Prevalence of Scalp Psoriasis

Scalp psoriasis is a common and difficult-to-treat manifestation of psoriasis.^1,2 The prevalence of scalp psoriasis in patients with psoriasis is estimated to be 45% to 56%.³ Other studies have shown 80% to 90% of patients with psoriasis have scalp involvement at some point during the course of their disease.^2,4-6 

Clinical Presentation

Scalp psoriasis typically presents as red thickened patches with silvery white scales that flake and may be mistaken for dandruff.^7,8 

The lesions may be limited to the hairline or may extend to the forehead, ears, and back of the neck.^1,9 Patients often report intense itching, feelings of soreness, and burning.^10,11 Patients with scalp psoriasis also are vulnerable to Koebner phenomenon because normal hair care along with scratching or picking at lesions can result in skin trauma and a cycle of exacerbating disease.¹¹ 

Quality of Life Implications

Scalp involvement can dramatically affect a patient’s quality of life and often poses considerable therapeutic challenges for dermatologists.^2,12,13 In one study, more than 70% of patients with scalp psoriasis reported difficulty with daily life.¹² Patients frequently report feelings of shame, embarrassment, or self-consciousness about scalp psoriasis; many grow their hair long or wear hats to hide scalp lesions. Others report that flaking sometimes, often, or always affects their choice of clothing color.^7,12 

Psoriatic Alopecia

Alopecia is another common sequala in the setting of scalp psoriasis, though it is not well understood.^14,15 First described by Shuster¹⁶ in 1972, psoriatic alopecia is associated with diminished hair density, follicular miniaturization, sebaceous gland atrophy, and an increased number of dystrophic bulbs in psoriatic plaques.^14,17 Clinically, it presents as pink scaly plaques consistent with psoriasis with overlying alopecia. In most patients, hair loss is usually reversible following effective treatment of psoriasis; however, instances of psoriatic alopecia have been reported as cicatricial (permanent) hair loss and generalized telogen effluvium. Cicatricial alopecia is increasingly being linked with chronic relapsing episodes of psoriasis.^14,15 Patients with psoriatic alopecia are known to have a higher proportion of telogen and catagen hairs.^14,18 Moreover, patients with psoriasis have more dystrophic hairs in affected and unaffected skin despite no differences in skin when compared to unaffected patients.¹⁴ 

The patient described here had scalp psoriasis with increased and preserved hair density. The case suggests that while most patients with scalp psoriasis experience psoriatic alopecia of the lesional skin, some may unconventionally experience increased hair density, which is contradictory to propositions that the friction associated with the application of topical treatments results in breakage of telogen hairs.^14,15  

Therapeutic Options

Although numerous treatment options for psoriasis are available, the scalp remains a difficult area to treat.^1,14 Increased hair density can complicate antipsoriatic treatment by making the scalp inaccessible and topical therapies even more difficult to apply.¹⁴ The presence of hair also has been shown to strongly influence treatment adherence.^1,8 Patients often discuss the greasy effect of medications in this area and difficulty removing products from the hair.¹ 

Topical corticosteroids, with or without the addition of the vitamin D analogs calcipotriol or calcipotriene, remain the first-line treatment of mild scalp psoriasis. It is possible that the development of new formulations in recent years—foams, shampoos, and sprays—may improve adherence. Systemic treatment should be considered in severe or intractable cases. 

Bottom Line

Although hair loss is more common, scalp psoriasis also may present with increased hair density, which may make topical medications more difficult to apply and can affect treatment adherence. Topical corticosteroids, with or without the addition of the vitamin D analog calcipotriol, remain the first-line treatment of mild scalp psoriasis. Systemic therapy should be considered in severe or recalcitrant cases.

Prevalence of Scalp Psoriasis

Scalp psoriasis is a common and difficult-to-treat manifestation of psoriasis.^1,2 The prevalence of scalp psoriasis in patients with psoriasis is estimated to be 45% to 56%.³ Other studies have shown 80% to 90% of patients with psoriasis have scalp involvement at some point during the course of their disease.^2,4-6 

Clinical Presentation

Scalp psoriasis typically presents as red thickened patches with silvery white scales that flake and may be mistaken for dandruff.^7,8 

The lesions may be limited to the hairline or may extend to the forehead, ears, and back of the neck.^1,9 Patients often report intense itching, feelings of soreness, and burning.^10,11 Patients with scalp psoriasis also are vulnerable to Koebner phenomenon because normal hair care along with scratching or picking at lesions can result in skin trauma and a cycle of exacerbating disease.¹¹ 

Quality of Life Implications

Scalp involvement can dramatically affect a patient’s quality of life and often poses considerable therapeutic challenges for dermatologists.^2,12,13 In one study, more than 70% of patients with scalp psoriasis reported difficulty with daily life.¹² Patients frequently report feelings of shame, embarrassment, or self-consciousness about scalp psoriasis; many grow their hair long or wear hats to hide scalp lesions. Others report that flaking sometimes, often, or always affects their choice of clothing color.^7,12 

Psoriatic Alopecia

Alopecia is another common sequala in the setting of scalp psoriasis, though it is not well understood.^14,15 First described by Shuster¹⁶ in 1972, psoriatic alopecia is associated with diminished hair density, follicular miniaturization, sebaceous gland atrophy, and an increased number of dystrophic bulbs in psoriatic plaques.^14,17 Clinically, it presents as pink scaly plaques consistent with psoriasis with overlying alopecia. In most patients, hair loss is usually reversible following effective treatment of psoriasis; however, instances of psoriatic alopecia have been reported as cicatricial (permanent) hair loss and generalized telogen effluvium. Cicatricial alopecia is increasingly being linked with chronic relapsing episodes of psoriasis.^14,15 Patients with psoriatic alopecia are known to have a higher proportion of telogen and catagen hairs.^14,18 Moreover, patients with psoriasis have more dystrophic hairs in affected and unaffected skin despite no differences in skin when compared to unaffected patients.¹⁴ 

The patient described here had scalp psoriasis with increased and preserved hair density. The case suggests that while most patients with scalp psoriasis experience psoriatic alopecia of the lesional skin, some may unconventionally experience increased hair density, which is contradictory to propositions that the friction associated with the application of topical treatments results in breakage of telogen hairs.^14,15  

Therapeutic Options

Although numerous treatment options for psoriasis are available, the scalp remains a difficult area to treat.^1,14 Increased hair density can complicate antipsoriatic treatment by making the scalp inaccessible and topical therapies even more difficult to apply.¹⁴ The presence of hair also has been shown to strongly influence treatment adherence.^1,8 Patients often discuss the greasy effect of medications in this area and difficulty removing products from the hair.¹ 

Topical corticosteroids, with or without the addition of the vitamin D analogs calcipotriol or calcipotriene, remain the first-line treatment of mild scalp psoriasis. It is possible that the development of new formulations in recent years—foams, shampoos, and sprays—may improve adherence. Systemic treatment should be considered in severe or intractable cases. 

Bottom Line

Although hair loss is more common, scalp psoriasis also may present with increased hair density, which may make topical medications more difficult to apply and can affect treatment adherence. Topical corticosteroids, with or without the addition of the vitamin D analog calcipotriol, remain the first-line treatment of mild scalp psoriasis. Systemic therapy should be considered in severe or recalcitrant cases.

Prevalence of Scalp Psoriasis

Scalp psoriasis is a common and difficult-to-treat manifestation of psoriasis.^1,2 The prevalence of scalp psoriasis in patients with psoriasis is estimated to be 45% to 56%.³ Other studies have shown 80% to 90% of patients with psoriasis have scalp involvement at some point during the course of their disease.^2,4-6 

Clinical Presentation

Scalp psoriasis typically presents as red thickened patches with silvery white scales that flake and may be mistaken for dandruff.^7,8 

The lesions may be limited to the hairline or may extend to the forehead, ears, and back of the neck.^1,9 Patients often report intense itching, feelings of soreness, and burning.^10,11 Patients with scalp psoriasis also are vulnerable to Koebner phenomenon because normal hair care along with scratching or picking at lesions can result in skin trauma and a cycle of exacerbating disease.¹¹ 

Quality of Life Implications

Scalp involvement can dramatically affect a patient’s quality of life and often poses considerable therapeutic challenges for dermatologists.^2,12,13 In one study, more than 70% of patients with scalp psoriasis reported difficulty with daily life.¹² Patients frequently report feelings of shame, embarrassment, or self-consciousness about scalp psoriasis; many grow their hair long or wear hats to hide scalp lesions. Others report that flaking sometimes, often, or always affects their choice of clothing color.^7,12 

Psoriatic Alopecia

Alopecia is another common sequala in the setting of scalp psoriasis, though it is not well understood.^14,15 First described by Shuster¹⁶ in 1972, psoriatic alopecia is associated with diminished hair density, follicular miniaturization, sebaceous gland atrophy, and an increased number of dystrophic bulbs in psoriatic plaques.^14,17 Clinically, it presents as pink scaly plaques consistent with psoriasis with overlying alopecia. In most patients, hair loss is usually reversible following effective treatment of psoriasis; however, instances of psoriatic alopecia have been reported as cicatricial (permanent) hair loss and generalized telogen effluvium. Cicatricial alopecia is increasingly being linked with chronic relapsing episodes of psoriasis.^14,15 Patients with psoriatic alopecia are known to have a higher proportion of telogen and catagen hairs.^14,18 Moreover, patients with psoriasis have more dystrophic hairs in affected and unaffected skin despite no differences in skin when compared to unaffected patients.¹⁴ 

The patient described here had scalp psoriasis with increased and preserved hair density. The case suggests that while most patients with scalp psoriasis experience psoriatic alopecia of the lesional skin, some may unconventionally experience increased hair density, which is contradictory to propositions that the friction associated with the application of topical treatments results in breakage of telogen hairs.^14,15  

Therapeutic Options

Although numerous treatment options for psoriasis are available, the scalp remains a difficult area to treat.^1,14 Increased hair density can complicate antipsoriatic treatment by making the scalp inaccessible and topical therapies even more difficult to apply.¹⁴ The presence of hair also has been shown to strongly influence treatment adherence.^1,8 Patients often discuss the greasy effect of medications in this area and difficulty removing products from the hair.¹ 

Topical corticosteroids, with or without the addition of the vitamin D analogs calcipotriol or calcipotriene, remain the first-line treatment of mild scalp psoriasis. It is possible that the development of new formulations in recent years—foams, shampoos, and sprays—may improve adherence. Systemic treatment should be considered in severe or intractable cases. 

Bottom Line

Although hair loss is more common, scalp psoriasis also may present with increased hair density, which may make topical medications more difficult to apply and can affect treatment adherence. Topical corticosteroids, with or without the addition of the vitamin D analog calcipotriol, remain the first-line treatment of mild scalp psoriasis. Systemic therapy should be considered in severe or recalcitrant cases.

BOSTON – While about one-third of overweight patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH) slimmed down after a weight-loss intervention, about 20% gained weight back within the next few years, according to results from a large, long-term observational cohort study.

Effectively, that meant about one-quarter of overweight subjects enrolled in the TARGET-NASH study were able to lose weight and keep it off, said investigator Miguel H. Malespin, MD, a transplant hepatologist at Tampa General Hospital.

These findings illustrate how challenging lifestyle interventions can be for patients with NAFLD and NASH, and have clinical implications for identifying those individuals who are more or less likely to respond to weight-loss intervention as an initial treatment, Dr. Malespin said.

“I think we as providers need to better identify what are the barriers for weight loss for these patients, and try to use data, such as this data from TARGET-NASH, to help our clinical judgment and to learn strategies to be able to help these patients optimize their weight loss,” he added in an interview.

With no approved pharmacologic treatments for NAFLD and NASH, weight reduction remains one of the mainstays of treatment, Dr. Malespin said.

However, there are few studies evaluating structured programs designed to achieve such weight loss, and the long-term sustainability of this approach remains in question, according to Dr. Malespin, who presented findings of TARGET-NASH at the annual meeting of the American Association for the Study of Liver Diseases.

To date, more than 4,500 patients have been enrolled in TARGET-NASH at 59 U.S. centers. The present analysis, which Dr. Malespin described in an oral abstract presentation, included 2,037 patients with a body mass index of at least 25 kg/m² and no decompensated cirrhosis, bariatric surgery, weight-loss medication use, or cancer diagnoses.

In sum, 34% of patients had 5% or more weight loss over about 3 years of follow-up, while about 10% had a 10% or greater weight loss, Dr. Malespin reported.

It took patients about 18 months, on average, to achieve 5% or greater weight loss. Those who achieved weight loss tended to be older, according to the investigator, and were about 1.5 times as likely to be obese class II or III, as opposed to just being overweight.

Patients were significantly more likely to lose weight, Dr. Malespin and coauthors found, if they had cirrhosis or comorbid medical conditions such as diabetes, osteoarthritis, or cardiovascular disease.

“All these factors essentially imply that these patients are hopefully being seen by multiple providers,” Dr. Malespin said, “so hopefully they’re getting the message [on the need for lifestyle modifications] from multiple different providers, and this is contributing to why we’re seeing some of this weight loss.”

