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SVS guidelines address scope of practice concerns
NEW YORK – Vascular surgeons are the only specialty qualified to treat all vascular disorders with open surgery and/or endovascular treatment, including the thoracic aorta, according to the updated “Guidelines for hospital privileges in vascular surgery and endovascular interventions: Recommendations of the Society for Vascular Surgery.”
The guidelines, published in May’s Journal of Vascular Surgery, were last updated in 2008, said Keith D. Calligaro, MD, who spoke on their importance and potential benefits to vascular surgeons during his presentation at the VEITHsymposium.
The thoracic aorta component of the guidelines addresses scope of practice concerns between vascular and thoracic surgeons, said Dr. Calligaro, who is a clinical professor of surgery, University of Pennsylvania, and chief of vascular surgery and endovascular therapy at Pennsylvania Hospital, both in Philadelphia.
The guidelines relied on training requirements to provide some of the data to define vascular surgeons and privileges. The open vascular surgery training requirements still are defined by the Residency Review Committee for surgery, and those requirements include 250 major open vascular cases during training, including 30 open abdominal operations, 25 carotid, 45 peripheral open surgery cases, and 10 complex vascular surgeries, said Dr. Calligaro. “In terms of endovascular treatment, the training requirements are over 100 diagnostic caths and over 80 therapeutic interventions, and during training you would have had to have done more than 20 EVARs [endovascular aneurysm repairs].” That number jumped up from five EVARs in the previous guidelines.
Ultimately, “the SVS is basically saying ‘you need to be a vascular surgeon to perform vascular surgery,’ and you need have to have completed an Accreditation Council for Graduate Medical Education–accredited vascular residency.
“So if you are a general surgeon or a heart surgeon and you go to a new hospital and say ‘I want to do vascular,’ the vascular surgeon at that institution can refer to this document and say ‘no, the SVS is saying [the surgeon doesn’t] have the training.’ And I think that’s a pretty gutsy and important call,” said Dr. Calligaro.
It is a different case for endovascular surgery, he said. In this case, the requirement is to have completed an ACGME-accredited program in either vascular surgery, interventional radiology, or interventional cardiology to indicate the appropriate level of training. But SVS agreed with the recommendation by the American College of Cardiology that cardiologists not only had to complete 1 year of coronary interventions but also 1 year of peripheral intervention training, as well.
“So if you are at your hospital and have a cardiologist who is starting to do peripheral vascular stuff, now at least you can wave part of this document and say ‘Hey, look, the most important vascular society in the country is saying that, unless this individual had a year of peripheral training, this cardiologist should not be allowed to do endovascular peripheral interventions,’ ” Dr. Calligaro said.
SOURCE: Calligaro KD et al. J Vasc Surg. 2018 May;67(5):1337-44.
NEW YORK – Vascular surgeons are the only specialty qualified to treat all vascular disorders with open surgery and/or endovascular treatment, including the thoracic aorta, according to the updated “Guidelines for hospital privileges in vascular surgery and endovascular interventions: Recommendations of the Society for Vascular Surgery.”
The guidelines, published in May’s Journal of Vascular Surgery, were last updated in 2008, said Keith D. Calligaro, MD, who spoke on their importance and potential benefits to vascular surgeons during his presentation at the VEITHsymposium.
The thoracic aorta component of the guidelines addresses scope of practice concerns between vascular and thoracic surgeons, said Dr. Calligaro, who is a clinical professor of surgery, University of Pennsylvania, and chief of vascular surgery and endovascular therapy at Pennsylvania Hospital, both in Philadelphia.
The guidelines relied on training requirements to provide some of the data to define vascular surgeons and privileges. The open vascular surgery training requirements still are defined by the Residency Review Committee for surgery, and those requirements include 250 major open vascular cases during training, including 30 open abdominal operations, 25 carotid, 45 peripheral open surgery cases, and 10 complex vascular surgeries, said Dr. Calligaro. “In terms of endovascular treatment, the training requirements are over 100 diagnostic caths and over 80 therapeutic interventions, and during training you would have had to have done more than 20 EVARs [endovascular aneurysm repairs].” That number jumped up from five EVARs in the previous guidelines.
Ultimately, “the SVS is basically saying ‘you need to be a vascular surgeon to perform vascular surgery,’ and you need have to have completed an Accreditation Council for Graduate Medical Education–accredited vascular residency.
“So if you are a general surgeon or a heart surgeon and you go to a new hospital and say ‘I want to do vascular,’ the vascular surgeon at that institution can refer to this document and say ‘no, the SVS is saying [the surgeon doesn’t] have the training.’ And I think that’s a pretty gutsy and important call,” said Dr. Calligaro.
It is a different case for endovascular surgery, he said. In this case, the requirement is to have completed an ACGME-accredited program in either vascular surgery, interventional radiology, or interventional cardiology to indicate the appropriate level of training. But SVS agreed with the recommendation by the American College of Cardiology that cardiologists not only had to complete 1 year of coronary interventions but also 1 year of peripheral intervention training, as well.
“So if you are at your hospital and have a cardiologist who is starting to do peripheral vascular stuff, now at least you can wave part of this document and say ‘Hey, look, the most important vascular society in the country is saying that, unless this individual had a year of peripheral training, this cardiologist should not be allowed to do endovascular peripheral interventions,’ ” Dr. Calligaro said.
SOURCE: Calligaro KD et al. J Vasc Surg. 2018 May;67(5):1337-44.
NEW YORK – Vascular surgeons are the only specialty qualified to treat all vascular disorders with open surgery and/or endovascular treatment, including the thoracic aorta, according to the updated “Guidelines for hospital privileges in vascular surgery and endovascular interventions: Recommendations of the Society for Vascular Surgery.”
The guidelines, published in May’s Journal of Vascular Surgery, were last updated in 2008, said Keith D. Calligaro, MD, who spoke on their importance and potential benefits to vascular surgeons during his presentation at the VEITHsymposium.
The thoracic aorta component of the guidelines addresses scope of practice concerns between vascular and thoracic surgeons, said Dr. Calligaro, who is a clinical professor of surgery, University of Pennsylvania, and chief of vascular surgery and endovascular therapy at Pennsylvania Hospital, both in Philadelphia.
The guidelines relied on training requirements to provide some of the data to define vascular surgeons and privileges. The open vascular surgery training requirements still are defined by the Residency Review Committee for surgery, and those requirements include 250 major open vascular cases during training, including 30 open abdominal operations, 25 carotid, 45 peripheral open surgery cases, and 10 complex vascular surgeries, said Dr. Calligaro. “In terms of endovascular treatment, the training requirements are over 100 diagnostic caths and over 80 therapeutic interventions, and during training you would have had to have done more than 20 EVARs [endovascular aneurysm repairs].” That number jumped up from five EVARs in the previous guidelines.
Ultimately, “the SVS is basically saying ‘you need to be a vascular surgeon to perform vascular surgery,’ and you need have to have completed an Accreditation Council for Graduate Medical Education–accredited vascular residency.
“So if you are a general surgeon or a heart surgeon and you go to a new hospital and say ‘I want to do vascular,’ the vascular surgeon at that institution can refer to this document and say ‘no, the SVS is saying [the surgeon doesn’t] have the training.’ And I think that’s a pretty gutsy and important call,” said Dr. Calligaro.
It is a different case for endovascular surgery, he said. In this case, the requirement is to have completed an ACGME-accredited program in either vascular surgery, interventional radiology, or interventional cardiology to indicate the appropriate level of training. But SVS agreed with the recommendation by the American College of Cardiology that cardiologists not only had to complete 1 year of coronary interventions but also 1 year of peripheral intervention training, as well.
“So if you are at your hospital and have a cardiologist who is starting to do peripheral vascular stuff, now at least you can wave part of this document and say ‘Hey, look, the most important vascular society in the country is saying that, unless this individual had a year of peripheral training, this cardiologist should not be allowed to do endovascular peripheral interventions,’ ” Dr. Calligaro said.
SOURCE: Calligaro KD et al. J Vasc Surg. 2018 May;67(5):1337-44.
REPORTING FROM THE VEITHSYMPOSIUM
FDA expands approval of brentuximab vedotin to PTCL
The
The drug, which is marketed by Seattle Genetics as Adcetris, is a monoclonal antibody that binds to CD30 protein found on some cancer cells.
It was previously approved for adult patients with untreated stage III or IV classical Hodgkin lymphoma (cHL), cHL after relapse, cHL after stem cell transplant in patients at high risk for relapse or progression, systemic anaplastic large cell lymphoma (ALCL) after other treatments fail, and primary cutaneous ALCL or CD30-expressing mycosis fungoides after other treatments fail.
The expanded approval, which followed the granting of Priority Review and Breakthrough Therapy designations for the supplemental Biologic License Application, was made using the FDA’s new Real-Time Oncology Review pilot program (RTOR). This program allows for data review and communication with a sponsor prior to official application submission with the goal of speeding up the review process.
The brentuximab vedotin approval now extends to previously untreated systemic ALCL and other CD30-expressing PTCLs in combination with chemotherapy.
Approval was based on the ECHELON-2 clinical trial involving 452 patients, which demonstrated improved progression-free survival (PFS) in patients with certain types of PTCL who were treated first-line with either brentuximab vedotin plus chemotherapy with cyclophosphamide, doxorubicin, prednisone (CHP), or standard chemotherapy with CHP and vincristine (CHOP). Median PFS was 48 months vs. 21 months in the groups, respectively (hazard ratio, 0.71).
The FDA advises health care providers to “monitor patients for infusion reactions, life-threatening allergic reactions (anaphylaxis), neuropathy, fever, gastrointestinal complications, and infections,” according to a press release announcing the approval, which also states that patients should be monitored for tumor lysis syndrome, serious skin reactions, pulmonary toxicity, and hepatotoxicity.
The drug may cause harm to a developing fetus or newborn and should not be used in women who are pregnant or breastfeeding. A Boxed Warning regarding risk of progressive multifocal leukoencephalopathy is also included in the prescribing information.
The current standard of care for initial treatment of PTCL is multiagent chemotherapy – a treatment that “has not significantly changed in decades and is too often unsuccessful in leading to long-term remissions, underscoring the need for new treatments, ” Steven Horwitz, MD, of Memorial Sloan Kettering Cancer Center, New York, said in a statement issued by Seattle Genetics.
