Most Americans diagnosed with serious illness will be hospitalized in their last months. During these hospitalizations, hospitalists direct their care.

For seriously ill patients, consultation with palliative care specialists has been shown to promote patient- and family-centered care, ensuring that care is consistent with patients’ goals, values, and preferences. Yet, many hospitalized patients lack access to palliative care consultation, and specialists have identified key domains of primary palliative care that can be delivered by nonspecialists.

There is now an important opportunity for hospitalists to lead prognosis and goals of care communication for their patients. To succeed in this role, hospitalists need training and structural support that may not yet be available to them.

To fill this gap, SHM’s Center for Quality Improvement partnered with The Hastings Center, a world-renowned bioethics research institution, to develop a resource room focused on hospitalists’ role in providing high-quality communication about prognosis and goals of care. The resource room presents a Prognosis and Goals of Care Communication Pathway, which highlights key processes and maps them onto the daily workflows of hospitalist physicians.

The care pathway is grounded in palliative care communication research and the consensus guidance of The Hastings Center Guidelines for Decisions on Life-Sustaining Treatment and Care Near the End of Life. It was informed by a national stakeholder meeting of hospitalists, other hospital clinicians, patient and family advocates, bioethicists, social scientists, and other experts, who identified professional values of hospital medicine aligned with communication as part of good care for seriously ill patients.

A collaborative interdisciplinary work group convened by SHM and including hospitalists, palliative medicine physicians, a bioethicist, and a palliative nursing specialist constructed the care pathway in terms of key processes occurring at admission, during hospitalization, and in discharge planning to support primary palliative care integration into normal workflow. The resource room also includes skills-building tools and resources for individual hospitals, teams, and institutions.

The work group will present a workshop on the care pathway at Hospital Medicine 2017: “Demystifying Difficult Decisions: Strategies and Skills to Equip Hospitalists for High-Quality Goals of Care Conversations with Seriously Ill Patients and Their Families.” For more information on the resource room, visit www.hospitalmedicine.org/EOL.
 

Dr. Anderson is associate professor in residence in the division of hospital medicine at the University of California, San Francisco. She also serves as attending physician in the Palliative Care Program and codirector of the School of Nursing Interprofessional Palliative Care Training Program at UCSF.

 

Most Americans diagnosed with serious illness will be hospitalized in their last months. During these hospitalizations, hospitalists direct their care.

For seriously ill patients, consultation with palliative care specialists has been shown to promote patient- and family-centered care, ensuring that care is consistent with patients’ goals, values, and preferences. Yet, many hospitalized patients lack access to palliative care consultation, and specialists have identified key domains of primary palliative care that can be delivered by nonspecialists.

There is now an important opportunity for hospitalists to lead prognosis and goals of care communication for their patients. To succeed in this role, hospitalists need training and structural support that may not yet be available to them.

To fill this gap, SHM’s Center for Quality Improvement partnered with The Hastings Center, a world-renowned bioethics research institution, to develop a resource room focused on hospitalists’ role in providing high-quality communication about prognosis and goals of care. The resource room presents a Prognosis and Goals of Care Communication Pathway, which highlights key processes and maps them onto the daily workflows of hospitalist physicians.

The care pathway is grounded in palliative care communication research and the consensus guidance of The Hastings Center Guidelines for Decisions on Life-Sustaining Treatment and Care Near the End of Life. It was informed by a national stakeholder meeting of hospitalists, other hospital clinicians, patient and family advocates, bioethicists, social scientists, and other experts, who identified professional values of hospital medicine aligned with communication as part of good care for seriously ill patients.

A collaborative interdisciplinary work group convened by SHM and including hospitalists, palliative medicine physicians, a bioethicist, and a palliative nursing specialist constructed the care pathway in terms of key processes occurring at admission, during hospitalization, and in discharge planning to support primary palliative care integration into normal workflow. The resource room also includes skills-building tools and resources for individual hospitals, teams, and institutions.

The work group will present a workshop on the care pathway at Hospital Medicine 2017: “Demystifying Difficult Decisions: Strategies and Skills to Equip Hospitalists for High-Quality Goals of Care Conversations with Seriously Ill Patients and Their Families.” For more information on the resource room, visit www.hospitalmedicine.org/EOL.
 

Dr. Anderson is associate professor in residence in the division of hospital medicine at the University of California, San Francisco. She also serves as attending physician in the Palliative Care Program and codirector of the School of Nursing Interprofessional Palliative Care Training Program at UCSF.

 

Most Americans diagnosed with serious illness will be hospitalized in their last months. During these hospitalizations, hospitalists direct their care.

For seriously ill patients, consultation with palliative care specialists has been shown to promote patient- and family-centered care, ensuring that care is consistent with patients’ goals, values, and preferences. Yet, many hospitalized patients lack access to palliative care consultation, and specialists have identified key domains of primary palliative care that can be delivered by nonspecialists.

There is now an important opportunity for hospitalists to lead prognosis and goals of care communication for their patients. To succeed in this role, hospitalists need training and structural support that may not yet be available to them.

To fill this gap, SHM’s Center for Quality Improvement partnered with The Hastings Center, a world-renowned bioethics research institution, to develop a resource room focused on hospitalists’ role in providing high-quality communication about prognosis and goals of care. The resource room presents a Prognosis and Goals of Care Communication Pathway, which highlights key processes and maps them onto the daily workflows of hospitalist physicians.

The care pathway is grounded in palliative care communication research and the consensus guidance of The Hastings Center Guidelines for Decisions on Life-Sustaining Treatment and Care Near the End of Life. It was informed by a national stakeholder meeting of hospitalists, other hospital clinicians, patient and family advocates, bioethicists, social scientists, and other experts, who identified professional values of hospital medicine aligned with communication as part of good care for seriously ill patients.

A collaborative interdisciplinary work group convened by SHM and including hospitalists, palliative medicine physicians, a bioethicist, and a palliative nursing specialist constructed the care pathway in terms of key processes occurring at admission, during hospitalization, and in discharge planning to support primary palliative care integration into normal workflow. The resource room also includes skills-building tools and resources for individual hospitals, teams, and institutions.

The work group will present a workshop on the care pathway at Hospital Medicine 2017: “Demystifying Difficult Decisions: Strategies and Skills to Equip Hospitalists for High-Quality Goals of Care Conversations with Seriously Ill Patients and Their Families.” For more information on the resource room, visit www.hospitalmedicine.org/EOL.
 

Dr. Anderson is associate professor in residence in the division of hospital medicine at the University of California, San Francisco. She also serves as attending physician in the Palliative Care Program and codirector of the School of Nursing Interprofessional Palliative Care Training Program at UCSF.

 

ORLANDO – Botulinum toxin may have a place in treating psoriasis and rosacea.

There is not a huge body of literature supporting the use of neuromodulators for these conditions, but a smattering of case reports have shown positive results and some clinicians are exploring their off label use, Erin Gilbert, MD, said at the annual meeting of the American Academy of Dermatology.

“I do believe that there is significant promise here and certainly enough evidence to warrant conducting well-designed randomized, controlled trials for these conditions,” said Dr. Gilbert, a dermatologist in Brooklyn, NY. “It is of utmost importance that we pair clinical outcome measures with methods that will help us better understand the mechanism of action of neuromodulators in human skin, such as skin biopsy.”

Her own interest was originally piqued when she began working with Nicole Ward, PhD, director of the morphology core of the Skin Diseases Research Center in the department of dermatology at Case Western Reserve University, Cleveland, who developed a transgenic mouse model of psoriasis. Dr. Ward discovered that transecting the thoracic-level cutaneous nerves at their entry site into back skin resulted in rapid and significant changes in the psoriatic phenotype (J Invest Dermatol. 2011 Jul;131[7]:1530–8). These included decreases of up to 40% in various immune cell populations and a 30% improvement in acanthosis relative to sham surgery sites on the same animals.

This gave rise to a new thought, Dr. Gilbert said. Could chemical denervation produce similar improvements?

Using the same mouse model, she and Dr. Ward evaluated the effect of injecting botulinum neurotoxin A (BoNT-A) 9 units/kg diluted in 1 ml saline at one site, and saline control at another site (J Invest Dermatol. 2012 Jul;132[7]:1927–30). The mice were euthanized at 2 and 6 weeks after treatment. The results were similar to those of the surgical denervation: At 6 weeks, a 25% reduction in acanthosis was observed relative to the control site, with decreases in immune cells and inflammatory markers.

BoNT-A inhibits the release of neurotransmitters by cleaving the SPAP25 protein, an inhibitor of acetylcholine, at the neuromuscular junction. This is the root of the toxin’s ability to relax muscle spasm and decrease hyperhidrosis. The investigators also suggested that BoNT-A inhibits nerve-derived release of calcitonin gene-related peptide and substance P – important peptides in pain and itch sensation.

Dr. Gilbert and Dr. Ward also published a case report in which abobotulinumtoxinA was used off label to treat a recalcitrant psoriatic plaque in a 75-year-old woman (J Drugs Dermatol. 2014;13[11]:1407-8).

“This patient had psoriatic plaques concentrated on her trunk, arms, buttocks, and legs. She had been using strong topical corticosteroids for quite a long time with incomplete relief. I asked her to withdraw from all steroids for 3 months and then treated one lesion.”

The treated plaque was on the patient’s buttock. Dr. Gilbert injected a total of 30 units of abobotulinumtoxinA intradermally at eight points, about 1 cm apart. Within 3 weeks, there was complete remission of that plaque, sustained for 7 months. During this time, new lesions formed on other areas of her body. At 8 months, the treated plaque returned in the same place.

Courtesy Dr. Erin Gilbert

Dr. Gilbert has also used the toxin on a few patients with rosacea characterized by severe facial and ear flushing, accompanied by itching and burning sensations.

“Some of my patients had been completely recalcitrant to other therapies, and, following off label injection with neuromodulators, they have had life-changing results. In my experience, the key to consistently successful treatment is using adequate doses of toxin.”

This practice is supported by case reports in 2012 and 2015 (J Drugs Dermatol. 2012;11[12]:e76-e79; Dermatology 2015;230:299-301). Some investigators seem to think that, along with the anti-inflammatory and neurotransmitter effects, the toxin alters vascular tone.

Dr. Gilbert acknowledged that these treatments are expensive and cannot, in the case of psoriasis, be used in disseminated disease. However, she said that, for many patients, the relief is so profound and the benefit so long-lasting, that the expense is worth it. An argument in favor of this approach is that, where effective, BoNT-A could be used as a steroid-sparing agent and one that might reduce the need for systemic therapies.

“I will tell you that, sometimes, we get only partial relief and still need adjunctive therapies. Ultimately, neuromodulators may be especially useful for psoriatic plaques that are of cosmetic concern, such as those in the scalp or on the face. Limitations to their use include cost, the need for further studies, and safety concerns, such as muscle weakness.”

Dr. Gilbert had no relevant financial disclosures.
 

 

[email protected]

On Twitter @alz_gal

 

ORLANDO – Botulinum toxin may have a place in treating psoriasis and rosacea.

There is not a huge body of literature supporting the use of neuromodulators for these conditions, but a smattering of case reports have shown positive results and some clinicians are exploring their off label use, Erin Gilbert, MD, said at the annual meeting of the American Academy of Dermatology.

“I do believe that there is significant promise here and certainly enough evidence to warrant conducting well-designed randomized, controlled trials for these conditions,” said Dr. Gilbert, a dermatologist in Brooklyn, NY. “It is of utmost importance that we pair clinical outcome measures with methods that will help us better understand the mechanism of action of neuromodulators in human skin, such as skin biopsy.”

Her own interest was originally piqued when she began working with Nicole Ward, PhD, director of the morphology core of the Skin Diseases Research Center in the department of dermatology at Case Western Reserve University, Cleveland, who developed a transgenic mouse model of psoriasis. Dr. Ward discovered that transecting the thoracic-level cutaneous nerves at their entry site into back skin resulted in rapid and significant changes in the psoriatic phenotype (J Invest Dermatol. 2011 Jul;131[7]:1530–8). These included decreases of up to 40% in various immune cell populations and a 30% improvement in acanthosis relative to sham surgery sites on the same animals.

This gave rise to a new thought, Dr. Gilbert said. Could chemical denervation produce similar improvements?

Using the same mouse model, she and Dr. Ward evaluated the effect of injecting botulinum neurotoxin A (BoNT-A) 9 units/kg diluted in 1 ml saline at one site, and saline control at another site (J Invest Dermatol. 2012 Jul;132[7]:1927–30). The mice were euthanized at 2 and 6 weeks after treatment. The results were similar to those of the surgical denervation: At 6 weeks, a 25% reduction in acanthosis was observed relative to the control site, with decreases in immune cells and inflammatory markers.

BoNT-A inhibits the release of neurotransmitters by cleaving the SPAP25 protein, an inhibitor of acetylcholine, at the neuromuscular junction. This is the root of the toxin’s ability to relax muscle spasm and decrease hyperhidrosis. The investigators also suggested that BoNT-A inhibits nerve-derived release of calcitonin gene-related peptide and substance P – important peptides in pain and itch sensation.

Dr. Gilbert and Dr. Ward also published a case report in which abobotulinumtoxinA was used off label to treat a recalcitrant psoriatic plaque in a 75-year-old woman (J Drugs Dermatol. 2014;13[11]:1407-8).

