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Ruling: Apologies can’t be used against doctors in court
The Ohio Supreme Court has ruled that apologies by physicians that include an admission of fault cannot be used against them in court, upholding a lower court decision that spared a doctor’s comments from being heard at trial.
In a Sept. 12 decision, state Supreme Court justices concluded that Ohio’s apology statute protects both expressions of regret for an unanticipated outcome and acknowledgments that the patient’s treatment fell below the standard of care. The decision resolves a split among Ohio appeals courts over whether expressions of fault are admissible.
The decision declaring Ohio’s apology statute “unambiguous” is an important and clarifying ruling for physicians and settles the differing opinions of some lower courts, said Reginald Fields, director of external and professional relations for the Ohio State Medical Association.
“We applaud the high court’s decision,” Mr. Fields said in an interview. “Even the two dissenting justices agreed that the apology law is clear; they just questioned whether it applied in this particular case. This ruling likely means pending legislation thought to be needed to clarify the law is now unnecessary. The OSMA will now focus on other aspects of tort reform, such as ‘loss of chance’ claims and further elimination of frivolous lawsuits.”
The Ohio Association for Justice, the state’s plaintiffs’ bar did not respond to a request for comment.
The case of Stewart v. Vivian resulted from a lawsuit filed by Dennis Stewart against Cincinnati psychiatrist Rodney Vivian, MD, after the death of Mr. Stewart’s wife by suicide. Michelle Stewart was admitted to the emergency department of Mt. Orab MediCenter in February 2010 after attempting suicide and was later transferred to the psychiatric unit at Mercy Hospital Clermont in Batavia, Ohio. After consulting with nurses, Dr. Vivian ordered that a staff member of the psychiatric unit visually observe Ms. Stewart every 15 minutes, according to court documents. The next evening, Mr. Stewart arrived at the psychiatric unit to visit his wife and found her unconscious as a result of hanging.
Two days later, Dr. Vivian went to Ms. Stewart’s room in the intensive care unit to speak with family members. The content of the conversation between Dr. Vivian and family members is disputed. Family members allege that Dr. Vivian expressed that it was a “terrible situation” and that the patient had told Dr. Vivian that she “wanted to be dead” would “keep trying” to kill herself. Dr. Vivian testified that he told the family he was “sorry this has happened.” Ms. Stewart was later taken off life support and died.
In 2011, Mr. Stewart sued Dr. Vivian and Mercy Hospital Clermont for medical malpractice, loss of spousal consortium, and wrongful death. Dr. Vivian argued that his statements to family members in the ICU room were inadmissible under the state’s apology law because they were “intended to express commiseration, condolence, or sympathy.” Mr. Stewart countered that Dr. Vivian’s statements were admissible because they were not “pure expressions of apology, sympathy, commiseration, condolence, compassion, or a general sense of benevolence.” The trial court sided with Dr. Vivian and his statements were kept from trial testimony. The jury returned a verdict in favor of Dr. Vivian, concluding that he was not negligent in his assessment, care, or treatment.
The 12th District Court of Appeals ruled that Dr. Vivian’s statements were properly excluded, finding that the Ohio’s apology law is ambiguous because according to the term’s dictionary definition, “apology” may or may not include an admission of fault. But the decision conflicted with the case of Davis v. Wooster Orthopaedics & Sports Medicine, Inc. in which the Court of Appeals for the 9th District in Ohio determined Ohio’s apology statute protects from admission “pure expressions of apology, sympathy, commiseration, condolence, compassion, or a general sense of benevolence,” but not “admission of fault.”
Resolving the split, the Ohio Supreme Court concluded that the state law is unambiguous and that its legislative intent is to shield expressions of regret for unexpected outcomes that may include acknowledgments that the patient’s medical care fell below the standard of care.
Ohio Supreme Court Chief Justice Maureen O’Connor and Justice William M. O’Neill partially dissented. While they agreed with the majority’s holding regarding the intent of Ohio’s apology law, Justice O’Connor wrote that the Dr. Vivian’s statements fell outside the law’s protection.
“Dr. Vivian’s statements were not an apology nor did they express regret or a type of shared sadness associated with sympathy or commiseration,” she wrote in her dissent.
At least 36 states have apology laws that shield against certain statements, expressions, or other evidence related to disclosures being used against physicians in court.
[email protected]
On Twitter @legal_med
The Ohio Supreme Court has ruled that apologies by physicians that include an admission of fault cannot be used against them in court, upholding a lower court decision that spared a doctor’s comments from being heard at trial.
In a Sept. 12 decision, state Supreme Court justices concluded that Ohio’s apology statute protects both expressions of regret for an unanticipated outcome and acknowledgments that the patient’s treatment fell below the standard of care. The decision resolves a split among Ohio appeals courts over whether expressions of fault are admissible.
The decision declaring Ohio’s apology statute “unambiguous” is an important and clarifying ruling for physicians and settles the differing opinions of some lower courts, said Reginald Fields, director of external and professional relations for the Ohio State Medical Association.
“We applaud the high court’s decision,” Mr. Fields said in an interview. “Even the two dissenting justices agreed that the apology law is clear; they just questioned whether it applied in this particular case. This ruling likely means pending legislation thought to be needed to clarify the law is now unnecessary. The OSMA will now focus on other aspects of tort reform, such as ‘loss of chance’ claims and further elimination of frivolous lawsuits.”
The Ohio Association for Justice, the state’s plaintiffs’ bar did not respond to a request for comment.
The case of Stewart v. Vivian resulted from a lawsuit filed by Dennis Stewart against Cincinnati psychiatrist Rodney Vivian, MD, after the death of Mr. Stewart’s wife by suicide. Michelle Stewart was admitted to the emergency department of Mt. Orab MediCenter in February 2010 after attempting suicide and was later transferred to the psychiatric unit at Mercy Hospital Clermont in Batavia, Ohio. After consulting with nurses, Dr. Vivian ordered that a staff member of the psychiatric unit visually observe Ms. Stewart every 15 minutes, according to court documents. The next evening, Mr. Stewart arrived at the psychiatric unit to visit his wife and found her unconscious as a result of hanging.
Two days later, Dr. Vivian went to Ms. Stewart’s room in the intensive care unit to speak with family members. The content of the conversation between Dr. Vivian and family members is disputed. Family members allege that Dr. Vivian expressed that it was a “terrible situation” and that the patient had told Dr. Vivian that she “wanted to be dead” would “keep trying” to kill herself. Dr. Vivian testified that he told the family he was “sorry this has happened.” Ms. Stewart was later taken off life support and died.
In 2011, Mr. Stewart sued Dr. Vivian and Mercy Hospital Clermont for medical malpractice, loss of spousal consortium, and wrongful death. Dr. Vivian argued that his statements to family members in the ICU room were inadmissible under the state’s apology law because they were “intended to express commiseration, condolence, or sympathy.” Mr. Stewart countered that Dr. Vivian’s statements were admissible because they were not “pure expressions of apology, sympathy, commiseration, condolence, compassion, or a general sense of benevolence.” The trial court sided with Dr. Vivian and his statements were kept from trial testimony. The jury returned a verdict in favor of Dr. Vivian, concluding that he was not negligent in his assessment, care, or treatment.
The 12th District Court of Appeals ruled that Dr. Vivian’s statements were properly excluded, finding that the Ohio’s apology law is ambiguous because according to the term’s dictionary definition, “apology” may or may not include an admission of fault. But the decision conflicted with the case of Davis v. Wooster Orthopaedics & Sports Medicine, Inc. in which the Court of Appeals for the 9th District in Ohio determined Ohio’s apology statute protects from admission “pure expressions of apology, sympathy, commiseration, condolence, compassion, or a general sense of benevolence,” but not “admission of fault.”
Resolving the split, the Ohio Supreme Court concluded that the state law is unambiguous and that its legislative intent is to shield expressions of regret for unexpected outcomes that may include acknowledgments that the patient’s medical care fell below the standard of care.
Ohio Supreme Court Chief Justice Maureen O’Connor and Justice William M. O’Neill partially dissented. While they agreed with the majority’s holding regarding the intent of Ohio’s apology law, Justice O’Connor wrote that the Dr. Vivian’s statements fell outside the law’s protection.
“Dr. Vivian’s statements were not an apology nor did they express regret or a type of shared sadness associated with sympathy or commiseration,” she wrote in her dissent.
At least 36 states have apology laws that shield against certain statements, expressions, or other evidence related to disclosures being used against physicians in court.
[email protected]
On Twitter @legal_med
The Ohio Supreme Court has ruled that apologies by physicians that include an admission of fault cannot be used against them in court, upholding a lower court decision that spared a doctor’s comments from being heard at trial.
In a Sept. 12 decision, state Supreme Court justices concluded that Ohio’s apology statute protects both expressions of regret for an unanticipated outcome and acknowledgments that the patient’s treatment fell below the standard of care. The decision resolves a split among Ohio appeals courts over whether expressions of fault are admissible.
The decision declaring Ohio’s apology statute “unambiguous” is an important and clarifying ruling for physicians and settles the differing opinions of some lower courts, said Reginald Fields, director of external and professional relations for the Ohio State Medical Association.
“We applaud the high court’s decision,” Mr. Fields said in an interview. “Even the two dissenting justices agreed that the apology law is clear; they just questioned whether it applied in this particular case. This ruling likely means pending legislation thought to be needed to clarify the law is now unnecessary. The OSMA will now focus on other aspects of tort reform, such as ‘loss of chance’ claims and further elimination of frivolous lawsuits.”
The Ohio Association for Justice, the state’s plaintiffs’ bar did not respond to a request for comment.
The case of Stewart v. Vivian resulted from a lawsuit filed by Dennis Stewart against Cincinnati psychiatrist Rodney Vivian, MD, after the death of Mr. Stewart’s wife by suicide. Michelle Stewart was admitted to the emergency department of Mt. Orab MediCenter in February 2010 after attempting suicide and was later transferred to the psychiatric unit at Mercy Hospital Clermont in Batavia, Ohio. After consulting with nurses, Dr. Vivian ordered that a staff member of the psychiatric unit visually observe Ms. Stewart every 15 minutes, according to court documents. The next evening, Mr. Stewart arrived at the psychiatric unit to visit his wife and found her unconscious as a result of hanging.
Two days later, Dr. Vivian went to Ms. Stewart’s room in the intensive care unit to speak with family members. The content of the conversation between Dr. Vivian and family members is disputed. Family members allege that Dr. Vivian expressed that it was a “terrible situation” and that the patient had told Dr. Vivian that she “wanted to be dead” would “keep trying” to kill herself. Dr. Vivian testified that he told the family he was “sorry this has happened.” Ms. Stewart was later taken off life support and died.
In 2011, Mr. Stewart sued Dr. Vivian and Mercy Hospital Clermont for medical malpractice, loss of spousal consortium, and wrongful death. Dr. Vivian argued that his statements to family members in the ICU room were inadmissible under the state’s apology law because they were “intended to express commiseration, condolence, or sympathy.” Mr. Stewart countered that Dr. Vivian’s statements were admissible because they were not “pure expressions of apology, sympathy, commiseration, condolence, compassion, or a general sense of benevolence.” The trial court sided with Dr. Vivian and his statements were kept from trial testimony. The jury returned a verdict in favor of Dr. Vivian, concluding that he was not negligent in his assessment, care, or treatment.
The 12th District Court of Appeals ruled that Dr. Vivian’s statements were properly excluded, finding that the Ohio’s apology law is ambiguous because according to the term’s dictionary definition, “apology” may or may not include an admission of fault. But the decision conflicted with the case of Davis v. Wooster Orthopaedics & Sports Medicine, Inc. in which the Court of Appeals for the 9th District in Ohio determined Ohio’s apology statute protects from admission “pure expressions of apology, sympathy, commiseration, condolence, compassion, or a general sense of benevolence,” but not “admission of fault.”
Resolving the split, the Ohio Supreme Court concluded that the state law is unambiguous and that its legislative intent is to shield expressions of regret for unexpected outcomes that may include acknowledgments that the patient’s medical care fell below the standard of care.
Ohio Supreme Court Chief Justice Maureen O’Connor and Justice William M. O’Neill partially dissented. While they agreed with the majority’s holding regarding the intent of Ohio’s apology law, Justice O’Connor wrote that the Dr. Vivian’s statements fell outside the law’s protection.
“Dr. Vivian’s statements were not an apology nor did they express regret or a type of shared sadness associated with sympathy or commiseration,” she wrote in her dissent.
At least 36 states have apology laws that shield against certain statements, expressions, or other evidence related to disclosures being used against physicians in court.
[email protected]
On Twitter @legal_med
Higher BP targets suggested for elderly, cognitively impaired
SAN FRANCISCO – Lowering blood pressure below 140/90 mm Hg might not be a good idea in the very elderly, especially if they have cognitive impairment, according to Philip Gorelick, MD.
“Lower blood pressure” in those patients “may be associated with worse cognitive outcomes,” he said at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The problem is that higher pressures may be needed to maintain cerebral perfusion. It’s possible the very elderly have impaired cerebral autoregulation, especially if there’s a history of hypertension. A little extra pressure is needed to overcome increased cerebral vascular resistance.
“Cautious blood pressure–lowering with a target of about 150 mm Hg systolic, may be prudent,” said Dr. Gorelick, professor of translational science and molecular medicine at Michigan State University in Grand Rapids. Meanwhile, “for those without cognitive impairment and who have intact cerebral autoregulation, lower blood pressure targets may be beneficial to preserve cognition.
It’s become clear in recent years that cognitive decline is not a strictly neurologic issue, but rather related to cardiovascular health, at least in some people. Good blood pressure control in midlife, in particular, seems to be important for prevention.
“The same risk factors for atherosclerotic disease [are] risks for Alzheimer’s disease. Vascular risks play a role in cognitive impairment, including Alzheimer’s,” he said.
