ACS Surgery News

CHICAGO – The extent of lymph node involvement provides independent prognostic information in patients with early-stage T1 or T2 small intestinal neuroendocrine tumors, according to a study involving nearly 3,000 lymph node–positive individuals.

This metric, best expressed as the lymph node ratio, or the number of positive nodes divided by the total number of lymph nodes examined, is not included in current European and American Joint Committee on Cancer staging classification guidelines. But it should be, Dr. Michelle K. Kim said at the annual Digestive Disease Week.

"The lymph node ratio is a readily available marker of disease progression. It’s available as part of usual clinical care; it’s not something extra you have to ask for. It may help identify patients who may require more-aggressive therapy," according to Dr. Kim of Mount Sinai School of Medicine, New York.

Current staging guidelines merely make a binary distinction: lymph node–positive or –negative. But previous studies in colon, gastric, and pancreatic cancers indicate the lymph node ratio (LNR) further differentiates outcomes in node-positive patients. The same now appears to be true for small intestinal neuroendocrine tumors (SI-NETs), which are the most common of the gastroenteropancreatic neuroendocrine tumors. Indeed, the incidence of SI-NETs has tripled during the last 3 decades, she noted.

Dr. Kim presented an analysis of the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) database, which included 2,984 patients with surgically resected lymph node–positive, metastasis-negative SI-NETs diagnosed in 1988-2010. Dr. Kim and coinvestigators classified patients into three LNR groups: 531 were LNR 1, defined as an LNR ratio of 0.2 or less; 1,525 patients were LNR 2, with a ratio of 0.21-0.5; and 928 were LNR 3, with a ratio greater than 0.5. Patients with T1 and T2 disease were overrepresented in the LNR 1 group.

The primary outcome in the study was disease-specific survival. The more-extensive the lymph node involvement in patients with T1 or T2 disease, the poorer their disease-specific survival. For example, LNR 1 patients with T1 or T2 SI-NETs were 1.6-fold more likely to experience disease-specific mortality during 10 years of follow-up than did a reference control group of node-negative T1/T2 patients, an elevation in risk that did not achieve statistical significance. However, the risk of disease-specific mortality was increased 2.29-fold in LNR 2 patients with T1/T2 disease and 4.52-fold in LNR 3 patients with T1/T2 SI-NETs, compared with node-negative controls, and those differences were significant.

In contrast, there was no difference in disease-specific survival according to LNR status in patients with more-advanced T3 or T4 disease.

This study was funded by Mount Sinai School of Medicine and the National Center for Advancing Translational Sciences. Dr. Kim reported having no financial conflicts.

[email protected]

CHICAGO – The extent of lymph node involvement provides independent prognostic information in patients with early-stage T1 or T2 small intestinal neuroendocrine tumors, according to a study involving nearly 3,000 lymph node–positive individuals.

This metric, best expressed as the lymph node ratio, or the number of positive nodes divided by the total number of lymph nodes examined, is not included in current European and American Joint Committee on Cancer staging classification guidelines. But it should be, Dr. Michelle K. Kim said at the annual Digestive Disease Week.

"The lymph node ratio is a readily available marker of disease progression. It’s available as part of usual clinical care; it’s not something extra you have to ask for. It may help identify patients who may require more-aggressive therapy," according to Dr. Kim of Mount Sinai School of Medicine, New York.

Current staging guidelines merely make a binary distinction: lymph node–positive or –negative. But previous studies in colon, gastric, and pancreatic cancers indicate the lymph node ratio (LNR) further differentiates outcomes in node-positive patients. The same now appears to be true for small intestinal neuroendocrine tumors (SI-NETs), which are the most common of the gastroenteropancreatic neuroendocrine tumors. Indeed, the incidence of SI-NETs has tripled during the last 3 decades, she noted.

Dr. Kim presented an analysis of the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) database, which included 2,984 patients with surgically resected lymph node–positive, metastasis-negative SI-NETs diagnosed in 1988-2010. Dr. Kim and coinvestigators classified patients into three LNR groups: 531 were LNR 1, defined as an LNR ratio of 0.2 or less; 1,525 patients were LNR 2, with a ratio of 0.21-0.5; and 928 were LNR 3, with a ratio greater than 0.5. Patients with T1 and T2 disease were overrepresented in the LNR 1 group.

The primary outcome in the study was disease-specific survival. The more-extensive the lymph node involvement in patients with T1 or T2 disease, the poorer their disease-specific survival. For example, LNR 1 patients with T1 or T2 SI-NETs were 1.6-fold more likely to experience disease-specific mortality during 10 years of follow-up than did a reference control group of node-negative T1/T2 patients, an elevation in risk that did not achieve statistical significance. However, the risk of disease-specific mortality was increased 2.29-fold in LNR 2 patients with T1/T2 disease and 4.52-fold in LNR 3 patients with T1/T2 SI-NETs, compared with node-negative controls, and those differences were significant.

In contrast, there was no difference in disease-specific survival according to LNR status in patients with more-advanced T3 or T4 disease.

This study was funded by Mount Sinai School of Medicine and the National Center for Advancing Translational Sciences. Dr. Kim reported having no financial conflicts.

[email protected]

CHICAGO – The extent of lymph node involvement provides independent prognostic information in patients with early-stage T1 or T2 small intestinal neuroendocrine tumors, according to a study involving nearly 3,000 lymph node–positive individuals.

This metric, best expressed as the lymph node ratio, or the number of positive nodes divided by the total number of lymph nodes examined, is not included in current European and American Joint Committee on Cancer staging classification guidelines. But it should be, Dr. Michelle K. Kim said at the annual Digestive Disease Week.

"The lymph node ratio is a readily available marker of disease progression. It’s available as part of usual clinical care; it’s not something extra you have to ask for. It may help identify patients who may require more-aggressive therapy," according to Dr. Kim of Mount Sinai School of Medicine, New York.

Current staging guidelines merely make a binary distinction: lymph node–positive or –negative. But previous studies in colon, gastric, and pancreatic cancers indicate the lymph node ratio (LNR) further differentiates outcomes in node-positive patients. The same now appears to be true for small intestinal neuroendocrine tumors (SI-NETs), which are the most common of the gastroenteropancreatic neuroendocrine tumors. Indeed, the incidence of SI-NETs has tripled during the last 3 decades, she noted.

Dr. Kim presented an analysis of the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) database, which included 2,984 patients with surgically resected lymph node–positive, metastasis-negative SI-NETs diagnosed in 1988-2010. Dr. Kim and coinvestigators classified patients into three LNR groups: 531 were LNR 1, defined as an LNR ratio of 0.2 or less; 1,525 patients were LNR 2, with a ratio of 0.21-0.5; and 928 were LNR 3, with a ratio greater than 0.5. Patients with T1 and T2 disease were overrepresented in the LNR 1 group.

The primary outcome in the study was disease-specific survival. The more-extensive the lymph node involvement in patients with T1 or T2 disease, the poorer their disease-specific survival. For example, LNR 1 patients with T1 or T2 SI-NETs were 1.6-fold more likely to experience disease-specific mortality during 10 years of follow-up than did a reference control group of node-negative T1/T2 patients, an elevation in risk that did not achieve statistical significance. However, the risk of disease-specific mortality was increased 2.29-fold in LNR 2 patients with T1/T2 disease and 4.52-fold in LNR 3 patients with T1/T2 SI-NETs, compared with node-negative controls, and those differences were significant.

In contrast, there was no difference in disease-specific survival according to LNR status in patients with more-advanced T3 or T4 disease.

This study was funded by Mount Sinai School of Medicine and the National Center for Advancing Translational Sciences. Dr. Kim reported having no financial conflicts.

[email protected]

Tedizolid, an oxazolidinone antibacterial drug, has been approved as an intravenous and oral treatment for acute bacterial skin and skin structure infections caused by gram positive bacteria, the Food and Drug Administration announced on June 20.

Tedizolid (Sivextro) is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by methicillin-resistant and methicillin-susceptible strains of Staphylococcus aureus, various streptococcus species, and Enterococcus faecalis.

At a meeting in March, the FDA’s Anti-infective Drugs Advisory Committee unanimously recommended that tedizolid be approved. The drug is the second new antibacterial drug to be approved by the FDA in the past month to treat ABSSSI. On May 23, the agency approved dalbavancin (Dalvance) to treat patients with ABSSSI caused by Staphylococcus aureus and various streptococcus species. Both drugs were designated as qualified infectious disease products, allowing them an additional 5 years of marketing exclusivity.

Tedizolid’s safety and efficacy were evaluated and shown to be as effective as linezolid in two clinical trials with 1,315 adults randomly assigned to receive tedizolid or linezolid.

One of the phase III studies, the ESTABLISH-2 study, an international, randomized study, compared 6 days of treatment with intravenous tedizolid to 10 days of treatment with IV linezolid in 666 patients with acute bacterial skin and skin structure infections, with the option of switching to oral treatment. The lesions were at least 75 cm² in size, and were known to be or were suspected to be associated with gram-positive bacteria. Half the patients had cellulitis, 20% had a major cutaneous abscess, and about 30% had an infected wound; about 27% had MRSA.

The primary endpoint, an early clinical response (at least a 20% reduction in the lesion area 48-72 hours after starting treatment), was achieved by 85% of those treated with tedizolid and by 83% of those treated with linezolid, a difference that met the non-inferiority margin. Clinical responses were also similar at 7-14 days. At late follow-up, 18-25 days after the end of treatment, outcomes of MRSA infections "matched the overall results," according to the study, which was published online in the Lancet Infectious Diseases.

Fewer patients on tedizolid (16%) developed gastrointestinal-related adverse events than those on linezolid (20%); otherwise, treatment- associated adverse events were similar in the two groups.

Tedizolid has not been evaluated in neutropenic patients, so alternative therapies should be considered, the FDA said in its statement announcing the approval.

Sivextro is marketed by Cubist Pharmaceuticals.

[email protected]

Tedizolid, an oxazolidinone antibacterial drug, has been approved as an intravenous and oral treatment for acute bacterial skin and skin structure infections caused by gram positive bacteria, the Food and Drug Administration announced on June 20.

Tedizolid (Sivextro) is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by methicillin-resistant and methicillin-susceptible strains of Staphylococcus aureus, various streptococcus species, and Enterococcus faecalis.

At a meeting in March, the FDA’s Anti-infective Drugs Advisory Committee unanimously recommended that tedizolid be approved. The drug is the second new antibacterial drug to be approved by the FDA in the past month to treat ABSSSI. On May 23, the agency approved dalbavancin (Dalvance) to treat patients with ABSSSI caused by Staphylococcus aureus and various streptococcus species. Both drugs were designated as qualified infectious disease products, allowing them an additional 5 years of marketing exclusivity.

Tedizolid’s safety and efficacy were evaluated and shown to be as effective as linezolid in two clinical trials with 1,315 adults randomly assigned to receive tedizolid or linezolid.

One of the phase III studies, the ESTABLISH-2 study, an international, randomized study, compared 6 days of treatment with intravenous tedizolid to 10 days of treatment with IV linezolid in 666 patients with acute bacterial skin and skin structure infections, with the option of switching to oral treatment. The lesions were at least 75 cm² in size, and were known to be or were suspected to be associated with gram-positive bacteria. Half the patients had cellulitis, 20% had a major cutaneous abscess, and about 30% had an infected wound; about 27% had MRSA.

The primary endpoint, an early clinical response (at least a 20% reduction in the lesion area 48-72 hours after starting treatment), was achieved by 85% of those treated with tedizolid and by 83% of those treated with linezolid, a difference that met the non-inferiority margin. Clinical responses were also similar at 7-14 days. At late follow-up, 18-25 days after the end of treatment, outcomes of MRSA infections "matched the overall results," according to the study, which was published online in the Lancet Infectious Diseases.

Fewer patients on tedizolid (16%) developed gastrointestinal-related adverse events than those on linezolid (20%); otherwise, treatment- associated adverse events were similar in the two groups.

Tedizolid has not been evaluated in neutropenic patients, so alternative therapies should be considered, the FDA said in its statement announcing the approval.

Sivextro is marketed by Cubist Pharmaceuticals.

[email protected]

Tedizolid, an oxazolidinone antibacterial drug, has been approved as an intravenous and oral treatment for acute bacterial skin and skin structure infections caused by gram positive bacteria, the Food and Drug Administration announced on June 20.