“This patient had psoriatic plaques concentrated on her trunk, arms, buttocks, and legs. She had been using strong topical corticosteroids for quite a long time with incomplete relief. I asked her to withdraw from all steroids for 3 months and then treated one lesion.”

The treated plaque was on the patient’s buttock. Dr. Gilbert injected a total of 30 units of abobotulinumtoxinA intradermally at eight points, about 1 cm apart. Within 3 weeks, there was complete remission of that plaque, sustained for 7 months. During this time, new lesions formed on other areas of her body. At 8 months, the treated plaque returned in the same place.

Courtesy Dr. Erin Gilbert

Dr. Gilbert has also used the toxin on a few patients with rosacea characterized by severe facial and ear flushing, accompanied by itching and burning sensations.

“Some of my patients had been completely recalcitrant to other therapies, and, following off label injection with neuromodulators, they have had life-changing results. In my experience, the key to consistently successful treatment is using adequate doses of toxin.”

This practice is supported by case reports in 2012 and 2015 (J Drugs Dermatol. 2012;11[12]:e76-e79; Dermatology 2015;230:299-301). Some investigators seem to think that, along with the anti-inflammatory and neurotransmitter effects, the toxin alters vascular tone.

Dr. Gilbert acknowledged that these treatments are expensive and cannot, in the case of psoriasis, be used in disseminated disease. However, she said that, for many patients, the relief is so profound and the benefit so long-lasting, that the expense is worth it. An argument in favor of this approach is that, where effective, BoNT-A could be used as a steroid-sparing agent and one that might reduce the need for systemic therapies.

“I will tell you that, sometimes, we get only partial relief and still need adjunctive therapies. Ultimately, neuromodulators may be especially useful for psoriatic plaques that are of cosmetic concern, such as those in the scalp or on the face. Limitations to their use include cost, the need for further studies, and safety concerns, such as muscle weakness.”

Dr. Gilbert had no relevant financial disclosures.
 

 

[email protected]

On Twitter @alz_gal

 

ORLANDO – Botulinum toxin may have a place in treating psoriasis and rosacea.

There is not a huge body of literature supporting the use of neuromodulators for these conditions, but a smattering of case reports have shown positive results and some clinicians are exploring their off label use, Erin Gilbert, MD, said at the annual meeting of the American Academy of Dermatology.

“I do believe that there is significant promise here and certainly enough evidence to warrant conducting well-designed randomized, controlled trials for these conditions,” said Dr. Gilbert, a dermatologist in Brooklyn, NY. “It is of utmost importance that we pair clinical outcome measures with methods that will help us better understand the mechanism of action of neuromodulators in human skin, such as skin biopsy.”

Her own interest was originally piqued when she began working with Nicole Ward, PhD, director of the morphology core of the Skin Diseases Research Center in the department of dermatology at Case Western Reserve University, Cleveland, who developed a transgenic mouse model of psoriasis. Dr. Ward discovered that transecting the thoracic-level cutaneous nerves at their entry site into back skin resulted in rapid and significant changes in the psoriatic phenotype (J Invest Dermatol. 2011 Jul;131[7]:1530–8). These included decreases of up to 40% in various immune cell populations and a 30% improvement in acanthosis relative to sham surgery sites on the same animals.

This gave rise to a new thought, Dr. Gilbert said. Could chemical denervation produce similar improvements?

Using the same mouse model, she and Dr. Ward evaluated the effect of injecting botulinum neurotoxin A (BoNT-A) 9 units/kg diluted in 1 ml saline at one site, and saline control at another site (J Invest Dermatol. 2012 Jul;132[7]:1927–30). The mice were euthanized at 2 and 6 weeks after treatment. The results were similar to those of the surgical denervation: At 6 weeks, a 25% reduction in acanthosis was observed relative to the control site, with decreases in immune cells and inflammatory markers.

BoNT-A inhibits the release of neurotransmitters by cleaving the SPAP25 protein, an inhibitor of acetylcholine, at the neuromuscular junction. This is the root of the toxin’s ability to relax muscle spasm and decrease hyperhidrosis. The investigators also suggested that BoNT-A inhibits nerve-derived release of calcitonin gene-related peptide and substance P – important peptides in pain and itch sensation.

Dr. Gilbert and Dr. Ward also published a case report in which abobotulinumtoxinA was used off label to treat a recalcitrant psoriatic plaque in a 75-year-old woman (J Drugs Dermatol. 2014;13[11]:1407-8).

“This patient had psoriatic plaques concentrated on her trunk, arms, buttocks, and legs. She had been using strong topical corticosteroids for quite a long time with incomplete relief. I asked her to withdraw from all steroids for 3 months and then treated one lesion.”

The treated plaque was on the patient’s buttock. Dr. Gilbert injected a total of 30 units of abobotulinumtoxinA intradermally at eight points, about 1 cm apart. Within 3 weeks, there was complete remission of that plaque, sustained for 7 months. During this time, new lesions formed on other areas of her body. At 8 months, the treated plaque returned in the same place.

Courtesy Dr. Erin Gilbert

Dr. Gilbert has also used the toxin on a few patients with rosacea characterized by severe facial and ear flushing, accompanied by itching and burning sensations.

“Some of my patients had been completely recalcitrant to other therapies, and, following off label injection with neuromodulators, they have had life-changing results. In my experience, the key to consistently successful treatment is using adequate doses of toxin.”

This practice is supported by case reports in 2012 and 2015 (J Drugs Dermatol. 2012;11[12]:e76-e79; Dermatology 2015;230:299-301). Some investigators seem to think that, along with the anti-inflammatory and neurotransmitter effects, the toxin alters vascular tone.

Dr. Gilbert acknowledged that these treatments are expensive and cannot, in the case of psoriasis, be used in disseminated disease. However, she said that, for many patients, the relief is so profound and the benefit so long-lasting, that the expense is worth it. An argument in favor of this approach is that, where effective, BoNT-A could be used as a steroid-sparing agent and one that might reduce the need for systemic therapies.

“I will tell you that, sometimes, we get only partial relief and still need adjunctive therapies. Ultimately, neuromodulators may be especially useful for psoriatic plaques that are of cosmetic concern, such as those in the scalp or on the face. Limitations to their use include cost, the need for further studies, and safety concerns, such as muscle weakness.”

Dr. Gilbert had no relevant financial disclosures.
 

 

[email protected]

On Twitter @alz_gal

 

PARIS – Patients hospitalized for heart failure increasingly present with a growing number of noncardiovascular comorbidities, according to registry data from more than 300 U.S. hospitals.

During the decade of 2005-2014, the percentage of patients hospitalized for heart failure diagnosed with three or more noncardiovascular comorbidities (NCCs) jumped from abut 17% of these patients in 2005 to about 28% in 2015, Abhinav Sharma, MD, said at a meeting held by the Heart Failure Association of the ESC. This increase occurred as the percentages of hospitalized heart failure patients with none or one NCC showed clear decreases.

Mitchel L. Zoler/Frontline Medical News

This time trend suggests that clinicians should be on the lookout for NCCs in patients admitted for heart failure, and that “strategies to address the growing burden of noncardiovascular comorbidities may be a way to improve outcomes,” said Dr. Sharma, a cardiologist at Duke University in Durham, N.C.

U.S. patients hospitalized for heart failure “appear to now be sicker and more medically complex. Probably, a large number of the noncardiovascular comorbidities are not being recognized when the focus is on treating the patient’s heart failure,” he said in an interview. “If we can identify the noncardiovascular comorbidities and target appropriate treatment, it may potentially decrease the risk of readmissions.”

He included five NCCs in his analysis: chronic obstructive pulmonary disease, anemia, diabetes, chronic kidney disease, and obesity.

His analysis showed that a higher rate of readmissions, as well as increased mortality both in hospital and during the 30 days following discharge, are outcomes that all connect with increased numbers of NCCs. Patients with three or more NCCs at the time of their heart failure admission were about 50% more likely to die in hospital, about 65% more likely to die during the 30 days following admission, about 35% more likely to be readmitted, and about half as likely to be discharged home following hospitalization, when compared with patients with no NCC in multivariate analyses that adjusted for demographic and other clinical variables. Patients with three or more NCCs were also about 67% more likely to have an index hospitalization of at least 4 days, compared with patients with no NCC.

Dr. Sharma speculated that the increased prevalence of multiple NCCs in acute heart failure patients may result, in part, from secular trends in the rates of diabetes and obesity and the noncardiovascular comorbidities associated with these conditions. All five of the NCCs included in his analysis showed increased prevalence rates from 2005 to 2014 in the patients he studied. The biggest jump occurred in the prevalence of chronic obstructive pulmonary disease, which rose from about 27% in 2005 to about 35% in 2014.

His study used data collected in the Get With the Guidelines–Heart Failure Registry, which began in 2005, and included just under 208,000 total patients. He acknowledged that it is hard to know how representative these patients are of the entire population of U.S. patients hospitalized for heart failure during the study period, because the patients he studied came from a self-selected group of more than 300 hospitals that opted to participate in the registry. “We need to see if this can be extrapolated to all U.S. hospitals,” Dr. Sharma said.

[email protected]

On Twitter @mitchelzoler

 

PARIS – Patients hospitalized for heart failure increasingly present with a growing number of noncardiovascular comorbidities, according to registry data from more than 300 U.S. hospitals.

During the decade of 2005-2014, the percentage of patients hospitalized for heart failure diagnosed with three or more noncardiovascular comorbidities (NCCs) jumped from abut 17% of these patients in 2005 to about 28% in 2015, Abhinav Sharma, MD, said at a meeting held by the Heart Failure Association of the ESC. This increase occurred as the percentages of hospitalized heart failure patients with none or one NCC showed clear decreases.

Mitchel L. Zoler/Frontline Medical News

This time trend suggests that clinicians should be on the lookout for NCCs in patients admitted for heart failure, and that “strategies to address the growing burden of noncardiovascular comorbidities may be a way to improve outcomes,” said Dr. Sharma, a cardiologist at Duke University in Durham, N.C.

U.S. patients hospitalized for heart failure “appear to now be sicker and more medically complex. Probably, a large number of the noncardiovascular comorbidities are not being recognized when the focus is on treating the patient’s heart failure,” he said in an interview. “If we can identify the noncardiovascular comorbidities and target appropriate treatment, it may potentially decrease the risk of readmissions.”

He included five NCCs in his analysis: chronic obstructive pulmonary disease, anemia, diabetes, chronic kidney disease, and obesity.

His analysis showed that a higher rate of readmissions, as well as increased mortality both in hospital and during the 30 days following discharge, are outcomes that all connect with increased numbers of NCCs. Patients with three or more NCCs at the time of their heart failure admission were about 50% more likely to die in hospital, about 65% more likely to die during the 30 days following admission, about 35% more likely to be readmitted, and about half as likely to be discharged home following hospitalization, when compared with patients with no NCC in multivariate analyses that adjusted for demographic and other clinical variables. Patients with three or more NCCs were also about 67% more likely to have an index hospitalization of at least 4 days, compared with patients with no NCC.

Dr. Sharma speculated that the increased prevalence of multiple NCCs in acute heart failure patients may result, in part, from secular trends in the rates of diabetes and obesity and the noncardiovascular comorbidities associated with these conditions. All five of the NCCs included in his analysis showed increased prevalence rates from 2005 to 2014 in the patients he studied. The biggest jump occurred in the prevalence of chronic obstructive pulmonary disease, which rose from about 27% in 2005 to about 35% in 2014.

His study used data collected in the Get With the Guidelines–Heart Failure Registry, which began in 2005, and included just under 208,000 total patients. He acknowledged that it is hard to know how representative these patients are of the entire population of U.S. patients hospitalized for heart failure during the study period, because the patients he studied came from a self-selected group of more than 300 hospitals that opted to participate in the registry. “We need to see if this can be extrapolated to all U.S. hospitals,” Dr. Sharma said.

[email protected]

On Twitter @mitchelzoler

 

PARIS – Patients hospitalized for heart failure increasingly present with a growing number of noncardiovascular comorbidities, according to registry data from more than 300 U.S. hospitals.

During the decade of 2005-2014, the percentage of patients hospitalized for heart failure diagnosed with three or more noncardiovascular comorbidities (NCCs) jumped from abut 17% of these patients in 2005 to about 28% in 2015, Abhinav Sharma, MD, said at a meeting held by the Heart Failure Association of the ESC. This increase occurred as the percentages of hospitalized heart failure patients with none or one NCC showed clear decreases.

Mitchel L. Zoler/Frontline Medical News

This time trend suggests that clinicians should be on the lookout for NCCs in patients admitted for heart failure, and that “strategies to address the growing burden of noncardiovascular comorbidities may be a way to improve outcomes,” said Dr. Sharma, a cardiologist at Duke University in Durham, N.C.

U.S. patients hospitalized for heart failure “appear to now be sicker and more medically complex. Probably, a large number of the noncardiovascular comorbidities are not being recognized when the focus is on treating the patient’s heart failure,” he said in an interview. “If we can identify the noncardiovascular comorbidities and target appropriate treatment, it may potentially decrease the risk of readmissions.”

He included five NCCs in his analysis: chronic obstructive pulmonary disease, anemia, diabetes, chronic kidney disease, and obesity.

His analysis showed that a higher rate of readmissions, as well as increased mortality both in hospital and during the 30 days following discharge, are outcomes that all connect with increased numbers of NCCs. Patients with three or more NCCs at the time of their heart failure admission were about 50% more likely to die in hospital, about 65% more likely to die during the 30 days following admission, about 35% more likely to be readmitted, and about half as likely to be discharged home following hospitalization, when compared with patients with no NCC in multivariate analyses that adjusted for demographic and other clinical variables. Patients with three or more NCCs were also about 67% more likely to have an index hospitalization of at least 4 days, compared with patients with no NCC.