But the evidence is not clear for blood pressure lowering after the age of 80. Several studies have suggested that angiotensin receptor blockers and other hypertension medications reduce pathologic and clinical changes associated with Alzheimer’s. “However, there’s certainly a downside” to using them in the elderly. “Everything that glistens is not gold,” Dr. Gorelick said.
“There have been studies in older persons with mild cognitive deficits who are placed on antihypertensives, and they actually have lower brain volumes: The brain is shrinking, possibly at a faster rate. Other studies have suggested that people around 80 years of age may have greater cognitive decline with lower blood pressure,” he said.
For those older than 80 and patients with cognitive impairment, the usefulness of blood pressure–lowering for prevention of dementia has not been established. Relaxing the blood pressure control targets might prevent harm, he said.
“There’s going to be a window of opportunity where were are going to see some benefit” in using, for instance, ARBs to slow cognitive decline, but “we have to be smart enough to find the right patients and the right window. We’re not there yet,” he said.
Dr. Gorelick is a consultant for Bayer, Novartis, and Amgen.
SAN FRANCISCO – Lowering blood pressure below 140/90 mm Hg might not be a good idea in the very elderly, especially if they have cognitive impairment, according to Philip Gorelick, MD.
“Lower blood pressure” in those patients “may be associated with worse cognitive outcomes,” he said at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The problem is that higher pressures may be needed to maintain cerebral perfusion. It’s possible the very elderly have impaired cerebral autoregulation, especially if there’s a history of hypertension. A little extra pressure is needed to overcome increased cerebral vascular resistance.
“Cautious blood pressure–lowering with a target of about 150 mm Hg systolic, may be prudent,” said Dr. Gorelick, professor of translational science and molecular medicine at Michigan State University in Grand Rapids. Meanwhile, “for those without cognitive impairment and who have intact cerebral autoregulation, lower blood pressure targets may be beneficial to preserve cognition.
It’s become clear in recent years that cognitive decline is not a strictly neurologic issue, but rather related to cardiovascular health, at least in some people. Good blood pressure control in midlife, in particular, seems to be important for prevention.
“The same risk factors for atherosclerotic disease [are] risks for Alzheimer’s disease. Vascular risks play a role in cognitive impairment, including Alzheimer’s,” he said.
But the evidence is not clear for blood pressure lowering after the age of 80. Several studies have suggested that angiotensin receptor blockers and other hypertension medications reduce pathologic and clinical changes associated with Alzheimer’s. “However, there’s certainly a downside” to using them in the elderly. “Everything that glistens is not gold,” Dr. Gorelick said.
“There have been studies in older persons with mild cognitive deficits who are placed on antihypertensives, and they actually have lower brain volumes: The brain is shrinking, possibly at a faster rate. Other studies have suggested that people around 80 years of age may have greater cognitive decline with lower blood pressure,” he said.
For those older than 80 and patients with cognitive impairment, the usefulness of blood pressure–lowering for prevention of dementia has not been established. Relaxing the blood pressure control targets might prevent harm, he said.
“There’s going to be a window of opportunity where were are going to see some benefit” in using, for instance, ARBs to slow cognitive decline, but “we have to be smart enough to find the right patients and the right window. We’re not there yet,” he said.
Dr. Gorelick is a consultant for Bayer, Novartis, and Amgen.
SAN FRANCISCO – Lowering blood pressure below 140/90 mm Hg might not be a good idea in the very elderly, especially if they have cognitive impairment, according to Philip Gorelick, MD.
“Lower blood pressure” in those patients “may be associated with worse cognitive outcomes,” he said at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The problem is that higher pressures may be needed to maintain cerebral perfusion. It’s possible the very elderly have impaired cerebral autoregulation, especially if there’s a history of hypertension. A little extra pressure is needed to overcome increased cerebral vascular resistance.
“Cautious blood pressure–lowering with a target of about 150 mm Hg systolic, may be prudent,” said Dr. Gorelick, professor of translational science and molecular medicine at Michigan State University in Grand Rapids. Meanwhile, “for those without cognitive impairment and who have intact cerebral autoregulation, lower blood pressure targets may be beneficial to preserve cognition.
It’s become clear in recent years that cognitive decline is not a strictly neurologic issue, but rather related to cardiovascular health, at least in some people. Good blood pressure control in midlife, in particular, seems to be important for prevention.
“The same risk factors for atherosclerotic disease [are] risks for Alzheimer’s disease. Vascular risks play a role in cognitive impairment, including Alzheimer’s,” he said.
But the evidence is not clear for blood pressure lowering after the age of 80. Several studies have suggested that angiotensin receptor blockers and other hypertension medications reduce pathologic and clinical changes associated with Alzheimer’s. “However, there’s certainly a downside” to using them in the elderly. “Everything that glistens is not gold,” Dr. Gorelick said.
“There have been studies in older persons with mild cognitive deficits who are placed on antihypertensives, and they actually have lower brain volumes: The brain is shrinking, possibly at a faster rate. Other studies have suggested that people around 80 years of age may have greater cognitive decline with lower blood pressure,” he said.
For those older than 80 and patients with cognitive impairment, the usefulness of blood pressure–lowering for prevention of dementia has not been established. Relaxing the blood pressure control targets might prevent harm, he said.
“There’s going to be a window of opportunity where were are going to see some benefit” in using, for instance, ARBs to slow cognitive decline, but “we have to be smart enough to find the right patients and the right window. We’re not there yet,” he said.
Dr. Gorelick is a consultant for Bayer, Novartis, and Amgen.
EXPERT ANALYSIS FROM Joint Hypertension 2017
Retrospective review: No difference in PFS, OS with radiation before PD-1/PD-L1 inhibition
CHICAGO – Exposure to radiation therapy prior to PD-1/PD-L1 therapy was not associated with improved outcomes in a retrospective review of 66 lung cancer patients.
The patients had stage IIIB or IV non–small cell lung cancer, median age of 64 years, received at least 6 weeks of single-agent anti-PD-1/PD-L1 therapy in the second-line setting or beyond, and had survived at least 8 weeks from immunotherapy initiation. Compared with 13 patients who received no radiation therapy, the 53 who received any prior radiation therapy – including 44 with extracranial radiation and 22 with intracranial radiation – did not differ significantly with respect to progression-free survival (median 4-5 months; hazard ratio, 0.83), or overall survival (median of about 12 months in both groups; HR, 0.96), Christopher Strouse, MD, of the University of Iowa, Iowa City, reported at the Chicago Multidisciplinary Symposium in Thoracic Oncology.
There also were no significant differences in the outcomes between those who had extracranial radiation and those who had intracranial radiation (HRs for PFS and OS, respectively, 0.91 and 1.19), or (on univariate analysis), between those receiving any vs. no intracranial radiation therapy (HRs for PFS and OS, respectively, 0.92 and 0.98), Dr. Strouse said.
The patients who received extracranial radiation therapy had lower lymphocyte counts at the time of anti-PD-1/PD-L1 therapy initiation vs. those who received only radiation therapy (mean lymphocyte count, 809 vs. 1,519), and those who received intracranial radiation therapy were younger than those who did not (median age, 59 vs. 65 years), but the groups were similar with respect to other variables, including gender, histology, performance status, smoking history, KRAS mutation, and number of prior lines of systemic therapies. Anti-PD-1/PD-L1 therapies are promising treatment options for metastatic non–small cell lung cancer, and combining these agents with other immune-modulating therapies may enhance their efficacy and lead to a greater proportion of patients with responses to these treatments, Dr. Strouse noted.
“It’s known that immune response depends on a lot of steps, even beyond the PD-1/PD-L1 axis, and one possible explanation for some of these patients [not responding] may be that there is some failure along the way in some other step,” he said. “Our hypothesis was that radiation therapy would be helpful in overcoming some of these barriers.”
However, in this study, which is limited by small sample size and single-institution retrospective design, no such effect was identified.
The findings conflict with some larger studies, including the recently-reported PACIFIC study, which showed a significant PFS benefit in lung cancer patients who received chemoradiation therapy followed by treatment with the PD-L1 inhibitor durvalumab.
Dr. Strouse said he looks forward to seeing further reports looking into the effects of radiation therapy at different doses and timing.
Invited discussant Heather Wakelee, MD, of Stanford (Calif.) University, also stressed the limitations of the University of Iowa study, and noted that while there are many unanswered questions, findings such as those from the PACIFIC trial show that radiation and PD-L1 inhibition is here to stay.
“It appears safe; there will be more coming,” she said.
Dr. Strouse reported having no disclosures. Dr. Wakelee has been the institutional principal investigator for studies of nivolumab, tocilizumab, and other agents. She has consulted for Peregrine, ACEA, Pfizer, Helsinn, Genentech/Roche, Clovis, and Lilly, and received research/grant support from Clovis, Exelixis, AstraZeneca/Medimmune, Genentech/Roche, BMS, Gilead, Novartis, Xcovery, Pfizer, Celgene, Gilead, Pharmacyclics, and Lilly.
CHICAGO – Exposure to radiation therapy prior to PD-1/PD-L1 therapy was not associated with improved outcomes in a retrospective review of 66 lung cancer patients.
The patients had stage IIIB or IV non–small cell lung cancer, median age of 64 years, received at least 6 weeks of single-agent anti-PD-1/PD-L1 therapy in the second-line setting or beyond, and had survived at least 8 weeks from immunotherapy initiation. Compared with 13 patients who received no radiation therapy, the 53 who received any prior radiation therapy – including 44 with extracranial radiation and 22 with intracranial radiation – did not differ significantly with respect to progression-free survival (median 4-5 months; hazard ratio, 0.83), or overall survival (median of about 12 months in both groups; HR, 0.96), Christopher Strouse, MD, of the University of Iowa, Iowa City, reported at the Chicago Multidisciplinary Symposium in Thoracic Oncology.
There also were no significant differences in the outcomes between those who had extracranial radiation and those who had intracranial radiation (HRs for PFS and OS, respectively, 0.91 and 1.19), or (on univariate analysis), between those receiving any vs. no intracranial radiation therapy (HRs for PFS and OS, respectively, 0.92 and 0.98), Dr. Strouse said.
The patients who received extracranial radiation therapy had lower lymphocyte counts at the time of anti-PD-1/PD-L1 therapy initiation vs. those who received only radiation therapy (mean lymphocyte count, 809 vs. 1,519), and those who received intracranial radiation therapy were younger than those who did not (median age, 59 vs. 65 years), but the groups were similar with respect to other variables, including gender, histology, performance status, smoking history, KRAS mutation, and number of prior lines of systemic therapies. Anti-PD-1/PD-L1 therapies are promising treatment options for metastatic non–small cell lung cancer, and combining these agents with other immune-modulating therapies may enhance their efficacy and lead to a greater proportion of patients with responses to these treatments, Dr. Strouse noted.
“It’s known that immune response depends on a lot of steps, even beyond the PD-1/PD-L1 axis, and one possible explanation for some of these patients [not responding] may be that there is some failure along the way in some other step,” he said. “Our hypothesis was that radiation therapy would be helpful in overcoming some of these barriers.”
However, in this study, which is limited by small sample size and single-institution retrospective design, no such effect was identified.
The findings conflict with some larger studies, including the recently-reported PACIFIC study, which showed a significant PFS benefit in lung cancer patients who received chemoradiation therapy followed by treatment with the PD-L1 inhibitor durvalumab.
Dr. Strouse said he looks forward to seeing further reports looking into the effects of radiation therapy at different doses and timing.
Invited discussant Heather Wakelee, MD, of Stanford (Calif.) University, also stressed the limitations of the University of Iowa study, and noted that while there are many unanswered questions, findings such as those from the PACIFIC trial show that radiation and PD-L1 inhibition is here to stay.
“It appears safe; there will be more coming,” she said.
Dr. Strouse reported having no disclosures. Dr. Wakelee has been the institutional principal investigator for studies of nivolumab, tocilizumab, and other agents. She has consulted for Peregrine, ACEA, Pfizer, Helsinn, Genentech/Roche, Clovis, and Lilly, and received research/grant support from Clovis, Exelixis, AstraZeneca/Medimmune, Genentech/Roche, BMS, Gilead, Novartis, Xcovery, Pfizer, Celgene, Gilead, Pharmacyclics, and Lilly.
CHICAGO – Exposure to radiation therapy prior to PD-1/PD-L1 therapy was not associated with improved outcomes in a retrospective review of 66 lung cancer patients.
The patients had stage IIIB or IV non–small cell lung cancer, median age of 64 years, received at least 6 weeks of single-agent anti-PD-1/PD-L1 therapy in the second-line setting or beyond, and had survived at least 8 weeks from immunotherapy initiation. Compared with 13 patients who received no radiation therapy, the 53 who received any prior radiation therapy – including 44 with extracranial radiation and 22 with intracranial radiation – did not differ significantly with respect to progression-free survival (median 4-5 months; hazard ratio, 0.83), or overall survival (median of about 12 months in both groups; HR, 0.96), Christopher Strouse, MD, of the University of Iowa, Iowa City, reported at the Chicago Multidisciplinary Symposium in Thoracic Oncology.
There also were no significant differences in the outcomes between those who had extracranial radiation and those who had intracranial radiation (HRs for PFS and OS, respectively, 0.91 and 1.19), or (on univariate analysis), between those receiving any vs. no intracranial radiation therapy (HRs for PFS and OS, respectively, 0.92 and 0.98), Dr. Strouse said.
The patients who received extracranial radiation therapy had lower lymphocyte counts at the time of anti-PD-1/PD-L1 therapy initiation vs. those who received only radiation therapy (mean lymphocyte count, 809 vs. 1,519), and those who received intracranial radiation therapy were younger than those who did not (median age, 59 vs. 65 years), but the groups were similar with respect to other variables, including gender, histology, performance status, smoking history, KRAS mutation, and number of prior lines of systemic therapies. Anti-PD-1/PD-L1 therapies are promising treatment options for metastatic non–small cell lung cancer, and combining these agents with other immune-modulating therapies may enhance their efficacy and lead to a greater proportion of patients with responses to these treatments, Dr. Strouse noted.