However, weight loss did not persist in all patients, with 20.2% regaining weight back up to baseline or greater, according to the report. The median time to weight regain was 24-31 months, depending on initial weight class.

TARGET-NASH, sponsored by TARGET PharmaSolutions, is a 5-year longitudinal observational study with an enrollment goal of 15,000 patients with NAFLD or NASH and an estimated study completion date of 2021, according to a ClinicalTrials.gov listing.

Dr. Malespin reported disclosures with Gilead (speaker board), Intercept (speaker board, advisory committee), and TARGET PharmaSolutions (research grant paid to institution).

SOURCE: Malespin MH et al. The Liver Meeting 2019, Abstract 240.

BOSTON – While about one-third of overweight patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH) slimmed down after a weight-loss intervention, about 20% gained weight back within the next few years, according to results from a large, long-term observational cohort study.

Effectively, that meant about one-quarter of overweight subjects enrolled in the TARGET-NASH study were able to lose weight and keep it off, said investigator Miguel H. Malespin, MD, a transplant hepatologist at Tampa General Hospital.

These findings illustrate how challenging lifestyle interventions can be for patients with NAFLD and NASH, and have clinical implications for identifying those individuals who are more or less likely to respond to weight-loss intervention as an initial treatment, Dr. Malespin said.

“I think we as providers need to better identify what are the barriers for weight loss for these patients, and try to use data, such as this data from TARGET-NASH, to help our clinical judgment and to learn strategies to be able to help these patients optimize their weight loss,” he added in an interview.

With no approved pharmacologic treatments for NAFLD and NASH, weight reduction remains one of the mainstays of treatment, Dr. Malespin said.

However, there are few studies evaluating structured programs designed to achieve such weight loss, and the long-term sustainability of this approach remains in question, according to Dr. Malespin, who presented findings of TARGET-NASH at the annual meeting of the American Association for the Study of Liver Diseases.

To date, more than 4,500 patients have been enrolled in TARGET-NASH at 59 U.S. centers. The present analysis, which Dr. Malespin described in an oral abstract presentation, included 2,037 patients with a body mass index of at least 25 kg/m² and no decompensated cirrhosis, bariatric surgery, weight-loss medication use, or cancer diagnoses.

In sum, 34% of patients had 5% or more weight loss over about 3 years of follow-up, while about 10% had a 10% or greater weight loss, Dr. Malespin reported.

It took patients about 18 months, on average, to achieve 5% or greater weight loss. Those who achieved weight loss tended to be older, according to the investigator, and were about 1.5 times as likely to be obese class II or III, as opposed to just being overweight.

Patients were significantly more likely to lose weight, Dr. Malespin and coauthors found, if they had cirrhosis or comorbid medical conditions such as diabetes, osteoarthritis, or cardiovascular disease.

“All these factors essentially imply that these patients are hopefully being seen by multiple providers,” Dr. Malespin said, “so hopefully they’re getting the message [on the need for lifestyle modifications] from multiple different providers, and this is contributing to why we’re seeing some of this weight loss.”

However, weight loss did not persist in all patients, with 20.2% regaining weight back up to baseline or greater, according to the report. The median time to weight regain was 24-31 months, depending on initial weight class.

TARGET-NASH, sponsored by TARGET PharmaSolutions, is a 5-year longitudinal observational study with an enrollment goal of 15,000 patients with NAFLD or NASH and an estimated study completion date of 2021, according to a ClinicalTrials.gov listing.

Dr. Malespin reported disclosures with Gilead (speaker board), Intercept (speaker board, advisory committee), and TARGET PharmaSolutions (research grant paid to institution).

SOURCE: Malespin MH et al. The Liver Meeting 2019, Abstract 240.

BOSTON – While about one-third of overweight patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH) slimmed down after a weight-loss intervention, about 20% gained weight back within the next few years, according to results from a large, long-term observational cohort study.

Effectively, that meant about one-quarter of overweight subjects enrolled in the TARGET-NASH study were able to lose weight and keep it off, said investigator Miguel H. Malespin, MD, a transplant hepatologist at Tampa General Hospital.

These findings illustrate how challenging lifestyle interventions can be for patients with NAFLD and NASH, and have clinical implications for identifying those individuals who are more or less likely to respond to weight-loss intervention as an initial treatment, Dr. Malespin said.

“I think we as providers need to better identify what are the barriers for weight loss for these patients, and try to use data, such as this data from TARGET-NASH, to help our clinical judgment and to learn strategies to be able to help these patients optimize their weight loss,” he added in an interview.

With no approved pharmacologic treatments for NAFLD and NASH, weight reduction remains one of the mainstays of treatment, Dr. Malespin said.

However, there are few studies evaluating structured programs designed to achieve such weight loss, and the long-term sustainability of this approach remains in question, according to Dr. Malespin, who presented findings of TARGET-NASH at the annual meeting of the American Association for the Study of Liver Diseases.

To date, more than 4,500 patients have been enrolled in TARGET-NASH at 59 U.S. centers. The present analysis, which Dr. Malespin described in an oral abstract presentation, included 2,037 patients with a body mass index of at least 25 kg/m² and no decompensated cirrhosis, bariatric surgery, weight-loss medication use, or cancer diagnoses.

In sum, 34% of patients had 5% or more weight loss over about 3 years of follow-up, while about 10% had a 10% or greater weight loss, Dr. Malespin reported.

It took patients about 18 months, on average, to achieve 5% or greater weight loss. Those who achieved weight loss tended to be older, according to the investigator, and were about 1.5 times as likely to be obese class II or III, as opposed to just being overweight.

Patients were significantly more likely to lose weight, Dr. Malespin and coauthors found, if they had cirrhosis or comorbid medical conditions such as diabetes, osteoarthritis, or cardiovascular disease.

“All these factors essentially imply that these patients are hopefully being seen by multiple providers,” Dr. Malespin said, “so hopefully they’re getting the message [on the need for lifestyle modifications] from multiple different providers, and this is contributing to why we’re seeing some of this weight loss.”

However, weight loss did not persist in all patients, with 20.2% regaining weight back up to baseline or greater, according to the report. The median time to weight regain was 24-31 months, depending on initial weight class.

TARGET-NASH, sponsored by TARGET PharmaSolutions, is a 5-year longitudinal observational study with an enrollment goal of 15,000 patients with NAFLD or NASH and an estimated study completion date of 2021, according to a ClinicalTrials.gov listing.

Dr. Malespin reported disclosures with Gilead (speaker board), Intercept (speaker board, advisory committee), and TARGET PharmaSolutions (research grant paid to institution).

SOURCE: Malespin MH et al. The Liver Meeting 2019, Abstract 240.

Key clinical point: Disability milestones are not being met as quickly for patients with multiple sclerosis (MS), as disease progression has slowed.

Major finding: In patients with relapsing-onset MS there was a decreased risk of reaching disability milestones by 3%, 6%, and 7% in Expanded Disability Status Score (EDSS) scores of 3.0, 4.0, and 6.0, respectively. In patients with progressive-onset MS there was no significant decrease.

Study details: This was a nationwide population-based retrospective cohort study of 12,512 patients in Sweden. Of those patients 7,331 (5,196 females) were diagnosed with MS at a mean age of 38.3 years between January 1995 and December 2010 and had 2 recorded EDSS scores.

Disclosures: Research was funded by the Swedish Research Council and the Swedish Brain Foundation.

Citation: Beiki O, et al. JAMA Neurol. 2019;76(6):665-671. doi: 10.1001/jamaneurol.2019.0330.

Key clinical point: Disability milestones are not being met as quickly for patients with multiple sclerosis (MS), as disease progression has slowed.

Major finding: In patients with relapsing-onset MS there was a decreased risk of reaching disability milestones by 3%, 6%, and 7% in Expanded Disability Status Score (EDSS) scores of 3.0, 4.0, and 6.0, respectively. In patients with progressive-onset MS there was no significant decrease.

Study details: This was a nationwide population-based retrospective cohort study of 12,512 patients in Sweden. Of those patients 7,331 (5,196 females) were diagnosed with MS at a mean age of 38.3 years between January 1995 and December 2010 and had 2 recorded EDSS scores.

Disclosures: Research was funded by the Swedish Research Council and the Swedish Brain Foundation.

Citation: Beiki O, et al. JAMA Neurol. 2019;76(6):665-671. doi: 10.1001/jamaneurol.2019.0330.

Key clinical point: Disability milestones are not being met as quickly for patients with multiple sclerosis (MS), as disease progression has slowed.

Major finding: In patients with relapsing-onset MS there was a decreased risk of reaching disability milestones by 3%, 6%, and 7% in Expanded Disability Status Score (EDSS) scores of 3.0, 4.0, and 6.0, respectively. In patients with progressive-onset MS there was no significant decrease.

Study details: This was a nationwide population-based retrospective cohort study of 12,512 patients in Sweden. Of those patients 7,331 (5,196 females) were diagnosed with MS at a mean age of 38.3 years between January 1995 and December 2010 and had 2 recorded EDSS scores.

Disclosures: Research was funded by the Swedish Research Council and the Swedish Brain Foundation.

Citation: Beiki O, et al. JAMA Neurol. 2019;76(6):665-671. doi: 10.1001/jamaneurol.2019.0330.

Key clinical point: The use, type, and timing of disease-modifying therapies (DMTs) in relapsing-remitting multiple sclerosis (RRMS) patients may lead to secondary progressive MS.

Major finding: RRMS patients beginning DMTs of fingolimod, alemtuzumab, or natalizumab had a lower chance of secondary progressive MS, whereas patients taking glatiramer acetate or interferon beta had a higher chance.

Study details: This was a cohort study that examined 1,555 RRMS patients (1,123 females) across 21 countries that began DMTs (interferon beta, glatiramer acetate, fingolimod, natalizumab, or alemtuzumab) between 1988 and 2012.

Disclosures: This study was financially supported by the National Health and Medical Research Council of Australia, the University of Melbourne, a Next Generation Fellowship funded by the Grand Charity of the Freemason’s, and the MSBase 2017 Fellowship. Alemtuzumab studies done in Cambridge were supported by the NIHR Cambridge Biomedical Research Centre and the MS Society UK.

Citation: Brown JWL, et al. JAMA. 2019;321(2):175-187. doi: 10.1001/jama.2018.20588.

Key clinical point: The use, type, and timing of disease-modifying therapies (DMTs) in relapsing-remitting multiple sclerosis (RRMS) patients may lead to secondary progressive MS.

Major finding: RRMS patients beginning DMTs of fingolimod, alemtuzumab, or natalizumab had a lower chance of secondary progressive MS, whereas patients taking glatiramer acetate or interferon beta had a higher chance.

Study details: This was a cohort study that examined 1,555 RRMS patients (1,123 females) across 21 countries that began DMTs (interferon beta, glatiramer acetate, fingolimod, natalizumab, or alemtuzumab) between 1988 and 2012.

Disclosures: This study was financially supported by the National Health and Medical Research Council of Australia, the University of Melbourne, a Next Generation Fellowship funded by the Grand Charity of the Freemason’s, and the MSBase 2017 Fellowship. Alemtuzumab studies done in Cambridge were supported by the NIHR Cambridge Biomedical Research Centre and the MS Society UK.

Citation: Brown JWL, et al. JAMA. 2019;321(2):175-187. doi: 10.1001/jama.2018.20588.

Key clinical point: The use, type, and timing of disease-modifying therapies (DMTs) in relapsing-remitting multiple sclerosis (RRMS) patients may lead to secondary progressive MS.

Major finding: RRMS patients beginning DMTs of fingolimod, alemtuzumab, or natalizumab had a lower chance of secondary progressive MS, whereas patients taking glatiramer acetate or interferon beta had a higher chance.

Study details: This was a cohort study that examined 1,555 RRMS patients (1,123 females) across 21 countries that began DMTs (interferon beta, glatiramer acetate, fingolimod, natalizumab, or alemtuzumab) between 1988 and 2012.

Disclosures: This study was financially supported by the National Health and Medical Research Council of Australia, the University of Melbourne, a Next Generation Fellowship funded by the Grand Charity of the Freemason’s, and the MSBase 2017 Fellowship. Alemtuzumab studies done in Cambridge were supported by the NIHR Cambridge Biomedical Research Centre and the MS Society UK.

Citation: Brown JWL, et al. JAMA. 2019;321(2):175-187. doi: 10.1001/jama.2018.20588.

“Do you vape?” may be one of the most important questions health care can providers can ask patients who present with respiratory symptoms this winter.

mauro grigollo/Thinkstock

Vaping-related lung injuries cause symptoms such as fever, cough, headache, and fatigue, making it challenging to differentiate them from influenza or respiratory infections, according to the Centers for Disease Control and Prevention.

Accordingly, providers need to ask patients with respiratory, gastrointestinal, or constitutional symptoms about their use of e-cigarette or vaping products, according to one several new CDC recommendations that appear in the Morbidity and Mortality Weekly Review.