Dr. Sharma speculated that the increased prevalence of multiple NCCs in acute heart failure patients may result, in part, from secular trends in the rates of diabetes and obesity and the noncardiovascular comorbidities associated with these conditions. All five of the NCCs included in his analysis showed increased prevalence rates from 2005 to 2014 in the patients he studied. The biggest jump occurred in the prevalence of chronic obstructive pulmonary disease, which rose from about 27% in 2005 to about 35% in 2014.

His study used data collected in the Get With the Guidelines–Heart Failure Registry, which began in 2005, and included just under 208,000 total patients. He acknowledged that it is hard to know how representative these patients are of the entire population of U.S. patients hospitalized for heart failure during the study period, because the patients he studied came from a self-selected group of more than 300 hospitals that opted to participate in the registry. “We need to see if this can be extrapolated to all U.S. hospitals,” Dr. Sharma said.

[email protected]

On Twitter @mitchelzoler

 

AMSTERDAM – While there was no overall or progression-free survival benefit, results of the randomized, controlled phase III SARAH trial showed that the use of selective internal radioactive therapy (SIRT) was better tolerated than sorafenib for the treatment of patients with advanced liver cancer.

There was also early evidence that SIRT, using the radiopharmaceutical yttrium-90 (SIR-Spheres microspheres), reduced radiologic progression in the liver and improved tumor responses to a greater extent that did sorafenib.

“I feel [the results] will open a new door in the treatment of HCC [hepatocellular carcinoma],” study investigator Valérie Vilgrain, MD, of Hôpital Beaujon, Paris, said at the International Liver Congress, sponsored by the European Association for the Study of the Liver.

The standard treatment for advanced HCC at present is sorafenib, which is based on the SHARP trial findings that showed an overall survival of around 10.7 months, Dr. Vilgrain observed.

Transarterial chemoembolization (TACE) is the reference treatment for intermediate HCC, she said, and of the 467 patients included in the SARAH trial, just over 40% had failed to respond to two rounds of this therapy and had inoperable or advanced disease.

Dr. Frank Tacke, EASL vice secretary and professor of medicine in the department of gastroenterology, metabolic diseases, and intensive care medicine at University Hospital Aachen, Germany, said during a press briefing that the trial was “the first phase III, randomized controlled trial putting this intervention in perspective with current therapy.”

Dr. Tacke, who was not involved in the trial, added: “The overall survival is the same but there are so many patient-relevant parameters that are actually better in the one treatment [SIRT].”

The SARAH trial was conduced at 25 centers in France and there were 237 patients with a life expectancy of at least 3 months who were randomized to treatment with SIRT and 222 to treatment with sorafenib 800 mg daily.

The mean age of all randomized patients was 65 years, 90% were male, and 90% had cirrhosis. Cirrhosis was caused by alcoholic liver disease in 65%, hepatitis C virus infection in about one-quarter, and nonalcoholic steatohepatitis in roughly one-fifth of cases.

Comparing SIRT with sorafenib in all patients who were randomized, the median overall survival was 8.0 months versus 9.9 months (P = .018) and the median progression-free survival was a respective 4.1 months versus 3.7 months (P = .76). No differences in survival were observed when only patients who actually received the treatments were compared.

While there was no difference in radiologic progression seen overall – one of the secondary endpoints – when progression in the liver as the first site of progression was considered, there was a significant difference favoring the use of SIRT over sorafenib (P = .014), Dr. Vilgrain reported.

In addition, 26 (19%) of SIRT versus 23 (11.6%) of sorafenib-treated patients showed an objective response at 6 months, so there was “a strong signal” that SIRT could have an eventual edge over sorafenib but perhaps effects take longer to materialize (P = .042).

Fewer patients receiving SIRT than sorafenib experienced treatment-related adverse events (76.5% vs. 95%), with a median number of adverse events per patient of 5 and 10, respectively.

Adverse events of note that occurred less frequently in the SIRT than sorafenib arm were fatigue (20% vs. 41%), diarrhea (3% vs. 30%), abdominal pain (6% vs. 14%), hand-foot reaction (1% vs. 12%), infection (3% vs. 9%), weight loss (0% vs. 6%), and hypertension (0% vs. 5%).

Quality of life was significantly better in the SIRT group than in the sorafenib group over time, Dr. Vilgrain said. Quality of life was measured via the Global Health Status subscore of the EORTC QLQ-C30 scale.

Dr. Vilgrain noted during a press briefing that patients in the sorafenib group were able to start oral treatment 1 or 2 days after randomization, whereas there was a delay of 1-2 weeks before the patients randomized to SIRT could receive their treatment and just over one-quarter did not get SIRT as per the protocol, compared to 7% of those randomized to sorafenib.

Whether the lag time in patients getting their treatment might have affected the survival outcomes seen with the treatment is not known. Future studies look at reducing the time between randomization and SIRT, she said.
 

Dr. Vilgrain noted in an interview that SIRT was given as a single injection after an initial test injection. While it is possible to retreat patients, the study design was such that patients had to wait 6 months before they could be retreated and in theory a second treatment should not be needed.

 

The study was sponsored Assistance Publique – Hôpitaux de Paris (supported by grants from Sirtex Medical Limited. Dr. Vilgrain disclosed acting as a study investigator and receiving speaker fees from Guerbet and Sirtex, and speaker fees from SuperSonic Imagine and Toshiba.

 

AMSTERDAM – While there was no overall or progression-free survival benefit, results of the randomized, controlled phase III SARAH trial showed that the use of selective internal radioactive therapy (SIRT) was better tolerated than sorafenib for the treatment of patients with advanced liver cancer.

There was also early evidence that SIRT, using the radiopharmaceutical yttrium-90 (SIR-Spheres microspheres), reduced radiologic progression in the liver and improved tumor responses to a greater extent that did sorafenib.

“I feel [the results] will open a new door in the treatment of HCC [hepatocellular carcinoma],” study investigator Valérie Vilgrain, MD, of Hôpital Beaujon, Paris, said at the International Liver Congress, sponsored by the European Association for the Study of the Liver.

The standard treatment for advanced HCC at present is sorafenib, which is based on the SHARP trial findings that showed an overall survival of around 10.7 months, Dr. Vilgrain observed.

Transarterial chemoembolization (TACE) is the reference treatment for intermediate HCC, she said, and of the 467 patients included in the SARAH trial, just over 40% had failed to respond to two rounds of this therapy and had inoperable or advanced disease.

Dr. Frank Tacke, EASL vice secretary and professor of medicine in the department of gastroenterology, metabolic diseases, and intensive care medicine at University Hospital Aachen, Germany, said during a press briefing that the trial was “the first phase III, randomized controlled trial putting this intervention in perspective with current therapy.”

Dr. Tacke, who was not involved in the trial, added: “The overall survival is the same but there are so many patient-relevant parameters that are actually better in the one treatment [SIRT].”

The SARAH trial was conduced at 25 centers in France and there were 237 patients with a life expectancy of at least 3 months who were randomized to treatment with SIRT and 222 to treatment with sorafenib 800 mg daily.

The mean age of all randomized patients was 65 years, 90% were male, and 90% had cirrhosis. Cirrhosis was caused by alcoholic liver disease in 65%, hepatitis C virus infection in about one-quarter, and nonalcoholic steatohepatitis in roughly one-fifth of cases.

Comparing SIRT with sorafenib in all patients who were randomized, the median overall survival was 8.0 months versus 9.9 months (P = .018) and the median progression-free survival was a respective 4.1 months versus 3.7 months (P = .76). No differences in survival were observed when only patients who actually received the treatments were compared.

While there was no difference in radiologic progression seen overall – one of the secondary endpoints – when progression in the liver as the first site of progression was considered, there was a significant difference favoring the use of SIRT over sorafenib (P = .014), Dr. Vilgrain reported.

In addition, 26 (19%) of SIRT versus 23 (11.6%) of sorafenib-treated patients showed an objective response at 6 months, so there was “a strong signal” that SIRT could have an eventual edge over sorafenib but perhaps effects take longer to materialize (P = .042).

Fewer patients receiving SIRT than sorafenib experienced treatment-related adverse events (76.5% vs. 95%), with a median number of adverse events per patient of 5 and 10, respectively.

Adverse events of note that occurred less frequently in the SIRT than sorafenib arm were fatigue (20% vs. 41%), diarrhea (3% vs. 30%), abdominal pain (6% vs. 14%), hand-foot reaction (1% vs. 12%), infection (3% vs. 9%), weight loss (0% vs. 6%), and hypertension (0% vs. 5%).

Quality of life was significantly better in the SIRT group than in the sorafenib group over time, Dr. Vilgrain said. Quality of life was measured via the Global Health Status subscore of the EORTC QLQ-C30 scale.

Dr. Vilgrain noted during a press briefing that patients in the sorafenib group were able to start oral treatment 1 or 2 days after randomization, whereas there was a delay of 1-2 weeks before the patients randomized to SIRT could receive their treatment and just over one-quarter did not get SIRT as per the protocol, compared to 7% of those randomized to sorafenib.

Whether the lag time in patients getting their treatment might have affected the survival outcomes seen with the treatment is not known. Future studies look at reducing the time between randomization and SIRT, she said.
 

Dr. Vilgrain noted in an interview that SIRT was given as a single injection after an initial test injection. While it is possible to retreat patients, the study design was such that patients had to wait 6 months before they could be retreated and in theory a second treatment should not be needed.

 

The study was sponsored Assistance Publique – Hôpitaux de Paris (supported by grants from Sirtex Medical Limited. Dr. Vilgrain disclosed acting as a study investigator and receiving speaker fees from Guerbet and Sirtex, and speaker fees from SuperSonic Imagine and Toshiba.

 

AMSTERDAM – While there was no overall or progression-free survival benefit, results of the randomized, controlled phase III SARAH trial showed that the use of selective internal radioactive therapy (SIRT) was better tolerated than sorafenib for the treatment of patients with advanced liver cancer.

There was also early evidence that SIRT, using the radiopharmaceutical yttrium-90 (SIR-Spheres microspheres), reduced radiologic progression in the liver and improved tumor responses to a greater extent that did sorafenib.

“I feel [the results] will open a new door in the treatment of HCC [hepatocellular carcinoma],” study investigator Valérie Vilgrain, MD, of Hôpital Beaujon, Paris, said at the International Liver Congress, sponsored by the European Association for the Study of the Liver.

The standard treatment for advanced HCC at present is sorafenib, which is based on the SHARP trial findings that showed an overall survival of around 10.7 months, Dr. Vilgrain observed.

Transarterial chemoembolization (TACE) is the reference treatment for intermediate HCC, she said, and of the 467 patients included in the SARAH trial, just over 40% had failed to respond to two rounds of this therapy and had inoperable or advanced disease.

Dr. Frank Tacke, EASL vice secretary and professor of medicine in the department of gastroenterology, metabolic diseases, and intensive care medicine at University Hospital Aachen, Germany, said during a press briefing that the trial was “the first phase III, randomized controlled trial putting this intervention in perspective with current therapy.”

Dr. Tacke, who was not involved in the trial, added: “The overall survival is the same but there are so many patient-relevant parameters that are actually better in the one treatment [SIRT].”

The SARAH trial was conduced at 25 centers in France and there were 237 patients with a life expectancy of at least 3 months who were randomized to treatment with SIRT and 222 to treatment with sorafenib 800 mg daily.

The mean age of all randomized patients was 65 years, 90% were male, and 90% had cirrhosis. Cirrhosis was caused by alcoholic liver disease in 65%, hepatitis C virus infection in about one-quarter, and nonalcoholic steatohepatitis in roughly one-fifth of cases.

Comparing SIRT with sorafenib in all patients who were randomized, the median overall survival was 8.0 months versus 9.9 months (P = .018) and the median progression-free survival was a respective 4.1 months versus 3.7 months (P = .76). No differences in survival were observed when only patients who actually received the treatments were compared.

While there was no difference in radiologic progression seen overall – one of the secondary endpoints – when progression in the liver as the first site of progression was considered, there was a significant difference favoring the use of SIRT over sorafenib (P = .014), Dr. Vilgrain reported.

In addition, 26 (19%) of SIRT versus 23 (11.6%) of sorafenib-treated patients showed an objective response at 6 months, so there was “a strong signal” that SIRT could have an eventual edge over sorafenib but perhaps effects take longer to materialize (P = .042).

Fewer patients receiving SIRT than sorafenib experienced treatment-related adverse events (76.5% vs. 95%), with a median number of adverse events per patient of 5 and 10, respectively.

Adverse events of note that occurred less frequently in the SIRT than sorafenib arm were fatigue (20% vs. 41%), diarrhea (3% vs. 30%), abdominal pain (6% vs. 14%), hand-foot reaction (1% vs. 12%), infection (3% vs. 9%), weight loss (0% vs. 6%), and hypertension (0% vs. 5%).

Quality of life was significantly better in the SIRT group than in the sorafenib group over time, Dr. Vilgrain said. Quality of life was measured via the Global Health Status subscore of the EORTC QLQ-C30 scale.