“It’s known that immune response depends on a lot of steps, even beyond the PD-1/PD-L1 axis, and one possible explanation for some of these patients [not responding] may be that there is some failure along the way in some other step,” he said. “Our hypothesis was that radiation therapy would be helpful in overcoming some of these barriers.”
However, in this study, which is limited by small sample size and single-institution retrospective design, no such effect was identified.
The findings conflict with some larger studies, including the recently-reported PACIFIC study, which showed a significant PFS benefit in lung cancer patients who received chemoradiation therapy followed by treatment with the PD-L1 inhibitor durvalumab.
Dr. Strouse said he looks forward to seeing further reports looking into the effects of radiation therapy at different doses and timing.
Invited discussant Heather Wakelee, MD, of Stanford (Calif.) University, also stressed the limitations of the University of Iowa study, and noted that while there are many unanswered questions, findings such as those from the PACIFIC trial show that radiation and PD-L1 inhibition is here to stay.
“It appears safe; there will be more coming,” she said.
Dr. Strouse reported having no disclosures. Dr. Wakelee has been the institutional principal investigator for studies of nivolumab, tocilizumab, and other agents. She has consulted for Peregrine, ACEA, Pfizer, Helsinn, Genentech/Roche, Clovis, and Lilly, and received research/grant support from Clovis, Exelixis, AstraZeneca/Medimmune, Genentech/Roche, BMS, Gilead, Novartis, Xcovery, Pfizer, Celgene, Gilead, Pharmacyclics, and Lilly.
AT A SYMPOSIUM IN THORACIC ONCOLOGY
Key clinical point:
Major finding: PFS and OS did not differ significantly between patients who did and did not receive prior radiation therapy (HRs for PFS and OS, respectively, 0.83 and 0.96).
Data source: A retrospective review of 66 patients.
Disclosures: Dr. Strouse reported having no disclosures. Dr. Wakelee has been the institutional principal investigator for studies of nivolumab, tocilizumab, and other agents. She has consulted for Peregrine, ACEA, Pfizer, Helsinn, Genentech/Roche, Clovis, and Lilly, and received research/grant support from Clovis, Exelixis, AstraZeneca/Medimmune, Genentech/Roche, BMS, Gilead, Novartis, Xcovery, Pfizer, Celgene, Gilead, Pharmacyclics, and Lilly.
Sen. Collins deals likely fatal blow to GOP’s health bill
Sen. Susan Collins (R-Maine) became the third GOP senator to confirm a no vote on the latest Republican attempt to repeal and replace the Affordable Care Act (ACA), a move that likely seals the bill’s fate.
The bill has the support of President Trump and many GOP leaders but has been roundly criticized by medical groups for insuring fewer Americans, failing to provide adequate protections for people with preexisting conditions, and barring Planned Parenthood from Medicaid participation.
“Sweeping reforms to our health care system and to Medicaid can’t be done well in a compressed time frame, especially when the actual bill is a moving target,” Sen. Collins said in a Sept. 25 statement announcing her opposition to a bill sponsored by Sen. Lindsey Graham (R-S.C.), Sen. Bill Cassidy (R-La.), Sen. Dean Heller (R-Nev.), and Sen. Ron Johnson (R-Wis.).
Since its introduction in mid September, the bill has undergone at least four published revisions, including providing additional funding to Maine and Alaska in an effort to flip Sen. Collins and Sen. Lisa Murkowski (R-Alaska) to the yes column. Both were no votes that helped kill a previous ACA repeal and replace effort.
“The fact is, Maine still loses money under whichever version of the Graham-Cassidy bill we consider because the bill uses what could be described as a ‘give with one hand, take with the other’ distribution model” to maintain the budget neutrality of the Medicaid block grants sent to states, Sen. Collins said. “Huge Medicaid cuts down the road more than offset any short-term influx of money.”
Sen. Collins’ opposition came on the heels of a damaging analysis from the Congressional Budget Office (CBO). The preliminary analysis looked at an earlier version of the bill and found that the number of people with comprehensive health insurance would be reduced by millions and the impact would be particularly large starting in 2020, when the bill would make changes to Medicaid funding and the nongroup insurance market.
Since Senate Republicans are using the budget reconciliation process to pass this legislation, they only need 50 votes to pass the legislation, with Vice President Mike Pence providing the tie-breaking vote. But with a slim 52-seat majority, there was little margin for error. Sen. John McCain (R-Ariz.) had already announced his opposition to the Graham-Cassidy bill on Sept. 22, primarily on process grounds.
“We should not be content to pass health care legislation on a party-line basis, as Democrats did when they rammed Obamacare through Congress in 2009. If we do, our success could be as short-lived as theirs, when the political winds shift, as they regularly do,” Sen. McCain said in a statement. “The issue is too important, and too many lives are at risk, for us to leave the American people guessing from one election to the next whether and how they will acquire health insurance. A bill of this impact requires a bipartisan approach.”
He praised the work of Senate Health, Education, Labor & Pensions Committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.), who have been working together on a small, focused package aimed at stabilizing the individual insurance market.
“Senators Alexander and Murray have been negotiating in good faith to fix some of the problems with Obamacare,” Sen. McCain said. “But I fear that the prospect of one last attempt at a strictly Republican bill has left the impression that their efforts cannot succeed. I hope they will resume their work should this last attempt at a partisan solution fail.”
Sen. Rand Paul (R-Ky.) also came out publicly against the Graham-Cassidy bill, though his opposition stems from it not going far enough in repealing elements of the ACA.
During a Sept. 25 Senate Finance Committee hearing on the Graham-Cassidy bill, Teresa Miller, acting secretary of the Pennsylvania Department of Human Services, testified that the real problem – the cost of health care – is getting pushed aside as everyone focuses on the coverage issue.
“This whole debate, for the last several years, has been about coverage and we haven’t been talking about the cost of health care,” Ms. Miller told the committee. “At the end of the day, insurance is a reflection of the cost of health care. So if we don’t have a debate in this county and discussion about how we get at the underlying cost of care, we have a major problem. That’s really the debate we should be having.”
Senate Majority Leader Mitch McConnell (R-Ky.) has not signaled whether he would still bring Graham-Cassidy to a vote, given that it appears not to have the votes needed for passage. If he chooses to move forward with the bill, the vote would need to happen before the end of the day on Sept. 30 to use the budget reconciliation process and gain passage with a simple majority.
Sen. Susan Collins (R-Maine) became the third GOP senator to confirm a no vote on the latest Republican attempt to repeal and replace the Affordable Care Act (ACA), a move that likely seals the bill’s fate.
The bill has the support of President Trump and many GOP leaders but has been roundly criticized by medical groups for insuring fewer Americans, failing to provide adequate protections for people with preexisting conditions, and barring Planned Parenthood from Medicaid participation.
“Sweeping reforms to our health care system and to Medicaid can’t be done well in a compressed time frame, especially when the actual bill is a moving target,” Sen. Collins said in a Sept. 25 statement announcing her opposition to a bill sponsored by Sen. Lindsey Graham (R-S.C.), Sen. Bill Cassidy (R-La.), Sen. Dean Heller (R-Nev.), and Sen. Ron Johnson (R-Wis.).
Since its introduction in mid September, the bill has undergone at least four published revisions, including providing additional funding to Maine and Alaska in an effort to flip Sen. Collins and Sen. Lisa Murkowski (R-Alaska) to the yes column. Both were no votes that helped kill a previous ACA repeal and replace effort.
“The fact is, Maine still loses money under whichever version of the Graham-Cassidy bill we consider because the bill uses what could be described as a ‘give with one hand, take with the other’ distribution model” to maintain the budget neutrality of the Medicaid block grants sent to states, Sen. Collins said. “Huge Medicaid cuts down the road more than offset any short-term influx of money.”
Sen. Collins’ opposition came on the heels of a damaging analysis from the Congressional Budget Office (CBO). The preliminary analysis looked at an earlier version of the bill and found that the number of people with comprehensive health insurance would be reduced by millions and the impact would be particularly large starting in 2020, when the bill would make changes to Medicaid funding and the nongroup insurance market.
Since Senate Republicans are using the budget reconciliation process to pass this legislation, they only need 50 votes to pass the legislation, with Vice President Mike Pence providing the tie-breaking vote. But with a slim 52-seat majority, there was little margin for error. Sen. John McCain (R-Ariz.) had already announced his opposition to the Graham-Cassidy bill on Sept. 22, primarily on process grounds.
“We should not be content to pass health care legislation on a party-line basis, as Democrats did when they rammed Obamacare through Congress in 2009. If we do, our success could be as short-lived as theirs, when the political winds shift, as they regularly do,” Sen. McCain said in a statement. “The issue is too important, and too many lives are at risk, for us to leave the American people guessing from one election to the next whether and how they will acquire health insurance. A bill of this impact requires a bipartisan approach.”
He praised the work of Senate Health, Education, Labor & Pensions Committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.), who have been working together on a small, focused package aimed at stabilizing the individual insurance market.
“Senators Alexander and Murray have been negotiating in good faith to fix some of the problems with Obamacare,” Sen. McCain said. “But I fear that the prospect of one last attempt at a strictly Republican bill has left the impression that their efforts cannot succeed. I hope they will resume their work should this last attempt at a partisan solution fail.”
Sen. Rand Paul (R-Ky.) also came out publicly against the Graham-Cassidy bill, though his opposition stems from it not going far enough in repealing elements of the ACA.
During a Sept. 25 Senate Finance Committee hearing on the Graham-Cassidy bill, Teresa Miller, acting secretary of the Pennsylvania Department of Human Services, testified that the real problem – the cost of health care – is getting pushed aside as everyone focuses on the coverage issue.
“This whole debate, for the last several years, has been about coverage and we haven’t been talking about the cost of health care,” Ms. Miller told the committee. “At the end of the day, insurance is a reflection of the cost of health care. So if we don’t have a debate in this county and discussion about how we get at the underlying cost of care, we have a major problem. That’s really the debate we should be having.”
Senate Majority Leader Mitch McConnell (R-Ky.) has not signaled whether he would still bring Graham-Cassidy to a vote, given that it appears not to have the votes needed for passage. If he chooses to move forward with the bill, the vote would need to happen before the end of the day on Sept. 30 to use the budget reconciliation process and gain passage with a simple majority.
Sen. Susan Collins (R-Maine) became the third GOP senator to confirm a no vote on the latest Republican attempt to repeal and replace the Affordable Care Act (ACA), a move that likely seals the bill’s fate.
The bill has the support of President Trump and many GOP leaders but has been roundly criticized by medical groups for insuring fewer Americans, failing to provide adequate protections for people with preexisting conditions, and barring Planned Parenthood from Medicaid participation.
“Sweeping reforms to our health care system and to Medicaid can’t be done well in a compressed time frame, especially when the actual bill is a moving target,” Sen. Collins said in a Sept. 25 statement announcing her opposition to a bill sponsored by Sen. Lindsey Graham (R-S.C.), Sen. Bill Cassidy (R-La.), Sen. Dean Heller (R-Nev.), and Sen. Ron Johnson (R-Wis.).
Since its introduction in mid September, the bill has undergone at least four published revisions, including providing additional funding to Maine and Alaska in an effort to flip Sen. Collins and Sen. Lisa Murkowski (R-Alaska) to the yes column. Both were no votes that helped kill a previous ACA repeal and replace effort.
“The fact is, Maine still loses money under whichever version of the Graham-Cassidy bill we consider because the bill uses what could be described as a ‘give with one hand, take with the other’ distribution model” to maintain the budget neutrality of the Medicaid block grants sent to states, Sen. Collins said. “Huge Medicaid cuts down the road more than offset any short-term influx of money.”
Sen. Collins’ opposition came on the heels of a damaging analysis from the Congressional Budget Office (CBO). The preliminary analysis looked at an earlier version of the bill and found that the number of people with comprehensive health insurance would be reduced by millions and the impact would be particularly large starting in 2020, when the bill would make changes to Medicaid funding and the nongroup insurance market.
Since Senate Republicans are using the budget reconciliation process to pass this legislation, they only need 50 votes to pass the legislation, with Vice President Mike Pence providing the tie-breaking vote. But with a slim 52-seat majority, there was little margin for error. Sen. John McCain (R-Ariz.) had already announced his opposition to the Graham-Cassidy bill on Sept. 22, primarily on process grounds.
“We should not be content to pass health care legislation on a party-line basis, as Democrats did when they rammed Obamacare through Congress in 2009. If we do, our success could be as short-lived as theirs, when the political winds shift, as they regularly do,” Sen. McCain said in a statement. “The issue is too important, and too many lives are at risk, for us to leave the American people guessing from one election to the next whether and how they will acquire health insurance. A bill of this impact requires a bipartisan approach.”
He praised the work of Senate Health, Education, Labor & Pensions Committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.), who have been working together on a small, focused package aimed at stabilizing the individual insurance market.
“Senators Alexander and Murray have been negotiating in good faith to fix some of the problems with Obamacare,” Sen. McCain said. “But I fear that the prospect of one last attempt at a strictly Republican bill has left the impression that their efforts cannot succeed. I hope they will resume their work should this last attempt at a partisan solution fail.”
Sen. Rand Paul (R-Ky.) also came out publicly against the Graham-Cassidy bill, though his opposition stems from it not going far enough in repealing elements of the ACA.
During a Sept. 25 Senate Finance Committee hearing on the Graham-Cassidy bill, Teresa Miller, acting secretary of the Pennsylvania Department of Human Services, testified that the real problem – the cost of health care – is getting pushed aside as everyone focuses on the coverage issue.
“This whole debate, for the last several years, has been about coverage and we haven’t been talking about the cost of health care,” Ms. Miller told the committee. “At the end of the day, insurance is a reflection of the cost of health care. So if we don’t have a debate in this county and discussion about how we get at the underlying cost of care, we have a major problem. That’s really the debate we should be having.”
Senate Majority Leader Mitch McConnell (R-Ky.) has not signaled whether he would still bring Graham-Cassidy to a vote, given that it appears not to have the votes needed for passage. If he chooses to move forward with the bill, the vote would need to happen before the end of the day on Sept. 30 to use the budget reconciliation process and gain passage with a simple majority.