Tedizolid (Sivextro) is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by methicillin-resistant and methicillin-susceptible strains of Staphylococcus aureus, various streptococcus species, and Enterococcus faecalis.

At a meeting in March, the FDA’s Anti-infective Drugs Advisory Committee unanimously recommended that tedizolid be approved. The drug is the second new antibacterial drug to be approved by the FDA in the past month to treat ABSSSI. On May 23, the agency approved dalbavancin (Dalvance) to treat patients with ABSSSI caused by Staphylococcus aureus and various streptococcus species. Both drugs were designated as qualified infectious disease products, allowing them an additional 5 years of marketing exclusivity.

Tedizolid’s safety and efficacy were evaluated and shown to be as effective as linezolid in two clinical trials with 1,315 adults randomly assigned to receive tedizolid or linezolid.

One of the phase III studies, the ESTABLISH-2 study, an international, randomized study, compared 6 days of treatment with intravenous tedizolid to 10 days of treatment with IV linezolid in 666 patients with acute bacterial skin and skin structure infections, with the option of switching to oral treatment. The lesions were at least 75 cm² in size, and were known to be or were suspected to be associated with gram-positive bacteria. Half the patients had cellulitis, 20% had a major cutaneous abscess, and about 30% had an infected wound; about 27% had MRSA.

The primary endpoint, an early clinical response (at least a 20% reduction in the lesion area 48-72 hours after starting treatment), was achieved by 85% of those treated with tedizolid and by 83% of those treated with linezolid, a difference that met the non-inferiority margin. Clinical responses were also similar at 7-14 days. At late follow-up, 18-25 days after the end of treatment, outcomes of MRSA infections "matched the overall results," according to the study, which was published online in the Lancet Infectious Diseases.

Fewer patients on tedizolid (16%) developed gastrointestinal-related adverse events than those on linezolid (20%); otherwise, treatment- associated adverse events were similar in the two groups.

Tedizolid has not been evaluated in neutropenic patients, so alternative therapies should be considered, the FDA said in its statement announcing the approval.

Sivextro is marketed by Cubist Pharmaceuticals.

[email protected]

CHICAGO – Early palliative care delivered almost exclusively by telephone improved survival among patients with advanced cancer in the ENABLE III study.

After a median follow-up of a little more than 1 year, 46% of patients receiving palliative care from the time of cancer diagnosis and 54% of those with delayed palliative care had died.

Overall median survival was 18.3 months for the immediate group and 11.9 months for the delayed group (P = .17).

In preplanned analyses, the risk of death at 1 year was significantly lower in the immediate group (hazard ratio 0.72; P = .003), with a catch-up effect thereafter, Marie Bakitas, DNSc, reported at the annual meeting of the American Society of Clinical Oncology.

"Enhanced medical care, reduced aggressive care and chemotherapy use, longer access to hospice, and biologic impacts of improved quality of life have all been proposed as mechanisms to explain this survival advantage," Dr. Bakitas said. "However, at the present time, we do not have the data to support a particular mechanism and we are actively exploring this question through secondary analyses."

ENABLE (Educate, Nurture, Advise, Before Life Ends) III is the first study to examine the timing of early palliative care, but not the first to identify a survival advantage.

A recent study (N. Engl. J. Med. 2010:363:733-42) found that patients with metastatic non–small cell lung cancer (NSCLC) who received palliative care at the time of randomization lived a significant 2.7 months longer than did those receiving standard oncologic care, despite receiving significantly less aggressive end-of-life care (33% vs. 54%).

In ENABLE III, 207 patients with advanced cancer, and their caregivers, were randomized as a dyad to begin usual cancer care plus the intervention at the time of diagnosis (immediate group) or usual care alone for 3 months followed by the intervention (delayed group).

The intervention consisted of a traditional outpatient palliative care consult and six weekly structured telephone calls with a nurse coach using a guidebook that covers such topics as problem solving, symptom management, communication, and advanced care planning, explained Dr. Bakitas, the Marie O’Koren Endowed Chair and Professor, School of Nursing, and associate director of the Center for Palliative and Supportive Care, University of Alabama, Birmingham.

Usual care included the clinical consult, but not the telephone intervention.

The participants’ mean age was 64 years, half were male, 60% lived in a rural area, and 65% were married or living with a partner. Lung cancer was the most common diagnosis at 42%.

At baseline, 75% of patients were receiving chemotherapy, 19% were undergoing radiation, and 43% had an advanced directive completed at diagnosis.

Unlike the group’s prior trial comparing palliative care to usual care at 3 months, immediate versus delayed palliative care did not lead to significant improvements in quality of life on the Functional Assessment of Chronic Illness Therapy-Palliative care scale (129.9 vs. 127.2; P = .34), mood on the Center for Epidemiologic Studies Depression scale (11.2 vs. 10.8; P = .33), or symptom impact on the Quality of Life at the End of Life symptom impact subscale (11.4 vs. 12.2; P = .09).

One plausible reason for the findings is that there may not have been enough care differences between the two groups, with 40% of the delayed group receiving their first palliative care contact an average of 30 days before they were scheduled to do so on day 84, Dr. Bakitas said.

Second, difficulties in accrual and decreased study power may have made it difficult to pick up between-group differences on the subjective instruments, resulting in a type 2 error.

"A 3-month delay is still very early," Dr. Bakitas said.

She noted that early intervention allowed the palliative care team to have contact with patients for 1 year on average (range 240-493 days), compared with a median of 41-90 days from referral to death reported for outpatient clinics in a national survey of 142 National Cancer Institute and non-NCI cancer centers (JAMA 2010;303:1054-61).

Resource and chemotherapy use in ENABLE III was also comparable in both groups. Decedents in the immediate and delayed groups spent a median of 5 and 6 days, respectively, in hospital in the 7-9 months preceding death, while 8% and 5% received chemotherapy in the last 2 weeks of life.

This compares favorably with a national average of more than 8 hospital days in the last 6 months of life observed in the 2014 Dartmouth Atlas of Health Care, and a chemotherapy rate of 17.5% reported in the previously noted NSCLC study, Dr. Bakitas said.

She called for more studies of early palliative care to determine the optimal timing, personnel, essential elements, and mechanisms of improved survival.

"While the benefits of these approaches have been demonstrated when provided early after a cancer diagnosis, in practice these potentially beneficial palliative care services are often provided very late, sometimes hours or weeks before death," Dr. Bakitas said. "This trend is likely to continue in the absence of clear direction on the very pragmatic questions of who, what, and when."

The study was funded by National Institute for Nursing Research. Dr. Bakitas reported having no relevant disclosures.

Palliative care support buoys caregivers of advanced cancer patients

Providing early palliative care support to caregivers of advanced cancer patients improves their quality of life, depression, and stress burden, the ENABLE III study found.

"Similar to patients, waiting to provide these caregiver services until patients are in their last weeks to days of life may not adequately address the distress that they experience," Nick Dionne-Odom, Ph.D., RN, said at the meeting.

Caregivers for the 13 million cancer patients in the United States living with advanced disease can spend up to 8 hours per day providing assistance in activities that include symptom management, emotional and spiritual support, meal preparation, arranging medical appointments, and transportation.

The combination of this burden and witnessing someone close to you struggle with illness can cause psychological distress equal to or sometimes greater than that experienced by the patient, said Dr. Dionne-Odom, a postdoctoral fellow at the University of Alabama at Birmingham.

In ENABLE III, 122 caregivers were randomized at the time of the patient’s cancer diagnosis or 12 weeks later to a palliative care intervention that consisted of three weekly structured educational telephone calls from an advanced practice nurse coach, monthly check-in calls to address new or ongoing issues, and a bereavement call for caregivers whose loved ones died.

Caregivers were not restricted to family members, but could include close friends and even neighbors. Their mean age was 60 years, 79% were female, 75% were spouses, and all had at least a high school education.

At 12 weeks from the start of the intervention, caregivers in the immediate versus delayed group had significantly better quality of life on the Caregiver Quality of Life Index–Cancer scale (mean 50.2 vs. 56.1; P = .02) and less depressive symptoms on the Center for Epidemiologic Studies Depression (CESD) scale (10.2 vs. 16.6; P = .0006), Dr. Dionne-Odom said. Notably, the delayed group surpassed the clinical cutoff for depression of 16 on the CESD scale, he added.

The intervention did not appear to change the perception among caregivers of what was demanded of them by the patient or their objective burden, though there was a trend among the immediate group for improved caregiver stress burden on the Montgomery Borgatta Caregiver Burden Scale (13.2 vs. 13.8; P = .10).

There was no significant difference between groups in depression or grief scores for caregivers of decedents. A difference may have been detected with a larger sample size, he said, adding that prior studies have shown that reducing caregiver stress before patients’ death is associated with better bereavement adjustment.

As for why caregivers appear to benefit more than the patients from the parallel palliative care interventions, Dr. Bakitas said in an interview it may be the timing of the assessments, adding that other studies have shown an impact of palliative care at 4 months, but not at 3 months.

[email protected]

CHICAGO – Early palliative care delivered almost exclusively by telephone improved survival among patients with advanced cancer in the ENABLE III study.

After a median follow-up of a little more than 1 year, 46% of patients receiving palliative care from the time of cancer diagnosis and 54% of those with delayed palliative care had died.

Overall median survival was 18.3 months for the immediate group and 11.9 months for the delayed group (P = .17).

In preplanned analyses, the risk of death at 1 year was significantly lower in the immediate group (hazard ratio 0.72; P = .003), with a catch-up effect thereafter, Marie Bakitas, DNSc, reported at the annual meeting of the American Society of Clinical Oncology.

"Enhanced medical care, reduced aggressive care and chemotherapy use, longer access to hospice, and biologic impacts of improved quality of life have all been proposed as mechanisms to explain this survival advantage," Dr. Bakitas said. "However, at the present time, we do not have the data to support a particular mechanism and we are actively exploring this question through secondary analyses."

ENABLE (Educate, Nurture, Advise, Before Life Ends) III is the first study to examine the timing of early palliative care, but not the first to identify a survival advantage.

A recent study (N. Engl. J. Med. 2010:363:733-42) found that patients with metastatic non–small cell lung cancer (NSCLC) who received palliative care at the time of randomization lived a significant 2.7 months longer than did those receiving standard oncologic care, despite receiving significantly less aggressive end-of-life care (33% vs. 54%).

In ENABLE III, 207 patients with advanced cancer, and their caregivers, were randomized as a dyad to begin usual cancer care plus the intervention at the time of diagnosis (immediate group) or usual care alone for 3 months followed by the intervention (delayed group).

The intervention consisted of a traditional outpatient palliative care consult and six weekly structured telephone calls with a nurse coach using a guidebook that covers such topics as problem solving, symptom management, communication, and advanced care planning, explained Dr. Bakitas, the Marie O’Koren Endowed Chair and Professor, School of Nursing, and associate director of the Center for Palliative and Supportive Care, University of Alabama, Birmingham.

Usual care included the clinical consult, but not the telephone intervention.

The participants’ mean age was 64 years, half were male, 60% lived in a rural area, and 65% were married or living with a partner. Lung cancer was the most common diagnosis at 42%.

At baseline, 75% of patients were receiving chemotherapy, 19% were undergoing radiation, and 43% had an advanced directive completed at diagnosis.

Unlike the group’s prior trial comparing palliative care to usual care at 3 months, immediate versus delayed palliative care did not lead to significant improvements in quality of life on the Functional Assessment of Chronic Illness Therapy-Palliative care scale (129.9 vs. 127.2; P = .34), mood on the Center for Epidemiologic Studies Depression scale (11.2 vs. 10.8; P = .33), or symptom impact on the Quality of Life at the End of Life symptom impact subscale (11.4 vs. 12.2; P = .09).

One plausible reason for the findings is that there may not have been enough care differences between the two groups, with 40% of the delayed group receiving their first palliative care contact an average of 30 days before they were scheduled to do so on day 84, Dr. Bakitas said.

Second, difficulties in accrual and decreased study power may have made it difficult to pick up between-group differences on the subjective instruments, resulting in a type 2 error.

"A 3-month delay is still very early," Dr. Bakitas said.

She noted that early intervention allowed the palliative care team to have contact with patients for 1 year on average (range 240-493 days), compared with a median of 41-90 days from referral to death reported for outpatient clinics in a national survey of 142 National Cancer Institute and non-NCI cancer centers (JAMA 2010;303:1054-61).