“With this approval, clinicians have the opportunity to transform the way newly diagnosed CD30-expressing PTCL patients are treated,” Dr. Horwitz said.
The ECHELON-2 data will be presented at the American Society of Hematology annual meeting in San Diego on Monday, Dec. 3, 2018.
The
The drug, which is marketed by Seattle Genetics as Adcetris, is a monoclonal antibody that binds to CD30 protein found on some cancer cells.
It was previously approved for adult patients with untreated stage III or IV classical Hodgkin lymphoma (cHL), cHL after relapse, cHL after stem cell transplant in patients at high risk for relapse or progression, systemic anaplastic large cell lymphoma (ALCL) after other treatments fail, and primary cutaneous ALCL or CD30-expressing mycosis fungoides after other treatments fail.
The expanded approval, which followed the granting of Priority Review and Breakthrough Therapy designations for the supplemental Biologic License Application, was made using the FDA’s new Real-Time Oncology Review pilot program (RTOR). This program allows for data review and communication with a sponsor prior to official application submission with the goal of speeding up the review process.
The brentuximab vedotin approval now extends to previously untreated systemic ALCL and other CD30-expressing PTCLs in combination with chemotherapy.
Approval was based on the ECHELON-2 clinical trial involving 452 patients, which demonstrated improved progression-free survival (PFS) in patients with certain types of PTCL who were treated first-line with either brentuximab vedotin plus chemotherapy with cyclophosphamide, doxorubicin, prednisone (CHP), or standard chemotherapy with CHP and vincristine (CHOP). Median PFS was 48 months vs. 21 months in the groups, respectively (hazard ratio, 0.71).
The FDA advises health care providers to “monitor patients for infusion reactions, life-threatening allergic reactions (anaphylaxis), neuropathy, fever, gastrointestinal complications, and infections,” according to a press release announcing the approval, which also states that patients should be monitored for tumor lysis syndrome, serious skin reactions, pulmonary toxicity, and hepatotoxicity.
The drug may cause harm to a developing fetus or newborn and should not be used in women who are pregnant or breastfeeding. A Boxed Warning regarding risk of progressive multifocal leukoencephalopathy is also included in the prescribing information.
The current standard of care for initial treatment of PTCL is multiagent chemotherapy – a treatment that “has not significantly changed in decades and is too often unsuccessful in leading to long-term remissions, underscoring the need for new treatments, ” Steven Horwitz, MD, of Memorial Sloan Kettering Cancer Center, New York, said in a statement issued by Seattle Genetics.
“With this approval, clinicians have the opportunity to transform the way newly diagnosed CD30-expressing PTCL patients are treated,” Dr. Horwitz said.
The ECHELON-2 data will be presented at the American Society of Hematology annual meeting in San Diego on Monday, Dec. 3, 2018.
The
The drug, which is marketed by Seattle Genetics as Adcetris, is a monoclonal antibody that binds to CD30 protein found on some cancer cells.
It was previously approved for adult patients with untreated stage III or IV classical Hodgkin lymphoma (cHL), cHL after relapse, cHL after stem cell transplant in patients at high risk for relapse or progression, systemic anaplastic large cell lymphoma (ALCL) after other treatments fail, and primary cutaneous ALCL or CD30-expressing mycosis fungoides after other treatments fail.
The expanded approval, which followed the granting of Priority Review and Breakthrough Therapy designations for the supplemental Biologic License Application, was made using the FDA’s new Real-Time Oncology Review pilot program (RTOR). This program allows for data review and communication with a sponsor prior to official application submission with the goal of speeding up the review process.
The brentuximab vedotin approval now extends to previously untreated systemic ALCL and other CD30-expressing PTCLs in combination with chemotherapy.
Approval was based on the ECHELON-2 clinical trial involving 452 patients, which demonstrated improved progression-free survival (PFS) in patients with certain types of PTCL who were treated first-line with either brentuximab vedotin plus chemotherapy with cyclophosphamide, doxorubicin, prednisone (CHP), or standard chemotherapy with CHP and vincristine (CHOP). Median PFS was 48 months vs. 21 months in the groups, respectively (hazard ratio, 0.71).
The FDA advises health care providers to “monitor patients for infusion reactions, life-threatening allergic reactions (anaphylaxis), neuropathy, fever, gastrointestinal complications, and infections,” according to a press release announcing the approval, which also states that patients should be monitored for tumor lysis syndrome, serious skin reactions, pulmonary toxicity, and hepatotoxicity.
The drug may cause harm to a developing fetus or newborn and should not be used in women who are pregnant or breastfeeding. A Boxed Warning regarding risk of progressive multifocal leukoencephalopathy is also included in the prescribing information.
The current standard of care for initial treatment of PTCL is multiagent chemotherapy – a treatment that “has not significantly changed in decades and is too often unsuccessful in leading to long-term remissions, underscoring the need for new treatments, ” Steven Horwitz, MD, of Memorial Sloan Kettering Cancer Center, New York, said in a statement issued by Seattle Genetics.
“With this approval, clinicians have the opportunity to transform the way newly diagnosed CD30-expressing PTCL patients are treated,” Dr. Horwitz said.
The ECHELON-2 data will be presented at the American Society of Hematology annual meeting in San Diego on Monday, Dec. 3, 2018.
Fear of blindness hobbles hydroxychloroquine treatment of SLE
CHICAGO – The dosage of hydroxychloroquine (HCQ) for treating patients with systemic lupus erythematosus (SLE) is often overly influenced by fear that the drug could cause blindness, Michelle A. Petri, MD, said at the annual meeting of the American College of Rheumatology.
HCQ “is the most important drug we have to treat lupus. It’s the only treatment shown to improve survival of lupus patients. There is no reason to make patients afraid of this very important drug. I am very concerned that fear of blindness is causing our patients to be less adherent” or making them receive an inadequate dosage, said Dr. Petri, a professor of medicine and the director of the Lupus Center at Johns Hopkins University in Baltimore. “I have had no patients who went blind on HCQ. A few patients developed retinopathy, but none went blind.”
Dr. Petri spoke about experiences with some of her SLE patients who were frightened by what an ophthalmologist told them about the retinal effects of HCQ and had their dosage of the drug unilaterally cut by the ophthalmologist.
“The message we should give patients is that retinopathy is a real complication that can happen, but usually not until after 16 years of treatment with HCQ, and we will work together to make sure you are regularly screened so that, if retinopathy developed, we would pick it up early and you’ll remain asymptomatic,” she said. ”We need to put the risk into perspective for our patients.”
Reports differ on the incidence of retinopathy in SLE patients on long-term HCQ treatment. During the session in which Dr. Petri spoke, James T. Rosenbaum, MD, cited a seminal report from 2014 that tracked 2,361 U.S. patients treated with HCQ daily for at least 5 years with regular retinal follow-up. The results showed a steady, cumulative increase in patients who developed retinopathy, an increase that was also dose dependent. For example, patients who received daily dosage of 5-5.9 mg/kg and took the drug for 20 or more years had a cumulative retinopathy incidence of 30% (JAMA Opthalmol. 2014 Dec;132[12]:1453-60). For patients on higher dosages, the cumulative risk at 20 years or longer jumped above 50%.
The findings from this study led directly to the most recent recommendations from the American Academy of Ophthalmology for retinopathy screening for patients on chronic HCQ treatment, said Dr. Rosenbaum, a professor of medicine and opthalmology at Oregon Health & Science University in Portland. The recommendations called for a dosage cap of less than 5 mg/kg real weight, a baseline retinal examination, and then at least annual follow-up examinations starting after 5 years of daily HCQ use, ideally using both automated visual fields and spectral-domain optical coherence tomography (Ophthalmology. 2016 June;123[6]:1386-94). The recommendations also noted that the presence of retinopathy risk factors, including renal disease or concomitant tamoxifen use, warrant starting screening at 5 years or sooner on HCQ.
Clinicians have often exceeded recommended dosage guidelines. Dr. Rosenbaum cited a 2017 report from one U.S. health care system that reviewed the treatment of 554 patients on HCQ and found that roughly half were overdosed in their starting regimen based on prevailing treatment recommendations (Opthalmology. 2017 May;124[5]:604-8).
But Dr. Petri contended that concerns about excessive HCQ dosages are overblown. At the meeting, she reported data showing a different perspective on the retinopathy risk of patients on chronic HCQ treatment. In a prospective series of 477 SLE patients on chronic HCQ treatment and followed at Johns Hopkins, the incidence of retinopathy was 10% among patients on treatment for 16 or more years, she reported in a talk at the meeting (Arthritis Rheumatol. 2018;70[Suppl 10]: Abstract 2897).
A 10% retinopathy rate after 16 or more years on treatment “sounds a lot safer to patients” than rates as high as 30% or 50% that were reported in the JAMA Opthalmology report from 2014, Dr. Petri said. “There is a danger relying on one retrospective study,” she warned. In addition, the 10% risk for retinopathy is “manageable” when patients receive regular screening that produces early detection of retinal damage.
“There has been acceptance of suboptimal dosing of HCQ when discussion has only been about safety, not about efficacy. We need to put the risks into perspective and stop scaring patients.”
Dr. Petri presented her recommendations for treating SLE patients with HCQ: Treat with dosages as high as 6.5 mg/kg but without exceeding 400 mg/day, and cut the dosage for patients with renal insufficiency or failure, those with liver disease, or the elderly. In addition, Dr. Petri endorsed monitoring blood levels of HCQ. Data she reported at the meeting showed a roughly fourfold higher rate of retinopathy among patients who had a maximum HCQ blood level of 1,733 ng/mL or higher when compared with patients whose maximum level remained at 1,194 ng/mL or lower. Clinicians could use blood levels of HCQ to better focus screening and its intensity, she said. “We should embrace monitoring HCQ blood levels.”
Dr. Petri has been a consultant to Amgen, Exagen, GlaxoSmithKline, Inova Diagnostics, Janssen, Lilly, Merck, Novartis, Quintiles, and EMD Serono, and she has received research funding from AstraZeneca and Exagen. Dr. Rosenbaum has been a consultant to AbbVie, Eyevensys, Gilead, Janssen, Novartis, Regeneron, and Roche, and has received research funding from Pfizer.
CHICAGO – The dosage of hydroxychloroquine (HCQ) for treating patients with systemic lupus erythematosus (SLE) is often overly influenced by fear that the drug could cause blindness, Michelle A. Petri, MD, said at the annual meeting of the American College of Rheumatology.