Medtronic, others push forward with HTN renal artery denervation
SAN FRANCISCO – Hypertensive patients averaged about a 10-mm Hg drop in 24-hour ambulatory systolic blood pressure and about a 12-mm Hg drop in office systolic blood pressure, 2 years after treatment with Medtronic’s new Symplicity Spyral renal artery denervation catheter, according to a review of the company’s renal artery denervation registry.
No major safety issues were reported, but there was no reduction from baseline in the number of antihypertensive drugs that patients were prescribed, which averaged more than four.
The company withdrew the Flex catheter from development after a large, randomized U.S. trial found no benefit over a sham procedure for resistant hypertension (N Engl J Med. 2014 Apr 10;370[15]:1393-401). “In the future, everything will be built around the Spyral catheter,” said Michael Weber, MD, a Medtronic investigator and a professor of medicine at State University of New York, Brooklyn. He presented the registry findings at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The Spyral, he said, has two key advantages over the Flex. The Flex had just a single electrode, so operators had to rotate the tip into four quadrants to fully denervate renal arteries, “a tricky business at the best of times and very often not successfully achieved.” Inadequate ablation might have contributed to the trial failure, Dr. Weber said.
The Spyral catheter, on the other hand, has four electrodes placed radially around a spiral catheter, so all four quadrants can be ablated at once, without undue gymnastics. The Spyral can also enter the smaller branches of the main renal arteries, which might allow for more complete denervation, he said.
“We all anticipate better results with the Spyral, but let’s be cautious. We need more data and obviously data from controlled clinical trials. There’s a lot to be learned yet about this whole procedure,” Dr. Weber said.
Medtronic is planning a large trial of its new device following the recent publication of a successful proof-of-concept study that pitted the Spyral in 38 hypertensives against a sham procedure in 42. The Spyral group had a 5 mm Hg greater reduction in systolic ambulatory blood pressure at 3 months, among other findings. To avoid confounding, investigators took patients off their blood pressure medications during the study (Lancet. 2017 Aug 25. pii: S0140-6736(17)32281-X. doi: 10.1016/S0140-6736[17]32281-X).
Other companies are pushing forward with renal artery denervation, as well; Boston Scientific has its own four-quadrant ablation catheter – Vessix – in the pipeline.
In Medtronic’s denervation registry, office systolic blood pressure reductions were a bit larger at 2 years for the older Flex catheter than with the newer Spyral, 15.7 versus 12.0 mm Hg from a baseline of about 170 mm Hg in both groups. Spyral had a slight edge on 24-hour ambulatory systolic blood pressure at 2 years, with an average reduction of 10.4 versus 8.7 mm Hg from a mean baseline of about 155 mm Hg.
For both devices, “when you look at results patient-by-patient, they are dramatically all over the place, including a significant number of patients whose pressures actually increase. I have to assume that it’s patients” who stop taking their medications after the procedure. On the flip side, “I suspect some of our terrific results are because people finally get a touch of religion after the intervention and start taking their drugs for the first time,” Dr. Weber said.
So far, only a handful of Spyral patients have had ablations in renal artery branches. “It seems to have some benefit as judged by office pressure, but the numbers are small, so it’s premature to draw any conclusions,” he said.
Registry patients were in their early 60s, on average, at baseline, and there were more men than women. As with Spyral, Flex patients had no decrease in hypertension prescriptions over time and averaged more than four. “We have not seen many miracle cures in the sense of patients suddenly requiring no drugs at all,” Dr. Weber said.
The procedure seems safe, according to the registry. “There’s nothing to suggest the use of these catheters in the renal arteries causes any sort of acute or later-appearing major renal artery compromise.” With the Flex, less than 1% of patients required renal artery reintervention, which was possibly related to ablation trauma stenosis, “but it’s something to keep on our list of things to look for,” Dr. Weber said.
When asked if the registry fully captures adverse events, Dr. Weber said that “I suspect once [Spyral] goes to market, assuming it does go to market, there will be far more rigorous reporting requirements.”
He reported receiving travel funding, as well as consulting and lecture fees, from Medtronic and Boston Scientific, among other companies.
We need to see randomized trials. This technology looks encouraging, but there’s nothing definitive yet in terms of direct applicability. The initial proof of concept study suggested it does lower blood pressure – but not by a lot. I think it’s a long way from common clinical use, but it’s reasonable to keep looking at it.
We need to see randomized trials. This technology looks encouraging, but there’s nothing definitive yet in terms of direct applicability. The initial proof of concept study suggested it does lower blood pressure – but not by a lot. I think it’s a long way from common clinical use, but it’s reasonable to keep looking at it.
We need to see randomized trials. This technology looks encouraging, but there’s nothing definitive yet in terms of direct applicability. The initial proof of concept study suggested it does lower blood pressure – but not by a lot. I think it’s a long way from common clinical use, but it’s reasonable to keep looking at it.
SAN FRANCISCO – Hypertensive patients averaged about a 10-mm Hg drop in 24-hour ambulatory systolic blood pressure and about a 12-mm Hg drop in office systolic blood pressure, 2 years after treatment with Medtronic’s new Symplicity Spyral renal artery denervation catheter, according to a review of the company’s renal artery denervation registry.
No major safety issues were reported, but there was no reduction from baseline in the number of antihypertensive drugs that patients were prescribed, which averaged more than four.
The company withdrew the Flex catheter from development after a large, randomized U.S. trial found no benefit over a sham procedure for resistant hypertension (N Engl J Med. 2014 Apr 10;370[15]:1393-401). “In the future, everything will be built around the Spyral catheter,” said Michael Weber, MD, a Medtronic investigator and a professor of medicine at State University of New York, Brooklyn. He presented the registry findings at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The Spyral, he said, has two key advantages over the Flex. The Flex had just a single electrode, so operators had to rotate the tip into four quadrants to fully denervate renal arteries, “a tricky business at the best of times and very often not successfully achieved.” Inadequate ablation might have contributed to the trial failure, Dr. Weber said.
The Spyral catheter, on the other hand, has four electrodes placed radially around a spiral catheter, so all four quadrants can be ablated at once, without undue gymnastics. The Spyral can also enter the smaller branches of the main renal arteries, which might allow for more complete denervation, he said.
“We all anticipate better results with the Spyral, but let’s be cautious. We need more data and obviously data from controlled clinical trials. There’s a lot to be learned yet about this whole procedure,” Dr. Weber said.
Medtronic is planning a large trial of its new device following the recent publication of a successful proof-of-concept study that pitted the Spyral in 38 hypertensives against a sham procedure in 42. The Spyral group had a 5 mm Hg greater reduction in systolic ambulatory blood pressure at 3 months, among other findings. To avoid confounding, investigators took patients off their blood pressure medications during the study (Lancet. 2017 Aug 25. pii: S0140-6736(17)32281-X. doi: 10.1016/S0140-6736[17]32281-X).
Other companies are pushing forward with renal artery denervation, as well; Boston Scientific has its own four-quadrant ablation catheter – Vessix – in the pipeline.
In Medtronic’s denervation registry, office systolic blood pressure reductions were a bit larger at 2 years for the older Flex catheter than with the newer Spyral, 15.7 versus 12.0 mm Hg from a baseline of about 170 mm Hg in both groups. Spyral had a slight edge on 24-hour ambulatory systolic blood pressure at 2 years, with an average reduction of 10.4 versus 8.7 mm Hg from a mean baseline of about 155 mm Hg.
For both devices, “when you look at results patient-by-patient, they are dramatically all over the place, including a significant number of patients whose pressures actually increase. I have to assume that it’s patients” who stop taking their medications after the procedure. On the flip side, “I suspect some of our terrific results are because people finally get a touch of religion after the intervention and start taking their drugs for the first time,” Dr. Weber said.
So far, only a handful of Spyral patients have had ablations in renal artery branches. “It seems to have some benefit as judged by office pressure, but the numbers are small, so it’s premature to draw any conclusions,” he said.
Registry patients were in their early 60s, on average, at baseline, and there were more men than women. As with Spyral, Flex patients had no decrease in hypertension prescriptions over time and averaged more than four. “We have not seen many miracle cures in the sense of patients suddenly requiring no drugs at all,” Dr. Weber said.
The procedure seems safe, according to the registry. “There’s nothing to suggest the use of these catheters in the renal arteries causes any sort of acute or later-appearing major renal artery compromise.” With the Flex, less than 1% of patients required renal artery reintervention, which was possibly related to ablation trauma stenosis, “but it’s something to keep on our list of things to look for,” Dr. Weber said.
When asked if the registry fully captures adverse events, Dr. Weber said that “I suspect once [Spyral] goes to market, assuming it does go to market, there will be far more rigorous reporting requirements.”
He reported receiving travel funding, as well as consulting and lecture fees, from Medtronic and Boston Scientific, among other companies.
SAN FRANCISCO – Hypertensive patients averaged about a 10-mm Hg drop in 24-hour ambulatory systolic blood pressure and about a 12-mm Hg drop in office systolic blood pressure, 2 years after treatment with Medtronic’s new Symplicity Spyral renal artery denervation catheter, according to a review of the company’s renal artery denervation registry.
No major safety issues were reported, but there was no reduction from baseline in the number of antihypertensive drugs that patients were prescribed, which averaged more than four.
The company withdrew the Flex catheter from development after a large, randomized U.S. trial found no benefit over a sham procedure for resistant hypertension (N Engl J Med. 2014 Apr 10;370[15]:1393-401). “In the future, everything will be built around the Spyral catheter,” said Michael Weber, MD, a Medtronic investigator and a professor of medicine at State University of New York, Brooklyn. He presented the registry findings at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The Spyral, he said, has two key advantages over the Flex. The Flex had just a single electrode, so operators had to rotate the tip into four quadrants to fully denervate renal arteries, “a tricky business at the best of times and very often not successfully achieved.” Inadequate ablation might have contributed to the trial failure, Dr. Weber said.
The Spyral catheter, on the other hand, has four electrodes placed radially around a spiral catheter, so all four quadrants can be ablated at once, without undue gymnastics. The Spyral can also enter the smaller branches of the main renal arteries, which might allow for more complete denervation, he said.
“We all anticipate better results with the Spyral, but let’s be cautious. We need more data and obviously data from controlled clinical trials. There’s a lot to be learned yet about this whole procedure,” Dr. Weber said.
Medtronic is planning a large trial of its new device following the recent publication of a successful proof-of-concept study that pitted the Spyral in 38 hypertensives against a sham procedure in 42. The Spyral group had a 5 mm Hg greater reduction in systolic ambulatory blood pressure at 3 months, among other findings. To avoid confounding, investigators took patients off their blood pressure medications during the study (Lancet. 2017 Aug 25. pii: S0140-6736(17)32281-X. doi: 10.1016/S0140-6736[17]32281-X).
Other companies are pushing forward with renal artery denervation, as well; Boston Scientific has its own four-quadrant ablation catheter – Vessix – in the pipeline.
In Medtronic’s denervation registry, office systolic blood pressure reductions were a bit larger at 2 years for the older Flex catheter than with the newer Spyral, 15.7 versus 12.0 mm Hg from a baseline of about 170 mm Hg in both groups. Spyral had a slight edge on 24-hour ambulatory systolic blood pressure at 2 years, with an average reduction of 10.4 versus 8.7 mm Hg from a mean baseline of about 155 mm Hg.
For both devices, “when you look at results patient-by-patient, they are dramatically all over the place, including a significant number of patients whose pressures actually increase. I have to assume that it’s patients” who stop taking their medications after the procedure. On the flip side, “I suspect some of our terrific results are because people finally get a touch of religion after the intervention and start taking their drugs for the first time,” Dr. Weber said.
So far, only a handful of Spyral patients have had ablations in renal artery branches. “It seems to have some benefit as judged by office pressure, but the numbers are small, so it’s premature to draw any conclusions,” he said.
Registry patients were in their early 60s, on average, at baseline, and there were more men than women. As with Spyral, Flex patients had no decrease in hypertension prescriptions over time and averaged more than four. “We have not seen many miracle cures in the sense of patients suddenly requiring no drugs at all,” Dr. Weber said.
The procedure seems safe, according to the registry. “There’s nothing to suggest the use of these catheters in the renal arteries causes any sort of acute or later-appearing major renal artery compromise.” With the Flex, less than 1% of patients required renal artery reintervention, which was possibly related to ablation trauma stenosis, “but it’s something to keep on our list of things to look for,” Dr. Weber said.
When asked if the registry fully captures adverse events, Dr. Weber said that “I suspect once [Spyral] goes to market, assuming it does go to market, there will be far more rigorous reporting requirements.”
He reported receiving travel funding, as well as consulting and lecture fees, from Medtronic and Boston Scientific, among other companies.
AT JOINT HYPERTENSION 2017
Key clinical point:
Major finding: Two years after treatment with Medtronic’s new Symplicity Spyral renal artery denervation catheter, hypertensive patients averaged about a 10-mm Hg drop in 24-hour ambulatory systolic blood pressure and about a 12-mm Hg drop in office systolic blood pressure.
Data source: Review of Medtronic’s renal artery denervation registry
Disclosures: The presenter reported travel funding and consulting and lecture fees from Medtronic and Boston Scientific, among other companies.
Battling physician burnout delivers monetary benefits for health care organizations
The financial impact of physician burnout can provide a guide to help organizations address the problem, according to a special communication published online in JAMA Internal Medicine.
Approximately half of U.S. physicians experience some degree of professional burnout, but health care organizations have done little to respond, wrote Tait Shanafelt, MD, of Stanford (Calif.) University, and colleagues (JAMA Intern Med. 2017 Sep 25. doi: 10.1001/jamainternmed.2017.4340).
The researchers cited “a lack of awareness regarding the economic costs of physician burnout” and a lack of confidence that anything can be done as key factors in why the organizational response to burnout has been so limited.