Resource and chemotherapy use in ENABLE III was also comparable in both groups. Decedents in the immediate and delayed groups spent a median of 5 and 6 days, respectively, in hospital in the 7-9 months preceding death, while 8% and 5% received chemotherapy in the last 2 weeks of life.

This compares favorably with a national average of more than 8 hospital days in the last 6 months of life observed in the 2014 Dartmouth Atlas of Health Care, and a chemotherapy rate of 17.5% reported in the previously noted NSCLC study, Dr. Bakitas said.

She called for more studies of early palliative care to determine the optimal timing, personnel, essential elements, and mechanisms of improved survival.

"While the benefits of these approaches have been demonstrated when provided early after a cancer diagnosis, in practice these potentially beneficial palliative care services are often provided very late, sometimes hours or weeks before death," Dr. Bakitas said. "This trend is likely to continue in the absence of clear direction on the very pragmatic questions of who, what, and when."

The study was funded by National Institute for Nursing Research. Dr. Bakitas reported having no relevant disclosures.

Palliative care support buoys caregivers of advanced cancer patients

Providing early palliative care support to caregivers of advanced cancer patients improves their quality of life, depression, and stress burden, the ENABLE III study found.

"Similar to patients, waiting to provide these caregiver services until patients are in their last weeks to days of life may not adequately address the distress that they experience," Nick Dionne-Odom, Ph.D., RN, said at the meeting.

Caregivers for the 13 million cancer patients in the United States living with advanced disease can spend up to 8 hours per day providing assistance in activities that include symptom management, emotional and spiritual support, meal preparation, arranging medical appointments, and transportation.

The combination of this burden and witnessing someone close to you struggle with illness can cause psychological distress equal to or sometimes greater than that experienced by the patient, said Dr. Dionne-Odom, a postdoctoral fellow at the University of Alabama at Birmingham.

In ENABLE III, 122 caregivers were randomized at the time of the patient’s cancer diagnosis or 12 weeks later to a palliative care intervention that consisted of three weekly structured educational telephone calls from an advanced practice nurse coach, monthly check-in calls to address new or ongoing issues, and a bereavement call for caregivers whose loved ones died.

Caregivers were not restricted to family members, but could include close friends and even neighbors. Their mean age was 60 years, 79% were female, 75% were spouses, and all had at least a high school education.

At 12 weeks from the start of the intervention, caregivers in the immediate versus delayed group had significantly better quality of life on the Caregiver Quality of Life Index–Cancer scale (mean 50.2 vs. 56.1; P = .02) and less depressive symptoms on the Center for Epidemiologic Studies Depression (CESD) scale (10.2 vs. 16.6; P = .0006), Dr. Dionne-Odom said. Notably, the delayed group surpassed the clinical cutoff for depression of 16 on the CESD scale, he added.

The intervention did not appear to change the perception among caregivers of what was demanded of them by the patient or their objective burden, though there was a trend among the immediate group for improved caregiver stress burden on the Montgomery Borgatta Caregiver Burden Scale (13.2 vs. 13.8; P = .10).

There was no significant difference between groups in depression or grief scores for caregivers of decedents. A difference may have been detected with a larger sample size, he said, adding that prior studies have shown that reducing caregiver stress before patients’ death is associated with better bereavement adjustment.

As for why caregivers appear to benefit more than the patients from the parallel palliative care interventions, Dr. Bakitas said in an interview it may be the timing of the assessments, adding that other studies have shown an impact of palliative care at 4 months, but not at 3 months.

[email protected]

CHICAGO – Early palliative care delivered almost exclusively by telephone improved survival among patients with advanced cancer in the ENABLE III study.

After a median follow-up of a little more than 1 year, 46% of patients receiving palliative care from the time of cancer diagnosis and 54% of those with delayed palliative care had died.

Overall median survival was 18.3 months for the immediate group and 11.9 months for the delayed group (P = .17).

In preplanned analyses, the risk of death at 1 year was significantly lower in the immediate group (hazard ratio 0.72; P = .003), with a catch-up effect thereafter, Marie Bakitas, DNSc, reported at the annual meeting of the American Society of Clinical Oncology.

"Enhanced medical care, reduced aggressive care and chemotherapy use, longer access to hospice, and biologic impacts of improved quality of life have all been proposed as mechanisms to explain this survival advantage," Dr. Bakitas said. "However, at the present time, we do not have the data to support a particular mechanism and we are actively exploring this question through secondary analyses."

ENABLE (Educate, Nurture, Advise, Before Life Ends) III is the first study to examine the timing of early palliative care, but not the first to identify a survival advantage.

A recent study (N. Engl. J. Med. 2010:363:733-42) found that patients with metastatic non–small cell lung cancer (NSCLC) who received palliative care at the time of randomization lived a significant 2.7 months longer than did those receiving standard oncologic care, despite receiving significantly less aggressive end-of-life care (33% vs. 54%).

In ENABLE III, 207 patients with advanced cancer, and their caregivers, were randomized as a dyad to begin usual cancer care plus the intervention at the time of diagnosis (immediate group) or usual care alone for 3 months followed by the intervention (delayed group).

The intervention consisted of a traditional outpatient palliative care consult and six weekly structured telephone calls with a nurse coach using a guidebook that covers such topics as problem solving, symptom management, communication, and advanced care planning, explained Dr. Bakitas, the Marie O’Koren Endowed Chair and Professor, School of Nursing, and associate director of the Center for Palliative and Supportive Care, University of Alabama, Birmingham.

Usual care included the clinical consult, but not the telephone intervention.

The participants’ mean age was 64 years, half were male, 60% lived in a rural area, and 65% were married or living with a partner. Lung cancer was the most common diagnosis at 42%.

At baseline, 75% of patients were receiving chemotherapy, 19% were undergoing radiation, and 43% had an advanced directive completed at diagnosis.

Unlike the group’s prior trial comparing palliative care to usual care at 3 months, immediate versus delayed palliative care did not lead to significant improvements in quality of life on the Functional Assessment of Chronic Illness Therapy-Palliative care scale (129.9 vs. 127.2; P = .34), mood on the Center for Epidemiologic Studies Depression scale (11.2 vs. 10.8; P = .33), or symptom impact on the Quality of Life at the End of Life symptom impact subscale (11.4 vs. 12.2; P = .09).

One plausible reason for the findings is that there may not have been enough care differences between the two groups, with 40% of the delayed group receiving their first palliative care contact an average of 30 days before they were scheduled to do so on day 84, Dr. Bakitas said.

Second, difficulties in accrual and decreased study power may have made it difficult to pick up between-group differences on the subjective instruments, resulting in a type 2 error.

"A 3-month delay is still very early," Dr. Bakitas said.

She noted that early intervention allowed the palliative care team to have contact with patients for 1 year on average (range 240-493 days), compared with a median of 41-90 days from referral to death reported for outpatient clinics in a national survey of 142 National Cancer Institute and non-NCI cancer centers (JAMA 2010;303:1054-61).

Resource and chemotherapy use in ENABLE III was also comparable in both groups. Decedents in the immediate and delayed groups spent a median of 5 and 6 days, respectively, in hospital in the 7-9 months preceding death, while 8% and 5% received chemotherapy in the last 2 weeks of life.

This compares favorably with a national average of more than 8 hospital days in the last 6 months of life observed in the 2014 Dartmouth Atlas of Health Care, and a chemotherapy rate of 17.5% reported in the previously noted NSCLC study, Dr. Bakitas said.

She called for more studies of early palliative care to determine the optimal timing, personnel, essential elements, and mechanisms of improved survival.

"While the benefits of these approaches have been demonstrated when provided early after a cancer diagnosis, in practice these potentially beneficial palliative care services are often provided very late, sometimes hours or weeks before death," Dr. Bakitas said. "This trend is likely to continue in the absence of clear direction on the very pragmatic questions of who, what, and when."

The study was funded by National Institute for Nursing Research. Dr. Bakitas reported having no relevant disclosures.

Palliative care support buoys caregivers of advanced cancer patients

Providing early palliative care support to caregivers of advanced cancer patients improves their quality of life, depression, and stress burden, the ENABLE III study found.

"Similar to patients, waiting to provide these caregiver services until patients are in their last weeks to days of life may not adequately address the distress that they experience," Nick Dionne-Odom, Ph.D., RN, said at the meeting.

Caregivers for the 13 million cancer patients in the United States living with advanced disease can spend up to 8 hours per day providing assistance in activities that include symptom management, emotional and spiritual support, meal preparation, arranging medical appointments, and transportation.

The combination of this burden and witnessing someone close to you struggle with illness can cause psychological distress equal to or sometimes greater than that experienced by the patient, said Dr. Dionne-Odom, a postdoctoral fellow at the University of Alabama at Birmingham.

In ENABLE III, 122 caregivers were randomized at the time of the patient’s cancer diagnosis or 12 weeks later to a palliative care intervention that consisted of three weekly structured educational telephone calls from an advanced practice nurse coach, monthly check-in calls to address new or ongoing issues, and a bereavement call for caregivers whose loved ones died.

Caregivers were not restricted to family members, but could include close friends and even neighbors. Their mean age was 60 years, 79% were female, 75% were spouses, and all had at least a high school education.

At 12 weeks from the start of the intervention, caregivers in the immediate versus delayed group had significantly better quality of life on the Caregiver Quality of Life Index–Cancer scale (mean 50.2 vs. 56.1; P = .02) and less depressive symptoms on the Center for Epidemiologic Studies Depression (CESD) scale (10.2 vs. 16.6; P = .0006), Dr. Dionne-Odom said. Notably, the delayed group surpassed the clinical cutoff for depression of 16 on the CESD scale, he added.

The intervention did not appear to change the perception among caregivers of what was demanded of them by the patient or their objective burden, though there was a trend among the immediate group for improved caregiver stress burden on the Montgomery Borgatta Caregiver Burden Scale (13.2 vs. 13.8; P = .10).

There was no significant difference between groups in depression or grief scores for caregivers of decedents. A difference may have been detected with a larger sample size, he said, adding that prior studies have shown that reducing caregiver stress before patients’ death is associated with better bereavement adjustment.

As for why caregivers appear to benefit more than the patients from the parallel palliative care interventions, Dr. Bakitas said in an interview it may be the timing of the assessments, adding that other studies have shown an impact of palliative care at 4 months, but not at 3 months.

[email protected]

TORONTO – Transcatheter mitral valve-in-valve/valve-in-ring implantation is an effective option in most patients with degenerative mitral valves after surgical intervention, according to Dr. Danny Dvir.

In the highest-risk patients (STS scores greater than 20%), however, mortality after this percutaneous technique approached 50% at 1 year, Dr. Dvir reported at the American Association for Thoracic Surgery annual meeting.

"Most of these procedures were clinically effective, with 1-year results that are comparable to native aortic valve transcatheter implantation," said Dr. Dvir of St. Paul’s Hospital, Vancouver, B.C.

"However, we saw safety and efficacy concerns that included relatively high in-hospital mortality, device malposition, sporadic cases with elevated LVOT [left ventricular outflow tract] gradient, and elevated postprocedural gradients in procedures performed inside small surgical valves."

Dr. Joseph E. Bavaria, professor of surgery and director of the thoracic aortic surgery program at the University of Pennsylvania Health System, Philadelphia, the scheduled discussant of the abstract, asked, referring to the STS score greater than 20% group: "Is this really a cohort C or futile situation, where [the intervention] is probably not better than medical management?"

Transcatheter VIV/VIR

The majority of prosthetic heart valves are tissue valves that tend to degenerate and eventually fail over time. Surgical replacement of these valves is associated with significant risks.

Transcatheter valve-in-valve/valve-in-ring (VIV/VIR) implantation within a failed bioprosthesis performed in the mitral position has been reported in only small case series, with the safety and efficacy of the technique being largely unknown. The Global Valve-in-Valve Registry, with 765 patients from 73 centers worldwide, was designed to track the efficacy and safety of this nonsurgical redo in either the aortic or mitral valve position. The registry included 190 patients from 23 centers who underwent percutaneous mitral valve procedures (VIV in 157 patients and VIR in 33).

The mechanism of failure was regurgitation in 37%, stenosis in 25%, and a combination of the two in 38%. Patients were a median of 9 years past their last cardiac surgery and were deemed at high risk, with a mean STS score of 14.4. The mean age was 73.6 years, and 65.2% were female. The median length of hospital stay was 8 days.