“E-cigarette or vaping product use–associated lung injury (EVALI) remains a diagnosis of exclusion because, at present, no specific test or marker exists for its diagnosis, and evaluation should be guided by clinical judgment,” the CDC report reads.

As of Nov. 13, there have been 2,172 cases of EVALI reported to CDC, of which 42 (1.9%) have been fatal. Most of the patients with EVALI have been white (79%), male (68%), and under the age of 35 years (77%), according to CDC data.

Although vitamin E acetate was recently implicated as a potential cause of EVALI, the agency said evidence is “not sufficient” at this point in their investigation to rule out other chemicals of potential concern.

“Many different substances and product sources are still under investigation, and it might be that there is more than one cause of this outbreak,” CDC said.

Further recommendations

Beyond asking about vape use, providers should evaluate suspected EVALI with pulse oximetry and chest imaging, and should consider outpatient management for patients who are clinically stable, according to the recommendations.

The agency said influenza testing should be “strongly considered,” especially during influenza season, given that EVALI is a diagnosis of exclusion and that it may co-occur with other respiratory illnesses. Antimicrobials (including antivirals) should be given as warranted, they added.

Corticosteroids may be helpful in treating EVALI, but may worsen respiratory infections typically seen in outpatients, and so should be prescribed with caution in the outpatient setting, the CDC recommended.

Behavioral counseling, addiction treatment services, and Food and Drug Administration–approved cessation medications are recommended to help patients quit vaping or e-cigarette products, CDC said.

Health care providers should emphasize the importance of an annual flu shot for all patients 6 months of age or older, including those who use e-cigarette or vaping products, according to the agency.

“It is not known whether patients with EVALI are at higher risk for severe complications of influenza or other respiratory infections,” the report reads.

Blame it on vitamin E? THC? Other?

The report details how, as previously reported, vitamin E acetate was detected in bronchoalveolar lavage fluid samples from 29 patients with EVALI. Although other chemicals could contribute to EVALI, that finding provided “direct evidence” of vitamin E acetate at the primary site of injury, according to CDC.

Most patients with EVALI, 83%, have reported using a tetrahydrocannabinol (THC)-containing e-cigarette or vaping product, according to CDC, while 61% reported using a nicotine-containing product.

Based on that, CDC recommended that people avoid using THC-containing products. However, the agency cautioned that the specific cause or causes of EVALI remain to be elucidated.

“The only way for persons to assure that they are not at risk is to consider refraining from use of all e-cigarette, or vaping, products while this investigation continues,” CDC said in the report.

The need for this additional clinical guidance was assessed in anticipation of the seasonal uptick in influenza and other respiratory infections, according to the CDC, which said the recommendations were based in part on individual clinical perspectives from nine national experts who participated in a previously published clinical guidance on managing patients with EVALI.

SOURCES: Jatlaoui TC et al. MMWR Morb Mortal Wkly Rep. 2019 Nov 19. doi. 10.15585/mmwr.mm6846e2; Chatham-Stephens K et al. MMWR Morb Mortal Wkly Rep. 2019 Nov 19. doi. 10.15585/mmwr.mm6846e1.

“Do you vape?” may be one of the most important questions health care can providers can ask patients who present with respiratory symptoms this winter.

mauro grigollo/Thinkstock

Vaping-related lung injuries cause symptoms such as fever, cough, headache, and fatigue, making it challenging to differentiate them from influenza or respiratory infections, according to the Centers for Disease Control and Prevention.

Accordingly, providers need to ask patients with respiratory, gastrointestinal, or constitutional symptoms about their use of e-cigarette or vaping products, according to one several new CDC recommendations that appear in the Morbidity and Mortality Weekly Review.

“E-cigarette or vaping product use–associated lung injury (EVALI) remains a diagnosis of exclusion because, at present, no specific test or marker exists for its diagnosis, and evaluation should be guided by clinical judgment,” the CDC report reads.

As of Nov. 13, there have been 2,172 cases of EVALI reported to CDC, of which 42 (1.9%) have been fatal. Most of the patients with EVALI have been white (79%), male (68%), and under the age of 35 years (77%), according to CDC data.

Although vitamin E acetate was recently implicated as a potential cause of EVALI, the agency said evidence is “not sufficient” at this point in their investigation to rule out other chemicals of potential concern.

“Many different substances and product sources are still under investigation, and it might be that there is more than one cause of this outbreak,” CDC said.

Further recommendations

Beyond asking about vape use, providers should evaluate suspected EVALI with pulse oximetry and chest imaging, and should consider outpatient management for patients who are clinically stable, according to the recommendations.

The agency said influenza testing should be “strongly considered,” especially during influenza season, given that EVALI is a diagnosis of exclusion and that it may co-occur with other respiratory illnesses. Antimicrobials (including antivirals) should be given as warranted, they added.

Corticosteroids may be helpful in treating EVALI, but may worsen respiratory infections typically seen in outpatients, and so should be prescribed with caution in the outpatient setting, the CDC recommended.

Behavioral counseling, addiction treatment services, and Food and Drug Administration–approved cessation medications are recommended to help patients quit vaping or e-cigarette products, CDC said.

Health care providers should emphasize the importance of an annual flu shot for all patients 6 months of age or older, including those who use e-cigarette or vaping products, according to the agency.

“It is not known whether patients with EVALI are at higher risk for severe complications of influenza or other respiratory infections,” the report reads.

Blame it on vitamin E? THC? Other?

The report details how, as previously reported, vitamin E acetate was detected in bronchoalveolar lavage fluid samples from 29 patients with EVALI. Although other chemicals could contribute to EVALI, that finding provided “direct evidence” of vitamin E acetate at the primary site of injury, according to CDC.

Most patients with EVALI, 83%, have reported using a tetrahydrocannabinol (THC)-containing e-cigarette or vaping product, according to CDC, while 61% reported using a nicotine-containing product.

Based on that, CDC recommended that people avoid using THC-containing products. However, the agency cautioned that the specific cause or causes of EVALI remain to be elucidated.

“The only way for persons to assure that they are not at risk is to consider refraining from use of all e-cigarette, or vaping, products while this investigation continues,” CDC said in the report.

The need for this additional clinical guidance was assessed in anticipation of the seasonal uptick in influenza and other respiratory infections, according to the CDC, which said the recommendations were based in part on individual clinical perspectives from nine national experts who participated in a previously published clinical guidance on managing patients with EVALI.

SOURCES: Jatlaoui TC et al. MMWR Morb Mortal Wkly Rep. 2019 Nov 19. doi. 10.15585/mmwr.mm6846e2; Chatham-Stephens K et al. MMWR Morb Mortal Wkly Rep. 2019 Nov 19. doi. 10.15585/mmwr.mm6846e1.

“Do you vape?” may be one of the most important questions health care can providers can ask patients who present with respiratory symptoms this winter.

mauro grigollo/Thinkstock

Vaping-related lung injuries cause symptoms such as fever, cough, headache, and fatigue, making it challenging to differentiate them from influenza or respiratory infections, according to the Centers for Disease Control and Prevention.

Accordingly, providers need to ask patients with respiratory, gastrointestinal, or constitutional symptoms about their use of e-cigarette or vaping products, according to one several new CDC recommendations that appear in the Morbidity and Mortality Weekly Review.

“E-cigarette or vaping product use–associated lung injury (EVALI) remains a diagnosis of exclusion because, at present, no specific test or marker exists for its diagnosis, and evaluation should be guided by clinical judgment,” the CDC report reads.

As of Nov. 13, there have been 2,172 cases of EVALI reported to CDC, of which 42 (1.9%) have been fatal. Most of the patients with EVALI have been white (79%), male (68%), and under the age of 35 years (77%), according to CDC data.

Although vitamin E acetate was recently implicated as a potential cause of EVALI, the agency said evidence is “not sufficient” at this point in their investigation to rule out other chemicals of potential concern.

“Many different substances and product sources are still under investigation, and it might be that there is more than one cause of this outbreak,” CDC said.

Further recommendations

Beyond asking about vape use, providers should evaluate suspected EVALI with pulse oximetry and chest imaging, and should consider outpatient management for patients who are clinically stable, according to the recommendations.

The agency said influenza testing should be “strongly considered,” especially during influenza season, given that EVALI is a diagnosis of exclusion and that it may co-occur with other respiratory illnesses. Antimicrobials (including antivirals) should be given as warranted, they added.

Corticosteroids may be helpful in treating EVALI, but may worsen respiratory infections typically seen in outpatients, and so should be prescribed with caution in the outpatient setting, the CDC recommended.

Behavioral counseling, addiction treatment services, and Food and Drug Administration–approved cessation medications are recommended to help patients quit vaping or e-cigarette products, CDC said.

Health care providers should emphasize the importance of an annual flu shot for all patients 6 months of age or older, including those who use e-cigarette or vaping products, according to the agency.

“It is not known whether patients with EVALI are at higher risk for severe complications of influenza or other respiratory infections,” the report reads.

Blame it on vitamin E? THC? Other?

The report details how, as previously reported, vitamin E acetate was detected in bronchoalveolar lavage fluid samples from 29 patients with EVALI. Although other chemicals could contribute to EVALI, that finding provided “direct evidence” of vitamin E acetate at the primary site of injury, according to CDC.

Most patients with EVALI, 83%, have reported using a tetrahydrocannabinol (THC)-containing e-cigarette or vaping product, according to CDC, while 61% reported using a nicotine-containing product.

Based on that, CDC recommended that people avoid using THC-containing products. However, the agency cautioned that the specific cause or causes of EVALI remain to be elucidated.

“The only way for persons to assure that they are not at risk is to consider refraining from use of all e-cigarette, or vaping, products while this investigation continues,” CDC said in the report.

The need for this additional clinical guidance was assessed in anticipation of the seasonal uptick in influenza and other respiratory infections, according to the CDC, which said the recommendations were based in part on individual clinical perspectives from nine national experts who participated in a previously published clinical guidance on managing patients with EVALI.

SOURCES: Jatlaoui TC et al. MMWR Morb Mortal Wkly Rep. 2019 Nov 19. doi. 10.15585/mmwr.mm6846e2; Chatham-Stephens K et al. MMWR Morb Mortal Wkly Rep. 2019 Nov 19. doi. 10.15585/mmwr.mm6846e1.

Key clinical point: Patients with migraine were found to be at a higher risk for developing open angle glaucoma (OAG).

Major finding: Risk factors for OAG in patients with migraine were age, hyperlipidemia, and diabetes mellitus. There was 1.68-fold higher risk for OAG in migraine patients aged 49 years or less.

Study details: This was a retrospective matched-cohort study that included data from 17,283 patients with migraine, compared with 69,132 randomly selected patients. Migraine patients were followed for 10 years to determine if they would receive a diagnosis of OAG.

Disclosures: None.

Citation: Huang JY, et al. BMC Ophthalmol. 2019 Feb; doi: 10.1186/s12886-019-1062-9.

Key clinical point: Patients with migraine were found to be at a higher risk for developing open angle glaucoma (OAG).

Major finding: Risk factors for OAG in patients with migraine were age, hyperlipidemia, and diabetes mellitus. There was 1.68-fold higher risk for OAG in migraine patients aged 49 years or less.

Study details: This was a retrospective matched-cohort study that included data from 17,283 patients with migraine, compared with 69,132 randomly selected patients. Migraine patients were followed for 10 years to determine if they would receive a diagnosis of OAG.

Disclosures: None.

Citation: Huang JY, et al. BMC Ophthalmol. 2019 Feb; doi: 10.1186/s12886-019-1062-9.

Key clinical point: Patients with migraine were found to be at a higher risk for developing open angle glaucoma (OAG).

Major finding: Risk factors for OAG in patients with migraine were age, hyperlipidemia, and diabetes mellitus. There was 1.68-fold higher risk for OAG in migraine patients aged 49 years or less.

Study details: This was a retrospective matched-cohort study that included data from 17,283 patients with migraine, compared with 69,132 randomly selected patients. Migraine patients were followed for 10 years to determine if they would receive a diagnosis of OAG.

Disclosures: None.

Citation: Huang JY, et al. BMC Ophthalmol. 2019 Feb; doi: 10.1186/s12886-019-1062-9.

Key clinical point: Gender-related differences should be kept in mind when it comes to experiments and treatment approaches for migraine patients

Major finding: Female migraine patients were found to be more anxious, compared with male patients. They also had “more severe impairment in attentive processing of visual stimuli than their male counterparts,” noted the investigators.

Study details: Forty-six migraine patients without aura (23 females) and 46 age-matched healthy controls (23 females) were evaluated and analyzed using a three-stimulus oddball paradigm.

Disclosures: None.

Citation: Guo Y, et al. J Headache Pain. 2019;20(1):38. doi: 10.1186/s10194-019-0995-y.

Key clinical point: Gender-related differences should be kept in mind when it comes to experiments and treatment approaches for migraine patients

Major finding: Female migraine patients were found to be more anxious, compared with male patients. They also had “more severe impairment in attentive processing of visual stimuli than their male counterparts,” noted the investigators.