Dr. Vilgrain noted during a press briefing that patients in the sorafenib group were able to start oral treatment 1 or 2 days after randomization, whereas there was a delay of 1-2 weeks before the patients randomized to SIRT could receive their treatment and just over one-quarter did not get SIRT as per the protocol, compared to 7% of those randomized to sorafenib.

Whether the lag time in patients getting their treatment might have affected the survival outcomes seen with the treatment is not known. Future studies look at reducing the time between randomization and SIRT, she said.
 

Dr. Vilgrain noted in an interview that SIRT was given as a single injection after an initial test injection. While it is possible to retreat patients, the study design was such that patients had to wait 6 months before they could be retreated and in theory a second treatment should not be needed.

 

The study was sponsored Assistance Publique – Hôpitaux de Paris (supported by grants from Sirtex Medical Limited. Dr. Vilgrain disclosed acting as a study investigator and receiving speaker fees from Guerbet and Sirtex, and speaker fees from SuperSonic Imagine and Toshiba.

 

LAS VEGAS – A new tool identifies patients with ductal carcinoma in situ (DCIS) who are at high risk for being upstaged as a result of the pathology report. The screen could encourage patients to undergo axillary nodal staging during the core needle biopsy (CNB), thus avoiding a second procedure.

“The risk factors have been well described, but they haven’t helped give individual risk or individual percentages. Our goal was to try to individualize that risk so that we could counsel patients,” said lead researcher James Jakub, MD, chair of the division of breast endocrine and metabolic surgery at Mayo Clinic Rochester, at the annual meeting of the American Society of Breast Surgeons.

The researchers reviewed data on 827 patients with pure DCIS who had a total of 834 operations at their institutions between 2004 and 2014. Of those, 90% had been identified by screening. The researchers used tumor and patient characteristics with a multivariable model to create a nomogram, which they then validated on a patient population of 579 patients from two other large academic centers.

The researchers found that grade on CNB, mass lesion on imaging, multifocal/centric disease, and linear dimension combined to predict the likelihood of being upstaged to invasive disease (C statistic, 0.71; 95% confidence interval, 0.66-0.77).

They then combined those characteristics to create a nomogram and tested it against the validation set. In that group, 11% of patients were upstaged to invasive disease. The nomogram performed almost identically in the external validation set (C statistic, 0.71; 95% CI, 0.63-0.79). The model predicted 56 upstages, and 46 occurred.

This wasn’t the first attempt to create a nomogram to predict upstaging in DCIS patients, but others were not tested against external datasets. “That’s a weakness with other studies. Unless it’s validated externally, you don’t really know if you can apply it to your population. That was a very large plus: having colleagues who were willing to collaborate to validate it,” said Dr. Jakub.

The team is working on posting the nomogram online for widespread use.

It remains to be seen whether the availability of the nomogram will, in fact, change patients’ decision-making and result in more axillary nodal biopsies during CNB procedures in high risk patients.

“We haven’t looked into that. It will be interesting to see how it influences [sentinel lymph node] biopsy rate at our institution, and we’d love to hear from institutions who apply it. My sense is that patients who are at high risk are going to be interested in doing that. I think it will definitely change their management,” said Dr. Jakub.

[email protected]

 

LAS VEGAS – A new tool identifies patients with ductal carcinoma in situ (DCIS) who are at high risk for being upstaged as a result of the pathology report. The screen could encourage patients to undergo axillary nodal staging during the core needle biopsy (CNB), thus avoiding a second procedure.

“The risk factors have been well described, but they haven’t helped give individual risk or individual percentages. Our goal was to try to individualize that risk so that we could counsel patients,” said lead researcher James Jakub, MD, chair of the division of breast endocrine and metabolic surgery at Mayo Clinic Rochester, at the annual meeting of the American Society of Breast Surgeons.

The researchers reviewed data on 827 patients with pure DCIS who had a total of 834 operations at their institutions between 2004 and 2014. Of those, 90% had been identified by screening. The researchers used tumor and patient characteristics with a multivariable model to create a nomogram, which they then validated on a patient population of 579 patients from two other large academic centers.

The researchers found that grade on CNB, mass lesion on imaging, multifocal/centric disease, and linear dimension combined to predict the likelihood of being upstaged to invasive disease (C statistic, 0.71; 95% confidence interval, 0.66-0.77).

They then combined those characteristics to create a nomogram and tested it against the validation set. In that group, 11% of patients were upstaged to invasive disease. The nomogram performed almost identically in the external validation set (C statistic, 0.71; 95% CI, 0.63-0.79). The model predicted 56 upstages, and 46 occurred.

This wasn’t the first attempt to create a nomogram to predict upstaging in DCIS patients, but others were not tested against external datasets. “That’s a weakness with other studies. Unless it’s validated externally, you don’t really know if you can apply it to your population. That was a very large plus: having colleagues who were willing to collaborate to validate it,” said Dr. Jakub.

The team is working on posting the nomogram online for widespread use.

It remains to be seen whether the availability of the nomogram will, in fact, change patients’ decision-making and result in more axillary nodal biopsies during CNB procedures in high risk patients.

“We haven’t looked into that. It will be interesting to see how it influences [sentinel lymph node] biopsy rate at our institution, and we’d love to hear from institutions who apply it. My sense is that patients who are at high risk are going to be interested in doing that. I think it will definitely change their management,” said Dr. Jakub.

[email protected]

 

LAS VEGAS – A new tool identifies patients with ductal carcinoma in situ (DCIS) who are at high risk for being upstaged as a result of the pathology report. The screen could encourage patients to undergo axillary nodal staging during the core needle biopsy (CNB), thus avoiding a second procedure.

“The risk factors have been well described, but they haven’t helped give individual risk or individual percentages. Our goal was to try to individualize that risk so that we could counsel patients,” said lead researcher James Jakub, MD, chair of the division of breast endocrine and metabolic surgery at Mayo Clinic Rochester, at the annual meeting of the American Society of Breast Surgeons.

The researchers reviewed data on 827 patients with pure DCIS who had a total of 834 operations at their institutions between 2004 and 2014. Of those, 90% had been identified by screening. The researchers used tumor and patient characteristics with a multivariable model to create a nomogram, which they then validated on a patient population of 579 patients from two other large academic centers.

The researchers found that grade on CNB, mass lesion on imaging, multifocal/centric disease, and linear dimension combined to predict the likelihood of being upstaged to invasive disease (C statistic, 0.71; 95% confidence interval, 0.66-0.77).

They then combined those characteristics to create a nomogram and tested it against the validation set. In that group, 11% of patients were upstaged to invasive disease. The nomogram performed almost identically in the external validation set (C statistic, 0.71; 95% CI, 0.63-0.79). The model predicted 56 upstages, and 46 occurred.

This wasn’t the first attempt to create a nomogram to predict upstaging in DCIS patients, but others were not tested against external datasets. “That’s a weakness with other studies. Unless it’s validated externally, you don’t really know if you can apply it to your population. That was a very large plus: having colleagues who were willing to collaborate to validate it,” said Dr. Jakub.

The team is working on posting the nomogram online for widespread use.

It remains to be seen whether the availability of the nomogram will, in fact, change patients’ decision-making and result in more axillary nodal biopsies during CNB procedures in high risk patients.

“We haven’t looked into that. It will be interesting to see how it influences [sentinel lymph node] biopsy rate at our institution, and we’d love to hear from institutions who apply it. My sense is that patients who are at high risk are going to be interested in doing that. I think it will definitely change their management,” said Dr. Jakub.

[email protected]

 

WASHINGTON – Coronary catheterization procedures done via transradial access produce significantly better patient outcomes, compared with transfemoral approaches, but transradial also leads to substantially higher radiation exposure to the operator, according to an analysis of 650 procedures.

When operators performed transradial coronary catheterizations they received on average nearly twice the radiation dose to their chest as they did when they performed transfemoral procedures, in a randomized trial that included 14 interventional cardiologists, Alessandro Sciahbasi, MD, reported at the annual meeting of the American College of Cardiology.

Mitchel L. Zoler/Frontline Medical News

The average difference in normalized, effective radiation exposure in the thorax – 1.1 mcSv per procedure – meant that for every 100 catheterizations performed transradially, the operator would receive an excess radiation dose nearly equal to six chest x-rays, compared with performing the same procedures transfemorally, said Dr. Sciahbasi, an interventional cardiologist at Sandro Pertini Hospital in Rome. Because study results have proven that transradial access results in superior patient outcomes to transfemoral, the solution is not to abandon the transradial approach, but to encourage operators to “reduce radiation doses and adopt adjunctive radiation protection,” he said. “We have methods available to reduce radiation exposure.”

Radiation exposures to the operators’ wrists and eyes showed no significant differences between the two catheterization routes. The difference was limited to thorax exposure.

“These data worry me,” commented Sunil V. Rao, MD, a long-time advocate for increased transradial catheterizations in U.S. practice. “We are pretty obsessive about radiation detection in our catheterization laboratory,” said Dr. Rao, an interventional cardiologist at Duke University in Durham, N.C.

Dr. Sciahbasi and his associates from the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of angioX) trial, ran the Radiation Dose-Matrix (RAD MATRIX) substudy using a subgroup of participating operators and their patients. The full MATRIX trial compared outcomes in 8,404 patients randomized to transradial or transfemoral access and helped establish that transradial procedures led to significantly reduced rates of major bleeds and all-cause mortality (Lancet. 2015 Jun 20;385[9986]:2465-76).

The RAD-MATRIX substudy focused on the radiation exposures received by 14 participating operators who wore radiation dosimeters on their wrist, chest, and near their eyes during each procedure. All operators performed both transradial and transfemoral catheterizations with the choice dictated by the randomization protocol. The transradial procedures underwent further randomization to access through either the patient’s left or right arm. The full analysis included 398 procedures performed by transfemoral access, and 252 with transradial access with 131 via the left forearm and 121 via the right forearm.

The analysis showed that, when the operators performed transradial catheterizations, they received an average, normalized, effective dose to their thorax of 2.3 mcSv per procedure and 1.2 mcSv when performing transfemoral catheterization, a statistically significant difference. The exposures from left and from right transradial access did not differ significantly. Concurrently with Dr. Sciahbasi’s report at the meeting the results also appeared in an online article (J Am Coll Card. 2017 Mar 18. doi: 10.1016/j.jacc.2017.03.018).

The analysis also showed a 10-fold variability in exposure level among the 14 participating operators. Dr. Sciahbasi hypothesized that this reflected substantive differences in the degree of radiation protection used by each operator and suggested this implied that some interventionalists were not protecting themselves from exposure as thoroughly as possible.

RAD-MATRIX received partial funding from The Medicines Company and Terumo. Dr. Sciahbasi had no disclosures. Dr. Rao has been a consultant to Boehringer Ingelheim, Cardinal Health, Corindus, Cardiovascular Systems, and Medtronic.

[email protected]

On Twitter @mitchelzoler

 

WASHINGTON – Coronary catheterization procedures done via transradial access produce significantly better patient outcomes, compared with transfemoral approaches, but transradial also leads to substantially higher radiation exposure to the operator, according to an analysis of 650 procedures.

When operators performed transradial coronary catheterizations they received on average nearly twice the radiation dose to their chest as they did when they performed transfemoral procedures, in a randomized trial that included 14 interventional cardiologists, Alessandro Sciahbasi, MD, reported at the annual meeting of the American College of Cardiology.

Mitchel L. Zoler/Frontline Medical News

The average difference in normalized, effective radiation exposure in the thorax – 1.1 mcSv per procedure – meant that for every 100 catheterizations performed transradially, the operator would receive an excess radiation dose nearly equal to six chest x-rays, compared with performing the same procedures transfemorally, said Dr. Sciahbasi, an interventional cardiologist at Sandro Pertini Hospital in Rome. Because study results have proven that transradial access results in superior patient outcomes to transfemoral, the solution is not to abandon the transradial approach, but to encourage operators to “reduce radiation doses and adopt adjunctive radiation protection,” he said. “We have methods available to reduce radiation exposure.”

Radiation exposures to the operators’ wrists and eyes showed no significant differences between the two catheterization routes. The difference was limited to thorax exposure.

“These data worry me,” commented Sunil V. Rao, MD, a long-time advocate for increased transradial catheterizations in U.S. practice. “We are pretty obsessive about radiation detection in our catheterization laboratory,” said Dr. Rao, an interventional cardiologist at Duke University in Durham, N.C.

Dr. Sciahbasi and his associates from the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of angioX) trial, ran the Radiation Dose-Matrix (RAD MATRIX) substudy using a subgroup of participating operators and their patients. The full MATRIX trial compared outcomes in 8,404 patients randomized to transradial or transfemoral access and helped establish that transradial procedures led to significantly reduced rates of major bleeds and all-cause mortality (Lancet. 2015 Jun 20;385[9986]:2465-76).

The RAD-MATRIX substudy focused on the radiation exposures received by 14 participating operators who wore radiation dosimeters on their wrist, chest, and near their eyes during each procedure. All operators performed both transradial and transfemoral catheterizations with the choice dictated by the randomization protocol. The transradial procedures underwent further randomization to access through either the patient’s left or right arm. The full analysis included 398 procedures performed by transfemoral access, and 252 with transradial access with 131 via the left forearm and 121 via the right forearm.

The analysis showed that, when the operators performed transradial catheterizations, they received an average, normalized, effective dose to their thorax of 2.3 mcSv per procedure and 1.2 mcSv when performing transfemoral catheterization, a statistically significant difference. The exposures from left and from right transradial access did not differ significantly. Concurrently with Dr. Sciahbasi’s report at the meeting the results also appeared in an online article (J Am Coll Card. 2017 Mar 18. doi: 10.1016/j.jacc.2017.03.018).