HCQ “is the most important drug we have to treat lupus. It’s the only treatment shown to improve survival of lupus patients. There is no reason to make patients afraid of this very important drug. I am very concerned that fear of blindness is causing our patients to be less adherent” or making them receive an inadequate dosage, said Dr. Petri, a professor of medicine and the director of the Lupus Center at Johns Hopkins University in Baltimore. “I have had no patients who went blind on HCQ. A few patients developed retinopathy, but none went blind.”
Dr. Petri spoke about experiences with some of her SLE patients who were frightened by what an ophthalmologist told them about the retinal effects of HCQ and had their dosage of the drug unilaterally cut by the ophthalmologist.
“The message we should give patients is that retinopathy is a real complication that can happen, but usually not until after 16 years of treatment with HCQ, and we will work together to make sure you are regularly screened so that, if retinopathy developed, we would pick it up early and you’ll remain asymptomatic,” she said. ”We need to put the risk into perspective for our patients.”
Reports differ on the incidence of retinopathy in SLE patients on long-term HCQ treatment. During the session in which Dr. Petri spoke, James T. Rosenbaum, MD, cited a seminal report from 2014 that tracked 2,361 U.S. patients treated with HCQ daily for at least 5 years with regular retinal follow-up. The results showed a steady, cumulative increase in patients who developed retinopathy, an increase that was also dose dependent. For example, patients who received daily dosage of 5-5.9 mg/kg and took the drug for 20 or more years had a cumulative retinopathy incidence of 30% (JAMA Opthalmol. 2014 Dec;132[12]:1453-60). For patients on higher dosages, the cumulative risk at 20 years or longer jumped above 50%.
The findings from this study led directly to the most recent recommendations from the American Academy of Ophthalmology for retinopathy screening for patients on chronic HCQ treatment, said Dr. Rosenbaum, a professor of medicine and opthalmology at Oregon Health & Science University in Portland. The recommendations called for a dosage cap of less than 5 mg/kg real weight, a baseline retinal examination, and then at least annual follow-up examinations starting after 5 years of daily HCQ use, ideally using both automated visual fields and spectral-domain optical coherence tomography (Ophthalmology. 2016 June;123[6]:1386-94). The recommendations also noted that the presence of retinopathy risk factors, including renal disease or concomitant tamoxifen use, warrant starting screening at 5 years or sooner on HCQ.
Clinicians have often exceeded recommended dosage guidelines. Dr. Rosenbaum cited a 2017 report from one U.S. health care system that reviewed the treatment of 554 patients on HCQ and found that roughly half were overdosed in their starting regimen based on prevailing treatment recommendations (Opthalmology. 2017 May;124[5]:604-8).
But Dr. Petri contended that concerns about excessive HCQ dosages are overblown. At the meeting, she reported data showing a different perspective on the retinopathy risk of patients on chronic HCQ treatment. In a prospective series of 477 SLE patients on chronic HCQ treatment and followed at Johns Hopkins, the incidence of retinopathy was 10% among patients on treatment for 16 or more years, she reported in a talk at the meeting (Arthritis Rheumatol. 2018;70[Suppl 10]: Abstract 2897).
A 10% retinopathy rate after 16 or more years on treatment “sounds a lot safer to patients” than rates as high as 30% or 50% that were reported in the JAMA Opthalmology report from 2014, Dr. Petri said. “There is a danger relying on one retrospective study,” she warned. In addition, the 10% risk for retinopathy is “manageable” when patients receive regular screening that produces early detection of retinal damage.
“There has been acceptance of suboptimal dosing of HCQ when discussion has only been about safety, not about efficacy. We need to put the risks into perspective and stop scaring patients.”
Dr. Petri presented her recommendations for treating SLE patients with HCQ: Treat with dosages as high as 6.5 mg/kg but without exceeding 400 mg/day, and cut the dosage for patients with renal insufficiency or failure, those with liver disease, or the elderly. In addition, Dr. Petri endorsed monitoring blood levels of HCQ. Data she reported at the meeting showed a roughly fourfold higher rate of retinopathy among patients who had a maximum HCQ blood level of 1,733 ng/mL or higher when compared with patients whose maximum level remained at 1,194 ng/mL or lower. Clinicians could use blood levels of HCQ to better focus screening and its intensity, she said. “We should embrace monitoring HCQ blood levels.”
Dr. Petri has been a consultant to Amgen, Exagen, GlaxoSmithKline, Inova Diagnostics, Janssen, Lilly, Merck, Novartis, Quintiles, and EMD Serono, and she has received research funding from AstraZeneca and Exagen. Dr. Rosenbaum has been a consultant to AbbVie, Eyevensys, Gilead, Janssen, Novartis, Regeneron, and Roche, and has received research funding from Pfizer.
CHICAGO – The dosage of hydroxychloroquine (HCQ) for treating patients with systemic lupus erythematosus (SLE) is often overly influenced by fear that the drug could cause blindness, Michelle A. Petri, MD, said at the annual meeting of the American College of Rheumatology.
HCQ “is the most important drug we have to treat lupus. It’s the only treatment shown to improve survival of lupus patients. There is no reason to make patients afraid of this very important drug. I am very concerned that fear of blindness is causing our patients to be less adherent” or making them receive an inadequate dosage, said Dr. Petri, a professor of medicine and the director of the Lupus Center at Johns Hopkins University in Baltimore. “I have had no patients who went blind on HCQ. A few patients developed retinopathy, but none went blind.”
Dr. Petri spoke about experiences with some of her SLE patients who were frightened by what an ophthalmologist told them about the retinal effects of HCQ and had their dosage of the drug unilaterally cut by the ophthalmologist.
“The message we should give patients is that retinopathy is a real complication that can happen, but usually not until after 16 years of treatment with HCQ, and we will work together to make sure you are regularly screened so that, if retinopathy developed, we would pick it up early and you’ll remain asymptomatic,” she said. ”We need to put the risk into perspective for our patients.”
Reports differ on the incidence of retinopathy in SLE patients on long-term HCQ treatment. During the session in which Dr. Petri spoke, James T. Rosenbaum, MD, cited a seminal report from 2014 that tracked 2,361 U.S. patients treated with HCQ daily for at least 5 years with regular retinal follow-up. The results showed a steady, cumulative increase in patients who developed retinopathy, an increase that was also dose dependent. For example, patients who received daily dosage of 5-5.9 mg/kg and took the drug for 20 or more years had a cumulative retinopathy incidence of 30% (JAMA Opthalmol. 2014 Dec;132[12]:1453-60). For patients on higher dosages, the cumulative risk at 20 years or longer jumped above 50%.
The findings from this study led directly to the most recent recommendations from the American Academy of Ophthalmology for retinopathy screening for patients on chronic HCQ treatment, said Dr. Rosenbaum, a professor of medicine and opthalmology at Oregon Health & Science University in Portland. The recommendations called for a dosage cap of less than 5 mg/kg real weight, a baseline retinal examination, and then at least annual follow-up examinations starting after 5 years of daily HCQ use, ideally using both automated visual fields and spectral-domain optical coherence tomography (Ophthalmology. 2016 June;123[6]:1386-94). The recommendations also noted that the presence of retinopathy risk factors, including renal disease or concomitant tamoxifen use, warrant starting screening at 5 years or sooner on HCQ.
Clinicians have often exceeded recommended dosage guidelines. Dr. Rosenbaum cited a 2017 report from one U.S. health care system that reviewed the treatment of 554 patients on HCQ and found that roughly half were overdosed in their starting regimen based on prevailing treatment recommendations (Opthalmology. 2017 May;124[5]:604-8).
But Dr. Petri contended that concerns about excessive HCQ dosages are overblown. At the meeting, she reported data showing a different perspective on the retinopathy risk of patients on chronic HCQ treatment. In a prospective series of 477 SLE patients on chronic HCQ treatment and followed at Johns Hopkins, the incidence of retinopathy was 10% among patients on treatment for 16 or more years, she reported in a talk at the meeting (Arthritis Rheumatol. 2018;70[Suppl 10]: Abstract 2897).
A 10% retinopathy rate after 16 or more years on treatment “sounds a lot safer to patients” than rates as high as 30% or 50% that were reported in the JAMA Opthalmology report from 2014, Dr. Petri said. “There is a danger relying on one retrospective study,” she warned. In addition, the 10% risk for retinopathy is “manageable” when patients receive regular screening that produces early detection of retinal damage.
“There has been acceptance of suboptimal dosing of HCQ when discussion has only been about safety, not about efficacy. We need to put the risks into perspective and stop scaring patients.”
Dr. Petri presented her recommendations for treating SLE patients with HCQ: Treat with dosages as high as 6.5 mg/kg but without exceeding 400 mg/day, and cut the dosage for patients with renal insufficiency or failure, those with liver disease, or the elderly. In addition, Dr. Petri endorsed monitoring blood levels of HCQ. Data she reported at the meeting showed a roughly fourfold higher rate of retinopathy among patients who had a maximum HCQ blood level of 1,733 ng/mL or higher when compared with patients whose maximum level remained at 1,194 ng/mL or lower. Clinicians could use blood levels of HCQ to better focus screening and its intensity, she said. “We should embrace monitoring HCQ blood levels.”
Dr. Petri has been a consultant to Amgen, Exagen, GlaxoSmithKline, Inova Diagnostics, Janssen, Lilly, Merck, Novartis, Quintiles, and EMD Serono, and she has received research funding from AstraZeneca and Exagen. Dr. Rosenbaum has been a consultant to AbbVie, Eyevensys, Gilead, Janssen, Novartis, Regeneron, and Roche, and has received research funding from Pfizer.
REPORTING FROM THE ACR ANNUAL MEETING
Quick FDA approval for brentuximab vedotin in PTCL
The U.S. Food and Drug Administration (FDA) has approved a new indication for brentuximab vedotin (ADCETRIS®) less than 2 weeks after receiving the completed supplemental biologics license application (sBLA).
Brentuximab vedotin is now approved for use in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) to treat adults with previously untreated systemic anaplastic large-cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCLs), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified.
The FDA granted priority review and breakthrough therapy designation to the sBLA for brentuximab vedotin in this indication.
The FDA reviewed the sBLA under the Real-Time Oncology Review Pilot Program, which led to approval less than 2 weeks after the application was submitted in full.