Study details: Forty-six migraine patients without aura (23 females) and 46 age-matched healthy controls (23 females) were evaluated and analyzed using a three-stimulus oddball paradigm.

Disclosures: None.

Citation: Guo Y, et al. J Headache Pain. 2019;20(1):38. doi: 10.1186/s10194-019-0995-y.

Key clinical point: Gender-related differences should be kept in mind when it comes to experiments and treatment approaches for migraine patients

Major finding: Female migraine patients were found to be more anxious, compared with male patients. They also had “more severe impairment in attentive processing of visual stimuli than their male counterparts,” noted the investigators.

Study details: Forty-six migraine patients without aura (23 females) and 46 age-matched healthy controls (23 females) were evaluated and analyzed using a three-stimulus oddball paradigm.

Disclosures: None.

Citation: Guo Y, et al. J Headache Pain. 2019;20(1):38. doi: 10.1186/s10194-019-0995-y.

Key clinical point: Migraine affects millions of patients in Europe. Yet, there aren’t enough specialists adhering to the national and international guidelines on migraines to treat those patients.

Major finding: Patients had seen general practitioners and neurologists for one year prior to seeing specialists. Fifty percent of those patients underwent unnecessary diagnostics and 34.2% had not been treated according to the recommended treatment guidelines.

Study details: Data was collected from 1,935 migraine patients between 2010 and 2018 visiting a headache clinic via standardized questionnaires regarding their prior history and treatment.

Disclosures: None.

Citation: Ziegeler C, et al. J Headache Pain. 2019;20(1):86. doi: 10.1186/s10194-019-1034-8.

Key clinical point: Migraine affects millions of patients in Europe. Yet, there aren’t enough specialists adhering to the national and international guidelines on migraines to treat those patients.

Major finding: Patients had seen general practitioners and neurologists for one year prior to seeing specialists. Fifty percent of those patients underwent unnecessary diagnostics and 34.2% had not been treated according to the recommended treatment guidelines.

Study details: Data was collected from 1,935 migraine patients between 2010 and 2018 visiting a headache clinic via standardized questionnaires regarding their prior history and treatment.

Disclosures: None.

Citation: Ziegeler C, et al. J Headache Pain. 2019;20(1):86. doi: 10.1186/s10194-019-1034-8.

Key clinical point: Migraine affects millions of patients in Europe. Yet, there aren’t enough specialists adhering to the national and international guidelines on migraines to treat those patients.

Major finding: Patients had seen general practitioners and neurologists for one year prior to seeing specialists. Fifty percent of those patients underwent unnecessary diagnostics and 34.2% had not been treated according to the recommended treatment guidelines.

Study details: Data was collected from 1,935 migraine patients between 2010 and 2018 visiting a headache clinic via standardized questionnaires regarding their prior history and treatment.

Disclosures: None.

Citation: Ziegeler C, et al. J Headache Pain. 2019;20(1):86. doi: 10.1186/s10194-019-1034-8.

Google: A hypochondriac’s dream

Thanks to Google, we have basically free and unlimited access to a huge amount of information right at our fingertips. So when you’re laid up at home with a cold that seems to be taking a turn for the worse, it’s only natural to pull out your phone and ask Google all about your strange new symptoms. After all, the doctor’s office is so far away, and it costs money and time, and who even wants to deal with doctors anyway?

spukkato/Thinkstock

According to a survey commissioned by LetsGetChecked, you’d hardly be alone in turning to Dr. Google. Although 51% of the 2,000 survey respondents consulted a doctor as their first choice for medical help, 65% admitted that they use Google to self-diagnose, 26% have no primary care physician, and about 60% actively avoid doctor’s offices.

So, for the two-thirds of Americans who made an appointment with the good internet doctor, how did things turn out? Not well. About three-quarters reported worrying more afterward, and 43% of all survey respondents managed to convince themselves that they had contracted a serious illness. And the information they looked up? It was wrong more than 60% of the time.

As it turns out, a trained medical professional is actually better than a search engine. Now all we need to do is make accessing health care cheaper, more convenient, and easier to understand. No problem, right?
 

Better the second time around?

“What’s this stuff?”

tezzstock/Thinkstock

“Recycled water. Supposed to taste just like regular water.”

“Did you drink it?”

“I’m not gonna drink it. You drink it.”

“I’m not gonna drink it.”

“Let’s get Mikey!”

“He won’t drink it. He hates everything.”

This time, the kids were right. Mikey did hate the recycled wastewater, or to be more accurate, he was disgusted by it. Like most people, he supports the idea of water conservation but is too disgusted by the source of recycled water to drink it, according to investigators at the University of California, Riverside.

In three separate experiments, volunteers were shown videos about water. One was about water conservation, another was about the urban myth that crocodiles live in New York City sewers, and the third was an educational video demonstrating that recycled wastewater is contaminant free.

In the first experiment, half of the subjects watched the conservation video and half watched the NYC sewer video. Afterward, nearly all participants in each group said no thanks to recycling. In the second experiment, subjects from the two video-watching groups were all shown the third video on recycled water’s purity. That led to a small but insubstantial increase in willingness to use recycled water.

In the third experiment, each of three groups watched one of the videos. Afterward, all subjects were asked to sign a petition supporting conservation and were offered a bottle of water labeled “SMARTdrop – Pure Recycled Water.” About two-thirds of each group signed the petition and took the bottle despite the investigators’ expectation that the group watching the water purity video would have greater acceptance.

Messaging involving water scarcity and conservation alone may not be enough in this case. Instead, the researchers urged “a focus on the more visceral roadblock of disgust.”

Maybe, or maybe not. For now, let’s get back to Mikey and company.

“Don’t tell the kids it’s the recycled wastewater you’ve been trying to get them to drink. You’re the only one who has to know.”
 

Chicken soup for the malarial soul

A nice hot cup of soup: The refuge of concerned parents who managed to resist looking at Google and decided that their child’s cold wasn’t actually stage IV lung cancer. It’s good, and it’s good for you. But just how good for you? Could the healing powers of soup be harnessed to treat something like, say, malaria?

Van Tan Tran/CC0 Public Domain

The research, published in Archives of Disease in Childhood, has perhaps the most adorable setup of any study our cold, stony hearts at LOTME world headquarters have ever seen. The researchers went to a London primary school and asked a group of students to bring in homemade soup for testing and analysis. The students obliged, bringing in dozens of unique soups, of which 56 were tested for 72 hours against the deadliest malaria species, Plasmodium falciparum.

Not every soup was effective, but extracts from five broths were able to halt growth of sexually immature parasites by more than 50%, two of which were about as effective as dihydroartemisinin, a leading antimalarial drug. In addition, four other broths were more than 50% effective at blocking sexual maturation.

The researchers noted that they haven’t analyzed the ingredients of the soups yet and that the utility of soup in combating malaria will depend on a number of factors; regardless, we hope those kids got some serious extra credit. Curing malaria is way more impressive than knowing that mitochondria are the powerhouse of the cell.

Google: A hypochondriac’s dream

Thanks to Google, we have basically free and unlimited access to a huge amount of information right at our fingertips. So when you’re laid up at home with a cold that seems to be taking a turn for the worse, it’s only natural to pull out your phone and ask Google all about your strange new symptoms. After all, the doctor’s office is so far away, and it costs money and time, and who even wants to deal with doctors anyway?

spukkato/Thinkstock

According to a survey commissioned by LetsGetChecked, you’d hardly be alone in turning to Dr. Google. Although 51% of the 2,000 survey respondents consulted a doctor as their first choice for medical help, 65% admitted that they use Google to self-diagnose, 26% have no primary care physician, and about 60% actively avoid doctor’s offices.

So, for the two-thirds of Americans who made an appointment with the good internet doctor, how did things turn out? Not well. About three-quarters reported worrying more afterward, and 43% of all survey respondents managed to convince themselves that they had contracted a serious illness. And the information they looked up? It was wrong more than 60% of the time.

As it turns out, a trained medical professional is actually better than a search engine. Now all we need to do is make accessing health care cheaper, more convenient, and easier to understand. No problem, right?
 

Better the second time around?

“What’s this stuff?”

tezzstock/Thinkstock

“Recycled water. Supposed to taste just like regular water.”

“Did you drink it?”

“I’m not gonna drink it. You drink it.”

“I’m not gonna drink it.”

“Let’s get Mikey!”

“He won’t drink it. He hates everything.”

This time, the kids were right. Mikey did hate the recycled wastewater, or to be more accurate, he was disgusted by it. Like most people, he supports the idea of water conservation but is too disgusted by the source of recycled water to drink it, according to investigators at the University of California, Riverside.

In three separate experiments, volunteers were shown videos about water. One was about water conservation, another was about the urban myth that crocodiles live in New York City sewers, and the third was an educational video demonstrating that recycled wastewater is contaminant free.

In the first experiment, half of the subjects watched the conservation video and half watched the NYC sewer video. Afterward, nearly all participants in each group said no thanks to recycling. In the second experiment, subjects from the two video-watching groups were all shown the third video on recycled water’s purity. That led to a small but insubstantial increase in willingness to use recycled water.

In the third experiment, each of three groups watched one of the videos. Afterward, all subjects were asked to sign a petition supporting conservation and were offered a bottle of water labeled “SMARTdrop – Pure Recycled Water.” About two-thirds of each group signed the petition and took the bottle despite the investigators’ expectation that the group watching the water purity video would have greater acceptance.

Messaging involving water scarcity and conservation alone may not be enough in this case. Instead, the researchers urged “a focus on the more visceral roadblock of disgust.”

Maybe, or maybe not. For now, let’s get back to Mikey and company.

“Don’t tell the kids it’s the recycled wastewater you’ve been trying to get them to drink. You’re the only one who has to know.”
 

Chicken soup for the malarial soul

A nice hot cup of soup: The refuge of concerned parents who managed to resist looking at Google and decided that their child’s cold wasn’t actually stage IV lung cancer. It’s good, and it’s good for you. But just how good for you? Could the healing powers of soup be harnessed to treat something like, say, malaria?

Van Tan Tran/CC0 Public Domain

The research, published in Archives of Disease in Childhood, has perhaps the most adorable setup of any study our cold, stony hearts at LOTME world headquarters have ever seen. The researchers went to a London primary school and asked a group of students to bring in homemade soup for testing and analysis. The students obliged, bringing in dozens of unique soups, of which 56 were tested for 72 hours against the deadliest malaria species, Plasmodium falciparum.

Not every soup was effective, but extracts from five broths were able to halt growth of sexually immature parasites by more than 50%, two of which were about as effective as dihydroartemisinin, a leading antimalarial drug. In addition, four other broths were more than 50% effective at blocking sexual maturation.

The researchers noted that they haven’t analyzed the ingredients of the soups yet and that the utility of soup in combating malaria will depend on a number of factors; regardless, we hope those kids got some serious extra credit. Curing malaria is way more impressive than knowing that mitochondria are the powerhouse of the cell.

Google: A hypochondriac’s dream

Thanks to Google, we have basically free and unlimited access to a huge amount of information right at our fingertips. So when you’re laid up at home with a cold that seems to be taking a turn for the worse, it’s only natural to pull out your phone and ask Google all about your strange new symptoms. After all, the doctor’s office is so far away, and it costs money and time, and who even wants to deal with doctors anyway?

spukkato/Thinkstock

According to a survey commissioned by LetsGetChecked, you’d hardly be alone in turning to Dr. Google. Although 51% of the 2,000 survey respondents consulted a doctor as their first choice for medical help, 65% admitted that they use Google to self-diagnose, 26% have no primary care physician, and about 60% actively avoid doctor’s offices.

So, for the two-thirds of Americans who made an appointment with the good internet doctor, how did things turn out? Not well. About three-quarters reported worrying more afterward, and 43% of all survey respondents managed to convince themselves that they had contracted a serious illness. And the information they looked up? It was wrong more than 60% of the time.

As it turns out, a trained medical professional is actually better than a search engine. Now all we need to do is make accessing health care cheaper, more convenient, and easier to understand. No problem, right?
 

Better the second time around?

“What’s this stuff?”

tezzstock/Thinkstock

“Recycled water. Supposed to taste just like regular water.”

“Did you drink it?”

“I’m not gonna drink it. You drink it.”

“I’m not gonna drink it.”

“Let’s get Mikey!”

“He won’t drink it. He hates everything.”

This time, the kids were right. Mikey did hate the recycled wastewater, or to be more accurate, he was disgusted by it. Like most people, he supports the idea of water conservation but is too disgusted by the source of recycled water to drink it, according to investigators at the University of California, Riverside.

In three separate experiments, volunteers were shown videos about water. One was about water conservation, another was about the urban myth that crocodiles live in New York City sewers, and the third was an educational video demonstrating that recycled wastewater is contaminant free.

In the first experiment, half of the subjects watched the conservation video and half watched the NYC sewer video. Afterward, nearly all participants in each group said no thanks to recycling. In the second experiment, subjects from the two video-watching groups were all shown the third video on recycled water’s purity. That led to a small but insubstantial increase in willingness to use recycled water.