The analysis also showed a 10-fold variability in exposure level among the 14 participating operators. Dr. Sciahbasi hypothesized that this reflected substantive differences in the degree of radiation protection used by each operator and suggested this implied that some interventionalists were not protecting themselves from exposure as thoroughly as possible.

RAD-MATRIX received partial funding from The Medicines Company and Terumo. Dr. Sciahbasi had no disclosures. Dr. Rao has been a consultant to Boehringer Ingelheim, Cardinal Health, Corindus, Cardiovascular Systems, and Medtronic.

[email protected]

On Twitter @mitchelzoler

 

WASHINGTON – Coronary catheterization procedures done via transradial access produce significantly better patient outcomes, compared with transfemoral approaches, but transradial also leads to substantially higher radiation exposure to the operator, according to an analysis of 650 procedures.

When operators performed transradial coronary catheterizations they received on average nearly twice the radiation dose to their chest as they did when they performed transfemoral procedures, in a randomized trial that included 14 interventional cardiologists, Alessandro Sciahbasi, MD, reported at the annual meeting of the American College of Cardiology.

Mitchel L. Zoler/Frontline Medical News

The average difference in normalized, effective radiation exposure in the thorax – 1.1 mcSv per procedure – meant that for every 100 catheterizations performed transradially, the operator would receive an excess radiation dose nearly equal to six chest x-rays, compared with performing the same procedures transfemorally, said Dr. Sciahbasi, an interventional cardiologist at Sandro Pertini Hospital in Rome. Because study results have proven that transradial access results in superior patient outcomes to transfemoral, the solution is not to abandon the transradial approach, but to encourage operators to “reduce radiation doses and adopt adjunctive radiation protection,” he said. “We have methods available to reduce radiation exposure.”

Radiation exposures to the operators’ wrists and eyes showed no significant differences between the two catheterization routes. The difference was limited to thorax exposure.

“These data worry me,” commented Sunil V. Rao, MD, a long-time advocate for increased transradial catheterizations in U.S. practice. “We are pretty obsessive about radiation detection in our catheterization laboratory,” said Dr. Rao, an interventional cardiologist at Duke University in Durham, N.C.

Dr. Sciahbasi and his associates from the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of angioX) trial, ran the Radiation Dose-Matrix (RAD MATRIX) substudy using a subgroup of participating operators and their patients. The full MATRIX trial compared outcomes in 8,404 patients randomized to transradial or transfemoral access and helped establish that transradial procedures led to significantly reduced rates of major bleeds and all-cause mortality (Lancet. 2015 Jun 20;385[9986]:2465-76).

The RAD-MATRIX substudy focused on the radiation exposures received by 14 participating operators who wore radiation dosimeters on their wrist, chest, and near their eyes during each procedure. All operators performed both transradial and transfemoral catheterizations with the choice dictated by the randomization protocol. The transradial procedures underwent further randomization to access through either the patient’s left or right arm. The full analysis included 398 procedures performed by transfemoral access, and 252 with transradial access with 131 via the left forearm and 121 via the right forearm.

The analysis showed that, when the operators performed transradial catheterizations, they received an average, normalized, effective dose to their thorax of 2.3 mcSv per procedure and 1.2 mcSv when performing transfemoral catheterization, a statistically significant difference. The exposures from left and from right transradial access did not differ significantly. Concurrently with Dr. Sciahbasi’s report at the meeting the results also appeared in an online article (J Am Coll Card. 2017 Mar 18. doi: 10.1016/j.jacc.2017.03.018).

The analysis also showed a 10-fold variability in exposure level among the 14 participating operators. Dr. Sciahbasi hypothesized that this reflected substantive differences in the degree of radiation protection used by each operator and suggested this implied that some interventionalists were not protecting themselves from exposure as thoroughly as possible.

RAD-MATRIX received partial funding from The Medicines Company and Terumo. Dr. Sciahbasi had no disclosures. Dr. Rao has been a consultant to Boehringer Ingelheim, Cardinal Health, Corindus, Cardiovascular Systems, and Medtronic.

[email protected]

On Twitter @mitchelzoler

 

Children may have a distinctive presentation of psoriasis, compared with adults, Dr. Wynnis Tom said at a pediatric dermatology meeting sponsored by Rady Children’s Hospital–San Diego and UC San Diego School of Medicine.

Infants may present with diaper involvement, also known as “napkin psoriasis,” which may be confused with irritant dermatitis or perineal infections. Moreover, guttate psoriasis, which can be preceded by infectious triggers such as Streptococcus and appears as small, salmon-pink bumps on the skin, is more frequent in children than adults, said Dr. Tom, associate professor of dermatology and pediatrics at the university.

Psoriasis is a complex disorder characterized by a ramped-up or dysregulated immune response, thus manifesting with thick, scaly, well-demarcated pink plaques. Approximately one-third of psoriasis cases initially present in the pediatric population. The prevalence of pediatric psoriasis is 0.5%-1.1% in the United States. “The increasing incidence, in addition to its impact on quality of life (QOL) of both families and patients, warrant increased educational importance of this chronic, inflammatory condition,” she said.

Patients with psoriasis are at higher risk for psychiatric disorders, especially depression and anxiety. A study by Varni et al. discussed QOL ratings by 208 children aged 4-17 years with moderate to severe plaque disease. The study demonstrated a significant negative QOL impact in patients with plaque psoriasis, comparable to the impairment of QOL from arthritis or asthma (Eur J Pediatr. 2011 Sep 30;171[3]485-92).

Dr. Tom talked about other comorbidities associated with psoriasis, including psoriatic arthritis, and encouraged physicians to inquire about morning stiffness, joint pains, swelling, and gait abnormalities. “Psoriatic arthritis occurs in about 10% of children, and it is essential to detect early to prevent permanent joint damage,” she said. “Over the past decade, psoriasis has resurfaced as a systemic disorder as it may be associated with obesity, metabolic syndrome, and inflammatory bowel disease.” Psoriasis also entails an increased risk for cardiovascular disease, myocardial infarction, and stroke.

Dr. Tom emphasized, “because of these risks, we need to extend comorbidity screening to the pediatric population.”

Management of pediatric psoriasis has focused on topical and systemic therapies, in addition to phototherapies. Most systemic agents are used off-label on the basis of experience rather than evidence. Clinical trials are currently underway to extend indications for systemic therapy to the pediatric age group, she said.

Dr. Tom disclosed she is an investigator for Promius Pharma, Celgene, and Janssen.

 

Children may have a distinctive presentation of psoriasis, compared with adults, Dr. Wynnis Tom said at a pediatric dermatology meeting sponsored by Rady Children’s Hospital–San Diego and UC San Diego School of Medicine.

Infants may present with diaper involvement, also known as “napkin psoriasis,” which may be confused with irritant dermatitis or perineal infections. Moreover, guttate psoriasis, which can be preceded by infectious triggers such as Streptococcus and appears as small, salmon-pink bumps on the skin, is more frequent in children than adults, said Dr. Tom, associate professor of dermatology and pediatrics at the university.

Psoriasis is a complex disorder characterized by a ramped-up or dysregulated immune response, thus manifesting with thick, scaly, well-demarcated pink plaques. Approximately one-third of psoriasis cases initially present in the pediatric population. The prevalence of pediatric psoriasis is 0.5%-1.1% in the United States. “The increasing incidence, in addition to its impact on quality of life (QOL) of both families and patients, warrant increased educational importance of this chronic, inflammatory condition,” she said.

Patients with psoriasis are at higher risk for psychiatric disorders, especially depression and anxiety. A study by Varni et al. discussed QOL ratings by 208 children aged 4-17 years with moderate to severe plaque disease. The study demonstrated a significant negative QOL impact in patients with plaque psoriasis, comparable to the impairment of QOL from arthritis or asthma (Eur J Pediatr. 2011 Sep 30;171[3]485-92).

Dr. Tom talked about other comorbidities associated with psoriasis, including psoriatic arthritis, and encouraged physicians to inquire about morning stiffness, joint pains, swelling, and gait abnormalities. “Psoriatic arthritis occurs in about 10% of children, and it is essential to detect early to prevent permanent joint damage,” she said. “Over the past decade, psoriasis has resurfaced as a systemic disorder as it may be associated with obesity, metabolic syndrome, and inflammatory bowel disease.” Psoriasis also entails an increased risk for cardiovascular disease, myocardial infarction, and stroke.

Dr. Tom emphasized, “because of these risks, we need to extend comorbidity screening to the pediatric population.”

Management of pediatric psoriasis has focused on topical and systemic therapies, in addition to phototherapies. Most systemic agents are used off-label on the basis of experience rather than evidence. Clinical trials are currently underway to extend indications for systemic therapy to the pediatric age group, she said.

Dr. Tom disclosed she is an investigator for Promius Pharma, Celgene, and Janssen.

 

Children may have a distinctive presentation of psoriasis, compared with adults, Dr. Wynnis Tom said at a pediatric dermatology meeting sponsored by Rady Children’s Hospital–San Diego and UC San Diego School of Medicine.

Infants may present with diaper involvement, also known as “napkin psoriasis,” which may be confused with irritant dermatitis or perineal infections. Moreover, guttate psoriasis, which can be preceded by infectious triggers such as Streptococcus and appears as small, salmon-pink bumps on the skin, is more frequent in children than adults, said Dr. Tom, associate professor of dermatology and pediatrics at the university.

Psoriasis is a complex disorder characterized by a ramped-up or dysregulated immune response, thus manifesting with thick, scaly, well-demarcated pink plaques. Approximately one-third of psoriasis cases initially present in the pediatric population. The prevalence of pediatric psoriasis is 0.5%-1.1% in the United States. “The increasing incidence, in addition to its impact on quality of life (QOL) of both families and patients, warrant increased educational importance of this chronic, inflammatory condition,” she said.

Patients with psoriasis are at higher risk for psychiatric disorders, especially depression and anxiety. A study by Varni et al. discussed QOL ratings by 208 children aged 4-17 years with moderate to severe plaque disease. The study demonstrated a significant negative QOL impact in patients with plaque psoriasis, comparable to the impairment of QOL from arthritis or asthma (Eur J Pediatr. 2011 Sep 30;171[3]485-92).

Dr. Tom talked about other comorbidities associated with psoriasis, including psoriatic arthritis, and encouraged physicians to inquire about morning stiffness, joint pains, swelling, and gait abnormalities. “Psoriatic arthritis occurs in about 10% of children, and it is essential to detect early to prevent permanent joint damage,” she said. “Over the past decade, psoriasis has resurfaced as a systemic disorder as it may be associated with obesity, metabolic syndrome, and inflammatory bowel disease.” Psoriasis also entails an increased risk for cardiovascular disease, myocardial infarction, and stroke.

Dr. Tom emphasized, “because of these risks, we need to extend comorbidity screening to the pediatric population.”

Management of pediatric psoriasis has focused on topical and systemic therapies, in addition to phototherapies. Most systemic agents are used off-label on the basis of experience rather than evidence. Clinical trials are currently underway to extend indications for systemic therapy to the pediatric age group, she said.

Dr. Tom disclosed she is an investigator for Promius Pharma, Celgene, and Janssen.

 

AMSTERDAM – Patients with primary biliary cholangitis (PBC) who are not responding to first-line therapy with ursodeoxycholic acid (UDCA) may benefit from the addition of bezafibrate, randomized, double-blind, placebo-controlled study findings have suggested.

Almost one-third of the 50 patients who were treated with bezafibrate in addition to UDCA in the 2-year, phase III BEZURSO study met the primary endpoint for response, compared with none of the 50 patients in the control arm of the study.

The findings, presented as a late-breaking abstract at the International Liver Congress, sponsored by the European Association for the Study of the Liver (EASL), could be practice changing for a population of patients who have relatively few treatment options.

“PBC is a progressive cholestatic liver disease and UDCA is the universal first-line treatment for this condition, but 30%-40% of the patients gave an inadequate biochemical response to this drug,” study investigator Christophe Corpechot, MD, of Hôpital Saint-Antoine in Paris, said during a press briefing.

Although obeticholic acid was recently approved as a second-line treatment in combination with UDCA for PBC, one of the side effects of obeticholic acid is that it can cause pruritus, which is one of the symptoms of the condition as well. It can be tricky to explain to patients that there is a treatment but that this treatment might also increase their symptoms, Dr. Corpechot observed.

Between October 2012 and December 2014, mostly female patients (more than 92%), mean age 53 years, who were being treated with UDCA were recruited at 21 centers in France. For inclusion in the study, patients had to have an inadequate biochemical response to UDCA, which was defined by the Paris-2 criteria of an alkaline phosphatase (ALP) or an aspartate aminotransferase (AST) of more than 1.5 times the upper limit of normal (ULN), or a total bilirubin level of more than 17 micromol/L.

Patients were randomized to continue UDCA treatment (13-15 mg/kg per day) with or without the addition of bezafibrate, given as a 400-mg daily dose.

The primary endpoint was a complete biochemical response as defined by normal serum levels of total bilirubin, ALP, aminotransferases, albumin, and a normal prothrombin time at 2 years. The hypothesis was that 40% of the patients in the bezafibrate group and only 10% of patients in the UDCA group would reach this primary endpoint. The actual percentages were 30% and 10% (P less than .0001).