“The Real-Time Oncology Review program allows the FDA to access key data prior to the official submission of the application, allowing the review team to begin their review earlier and communicate with the sponsor prior to the application’s actual submission,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products.
“When the sponsor submits the completed application, the review team will already be familiar with the data and be able to conduct a more efficient, timely, and thorough review.”
Trial data
The FDA’s approval is based on results from the phase 3 ECHELON-2 trial (NCT01777152).
Seattle Genetics, Inc. and Takeda Pharmaceutical Company Limited announced results from this trial last month. Additional results are scheduled to be presented at the 2018 ASH Annual Meeting (abstract 997).
The trial enrolled 452 patients with CD30-positive PTCL. The patients were randomized to receive brentuximab vedotin (BV) plus CHP or cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP).
The objective response rate was 83% in the BV-CHP arm and 72% in the CHOP arm (P=0.003). The complete response rate was 68% and 56%, respectively (P=0.007).
Progression-free survival was significantly better in the BV-CHP arm than in the CHOP arm (hazard ratio=0.71; P=0.011), as was overall survival (hazard ratio=0.66; P=0.024).
The most common adverse events of any grade that occurred in at least 20% of patients in the BV-CHP arm were peripheral neuropathy, nausea, diarrhea, neutropenia, lymphopenia, fatigue, mucositis, constipation, alopecia, pyrexia, vomiting, and anemia.
Serious adverse events occurring in at least 2% of patients in the BV-CHP arm included febrile neutropenia, pneumonia, pyrexia, and sepsis.
Results of this trial suggest prophylactic growth factors should be given to previously untreated PTCL patients receiving BV-CHP (starting at cycle 1).
The U.S. Food and Drug Administration (FDA) has approved a new indication for brentuximab vedotin (ADCETRIS®) less than 2 weeks after receiving the completed supplemental biologics license application (sBLA).
Brentuximab vedotin is now approved for use in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) to treat adults with previously untreated systemic anaplastic large-cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCLs), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified.
The FDA granted priority review and breakthrough therapy designation to the sBLA for brentuximab vedotin in this indication.
The FDA reviewed the sBLA under the Real-Time Oncology Review Pilot Program, which led to approval less than 2 weeks after the application was submitted in full.
“The Real-Time Oncology Review program allows the FDA to access key data prior to the official submission of the application, allowing the review team to begin their review earlier and communicate with the sponsor prior to the application’s actual submission,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products.
“When the sponsor submits the completed application, the review team will already be familiar with the data and be able to conduct a more efficient, timely, and thorough review.”
Trial data
The FDA’s approval is based on results from the phase 3 ECHELON-2 trial (NCT01777152).
Seattle Genetics, Inc. and Takeda Pharmaceutical Company Limited announced results from this trial last month. Additional results are scheduled to be presented at the 2018 ASH Annual Meeting (abstract 997).
The trial enrolled 452 patients with CD30-positive PTCL. The patients were randomized to receive brentuximab vedotin (BV) plus CHP or cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP).
The objective response rate was 83% in the BV-CHP arm and 72% in the CHOP arm (P=0.003). The complete response rate was 68% and 56%, respectively (P=0.007).
Progression-free survival was significantly better in the BV-CHP arm than in the CHOP arm (hazard ratio=0.71; P=0.011), as was overall survival (hazard ratio=0.66; P=0.024).
The most common adverse events of any grade that occurred in at least 20% of patients in the BV-CHP arm were peripheral neuropathy, nausea, diarrhea, neutropenia, lymphopenia, fatigue, mucositis, constipation, alopecia, pyrexia, vomiting, and anemia.
Serious adverse events occurring in at least 2% of patients in the BV-CHP arm included febrile neutropenia, pneumonia, pyrexia, and sepsis.
Results of this trial suggest prophylactic growth factors should be given to previously untreated PTCL patients receiving BV-CHP (starting at cycle 1).
The U.S. Food and Drug Administration (FDA) has approved a new indication for brentuximab vedotin (ADCETRIS®) less than 2 weeks after receiving the completed supplemental biologics license application (sBLA).
Brentuximab vedotin is now approved for use in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) to treat adults with previously untreated systemic anaplastic large-cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCLs), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified.
The FDA granted priority review and breakthrough therapy designation to the sBLA for brentuximab vedotin in this indication.
The FDA reviewed the sBLA under the Real-Time Oncology Review Pilot Program, which led to approval less than 2 weeks after the application was submitted in full.
“The Real-Time Oncology Review program allows the FDA to access key data prior to the official submission of the application, allowing the review team to begin their review earlier and communicate with the sponsor prior to the application’s actual submission,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products.
“When the sponsor submits the completed application, the review team will already be familiar with the data and be able to conduct a more efficient, timely, and thorough review.”
Trial data
The FDA’s approval is based on results from the phase 3 ECHELON-2 trial (NCT01777152).
Seattle Genetics, Inc. and Takeda Pharmaceutical Company Limited announced results from this trial last month. Additional results are scheduled to be presented at the 2018 ASH Annual Meeting (abstract 997).
The trial enrolled 452 patients with CD30-positive PTCL. The patients were randomized to receive brentuximab vedotin (BV) plus CHP or cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP).
The objective response rate was 83% in the BV-CHP arm and 72% in the CHOP arm (P=0.003). The complete response rate was 68% and 56%, respectively (P=0.007).
Progression-free survival was significantly better in the BV-CHP arm than in the CHOP arm (hazard ratio=0.71; P=0.011), as was overall survival (hazard ratio=0.66; P=0.024).
The most common adverse events of any grade that occurred in at least 20% of patients in the BV-CHP arm were peripheral neuropathy, nausea, diarrhea, neutropenia, lymphopenia, fatigue, mucositis, constipation, alopecia, pyrexia, vomiting, and anemia.
Serious adverse events occurring in at least 2% of patients in the BV-CHP arm included febrile neutropenia, pneumonia, pyrexia, and sepsis.
Results of this trial suggest prophylactic growth factors should be given to previously untreated PTCL patients receiving BV-CHP (starting at cycle 1).
AEDs strongly linked to rare serious skin reactions
Antiepileptic drugs were found to be linked with almost ninefold increased odds for two adverse skin reactions, Steven‐Johnson syndrome and toxic epidermal necrolysis, compared with non-AED medication classes in an analysis of adverse-event data from the Food and Drug Administration Adverse Event Reporting System.
Researchers at the University of Rhode Island College of Pharmacy in Kingston, who performed the retrospective study, also found that six drugs within the antiepileptic drug (AED) class had a reporting odds ratio estimate of more than 20, compared with other non-AEDs.
“Although several antiepileptic drugs have been associated with Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), the class effect and impact of other AEDs are not well described,” Eric P. Borrelli, PharmD, and his colleagues reported in Epilepsia.
The investigators examined rates of SJS and TEN for several AEDs using adverse event data from the Food and Drug Administration Adverse Event Reporting System between July 2014 and December 2017. The study investigators examined 198 adverse reaction reports related to AEDs, which was greater than any other drug class.
Overall, AEDs as a group had a reporting odds ratio risk estimate of 8.7 (95% confidence interval, 7.5-10.2), compared with non-AEDs. Similarly, the proportional reporting ratio was found to be 8.7 (95% CI, 7.5-10.2) in the AED group.
Within the class, the medications with the highest risk were zonisamide, rufinamide, and clorazepate, which had about 70-, 60-, and 56-fold higher odds for SJS and TEN, compared with all other medications. Other high-risk AEDs in the group included lamotrigine (reporting odds ratio, 53.0), carbamazepine (reporting OR, 24.5), and phenytoin (reporting OR, 26.3).
“Greater than 90% of SJS [and] TEN reactions associated with AEDs occur within the first 2 months of treatment initiation, although some AEDs have been associated with such reactions during long‐term use,” the researchers wrote.
The authors acknowledged that measures of prevalence and incidence could not be determined from these data since the number of patients taking AEDs is unknown.
“Increased awareness of this risk among both prescribers and patients, particularly variations in risk among different AEDs, along with education on early recognition of SJS [and] TEN signs [and] symptoms, may help mitigate the number and severity of these adverse events,” the researchers concluded.
The study was partially funded by the Department of Veterans Affairs. One coauthor reported receiving research funding from Pfizer, Merck (Cubist), and The Medicines Company.
SOURCE: Borrelli EP et al. Epilepsia. 2018 Nov 5. doi: 10.1111/epi.14591.
Antiepileptic drugs were found to be linked with almost ninefold increased odds for two adverse skin reactions, Steven‐Johnson syndrome and toxic epidermal necrolysis, compared with non-AED medication classes in an analysis of adverse-event data from the Food and Drug Administration Adverse Event Reporting System.
Researchers at the University of Rhode Island College of Pharmacy in Kingston, who performed the retrospective study, also found that six drugs within the antiepileptic drug (AED) class had a reporting odds ratio estimate of more than 20, compared with other non-AEDs.
“Although several antiepileptic drugs have been associated with Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), the class effect and impact of other AEDs are not well described,” Eric P. Borrelli, PharmD, and his colleagues reported in Epilepsia.
The investigators examined rates of SJS and TEN for several AEDs using adverse event data from the Food and Drug Administration Adverse Event Reporting System between July 2014 and December 2017. The study investigators examined 198 adverse reaction reports related to AEDs, which was greater than any other drug class.
Overall, AEDs as a group had a reporting odds ratio risk estimate of 8.7 (95% confidence interval, 7.5-10.2), compared with non-AEDs. Similarly, the proportional reporting ratio was found to be 8.7 (95% CI, 7.5-10.2) in the AED group.
Within the class, the medications with the highest risk were zonisamide, rufinamide, and clorazepate, which had about 70-, 60-, and 56-fold higher odds for SJS and TEN, compared with all other medications. Other high-risk AEDs in the group included lamotrigine (reporting odds ratio, 53.0), carbamazepine (reporting OR, 24.5), and phenytoin (reporting OR, 26.3).
“Greater than 90% of SJS [and] TEN reactions associated with AEDs occur within the first 2 months of treatment initiation, although some AEDs have been associated with such reactions during long‐term use,” the researchers wrote.
The authors acknowledged that measures of prevalence and incidence could not be determined from these data since the number of patients taking AEDs is unknown.