In the third experiment, each of three groups watched one of the videos. Afterward, all subjects were asked to sign a petition supporting conservation and were offered a bottle of water labeled “SMARTdrop – Pure Recycled Water.” About two-thirds of each group signed the petition and took the bottle despite the investigators’ expectation that the group watching the water purity video would have greater acceptance.

Messaging involving water scarcity and conservation alone may not be enough in this case. Instead, the researchers urged “a focus on the more visceral roadblock of disgust.”

Maybe, or maybe not. For now, let’s get back to Mikey and company.

“Don’t tell the kids it’s the recycled wastewater you’ve been trying to get them to drink. You’re the only one who has to know.”
 

Chicken soup for the malarial soul

A nice hot cup of soup: The refuge of concerned parents who managed to resist looking at Google and decided that their child’s cold wasn’t actually stage IV lung cancer. It’s good, and it’s good for you. But just how good for you? Could the healing powers of soup be harnessed to treat something like, say, malaria?

Van Tan Tran/CC0 Public Domain

The research, published in Archives of Disease in Childhood, has perhaps the most adorable setup of any study our cold, stony hearts at LOTME world headquarters have ever seen. The researchers went to a London primary school and asked a group of students to bring in homemade soup for testing and analysis. The students obliged, bringing in dozens of unique soups, of which 56 were tested for 72 hours against the deadliest malaria species, Plasmodium falciparum.

Not every soup was effective, but extracts from five broths were able to halt growth of sexually immature parasites by more than 50%, two of which were about as effective as dihydroartemisinin, a leading antimalarial drug. In addition, four other broths were more than 50% effective at blocking sexual maturation.

The researchers noted that they haven’t analyzed the ingredients of the soups yet and that the utility of soup in combating malaria will depend on a number of factors; regardless, we hope those kids got some serious extra credit. Curing malaria is way more impressive than knowing that mitochondria are the powerhouse of the cell.

Roughly a third of patients with heart failure also have atrial fibrillation, a comorbid combination notorious for working synergistically to worsen a patient’s quality of life and life expectancy.

During the past year, radiofrequency catheter ablation of atrial fibrillation in patients with both conditions has gathered steam as a way to intervene in at least selected patients, driven by study results that featured attention-grabbing reductions in death and cardiovascular hospitalizations.

Mitchel L. Zoler/MDedge News

The evidence favoring catheter ablation of atrial fibrillation (AFib) in patients with heart failure, particularly patients with heart failure with reduced ejection fraction (HFrEF), ramped up in 2019, spurred largely by a subgroup analysis from the CABANA trial, the largest randomized comparison by far of AFib ablation with antiarrhythmic drug treatment with 2,204 patients.

The past few months also featured release of two meta-analyses that took the CABANA results into account plus findings from about a dozen earlier randomized studies. Both meta-analyses, as well as the heart failure analysis from CABANA, all point in one direction, as stated in the conclusion of one of the meta-analyses: “In patients with AFib, catheter ablation is associated with all-cause mortality benefit, compared with medical therapy, that is driven by patients with AFib and HFrEF. Catheter ablation is safe and reduces cardiovascular hospitalizations and recurrences of atrial arrhythmias” both in patients with paroxysmal and persistent AFib,” wrote Stavros Stavrakis, MD, and his associates in their systematic review of 18 randomized, controlled trials of catheter ablation of AFib in a total of 4,464 patients with or without heart failure (Circ Arrhythm Electrophysiol. 2019 Sep;12[9]: e007414).

Despite these new data and analyses, clinicians seem to have very mixed reactions. Some call for an upgraded recommendation by professional societies that would support more aggressive use of AFib ablation in heart failure patients, and the anecdotal impressions of people who manage these patients are that ablation procedures have recently increased. But others advise caution, and note that in their opinion the efficacy data remain preliminary; the procedure has safety, logistical, and economic concerns; and questions remain about the ability of all active ablation programs to consistently deliver the results seen in published trials.

The meta-analysis led by Dr. Stavrakis showed that catheter ablation of AFib cut all-cause mortality during follow-up by a statistically significant 31%, compared with medical therapy, in all patients regardless of their heart failure status. But in patients with HFrEF, the reduction was 48%, along with a 38% cut in cardiovascular hospitalizations. In contrast, patients without heart failure who underwent AFib ablation showed no significant change in their all-cause mortality, compared with medical management of these patients.

“Based both on our meta-analysis and the CABANA data, patients with AFib most likely to benefit from ablation are patients younger than 65 and those with heart failure,” summed up Dr. Stavrakis, a cardiac electrophysiologist at the Heart Rhythm Institute of the University of Oklahoma in Oklahoma City.

The second meta-analysis, which initially appeared in July, analyzed data from 11 randomized trials of catheter ablations compared with anti-arrhythmic medical therapy for rate or rhythm control with in a total of 3,598 patients who all had heart failure, again including the patients enrolled in the CABANA study. The results showed a significant 49% relative drop in all cause mortality with ablation compared with medical treatment, and a statistically significant 56% cut in hospitalizations, as well as a significant, nearly 7% average, absolute improvement in left ventricular ejection fraction, plus benefits for preventing arrhythmia recurrence and improving quality of life (Eur Heart J. 2019 Jul 11. doi: 10.1093/eurheartj/ehz443).

“The magnitude of the effect seen in the meta-analysis, a 49% reduction in total mortality and a 56% reduction in hospitalizations, is rather staggering, and is larger than typically quoted for other medical interventions or device therapy in heart failure. The treatment effect was uniform among studies, and entirely compatible with the changes in left ventricular function, exercise capacity, and heart failure symptoms. Therefore, although more data are desirable, there are already arguably sufficient data to understand a great deal regarding the impact of a fib ablation,” commented Ross J. Hunter, MRCP, a cardiac electrophysiologist at Barts Heart Centre in London, and his associates in an editorial about this meta-analysis (Eur Heart J. 2019 Oct 22. doi: 10.1093/eurheartj/ehz704).

Mitchel L. Zoler/MDedge News

The heart failure analysis of CABANA (Catheter Ablation vs. Anti-Arrhythmic Drug Therapy for Atrial Fibrillation Trial) itself also showed striking findings when first reported at the annual scientific sessions of the Heart Rhythm Society last May. In presentations he made at this meeting, Douglas L. Packer, MD, CABANA’s lead investigator, reported details of a prespecified subgroup analysis of the 778 patients enrolled in CABANA who had heart failure at baseline, slightly more than a third of the total study enrollment. This was more than double the number of patients identified as specifically having heart failure at entry in the initial publication of CABANA’s findings (JAMA. 2019 Mar 15;321[134]:1261-74). Comparison of the 378 patients with heart failure and randomized to undergo ablation with the 400 with heart failure randomized to medical treatment showed a 36% reduction in the study’s primary, composite endpoint relative to the control group in an intention-to-treat analysis, and a 43% relative cut in all-cause mortality during follow-up, Dr. Packer reported at the May meeting. (As of early November 2019, these results had not yet appeared in a published article.) In contrast, in the 1,422 CABANA patients randomized who did not have heart failure, ablation produced results for these endpoints that were similar to and not statistically different from the outcomes in patients treated medically, said Dr. Packer, a cardiac electrophysiologist and professor of medicine at the Mayo Clinic in Rochester, Minn.

The CABANA results added to what had been previously reported from two other landmark studies that documented incremental efficacy of AFib ablation compared with medical treatment in patients with heart failure: The AATAC (Ablation vs Amiodarone for Treatment of AFib in Patients With Congestive HF and an Implanted Device) study, which randomized 203 patients (Circulation. 2016 Apr 26;133[17]:1637-44), and CASTLE-AF (Catheter Ablation vs. Standard Conventional Therapy in Patients with Left Ventricular Dysfunction and Atrial Fibrillation) trial, which randomized 363 patients (N Engl J Med. 2018 Feb 1;378[5]:417-27). These three studies contributed the most patients and outcomes to the two recent meta-analyses.

Mitchel L. Zoler/MDedge News

“The CASTLE-AF and AATAC trials both showed improved cardiovascular outcomes with ablation in patients with heart failure and AFib. The meta-analysis [by Dr. Stavrakis and his associates] and CABANA subgroup analysis further support use of catheter ablation to improve the outcomes in these patients,” noted Jonathan P. Piccini, MD, a cardiac electrophysiologist at Duke University, Durham, N.C., and a CABANA coinvestigator.

“The CABANA trial was very important because it confirmed the safety of catheter ablation, and more importantly suggested that patients with heart failure may benefit the most [from AFib ablation]. The evidence is very strong to advocate ablation as first-line therapy for selected patients with heart failure. Perhaps the optimal patients are those with [New York Heart Association] class I-III or ambulatory class IV heart failure who are on optimized, guideline-directed medical therapy. We have enough data to make this a class I recommendation. The question that remains is whether this is a cost effective strategy. Because it lowers rehospitalization and death, I suspect it is,” said Luigi Di Biase, MD, lead investigator of AATAC, and director of arrhythmia services at Montefiore Medical Center and professor of medicine at Albert Einstein College of Medicine, both in New York.

Opinions differ on AFib ablation’s role

Despite this expansive assessment of the current status of AFib ablation for patients with heart failure from Dr. Di Biase and shared by others, another camp of cardiologists currently sees ablation as having more limited current utility, as recommended earlier this year by a guideline-update panel representing the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society. The guideline update included this new recommendation for how to use AFib ablation in heart failure patients: “AF catheter ablation may be reasonable in selected patients with symptomatic AFib and heart failure with reduced left ventricular ejection fraction to potentially lower mortality rate and reduce hospitalization for heart failure,” a class IIb recommendation. (J Am Coll Cardiol. 2019 Jul 9;74[1]:104-32). The guideline’s text cited the findings from AATAC and CASTLE-AF, but qualified both studies as “relatively small” and with “highly selected patient populations.” The guideline also incorporated the CABANA results into its considerations (although they may not have had the full analysis in heart failure patients available during their deliberations), but cited the study’s main limitation: CABANA failed to show a statistically significant difference in the primary endpoint in its primary, intention-to-treat analysis, which meant that by the strict statistical criteria that trialists apply to study findings, all other endpoints analyzed using CABANA’s are merely “hypothesis generating” and not definitive.

Questions about the extent of patient selection required to see a clear clinical-endpoint benefit from AFib ablation in heart failure patients, as well as the flawed validity of the CABANA results for making unqualified practice recommendation are the main arguments advanced by experts who caution against broader and more routine ablations.

Mitchel L. Zoler/MDedge News

“The findings from the heart failure subgroup of CABANA are hypothesis generating rather than definitive. Even with the recent meta-analysis, uncertainty remains regarding the ability of catheter ablation to improve outcomes beyond reducing AFib-related symptoms,” commented Gregg Fonarow, MD, a heart failure physician and professor of medicine at the University of California, Los Angeles.

“CASTLE-HF had fewer than 100 deaths combined in both arms, which means very unstable results. We don’t know a lot of detail about the heart failure patients in CABANA, and overall we do not have much data from patients with heart failure with preserved ejection fraction [HFpEF],” said Javed Butler, MD, a heart failure physician and professor and chairman of medicine at the University of Mississippi in Jackson. Dr. Butler also voiced his concerns (shared by other heart failure specialists) about the safety of ablation in heart failure patients, noting that “many patients require multiple ablations; many burns result in scarring and can worsen atrial function. In short, ablation of AFib is probably good for selected patients, but to have a class 1 recommendation, we need much larger trials with well-phenotyped heart failure patients,” Dr. Butler said in an interview.

Mitchel L. Zoler/MDedge News

“The totality of data still captures a relatively small number of patients. CASTLE-HF took 8 years to enroll fewer than 400 patients, and the results showed some heterogeneity. Study patients were a decade younger than average HFrEF patients in the community, and thus the effectiveness and safety of catheter ablation in people with more comorbidity and frailty remains in question. Certain HFrEF patients may be less likely to benefit, such as those with amyloid cardiomyopathy. And with the increasing availability of other treatments for HFrEF such as sacubitril/valsartan, dapagliflozin, and MitraClip, it is less clear how catheter ablation would [benefit patients] on top of what is now current best therapy,” said Larry Allen, MD, a heart failure physician and professor of medicine at the University of Colorado in Aurora.

“With these limitations and the fact that catheter ablation is not a simple procedure, a large randomized, controlled trial of ablation, compared with no ablation, in a wide range of HFrEF patients on contemporary therapy would be welcome,” Dr. Allen said. “Given the prevalence of heart failure and AFib and the potential positive and negative implications of catheter ablation running such a trial seems critical for patients and for society.”

“For ablation of AFib in heart failure to become a class I recommendation there will need to be results from larger randomized studies,” summed up Dr. Stavrakis. The meta-analysis that he coauthored noted that “the benefits of catheter ablation for AFib in HFrEF patients have been consistently shown for over a decade now; however, the uptake of this procedure by clinicians in practice has been slow.”