The business end of physician burnout includes the costs associated with physician turnover and decreased productivity, as well as “financial risks to the organization’s long-term viability due to the relationship between burnout and lower quality of care, decreased patient satisfaction, and problems with patient safety,” the researchers said.
Organizations can combat physician burnout, the authors noted, and the effort is financially worthwhile, as well as morally and ethically important. “Burnout is primarily a system-level problem driven by excess job demands and inadequate resources and support, not an individual problem triggered by personal limitations,” they wrote.
The researchers developed a model outlining “Typical Steps in an Organization’s Journey Toward Expertise in Physician Well-being.” The steps begin with strategies that have a minor impact, including awareness of the problem of physician burnout and a focus on individual interventions such as mindfulness training, exercise, and nutrition.
However, the “transformative” changes in an organization include developing a “culture of wellness,” strategic investment in physician well-being, the presence of a “chief well-being officer” at the executive level, and accountability for physician wellness shared among organizational leaders.
The cost of such strategies varies among institutions, and the researchers provided worksheets to calculate the organizational cost of burnout and the return on investment if intervention steps are taken.
For example, an organization employing 450 physicians could potentially spend $1 million per year on an intervention to reduce physician burnout from 50% to 40%. The intervention investment could yield organizational cost savings of $1.125 million per year, with a 12.5% return on investment, as well as the potential financial benefits of improved patient satisfaction and quality of care.
“Understanding the business case to reduce burnout and promote engagement, as well as overcoming the misperception that nothing meaningful can be done, are key steps for organizations to begin to take action,” the researchers concluded.
“Improvement is possible, investment is justified, and return on investment measurable,” they said.
Dr. Shanafelt is a coinventor of the Physician Well-Being Index, Medical Student Well-Being Index, and Well-Being Index; copyright and licensing rights for these tools belong to the Mayo Clinic, and Dr. Shanafelt receives part of the royalties. The researchers had no other financial conflicts to disclose.
The financial impact of physician burnout can provide a guide to help organizations address the problem, according to a special communication published online in JAMA Internal Medicine.
Approximately half of U.S. physicians experience some degree of professional burnout, but health care organizations have done little to respond, wrote Tait Shanafelt, MD, of Stanford (Calif.) University, and colleagues (JAMA Intern Med. 2017 Sep 25. doi: 10.1001/jamainternmed.2017.4340).
The researchers cited “a lack of awareness regarding the economic costs of physician burnout” and a lack of confidence that anything can be done as key factors in why the organizational response to burnout has been so limited.
The business end of physician burnout includes the costs associated with physician turnover and decreased productivity, as well as “financial risks to the organization’s long-term viability due to the relationship between burnout and lower quality of care, decreased patient satisfaction, and problems with patient safety,” the researchers said.
Organizations can combat physician burnout, the authors noted, and the effort is financially worthwhile, as well as morally and ethically important. “Burnout is primarily a system-level problem driven by excess job demands and inadequate resources and support, not an individual problem triggered by personal limitations,” they wrote.
The researchers developed a model outlining “Typical Steps in an Organization’s Journey Toward Expertise in Physician Well-being.” The steps begin with strategies that have a minor impact, including awareness of the problem of physician burnout and a focus on individual interventions such as mindfulness training, exercise, and nutrition.
However, the “transformative” changes in an organization include developing a “culture of wellness,” strategic investment in physician well-being, the presence of a “chief well-being officer” at the executive level, and accountability for physician wellness shared among organizational leaders.
The cost of such strategies varies among institutions, and the researchers provided worksheets to calculate the organizational cost of burnout and the return on investment if intervention steps are taken.
For example, an organization employing 450 physicians could potentially spend $1 million per year on an intervention to reduce physician burnout from 50% to 40%. The intervention investment could yield organizational cost savings of $1.125 million per year, with a 12.5% return on investment, as well as the potential financial benefits of improved patient satisfaction and quality of care.
“Understanding the business case to reduce burnout and promote engagement, as well as overcoming the misperception that nothing meaningful can be done, are key steps for organizations to begin to take action,” the researchers concluded.
“Improvement is possible, investment is justified, and return on investment measurable,” they said.
Dr. Shanafelt is a coinventor of the Physician Well-Being Index, Medical Student Well-Being Index, and Well-Being Index; copyright and licensing rights for these tools belong to the Mayo Clinic, and Dr. Shanafelt receives part of the royalties. The researchers had no other financial conflicts to disclose.
The financial impact of physician burnout can provide a guide to help organizations address the problem, according to a special communication published online in JAMA Internal Medicine.
Approximately half of U.S. physicians experience some degree of professional burnout, but health care organizations have done little to respond, wrote Tait Shanafelt, MD, of Stanford (Calif.) University, and colleagues (JAMA Intern Med. 2017 Sep 25. doi: 10.1001/jamainternmed.2017.4340).
The researchers cited “a lack of awareness regarding the economic costs of physician burnout” and a lack of confidence that anything can be done as key factors in why the organizational response to burnout has been so limited.
The business end of physician burnout includes the costs associated with physician turnover and decreased productivity, as well as “financial risks to the organization’s long-term viability due to the relationship between burnout and lower quality of care, decreased patient satisfaction, and problems with patient safety,” the researchers said.
Organizations can combat physician burnout, the authors noted, and the effort is financially worthwhile, as well as morally and ethically important. “Burnout is primarily a system-level problem driven by excess job demands and inadequate resources and support, not an individual problem triggered by personal limitations,” they wrote.
The researchers developed a model outlining “Typical Steps in an Organization’s Journey Toward Expertise in Physician Well-being.” The steps begin with strategies that have a minor impact, including awareness of the problem of physician burnout and a focus on individual interventions such as mindfulness training, exercise, and nutrition.
However, the “transformative” changes in an organization include developing a “culture of wellness,” strategic investment in physician well-being, the presence of a “chief well-being officer” at the executive level, and accountability for physician wellness shared among organizational leaders.
The cost of such strategies varies among institutions, and the researchers provided worksheets to calculate the organizational cost of burnout and the return on investment if intervention steps are taken.
For example, an organization employing 450 physicians could potentially spend $1 million per year on an intervention to reduce physician burnout from 50% to 40%. The intervention investment could yield organizational cost savings of $1.125 million per year, with a 12.5% return on investment, as well as the potential financial benefits of improved patient satisfaction and quality of care.
“Understanding the business case to reduce burnout and promote engagement, as well as overcoming the misperception that nothing meaningful can be done, are key steps for organizations to begin to take action,” the researchers concluded.
“Improvement is possible, investment is justified, and return on investment measurable,” they said.
Dr. Shanafelt is a coinventor of the Physician Well-Being Index, Medical Student Well-Being Index, and Well-Being Index; copyright and licensing rights for these tools belong to the Mayo Clinic, and Dr. Shanafelt receives part of the royalties. The researchers had no other financial conflicts to disclose.
FROM JAMA INTERNAL MEDICINE
Can arterial switch operation impact cognitive deficits?
With dramatic advances of neonatal repair of complex cardiac disease, the population of adults with congenital heart disease (CHD) has increased dramatically, and while studies have shown an increased risk of neurodevelopmental and psychological disorders in these patients, few studies have evaluated their cognitive and psychosocial outcomes. Now, a review of young adults who had an arterial switch operation for transposition of the great arteries in France has found that they have almost twice the rate of cognitive difficulties and more than triple the rate of cognitive impairment as healthy peers.
“Despite satisfactory outcomes in most adults with transposition of the great arteries (TGA), a substantial proportion has cognitive or psychologic difficulties that may reduce their academic success and quality of life,” said lead author David Kalfa, MD, PhD, of Morgan Stanley Children’s Hospital of New York-Presbyterian, Columbia University Medical Center and coauthors in the September issue of the Journal of Thoracic and Cardiovascular Surgery (2017;154:1028-35).
The study involved a review of 67 adults aged 18 and older born with TGA between 1984 and 1985 who had an arterial switch operation (ASO) at two hospitals in France: Necker Children’s Hospital in Paris and Marie Lannelongue Hospital in Le Plessis-Robinson. The researchers performed a matched analysis with 43 healthy subjects for age, gender, and education level.
The researchers found that 69% of the TGA patients had an intelligence quotient in the normal range of 85-115. The TGA patients had lower quotients for mean full-scale (94.9 plus or minus 15.3 vs. 103.4 plus or minus 12.3 in healthy subjects; P = 0.003), verbal (96.8 plus or minus 16.2 vs. 102.5 plus or minus 11.5; P =.033) and performance intelligence (93.7 plus or minus 14.6 vs. 103.8 plus or minus 14.3; P less than .001).
The TGA patients also had higher rates of cognitive difficulties, measured as intelligence quotient less than or equal to –1 standard deviation, and cognitive impairment, measured as intelligence quotient less than or equal to –2 standard deviation; 31% vs. 16% (P = .001) for the former and 6% vs. 2% (P = .030) for the latter.
TGA patients with cognitive difficulties had lower educational levels and were also more likely to repeat grades in school, Dr. Kalfa and coauthors noted. “Patients reported an overall satisfactory health-related quality of life,” Dr. Kalfa and coauthors said of the TGA group; “however, those with cognitive or psychologic difficulties reported poorer quality of life.” The researchers identified three predictors of worse outcomes: lower parental socioeconomic and educational status; older age at surgery; and longer hospital stays.
“Our findings suggest that the cognitive morbidities commonly reported in children and adolescents with complex CHD persist into adulthood in individuals with TGA after the ASO,” Dr. Kalfa and coauthors said. Future research should evaluate specific cognitive domains such as attention, memory, and executive functions. “This consideration is important for evaluation of the whole [adult] CHD population because specific cognitive impairments are increasingly documented into adolescence but remain rarely investigated in adulthood,” the researchers said.
Dr. Kalfa and coauthors reported having no financial disclosures.
The findings by Dr. Kalfa and coauthors may point the way to improve cognitive outcomes in children who have the arterial switch operation, said Ryan R. Davies, MD, of A.I duPont Hospital for Children in Wilmington, Del., in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:1036-7.) “Modifiable factors may exist both during the perioperative stage (perfusion strategies, intensive care management) and over the longer term (early neurocognitive assessments and interventions,” Dr. Davies said.
That parental socioeconomic status is associated with cognitive performance suggests early intervention and education “may pay long-term dividends,” Dr. Davies said. Future studies should focus on the impact of specific interventions and identify modifiable developmental factors, he said.
Dr. Kalfa and coauthors have provided an “important start” in that direction, Dr. Davies said. “They have shown that the neurodevelopmental deficits seen early in children with CHD persist into adulthood,” he said. “There are also hints here as to where interventions may be effective in ameliorating those deficits.”
Dr. Davies reported having no financial disclosures.
The findings by Dr. Kalfa and coauthors may point the way to improve cognitive outcomes in children who have the arterial switch operation, said Ryan R. Davies, MD, of A.I duPont Hospital for Children in Wilmington, Del., in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:1036-7.) “Modifiable factors may exist both during the perioperative stage (perfusion strategies, intensive care management) and over the longer term (early neurocognitive assessments and interventions,” Dr. Davies said.
That parental socioeconomic status is associated with cognitive performance suggests early intervention and education “may pay long-term dividends,” Dr. Davies said. Future studies should focus on the impact of specific interventions and identify modifiable developmental factors, he said.
Dr. Kalfa and coauthors have provided an “important start” in that direction, Dr. Davies said. “They have shown that the neurodevelopmental deficits seen early in children with CHD persist into adulthood,” he said. “There are also hints here as to where interventions may be effective in ameliorating those deficits.”
Dr. Davies reported having no financial disclosures.
The findings by Dr. Kalfa and coauthors may point the way to improve cognitive outcomes in children who have the arterial switch operation, said Ryan R. Davies, MD, of A.I duPont Hospital for Children in Wilmington, Del., in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:1036-7.) “Modifiable factors may exist both during the perioperative stage (perfusion strategies, intensive care management) and over the longer term (early neurocognitive assessments and interventions,” Dr. Davies said.
That parental socioeconomic status is associated with cognitive performance suggests early intervention and education “may pay long-term dividends,” Dr. Davies said. Future studies should focus on the impact of specific interventions and identify modifiable developmental factors, he said.
Dr. Kalfa and coauthors have provided an “important start” in that direction, Dr. Davies said. “They have shown that the neurodevelopmental deficits seen early in children with CHD persist into adulthood,” he said. “There are also hints here as to where interventions may be effective in ameliorating those deficits.”
Dr. Davies reported having no financial disclosures.
With dramatic advances of neonatal repair of complex cardiac disease, the population of adults with congenital heart disease (CHD) has increased dramatically, and while studies have shown an increased risk of neurodevelopmental and psychological disorders in these patients, few studies have evaluated their cognitive and psychosocial outcomes. Now, a review of young adults who had an arterial switch operation for transposition of the great arteries in France has found that they have almost twice the rate of cognitive difficulties and more than triple the rate of cognitive impairment as healthy peers.
“Despite satisfactory outcomes in most adults with transposition of the great arteries (TGA), a substantial proportion has cognitive or psychologic difficulties that may reduce their academic success and quality of life,” said lead author David Kalfa, MD, PhD, of Morgan Stanley Children’s Hospital of New York-Presbyterian, Columbia University Medical Center and coauthors in the September issue of the Journal of Thoracic and Cardiovascular Surgery (2017;154:1028-35).
The study involved a review of 67 adults aged 18 and older born with TGA between 1984 and 1985 who had an arterial switch operation (ASO) at two hospitals in France: Necker Children’s Hospital in Paris and Marie Lannelongue Hospital in Le Plessis-Robinson. The researchers performed a matched analysis with 43 healthy subjects for age, gender, and education level.
The researchers found that 69% of the TGA patients had an intelligence quotient in the normal range of 85-115. The TGA patients had lower quotients for mean full-scale (94.9 plus or minus 15.3 vs. 103.4 plus or minus 12.3 in healthy subjects; P = 0.003), verbal (96.8 plus or minus 16.2 vs. 102.5 plus or minus 11.5; P =.033) and performance intelligence (93.7 plus or minus 14.6 vs. 103.8 plus or minus 14.3; P less than .001).