A significantly higher (67% vs. 0%) percentage of patients treated with the fibrate versus UDCA also achieved a normal serum ALP by 2 years, Dr. Corpechot reported, with a significant decrease seen by the third month of treatment.

The mean changes in all the biochemical parameters tested from baseline to the end of the study comparing the bezafibrate group with the control group were a respective –14% and +18% (P less than .0001) for total bilirubin, –60% and 0% for ALP (P less than .0001), –36% and 0% for alanine aminotransferase (P less than .0001), –8% and +8% for AST (P less than .05), –38% and +7% for gamma-glutamyl transferase (P less than .0001), 0% and –3% for albumin (P less than .05), and –16% and 0% for cholesterol (P less than .0001).

Other significant findings favoring the fibrate therapy were a significantly (–75% vs. 0%, P less than .01) decreased itch score (assessed with a visual analog scale) and a significantly lower (–10% vs. +10%, P less than .01) liver stiffness (assessed by transient elastography) at 2 years.

Importantly, the frequency of adverse events, including serious adverse events, did not differ significantly between the two groups.

Providing independent comment at the press conference, EASL Vice Secretary Frank Tacke, MD, observed: “We do have the standard treatment, which is UDCA, and we have one drug that is approved in Europe, obeticholic acid, that is very new, expensive, and with some safety concerns of itching.” Although the latter is manageable, it can be annoying for patients.

Fibrates could thus offer a well tolerated and cheaper alternative, as they are already widely used in clinical practice, although they are not licensed for PBC treatment at the current time.

Dr. Tacke, professor of medicine in the department of gastroenterology, metabolic diseases and intensive care medicine at University Hospital Aachen, Germany, also noted that bezafibrate was a drug that “had been on the market for a very long time,” and was very inexpensive in comparison to obeticholic acid and, importantly, seemed to be very well tolerated in the study.

“One question the community will want to know is whether [bezafibrate] is as effective as obeticholic acid in the second-line treatment of PBC,” Dr. Tacke said. This is a question only a head-to-head study can answer and also it is not possible to say whether other fibrates may have the same benefit as bezafibrate as seen in this trial.

Although the study included only 100 patients, this was a relatively large study considering the disease area and that most patients given the primary treatment of UDCA will do well on it, Dr. Tacke acknowledged in an interview.

“What I like about this study is that they treated patients for 2 years and bezafibrate was given as an add-on treatment, so nobody was at risk for not receiving the UDCA, and they saw a very stable and solid improvement in the parameters studied,” Dr. Tacke said.

EASL launched new guidelines for the diagnosis and treatment of PBC to coincide with the meeting, which state that patients should be treated with UDCA for 1 year and then their biochemical response to treatment should assessed to see if they might need additional treatment. “Up to now, the second-line treatment recommended is obeticholic acid but off-label therapy is mentioned,” Dr. Tacke said.

He noted that there were small, nonrandomized studies with two fibrates – bezafibrate and fenofibrate – that have shown “very encouraging” results but that the current findings suggested that bezafibrate therapy may be an alternative, well-tolerated treatment option for patients failing to respond to standard UDCA therapy that could well be added into the guidelines when they are next revised.

The BEZURSO study was an investigator-led trial sponsored by the Assistance Publique – Hôpitaux de Paris. Dr. Corpechot disclosed financial relationships with Arrow Génériques, Intercept Pharma France, Mayoly-Spindler. Dr. Tacke had nothing to disclose.

 

 

AMSTERDAM – Patients with primary biliary cholangitis (PBC) who are not responding to first-line therapy with ursodeoxycholic acid (UDCA) may benefit from the addition of bezafibrate, randomized, double-blind, placebo-controlled study findings have suggested.

Almost one-third of the 50 patients who were treated with bezafibrate in addition to UDCA in the 2-year, phase III BEZURSO study met the primary endpoint for response, compared with none of the 50 patients in the control arm of the study.

The findings, presented as a late-breaking abstract at the International Liver Congress, sponsored by the European Association for the Study of the Liver (EASL), could be practice changing for a population of patients who have relatively few treatment options.

“PBC is a progressive cholestatic liver disease and UDCA is the universal first-line treatment for this condition, but 30%-40% of the patients gave an inadequate biochemical response to this drug,” study investigator Christophe Corpechot, MD, of Hôpital Saint-Antoine in Paris, said during a press briefing.

Although obeticholic acid was recently approved as a second-line treatment in combination with UDCA for PBC, one of the side effects of obeticholic acid is that it can cause pruritus, which is one of the symptoms of the condition as well. It can be tricky to explain to patients that there is a treatment but that this treatment might also increase their symptoms, Dr. Corpechot observed.

Between October 2012 and December 2014, mostly female patients (more than 92%), mean age 53 years, who were being treated with UDCA were recruited at 21 centers in France. For inclusion in the study, patients had to have an inadequate biochemical response to UDCA, which was defined by the Paris-2 criteria of an alkaline phosphatase (ALP) or an aspartate aminotransferase (AST) of more than 1.5 times the upper limit of normal (ULN), or a total bilirubin level of more than 17 micromol/L.

Patients were randomized to continue UDCA treatment (13-15 mg/kg per day) with or without the addition of bezafibrate, given as a 400-mg daily dose.

The primary endpoint was a complete biochemical response as defined by normal serum levels of total bilirubin, ALP, aminotransferases, albumin, and a normal prothrombin time at 2 years. The hypothesis was that 40% of the patients in the bezafibrate group and only 10% of patients in the UDCA group would reach this primary endpoint. The actual percentages were 30% and 10% (P less than .0001).

A significantly higher (67% vs. 0%) percentage of patients treated with the fibrate versus UDCA also achieved a normal serum ALP by 2 years, Dr. Corpechot reported, with a significant decrease seen by the third month of treatment.

The mean changes in all the biochemical parameters tested from baseline to the end of the study comparing the bezafibrate group with the control group were a respective –14% and +18% (P less than .0001) for total bilirubin, –60% and 0% for ALP (P less than .0001), –36% and 0% for alanine aminotransferase (P less than .0001), –8% and +8% for AST (P less than .05), –38% and +7% for gamma-glutamyl transferase (P less than .0001), 0% and –3% for albumin (P less than .05), and –16% and 0% for cholesterol (P less than .0001).

Other significant findings favoring the fibrate therapy were a significantly (–75% vs. 0%, P less than .01) decreased itch score (assessed with a visual analog scale) and a significantly lower (–10% vs. +10%, P less than .01) liver stiffness (assessed by transient elastography) at 2 years.

Importantly, the frequency of adverse events, including serious adverse events, did not differ significantly between the two groups.

Providing independent comment at the press conference, EASL Vice Secretary Frank Tacke, MD, observed: “We do have the standard treatment, which is UDCA, and we have one drug that is approved in Europe, obeticholic acid, that is very new, expensive, and with some safety concerns of itching.” Although the latter is manageable, it can be annoying for patients.

Fibrates could thus offer a well tolerated and cheaper alternative, as they are already widely used in clinical practice, although they are not licensed for PBC treatment at the current time.

Dr. Tacke, professor of medicine in the department of gastroenterology, metabolic diseases and intensive care medicine at University Hospital Aachen, Germany, also noted that bezafibrate was a drug that “had been on the market for a very long time,” and was very inexpensive in comparison to obeticholic acid and, importantly, seemed to be very well tolerated in the study.

“One question the community will want to know is whether [bezafibrate] is as effective as obeticholic acid in the second-line treatment of PBC,” Dr. Tacke said. This is a question only a head-to-head study can answer and also it is not possible to say whether other fibrates may have the same benefit as bezafibrate as seen in this trial.

Although the study included only 100 patients, this was a relatively large study considering the disease area and that most patients given the primary treatment of UDCA will do well on it, Dr. Tacke acknowledged in an interview.

“What I like about this study is that they treated patients for 2 years and bezafibrate was given as an add-on treatment, so nobody was at risk for not receiving the UDCA, and they saw a very stable and solid improvement in the parameters studied,” Dr. Tacke said.

EASL launched new guidelines for the diagnosis and treatment of PBC to coincide with the meeting, which state that patients should be treated with UDCA for 1 year and then their biochemical response to treatment should assessed to see if they might need additional treatment. “Up to now, the second-line treatment recommended is obeticholic acid but off-label therapy is mentioned,” Dr. Tacke said.

He noted that there were small, nonrandomized studies with two fibrates – bezafibrate and fenofibrate – that have shown “very encouraging” results but that the current findings suggested that bezafibrate therapy may be an alternative, well-tolerated treatment option for patients failing to respond to standard UDCA therapy that could well be added into the guidelines when they are next revised.

The BEZURSO study was an investigator-led trial sponsored by the Assistance Publique – Hôpitaux de Paris. Dr. Corpechot disclosed financial relationships with Arrow Génériques, Intercept Pharma France, Mayoly-Spindler. Dr. Tacke had nothing to disclose.

 

 

AMSTERDAM – Patients with primary biliary cholangitis (PBC) who are not responding to first-line therapy with ursodeoxycholic acid (UDCA) may benefit from the addition of bezafibrate, randomized, double-blind, placebo-controlled study findings have suggested.

Almost one-third of the 50 patients who were treated with bezafibrate in addition to UDCA in the 2-year, phase III BEZURSO study met the primary endpoint for response, compared with none of the 50 patients in the control arm of the study.

The findings, presented as a late-breaking abstract at the International Liver Congress, sponsored by the European Association for the Study of the Liver (EASL), could be practice changing for a population of patients who have relatively few treatment options.

“PBC is a progressive cholestatic liver disease and UDCA is the universal first-line treatment for this condition, but 30%-40% of the patients gave an inadequate biochemical response to this drug,” study investigator Christophe Corpechot, MD, of Hôpital Saint-Antoine in Paris, said during a press briefing.

Although obeticholic acid was recently approved as a second-line treatment in combination with UDCA for PBC, one of the side effects of obeticholic acid is that it can cause pruritus, which is one of the symptoms of the condition as well. It can be tricky to explain to patients that there is a treatment but that this treatment might also increase their symptoms, Dr. Corpechot observed.

Between October 2012 and December 2014, mostly female patients (more than 92%), mean age 53 years, who were being treated with UDCA were recruited at 21 centers in France. For inclusion in the study, patients had to have an inadequate biochemical response to UDCA, which was defined by the Paris-2 criteria of an alkaline phosphatase (ALP) or an aspartate aminotransferase (AST) of more than 1.5 times the upper limit of normal (ULN), or a total bilirubin level of more than 17 micromol/L.

Patients were randomized to continue UDCA treatment (13-15 mg/kg per day) with or without the addition of bezafibrate, given as a 400-mg daily dose.

The primary endpoint was a complete biochemical response as defined by normal serum levels of total bilirubin, ALP, aminotransferases, albumin, and a normal prothrombin time at 2 years. The hypothesis was that 40% of the patients in the bezafibrate group and only 10% of patients in the UDCA group would reach this primary endpoint. The actual percentages were 30% and 10% (P less than .0001).

A significantly higher (67% vs. 0%) percentage of patients treated with the fibrate versus UDCA also achieved a normal serum ALP by 2 years, Dr. Corpechot reported, with a significant decrease seen by the third month of treatment.

The mean changes in all the biochemical parameters tested from baseline to the end of the study comparing the bezafibrate group with the control group were a respective –14% and +18% (P less than .0001) for total bilirubin, –60% and 0% for ALP (P less than .0001), –36% and 0% for alanine aminotransferase (P less than .0001), –8% and +8% for AST (P less than .05), –38% and +7% for gamma-glutamyl transferase (P less than .0001), 0% and –3% for albumin (P less than .05), and –16% and 0% for cholesterol (P less than .0001).

Other significant findings favoring the fibrate therapy were a significantly (–75% vs. 0%, P less than .01) decreased itch score (assessed with a visual analog scale) and a significantly lower (–10% vs. +10%, P less than .01) liver stiffness (assessed by transient elastography) at 2 years.

Importantly, the frequency of adverse events, including serious adverse events, did not differ significantly between the two groups.

Providing independent comment at the press conference, EASL Vice Secretary Frank Tacke, MD, observed: “We do have the standard treatment, which is UDCA, and we have one drug that is approved in Europe, obeticholic acid, that is very new, expensive, and with some safety concerns of itching.” Although the latter is manageable, it can be annoying for patients.

Fibrates could thus offer a well tolerated and cheaper alternative, as they are already widely used in clinical practice, although they are not licensed for PBC treatment at the current time.

Dr. Tacke, professor of medicine in the department of gastroenterology, metabolic diseases and intensive care medicine at University Hospital Aachen, Germany, also noted that bezafibrate was a drug that “had been on the market for a very long time,” and was very inexpensive in comparison to obeticholic acid and, importantly, seemed to be very well tolerated in the study.

“One question the community will want to know is whether [bezafibrate] is as effective as obeticholic acid in the second-line treatment of PBC,” Dr. Tacke said. This is a question only a head-to-head study can answer and also it is not possible to say whether other fibrates may have the same benefit as bezafibrate as seen in this trial.

Although the study included only 100 patients, this was a relatively large study considering the disease area and that most patients given the primary treatment of UDCA will do well on it, Dr. Tacke acknowledged in an interview.

“What I like about this study is that they treated patients for 2 years and bezafibrate was given as an add-on treatment, so nobody was at risk for not receiving the UDCA, and they saw a very stable and solid improvement in the parameters studied,” Dr. Tacke said.