Despite this history of reticence and ongoing caution about ablation, some cardiology experts see the indications for AFib ablation in heart failure steadily creeping forward, buoyed by a safety record that has more benign than ablation’s reputation suggests.

Mitchel L. Zoler/MDedge News

The CABANA results showed that “ablation is remarkably safe in the hands of experienced clinicians, with risks comparable to anti-arrhythmic drugs,” said Peter R. Kowey, MD, a specialist in treating AFib and professor of medicine at Thomas Jefferson University in Philadelphia, who made this assessment during a talk at an AFib meeting in early 2019. Dr. Kowey’s take on what the CABANA safety data showed contrasts with the impression of other cardiologists who are wary of perceived dangers from ablation.

“Ablation comes with a lot of morbidity and mortality. It’s not that the idea of ablation is wrong, but the ability to do it without a lot of adverse effects. ... We’re not quite there yet,” said Douglas L. Mann, MD, a heart failure physician and professor of medicine and chief of the cardiovascular division at Washington University in St. Louis.

“If I had a patient with HFrEF and AFib who was really sick, I’m not so sure I’d send them for ablation, which is not a simple procedure. The patients we tend to send for ablation are selected. Ablation is a big undertaking in patients who are already sick, and it’s expensive. I don’t think the data we have now will change the consensus view, but every heart failure physician is sending some patients for AFib ablation. People are turning to AFib ablation earlier than before. I think the consensus is that ablation is for symptoms or poor rate control, not for better outcomes,” said Mariell Jessup, MD, a heart failure specialist and chief science and medical officer of the American Heart Association in Dallas.

However, this caution about safety and skepticism over efficacy may be dissipating as experience with ablation accumulates.

“CASTLE-AF and other data, including evidence for the apparent isolation of beta-blocker benefit to patients in sinus rhythm, have made me much more proactive about considering catheter ablation in my HFrEF patients. I think many other cardiologists have a similar view,” said Dr. Allen in an interview.

“A lot [of heart failure] patients are [being] referred for ablation, depending on the practice, setting, the local availability of electrophysiologists, and patient interest in ablation,” said Dr. Butler.

Mitchel L. Zoler/MDedge News

“We have no absolutely compelling data, but the data we have all point in the same direction. Like most, I am becoming convinced that AFib ablation in heart failure patients is a very valuable method for managing patients, but I can’t point to one study that was conclusive. Results from lots of studies show that it is likely, and when you add them all together it looks indisputable,” commented A. John Camm, MD, an atrial fibrillation specialist and professor of clinical cardiology at St. George’s University in London. “The findings put a responsibility on cardiologists to assess patients with heart failure for AFib. But there are nothing like enough resources to deal with all the patients who have heart failure who also have AFib.”

A rough estimate of just the U.S. volume of patients with heart failure and AFib is likely in the ball park of 2 million people (a third of the estimated 6 million American currently living with heart failure), and with the prevalence of each of these disorders rising precipitously (more than 5 million Americans have AFib) the confluence of the two should also show a steady increase. “It will take a major change in our concept of heart failure management to really address this. Potentially it would mean a large increase in the number of RF ablations of AFib, but the resources for that are not now present,” Dr. Camm said in an interview.

The attractions of catheter ablation also stand in contrast to the limitations of alternative treatments. Ablation is effective in a majority of patients for reducing AFib burden, both the frequency and duration of AFib episodes, and safety issues are mostly limited to the procedural and immediate postprocedural periods. The drugs available for trying to control AFib are beta-blockers, which provide rate control and can help prevent AFib onset, and rhythm-controlling anti-arrhythmic drugs like amiodarone, which have substantial limitations in both their ability to prevent arrhythmia recurrences as well as for safety.

“Most of the conventional antiarrhythmic drugs are contraindicated, frequently ineffective, or not well tolerated in patients with HFrEF. Catheter ablation of AFib provides an increasingly important option for rhythm control in these patients without using antiarrhythmic drugs,” Dr. Di Biase and his associates wrote in a recent review of AFib ablation in heart failure patients (Eur Heart J. 2019 Feb 21;40[8]:663-71).

“The guidelines that are controversial still make amiodarone a class I drug even though it’s been associated with serious side effects and has been shown in several heart failure trials to increase mortality. I can’t believe that ablation is a class IIb recommendation while a drug like amiodarone is a class I recommendation,” Dr. Di Biase said.

And although beta-blockers are a mainstay of heart failure treatment, once AFib becomes established they are less useful for maintaining sinus rhythm. “Beta-blockers provide effective rate control, but they can’t convert patients to sinus rhythm [once AFib begins], and there is no convincing evidence that patients on beta-blockers stay in sinus rhythm longer. You can’t just say: the patient is on a beta-blocker so I’ve done my best,” noted Dr. Jessup.

CABANA received funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Stavrakis, Dr, Jessup, and Dr. Di Biase. Dr. Hunter has received research funding, educational grants, and speakers fees from Biosense Webster and Medtronic. Dr. Packer had received honoraria from Biotronik and MediaSphere Medical and research support from several companies. Dr. Piccini has been a consultant to Allergan, Biotronik, Medtronic, Phillips, and Sanofi Aventis, he has received research funding from Abbott, ARCA biopharma, Boston Scientific, Gilead, and Johnson & Johnson, and he had a financial relationship with GlaxoSmithKline. Dr. Fonarow has been a consultant to Abbott, Amgen, Bayer, Janssen, and Novartis. Dr. Butler has been a consultant to several companies. Dr. Allen has been a consultant to Boston Scientific, Janssen, and Novartis. Dr. Kowey has been a consultant to several companies. Dr. Mann has been a consultant to Bristol-Myers Squibb, Corvia, and Novartis, and an adviser to miRagen. Dr. Camm has been a consultant to several companies.

This is part one of a two-part article.

[email protected]

Roughly a third of patients with heart failure also have atrial fibrillation, a comorbid combination notorious for working synergistically to worsen a patient’s quality of life and life expectancy.

During the past year, radiofrequency catheter ablation of atrial fibrillation in patients with both conditions has gathered steam as a way to intervene in at least selected patients, driven by study results that featured attention-grabbing reductions in death and cardiovascular hospitalizations.

Mitchel L. Zoler/MDedge News

The evidence favoring catheter ablation of atrial fibrillation (AFib) in patients with heart failure, particularly patients with heart failure with reduced ejection fraction (HFrEF), ramped up in 2019, spurred largely by a subgroup analysis from the CABANA trial, the largest randomized comparison by far of AFib ablation with antiarrhythmic drug treatment with 2,204 patients.

The past few months also featured release of two meta-analyses that took the CABANA results into account plus findings from about a dozen earlier randomized studies. Both meta-analyses, as well as the heart failure analysis from CABANA, all point in one direction, as stated in the conclusion of one of the meta-analyses: “In patients with AFib, catheter ablation is associated with all-cause mortality benefit, compared with medical therapy, that is driven by patients with AFib and HFrEF. Catheter ablation is safe and reduces cardiovascular hospitalizations and recurrences of atrial arrhythmias” both in patients with paroxysmal and persistent AFib,” wrote Stavros Stavrakis, MD, and his associates in their systematic review of 18 randomized, controlled trials of catheter ablation of AFib in a total of 4,464 patients with or without heart failure (Circ Arrhythm Electrophysiol. 2019 Sep;12[9]: e007414).

Despite these new data and analyses, clinicians seem to have very mixed reactions. Some call for an upgraded recommendation by professional societies that would support more aggressive use of AFib ablation in heart failure patients, and the anecdotal impressions of people who manage these patients are that ablation procedures have recently increased. But others advise caution, and note that in their opinion the efficacy data remain preliminary; the procedure has safety, logistical, and economic concerns; and questions remain about the ability of all active ablation programs to consistently deliver the results seen in published trials.

The meta-analysis led by Dr. Stavrakis showed that catheter ablation of AFib cut all-cause mortality during follow-up by a statistically significant 31%, compared with medical therapy, in all patients regardless of their heart failure status. But in patients with HFrEF, the reduction was 48%, along with a 38% cut in cardiovascular hospitalizations. In contrast, patients without heart failure who underwent AFib ablation showed no significant change in their all-cause mortality, compared with medical management of these patients.

“Based both on our meta-analysis and the CABANA data, patients with AFib most likely to benefit from ablation are patients younger than 65 and those with heart failure,” summed up Dr. Stavrakis, a cardiac electrophysiologist at the Heart Rhythm Institute of the University of Oklahoma in Oklahoma City.

The second meta-analysis, which initially appeared in July, analyzed data from 11 randomized trials of catheter ablations compared with anti-arrhythmic medical therapy for rate or rhythm control with in a total of 3,598 patients who all had heart failure, again including the patients enrolled in the CABANA study. The results showed a significant 49% relative drop in all cause mortality with ablation compared with medical treatment, and a statistically significant 56% cut in hospitalizations, as well as a significant, nearly 7% average, absolute improvement in left ventricular ejection fraction, plus benefits for preventing arrhythmia recurrence and improving quality of life (Eur Heart J. 2019 Jul 11. doi: 10.1093/eurheartj/ehz443).

“The magnitude of the effect seen in the meta-analysis, a 49% reduction in total mortality and a 56% reduction in hospitalizations, is rather staggering, and is larger than typically quoted for other medical interventions or device therapy in heart failure. The treatment effect was uniform among studies, and entirely compatible with the changes in left ventricular function, exercise capacity, and heart failure symptoms. Therefore, although more data are desirable, there are already arguably sufficient data to understand a great deal regarding the impact of a fib ablation,” commented Ross J. Hunter, MRCP, a cardiac electrophysiologist at Barts Heart Centre in London, and his associates in an editorial about this meta-analysis (Eur Heart J. 2019 Oct 22. doi: 10.1093/eurheartj/ehz704).

Mitchel L. Zoler/MDedge News

The heart failure analysis of CABANA (Catheter Ablation vs. Anti-Arrhythmic Drug Therapy for Atrial Fibrillation Trial) itself also showed striking findings when first reported at the annual scientific sessions of the Heart Rhythm Society last May. In presentations he made at this meeting, Douglas L. Packer, MD, CABANA’s lead investigator, reported details of a prespecified subgroup analysis of the 778 patients enrolled in CABANA who had heart failure at baseline, slightly more than a third of the total study enrollment. This was more than double the number of patients identified as specifically having heart failure at entry in the initial publication of CABANA’s findings (JAMA. 2019 Mar 15;321[134]:1261-74). Comparison of the 378 patients with heart failure and randomized to undergo ablation with the 400 with heart failure randomized to medical treatment showed a 36% reduction in the study’s primary, composite endpoint relative to the control group in an intention-to-treat analysis, and a 43% relative cut in all-cause mortality during follow-up, Dr. Packer reported at the May meeting. (As of early November 2019, these results had not yet appeared in a published article.) In contrast, in the 1,422 CABANA patients randomized who did not have heart failure, ablation produced results for these endpoints that were similar to and not statistically different from the outcomes in patients treated medically, said Dr. Packer, a cardiac electrophysiologist and professor of medicine at the Mayo Clinic in Rochester, Minn.

The CABANA results added to what had been previously reported from two other landmark studies that documented incremental efficacy of AFib ablation compared with medical treatment in patients with heart failure: The AATAC (Ablation vs Amiodarone for Treatment of AFib in Patients With Congestive HF and an Implanted Device) study, which randomized 203 patients (Circulation. 2016 Apr 26;133[17]:1637-44), and CASTLE-AF (Catheter Ablation vs. Standard Conventional Therapy in Patients with Left Ventricular Dysfunction and Atrial Fibrillation) trial, which randomized 363 patients (N Engl J Med. 2018 Feb 1;378[5]:417-27). These three studies contributed the most patients and outcomes to the two recent meta-analyses.

Mitchel L. Zoler/MDedge News

“The CASTLE-AF and AATAC trials both showed improved cardiovascular outcomes with ablation in patients with heart failure and AFib. The meta-analysis [by Dr. Stavrakis and his associates] and CABANA subgroup analysis further support use of catheter ablation to improve the outcomes in these patients,” noted Jonathan P. Piccini, MD, a cardiac electrophysiologist at Duke University, Durham, N.C., and a CABANA coinvestigator.

“The CABANA trial was very important because it confirmed the safety of catheter ablation, and more importantly suggested that patients with heart failure may benefit the most [from AFib ablation]. The evidence is very strong to advocate ablation as first-line therapy for selected patients with heart failure. Perhaps the optimal patients are those with [New York Heart Association] class I-III or ambulatory class IV heart failure who are on optimized, guideline-directed medical therapy. We have enough data to make this a class I recommendation. The question that remains is whether this is a cost effective strategy. Because it lowers rehospitalization and death, I suspect it is,” said Luigi Di Biase, MD, lead investigator of AATAC, and director of arrhythmia services at Montefiore Medical Center and professor of medicine at Albert Einstein College of Medicine, both in New York.