“Increased awareness of this risk among both prescribers and patients, particularly variations in risk among different AEDs, along with education on early recognition of SJS [and] TEN signs [and] symptoms, may help mitigate the number and severity of these adverse events,” the researchers concluded.
The study was partially funded by the Department of Veterans Affairs. One coauthor reported receiving research funding from Pfizer, Merck (Cubist), and The Medicines Company.
SOURCE: Borrelli EP et al. Epilepsia. 2018 Nov 5. doi: 10.1111/epi.14591.
Antiepileptic drugs were found to be linked with almost ninefold increased odds for two adverse skin reactions, Steven‐Johnson syndrome and toxic epidermal necrolysis, compared with non-AED medication classes in an analysis of adverse-event data from the Food and Drug Administration Adverse Event Reporting System.
Researchers at the University of Rhode Island College of Pharmacy in Kingston, who performed the retrospective study, also found that six drugs within the antiepileptic drug (AED) class had a reporting odds ratio estimate of more than 20, compared with other non-AEDs.
“Although several antiepileptic drugs have been associated with Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), the class effect and impact of other AEDs are not well described,” Eric P. Borrelli, PharmD, and his colleagues reported in Epilepsia.
The investigators examined rates of SJS and TEN for several AEDs using adverse event data from the Food and Drug Administration Adverse Event Reporting System between July 2014 and December 2017. The study investigators examined 198 adverse reaction reports related to AEDs, which was greater than any other drug class.
Overall, AEDs as a group had a reporting odds ratio risk estimate of 8.7 (95% confidence interval, 7.5-10.2), compared with non-AEDs. Similarly, the proportional reporting ratio was found to be 8.7 (95% CI, 7.5-10.2) in the AED group.
Within the class, the medications with the highest risk were zonisamide, rufinamide, and clorazepate, which had about 70-, 60-, and 56-fold higher odds for SJS and TEN, compared with all other medications. Other high-risk AEDs in the group included lamotrigine (reporting odds ratio, 53.0), carbamazepine (reporting OR, 24.5), and phenytoin (reporting OR, 26.3).
“Greater than 90% of SJS [and] TEN reactions associated with AEDs occur within the first 2 months of treatment initiation, although some AEDs have been associated with such reactions during long‐term use,” the researchers wrote.
The authors acknowledged that measures of prevalence and incidence could not be determined from these data since the number of patients taking AEDs is unknown.
“Increased awareness of this risk among both prescribers and patients, particularly variations in risk among different AEDs, along with education on early recognition of SJS [and] TEN signs [and] symptoms, may help mitigate the number and severity of these adverse events,” the researchers concluded.
The study was partially funded by the Department of Veterans Affairs. One coauthor reported receiving research funding from Pfizer, Merck (Cubist), and The Medicines Company.
SOURCE: Borrelli EP et al. Epilepsia. 2018 Nov 5. doi: 10.1111/epi.14591.
FROM EPILEPSIA
Key clinical point:
Major finding: The reporting odds ratio risk estimate for SJS and TEN in the AED group was 8.7 (95% CI, 7.5-10.2), compared with non-AEDs.
Study details: A retrospective analysis of 198 adverse reaction reports from the Food and Drug Administration Adverse Event Reporting System.
Disclosures: The study was partially funded by the Department of Veterans Affairs. One coauthor reported receiving research funding from Pfizer, Merck (Cubist), and The Medicines Company.
Source: Borrelli EP et al. Epilepsia. 2018 Nov 5. doi: 10.1111/epi.14591.
How do hospital medicine groups deal with staffing shortages?
Persistent demand for hospitalists nationally
During the last two decades, the United States health care labor market had an almost insatiable appetite for hospitalists, driving the specialty from nothing to over 50,000 members. Evidence of persistent demand for hospitalists abounds in the freshly released 2018 State of Hospital Medicine (SoHM) report: rising salaries, growing responsibility for the overall hospital census, and a diversifying scope of services.
The SoHM offers fascinating and detailed insights into these trends, as well as hundreds of other aspects of the field’s growth. Unfortunately, this expanding and dynamic labor market has a challenging side for hospitals, management companies, and hospitalist group leaders – we are constantly recruiting and dealing with open positions!
As a multisite leader at an academic health system, I’m looking toward the next season of recruitment with excitement. In the fall and winter we’re fortunate to receive applications from the best and brightest graduating residents and hospitalists. I realize this is a blessing, particularly compared with programs in rural areas that may not hear from many applicants. However, even when we succeed at filling the openings, there is an inevitable trickle of talent out of our clinical labor pool during the spring and summer. One person is invited to spend 20% of their time leading a teaching program, another secures a highly coveted grant, and yet another has to move because their spouse is relocated. By then, we don’t have a packed roster of applicants and have to solve the challenge in other ways. What does the typical hospital medicine program do when faced with this circumstance?
The 2018 SoHM survey first asked program leaders whether they had open and unfilled physician positions during the last year because of turnover, growth, or other factors. On average, 66% of groups serving adults and 48% of groups serving children said “yes.” For the job seekers out there, take note of some important regional differences: The regions with the highest percentage of programs dealing with unfilled positions were the East and West Coasts at 79% and 73%, respectively.
Next, the survey asked respondents to describe the percentage of total approved physician staffing that was open or unfilled during the year. On average, 12% of positions went unfilled, with important variation between different types of employers. For a typical HM group with 15 full-time equivalents, that means constantly working short two physicians!
Not only is it hard for group leaders to manage chronic understaffing, it definitely takes a toll on the group. We asked leaders to describe all of the ways their groups address coverage of the open positions. The most common tactics were for existing hospitalists to perform voluntary extra shifts (70%) and the use of moonlighters (57%). Also important were the use of locum tenens physicians (44%) and just leaving some shifts uncovered (31%).
The last option might work in a large group, where everyone can pick up an extra couple of patients, but it nonetheless degrades continuity and care progression. In a small group, leaving shifts uncovered sounds like a recipe for burnout and unsafe care – hopefully subsequent surveys will find that we can avoid that approach! Obviously, the solutions must be tailored to the group, their resources, and the alternative sources of labor available in that locality.
The SoHM report provides insight into how this is commonly handled by different employers and in different regions – we encourage anyone who is interested to purchase the report (www.hospitalmedicine.org/sohm) to dig deeper. For better or worse, the issue of unfilled positions looks likely to persist for the intermediate future. The exciting rise of hospital medicine against the backdrop of an aging population means job security, rising income, and opportunities for many to live where they choose. Until the job market saturates, though, we’ll all find ourselves looking at email inboxes with a request or two to pick up an extra shift!
Dr. White is associate professor of medicine at the University of Washington, Seattle. He is the chair of SHM’s Practice Analysis Committee.
Reference
Society of Hospital Medicine. 2018 State of Hospital Medicine Report. pp. 89, 90, 181, 152.
Persistent demand for hospitalists nationally
Persistent demand for hospitalists nationally
During the last two decades, the United States health care labor market had an almost insatiable appetite for hospitalists, driving the specialty from nothing to over 50,000 members. Evidence of persistent demand for hospitalists abounds in the freshly released 2018 State of Hospital Medicine (SoHM) report: rising salaries, growing responsibility for the overall hospital census, and a diversifying scope of services.
The SoHM offers fascinating and detailed insights into these trends, as well as hundreds of other aspects of the field’s growth. Unfortunately, this expanding and dynamic labor market has a challenging side for hospitals, management companies, and hospitalist group leaders – we are constantly recruiting and dealing with open positions!
As a multisite leader at an academic health system, I’m looking toward the next season of recruitment with excitement. In the fall and winter we’re fortunate to receive applications from the best and brightest graduating residents and hospitalists. I realize this is a blessing, particularly compared with programs in rural areas that may not hear from many applicants. However, even when we succeed at filling the openings, there is an inevitable trickle of talent out of our clinical labor pool during the spring and summer. One person is invited to spend 20% of their time leading a teaching program, another secures a highly coveted grant, and yet another has to move because their spouse is relocated. By then, we don’t have a packed roster of applicants and have to solve the challenge in other ways. What does the typical hospital medicine program do when faced with this circumstance?
The 2018 SoHM survey first asked program leaders whether they had open and unfilled physician positions during the last year because of turnover, growth, or other factors. On average, 66% of groups serving adults and 48% of groups serving children said “yes.” For the job seekers out there, take note of some important regional differences: The regions with the highest percentage of programs dealing with unfilled positions were the East and West Coasts at 79% and 73%, respectively.
Next, the survey asked respondents to describe the percentage of total approved physician staffing that was open or unfilled during the year. On average, 12% of positions went unfilled, with important variation between different types of employers. For a typical HM group with 15 full-time equivalents, that means constantly working short two physicians!
Not only is it hard for group leaders to manage chronic understaffing, it definitely takes a toll on the group. We asked leaders to describe all of the ways their groups address coverage of the open positions. The most common tactics were for existing hospitalists to perform voluntary extra shifts (70%) and the use of moonlighters (57%). Also important were the use of locum tenens physicians (44%) and just leaving some shifts uncovered (31%).
The last option might work in a large group, where everyone can pick up an extra couple of patients, but it nonetheless degrades continuity and care progression. In a small group, leaving shifts uncovered sounds like a recipe for burnout and unsafe care – hopefully subsequent surveys will find that we can avoid that approach! Obviously, the solutions must be tailored to the group, their resources, and the alternative sources of labor available in that locality.
The SoHM report provides insight into how this is commonly handled by different employers and in different regions – we encourage anyone who is interested to purchase the report (www.hospitalmedicine.org/sohm) to dig deeper. For better or worse, the issue of unfilled positions looks likely to persist for the intermediate future. The exciting rise of hospital medicine against the backdrop of an aging population means job security, rising income, and opportunities for many to live where they choose. Until the job market saturates, though, we’ll all find ourselves looking at email inboxes with a request or two to pick up an extra shift!
Dr. White is associate professor of medicine at the University of Washington, Seattle. He is the chair of SHM’s Practice Analysis Committee.
Reference
Society of Hospital Medicine. 2018 State of Hospital Medicine Report. pp. 89, 90, 181, 152.
During the last two decades, the United States health care labor market had an almost insatiable appetite for hospitalists, driving the specialty from nothing to over 50,000 members. Evidence of persistent demand for hospitalists abounds in the freshly released 2018 State of Hospital Medicine (SoHM) report: rising salaries, growing responsibility for the overall hospital census, and a diversifying scope of services.