A SAPIEN or SAPIEN XT device was used in the majority of cases (93.7%), mostly deployed via transapical access (84.7%).

During the procedure, initial device malpositioning occurred in 5.3% of cases, with a second device implanted in 4.3%. Postimplantation valvuloplasty was utilized in 8%.

"We saw a high rate of malpositioning," Dr. Dvir said. "In some of the cases, this led to a decision to leave the malpositioned device in the left atrium and implant a second device."

The incidence of all-cause death at 30 days was 8.9%, with cardiovascular death seen in 6.8% and major stroke in 2.2%. Importantly, 85.8% of patients were in NYHA function class I or II at 30 days, Dr. Dvir said.

"We were very happy to see this," he commented. "If you survive the valve-in-valve or valve-in-ring procedure, you will most likely have a good functional class.

Overall, the Kaplan-Meier mortality rate was 22.3% at 1 year. When stratified according to STS score, however, mortality in the group of patients with an STS score greater than 20% was 45.6%, falling to 23.2% for an STS score of 10%-20% and 12.9% for an STS score less than 10%. Predictors of 1-year mortality included STS score and renal failure.

"In these patients with STS greater than 20%, there is really a big problem. We need to understand which patients should not undergo a procedure, and maybe should be treated with an alternative approach," Dr. Dvir said. He noted that 28% of cases in the registry were in this highest-risk category.

"An 8.9% mortality at 1 year is not so bad in a group with a mean STS score of 14.1," noted Dr. Bavaria. "[But] this is not really a benign procedure as the length of stay was over 8 days."

Surgical valve sizing gone wrong?

After the VIV/VIR procedure, the mean mitral valve area was 2.1 ± 0.7 cm², with a mean residual gradient of 6.2 mm Hg. Significant mitral regurgitation was noted in 4.2% of patients, and a left ventricular outflow tract mean gradient greater than 20 mm Hg was noted in only 2.1% of cases.

"We saw a trend for elevated gradients especially when we were treating small valves with a valve-in-valve approach," Dr. Dvir said.

Indeed, in the patients with smaller surgical valve label size, one-third had postprocedural mean gradients greater than 10 mm Hg. The rates of mean gradient greater than 10 mm Hg dropped to 7.4% and 5.3% with progressively larger surgical valve label sizes.

"I am very worried about the cardiac surgery and interventional cardiology decision-making process, as over 60% of valve-in-ring cases were 26-mm and 28-mm rings and over 56% of valve-in-valve cases were less than or equal to 27-mm prosthetic valves," said Dr. Bavaria. "There will obviously be significant mitral gradients in these cases, as this study showed. Is this simply a lack of knowledge in the operators, should these small valve-in-valve cases be done, or is this a limit of this technology?"

"I think this issue of residual gradients will haunt valve in valve for many years to come," said Dr. Dvir. "However, we know from the aortic arena, that even if you have a high residual gradient, the results at 1 year are not different than the other groups. So, it doesn’t affect 1-year outcomes, although I predict that it will affect the durability of the device and the long-term outcome."

TORONTO – Transcatheter mitral valve-in-valve/valve-in-ring implantation is an effective option in most patients with degenerative mitral valves after surgical intervention, according to Dr. Danny Dvir.

In the highest-risk patients (STS scores greater than 20%), however, mortality after this percutaneous technique approached 50% at 1 year, Dr. Dvir reported at the American Association for Thoracic Surgery annual meeting.

"Most of these procedures were clinically effective, with 1-year results that are comparable to native aortic valve transcatheter implantation," said Dr. Dvir of St. Paul’s Hospital, Vancouver, B.C.

"However, we saw safety and efficacy concerns that included relatively high in-hospital mortality, device malposition, sporadic cases with elevated LVOT [left ventricular outflow tract] gradient, and elevated postprocedural gradients in procedures performed inside small surgical valves."

Dr. Joseph E. Bavaria, professor of surgery and director of the thoracic aortic surgery program at the University of Pennsylvania Health System, Philadelphia, the scheduled discussant of the abstract, asked, referring to the STS score greater than 20% group: "Is this really a cohort C or futile situation, where [the intervention] is probably not better than medical management?"

Transcatheter VIV/VIR

The majority of prosthetic heart valves are tissue valves that tend to degenerate and eventually fail over time. Surgical replacement of these valves is associated with significant risks.

Transcatheter valve-in-valve/valve-in-ring (VIV/VIR) implantation within a failed bioprosthesis performed in the mitral position has been reported in only small case series, with the safety and efficacy of the technique being largely unknown. The Global Valve-in-Valve Registry, with 765 patients from 73 centers worldwide, was designed to track the efficacy and safety of this nonsurgical redo in either the aortic or mitral valve position. The registry included 190 patients from 23 centers who underwent percutaneous mitral valve procedures (VIV in 157 patients and VIR in 33).

The mechanism of failure was regurgitation in 37%, stenosis in 25%, and a combination of the two in 38%. Patients were a median of 9 years past their last cardiac surgery and were deemed at high risk, with a mean STS score of 14.4. The mean age was 73.6 years, and 65.2% were female. The median length of hospital stay was 8 days.

A SAPIEN or SAPIEN XT device was used in the majority of cases (93.7%), mostly deployed via transapical access (84.7%).

During the procedure, initial device malpositioning occurred in 5.3% of cases, with a second device implanted in 4.3%. Postimplantation valvuloplasty was utilized in 8%.

"We saw a high rate of malpositioning," Dr. Dvir said. "In some of the cases, this led to a decision to leave the malpositioned device in the left atrium and implant a second device."

The incidence of all-cause death at 30 days was 8.9%, with cardiovascular death seen in 6.8% and major stroke in 2.2%. Importantly, 85.8% of patients were in NYHA function class I or II at 30 days, Dr. Dvir said.

"We were very happy to see this," he commented. "If you survive the valve-in-valve or valve-in-ring procedure, you will most likely have a good functional class.

Overall, the Kaplan-Meier mortality rate was 22.3% at 1 year. When stratified according to STS score, however, mortality in the group of patients with an STS score greater than 20% was 45.6%, falling to 23.2% for an STS score of 10%-20% and 12.9% for an STS score less than 10%. Predictors of 1-year mortality included STS score and renal failure.

"In these patients with STS greater than 20%, there is really a big problem. We need to understand which patients should not undergo a procedure, and maybe should be treated with an alternative approach," Dr. Dvir said. He noted that 28% of cases in the registry were in this highest-risk category.

"An 8.9% mortality at 1 year is not so bad in a group with a mean STS score of 14.1," noted Dr. Bavaria. "[But] this is not really a benign procedure as the length of stay was over 8 days."

Surgical valve sizing gone wrong?

After the VIV/VIR procedure, the mean mitral valve area was 2.1 ± 0.7 cm², with a mean residual gradient of 6.2 mm Hg. Significant mitral regurgitation was noted in 4.2% of patients, and a left ventricular outflow tract mean gradient greater than 20 mm Hg was noted in only 2.1% of cases.

"We saw a trend for elevated gradients especially when we were treating small valves with a valve-in-valve approach," Dr. Dvir said.

Indeed, in the patients with smaller surgical valve label size, one-third had postprocedural mean gradients greater than 10 mm Hg. The rates of mean gradient greater than 10 mm Hg dropped to 7.4% and 5.3% with progressively larger surgical valve label sizes.

"I am very worried about the cardiac surgery and interventional cardiology decision-making process, as over 60% of valve-in-ring cases were 26-mm and 28-mm rings and over 56% of valve-in-valve cases were less than or equal to 27-mm prosthetic valves," said Dr. Bavaria. "There will obviously be significant mitral gradients in these cases, as this study showed. Is this simply a lack of knowledge in the operators, should these small valve-in-valve cases be done, or is this a limit of this technology?"

"I think this issue of residual gradients will haunt valve in valve for many years to come," said Dr. Dvir. "However, we know from the aortic arena, that even if you have a high residual gradient, the results at 1 year are not different than the other groups. So, it doesn’t affect 1-year outcomes, although I predict that it will affect the durability of the device and the long-term outcome."

TORONTO – Transcatheter mitral valve-in-valve/valve-in-ring implantation is an effective option in most patients with degenerative mitral valves after surgical intervention, according to Dr. Danny Dvir.

In the highest-risk patients (STS scores greater than 20%), however, mortality after this percutaneous technique approached 50% at 1 year, Dr. Dvir reported at the American Association for Thoracic Surgery annual meeting.

"Most of these procedures were clinically effective, with 1-year results that are comparable to native aortic valve transcatheter implantation," said Dr. Dvir of St. Paul’s Hospital, Vancouver, B.C.

"However, we saw safety and efficacy concerns that included relatively high in-hospital mortality, device malposition, sporadic cases with elevated LVOT [left ventricular outflow tract] gradient, and elevated postprocedural gradients in procedures performed inside small surgical valves."

Dr. Joseph E. Bavaria, professor of surgery and director of the thoracic aortic surgery program at the University of Pennsylvania Health System, Philadelphia, the scheduled discussant of the abstract, asked, referring to the STS score greater than 20% group: "Is this really a cohort C or futile situation, where [the intervention] is probably not better than medical management?"

Transcatheter VIV/VIR

The majority of prosthetic heart valves are tissue valves that tend to degenerate and eventually fail over time. Surgical replacement of these valves is associated with significant risks.

Transcatheter valve-in-valve/valve-in-ring (VIV/VIR) implantation within a failed bioprosthesis performed in the mitral position has been reported in only small case series, with the safety and efficacy of the technique being largely unknown. The Global Valve-in-Valve Registry, with 765 patients from 73 centers worldwide, was designed to track the efficacy and safety of this nonsurgical redo in either the aortic or mitral valve position. The registry included 190 patients from 23 centers who underwent percutaneous mitral valve procedures (VIV in 157 patients and VIR in 33).

The mechanism of failure was regurgitation in 37%, stenosis in 25%, and a combination of the two in 38%. Patients were a median of 9 years past their last cardiac surgery and were deemed at high risk, with a mean STS score of 14.4. The mean age was 73.6 years, and 65.2% were female. The median length of hospital stay was 8 days.

A SAPIEN or SAPIEN XT device was used in the majority of cases (93.7%), mostly deployed via transapical access (84.7%).

During the procedure, initial device malpositioning occurred in 5.3% of cases, with a second device implanted in 4.3%. Postimplantation valvuloplasty was utilized in 8%.

"We saw a high rate of malpositioning," Dr. Dvir said. "In some of the cases, this led to a decision to leave the malpositioned device in the left atrium and implant a second device."

The incidence of all-cause death at 30 days was 8.9%, with cardiovascular death seen in 6.8% and major stroke in 2.2%. Importantly, 85.8% of patients were in NYHA function class I or II at 30 days, Dr. Dvir said.

"We were very happy to see this," he commented. "If you survive the valve-in-valve or valve-in-ring procedure, you will most likely have a good functional class.

Overall, the Kaplan-Meier mortality rate was 22.3% at 1 year. When stratified according to STS score, however, mortality in the group of patients with an STS score greater than 20% was 45.6%, falling to 23.2% for an STS score of 10%-20% and 12.9% for an STS score less than 10%. Predictors of 1-year mortality included STS score and renal failure.

"In these patients with STS greater than 20%, there is really a big problem. We need to understand which patients should not undergo a procedure, and maybe should be treated with an alternative approach," Dr. Dvir said. He noted that 28% of cases in the registry were in this highest-risk category.

"An 8.9% mortality at 1 year is not so bad in a group with a mean STS score of 14.1," noted Dr. Bavaria. "[But] this is not really a benign procedure as the length of stay was over 8 days."

Surgical valve sizing gone wrong?

After the VIV/VIR procedure, the mean mitral valve area was 2.1 ± 0.7 cm², with a mean residual gradient of 6.2 mm Hg. Significant mitral regurgitation was noted in 4.2% of patients, and a left ventricular outflow tract mean gradient greater than 20 mm Hg was noted in only 2.1% of cases.

"We saw a trend for elevated gradients especially when we were treating small valves with a valve-in-valve approach," Dr. Dvir said.

Indeed, in the patients with smaller surgical valve label size, one-third had postprocedural mean gradients greater than 10 mm Hg. The rates of mean gradient greater than 10 mm Hg dropped to 7.4% and 5.3% with progressively larger surgical valve label sizes.