EASL launched new guidelines for the diagnosis and treatment of PBC to coincide with the meeting, which state that patients should be treated with UDCA for 1 year and then their biochemical response to treatment should assessed to see if they might need additional treatment. “Up to now, the second-line treatment recommended is obeticholic acid but off-label therapy is mentioned,” Dr. Tacke said.

He noted that there were small, nonrandomized studies with two fibrates – bezafibrate and fenofibrate – that have shown “very encouraging” results but that the current findings suggested that bezafibrate therapy may be an alternative, well-tolerated treatment option for patients failing to respond to standard UDCA therapy that could well be added into the guidelines when they are next revised.

The BEZURSO study was an investigator-led trial sponsored by the Assistance Publique – Hôpitaux de Paris. Dr. Corpechot disclosed financial relationships with Arrow Génériques, Intercept Pharma France, Mayoly-Spindler. Dr. Tacke had nothing to disclose.

 

 

There are four key findings in patients with suspected severe drug reactions: a high risk medication, mucosal involvement, presence of pustules, and laboratory abnormalities, especially a CBC with differential and liver function tests, James R. Treat, MD, said at a pediatric dermatology meeting sponsored by Rady Children’s Hospital–San Diego and UC San Diego School of Medicine.

Several cutaneous drug reactions that were discussed during the conference included acute generalized exanthematous pustulosis (AGEP), a drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).

Adverse drug reactions may lead to significant morbidity and mortality in the pediatric population. It is essential to differentiate severe medication reactions early in the course of the disease to promptly recognize the disease process and initiate proper management.

AGEP is characterized by fever and generalized pustular eruption arising swiftly after administration of the causative drug. Such drugs include antibiotics, contrast agents, antifungals, and calcium channel blockers. Withdrawal of the offending drug and optimization of fluid and electrolyte balance are warranted in the management of AGEP. Topical steroids may decrease hospital length-of-stay and help with symptomatic treatment of AGEP, said Dr. Treat, a pediatric dermatologist at Children’s Hospital of Philadelphia and an assistant professor of pediatrics and dermatology at the Perelman School of Medicine at the University of Pennsylvania.

A DRESS, also known as drug hypersensitivity syndrome, or drug-induced hypersensitivity syndrome, is a skin eruption that generally occurs 2-6 weeks after the patient starts the offending medication. Clinical signs of this condition include ill-appearance, fever (greater than 100.4° F), facial and hand edema, lymphadenopathy, and lab abnormalities, including hypereosinophilia, atypical lymphocytosis, transaminitis, and human herpesvirus 6 reactivation. DRESS may be misdiagnosed as viral infection, Kawasaki’s disease, or SJS.

Commonly implicated drugs include antiepileptic drugs, antibiotics, HIV medications, and sulfa-containing medications.

“While withdrawal of the offending drug is promptly warranted, this condition may require other therapeutics, particularly if there is significant systemic involvement,” Dr. Treat emphasized. There is evidence that systemic steroids (1-2 mg/kg/day) and cyclosporine can help improve the disease course, although their use is off-label.

SJS and TEN are other severe cutaneous adverse reactions caused by Mycoplasma infection or medications, such as anticonvulsants, antibiotics, HIV medications, and sulfa-containing drugs. “These entities are characterized by an ill-appearing, febrile patient with painful skin and mucosal membrane involvement,” Dr. Treat described.

Mucosal predominance may be seen in cases associated with Mycoplasma and have been termed “Mycoplasma-induced rash and mucositis,” although the terminology is controversial. In a case series by Darren G. Gregory, MD, treatment with amniotic membrane transplantation applied to the eyelid margins, palpebral conjunctiva, and ocular surface during the acute phases of SJS and TEN has been shown to be effective, decreasing the risk of significant oculovisual sequelae (Ophthalmol. 2011 May;118[5]:908-14).

Diagnostic criteria have been detailed to classify each of these adverse reactions. Dr. Treat concluded his lecture with a discussion of a retrospective study by Bouvresse et al. that projected AGEP, DRESS, and SJS-TEN as distinct entities (Orphanet J Rare Dis. 2012. doi: 10.1186/1750-1172-7-72).

Dr. Treat reported having no relevant financial disclosures.

[email protected]

 

There are four key findings in patients with suspected severe drug reactions: a high risk medication, mucosal involvement, presence of pustules, and laboratory abnormalities, especially a CBC with differential and liver function tests, James R. Treat, MD, said at a pediatric dermatology meeting sponsored by Rady Children’s Hospital–San Diego and UC San Diego School of Medicine.

Several cutaneous drug reactions that were discussed during the conference included acute generalized exanthematous pustulosis (AGEP), a drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).

Adverse drug reactions may lead to significant morbidity and mortality in the pediatric population. It is essential to differentiate severe medication reactions early in the course of the disease to promptly recognize the disease process and initiate proper management.

AGEP is characterized by fever and generalized pustular eruption arising swiftly after administration of the causative drug. Such drugs include antibiotics, contrast agents, antifungals, and calcium channel blockers. Withdrawal of the offending drug and optimization of fluid and electrolyte balance are warranted in the management of AGEP. Topical steroids may decrease hospital length-of-stay and help with symptomatic treatment of AGEP, said Dr. Treat, a pediatric dermatologist at Children’s Hospital of Philadelphia and an assistant professor of pediatrics and dermatology at the Perelman School of Medicine at the University of Pennsylvania.

A DRESS, also known as drug hypersensitivity syndrome, or drug-induced hypersensitivity syndrome, is a skin eruption that generally occurs 2-6 weeks after the patient starts the offending medication. Clinical signs of this condition include ill-appearance, fever (greater than 100.4° F), facial and hand edema, lymphadenopathy, and lab abnormalities, including hypereosinophilia, atypical lymphocytosis, transaminitis, and human herpesvirus 6 reactivation. DRESS may be misdiagnosed as viral infection, Kawasaki’s disease, or SJS.

Commonly implicated drugs include antiepileptic drugs, antibiotics, HIV medications, and sulfa-containing medications.

“While withdrawal of the offending drug is promptly warranted, this condition may require other therapeutics, particularly if there is significant systemic involvement,” Dr. Treat emphasized. There is evidence that systemic steroids (1-2 mg/kg/day) and cyclosporine can help improve the disease course, although their use is off-label.

SJS and TEN are other severe cutaneous adverse reactions caused by Mycoplasma infection or medications, such as anticonvulsants, antibiotics, HIV medications, and sulfa-containing drugs. “These entities are characterized by an ill-appearing, febrile patient with painful skin and mucosal membrane involvement,” Dr. Treat described.

Mucosal predominance may be seen in cases associated with Mycoplasma and have been termed “Mycoplasma-induced rash and mucositis,” although the terminology is controversial. In a case series by Darren G. Gregory, MD, treatment with amniotic membrane transplantation applied to the eyelid margins, palpebral conjunctiva, and ocular surface during the acute phases of SJS and TEN has been shown to be effective, decreasing the risk of significant oculovisual sequelae (Ophthalmol. 2011 May;118[5]:908-14).

Diagnostic criteria have been detailed to classify each of these adverse reactions. Dr. Treat concluded his lecture with a discussion of a retrospective study by Bouvresse et al. that projected AGEP, DRESS, and SJS-TEN as distinct entities (Orphanet J Rare Dis. 2012. doi: 10.1186/1750-1172-7-72).

Dr. Treat reported having no relevant financial disclosures.

[email protected]

 

There are four key findings in patients with suspected severe drug reactions: a high risk medication, mucosal involvement, presence of pustules, and laboratory abnormalities, especially a CBC with differential and liver function tests, James R. Treat, MD, said at a pediatric dermatology meeting sponsored by Rady Children’s Hospital–San Diego and UC San Diego School of Medicine.

Several cutaneous drug reactions that were discussed during the conference included acute generalized exanthematous pustulosis (AGEP), a drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).

Adverse drug reactions may lead to significant morbidity and mortality in the pediatric population. It is essential to differentiate severe medication reactions early in the course of the disease to promptly recognize the disease process and initiate proper management.

AGEP is characterized by fever and generalized pustular eruption arising swiftly after administration of the causative drug. Such drugs include antibiotics, contrast agents, antifungals, and calcium channel blockers. Withdrawal of the offending drug and optimization of fluid and electrolyte balance are warranted in the management of AGEP. Topical steroids may decrease hospital length-of-stay and help with symptomatic treatment of AGEP, said Dr. Treat, a pediatric dermatologist at Children’s Hospital of Philadelphia and an assistant professor of pediatrics and dermatology at the Perelman School of Medicine at the University of Pennsylvania.

A DRESS, also known as drug hypersensitivity syndrome, or drug-induced hypersensitivity syndrome, is a skin eruption that generally occurs 2-6 weeks after the patient starts the offending medication. Clinical signs of this condition include ill-appearance, fever (greater than 100.4° F), facial and hand edema, lymphadenopathy, and lab abnormalities, including hypereosinophilia, atypical lymphocytosis, transaminitis, and human herpesvirus 6 reactivation. DRESS may be misdiagnosed as viral infection, Kawasaki’s disease, or SJS.

Commonly implicated drugs include antiepileptic drugs, antibiotics, HIV medications, and sulfa-containing medications.

“While withdrawal of the offending drug is promptly warranted, this condition may require other therapeutics, particularly if there is significant systemic involvement,” Dr. Treat emphasized. There is evidence that systemic steroids (1-2 mg/kg/day) and cyclosporine can help improve the disease course, although their use is off-label.

SJS and TEN are other severe cutaneous adverse reactions caused by Mycoplasma infection or medications, such as anticonvulsants, antibiotics, HIV medications, and sulfa-containing drugs. “These entities are characterized by an ill-appearing, febrile patient with painful skin and mucosal membrane involvement,” Dr. Treat described.

Mucosal predominance may be seen in cases associated with Mycoplasma and have been termed “Mycoplasma-induced rash and mucositis,” although the terminology is controversial. In a case series by Darren G. Gregory, MD, treatment with amniotic membrane transplantation applied to the eyelid margins, palpebral conjunctiva, and ocular surface during the acute phases of SJS and TEN has been shown to be effective, decreasing the risk of significant oculovisual sequelae (Ophthalmol. 2011 May;118[5]:908-14).

Diagnostic criteria have been detailed to classify each of these adverse reactions. Dr. Treat concluded his lecture with a discussion of a retrospective study by Bouvresse et al. that projected AGEP, DRESS, and SJS-TEN as distinct entities (Orphanet J Rare Dis. 2012. doi: 10.1186/1750-1172-7-72).

Dr. Treat reported having no relevant financial disclosures.

[email protected]

 

The fourth biennial the American Association for Thoracic Surgery (AATS) Mitral Conclave 2017 was attended by a large audience of cardiothoracic surgeons and other professionals from 67 countries on Thursday and Friday to hear the latest on repair and replacement of the mitral valve.

Conference chair David H. Adams, MD, of Mount Sinai Health System noted that this was the first time the AATS had directly managed the meeting. The conclave included more than 200 oral presentations and 207 e-posters.

AATS

“What a great way to start off AATS week,” said AATS President Thoralf M. Sundt III, MD, of Massachusetts General Hospital in his opening remarks. The meeting fits well with the AATS Week theme of “always learning,” Dr. Sundt said. “And I think that is what is spectacular about this meeting; it demonstrates the desire and the drive to learn,” he said. He also said the Mitral Conclave was a “tribute” to Dr. Adams’ energy and creativity as the meeting founder.

The faculty included more than 70 international thought leaders in mitral valve repair, and the live sessions featured more than 200 lectures, abstracts, and video presentations. Twenty-two breakout sessions reported on more than 80 submitted abstracts.

Rich Kirkner/Frontline Medical News

Among the breakouts was a mini-oral session on minimal access surgery, in which international leaders shared pearls on integrating minimally invasive surgery in the cardiothoracic practice. Frequency and repetition are key to improving minimally invasive surgical skills, Jean-Francois Obadia, MD, of Lyon, France, emphasized. “If you want to be involved in minimally invasive surgery, you need to do at least one or two a week,” he said.

Mastering videography skills also improves one’s minimally invasive skills, said Vinay Badhwar, MD, of West Virginia University. “To do mitral surgery robotically and do minimally invasive surgery, you have to become a videographer,” he said. The surgeon must also be engaged in carefully selecting his or her team, Dr. Badhwar added.

Rich Kirkner/Frontline Medical News

In another breakout, investigators provided updates on eight different transcatheter mitral valve trials: Tendyne (Tendyne); Intrepid (Medtronic); CardiAQ (Edwards Lifesciences); Harpoon (Harpoon Medical); NeoChord (NeoChord); Cardioband (Valtech); and Trialign (Mitralign).

In seven different plenary sessions, international experts participated in panels that discussed management of complications and explored scenarios in which they would not intervene. A debate format modeled on the movie Thunderdome—“four men enter, one man leaves”—featured a spirited discussion on when to repair functional tricuspid regurgitation. Dr. Adams and Tirone E. David, MD, of Toronto General Hospital, took rather strident opposing views, with Dr. Adams advocating for repair. The goal, Dr. Adams said, is to provide normal tricuspid valve function for the long term. “We got aggressive because we were doing a lot of reoperations for tricuspid disease in patients who had mitral valve surgery,” Dr. Adams said.

One plenary roundtable tackled the subject of when to use mechanical valves instead of biological valves. “Has the pendulum swung too far away from mechanical valves and are there cases where mechanical valves should be the first choice?” Dr. Sundt, session chair, asked the panelists.