The TGA patients also had higher rates of cognitive difficulties, measured as intelligence quotient less than or equal to –1 standard deviation, and cognitive impairment, measured as intelligence quotient less than or equal to –2 standard deviation; 31% vs. 16% (P = .001) for the former and 6% vs. 2% (P = .030) for the latter.
TGA patients with cognitive difficulties had lower educational levels and were also more likely to repeat grades in school, Dr. Kalfa and coauthors noted. “Patients reported an overall satisfactory health-related quality of life,” Dr. Kalfa and coauthors said of the TGA group; “however, those with cognitive or psychologic difficulties reported poorer quality of life.” The researchers identified three predictors of worse outcomes: lower parental socioeconomic and educational status; older age at surgery; and longer hospital stays.
“Our findings suggest that the cognitive morbidities commonly reported in children and adolescents with complex CHD persist into adulthood in individuals with TGA after the ASO,” Dr. Kalfa and coauthors said. Future research should evaluate specific cognitive domains such as attention, memory, and executive functions. “This consideration is important for evaluation of the whole [adult] CHD population because specific cognitive impairments are increasingly documented into adolescence but remain rarely investigated in adulthood,” the researchers said.
Dr. Kalfa and coauthors reported having no financial disclosures.
With dramatic advances of neonatal repair of complex cardiac disease, the population of adults with congenital heart disease (CHD) has increased dramatically, and while studies have shown an increased risk of neurodevelopmental and psychological disorders in these patients, few studies have evaluated their cognitive and psychosocial outcomes. Now, a review of young adults who had an arterial switch operation for transposition of the great arteries in France has found that they have almost twice the rate of cognitive difficulties and more than triple the rate of cognitive impairment as healthy peers.
“Despite satisfactory outcomes in most adults with transposition of the great arteries (TGA), a substantial proportion has cognitive or psychologic difficulties that may reduce their academic success and quality of life,” said lead author David Kalfa, MD, PhD, of Morgan Stanley Children’s Hospital of New York-Presbyterian, Columbia University Medical Center and coauthors in the September issue of the Journal of Thoracic and Cardiovascular Surgery (2017;154:1028-35).
The study involved a review of 67 adults aged 18 and older born with TGA between 1984 and 1985 who had an arterial switch operation (ASO) at two hospitals in France: Necker Children’s Hospital in Paris and Marie Lannelongue Hospital in Le Plessis-Robinson. The researchers performed a matched analysis with 43 healthy subjects for age, gender, and education level.
The researchers found that 69% of the TGA patients had an intelligence quotient in the normal range of 85-115. The TGA patients had lower quotients for mean full-scale (94.9 plus or minus 15.3 vs. 103.4 plus or minus 12.3 in healthy subjects; P = 0.003), verbal (96.8 plus or minus 16.2 vs. 102.5 plus or minus 11.5; P =.033) and performance intelligence (93.7 plus or minus 14.6 vs. 103.8 plus or minus 14.3; P less than .001).
The TGA patients also had higher rates of cognitive difficulties, measured as intelligence quotient less than or equal to –1 standard deviation, and cognitive impairment, measured as intelligence quotient less than or equal to –2 standard deviation; 31% vs. 16% (P = .001) for the former and 6% vs. 2% (P = .030) for the latter.
TGA patients with cognitive difficulties had lower educational levels and were also more likely to repeat grades in school, Dr. Kalfa and coauthors noted. “Patients reported an overall satisfactory health-related quality of life,” Dr. Kalfa and coauthors said of the TGA group; “however, those with cognitive or psychologic difficulties reported poorer quality of life.” The researchers identified three predictors of worse outcomes: lower parental socioeconomic and educational status; older age at surgery; and longer hospital stays.
“Our findings suggest that the cognitive morbidities commonly reported in children and adolescents with complex CHD persist into adulthood in individuals with TGA after the ASO,” Dr. Kalfa and coauthors said. Future research should evaluate specific cognitive domains such as attention, memory, and executive functions. “This consideration is important for evaluation of the whole [adult] CHD population because specific cognitive impairments are increasingly documented into adolescence but remain rarely investigated in adulthood,” the researchers said.
Dr. Kalfa and coauthors reported having no financial disclosures.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: A substantial proportion of young adults who had transposition of the great arteries have cognitive or psychological difficulties.
Major finding: Cognitive difficulties were significantly more frequent in the study population than the general population, 31% vs. 16%.
Data source: Age-, gender-, and education level–matched population of 67 young adults with transposition of the great arteries and 43 healthy subjects.
Disclosures: Dr. Kalfa and coauthors reported having no financial disclosures.
Motesanib flops again in lung cancer
Motesanib has flunked another phase III trial in advanced nonsquamous non–small-cell lung cancer, this time in East Asian patients.
Compared with placebo, the investigational oral vascular endothelial growth factor (VEGF) inhibitor did not significantly improve progression-free survival (PFS) or the secondary endpoint, overall survival (OS), when added to paclitaxel and carboplatin (P/C), reported Kaoru Kubota, MD, of Nippon Medical School, Tokyo, and his associates. “The findings are consistent with overall findings of the phase III MONET1 study but do not replicate those of the subgroup analysis of Asian patients,” they wrote in Journal of Clinical Oncology.
Motesanib is a small-molecular inhibitor of VEGF receptors 1, 2, and 3. In a phase II trial of patients with advanced nonsquamous non–small-cell lung cancer, motesanib resembled the anti-VEGF-A monoclonal antibody bevacizumab in terms of objective response rate, median PFS, and OS when added to paclitaxel and carboplatin. In the subsequent phase III MONET1 trial, however, motesanib plus P/C did not improve PFS over placebo plus P/C, except in a preplanned subgroup analysis of 227 East Asian patients, where it was associated with a 6.4-month greater median PFS (P = .02) and a 1.7-month greater OS (P = .001).
Based on those findings, Dr. Kubota and his associates randomly assigned 401 patients with advanced nonsquamous non–small-cell lung cancer to receive oral motesanib (125 mg) or placebo once daily plus paclitaxel (200 mg/m2 IV) and carboplatin (area under the concentration-time curve, 6 mg/mL per min IV) for up to six 3-week cycles. Patients were from Hong Kong, Korea, Japan, and Taiwan; averaged 65 years of age; and 72% were male (J Clin Oncol. 2017 Sep 13. doi: 10.1200/JCO.2017.72.7297).
After a median follow-up of 10 months, median PFS was 6.1 months in the motesanib plus P/C arm and 5.6 months in the placebo plus P/C arm (hazard ratio, 0.81; P = .08). Respective objective response rates were 60% and 42% (P less than .001), median times to tumor response were 1.4 and 1.6 months, and median durations of response were 5.3 and 4.1 months. Motesanib was associated with a higher rate of serious adverse events (87% versus 68%) and a higher rate of treatment discontinuation due to adverse events (33% versus 14%). Motesanib most often caused gastrointestinal disorders, hypertension, cholecystitis, gallbladder enlargement, and liver disorders.
Takeda Pharmaceuticals makes motesanib and sponsored the trial. Dr. Kubota disclosed honoraria and research funding from numerous pharmaceutical companies excluding Takeda. Four coinvestigators disclosed research funding from Takeda and two coinvestigators reported employment with the company. The remaining five researchers had no conflicts.
Motesanib has flunked another phase III trial in advanced nonsquamous non–small-cell lung cancer, this time in East Asian patients.
Compared with placebo, the investigational oral vascular endothelial growth factor (VEGF) inhibitor did not significantly improve progression-free survival (PFS) or the secondary endpoint, overall survival (OS), when added to paclitaxel and carboplatin (P/C), reported Kaoru Kubota, MD, of Nippon Medical School, Tokyo, and his associates. “The findings are consistent with overall findings of the phase III MONET1 study but do not replicate those of the subgroup analysis of Asian patients,” they wrote in Journal of Clinical Oncology.
Motesanib is a small-molecular inhibitor of VEGF receptors 1, 2, and 3. In a phase II trial of patients with advanced nonsquamous non–small-cell lung cancer, motesanib resembled the anti-VEGF-A monoclonal antibody bevacizumab in terms of objective response rate, median PFS, and OS when added to paclitaxel and carboplatin. In the subsequent phase III MONET1 trial, however, motesanib plus P/C did not improve PFS over placebo plus P/C, except in a preplanned subgroup analysis of 227 East Asian patients, where it was associated with a 6.4-month greater median PFS (P = .02) and a 1.7-month greater OS (P = .001).
Based on those findings, Dr. Kubota and his associates randomly assigned 401 patients with advanced nonsquamous non–small-cell lung cancer to receive oral motesanib (125 mg) or placebo once daily plus paclitaxel (200 mg/m2 IV) and carboplatin (area under the concentration-time curve, 6 mg/mL per min IV) for up to six 3-week cycles. Patients were from Hong Kong, Korea, Japan, and Taiwan; averaged 65 years of age; and 72% were male (J Clin Oncol. 2017 Sep 13. doi: 10.1200/JCO.2017.72.7297).
After a median follow-up of 10 months, median PFS was 6.1 months in the motesanib plus P/C arm and 5.6 months in the placebo plus P/C arm (hazard ratio, 0.81; P = .08). Respective objective response rates were 60% and 42% (P less than .001), median times to tumor response were 1.4 and 1.6 months, and median durations of response were 5.3 and 4.1 months. Motesanib was associated with a higher rate of serious adverse events (87% versus 68%) and a higher rate of treatment discontinuation due to adverse events (33% versus 14%). Motesanib most often caused gastrointestinal disorders, hypertension, cholecystitis, gallbladder enlargement, and liver disorders.
Takeda Pharmaceuticals makes motesanib and sponsored the trial. Dr. Kubota disclosed honoraria and research funding from numerous pharmaceutical companies excluding Takeda. Four coinvestigators disclosed research funding from Takeda and two coinvestigators reported employment with the company. The remaining five researchers had no conflicts.
Motesanib has flunked another phase III trial in advanced nonsquamous non–small-cell lung cancer, this time in East Asian patients.
Compared with placebo, the investigational oral vascular endothelial growth factor (VEGF) inhibitor did not significantly improve progression-free survival (PFS) or the secondary endpoint, overall survival (OS), when added to paclitaxel and carboplatin (P/C), reported Kaoru Kubota, MD, of Nippon Medical School, Tokyo, and his associates. “The findings are consistent with overall findings of the phase III MONET1 study but do not replicate those of the subgroup analysis of Asian patients,” they wrote in Journal of Clinical Oncology.
Motesanib is a small-molecular inhibitor of VEGF receptors 1, 2, and 3. In a phase II trial of patients with advanced nonsquamous non–small-cell lung cancer, motesanib resembled the anti-VEGF-A monoclonal antibody bevacizumab in terms of objective response rate, median PFS, and OS when added to paclitaxel and carboplatin. In the subsequent phase III MONET1 trial, however, motesanib plus P/C did not improve PFS over placebo plus P/C, except in a preplanned subgroup analysis of 227 East Asian patients, where it was associated with a 6.4-month greater median PFS (P = .02) and a 1.7-month greater OS (P = .001).
Based on those findings, Dr. Kubota and his associates randomly assigned 401 patients with advanced nonsquamous non–small-cell lung cancer to receive oral motesanib (125 mg) or placebo once daily plus paclitaxel (200 mg/m2 IV) and carboplatin (area under the concentration-time curve, 6 mg/mL per min IV) for up to six 3-week cycles. Patients were from Hong Kong, Korea, Japan, and Taiwan; averaged 65 years of age; and 72% were male (J Clin Oncol. 2017 Sep 13. doi: 10.1200/JCO.2017.72.7297).
After a median follow-up of 10 months, median PFS was 6.1 months in the motesanib plus P/C arm and 5.6 months in the placebo plus P/C arm (hazard ratio, 0.81; P = .08). Respective objective response rates were 60% and 42% (P less than .001), median times to tumor response were 1.4 and 1.6 months, and median durations of response were 5.3 and 4.1 months. Motesanib was associated with a higher rate of serious adverse events (87% versus 68%) and a higher rate of treatment discontinuation due to adverse events (33% versus 14%). Motesanib most often caused gastrointestinal disorders, hypertension, cholecystitis, gallbladder enlargement, and liver disorders.
Takeda Pharmaceuticals makes motesanib and sponsored the trial. Dr. Kubota disclosed honoraria and research funding from numerous pharmaceutical companies excluding Takeda. Four coinvestigators disclosed research funding from Takeda and two coinvestigators reported employment with the company. The remaining five researchers had no conflicts.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Belying a previous subgroup analysis, motesanib, an investigational oral vascular endothelial growth factor inhibitor, did not significantly improve progression-free survival when added to paclitaxel/carboplatin in East Asian patients with advanced nonsquamous non–small-cell lung cancer.
Major finding: After a median follow-up of 10 months, median PFS was 6.1 months among motesanib recipients and 5.6 months in the placebo group (hazard ratio, 0.81; P = .08).
Data source: A double-blind, phase III trial of 401 patients.
Disclosures: Takeda Pharmaceuticals makes motesanib and sponsored the trial. Dr. Kubota disclosed honoraria and research funding from numerous pharmaceutical companies excluding Takeda. Four coinvestigators disclosed research funding from Takeda and two coinvestigators reported employment with the company. The remaining five researchers had no conflicts.
Electronic Medical Record: Friend or Foe?
The Resident Viewpoint:
As a recent cardiothoracic surgery residency graduate, and having trained at multiple hospitals (those with electronic medical records and those with paper medical records), I believe I have a unique perspective on electronic medical records (EMRs). With our tech-savvy culture, it is no surprise that the medical record followed suit, evolving from a paper to electronic system. It is important to note that mandates were initiated years prior, which tie electronic medical record use to Medicare and Medicaid reimbursement. Much like the old adage, “bigger is not always better,” I have found myself questioning: “Is electronic better?” This topic has been much of a debate at my training institution as well, and it deserves more attention. As such, below are outlined what I believe to be the top three positives and negatives of the EMR. Maybe this will help settle the debate: Is the EMR our friend or foe?