"I am very worried about the cardiac surgery and interventional cardiology decision-making process, as over 60% of valve-in-ring cases were 26-mm and 28-mm rings and over 56% of valve-in-valve cases were less than or equal to 27-mm prosthetic valves," said Dr. Bavaria. "There will obviously be significant mitral gradients in these cases, as this study showed. Is this simply a lack of knowledge in the operators, should these small valve-in-valve cases be done, or is this a limit of this technology?"

"I think this issue of residual gradients will haunt valve in valve for many years to come," said Dr. Dvir. "However, we know from the aortic arena, that even if you have a high residual gradient, the results at 1 year are not different than the other groups. So, it doesn’t affect 1-year outcomes, although I predict that it will affect the durability of the device and the long-term outcome."

As previously reported, obesity poses many challenges to gynecologic surgery, from open to minimally invasive to vaginal surgery (Int. J. Gynecol. Cancer 2012;22:76-81; Gynecol. Oncol. 2008;111:41-5; J. Minim. Invasive Gynecol. 2014;21:259-65). Concerns relevant to operative management in the obese include difficulty with patient positioning, access to the abdominal cavity, visualization, and ventilation. This article will review tips for overcoming these challenges.

Positioning of obese patients often requires specialized equipment including bariatric beds, large padded stirrups, bed extenders, and arm sleds. Extra time and care should be taken while positioning obese patients given the increased propensity for pressure ulcers and nerve injuries. The basics of positioning begin with requesting additional help for patient moving and positioning as needed.

With regard to minimally invasive surgery, the use of antislip devices such as egg crate, gel pad, or a surgical beanbag is important for prevention of slippage when the patient is placed in the Trendelenburg position (J. Minim. Invasive Gynecol. 2014;21:182-95). The best laparoscopic positioning for these patients is in low lithotomy, with both arms tucked at the side in the military position and with liberal corporeal padding (Am. J. Obstet. Gynecol. 2004;191:669-74). When placing the patient in lithotomy, care should be taken to avoid hyperflexion of the hip, as obese patients are particularly prone to femoral nerve stretch injuries in this position.

Access to the abdominal cavity can be difficult because of the thickness of the abdominal wall in these patients. In open surgery, this is overcome with deep blades on retractors. In minimally invasive surgery, this requires longer trocars and Veress needles, which are now routinely available. If there is difficulty accessing the abdominal cavity with a Veress needle, a Hassan entry technique or ports with see-through trocars also can be used to ensure safe entry into the abdomen.

It is important to remember that the abdominal wall is the thinnest at the umbilical stalk. Additionally, using the upper abdomen can help assist with entry as the abdominal wall is often thinner above the umbilicus than below. For this reason, a left upper quadrant entry is often utilized at Palmer’s point. Care should be taken that entry is not so high as to limit the operator’s ability to reach the deep pelvis with laparoscopic instruments. Further, anesthesia must decompress the stomach prior to port placement in order to avoid a gastric injury.

Obese patients have a higher concentration of intraperitoneal and visceral fat, which can cause decreased visualization in the pelvis. In addition, the thick abdominal wall creates more torque on laparoscopic instruments, which can impair a surgeon’s ability to easily maneuver instruments. To decrease torque, trocars should be placed in the direction of the operative field. Draping the omentum over the liver can help to increase visualization, and always consider additional trocar placement to assist in visualization (Am. J. Obstet. Gynecol. 2004;191:669-74). Robotic instruments may further assist with feasibility of laparoscopy in the obese by obviating the role of abdominal wall torque.

Finally, patients can be difficult to ventilate in steep Trendelenburg required for laparoscopic surgery, as the weight of the breasts and abdomen shifts onto the thorax (J. Anesth. 2012;26:758-65; Ann. Surg. 2005;241:219-26; Anesth. Analg. 2002;94:1345-50). By slowly tilting the patient into steep Trendelenburg, the body has a chance to acclimate to ventilation in this position. One needs to remember to insufflate the abdomen in the supine position prior to proceeding with Trendelenburg.

Of course, one should always consider that vaginal surgery provides a "minimally invasive" approach without the difficulty of ventilating an obese patient in steep Trendelenburg position. A recent review of the effect of obesity on vaginal surgery concludes that obesity increases the difficulty of vaginal surgery and may be best performed by high-volume surgeons, given the difficulties that are often encountered (J. Minim. Invasive Gynecol. 2014;21:168-75).

As the obesity epidemic continues, figuring out safe and effective ways to provide surgical care will continue to remain a challenge to surgeons. Utilizing these tips is a start, but continued innovation and experience will be required to provide optimal care to our ever-growing population.

Dr. Clark is a chief resident in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Gehrig is professor and director of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Clark and Dr. Gehrig said they had no relevant financial disclosures.

As previously reported, obesity poses many challenges to gynecologic surgery, from open to minimally invasive to vaginal surgery (Int. J. Gynecol. Cancer 2012;22:76-81; Gynecol. Oncol. 2008;111:41-5; J. Minim. Invasive Gynecol. 2014;21:259-65). Concerns relevant to operative management in the obese include difficulty with patient positioning, access to the abdominal cavity, visualization, and ventilation. This article will review tips for overcoming these challenges.

Positioning of obese patients often requires specialized equipment including bariatric beds, large padded stirrups, bed extenders, and arm sleds. Extra time and care should be taken while positioning obese patients given the increased propensity for pressure ulcers and nerve injuries. The basics of positioning begin with requesting additional help for patient moving and positioning as needed.

With regard to minimally invasive surgery, the use of antislip devices such as egg crate, gel pad, or a surgical beanbag is important for prevention of slippage when the patient is placed in the Trendelenburg position (J. Minim. Invasive Gynecol. 2014;21:182-95). The best laparoscopic positioning for these patients is in low lithotomy, with both arms tucked at the side in the military position and with liberal corporeal padding (Am. J. Obstet. Gynecol. 2004;191:669-74). When placing the patient in lithotomy, care should be taken to avoid hyperflexion of the hip, as obese patients are particularly prone to femoral nerve stretch injuries in this position.

Access to the abdominal cavity can be difficult because of the thickness of the abdominal wall in these patients. In open surgery, this is overcome with deep blades on retractors. In minimally invasive surgery, this requires longer trocars and Veress needles, which are now routinely available. If there is difficulty accessing the abdominal cavity with a Veress needle, a Hassan entry technique or ports with see-through trocars also can be used to ensure safe entry into the abdomen.

It is important to remember that the abdominal wall is the thinnest at the umbilical stalk. Additionally, using the upper abdomen can help assist with entry as the abdominal wall is often thinner above the umbilicus than below. For this reason, a left upper quadrant entry is often utilized at Palmer’s point. Care should be taken that entry is not so high as to limit the operator’s ability to reach the deep pelvis with laparoscopic instruments. Further, anesthesia must decompress the stomach prior to port placement in order to avoid a gastric injury.

Obese patients have a higher concentration of intraperitoneal and visceral fat, which can cause decreased visualization in the pelvis. In addition, the thick abdominal wall creates more torque on laparoscopic instruments, which can impair a surgeon’s ability to easily maneuver instruments. To decrease torque, trocars should be placed in the direction of the operative field. Draping the omentum over the liver can help to increase visualization, and always consider additional trocar placement to assist in visualization (Am. J. Obstet. Gynecol. 2004;191:669-74). Robotic instruments may further assist with feasibility of laparoscopy in the obese by obviating the role of abdominal wall torque.

Finally, patients can be difficult to ventilate in steep Trendelenburg required for laparoscopic surgery, as the weight of the breasts and abdomen shifts onto the thorax (J. Anesth. 2012;26:758-65; Ann. Surg. 2005;241:219-26; Anesth. Analg. 2002;94:1345-50). By slowly tilting the patient into steep Trendelenburg, the body has a chance to acclimate to ventilation in this position. One needs to remember to insufflate the abdomen in the supine position prior to proceeding with Trendelenburg.

Of course, one should always consider that vaginal surgery provides a "minimally invasive" approach without the difficulty of ventilating an obese patient in steep Trendelenburg position. A recent review of the effect of obesity on vaginal surgery concludes that obesity increases the difficulty of vaginal surgery and may be best performed by high-volume surgeons, given the difficulties that are often encountered (J. Minim. Invasive Gynecol. 2014;21:168-75).

As the obesity epidemic continues, figuring out safe and effective ways to provide surgical care will continue to remain a challenge to surgeons. Utilizing these tips is a start, but continued innovation and experience will be required to provide optimal care to our ever-growing population.

Dr. Clark is a chief resident in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Gehrig is professor and director of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Clark and Dr. Gehrig said they had no relevant financial disclosures.

As previously reported, obesity poses many challenges to gynecologic surgery, from open to minimally invasive to vaginal surgery (Int. J. Gynecol. Cancer 2012;22:76-81; Gynecol. Oncol. 2008;111:41-5; J. Minim. Invasive Gynecol. 2014;21:259-65). Concerns relevant to operative management in the obese include difficulty with patient positioning, access to the abdominal cavity, visualization, and ventilation. This article will review tips for overcoming these challenges.

Positioning of obese patients often requires specialized equipment including bariatric beds, large padded stirrups, bed extenders, and arm sleds. Extra time and care should be taken while positioning obese patients given the increased propensity for pressure ulcers and nerve injuries. The basics of positioning begin with requesting additional help for patient moving and positioning as needed.

With regard to minimally invasive surgery, the use of antislip devices such as egg crate, gel pad, or a surgical beanbag is important for prevention of slippage when the patient is placed in the Trendelenburg position (J. Minim. Invasive Gynecol. 2014;21:182-95). The best laparoscopic positioning for these patients is in low lithotomy, with both arms tucked at the side in the military position and with liberal corporeal padding (Am. J. Obstet. Gynecol. 2004;191:669-74). When placing the patient in lithotomy, care should be taken to avoid hyperflexion of the hip, as obese patients are particularly prone to femoral nerve stretch injuries in this position.

Access to the abdominal cavity can be difficult because of the thickness of the abdominal wall in these patients. In open surgery, this is overcome with deep blades on retractors. In minimally invasive surgery, this requires longer trocars and Veress needles, which are now routinely available. If there is difficulty accessing the abdominal cavity with a Veress needle, a Hassan entry technique or ports with see-through trocars also can be used to ensure safe entry into the abdomen.

It is important to remember that the abdominal wall is the thinnest at the umbilical stalk. Additionally, using the upper abdomen can help assist with entry as the abdominal wall is often thinner above the umbilicus than below. For this reason, a left upper quadrant entry is often utilized at Palmer’s point. Care should be taken that entry is not so high as to limit the operator’s ability to reach the deep pelvis with laparoscopic instruments. Further, anesthesia must decompress the stomach prior to port placement in order to avoid a gastric injury.

Obese patients have a higher concentration of intraperitoneal and visceral fat, which can cause decreased visualization in the pelvis. In addition, the thick abdominal wall creates more torque on laparoscopic instruments, which can impair a surgeon’s ability to easily maneuver instruments. To decrease torque, trocars should be placed in the direction of the operative field. Draping the omentum over the liver can help to increase visualization, and always consider additional trocar placement to assist in visualization (Am. J. Obstet. Gynecol. 2004;191:669-74). Robotic instruments may further assist with feasibility of laparoscopy in the obese by obviating the role of abdominal wall torque.

Finally, patients can be difficult to ventilate in steep Trendelenburg required for laparoscopic surgery, as the weight of the breasts and abdomen shifts onto the thorax (J. Anesth. 2012;26:758-65; Ann. Surg. 2005;241:219-26; Anesth. Analg. 2002;94:1345-50). By slowly tilting the patient into steep Trendelenburg, the body has a chance to acclimate to ventilation in this position. One needs to remember to insufflate the abdomen in the supine position prior to proceeding with Trendelenburg.

Of course, one should always consider that vaginal surgery provides a "minimally invasive" approach without the difficulty of ventilating an obese patient in steep Trendelenburg position. A recent review of the effect of obesity on vaginal surgery concludes that obesity increases the difficulty of vaginal surgery and may be best performed by high-volume surgeons, given the difficulties that are often encountered (J. Minim. Invasive Gynecol. 2014;21:168-75).

As the obesity epidemic continues, figuring out safe and effective ways to provide surgical care will continue to remain a challenge to surgeons. Utilizing these tips is a start, but continued innovation and experience will be required to provide optimal care to our ever-growing population.