Opinions differ on AFib ablation’s role

Despite this expansive assessment of the current status of AFib ablation for patients with heart failure from Dr. Di Biase and shared by others, another camp of cardiologists currently sees ablation as having more limited current utility, as recommended earlier this year by a guideline-update panel representing the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society. The guideline update included this new recommendation for how to use AFib ablation in heart failure patients: “AF catheter ablation may be reasonable in selected patients with symptomatic AFib and heart failure with reduced left ventricular ejection fraction to potentially lower mortality rate and reduce hospitalization for heart failure,” a class IIb recommendation. (J Am Coll Cardiol. 2019 Jul 9;74[1]:104-32). The guideline’s text cited the findings from AATAC and CASTLE-AF, but qualified both studies as “relatively small” and with “highly selected patient populations.” The guideline also incorporated the CABANA results into its considerations (although they may not have had the full analysis in heart failure patients available during their deliberations), but cited the study’s main limitation: CABANA failed to show a statistically significant difference in the primary endpoint in its primary, intention-to-treat analysis, which meant that by the strict statistical criteria that trialists apply to study findings, all other endpoints analyzed using CABANA’s are merely “hypothesis generating” and not definitive.

Questions about the extent of patient selection required to see a clear clinical-endpoint benefit from AFib ablation in heart failure patients, as well as the flawed validity of the CABANA results for making unqualified practice recommendation are the main arguments advanced by experts who caution against broader and more routine ablations.

Mitchel L. Zoler/MDedge News

“The findings from the heart failure subgroup of CABANA are hypothesis generating rather than definitive. Even with the recent meta-analysis, uncertainty remains regarding the ability of catheter ablation to improve outcomes beyond reducing AFib-related symptoms,” commented Gregg Fonarow, MD, a heart failure physician and professor of medicine at the University of California, Los Angeles.

“CASTLE-HF had fewer than 100 deaths combined in both arms, which means very unstable results. We don’t know a lot of detail about the heart failure patients in CABANA, and overall we do not have much data from patients with heart failure with preserved ejection fraction [HFpEF],” said Javed Butler, MD, a heart failure physician and professor and chairman of medicine at the University of Mississippi in Jackson. Dr. Butler also voiced his concerns (shared by other heart failure specialists) about the safety of ablation in heart failure patients, noting that “many patients require multiple ablations; many burns result in scarring and can worsen atrial function. In short, ablation of AFib is probably good for selected patients, but to have a class 1 recommendation, we need much larger trials with well-phenotyped heart failure patients,” Dr. Butler said in an interview.

Mitchel L. Zoler/MDedge News

“The totality of data still captures a relatively small number of patients. CASTLE-HF took 8 years to enroll fewer than 400 patients, and the results showed some heterogeneity. Study patients were a decade younger than average HFrEF patients in the community, and thus the effectiveness and safety of catheter ablation in people with more comorbidity and frailty remains in question. Certain HFrEF patients may be less likely to benefit, such as those with amyloid cardiomyopathy. And with the increasing availability of other treatments for HFrEF such as sacubitril/valsartan, dapagliflozin, and MitraClip, it is less clear how catheter ablation would [benefit patients] on top of what is now current best therapy,” said Larry Allen, MD, a heart failure physician and professor of medicine at the University of Colorado in Aurora.

“With these limitations and the fact that catheter ablation is not a simple procedure, a large randomized, controlled trial of ablation, compared with no ablation, in a wide range of HFrEF patients on contemporary therapy would be welcome,” Dr. Allen said. “Given the prevalence of heart failure and AFib and the potential positive and negative implications of catheter ablation running such a trial seems critical for patients and for society.”

“For ablation of AFib in heart failure to become a class I recommendation there will need to be results from larger randomized studies,” summed up Dr. Stavrakis. The meta-analysis that he coauthored noted that “the benefits of catheter ablation for AFib in HFrEF patients have been consistently shown for over a decade now; however, the uptake of this procedure by clinicians in practice has been slow.”

Despite this history of reticence and ongoing caution about ablation, some cardiology experts see the indications for AFib ablation in heart failure steadily creeping forward, buoyed by a safety record that has more benign than ablation’s reputation suggests.

Mitchel L. Zoler/MDedge News

The CABANA results showed that “ablation is remarkably safe in the hands of experienced clinicians, with risks comparable to anti-arrhythmic drugs,” said Peter R. Kowey, MD, a specialist in treating AFib and professor of medicine at Thomas Jefferson University in Philadelphia, who made this assessment during a talk at an AFib meeting in early 2019. Dr. Kowey’s take on what the CABANA safety data showed contrasts with the impression of other cardiologists who are wary of perceived dangers from ablation.

“Ablation comes with a lot of morbidity and mortality. It’s not that the idea of ablation is wrong, but the ability to do it without a lot of adverse effects. ... We’re not quite there yet,” said Douglas L. Mann, MD, a heart failure physician and professor of medicine and chief of the cardiovascular division at Washington University in St. Louis.

“If I had a patient with HFrEF and AFib who was really sick, I’m not so sure I’d send them for ablation, which is not a simple procedure. The patients we tend to send for ablation are selected. Ablation is a big undertaking in patients who are already sick, and it’s expensive. I don’t think the data we have now will change the consensus view, but every heart failure physician is sending some patients for AFib ablation. People are turning to AFib ablation earlier than before. I think the consensus is that ablation is for symptoms or poor rate control, not for better outcomes,” said Mariell Jessup, MD, a heart failure specialist and chief science and medical officer of the American Heart Association in Dallas.

However, this caution about safety and skepticism over efficacy may be dissipating as experience with ablation accumulates.

“CASTLE-AF and other data, including evidence for the apparent isolation of beta-blocker benefit to patients in sinus rhythm, have made me much more proactive about considering catheter ablation in my HFrEF patients. I think many other cardiologists have a similar view,” said Dr. Allen in an interview.

“A lot [of heart failure] patients are [being] referred for ablation, depending on the practice, setting, the local availability of electrophysiologists, and patient interest in ablation,” said Dr. Butler.

Mitchel L. Zoler/MDedge News

“We have no absolutely compelling data, but the data we have all point in the same direction. Like most, I am becoming convinced that AFib ablation in heart failure patients is a very valuable method for managing patients, but I can’t point to one study that was conclusive. Results from lots of studies show that it is likely, and when you add them all together it looks indisputable,” commented A. John Camm, MD, an atrial fibrillation specialist and professor of clinical cardiology at St. George’s University in London. “The findings put a responsibility on cardiologists to assess patients with heart failure for AFib. But there are nothing like enough resources to deal with all the patients who have heart failure who also have AFib.”

A rough estimate of just the U.S. volume of patients with heart failure and AFib is likely in the ball park of 2 million people (a third of the estimated 6 million American currently living with heart failure), and with the prevalence of each of these disorders rising precipitously (more than 5 million Americans have AFib) the confluence of the two should also show a steady increase. “It will take a major change in our concept of heart failure management to really address this. Potentially it would mean a large increase in the number of RF ablations of AFib, but the resources for that are not now present,” Dr. Camm said in an interview.

The attractions of catheter ablation also stand in contrast to the limitations of alternative treatments. Ablation is effective in a majority of patients for reducing AFib burden, both the frequency and duration of AFib episodes, and safety issues are mostly limited to the procedural and immediate postprocedural periods. The drugs available for trying to control AFib are beta-blockers, which provide rate control and can help prevent AFib onset, and rhythm-controlling anti-arrhythmic drugs like amiodarone, which have substantial limitations in both their ability to prevent arrhythmia recurrences as well as for safety.

“Most of the conventional antiarrhythmic drugs are contraindicated, frequently ineffective, or not well tolerated in patients with HFrEF. Catheter ablation of AFib provides an increasingly important option for rhythm control in these patients without using antiarrhythmic drugs,” Dr. Di Biase and his associates wrote in a recent review of AFib ablation in heart failure patients (Eur Heart J. 2019 Feb 21;40[8]:663-71).

“The guidelines that are controversial still make amiodarone a class I drug even though it’s been associated with serious side effects and has been shown in several heart failure trials to increase mortality. I can’t believe that ablation is a class IIb recommendation while a drug like amiodarone is a class I recommendation,” Dr. Di Biase said.

And although beta-blockers are a mainstay of heart failure treatment, once AFib becomes established they are less useful for maintaining sinus rhythm. “Beta-blockers provide effective rate control, but they can’t convert patients to sinus rhythm [once AFib begins], and there is no convincing evidence that patients on beta-blockers stay in sinus rhythm longer. You can’t just say: the patient is on a beta-blocker so I’ve done my best,” noted Dr. Jessup.

CABANA received funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Stavrakis, Dr, Jessup, and Dr. Di Biase. Dr. Hunter has received research funding, educational grants, and speakers fees from Biosense Webster and Medtronic. Dr. Packer had received honoraria from Biotronik and MediaSphere Medical and research support from several companies. Dr. Piccini has been a consultant to Allergan, Biotronik, Medtronic, Phillips, and Sanofi Aventis, he has received research funding from Abbott, ARCA biopharma, Boston Scientific, Gilead, and Johnson & Johnson, and he had a financial relationship with GlaxoSmithKline. Dr. Fonarow has been a consultant to Abbott, Amgen, Bayer, Janssen, and Novartis. Dr. Butler has been a consultant to several companies. Dr. Allen has been a consultant to Boston Scientific, Janssen, and Novartis. Dr. Kowey has been a consultant to several companies. Dr. Mann has been a consultant to Bristol-Myers Squibb, Corvia, and Novartis, and an adviser to miRagen. Dr. Camm has been a consultant to several companies.

This is part one of a two-part article.

[email protected]

Roughly a third of patients with heart failure also have atrial fibrillation, a comorbid combination notorious for working synergistically to worsen a patient’s quality of life and life expectancy.

During the past year, radiofrequency catheter ablation of atrial fibrillation in patients with both conditions has gathered steam as a way to intervene in at least selected patients, driven by study results that featured attention-grabbing reductions in death and cardiovascular hospitalizations.

Mitchel L. Zoler/MDedge News

The evidence favoring catheter ablation of atrial fibrillation (AFib) in patients with heart failure, particularly patients with heart failure with reduced ejection fraction (HFrEF), ramped up in 2019, spurred largely by a subgroup analysis from the CABANA trial, the largest randomized comparison by far of AFib ablation with antiarrhythmic drug treatment with 2,204 patients.

The past few months also featured release of two meta-analyses that took the CABANA results into account plus findings from about a dozen earlier randomized studies. Both meta-analyses, as well as the heart failure analysis from CABANA, all point in one direction, as stated in the conclusion of one of the meta-analyses: “In patients with AFib, catheter ablation is associated with all-cause mortality benefit, compared with medical therapy, that is driven by patients with AFib and HFrEF. Catheter ablation is safe and reduces cardiovascular hospitalizations and recurrences of atrial arrhythmias” both in patients with paroxysmal and persistent AFib,” wrote Stavros Stavrakis, MD, and his associates in their systematic review of 18 randomized, controlled trials of catheter ablation of AFib in a total of 4,464 patients with or without heart failure (Circ Arrhythm Electrophysiol. 2019 Sep;12[9]: e007414).

Despite these new data and analyses, clinicians seem to have very mixed reactions. Some call for an upgraded recommendation by professional societies that would support more aggressive use of AFib ablation in heart failure patients, and the anecdotal impressions of people who manage these patients are that ablation procedures have recently increased. But others advise caution, and note that in their opinion the efficacy data remain preliminary; the procedure has safety, logistical, and economic concerns; and questions remain about the ability of all active ablation programs to consistently deliver the results seen in published trials.

The meta-analysis led by Dr. Stavrakis showed that catheter ablation of AFib cut all-cause mortality during follow-up by a statistically significant 31%, compared with medical therapy, in all patients regardless of their heart failure status. But in patients with HFrEF, the reduction was 48%, along with a 38% cut in cardiovascular hospitalizations. In contrast, patients without heart failure who underwent AFib ablation showed no significant change in their all-cause mortality, compared with medical management of these patients.

“Based both on our meta-analysis and the CABANA data, patients with AFib most likely to benefit from ablation are patients younger than 65 and those with heart failure,” summed up Dr. Stavrakis, a cardiac electrophysiologist at the Heart Rhythm Institute of the University of Oklahoma in Oklahoma City.

The second meta-analysis, which initially appeared in July, analyzed data from 11 randomized trials of catheter ablations compared with anti-arrhythmic medical therapy for rate or rhythm control with in a total of 3,598 patients who all had heart failure, again including the patients enrolled in the CABANA study. The results showed a significant 49% relative drop in all cause mortality with ablation compared with medical treatment, and a statistically significant 56% cut in hospitalizations, as well as a significant, nearly 7% average, absolute improvement in left ventricular ejection fraction, plus benefits for preventing arrhythmia recurrence and improving quality of life (Eur Heart J. 2019 Jul 11. doi: 10.1093/eurheartj/ehz443).