The SoHM offers fascinating and detailed insights into these trends, as well as hundreds of other aspects of the field’s growth. Unfortunately, this expanding and dynamic labor market has a challenging side for hospitals, management companies, and hospitalist group leaders – we are constantly recruiting and dealing with open positions!
As a multisite leader at an academic health system, I’m looking toward the next season of recruitment with excitement. In the fall and winter we’re fortunate to receive applications from the best and brightest graduating residents and hospitalists. I realize this is a blessing, particularly compared with programs in rural areas that may not hear from many applicants. However, even when we succeed at filling the openings, there is an inevitable trickle of talent out of our clinical labor pool during the spring and summer. One person is invited to spend 20% of their time leading a teaching program, another secures a highly coveted grant, and yet another has to move because their spouse is relocated. By then, we don’t have a packed roster of applicants and have to solve the challenge in other ways. What does the typical hospital medicine program do when faced with this circumstance?
The 2018 SoHM survey first asked program leaders whether they had open and unfilled physician positions during the last year because of turnover, growth, or other factors. On average, 66% of groups serving adults and 48% of groups serving children said “yes.” For the job seekers out there, take note of some important regional differences: The regions with the highest percentage of programs dealing with unfilled positions were the East and West Coasts at 79% and 73%, respectively.
Next, the survey asked respondents to describe the percentage of total approved physician staffing that was open or unfilled during the year. On average, 12% of positions went unfilled, with important variation between different types of employers. For a typical HM group with 15 full-time equivalents, that means constantly working short two physicians!
Not only is it hard for group leaders to manage chronic understaffing, it definitely takes a toll on the group. We asked leaders to describe all of the ways their groups address coverage of the open positions. The most common tactics were for existing hospitalists to perform voluntary extra shifts (70%) and the use of moonlighters (57%). Also important were the use of locum tenens physicians (44%) and just leaving some shifts uncovered (31%).
The last option might work in a large group, where everyone can pick up an extra couple of patients, but it nonetheless degrades continuity and care progression. In a small group, leaving shifts uncovered sounds like a recipe for burnout and unsafe care – hopefully subsequent surveys will find that we can avoid that approach! Obviously, the solutions must be tailored to the group, their resources, and the alternative sources of labor available in that locality.
The SoHM report provides insight into how this is commonly handled by different employers and in different regions – we encourage anyone who is interested to purchase the report (www.hospitalmedicine.org/sohm) to dig deeper. For better or worse, the issue of unfilled positions looks likely to persist for the intermediate future. The exciting rise of hospital medicine against the backdrop of an aging population means job security, rising income, and opportunities for many to live where they choose. Until the job market saturates, though, we’ll all find ourselves looking at email inboxes with a request or two to pick up an extra shift!
Dr. White is associate professor of medicine at the University of Washington, Seattle. He is the chair of SHM’s Practice Analysis Committee.
Reference
Society of Hospital Medicine. 2018 State of Hospital Medicine Report. pp. 89, 90, 181, 152.
CMS delays controversial E/M changes in final rule
After a torrent of criticism from the physician community,
.The agency’s final 2019 Physician Fee Schedule, announced Nov. 1, rescinds a proposal that would have blended payments for new and established patients for office/outpatient E/M levels 2 through 5 into single payments. Instead, the agency will continue to hear perspective on the proposal with plans to collapse E/M code levels 2 through 4 into single payments beginning in 2021, while maintaining level 5.
CMS also pulled back its proposal to apply a multiple procedure payment reduction to E/M visits furnished on the same day as a procedure. Payment rates for the less expensive of the two will be maintained, rather than cut in half as initially proposed.
The final rule released is much different than the one proposed, which shows that CMS heeded concerns by physicians and took time to craft a more realistic fee schedule, said Orly Avitzur, MD, chair of the American Academy of Neurology’s Medical Economics and Management Committee. The proposed collapsed E/M levels would have likely led to shorter visit times, negatively impacting the doctor-patient relationship and patient care, she said.
As part of its final rule, CMS moved forward with several other changes to coding and documentation, including eliminating the need to document the medical necessity of a home visit in lieu of an office visit, and allowing physicians to skip documentation of changes since a prior patient visit when relevant information is already contained in the record.
Additionally, the final rule clarifies that for E/M office/outpatient visits physicians do not need to re-enter information on the patient’s chief complaint and history that has already been entered by ancillary staff or the patient. The physician may just indicate in the medical record that he or she has reviewed and verified the information.
In a statement, CMS administrator Seema Verma said the final rule cements dramatic improvements for clinicians and patients and reflects extensive input from the medical community.
“Addressing clinician burnout is critical to keeping doctors in the workforce to meet the growing needs of America’s seniors,” Ms. Verma said in the statement. “[The] rule offers immediate relief from onerous requirements that contribute to burnout in the medical profession and detract from patient care. It also delays even more significant changes to give clinicians the time they need for implementation and provides time for us to continue to work with the medical community on this effort.”
“In the final rule, CMS acknowledges concerns from physicians regarding many aspects of the proposed rule,” said Anton Decker, MD, chair of the American Gastroenterological Association’s Practice Management and Economics Committee. “In particular, proposed revisions to E/M services would have negatively impacted the doctor-patient relationship and patient care, especially for the most complex patients,” he said.
“Overall, the AGA is pleased that CMS listened to concerns and reversed certain proposals such as the multiple procedure payment reduction for E/M visits furnished on the same day as a procedure,” Dr. Decker said. “We are also pleased that CMS is giving stakeholders an additional 2 years to provide input on how best to refine E/M documentation and coding.”
Shivan Mehta, MD, MBA, AGA’s advisor to the AMA Relative-value Update Committee (RUC), the body that provides code value recommendations to CMS, noted, “Although CMS heeded concerns from physicians on many aspects on the proposed rule, in a surprise move, CMS took direction from Anthem Inc., a large health insurance company, and recommended two endoscopy services be revalued by the AMA’s RUC. Private health insurers don’t typically influence the appropriateness of Medicare payment amounts, and we question Anthem’s motivation as commercial payers frequently link their payment rates to a percentage of Medicare payment amounts or use those amounts as benchmarks when negotiating physician contracts.”
CMS finalized a number of proposals to pay doctors separately for communication technology services. This includes HCPCS code G2012 for brief communication technology-based services, such as virtual check-ins and HCPCS code G2010 for remote evaluation of a recorded video and/or images submitted by an established patient, also known as store and forward.
Additionally, CMS will pay separately for new codes that describe chronic care remote physiologic monitoring (CPT codes 99453, 99454, and 99457) and interprofessional Internet consultation (CPT codes 99451, 99452, 99446, 99447, 99448, and 99449). Also new to the list of reimbursable telehealth services are HCPCS codes G0513 and G0514 for prolonged preventive services.
Telehealth physicians who treat opioid use disorder received more flexibility under the CMS 2019 fee schedule through the agency’s removal of originating site geographic requirements. CMS will now allow a patient’s home to be an originating site for telehealth services for substance use disorder treatment or co-occurring mental health disorder. The agency is also accepting comments on a new Medicare benefit category for opioid use disorder treatment furnished by opioid treatment programs under Part B beginning on or after Jan. 1, 2020.
CMS also approved updates to its Medicare Shared Savings Program, including finalizing time-sensitive program policy changes for currently participating Accountable Care Organizations (ACOs). These changes include:
- A voluntary 6-month extension for existing ACOs whose participation agreements expire on Dec. 31, 2018, and the methodology for determining financial and quality performance for the 6-month performance year from Jan. 1 to June 30, 2019.
- Revising the definition of primary care services used in beneficiary assignment.
- Providing relief for ACOs and their clinicians impacted by extreme and uncontrollable circumstances in 2018 and subsequent years.
After a torrent of criticism from the physician community,
.The agency’s final 2019 Physician Fee Schedule, announced Nov. 1, rescinds a proposal that would have blended payments for new and established patients for office/outpatient E/M levels 2 through 5 into single payments. Instead, the agency will continue to hear perspective on the proposal with plans to collapse E/M code levels 2 through 4 into single payments beginning in 2021, while maintaining level 5.
CMS also pulled back its proposal to apply a multiple procedure payment reduction to E/M visits furnished on the same day as a procedure. Payment rates for the less expensive of the two will be maintained, rather than cut in half as initially proposed.
The final rule released is much different than the one proposed, which shows that CMS heeded concerns by physicians and took time to craft a more realistic fee schedule, said Orly Avitzur, MD, chair of the American Academy of Neurology’s Medical Economics and Management Committee. The proposed collapsed E/M levels would have likely led to shorter visit times, negatively impacting the doctor-patient relationship and patient care, she said.
As part of its final rule, CMS moved forward with several other changes to coding and documentation, including eliminating the need to document the medical necessity of a home visit in lieu of an office visit, and allowing physicians to skip documentation of changes since a prior patient visit when relevant information is already contained in the record.
Additionally, the final rule clarifies that for E/M office/outpatient visits physicians do not need to re-enter information on the patient’s chief complaint and history that has already been entered by ancillary staff or the patient. The physician may just indicate in the medical record that he or she has reviewed and verified the information.
In a statement, CMS administrator Seema Verma said the final rule cements dramatic improvements for clinicians and patients and reflects extensive input from the medical community.
“Addressing clinician burnout is critical to keeping doctors in the workforce to meet the growing needs of America’s seniors,” Ms. Verma said in the statement. “[The] rule offers immediate relief from onerous requirements that contribute to burnout in the medical profession and detract from patient care. It also delays even more significant changes to give clinicians the time they need for implementation and provides time for us to continue to work with the medical community on this effort.”
“In the final rule, CMS acknowledges concerns from physicians regarding many aspects of the proposed rule,” said Anton Decker, MD, chair of the American Gastroenterological Association’s Practice Management and Economics Committee. “In particular, proposed revisions to E/M services would have negatively impacted the doctor-patient relationship and patient care, especially for the most complex patients,” he said.
“Overall, the AGA is pleased that CMS listened to concerns and reversed certain proposals such as the multiple procedure payment reduction for E/M visits furnished on the same day as a procedure,” Dr. Decker said. “We are also pleased that CMS is giving stakeholders an additional 2 years to provide input on how best to refine E/M documentation and coding.”