Dr. Clark is a chief resident in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Gehrig is professor and director of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Clark and Dr. Gehrig said they had no relevant financial disclosures.

An expert review panel from the American Society for Clinical Oncology largely endorsed new guidelines for "no ink on tumor" margins in early breast conservation surgery, while emphasizing the role of post-lumpectomy imaging in patients with microcalcifications and adding several other "minor qualifications."

Published earlier this year, the guidelines from the Society of Surgical Oncology (SSO) and the American Society of Radiation Oncology (ASTRO) focus on stage I and II breast cancer patients who are undergoing lumpectomy with whole-breast radiation. In these patients, a "no ink on tumor" margin "is associated with low rates of [ipsilateral breast tumor recurrence] and has the potential to decrease re-excision rates, improve cosmetic outcomes, and decrease health care costs," the guideline’s authors wrote (Ann. Surg. Oncol. 2014;21:704-16). The guidelines mark a step toward consensus on a historically controversial topic. "Widespread adoption of this guideline, which defines a margin as being adequate as long as there is no cancer at the inked lumpectomy surface by microscopic pathology evaluation, will result in fewer re-excision lumpectomies and enhanced cosmesis with breast conserving surgery," said Dr. Lisa Newman.

The recommended margin reflects the current era of treatment, in which better systemic therapies and earlier diagnosis of breast cancer mean that patients may no longer derive extra benefit from thicker or "widely negative" lumpectomy margins, Dr. Newman added in an interview.

Two staff members at ASCO reviewed the guidelines for developmental rigor. The guidelines "scored high (77%) in terms of methodologic quality, with only minor deviations from the ideal," members of the separate ad hoc panel of ASCO experts wrote (J. Clin. Onc. 2014 [doi:10.1200/JCO.2014.55.1572]). But panel members also called for flexibility in applying the guideline, citing the "inherent weaknesses" and "selection bias" of the retrospective, observational studies on which the recommendations were based.

The guidelines provide a framework, but clinical judgment remains important in managing breast-conserving surgery patients, emphasized Dr. Newman, who served as cochair on the ASCO panel that reviewed the guideline and who is a surgical oncologist, professor of surgery, and director of the Breast Care Center for the University of Michigan, Ann Arbor. She said clinicians should carefully evaluate lumpectomy margins, which "can provide important clues regarding the burden of disease in the breast, and the likelihood of successful treatment with lumpectomy and breast radiation."

ASCO panel members also stressed the importance of postsurgical imaging in cases involving microcalcifications. Imaging is important to minimize the risk of leaving pockets of disease in the breast despite achieving microscopically negative margins, Dr. Newman said. Surgeons can work with their colleagues in breast imaging to review microcalcifications and correlate them with pathology findings, she added.

In particular, a lumpectomy specimen that has several close margins and evidence of diffuse disease "may well represent a different category of risk regarding local recurrence, compared to a well defined, unifocal cancer that has a single microscopic focus of cancer abutting one margin," Dr. Newman added. Ideally, surgeons and radiation oncologists should discuss these aspects of cases, and should consider them when counseling patients about outcomes from lumpectomy surgery, she said.

Both ASCO and SSO/ASTRO recommended monitoring outcomes as institutions implement the new margin guidelines. Authors of the ASCO opinion reported having no conflicts of interest.

An expert review panel from the American Society for Clinical Oncology largely endorsed new guidelines for "no ink on tumor" margins in early breast conservation surgery, while emphasizing the role of post-lumpectomy imaging in patients with microcalcifications and adding several other "minor qualifications."

Published earlier this year, the guidelines from the Society of Surgical Oncology (SSO) and the American Society of Radiation Oncology (ASTRO) focus on stage I and II breast cancer patients who are undergoing lumpectomy with whole-breast radiation. In these patients, a "no ink on tumor" margin "is associated with low rates of [ipsilateral breast tumor recurrence] and has the potential to decrease re-excision rates, improve cosmetic outcomes, and decrease health care costs," the guideline’s authors wrote (Ann. Surg. Oncol. 2014;21:704-16). The guidelines mark a step toward consensus on a historically controversial topic. "Widespread adoption of this guideline, which defines a margin as being adequate as long as there is no cancer at the inked lumpectomy surface by microscopic pathology evaluation, will result in fewer re-excision lumpectomies and enhanced cosmesis with breast conserving surgery," said Dr. Lisa Newman.

The recommended margin reflects the current era of treatment, in which better systemic therapies and earlier diagnosis of breast cancer mean that patients may no longer derive extra benefit from thicker or "widely negative" lumpectomy margins, Dr. Newman added in an interview.

Two staff members at ASCO reviewed the guidelines for developmental rigor. The guidelines "scored high (77%) in terms of methodologic quality, with only minor deviations from the ideal," members of the separate ad hoc panel of ASCO experts wrote (J. Clin. Onc. 2014 [doi:10.1200/JCO.2014.55.1572]). But panel members also called for flexibility in applying the guideline, citing the "inherent weaknesses" and "selection bias" of the retrospective, observational studies on which the recommendations were based.

The guidelines provide a framework, but clinical judgment remains important in managing breast-conserving surgery patients, emphasized Dr. Newman, who served as cochair on the ASCO panel that reviewed the guideline and who is a surgical oncologist, professor of surgery, and director of the Breast Care Center for the University of Michigan, Ann Arbor. She said clinicians should carefully evaluate lumpectomy margins, which "can provide important clues regarding the burden of disease in the breast, and the likelihood of successful treatment with lumpectomy and breast radiation."

ASCO panel members also stressed the importance of postsurgical imaging in cases involving microcalcifications. Imaging is important to minimize the risk of leaving pockets of disease in the breast despite achieving microscopically negative margins, Dr. Newman said. Surgeons can work with their colleagues in breast imaging to review microcalcifications and correlate them with pathology findings, she added.

In particular, a lumpectomy specimen that has several close margins and evidence of diffuse disease "may well represent a different category of risk regarding local recurrence, compared to a well defined, unifocal cancer that has a single microscopic focus of cancer abutting one margin," Dr. Newman added. Ideally, surgeons and radiation oncologists should discuss these aspects of cases, and should consider them when counseling patients about outcomes from lumpectomy surgery, she said.

Both ASCO and SSO/ASTRO recommended monitoring outcomes as institutions implement the new margin guidelines. Authors of the ASCO opinion reported having no conflicts of interest.

An expert review panel from the American Society for Clinical Oncology largely endorsed new guidelines for "no ink on tumor" margins in early breast conservation surgery, while emphasizing the role of post-lumpectomy imaging in patients with microcalcifications and adding several other "minor qualifications."

Published earlier this year, the guidelines from the Society of Surgical Oncology (SSO) and the American Society of Radiation Oncology (ASTRO) focus on stage I and II breast cancer patients who are undergoing lumpectomy with whole-breast radiation. In these patients, a "no ink on tumor" margin "is associated with low rates of [ipsilateral breast tumor recurrence] and has the potential to decrease re-excision rates, improve cosmetic outcomes, and decrease health care costs," the guideline’s authors wrote (Ann. Surg. Oncol. 2014;21:704-16). The guidelines mark a step toward consensus on a historically controversial topic. "Widespread adoption of this guideline, which defines a margin as being adequate as long as there is no cancer at the inked lumpectomy surface by microscopic pathology evaluation, will result in fewer re-excision lumpectomies and enhanced cosmesis with breast conserving surgery," said Dr. Lisa Newman.

The recommended margin reflects the current era of treatment, in which better systemic therapies and earlier diagnosis of breast cancer mean that patients may no longer derive extra benefit from thicker or "widely negative" lumpectomy margins, Dr. Newman added in an interview.

Two staff members at ASCO reviewed the guidelines for developmental rigor. The guidelines "scored high (77%) in terms of methodologic quality, with only minor deviations from the ideal," members of the separate ad hoc panel of ASCO experts wrote (J. Clin. Onc. 2014 [doi:10.1200/JCO.2014.55.1572]). But panel members also called for flexibility in applying the guideline, citing the "inherent weaknesses" and "selection bias" of the retrospective, observational studies on which the recommendations were based.

The guidelines provide a framework, but clinical judgment remains important in managing breast-conserving surgery patients, emphasized Dr. Newman, who served as cochair on the ASCO panel that reviewed the guideline and who is a surgical oncologist, professor of surgery, and director of the Breast Care Center for the University of Michigan, Ann Arbor. She said clinicians should carefully evaluate lumpectomy margins, which "can provide important clues regarding the burden of disease in the breast, and the likelihood of successful treatment with lumpectomy and breast radiation."

ASCO panel members also stressed the importance of postsurgical imaging in cases involving microcalcifications. Imaging is important to minimize the risk of leaving pockets of disease in the breast despite achieving microscopically negative margins, Dr. Newman said. Surgeons can work with their colleagues in breast imaging to review microcalcifications and correlate them with pathology findings, she added.

In particular, a lumpectomy specimen that has several close margins and evidence of diffuse disease "may well represent a different category of risk regarding local recurrence, compared to a well defined, unifocal cancer that has a single microscopic focus of cancer abutting one margin," Dr. Newman added. Ideally, surgeons and radiation oncologists should discuss these aspects of cases, and should consider them when counseling patients about outcomes from lumpectomy surgery, she said.

Both ASCO and SSO/ASTRO recommended monitoring outcomes as institutions implement the new margin guidelines. Authors of the ASCO opinion reported having no conflicts of interest.

NEW YORK – Five-year results from the INSTEAD trial showed that patients with stable type B aortic dissections who were randomized to receive thoracic endovascular aneurysm repair plus optimal medical treatment showed significantly less aorta-specific mortality and delayed disease progression than did those who received OMT alone, according to Rachel Clough Ph.D., MRCS, who presented the findings at Aortic Symposium 2014, a meeting sponsored by the American Association for Thoracic Surgery.

The results indicate that delayed adverse events, such as sudden fatalities, expansion of the false lumen, rupture, and other late complications that occur in patients treated medically in the years subsequent to dissection are prevented or attenuated in those who receive stent grafts.

"Uncomplicated patients with type B aortic dissection have traditionally been treated with antihypertensive medication but what we see is, even in patients with very good blood pressure control, there is a continued attrition rate looking out toward 5 years. In some series, more than 50% of patients are dead [at that time point]," said Dr. Clough of Guy’s and St. Thomas NHS Foundation Trust and King’s College London (England).

INSTEAD (Investigation of Stent Grafts in Aortic Dissection) is the first randomized trial comparing thoracic endovascular aneurysm repair (TEVAR) with a stent graft. When 2-year results were published in 2009 (Circulation 2009;120:2519-28), there was criticism that the study was underpowered as no differences were seen in all-cause deaths, aorta-related deaths due to aortic rupture, or dissection progression plus rupture. There was even a trend toward better cumulative survival in the OMT group.

Sixty-eight patients were randomized to receive OMT and 72 patients received TEVAR + OMT. Eighty-three percent had one stent placed, 11% had two stents, and 6% had three stents. The proximal thoracic aorta was covered in all cases, and the range of coverage was 15-35 cm. No significant differences between groups were found in the comorbidity profile, presence of risk factors, or dissection morphology. There were two periprocedural deaths (one retrograde type A dissection and one rupture of the iliac vessels) and a "reasonably low" incidence of neurologic events, according to Dr. Clough.

By following the patients for 5 years, differences in outcomes between patients who had undergone TEVAR plus OMT and those who only received OMT began to emerge. Analysis of this long-term data shows that patients with stable type B aortic dissections who were randomized to receive TEVAR plus OMT showed less aorta-specific mortality (7 vs 19%, P = .04) and delayed disease progression (27% vs 46%, P = .04) than did those who received OMT alone. Landmark analysis suggested a benefit of TEVAR for all endpoints between 2 and 5 years, including all-cause mortality (0 vs 17%, P = .0003).

Both improved survival and less progression of disease over 5 years after elective TEVAR were associated with stent graft–induced false lumen thrombosis in 91% of cases (P less than .0001). Placement of the stent graft resulted in a significant reduction in false lumen diameter (P less than .0001) and significant increase in true lumen diameter (P less than .001). In contrast, a significant increase in aortic diameter was noted in those who received only OMT (P less than .0001).