Votes for “Friend”:
Portability 
Centralized data
Having easily accessible, legible data is vital in caring for our patient population. You never have to guess what a providers are trying to write in their notes in the EMR (no hand-written notes). Most EMRs allow laboratory data, imaging, and notes to be viewed using one platform. Capabilities such as trends of vitals and laboratory values are useful to providers as well. As noted above, providers no longer have to physically gather laboratory slips or imaging films. Having centralized data for each patient saves on a provider’s time.
Standardization of orders
This has to be one of the greatest attributes of the EMR, especially when considering a teaching institution where trainees are constantly learning. Whether a provider orders Tylenol, a thoracic angiogram, echocardiogram, or a diet for a patient, the order is standardized. With medication orders, the usual dose is provided, along with other important information (renal dosing suggestions, etc.). Pharmacists and nursing staff do not have to worry about the legibility when reading and performing medication orders, for example.
Votes for “Foe”:
Cumbersome
There is no question that there is a considerable amount of time that adds up when logging into the EMR, entering orders, and writing notes. That time does not include any restarts or rebooting that can occur, not to mention the various “warnings” that pop up during each of the processes (e.g. creatinine level for all contrasted imaging studies or patient allergies). Depending on the type of note a provider writes (free text versus standardized format) a note can seem to require endless “clicks” to get to the end. Sometimes you find yourself wishing to just have a pen and paper.
Reliance on technology
When data gathering and documentation is centered on a computer, focus often shifts from the patient’s bedside to a desk. Although “computers on wheels” and computer stations positioned throughout the intensive care unit and ward have helped move providers closer to the bedside, a significant amount of time is still tied to the computer itself. Further, review of patient information on a computer is absolutely no substitute to bedside evaluation of a patient, especially in our line of work.
Lack of single EMR
I have lost track of the number of times I have been frustrated by this fact. At tertiary care centers, we often receive patients that had initial treatment or surgery at another institution. Full detail and information from those prior visits is usually not available. As a result, many tests (laboratory and imaging) have to be repeated. As stewards of health care cost, we do no justice by simply repeating each test. Unfortunately, given the “business” aspects of EMRs, a single EMR, which all providers can access, is not in our near future. This is unfortunate, as I strongly feel it would improve communication among providers across cities/states, and reduce health care costs (one example being the elimination of repeating tests).
As one can see, EMR offers a great deal but still has serious shortcomings. In my mind, the jury is still out. Hopefully as we refine the current models of EMR we will get closer to the ideal EMR: one that continues to be portable, can house centralized data, and allows for standardization of orders but at the same time offers efficient use, thereby decreasing the time tied to a computer, and is accessible to all providers.
Dr. Eilers is a general thoracic surgeon at the University of Texas Health Science Center at San Antonio, Division of Thoracic Surgery.
The Attending Viewpoint:
Some of us embraced the idea of the EMR while others resisted until failure to use one led to financial penalty. Even so, it is absolutely clear that EMRs are here to stay. As is true of all technology, there are pros and cons to their deployment.
Pro EMR
Notes can be read. We have all suffered the indignity of trying to read illegible handwriting to guess what a consultant has recommended, or as the consultant trying to understand the question you are being asked. Even more than handwriting issues, with the paper chart there was always the challenge of finding the chart or the note walking around in a resident’s pocket awaiting rounds with the attending. With the EMR, what is written is legible and it can be found/reviewed remotely before going in search of the patient. This has the potential to save time and offers the consultant the advantage of knowing about the patient prior to the visit. In the academic setting, the EMR affords the attending opportunity to review and amend a resident’s note for accuracy that sometimes leads to a “teachable moment.”
Communication among providers can be shared more efficiently. To the extent that the patient’s providers access the same record this is very useful. On completion of any procedure or note, the outcome can be promptly sent electronically or by fax to other providers with the need to know. This can really optimize health care in many ways.
Con EMR
The worst thing about the EMR is the separation of patient from provider at all levels! In the “old days” we were all at the patient’s bedside. Today I often find decisions made based on limited data in the record without benefit of seeing the patient. Failing to observe whether the patient is breathing comfortably, feel whether the feet are warm, or notice whether the pressure transducers are appropriately placed in relation to the patient takes away the real art of medicine. Worse, decisions are made and interventions selected that may be quite inappropriate. It seems that nurses spend more time in the hallway on their workstations clicking away to satisfy documentation demands than spending time assessing and knowing their patients. The patient becomes “Room 920” not “Mr. Smith.” I see this as a real tragedy of our reliance on electronic media.
Data can be reviewed remotely sometimes. This is indeed a two-edged sword in that it separates us from our patients too easily. The ultimate time saver of the computer too often becomes a time sink with the need to negotiate multiple securities to access the EMR at all. Also, we must often seek information in more than one source to review relevant data from the in- or outpatient environment, from a referring doctor in another system, or to review an actual image rather than just the report. It becomes an expensive endeavor when we need additional staff to track down data, images, and other records.
Overall, I am very happy to be practicing with the great technology we have today. I am excited to watch as all these technologies evolve to make better our health care delivery. In reality, the EMR is not our enemy. It is a friend with a bad temper.
Dr. Carpenter is an adult cardiac surgeon and program director, Thoracic Surgery Residency, at the University of Texas Health Science Center at San Antonio, Division of Thoracic Surgery.
The Resident Viewpoint:
As a recent cardiothoracic surgery residency graduate, and having trained at multiple hospitals (those with electronic medical records and those with paper medical records), I believe I have a unique perspective on electronic medical records (EMRs). With our tech-savvy culture, it is no surprise that the medical record followed suit, evolving from a paper to electronic system. It is important to note that mandates were initiated years prior, which tie electronic medical record use to Medicare and Medicaid reimbursement. Much like the old adage, “bigger is not always better,” I have found myself questioning: “Is electronic better?” This topic has been much of a debate at my training institution as well, and it deserves more attention. As such, below are outlined what I believe to be the top three positives and negatives of the EMR. Maybe this will help settle the debate: Is the EMR our friend or foe?
Votes for “Friend”:
Portability
Centralized data
Having easily accessible, legible data is vital in caring for our patient population. You never have to guess what a providers are trying to write in their notes in the EMR (no hand-written notes). Most EMRs allow laboratory data, imaging, and notes to be viewed using one platform. Capabilities such as trends of vitals and laboratory values are useful to providers as well. As noted above, providers no longer have to physically gather laboratory slips or imaging films. Having centralized data for each patient saves on a provider’s time.
Standardization of orders
This has to be one of the greatest attributes of the EMR, especially when considering a teaching institution where trainees are constantly learning. Whether a provider orders Tylenol, a thoracic angiogram, echocardiogram, or a diet for a patient, the order is standardized. With medication orders, the usual dose is provided, along with other important information (renal dosing suggestions, etc.). Pharmacists and nursing staff do not have to worry about the legibility when reading and performing medication orders, for example.
Votes for “Foe”:
Cumbersome
There is no question that there is a considerable amount of time that adds up when logging into the EMR, entering orders, and writing notes. That time does not include any restarts or rebooting that can occur, not to mention the various “warnings” that pop up during each of the processes (e.g. creatinine level for all contrasted imaging studies or patient allergies). Depending on the type of note a provider writes (free text versus standardized format) a note can seem to require endless “clicks” to get to the end. Sometimes you find yourself wishing to just have a pen and paper.
Reliance on technology
When data gathering and documentation is centered on a computer, focus often shifts from the patient’s bedside to a desk. Although “computers on wheels” and computer stations positioned throughout the intensive care unit and ward have helped move providers closer to the bedside, a significant amount of time is still tied to the computer itself. Further, review of patient information on a computer is absolutely no substitute to bedside evaluation of a patient, especially in our line of work.
Lack of single EMR
I have lost track of the number of times I have been frustrated by this fact. At tertiary care centers, we often receive patients that had initial treatment or surgery at another institution. Full detail and information from those prior visits is usually not available. As a result, many tests (laboratory and imaging) have to be repeated. As stewards of health care cost, we do no justice by simply repeating each test. Unfortunately, given the “business” aspects of EMRs, a single EMR, which all providers can access, is not in our near future. This is unfortunate, as I strongly feel it would improve communication among providers across cities/states, and reduce health care costs (one example being the elimination of repeating tests).
As one can see, EMR offers a great deal but still has serious shortcomings. In my mind, the jury is still out. Hopefully as we refine the current models of EMR we will get closer to the ideal EMR: one that continues to be portable, can house centralized data, and allows for standardization of orders but at the same time offers efficient use, thereby decreasing the time tied to a computer, and is accessible to all providers.
Dr. Eilers is a general thoracic surgeon at the University of Texas Health Science Center at San Antonio, Division of Thoracic Surgery.
The Attending Viewpoint:
Some of us embraced the idea of the EMR while others resisted until failure to use one led to financial penalty. Even so, it is absolutely clear that EMRs are here to stay. As is true of all technology, there are pros and cons to their deployment.
Pro EMR
Notes can be read. We have all suffered the indignity of trying to read illegible handwriting to guess what a consultant has recommended, or as the consultant trying to understand the question you are being asked. Even more than handwriting issues, with the paper chart there was always the challenge of finding the chart or the note walking around in a resident’s pocket awaiting rounds with the attending. With the EMR, what is written is legible and it can be found/reviewed remotely before going in search of the patient. This has the potential to save time and offers the consultant the advantage of knowing about the patient prior to the visit. In the academic setting, the EMR affords the attending opportunity to review and amend a resident’s note for accuracy that sometimes leads to a “teachable moment.”
Communication among providers can be shared more efficiently. To the extent that the patient’s providers access the same record this is very useful. On completion of any procedure or note, the outcome can be promptly sent electronically or by fax to other providers with the need to know. This can really optimize health care in many ways.
Con EMR
The worst thing about the EMR is the separation of patient from provider at all levels! In the “old days” we were all at the patient’s bedside. Today I often find decisions made based on limited data in the record without benefit of seeing the patient. Failing to observe whether the patient is breathing comfortably, feel whether the feet are warm, or notice whether the pressure transducers are appropriately placed in relation to the patient takes away the real art of medicine. Worse, decisions are made and interventions selected that may be quite inappropriate. It seems that nurses spend more time in the hallway on their workstations clicking away to satisfy documentation demands than spending time assessing and knowing their patients. The patient becomes “Room 920” not “Mr. Smith.” I see this as a real tragedy of our reliance on electronic media.
Data can be reviewed remotely sometimes. This is indeed a two-edged sword in that it separates us from our patients too easily. The ultimate time saver of the computer too often becomes a time sink with the need to negotiate multiple securities to access the EMR at all. Also, we must often seek information in more than one source to review relevant data from the in- or outpatient environment, from a referring doctor in another system, or to review an actual image rather than just the report. It becomes an expensive endeavor when we need additional staff to track down data, images, and other records.
Overall, I am very happy to be practicing with the great technology we have today. I am excited to watch as all these technologies evolve to make better our health care delivery. In reality, the EMR is not our enemy. It is a friend with a bad temper.
Dr. Carpenter is an adult cardiac surgeon and program director, Thoracic Surgery Residency, at the University of Texas Health Science Center at San Antonio, Division of Thoracic Surgery.
The Resident Viewpoint:
As a recent cardiothoracic surgery residency graduate, and having trained at multiple hospitals (those with electronic medical records and those with paper medical records), I believe I have a unique perspective on electronic medical records (EMRs). With our tech-savvy culture, it is no surprise that the medical record followed suit, evolving from a paper to electronic system. It is important to note that mandates were initiated years prior, which tie electronic medical record use to Medicare and Medicaid reimbursement. Much like the old adage, “bigger is not always better,” I have found myself questioning: “Is electronic better?” This topic has been much of a debate at my training institution as well, and it deserves more attention. As such, below are outlined what I believe to be the top three positives and negatives of the EMR. Maybe this will help settle the debate: Is the EMR our friend or foe?
Votes for “Friend”:
Portability
Centralized data
Having easily accessible, legible data is vital in caring for our patient population. You never have to guess what a providers are trying to write in their notes in the EMR (no hand-written notes). Most EMRs allow laboratory data, imaging, and notes to be viewed using one platform. Capabilities such as trends of vitals and laboratory values are useful to providers as well. As noted above, providers no longer have to physically gather laboratory slips or imaging films. Having centralized data for each patient saves on a provider’s time.
Standardization of orders
This has to be one of the greatest attributes of the EMR, especially when considering a teaching institution where trainees are constantly learning. Whether a provider orders Tylenol, a thoracic angiogram, echocardiogram, or a diet for a patient, the order is standardized. With medication orders, the usual dose is provided, along with other important information (renal dosing suggestions, etc.). Pharmacists and nursing staff do not have to worry about the legibility when reading and performing medication orders, for example.
Votes for “Foe”:
Cumbersome
There is no question that there is a considerable amount of time that adds up when logging into the EMR, entering orders, and writing notes. That time does not include any restarts or rebooting that can occur, not to mention the various “warnings” that pop up during each of the processes (e.g. creatinine level for all contrasted imaging studies or patient allergies). Depending on the type of note a provider writes (free text versus standardized format) a note can seem to require endless “clicks” to get to the end. Sometimes you find yourself wishing to just have a pen and paper.
Reliance on technology
When data gathering and documentation is centered on a computer, focus often shifts from the patient’s bedside to a desk. Although “computers on wheels” and computer stations positioned throughout the intensive care unit and ward have helped move providers closer to the bedside, a significant amount of time is still tied to the computer itself. Further, review of patient information on a computer is absolutely no substitute to bedside evaluation of a patient, especially in our line of work.