The panelists concurred that a patient’s individual needs would drive decision-making. Anelechi Anyanwu, MD, of Mount Sinai, said he’d be inclined to use a mechanical valve in a 25-year-old man with rheumatic mitral stenosis.* In younger patients, namely teenagers, valve selection depends on the activity level they’d pursue after surgery, said Pedro J. del Nido, MD, of Children’s Hospital Boston.

At the plenary on transcatheter mitral therapy, John Laschinger, MD, of the Food and Drug Administration, reviewed the approval process for new mitral devices. “It comes down to the benefit-risk determination where we look at the standard-of-care surgery and look to see if the device is an acceptable alternative – that is, if it is safer and more effective,” Dr. Laschinger said.

James S. Gammie, MD, of the University of Maryland, also reported on an analysis of 87,214 mitral procedures from the Society for Thoracic Surgeons database over the past 5 years. Among the revelations from this analysis are that 96.1% of procedures for leaflet prolapse involved annuloplasty and that 75.8% receive a bioprosthetic valve.

The plenary and breakouts also included seven different video sessions ranging from managing leaflet prolapse to adult congenital surgery and complex scenarios.

Robert A. Dion, MD, Genk, Belgium, delivered the Conclave Honored Lecture and received the Mitral Conclave Achievement Award. He talked about the operative team as a geese flight. “The geese flight is always a unit of hierarchy,” Dr. Dion said. “The figure of the geese flight is V and the chief chooses the lead goose for the capacity to fly high enough and fast enough.”

In the Honored Cardiology Lecture, Robert O. Bonow, MD, of Northwestern Memorial Hospital, explored clinical guidelines for mitral valve repair and replacement and their application in the clinic. “Both sets of guidelines in Europe and the United States make the clear point that is obvious to all of you but less so to cardiologists, that there are two forms of mitral valve disease: degenerative or primary, and functional, which is secondary,” he said. He called for thoracic surgeons to collaborate with their cardiology colleagues. “You and I have lots of work to do, not only in caring for our patients but also in starting to devise appropriate quality metrics, hopefully working together in a team-based approach,” Dr. Bonow said. “This is what gives the best patient care but also gives us the best recommendations for our policy issues. And I look forward to further enhancements from your field and mine as well.”

The AATS Mitral Conclave skips a year in 2018. Instead, New York will host the biennial AATS Aortic Symposium April 26–28 next year.

* CORRECTION: Dr. Anyanwu's remarks were corrected read "he’d be inclined to use a mechanical valve in a 25-year-old man with rheumatic mitral stenosis."  5/5/2017

 

The fourth biennial the American Association for Thoracic Surgery (AATS) Mitral Conclave 2017 was attended by a large audience of cardiothoracic surgeons and other professionals from 67 countries on Thursday and Friday to hear the latest on repair and replacement of the mitral valve.

Conference chair David H. Adams, MD, of Mount Sinai Health System noted that this was the first time the AATS had directly managed the meeting. The conclave included more than 200 oral presentations and 207 e-posters.

AATS

“What a great way to start off AATS week,” said AATS President Thoralf M. Sundt III, MD, of Massachusetts General Hospital in his opening remarks. The meeting fits well with the AATS Week theme of “always learning,” Dr. Sundt said. “And I think that is what is spectacular about this meeting; it demonstrates the desire and the drive to learn,” he said. He also said the Mitral Conclave was a “tribute” to Dr. Adams’ energy and creativity as the meeting founder.

The faculty included more than 70 international thought leaders in mitral valve repair, and the live sessions featured more than 200 lectures, abstracts, and video presentations. Twenty-two breakout sessions reported on more than 80 submitted abstracts.

Rich Kirkner/Frontline Medical News

Among the breakouts was a mini-oral session on minimal access surgery, in which international leaders shared pearls on integrating minimally invasive surgery in the cardiothoracic practice. Frequency and repetition are key to improving minimally invasive surgical skills, Jean-Francois Obadia, MD, of Lyon, France, emphasized. “If you want to be involved in minimally invasive surgery, you need to do at least one or two a week,” he said.

Mastering videography skills also improves one’s minimally invasive skills, said Vinay Badhwar, MD, of West Virginia University. “To do mitral surgery robotically and do minimally invasive surgery, you have to become a videographer,” he said. The surgeon must also be engaged in carefully selecting his or her team, Dr. Badhwar added.

Rich Kirkner/Frontline Medical News

In another breakout, investigators provided updates on eight different transcatheter mitral valve trials: Tendyne (Tendyne); Intrepid (Medtronic); CardiAQ (Edwards Lifesciences); Harpoon (Harpoon Medical); NeoChord (NeoChord); Cardioband (Valtech); and Trialign (Mitralign).

In seven different plenary sessions, international experts participated in panels that discussed management of complications and explored scenarios in which they would not intervene. A debate format modeled on the movie Thunderdome—“four men enter, one man leaves”—featured a spirited discussion on when to repair functional tricuspid regurgitation. Dr. Adams and Tirone E. David, MD, of Toronto General Hospital, took rather strident opposing views, with Dr. Adams advocating for repair. The goal, Dr. Adams said, is to provide normal tricuspid valve function for the long term. “We got aggressive because we were doing a lot of reoperations for tricuspid disease in patients who had mitral valve surgery,” Dr. Adams said.

One plenary roundtable tackled the subject of when to use mechanical valves instead of biological valves. “Has the pendulum swung too far away from mechanical valves and are there cases where mechanical valves should be the first choice?” Dr. Sundt, session chair, asked the panelists.

The panelists concurred that a patient’s individual needs would drive decision-making. Anelechi Anyanwu, MD, of Mount Sinai, said he’d be inclined to use a mechanical valve in a 25-year-old man with rheumatic mitral stenosis.* In younger patients, namely teenagers, valve selection depends on the activity level they’d pursue after surgery, said Pedro J. del Nido, MD, of Children’s Hospital Boston.

At the plenary on transcatheter mitral therapy, John Laschinger, MD, of the Food and Drug Administration, reviewed the approval process for new mitral devices. “It comes down to the benefit-risk determination where we look at the standard-of-care surgery and look to see if the device is an acceptable alternative – that is, if it is safer and more effective,” Dr. Laschinger said.

James S. Gammie, MD, of the University of Maryland, also reported on an analysis of 87,214 mitral procedures from the Society for Thoracic Surgeons database over the past 5 years. Among the revelations from this analysis are that 96.1% of procedures for leaflet prolapse involved annuloplasty and that 75.8% receive a bioprosthetic valve.

The plenary and breakouts also included seven different video sessions ranging from managing leaflet prolapse to adult congenital surgery and complex scenarios.

Robert A. Dion, MD, Genk, Belgium, delivered the Conclave Honored Lecture and received the Mitral Conclave Achievement Award. He talked about the operative team as a geese flight. “The geese flight is always a unit of hierarchy,” Dr. Dion said. “The figure of the geese flight is V and the chief chooses the lead goose for the capacity to fly high enough and fast enough.”

In the Honored Cardiology Lecture, Robert O. Bonow, MD, of Northwestern Memorial Hospital, explored clinical guidelines for mitral valve repair and replacement and their application in the clinic. “Both sets of guidelines in Europe and the United States make the clear point that is obvious to all of you but less so to cardiologists, that there are two forms of mitral valve disease: degenerative or primary, and functional, which is secondary,” he said. He called for thoracic surgeons to collaborate with their cardiology colleagues. “You and I have lots of work to do, not only in caring for our patients but also in starting to devise appropriate quality metrics, hopefully working together in a team-based approach,” Dr. Bonow said. “This is what gives the best patient care but also gives us the best recommendations for our policy issues. And I look forward to further enhancements from your field and mine as well.”

The AATS Mitral Conclave skips a year in 2018. Instead, New York will host the biennial AATS Aortic Symposium April 26–28 next year.

* CORRECTION: Dr. Anyanwu's remarks were corrected read "he’d be inclined to use a mechanical valve in a 25-year-old man with rheumatic mitral stenosis."  5/5/2017

 

The fourth biennial the American Association for Thoracic Surgery (AATS) Mitral Conclave 2017 was attended by a large audience of cardiothoracic surgeons and other professionals from 67 countries on Thursday and Friday to hear the latest on repair and replacement of the mitral valve.

Conference chair David H. Adams, MD, of Mount Sinai Health System noted that this was the first time the AATS had directly managed the meeting. The conclave included more than 200 oral presentations and 207 e-posters.

AATS

“What a great way to start off AATS week,” said AATS President Thoralf M. Sundt III, MD, of Massachusetts General Hospital in his opening remarks. The meeting fits well with the AATS Week theme of “always learning,” Dr. Sundt said. “And I think that is what is spectacular about this meeting; it demonstrates the desire and the drive to learn,” he said. He also said the Mitral Conclave was a “tribute” to Dr. Adams’ energy and creativity as the meeting founder.

The faculty included more than 70 international thought leaders in mitral valve repair, and the live sessions featured more than 200 lectures, abstracts, and video presentations. Twenty-two breakout sessions reported on more than 80 submitted abstracts.

Rich Kirkner/Frontline Medical News

Among the breakouts was a mini-oral session on minimal access surgery, in which international leaders shared pearls on integrating minimally invasive surgery in the cardiothoracic practice. Frequency and repetition are key to improving minimally invasive surgical skills, Jean-Francois Obadia, MD, of Lyon, France, emphasized. “If you want to be involved in minimally invasive surgery, you need to do at least one or two a week,” he said.

Mastering videography skills also improves one’s minimally invasive skills, said Vinay Badhwar, MD, of West Virginia University. “To do mitral surgery robotically and do minimally invasive surgery, you have to become a videographer,” he said. The surgeon must also be engaged in carefully selecting his or her team, Dr. Badhwar added.

Rich Kirkner/Frontline Medical News

In another breakout, investigators provided updates on eight different transcatheter mitral valve trials: Tendyne (Tendyne); Intrepid (Medtronic); CardiAQ (Edwards Lifesciences); Harpoon (Harpoon Medical); NeoChord (NeoChord); Cardioband (Valtech); and Trialign (Mitralign).

In seven different plenary sessions, international experts participated in panels that discussed management of complications and explored scenarios in which they would not intervene. A debate format modeled on the movie Thunderdome—“four men enter, one man leaves”—featured a spirited discussion on when to repair functional tricuspid regurgitation. Dr. Adams and Tirone E. David, MD, of Toronto General Hospital, took rather strident opposing views, with Dr. Adams advocating for repair. The goal, Dr. Adams said, is to provide normal tricuspid valve function for the long term. “We got aggressive because we were doing a lot of reoperations for tricuspid disease in patients who had mitral valve surgery,” Dr. Adams said.

One plenary roundtable tackled the subject of when to use mechanical valves instead of biological valves. “Has the pendulum swung too far away from mechanical valves and are there cases where mechanical valves should be the first choice?” Dr. Sundt, session chair, asked the panelists.

The panelists concurred that a patient’s individual needs would drive decision-making. Anelechi Anyanwu, MD, of Mount Sinai, said he’d be inclined to use a mechanical valve in a 25-year-old man with rheumatic mitral stenosis.* In younger patients, namely teenagers, valve selection depends on the activity level they’d pursue after surgery, said Pedro J. del Nido, MD, of Children’s Hospital Boston.

At the plenary on transcatheter mitral therapy, John Laschinger, MD, of the Food and Drug Administration, reviewed the approval process for new mitral devices. “It comes down to the benefit-risk determination where we look at the standard-of-care surgery and look to see if the device is an acceptable alternative – that is, if it is safer and more effective,” Dr. Laschinger said.

James S. Gammie, MD, of the University of Maryland, also reported on an analysis of 87,214 mitral procedures from the Society for Thoracic Surgeons database over the past 5 years. Among the revelations from this analysis are that 96.1% of procedures for leaflet prolapse involved annuloplasty and that 75.8% receive a bioprosthetic valve.

The plenary and breakouts also included seven different video sessions ranging from managing leaflet prolapse to adult congenital surgery and complex scenarios.

Robert A. Dion, MD, Genk, Belgium, delivered the Conclave Honored Lecture and received the Mitral Conclave Achievement Award. He talked about the operative team as a geese flight. “The geese flight is always a unit of hierarchy,” Dr. Dion said. “The figure of the geese flight is V and the chief chooses the lead goose for the capacity to fly high enough and fast enough.”

In the Honored Cardiology Lecture, Robert O. Bonow, MD, of Northwestern Memorial Hospital, explored clinical guidelines for mitral valve repair and replacement and their application in the clinic. “Both sets of guidelines in Europe and the United States make the clear point that is obvious to all of you but less so to cardiologists, that there are two forms of mitral valve disease: degenerative or primary, and functional, which is secondary,” he said. He called for thoracic surgeons to collaborate with their cardiology colleagues. “You and I have lots of work to do, not only in caring for our patients but also in starting to devise appropriate quality metrics, hopefully working together in a team-based approach,” Dr. Bonow said. “This is what gives the best patient care but also gives us the best recommendations for our policy issues. And I look forward to further enhancements from your field and mine as well.”

The AATS Mitral Conclave skips a year in 2018. Instead, New York will host the biennial AATS Aortic Symposium April 26–28 next year.

* CORRECTION: Dr. Anyanwu's remarks were corrected read "he’d be inclined to use a mechanical valve in a 25-year-old man with rheumatic mitral stenosis."  5/5/2017