Shivan Mehta, MD, MBA, AGA’s advisor to the AMA Relative-value Update Committee (RUC), the body that provides code value recommendations to CMS, noted, “Although CMS heeded concerns from physicians on many aspects on the proposed rule, in a surprise move, CMS took direction from Anthem Inc., a large health insurance company, and recommended two endoscopy services be revalued by the AMA’s RUC. Private health insurers don’t typically influence the appropriateness of Medicare payment amounts, and we question Anthem’s motivation as commercial payers frequently link their payment rates to a percentage of Medicare payment amounts or use those amounts as benchmarks when negotiating physician contracts.”
CMS finalized a number of proposals to pay doctors separately for communication technology services. This includes HCPCS code G2012 for brief communication technology-based services, such as virtual check-ins and HCPCS code G2010 for remote evaluation of a recorded video and/or images submitted by an established patient, also known as store and forward.
Additionally, CMS will pay separately for new codes that describe chronic care remote physiologic monitoring (CPT codes 99453, 99454, and 99457) and interprofessional Internet consultation (CPT codes 99451, 99452, 99446, 99447, 99448, and 99449). Also new to the list of reimbursable telehealth services are HCPCS codes G0513 and G0514 for prolonged preventive services.
Telehealth physicians who treat opioid use disorder received more flexibility under the CMS 2019 fee schedule through the agency’s removal of originating site geographic requirements. CMS will now allow a patient’s home to be an originating site for telehealth services for substance use disorder treatment or co-occurring mental health disorder. The agency is also accepting comments on a new Medicare benefit category for opioid use disorder treatment furnished by opioid treatment programs under Part B beginning on or after Jan. 1, 2020.
CMS also approved updates to its Medicare Shared Savings Program, including finalizing time-sensitive program policy changes for currently participating Accountable Care Organizations (ACOs). These changes include:
- A voluntary 6-month extension for existing ACOs whose participation agreements expire on Dec. 31, 2018, and the methodology for determining financial and quality performance for the 6-month performance year from Jan. 1 to June 30, 2019.
- Revising the definition of primary care services used in beneficiary assignment.
- Providing relief for ACOs and their clinicians impacted by extreme and uncontrollable circumstances in 2018 and subsequent years.
After a torrent of criticism from the physician community,
.The agency’s final 2019 Physician Fee Schedule, announced Nov. 1, rescinds a proposal that would have blended payments for new and established patients for office/outpatient E/M levels 2 through 5 into single payments. Instead, the agency will continue to hear perspective on the proposal with plans to collapse E/M code levels 2 through 4 into single payments beginning in 2021, while maintaining level 5.
CMS also pulled back its proposal to apply a multiple procedure payment reduction to E/M visits furnished on the same day as a procedure. Payment rates for the less expensive of the two will be maintained, rather than cut in half as initially proposed.
The final rule released is much different than the one proposed, which shows that CMS heeded concerns by physicians and took time to craft a more realistic fee schedule, said Orly Avitzur, MD, chair of the American Academy of Neurology’s Medical Economics and Management Committee. The proposed collapsed E/M levels would have likely led to shorter visit times, negatively impacting the doctor-patient relationship and patient care, she said.
As part of its final rule, CMS moved forward with several other changes to coding and documentation, including eliminating the need to document the medical necessity of a home visit in lieu of an office visit, and allowing physicians to skip documentation of changes since a prior patient visit when relevant information is already contained in the record.
Additionally, the final rule clarifies that for E/M office/outpatient visits physicians do not need to re-enter information on the patient’s chief complaint and history that has already been entered by ancillary staff or the patient. The physician may just indicate in the medical record that he or she has reviewed and verified the information.
In a statement, CMS administrator Seema Verma said the final rule cements dramatic improvements for clinicians and patients and reflects extensive input from the medical community.
“Addressing clinician burnout is critical to keeping doctors in the workforce to meet the growing needs of America’s seniors,” Ms. Verma said in the statement. “[The] rule offers immediate relief from onerous requirements that contribute to burnout in the medical profession and detract from patient care. It also delays even more significant changes to give clinicians the time they need for implementation and provides time for us to continue to work with the medical community on this effort.”
“In the final rule, CMS acknowledges concerns from physicians regarding many aspects of the proposed rule,” said Anton Decker, MD, chair of the American Gastroenterological Association’s Practice Management and Economics Committee. “In particular, proposed revisions to E/M services would have negatively impacted the doctor-patient relationship and patient care, especially for the most complex patients,” he said.
“Overall, the AGA is pleased that CMS listened to concerns and reversed certain proposals such as the multiple procedure payment reduction for E/M visits furnished on the same day as a procedure,” Dr. Decker said. “We are also pleased that CMS is giving stakeholders an additional 2 years to provide input on how best to refine E/M documentation and coding.”
Shivan Mehta, MD, MBA, AGA’s advisor to the AMA Relative-value Update Committee (RUC), the body that provides code value recommendations to CMS, noted, “Although CMS heeded concerns from physicians on many aspects on the proposed rule, in a surprise move, CMS took direction from Anthem Inc., a large health insurance company, and recommended two endoscopy services be revalued by the AMA’s RUC. Private health insurers don’t typically influence the appropriateness of Medicare payment amounts, and we question Anthem’s motivation as commercial payers frequently link their payment rates to a percentage of Medicare payment amounts or use those amounts as benchmarks when negotiating physician contracts.”
CMS finalized a number of proposals to pay doctors separately for communication technology services. This includes HCPCS code G2012 for brief communication technology-based services, such as virtual check-ins and HCPCS code G2010 for remote evaluation of a recorded video and/or images submitted by an established patient, also known as store and forward.
Additionally, CMS will pay separately for new codes that describe chronic care remote physiologic monitoring (CPT codes 99453, 99454, and 99457) and interprofessional Internet consultation (CPT codes 99451, 99452, 99446, 99447, 99448, and 99449). Also new to the list of reimbursable telehealth services are HCPCS codes G0513 and G0514 for prolonged preventive services.
Telehealth physicians who treat opioid use disorder received more flexibility under the CMS 2019 fee schedule through the agency’s removal of originating site geographic requirements. CMS will now allow a patient’s home to be an originating site for telehealth services for substance use disorder treatment or co-occurring mental health disorder. The agency is also accepting comments on a new Medicare benefit category for opioid use disorder treatment furnished by opioid treatment programs under Part B beginning on or after Jan. 1, 2020.
CMS also approved updates to its Medicare Shared Savings Program, including finalizing time-sensitive program policy changes for currently participating Accountable Care Organizations (ACOs). These changes include:
- A voluntary 6-month extension for existing ACOs whose participation agreements expire on Dec. 31, 2018, and the methodology for determining financial and quality performance for the 6-month performance year from Jan. 1 to June 30, 2019.
- Revising the definition of primary care services used in beneficiary assignment.
- Providing relief for ACOs and their clinicians impacted by extreme and uncontrollable circumstances in 2018 and subsequent years.
At 10 years, reintervention rate for EVAR is 20%
NEW YORK – A clever strategy to evaluate long term outcomes in patients undergoing endovascular abdominal aortic aneurysm repair identified a 20% rate of reintervention, according to data presented at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation by Philip P. Goodney, MD.
In this video interview with Dr. Goodney, an associate professor of vascular surgery at Geisel School of Medicine at Dartmouth, Hanover, N.H., he explains how Medicare data were employed to track patients long term, even when they had moved to other hospital systems.
The main message from the long-term follow-up is that there is a persistent risk of recurrence and need for reintervention, according to Dr. Goodney. The hypothesis was that there would be an early risk of failure, followed by a diminishing need for reintervention over time, but this was not what was observed.Rather, the findings suggest that the rate of reinterventions was relatively steady over the course of follow-up, suggesting that patients should be informed of a persistent risk. However, Dr. Goodney reports that age was not a predictor of reintervention, so that older patients were at no greater risk.
NEW YORK – A clever strategy to evaluate long term outcomes in patients undergoing endovascular abdominal aortic aneurysm repair identified a 20% rate of reintervention, according to data presented at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation by Philip P. Goodney, MD.
In this video interview with Dr. Goodney, an associate professor of vascular surgery at Geisel School of Medicine at Dartmouth, Hanover, N.H., he explains how Medicare data were employed to track patients long term, even when they had moved to other hospital systems.
The main message from the long-term follow-up is that there is a persistent risk of recurrence and need for reintervention, according to Dr. Goodney. The hypothesis was that there would be an early risk of failure, followed by a diminishing need for reintervention over time, but this was not what was observed.Rather, the findings suggest that the rate of reinterventions was relatively steady over the course of follow-up, suggesting that patients should be informed of a persistent risk. However, Dr. Goodney reports that age was not a predictor of reintervention, so that older patients were at no greater risk.
NEW YORK – A clever strategy to evaluate long term outcomes in patients undergoing endovascular abdominal aortic aneurysm repair identified a 20% rate of reintervention, according to data presented at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation by Philip P. Goodney, MD.
In this video interview with Dr. Goodney, an associate professor of vascular surgery at Geisel School of Medicine at Dartmouth, Hanover, N.H., he explains how Medicare data were employed to track patients long term, even when they had moved to other hospital systems.
The main message from the long-term follow-up is that there is a persistent risk of recurrence and need for reintervention, according to Dr. Goodney. The hypothesis was that there would be an early risk of failure, followed by a diminishing need for reintervention over time, but this was not what was observed.Rather, the findings suggest that the rate of reinterventions was relatively steady over the course of follow-up, suggesting that patients should be informed of a persistent risk. However, Dr. Goodney reports that age was not a predictor of reintervention, so that older patients were at no greater risk.
FROM 2018 VEITH SYMPOSIUM
Snorkel/chimney repair of aortic aneurysms is still effective after 4 years
NEW YORK – With a median follow-up of almost 4 years in more than 200 patients, the snorkel/chimney technique of endovascular repair of complex abdominal aortic aneurysms continues to generate very good results, according data presented at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
In a video interview with Jason T. Lee, MD, professor of vascular surgery, Stanford (Calif.) University, who presented the long-term results, he explains why these findings are important.
After several single-center studies associated the snorkel/chimney technique with good rates of patency and durability, the PERICLES Registry was created almost 10 years ago to test whether these data could be reproduced in the real world.The data presented by Dr. Lee involved outcomes in 244 patients who were followed for at least 2.5 years. The median follow-up is 47 months.