"In conclusion, endovascular therapy in addition to medical therapy is associated with improved 5-year aortic specific survival and delayed disease progression. In uncomplicated type B dissection with suitable anatomy, preemptive TEVAR should be considered to improve late outcomes," said Dr. Clough.

Dr. Clough had nothing to disclose. INSTEAD was sponsored by the Medtronic Bakken Research Center. Medtronic manufactures the Medtronic Talent Stent-Graft-System used as the endograft.

NEW YORK – Five-year results from the INSTEAD trial showed that patients with stable type B aortic dissections who were randomized to receive thoracic endovascular aneurysm repair plus optimal medical treatment showed significantly less aorta-specific mortality and delayed disease progression than did those who received OMT alone, according to Rachel Clough Ph.D., MRCS, who presented the findings at Aortic Symposium 2014, a meeting sponsored by the American Association for Thoracic Surgery.

The results indicate that delayed adverse events, such as sudden fatalities, expansion of the false lumen, rupture, and other late complications that occur in patients treated medically in the years subsequent to dissection are prevented or attenuated in those who receive stent grafts.

"Uncomplicated patients with type B aortic dissection have traditionally been treated with antihypertensive medication but what we see is, even in patients with very good blood pressure control, there is a continued attrition rate looking out toward 5 years. In some series, more than 50% of patients are dead [at that time point]," said Dr. Clough of Guy’s and St. Thomas NHS Foundation Trust and King’s College London (England).

INSTEAD (Investigation of Stent Grafts in Aortic Dissection) is the first randomized trial comparing thoracic endovascular aneurysm repair (TEVAR) with a stent graft. When 2-year results were published in 2009 (Circulation 2009;120:2519-28), there was criticism that the study was underpowered as no differences were seen in all-cause deaths, aorta-related deaths due to aortic rupture, or dissection progression plus rupture. There was even a trend toward better cumulative survival in the OMT group.

Sixty-eight patients were randomized to receive OMT and 72 patients received TEVAR + OMT. Eighty-three percent had one stent placed, 11% had two stents, and 6% had three stents. The proximal thoracic aorta was covered in all cases, and the range of coverage was 15-35 cm. No significant differences between groups were found in the comorbidity profile, presence of risk factors, or dissection morphology. There were two periprocedural deaths (one retrograde type A dissection and one rupture of the iliac vessels) and a "reasonably low" incidence of neurologic events, according to Dr. Clough.

By following the patients for 5 years, differences in outcomes between patients who had undergone TEVAR plus OMT and those who only received OMT began to emerge. Analysis of this long-term data shows that patients with stable type B aortic dissections who were randomized to receive TEVAR plus OMT showed less aorta-specific mortality (7 vs 19%, P = .04) and delayed disease progression (27% vs 46%, P = .04) than did those who received OMT alone. Landmark analysis suggested a benefit of TEVAR for all endpoints between 2 and 5 years, including all-cause mortality (0 vs 17%, P = .0003).

Both improved survival and less progression of disease over 5 years after elective TEVAR were associated with stent graft–induced false lumen thrombosis in 91% of cases (P less than .0001). Placement of the stent graft resulted in a significant reduction in false lumen diameter (P less than .0001) and significant increase in true lumen diameter (P less than .001). In contrast, a significant increase in aortic diameter was noted in those who received only OMT (P less than .0001).

"In conclusion, endovascular therapy in addition to medical therapy is associated with improved 5-year aortic specific survival and delayed disease progression. In uncomplicated type B dissection with suitable anatomy, preemptive TEVAR should be considered to improve late outcomes," said Dr. Clough.

Dr. Clough had nothing to disclose. INSTEAD was sponsored by the Medtronic Bakken Research Center. Medtronic manufactures the Medtronic Talent Stent-Graft-System used as the endograft.

NEW YORK – Five-year results from the INSTEAD trial showed that patients with stable type B aortic dissections who were randomized to receive thoracic endovascular aneurysm repair plus optimal medical treatment showed significantly less aorta-specific mortality and delayed disease progression than did those who received OMT alone, according to Rachel Clough Ph.D., MRCS, who presented the findings at Aortic Symposium 2014, a meeting sponsored by the American Association for Thoracic Surgery.

The results indicate that delayed adverse events, such as sudden fatalities, expansion of the false lumen, rupture, and other late complications that occur in patients treated medically in the years subsequent to dissection are prevented or attenuated in those who receive stent grafts.

"Uncomplicated patients with type B aortic dissection have traditionally been treated with antihypertensive medication but what we see is, even in patients with very good blood pressure control, there is a continued attrition rate looking out toward 5 years. In some series, more than 50% of patients are dead [at that time point]," said Dr. Clough of Guy’s and St. Thomas NHS Foundation Trust and King’s College London (England).

INSTEAD (Investigation of Stent Grafts in Aortic Dissection) is the first randomized trial comparing thoracic endovascular aneurysm repair (TEVAR) with a stent graft. When 2-year results were published in 2009 (Circulation 2009;120:2519-28), there was criticism that the study was underpowered as no differences were seen in all-cause deaths, aorta-related deaths due to aortic rupture, or dissection progression plus rupture. There was even a trend toward better cumulative survival in the OMT group.

Sixty-eight patients were randomized to receive OMT and 72 patients received TEVAR + OMT. Eighty-three percent had one stent placed, 11% had two stents, and 6% had three stents. The proximal thoracic aorta was covered in all cases, and the range of coverage was 15-35 cm. No significant differences between groups were found in the comorbidity profile, presence of risk factors, or dissection morphology. There were two periprocedural deaths (one retrograde type A dissection and one rupture of the iliac vessels) and a "reasonably low" incidence of neurologic events, according to Dr. Clough.

By following the patients for 5 years, differences in outcomes between patients who had undergone TEVAR plus OMT and those who only received OMT began to emerge. Analysis of this long-term data shows that patients with stable type B aortic dissections who were randomized to receive TEVAR plus OMT showed less aorta-specific mortality (7 vs 19%, P = .04) and delayed disease progression (27% vs 46%, P = .04) than did those who received OMT alone. Landmark analysis suggested a benefit of TEVAR for all endpoints between 2 and 5 years, including all-cause mortality (0 vs 17%, P = .0003).

Both improved survival and less progression of disease over 5 years after elective TEVAR were associated with stent graft–induced false lumen thrombosis in 91% of cases (P less than .0001). Placement of the stent graft resulted in a significant reduction in false lumen diameter (P less than .0001) and significant increase in true lumen diameter (P less than .001). In contrast, a significant increase in aortic diameter was noted in those who received only OMT (P less than .0001).

"In conclusion, endovascular therapy in addition to medical therapy is associated with improved 5-year aortic specific survival and delayed disease progression. In uncomplicated type B dissection with suitable anatomy, preemptive TEVAR should be considered to improve late outcomes," said Dr. Clough.

Dr. Clough had nothing to disclose. INSTEAD was sponsored by the Medtronic Bakken Research Center. Medtronic manufactures the Medtronic Talent Stent-Graft-System used as the endograft.

Clinicians should perform a basic six-step evaluation of women with symptoms of uncomplicated stress urinary incontinence before these patients undergo midurethral sling surgery, according to first-time guidelines from the American College of Obstetricians and Gynecologists and the American Urogynecologic Society.

The recommended steps exclude preoperative urodynamic testing, which has not been shown to improve surgical outcomes in patients with uncomplicated SUI, stated Committee Opinion No. 603, published in the June issue of Obstetrics and Gynecology (2014;123:1403-7).

"Until now, there has never been any consistency in the evaluation of uncomplicated SUI before surgery," said Dr. Charles Nager, professor of obstetrics and gynecology and director of female pelvic medicine and reconstructive surgery at the University of California, San Diego. "This is the first time the leading specialty organizations, ACOG and the American Urogynecologic Society [AUGS], have set a standard for physicians to follow before they operate on patients with uncomplicated SUI."

The criteria are common sense, are evidence based, and "don’t require that everyone undergo urodynamic testing," added Dr. Nager, who is president of AUGS and a member of ACOG’s subcommittee on urogynecology of the Committee on Gynecologic Practice, which was involved in drafting the guidelines.

The opinion guides clinicians in evaluating women with urinary leakage without necessarily requiring a costly work-up, said Dr. Cheryl Iglesia, who also contributed to the guidelines and is director of female pelvic medicine and reconstructive surgery at MedStar Washington (D.C.) Hospital Center and professor of obstetrics, gynecology, and urology at Georgetown University, Washington. If the minimum six-step evaluation confirms uncomplicated SUI, "you don’t need to do a test that would run upwards of thousands of dollars and doesn’t change the outcome," she said.

The recommended six-step evaluation includes:

1. A urologic, medical, neurologic, and medication history.

2. A urinalysis to rule out urinary tract infection.

3. A physical examination to assess for contributing or confounding factors, including urethral diverticulum, vaginal discharge, extraurethral incontinence, and pelvic organ prolapse (which leads to a diagnosis of complicated SUI if the prolapse is beyond the hymen).

4. A cough stress test to demonstrate SUI.

5. A urethral mobility assessment to help determine the likelihood of success from anti-incontinence surgery.

6. Measurement of postvoid residual urine volume to identify bladder-emptying abnormalities or incontinence resulting from chronic urinary retention.

Women with uncomplicated SUI will have urinary leakage from the urethra by provocative stress measures such as the cough test, a normal urinalysis that rules out urinary tract infection, no pelvic organ prolapse beyond the hymen, and a normal postvoid residual urine volume, the guidelines specify, adding that patients who meet these criteria and have not responded to conservative interventions do not need urodynamic testing before proceeding to surgery.

In contrast, women with complicated SUI "may benefit from multichannel urodynamic testing, particularly before surgical treatment," the guidelines stated. "In these women, the results of the basic six-step evaluation and clinical judgment should guide the decision to perform preoperative multichannel urodynamic testing."

Clinicians should perform a basic six-step evaluation of women with symptoms of uncomplicated stress urinary incontinence before these patients undergo midurethral sling surgery, according to first-time guidelines from the American College of Obstetricians and Gynecologists and the American Urogynecologic Society.

The recommended steps exclude preoperative urodynamic testing, which has not been shown to improve surgical outcomes in patients with uncomplicated SUI, stated Committee Opinion No. 603, published in the June issue of Obstetrics and Gynecology (2014;123:1403-7).

"Until now, there has never been any consistency in the evaluation of uncomplicated SUI before surgery," said Dr. Charles Nager, professor of obstetrics and gynecology and director of female pelvic medicine and reconstructive surgery at the University of California, San Diego. "This is the first time the leading specialty organizations, ACOG and the American Urogynecologic Society [AUGS], have set a standard for physicians to follow before they operate on patients with uncomplicated SUI."

The criteria are common sense, are evidence based, and "don’t require that everyone undergo urodynamic testing," added Dr. Nager, who is president of AUGS and a member of ACOG’s subcommittee on urogynecology of the Committee on Gynecologic Practice, which was involved in drafting the guidelines.

The opinion guides clinicians in evaluating women with urinary leakage without necessarily requiring a costly work-up, said Dr. Cheryl Iglesia, who also contributed to the guidelines and is director of female pelvic medicine and reconstructive surgery at MedStar Washington (D.C.) Hospital Center and professor of obstetrics, gynecology, and urology at Georgetown University, Washington. If the minimum six-step evaluation confirms uncomplicated SUI, "you don’t need to do a test that would run upwards of thousands of dollars and doesn’t change the outcome," she said.

The recommended six-step evaluation includes:

1. A urologic, medical, neurologic, and medication history.

2. A urinalysis to rule out urinary tract infection.

3. A physical examination to assess for contributing or confounding factors, including urethral diverticulum, vaginal discharge, extraurethral incontinence, and pelvic organ prolapse (which leads to a diagnosis of complicated SUI if the prolapse is beyond the hymen).

4. A cough stress test to demonstrate SUI.

5. A urethral mobility assessment to help determine the likelihood of success from anti-incontinence surgery.

6. Measurement of postvoid residual urine volume to identify bladder-emptying abnormalities or incontinence resulting from chronic urinary retention.

Women with uncomplicated SUI will have urinary leakage from the urethra by provocative stress measures such as the cough test, a normal urinalysis that rules out urinary tract infection, no pelvic organ prolapse beyond the hymen, and a normal postvoid residual urine volume, the guidelines specify, adding that patients who meet these criteria and have not responded to conservative interventions do not need urodynamic testing before proceeding to surgery.