Lack of single EMR
I have lost track of the number of times I have been frustrated by this fact. At tertiary care centers, we often receive patients that had initial treatment or surgery at another institution. Full detail and information from those prior visits is usually not available. As a result, many tests (laboratory and imaging) have to be repeated. As stewards of health care cost, we do no justice by simply repeating each test. Unfortunately, given the “business” aspects of EMRs, a single EMR, which all providers can access, is not in our near future. This is unfortunate, as I strongly feel it would improve communication among providers across cities/states, and reduce health care costs (one example being the elimination of repeating tests).
As one can see, EMR offers a great deal but still has serious shortcomings. In my mind, the jury is still out. Hopefully as we refine the current models of EMR we will get closer to the ideal EMR: one that continues to be portable, can house centralized data, and allows for standardization of orders but at the same time offers efficient use, thereby decreasing the time tied to a computer, and is accessible to all providers.
Dr. Eilers is a general thoracic surgeon at the University of Texas Health Science Center at San Antonio, Division of Thoracic Surgery.
The Attending Viewpoint:
Some of us embraced the idea of the EMR while others resisted until failure to use one led to financial penalty. Even so, it is absolutely clear that EMRs are here to stay. As is true of all technology, there are pros and cons to their deployment.
Pro EMR
Notes can be read. We have all suffered the indignity of trying to read illegible handwriting to guess what a consultant has recommended, or as the consultant trying to understand the question you are being asked. Even more than handwriting issues, with the paper chart there was always the challenge of finding the chart or the note walking around in a resident’s pocket awaiting rounds with the attending. With the EMR, what is written is legible and it can be found/reviewed remotely before going in search of the patient. This has the potential to save time and offers the consultant the advantage of knowing about the patient prior to the visit. In the academic setting, the EMR affords the attending opportunity to review and amend a resident’s note for accuracy that sometimes leads to a “teachable moment.”
Communication among providers can be shared more efficiently. To the extent that the patient’s providers access the same record this is very useful. On completion of any procedure or note, the outcome can be promptly sent electronically or by fax to other providers with the need to know. This can really optimize health care in many ways.
Con EMR
The worst thing about the EMR is the separation of patient from provider at all levels! In the “old days” we were all at the patient’s bedside. Today I often find decisions made based on limited data in the record without benefit of seeing the patient. Failing to observe whether the patient is breathing comfortably, feel whether the feet are warm, or notice whether the pressure transducers are appropriately placed in relation to the patient takes away the real art of medicine. Worse, decisions are made and interventions selected that may be quite inappropriate. It seems that nurses spend more time in the hallway on their workstations clicking away to satisfy documentation demands than spending time assessing and knowing their patients. The patient becomes “Room 920” not “Mr. Smith.” I see this as a real tragedy of our reliance on electronic media.
Data can be reviewed remotely sometimes. This is indeed a two-edged sword in that it separates us from our patients too easily. The ultimate time saver of the computer too often becomes a time sink with the need to negotiate multiple securities to access the EMR at all. Also, we must often seek information in more than one source to review relevant data from the in- or outpatient environment, from a referring doctor in another system, or to review an actual image rather than just the report. It becomes an expensive endeavor when we need additional staff to track down data, images, and other records.
Overall, I am very happy to be practicing with the great technology we have today. I am excited to watch as all these technologies evolve to make better our health care delivery. In reality, the EMR is not our enemy. It is a friend with a bad temper.
Dr. Carpenter is an adult cardiac surgeon and program director, Thoracic Surgery Residency, at the University of Texas Health Science Center at San Antonio, Division of Thoracic Surgery.
Docs, insurers condemn latest ‘repeal and replace’ plan
Medical societies and insurers are voicing their opposition to legislation that would alter provisions of the Affordable Care Act and fundamentally change how Medicaid is funded.
The bill, introduced by Sen. Lindsey Graham (R-S.C.), Sen. Bill Cassidy (R-La.), Sen. Dean Heller (R-Nev.), and Sen. Ron Johnson (R-Wis.), features a number of provisions long sought by the GOP, including the repeal of the individual and employer mandates, repeal of individual tax credits as of 2020, and repeal of the medical device tax. The bill also would promote the use of health savings accounts and turn Medicaid funding into a block grant program, allowing states to implement policies such as work requirements.
James L. Madara, MD, CEO of the American Medical Association, told congressional leaders in a Sept. 19 letter that the bill would violate the precept of “first do no harm” and results in millions of Americans losing their health coverage. Additionally, it would destabilize health insurance markets and decrease access to affordable coverage.
“We are also concerned that the proposal would convert the Medicaid program into a system that limits federal support to care for needy patients to an insufficient predetermined formula based on per capita caps,” Dr. Madara continued. “Per capita caps fail to take into account unanticipated costs of new medical innovations or the fiscal impact of public health epidemics, such as the crisis of opioid abuse currently ravaging our nation. In addition, the amendment does not take steps toward coverage and access for all Americans, and while insurers are still required to offer coverage to patients with preexisting conditions, allowing states to get waivers to vary premiums based on health status would allow insurers to charge unaffordable premiums based on those preexisting conditions. Also, waivers of essential health benefits will mean patients may not have access to coverage for services pertinent to treating their conditions.”
The American Congress of Obstetricians and Gynecologists called the bill an “assault on women’s health.” The bill would end guaranteed insurance coverage of maternity care and women’s health preventive services, including cancer screenings and contraception, ACOG president Haywood Brown, MD, said in a statement.
Dr. Brown added that the bill “jeopardizes access to care for women with high-risk and expensive pregnancies, such as those with Zika virus, opioid use disorder, and preeclampsia. It further obstructs safety net patients’ access to care by forbidding Planned Parenthood’s participation in the Medicaid program.”
Doctors aren’t the only ones objecting to the GOP legislation. America’s Health Insurance Plans president and CEO Marilyn Tavenner said in a Sept. 20 letter to Congress that the bill would further destabilize the individual health insurance market.
The bill’s road to passage is far from certain. Once again, the GOP is aiming to use the budget reconciliation process to pass this legislation, which means it needs only a simple majority to pass (a minimum of 50 votes with Vice President Mike Pence offering the tiebreaker if the bill cannot get 51 votes). But even getting to 50 votes is going to be a challenge as the last attempt to pass similar repeal and replace language failed when Sen. Susan Collins (R-Maine), Sen. Lisa Murkowski (R-Alaska), and Sen. John McCain (R-Ariz.) voted that package down. Given the similar features, Sen. Collins and Sen. Murkowski may still oppose the bill, while Sen. Rand Paul (R-Ky.) has been vocal about his displeasure with the bill and other GOP senators are getting pressure from their state governors to oppose the bill.
The Senate Finance Committee has scheduled a Sept. 25 hearing to consider the bill, but as of press time, no witnesses have been announced, and the bill likely will not follow the regular order of allowing for amendments by committee members prior to its introduction on the Senate floor later that week.
Based on current budget rules, the bill must be passed by Sept. 30 in order for the budget reconciliation process to be used and to allow for passage with a simple majority. If the Senate is able to pass the bill, House Speaker Paul Ryan (R-Wisc.) has said he will bring it up in the House. President Trump has indicated he will sign it into law if it reaches his desk.
Medical societies and insurers are voicing their opposition to legislation that would alter provisions of the Affordable Care Act and fundamentally change how Medicaid is funded.
The bill, introduced by Sen. Lindsey Graham (R-S.C.), Sen. Bill Cassidy (R-La.), Sen. Dean Heller (R-Nev.), and Sen. Ron Johnson (R-Wis.), features a number of provisions long sought by the GOP, including the repeal of the individual and employer mandates, repeal of individual tax credits as of 2020, and repeal of the medical device tax. The bill also would promote the use of health savings accounts and turn Medicaid funding into a block grant program, allowing states to implement policies such as work requirements.
James L. Madara, MD, CEO of the American Medical Association, told congressional leaders in a Sept. 19 letter that the bill would violate the precept of “first do no harm” and results in millions of Americans losing their health coverage. Additionally, it would destabilize health insurance markets and decrease access to affordable coverage.
“We are also concerned that the proposal would convert the Medicaid program into a system that limits federal support to care for needy patients to an insufficient predetermined formula based on per capita caps,” Dr. Madara continued. “Per capita caps fail to take into account unanticipated costs of new medical innovations or the fiscal impact of public health epidemics, such as the crisis of opioid abuse currently ravaging our nation. In addition, the amendment does not take steps toward coverage and access for all Americans, and while insurers are still required to offer coverage to patients with preexisting conditions, allowing states to get waivers to vary premiums based on health status would allow insurers to charge unaffordable premiums based on those preexisting conditions. Also, waivers of essential health benefits will mean patients may not have access to coverage for services pertinent to treating their conditions.”
The American Congress of Obstetricians and Gynecologists called the bill an “assault on women’s health.” The bill would end guaranteed insurance coverage of maternity care and women’s health preventive services, including cancer screenings and contraception, ACOG president Haywood Brown, MD, said in a statement.
Dr. Brown added that the bill “jeopardizes access to care for women with high-risk and expensive pregnancies, such as those with Zika virus, opioid use disorder, and preeclampsia. It further obstructs safety net patients’ access to care by forbidding Planned Parenthood’s participation in the Medicaid program.”
Doctors aren’t the only ones objecting to the GOP legislation. America’s Health Insurance Plans president and CEO Marilyn Tavenner said in a Sept. 20 letter to Congress that the bill would further destabilize the individual health insurance market.
The bill’s road to passage is far from certain. Once again, the GOP is aiming to use the budget reconciliation process to pass this legislation, which means it needs only a simple majority to pass (a minimum of 50 votes with Vice President Mike Pence offering the tiebreaker if the bill cannot get 51 votes). But even getting to 50 votes is going to be a challenge as the last attempt to pass similar repeal and replace language failed when Sen. Susan Collins (R-Maine), Sen. Lisa Murkowski (R-Alaska), and Sen. John McCain (R-Ariz.) voted that package down. Given the similar features, Sen. Collins and Sen. Murkowski may still oppose the bill, while Sen. Rand Paul (R-Ky.) has been vocal about his displeasure with the bill and other GOP senators are getting pressure from their state governors to oppose the bill.
The Senate Finance Committee has scheduled a Sept. 25 hearing to consider the bill, but as of press time, no witnesses have been announced, and the bill likely will not follow the regular order of allowing for amendments by committee members prior to its introduction on the Senate floor later that week.
Based on current budget rules, the bill must be passed by Sept. 30 in order for the budget reconciliation process to be used and to allow for passage with a simple majority. If the Senate is able to pass the bill, House Speaker Paul Ryan (R-Wisc.) has said he will bring it up in the House. President Trump has indicated he will sign it into law if it reaches his desk.
Medical societies and insurers are voicing their opposition to legislation that would alter provisions of the Affordable Care Act and fundamentally change how Medicaid is funded.
The bill, introduced by Sen. Lindsey Graham (R-S.C.), Sen. Bill Cassidy (R-La.), Sen. Dean Heller (R-Nev.), and Sen. Ron Johnson (R-Wis.), features a number of provisions long sought by the GOP, including the repeal of the individual and employer mandates, repeal of individual tax credits as of 2020, and repeal of the medical device tax. The bill also would promote the use of health savings accounts and turn Medicaid funding into a block grant program, allowing states to implement policies such as work requirements.
James L. Madara, MD, CEO of the American Medical Association, told congressional leaders in a Sept. 19 letter that the bill would violate the precept of “first do no harm” and results in millions of Americans losing their health coverage. Additionally, it would destabilize health insurance markets and decrease access to affordable coverage.
“We are also concerned that the proposal would convert the Medicaid program into a system that limits federal support to care for needy patients to an insufficient predetermined formula based on per capita caps,” Dr. Madara continued. “Per capita caps fail to take into account unanticipated costs of new medical innovations or the fiscal impact of public health epidemics, such as the crisis of opioid abuse currently ravaging our nation. In addition, the amendment does not take steps toward coverage and access for all Americans, and while insurers are still required to offer coverage to patients with preexisting conditions, allowing states to get waivers to vary premiums based on health status would allow insurers to charge unaffordable premiums based on those preexisting conditions. Also, waivers of essential health benefits will mean patients may not have access to coverage for services pertinent to treating their conditions.”
The American Congress of Obstetricians and Gynecologists called the bill an “assault on women’s health.” The bill would end guaranteed insurance coverage of maternity care and women’s health preventive services, including cancer screenings and contraception, ACOG president Haywood Brown, MD, said in a statement.
Dr. Brown added that the bill “jeopardizes access to care for women with high-risk and expensive pregnancies, such as those with Zika virus, opioid use disorder, and preeclampsia. It further obstructs safety net patients’ access to care by forbidding Planned Parenthood’s participation in the Medicaid program.”
Doctors aren’t the only ones objecting to the GOP legislation. America’s Health Insurance Plans president and CEO Marilyn Tavenner said in a Sept. 20 letter to Congress that the bill would further destabilize the individual health insurance market.
The bill’s road to passage is far from certain. Once again, the GOP is aiming to use the budget reconciliation process to pass this legislation, which means it needs only a simple majority to pass (a minimum of 50 votes with Vice President Mike Pence offering the tiebreaker if the bill cannot get 51 votes). But even getting to 50 votes is going to be a challenge as the last attempt to pass similar repeal and replace language failed when Sen. Susan Collins (R-Maine), Sen. Lisa Murkowski (R-Alaska), and Sen. John McCain (R-Ariz.) voted that package down. Given the similar features, Sen. Collins and Sen. Murkowski may still oppose the bill, while Sen. Rand Paul (R-Ky.) has been vocal about his displeasure with the bill and other GOP senators are getting pressure from their state governors to oppose the bill.
The Senate Finance Committee has scheduled a Sept. 25 hearing to consider the bill, but as of press time, no witnesses have been announced, and the bill likely will not follow the regular order of allowing for amendments by committee members prior to its introduction on the Senate floor later that week.
Based on current budget rules, the bill must be passed by Sept. 30 in order for the budget reconciliation process to be used and to allow for passage with a simple majority. If the Senate is able to pass the bill, House Speaker Paul Ryan (R-Wisc.) has said he will bring it up in the House. President Trump has indicated he will sign it into law if it reaches his desk.