Medical University Innsbruck, Austria, and coauthors. “Better patient selection could lead to a reduced number of devices needing to be implanted to save a life.

“Our results should help patients to make decisions about their treatment that take into account individual circumstances and preferences,” the researchers noted.

SOURCE: Bauer A et al. Lancet. 2019 Sep 2. doi: 10.1016/S0140-6736(19)31996-8.