“The magnitude of the effect seen in the meta-analysis, a 49% reduction in total mortality and a 56% reduction in hospitalizations, is rather staggering, and is larger than typically quoted for other medical interventions or device therapy in heart failure. The treatment effect was uniform among studies, and entirely compatible with the changes in left ventricular function, exercise capacity, and heart failure symptoms. Therefore, although more data are desirable, there are already arguably sufficient data to understand a great deal regarding the impact of a fib ablation,” commented Ross J. Hunter, MRCP, a cardiac electrophysiologist at Barts Heart Centre in London, and his associates in an editorial about this meta-analysis (Eur Heart J. 2019 Oct 22. doi: 10.1093/eurheartj/ehz704).

Mitchel L. Zoler/MDedge News

The heart failure analysis of CABANA (Catheter Ablation vs. Anti-Arrhythmic Drug Therapy for Atrial Fibrillation Trial) itself also showed striking findings when first reported at the annual scientific sessions of the Heart Rhythm Society last May. In presentations he made at this meeting, Douglas L. Packer, MD, CABANA’s lead investigator, reported details of a prespecified subgroup analysis of the 778 patients enrolled in CABANA who had heart failure at baseline, slightly more than a third of the total study enrollment. This was more than double the number of patients identified as specifically having heart failure at entry in the initial publication of CABANA’s findings (JAMA. 2019 Mar 15;321[134]:1261-74). Comparison of the 378 patients with heart failure and randomized to undergo ablation with the 400 with heart failure randomized to medical treatment showed a 36% reduction in the study’s primary, composite endpoint relative to the control group in an intention-to-treat analysis, and a 43% relative cut in all-cause mortality during follow-up, Dr. Packer reported at the May meeting. (As of early November 2019, these results had not yet appeared in a published article.) In contrast, in the 1,422 CABANA patients randomized who did not have heart failure, ablation produced results for these endpoints that were similar to and not statistically different from the outcomes in patients treated medically, said Dr. Packer, a cardiac electrophysiologist and professor of medicine at the Mayo Clinic in Rochester, Minn.

The CABANA results added to what had been previously reported from two other landmark studies that documented incremental efficacy of AFib ablation compared with medical treatment in patients with heart failure: The AATAC (Ablation vs Amiodarone for Treatment of AFib in Patients With Congestive HF and an Implanted Device) study, which randomized 203 patients (Circulation. 2016 Apr 26;133[17]:1637-44), and CASTLE-AF (Catheter Ablation vs. Standard Conventional Therapy in Patients with Left Ventricular Dysfunction and Atrial Fibrillation) trial, which randomized 363 patients (N Engl J Med. 2018 Feb 1;378[5]:417-27). These three studies contributed the most patients and outcomes to the two recent meta-analyses.

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“The CASTLE-AF and AATAC trials both showed improved cardiovascular outcomes with ablation in patients with heart failure and AFib. The meta-analysis [by Dr. Stavrakis and his associates] and CABANA subgroup analysis further support use of catheter ablation to improve the outcomes in these patients,” noted Jonathan P. Piccini, MD, a cardiac electrophysiologist at Duke University, Durham, N.C., and a CABANA coinvestigator.

“The CABANA trial was very important because it confirmed the safety of catheter ablation, and more importantly suggested that patients with heart failure may benefit the most [from AFib ablation]. The evidence is very strong to advocate ablation as first-line therapy for selected patients with heart failure. Perhaps the optimal patients are those with [New York Heart Association] class I-III or ambulatory class IV heart failure who are on optimized, guideline-directed medical therapy. We have enough data to make this a class I recommendation. The question that remains is whether this is a cost effective strategy. Because it lowers rehospitalization and death, I suspect it is,” said Luigi Di Biase, MD, lead investigator of AATAC, and director of arrhythmia services at Montefiore Medical Center and professor of medicine at Albert Einstein College of Medicine, both in New York.

Opinions differ on AFib ablation’s role

Despite this expansive assessment of the current status of AFib ablation for patients with heart failure from Dr. Di Biase and shared by others, another camp of cardiologists currently sees ablation as having more limited current utility, as recommended earlier this year by a guideline-update panel representing the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society. The guideline update included this new recommendation for how to use AFib ablation in heart failure patients: “AF catheter ablation may be reasonable in selected patients with symptomatic AFib and heart failure with reduced left ventricular ejection fraction to potentially lower mortality rate and reduce hospitalization for heart failure,” a class IIb recommendation. (J Am Coll Cardiol. 2019 Jul 9;74[1]:104-32). The guideline’s text cited the findings from AATAC and CASTLE-AF, but qualified both studies as “relatively small” and with “highly selected patient populations.” The guideline also incorporated the CABANA results into its considerations (although they may not have had the full analysis in heart failure patients available during their deliberations), but cited the study’s main limitation: CABANA failed to show a statistically significant difference in the primary endpoint in its primary, intention-to-treat analysis, which meant that by the strict statistical criteria that trialists apply to study findings, all other endpoints analyzed using CABANA’s are merely “hypothesis generating” and not definitive.

Questions about the extent of patient selection required to see a clear clinical-endpoint benefit from AFib ablation in heart failure patients, as well as the flawed validity of the CABANA results for making unqualified practice recommendation are the main arguments advanced by experts who caution against broader and more routine ablations.

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“The findings from the heart failure subgroup of CABANA are hypothesis generating rather than definitive. Even with the recent meta-analysis, uncertainty remains regarding the ability of catheter ablation to improve outcomes beyond reducing AFib-related symptoms,” commented Gregg Fonarow, MD, a heart failure physician and professor of medicine at the University of California, Los Angeles.

“CASTLE-HF had fewer than 100 deaths combined in both arms, which means very unstable results. We don’t know a lot of detail about the heart failure patients in CABANA, and overall we do not have much data from patients with heart failure with preserved ejection fraction [HFpEF],” said Javed Butler, MD, a heart failure physician and professor and chairman of medicine at the University of Mississippi in Jackson. Dr. Butler also voiced his concerns (shared by other heart failure specialists) about the safety of ablation in heart failure patients, noting that “many patients require multiple ablations; many burns result in scarring and can worsen atrial function. In short, ablation of AFib is probably good for selected patients, but to have a class 1 recommendation, we need much larger trials with well-phenotyped heart failure patients,” Dr. Butler said in an interview.

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“The totality of data still captures a relatively small number of patients. CASTLE-HF took 8 years to enroll fewer than 400 patients, and the results showed some heterogeneity. Study patients were a decade younger than average HFrEF patients in the community, and thus the effectiveness and safety of catheter ablation in people with more comorbidity and frailty remains in question. Certain HFrEF patients may be less likely to benefit, such as those with amyloid cardiomyopathy. And with the increasing availability of other treatments for HFrEF such as sacubitril/valsartan, dapagliflozin, and MitraClip, it is less clear how catheter ablation would [benefit patients] on top of what is now current best therapy,” said Larry Allen, MD, a heart failure physician and professor of medicine at the University of Colorado in Aurora.

“With these limitations and the fact that catheter ablation is not a simple procedure, a large randomized, controlled trial of ablation, compared with no ablation, in a wide range of HFrEF patients on contemporary therapy would be welcome,” Dr. Allen said. “Given the prevalence of heart failure and AFib and the potential positive and negative implications of catheter ablation running such a trial seems critical for patients and for society.”

“For ablation of AFib in heart failure to become a class I recommendation there will need to be results from larger randomized studies,” summed up Dr. Stavrakis. The meta-analysis that he coauthored noted that “the benefits of catheter ablation for AFib in HFrEF patients have been consistently shown for over a decade now; however, the uptake of this procedure by clinicians in practice has been slow.”

Despite this history of reticence and ongoing caution about ablation, some cardiology experts see the indications for AFib ablation in heart failure steadily creeping forward, buoyed by a safety record that has more benign than ablation’s reputation suggests.

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The CABANA results showed that “ablation is remarkably safe in the hands of experienced clinicians, with risks comparable to anti-arrhythmic drugs,” said Peter R. Kowey, MD, a specialist in treating AFib and professor of medicine at Thomas Jefferson University in Philadelphia, who made this assessment during a talk at an AFib meeting in early 2019. Dr. Kowey’s take on what the CABANA safety data showed contrasts with the impression of other cardiologists who are wary of perceived dangers from ablation.

“Ablation comes with a lot of morbidity and mortality. It’s not that the idea of ablation is wrong, but the ability to do it without a lot of adverse effects. ... We’re not quite there yet,” said Douglas L. Mann, MD, a heart failure physician and professor of medicine and chief of the cardiovascular division at Washington University in St. Louis.

“If I had a patient with HFrEF and AFib who was really sick, I’m not so sure I’d send them for ablation, which is not a simple procedure. The patients we tend to send for ablation are selected. Ablation is a big undertaking in patients who are already sick, and it’s expensive. I don’t think the data we have now will change the consensus view, but every heart failure physician is sending some patients for AFib ablation. People are turning to AFib ablation earlier than before. I think the consensus is that ablation is for symptoms or poor rate control, not for better outcomes,” said Mariell Jessup, MD, a heart failure specialist and chief science and medical officer of the American Heart Association in Dallas.

However, this caution about safety and skepticism over efficacy may be dissipating as experience with ablation accumulates.

“CASTLE-AF and other data, including evidence for the apparent isolation of beta-blocker benefit to patients in sinus rhythm, have made me much more proactive about considering catheter ablation in my HFrEF patients. I think many other cardiologists have a similar view,” said Dr. Allen in an interview.

“A lot [of heart failure] patients are [being] referred for ablation, depending on the practice, setting, the local availability of electrophysiologists, and patient interest in ablation,” said Dr. Butler.

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“We have no absolutely compelling data, but the data we have all point in the same direction. Like most, I am becoming convinced that AFib ablation in heart failure patients is a very valuable method for managing patients, but I can’t point to one study that was conclusive. Results from lots of studies show that it is likely, and when you add them all together it looks indisputable,” commented A. John Camm, MD, an atrial fibrillation specialist and professor of clinical cardiology at St. George’s University in London. “The findings put a responsibility on cardiologists to assess patients with heart failure for AFib. But there are nothing like enough resources to deal with all the patients who have heart failure who also have AFib.”

A rough estimate of just the U.S. volume of patients with heart failure and AFib is likely in the ball park of 2 million people (a third of the estimated 6 million American currently living with heart failure), and with the prevalence of each of these disorders rising precipitously (more than 5 million Americans have AFib) the confluence of the two should also show a steady increase. “It will take a major change in our concept of heart failure management to really address this. Potentially it would mean a large increase in the number of RF ablations of AFib, but the resources for that are not now present,” Dr. Camm said in an interview.

The attractions of catheter ablation also stand in contrast to the limitations of alternative treatments. Ablation is effective in a majority of patients for reducing AFib burden, both the frequency and duration of AFib episodes, and safety issues are mostly limited to the procedural and immediate postprocedural periods. The drugs available for trying to control AFib are beta-blockers, which provide rate control and can help prevent AFib onset, and rhythm-controlling anti-arrhythmic drugs like amiodarone, which have substantial limitations in both their ability to prevent arrhythmia recurrences as well as for safety.

“Most of the conventional antiarrhythmic drugs are contraindicated, frequently ineffective, or not well tolerated in patients with HFrEF. Catheter ablation of AFib provides an increasingly important option for rhythm control in these patients without using antiarrhythmic drugs,” Dr. Di Biase and his associates wrote in a recent review of AFib ablation in heart failure patients (Eur Heart J. 2019 Feb 21;40[8]:663-71).

“The guidelines that are controversial still make amiodarone a class I drug even though it’s been associated with serious side effects and has been shown in several heart failure trials to increase mortality. I can’t believe that ablation is a class IIb recommendation while a drug like amiodarone is a class I recommendation,” Dr. Di Biase said.

And although beta-blockers are a mainstay of heart failure treatment, once AFib becomes established they are less useful for maintaining sinus rhythm. “Beta-blockers provide effective rate control, but they can’t convert patients to sinus rhythm [once AFib begins], and there is no convincing evidence that patients on beta-blockers stay in sinus rhythm longer. You can’t just say: the patient is on a beta-blocker so I’ve done my best,” noted Dr. Jessup.

CABANA received funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Stavrakis, Dr, Jessup, and Dr. Di Biase. Dr. Hunter has received research funding, educational grants, and speakers fees from Biosense Webster and Medtronic. Dr. Packer had received honoraria from Biotronik and MediaSphere Medical and research support from several companies. Dr. Piccini has been a consultant to Allergan, Biotronik, Medtronic, Phillips, and Sanofi Aventis, he has received research funding from Abbott, ARCA biopharma, Boston Scientific, Gilead, and Johnson & Johnson, and he had a financial relationship with GlaxoSmithKline. Dr. Fonarow has been a consultant to Abbott, Amgen, Bayer, Janssen, and Novartis. Dr. Butler has been a consultant to several companies. Dr. Allen has been a consultant to Boston Scientific, Janssen, and Novartis. Dr. Kowey has been a consultant to several companies. Dr. Mann has been a consultant to Bristol-Myers Squibb, Corvia, and Novartis, and an adviser to miRagen. Dr. Camm has been a consultant to several companies.

This is part one of a two-part article.

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