The results overall confirm that this is a viable technique, according to Dr. Lee who noted very little diminution of patency rates in this long-term cohort relative to the previously published follow-up of 17.1 months.
He acknowledged that the snorkel/chimney repair is not free of potential complications, particularly gutter endovascular leaks, but he recounted that at least some resolve over time. Moreover, he suggests that several strategies are being pursued that appear promising for avoiding this risk.
Most importantly, the registry, which captured the experience at 13 centers in the United States and Europe, shows outcomes that are similar to those reported at centers where the techniques were developed and championed.
NEW YORK – With a median follow-up of almost 4 years in more than 200 patients, the snorkel/chimney technique of endovascular repair of complex abdominal aortic aneurysms continues to generate very good results, according data presented at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
In a video interview with Jason T. Lee, MD, professor of vascular surgery, Stanford (Calif.) University, who presented the long-term results, he explains why these findings are important.
After several single-center studies associated the snorkel/chimney technique with good rates of patency and durability, the PERICLES Registry was created almost 10 years ago to test whether these data could be reproduced in the real world.The data presented by Dr. Lee involved outcomes in 244 patients who were followed for at least 2.5 years. The median follow-up is 47 months.
The results overall confirm that this is a viable technique, according to Dr. Lee who noted very little diminution of patency rates in this long-term cohort relative to the previously published follow-up of 17.1 months.
He acknowledged that the snorkel/chimney repair is not free of potential complications, particularly gutter endovascular leaks, but he recounted that at least some resolve over time. Moreover, he suggests that several strategies are being pursued that appear promising for avoiding this risk.
Most importantly, the registry, which captured the experience at 13 centers in the United States and Europe, shows outcomes that are similar to those reported at centers where the techniques were developed and championed.
NEW YORK – With a median follow-up of almost 4 years in more than 200 patients, the snorkel/chimney technique of endovascular repair of complex abdominal aortic aneurysms continues to generate very good results, according data presented at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
In a video interview with Jason T. Lee, MD, professor of vascular surgery, Stanford (Calif.) University, who presented the long-term results, he explains why these findings are important.
After several single-center studies associated the snorkel/chimney technique with good rates of patency and durability, the PERICLES Registry was created almost 10 years ago to test whether these data could be reproduced in the real world.The data presented by Dr. Lee involved outcomes in 244 patients who were followed for at least 2.5 years. The median follow-up is 47 months.
The results overall confirm that this is a viable technique, according to Dr. Lee who noted very little diminution of patency rates in this long-term cohort relative to the previously published follow-up of 17.1 months.
He acknowledged that the snorkel/chimney repair is not free of potential complications, particularly gutter endovascular leaks, but he recounted that at least some resolve over time. Moreover, he suggests that several strategies are being pursued that appear promising for avoiding this risk.
Most importantly, the registry, which captured the experience at 13 centers in the United States and Europe, shows outcomes that are similar to those reported at centers where the techniques were developed and championed.
FROM 2018 VEITH SYMPOSIUM
Will AI or robotics steal your job?
NEW YORK – Artificial intelligence is currently linked to specific problem solving and is not some form of Terminator model capable of handling multiple tasks with autonomy. In other words, each time you hear the term “AI,” it is a computer solving a specific problem or task using algorithms “and not ‘thinking’ like you and me,” said Ido Weinberg, MD, assistant professor, Harvard Medical School, Boston.
AI is present in daily life – everything from cellphones to the Alexa voice interface on a smart speaker. That AI system, however, is amassing data, learning about you, and using that data intelligently, Dr. Weinberg said at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
AI in health care make sense, he said, because the health sector is a vast consumer market with potential for financial gain. Repetition, which is common in the health sector, is one of the foundations required for using AI and robotics. If a task can be repeated, then it means a machine can do it, said Dr. Weinberg.
The spread of AI and robotics one day may improve health care accessibility in remote areas where physicians with the appropriate training may not be available.
AI is already at work in the health care industry. “Pulmonary nodule detection can be done better with machines than by people, pathological identification and scanning of various slides can be done better by a machine than by a humans,” he said.
Artificial intelligence also can be designed to detect emotion by assessing various cues in phrasing, key words, and tone. These AI functions already are being used by sales reps on the phone to defuse and control interactions with customers and complainants. AI also can be implemented in interactions with people, which is an important part of dealing with patients, Dr. Weinberg said. Drug discovery is a key area where AI is flourishing, as well.
Luckily, in terms of physicians keeping their jobs, there are barriers to the use of AI to replace clinicians, Dr. Weinberg pointed out. Health care is not a monolith, and every specialty is different, meaning AI would have to be tailored to each task and specialty for each unique field. Quick proliferation of AI across the board is unlikely, especially when the varying roles of nurses and physician assistants are included.
Although robots in science fiction stories and films often are capable of multitasking a variety of needs, robots at present are much more limited in real life. In surgical situations, for example, they can perform specifically tailored tasks but cannot extend beyond those defined parameters as a real surgeon can, according to Dr. Weinberg, and this lack of flexibility is a severe limitation on the expansion of AI into health care.
Despite these limitations, Dr. Weinberg urged attendees to consider how AI can be used to facilitate their work.
“Believe in the roadblocks, but be a fast adopter – an early adopter – and understand where AI can currently augment you and make you better and more productive,” he said. “And keep doing procedures; AI and robotics currently have a problem with most of those,” Dr. Weinberg concluded.
Dr. Weinberg reported no conflicts relevant to his talk.
NEW YORK – Artificial intelligence is currently linked to specific problem solving and is not some form of Terminator model capable of handling multiple tasks with autonomy. In other words, each time you hear the term “AI,” it is a computer solving a specific problem or task using algorithms “and not ‘thinking’ like you and me,” said Ido Weinberg, MD, assistant professor, Harvard Medical School, Boston.
AI is present in daily life – everything from cellphones to the Alexa voice interface on a smart speaker. That AI system, however, is amassing data, learning about you, and using that data intelligently, Dr. Weinberg said at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
AI in health care make sense, he said, because the health sector is a vast consumer market with potential for financial gain. Repetition, which is common in the health sector, is one of the foundations required for using AI and robotics. If a task can be repeated, then it means a machine can do it, said Dr. Weinberg.
The spread of AI and robotics one day may improve health care accessibility in remote areas where physicians with the appropriate training may not be available.
AI is already at work in the health care industry. “Pulmonary nodule detection can be done better with machines than by people, pathological identification and scanning of various slides can be done better by a machine than by a humans,” he said.
Artificial intelligence also can be designed to detect emotion by assessing various cues in phrasing, key words, and tone. These AI functions already are being used by sales reps on the phone to defuse and control interactions with customers and complainants. AI also can be implemented in interactions with people, which is an important part of dealing with patients, Dr. Weinberg said. Drug discovery is a key area where AI is flourishing, as well.
Luckily, in terms of physicians keeping their jobs, there are barriers to the use of AI to replace clinicians, Dr. Weinberg pointed out. Health care is not a monolith, and every specialty is different, meaning AI would have to be tailored to each task and specialty for each unique field. Quick proliferation of AI across the board is unlikely, especially when the varying roles of nurses and physician assistants are included.
Although robots in science fiction stories and films often are capable of multitasking a variety of needs, robots at present are much more limited in real life. In surgical situations, for example, they can perform specifically tailored tasks but cannot extend beyond those defined parameters as a real surgeon can, according to Dr. Weinberg, and this lack of flexibility is a severe limitation on the expansion of AI into health care.
Despite these limitations, Dr. Weinberg urged attendees to consider how AI can be used to facilitate their work.
“Believe in the roadblocks, but be a fast adopter – an early adopter – and understand where AI can currently augment you and make you better and more productive,” he said. “And keep doing procedures; AI and robotics currently have a problem with most of those,” Dr. Weinberg concluded.
Dr. Weinberg reported no conflicts relevant to his talk.
NEW YORK – Artificial intelligence is currently linked to specific problem solving and is not some form of Terminator model capable of handling multiple tasks with autonomy. In other words, each time you hear the term “AI,” it is a computer solving a specific problem or task using algorithms “and not ‘thinking’ like you and me,” said Ido Weinberg, MD, assistant professor, Harvard Medical School, Boston.
AI is present in daily life – everything from cellphones to the Alexa voice interface on a smart speaker. That AI system, however, is amassing data, learning about you, and using that data intelligently, Dr. Weinberg said at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
AI in health care make sense, he said, because the health sector is a vast consumer market with potential for financial gain. Repetition, which is common in the health sector, is one of the foundations required for using AI and robotics. If a task can be repeated, then it means a machine can do it, said Dr. Weinberg.
The spread of AI and robotics one day may improve health care accessibility in remote areas where physicians with the appropriate training may not be available.
AI is already at work in the health care industry. “Pulmonary nodule detection can be done better with machines than by people, pathological identification and scanning of various slides can be done better by a machine than by a humans,” he said.
Artificial intelligence also can be designed to detect emotion by assessing various cues in phrasing, key words, and tone. These AI functions already are being used by sales reps on the phone to defuse and control interactions with customers and complainants. AI also can be implemented in interactions with people, which is an important part of dealing with patients, Dr. Weinberg said. Drug discovery is a key area where AI is flourishing, as well.
Luckily, in terms of physicians keeping their jobs, there are barriers to the use of AI to replace clinicians, Dr. Weinberg pointed out. Health care is not a monolith, and every specialty is different, meaning AI would have to be tailored to each task and specialty for each unique field. Quick proliferation of AI across the board is unlikely, especially when the varying roles of nurses and physician assistants are included.
Although robots in science fiction stories and films often are capable of multitasking a variety of needs, robots at present are much more limited in real life. In surgical situations, for example, they can perform specifically tailored tasks but cannot extend beyond those defined parameters as a real surgeon can, according to Dr. Weinberg, and this lack of flexibility is a severe limitation on the expansion of AI into health care.
Despite these limitations, Dr. Weinberg urged attendees to consider how AI can be used to facilitate their work.
“Believe in the roadblocks, but be a fast adopter – an early adopter – and understand where AI can currently augment you and make you better and more productive,” he said. “And keep doing procedures; AI and robotics currently have a problem with most of those,” Dr. Weinberg concluded.
Dr. Weinberg reported no conflicts relevant to his talk.
REPORTING FROM THE VEITHSYMPOSIUM