In contrast, women with complicated SUI "may benefit from multichannel urodynamic testing, particularly before surgical treatment," the guidelines stated. "In these women, the results of the basic six-step evaluation and clinical judgment should guide the decision to perform preoperative multichannel urodynamic testing."

Clinicians should perform a basic six-step evaluation of women with symptoms of uncomplicated stress urinary incontinence before these patients undergo midurethral sling surgery, according to first-time guidelines from the American College of Obstetricians and Gynecologists and the American Urogynecologic Society.

The recommended steps exclude preoperative urodynamic testing, which has not been shown to improve surgical outcomes in patients with uncomplicated SUI, stated Committee Opinion No. 603, published in the June issue of Obstetrics and Gynecology (2014;123:1403-7).

"Until now, there has never been any consistency in the evaluation of uncomplicated SUI before surgery," said Dr. Charles Nager, professor of obstetrics and gynecology and director of female pelvic medicine and reconstructive surgery at the University of California, San Diego. "This is the first time the leading specialty organizations, ACOG and the American Urogynecologic Society [AUGS], have set a standard for physicians to follow before they operate on patients with uncomplicated SUI."

The criteria are common sense, are evidence based, and "don’t require that everyone undergo urodynamic testing," added Dr. Nager, who is president of AUGS and a member of ACOG’s subcommittee on urogynecology of the Committee on Gynecologic Practice, which was involved in drafting the guidelines.

The opinion guides clinicians in evaluating women with urinary leakage without necessarily requiring a costly work-up, said Dr. Cheryl Iglesia, who also contributed to the guidelines and is director of female pelvic medicine and reconstructive surgery at MedStar Washington (D.C.) Hospital Center and professor of obstetrics, gynecology, and urology at Georgetown University, Washington. If the minimum six-step evaluation confirms uncomplicated SUI, "you don’t need to do a test that would run upwards of thousands of dollars and doesn’t change the outcome," she said.

The recommended six-step evaluation includes:

1. A urologic, medical, neurologic, and medication history.

2. A urinalysis to rule out urinary tract infection.

3. A physical examination to assess for contributing or confounding factors, including urethral diverticulum, vaginal discharge, extraurethral incontinence, and pelvic organ prolapse (which leads to a diagnosis of complicated SUI if the prolapse is beyond the hymen).

4. A cough stress test to demonstrate SUI.

5. A urethral mobility assessment to help determine the likelihood of success from anti-incontinence surgery.

6. Measurement of postvoid residual urine volume to identify bladder-emptying abnormalities or incontinence resulting from chronic urinary retention.

Women with uncomplicated SUI will have urinary leakage from the urethra by provocative stress measures such as the cough test, a normal urinalysis that rules out urinary tract infection, no pelvic organ prolapse beyond the hymen, and a normal postvoid residual urine volume, the guidelines specify, adding that patients who meet these criteria and have not responded to conservative interventions do not need urodynamic testing before proceeding to surgery.

In contrast, women with complicated SUI "may benefit from multichannel urodynamic testing, particularly before surgical treatment," the guidelines stated. "In these women, the results of the basic six-step evaluation and clinical judgment should guide the decision to perform preoperative multichannel urodynamic testing."

Question: Which of the following is likely to run afoul of antitrust laws?

A. A medical center in a big city buys the practices of several retiring doctors.

B. The only two hospitals in a rural area agree to merge to integrate better delivery of health care at lower cost.

C. A medical association’s president advises members of the drawbacks of a new managed care health plan.

D. All of the above.

E. None of the above.

Answer: B. Choice B constitutes illegal monopolization, whereas A is not likely to wield market power and C, without more, does not amount to a boycott. This article, the last in the series on health care antitrust, will showcase several cases illustrative of recurring themes such as the "state action doctrine," exclusive dealings, and mergers.

One broad category of cases concerns the so-called "state action doctrine," which confers antitrust immunity to all state governmental agencies.

For doctors, the most dramatic example is probably Patrick v. Burget (108 S. Ct. 1658 [1988]), an adverse peer review action against a physician who challenged it as nothing less than an anticompetitive ploy. In 1973, Dr. Timothy Patrick, a surgeon, chose to leave the Astoria Clinic in Oregon to establish an independent practice in general and vascular surgery. He continued to have staff privileges at Columbia Memorial Hospital, Astoria, but experienced refusal of professional dealings by former colleagues who were still at the clinic. One of them lodged a complaint that Dr. Patrick had left a patient unattended following surgery. In due course, the hospital medical staff voted to revoke his privileges because of substandard care.

Dr. Patrick’s lawsuit alleged that the staff’s true purpose was to eliminate him as a competitor, rather than to improve quality. The U.S. Court of Appeals for the Ninth Circuit found that the state of Oregon had articulated a policy in favor of peer review and had supervised the process. It therefore held that the "state action doctrine" exemption protected the hospital staff from antitrust liability even if the peer review proceedings were abused to disadvantage a competitor.

However, in a unanimous decision, the U.S. Supreme Court reversed, finding that the "active supervision" requirement was not satisfied, because that required Oregon to exercise ultimate control over the conduct of peer review, not simply some state involvement or monitoring. The state’s agencies were the Oregon Board of Medical Examiners and the Health Division, neither of which had the authority to expressly supervise the peer review process.

In a recent merger case, Federal Trade Commission v. Phoebe Putney Health System Inc. (133 S. Ct. 1003 [2013]) the U.S. Supreme Court again refuted the use of the "state action doctrine" defense.

The state of Georgia had claimed immunity when county-owned Phoebe Putney Memorial Hospital, Albany, Ga., made a bid to purchase Palmyra Park Hospital, also in Albany, its chief competitor. The Eleventh Circuit acknowledged that the challenged transaction would substantially lessen competition. However, the court reasoned that the transaction was exempted from the antitrust laws because the legislature, under the Georgia Hospital Authorities Law, had given hospital authorities the power to acquire or lease out hospitals despite potential anticompetitive effects.

However, the U.S. Supreme Court disagreed and reversed, holding the doctrine inapplicable because the general grant of power to the hospital authority did not clearly articulate the state’s intent to restrict competition.

Another remarkable example of the "state action doctrine" at play is North Carolina State Board of Dental Examiners v. Federal Trade Commission (719 F.3d 359 [4th Cir. 2013]). The case, currently under appeal, deals with the North Carolina State Board of Dental Examiners’ (NCSBDE) actions to forbid nondentists from providing teeth-whitening services to the public at spas, salons, and various retail outlets. NCSBDE also urged mall owners not to lease space to such providers. The FTC argued that most of the board members were practicing dentists rather than state employees; so, for purposes of the antitrust laws, the NCSBDE should be deemed a private person rather than part of a state government. Because North Carolina did not actively supervise its actions, the NCSBDE could not hide behind the protection of the "state action doctrine."

The United States Court of Appeals for the Fourth Circuit sided with the FTC, holding that NCSBDE could not restrain competition through means such as the use of cease and desist letters. The U.S. Supreme Court has agreed to hear the case, which has major implications for the regulatory authority of professional licensing boards.

A different recurring antitrust issue concerns the exclusion of doctors from a provider network. In Little Rock Cardiology Clinic v. Baptist Health (591 F.3d 591 [8th Cir. 2009]), the Little Rock (Ark.) Cardiology Clinic sued Baptist Health for entering into an exclusive contract with Blue Cross/Blue Shield of Arkansas in order to monopolize the market for cardiac care services. However, the trial court as well as the U.S. Court of Appeals for the Eighth Circuit held that the complaint failed to identify the relevant geographic area, product, or service market, without which it was impossible to reach a finding of monopolization.

Can a professional organization advise its members of pitfalls or drawbacks of health care plans? In International Healthcare Management v. Hawaii Coalition for Health (332 F.3d 600 [9th Cir. 2003]), the Hawaii Medical Association (HMA), the state’s medical organization, was sued for allegedly organizing a boycott of two managed care organizations when it advised its doctor members of certain problems with the proposed provider contracts. HMA argued that it neither forged an agreement to act in concert nor encouraged its members to participate in any boycott. It won a summary judgment in the U.S. District Court dismissing the suit, which the U.S. Court of Appeals for the Ninth Circuit affirmed.

Finally, antitrust prosecutions may be expected to increase under Obamacare, which advocates the efficient integration and consolidation of quality health services to achieve health cost savings. Any action taken, however, must still pass antitrust scrutiny.

One scenario is the trend toward hospital acquisitions of physician practices. The case of Idaho’s St. Luke Health Systems, a nonprofit, six-hospital system based in Boise and the largest in the state, is a prime example.

In a recent decision, a federal judge sided with the FTC in blocking St. Luke’s Health System from acquiring the 40-doctor Saltzer Medical Group – an acquisition made in the name of better "integrated health care." The FTC had alleged that the merger would give St. Luke a nearly 60% share of the primary-care market, resulting in diminished competition among primary care physicians. Idaho’s attorney general, as well as two other competitor health systems in Boise, also joined in the suit.

The federal court ruled against St. Luke’s, claiming that there was a legal and less anticompetitive way to achieve its goal of improving health care delivery in the area. The acquisition had in fact taken place more than a year ago, and St. Luke’s is now left with the task of dismantling the acquisition.

Antitrust law is complex and difficult, some issues and results may appear surprising and counterintuitive, and penalties can be severe (such as treble damages). All business transactions including those that touch on health care should therefore proactively examine whether they illegally affect free market competition.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk," and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].

Question: Which of the following is likely to run afoul of antitrust laws?

A. A medical center in a big city buys the practices of several retiring doctors.

B. The only two hospitals in a rural area agree to merge to integrate better delivery of health care at lower cost.

C. A medical association’s president advises members of the drawbacks of a new managed care health plan.

D. All of the above.

E. None of the above.

Answer: B. Choice B constitutes illegal monopolization, whereas A is not likely to wield market power and C, without more, does not amount to a boycott. This article, the last in the series on health care antitrust, will showcase several cases illustrative of recurring themes such as the "state action doctrine," exclusive dealings, and mergers.

One broad category of cases concerns the so-called "state action doctrine," which confers antitrust immunity to all state governmental agencies.

For doctors, the most dramatic example is probably Patrick v. Burget (108 S. Ct. 1658 [1988]), an adverse peer review action against a physician who challenged it as nothing less than an anticompetitive ploy. In 1973, Dr. Timothy Patrick, a surgeon, chose to leave the Astoria Clinic in Oregon to establish an independent practice in general and vascular surgery. He continued to have staff privileges at Columbia Memorial Hospital, Astoria, but experienced refusal of professional dealings by former colleagues who were still at the clinic. One of them lodged a complaint that Dr. Patrick had left a patient unattended following surgery. In due course, the hospital medical staff voted to revoke his privileges because of substandard care.

Dr. Patrick’s lawsuit alleged that the staff’s true purpose was to eliminate him as a competitor, rather than to improve quality. The U.S. Court of Appeals for the Ninth Circuit found that the state of Oregon had articulated a policy in favor of peer review and had supervised the process. It therefore held that the "state action doctrine" exemption protected the hospital staff from antitrust liability even if the peer review proceedings were abused to disadvantage a competitor.

However, in a unanimous decision, the U.S. Supreme Court reversed, finding that the "active supervision" requirement was not satisfied, because that required Oregon to exercise ultimate control over the conduct of peer review, not simply some state involvement or monitoring. The state’s agencies were the Oregon Board of Medical Examiners and the Health Division, neither of which had the authority to expressly supervise the peer review process.

In a recent merger case, Federal Trade Commission v. Phoebe Putney Health System Inc. (133 S. Ct. 1003 [2013]) the U.S. Supreme Court again refuted the use of the "state action doctrine" defense.

The state of Georgia had claimed immunity when county-owned Phoebe Putney Memorial Hospital, Albany, Ga., made a bid to purchase Palmyra Park Hospital, also in Albany, its chief competitor. The Eleventh Circuit acknowledged that the challenged transaction would substantially lessen competition. However, the court reasoned that the transaction was exempted from the antitrust laws because the legislature, under the Georgia Hospital Authorities Law, had given hospital authorities the power to acquire or lease out hospitals despite potential anticompetitive effects.

However, the U.S. Supreme Court disagreed and reversed, holding the doctrine inapplicable because the general grant of power to the hospital authority did not clearly articulate the state’s intent to restrict competition.

Another remarkable example of the "state action doctrine" at play is North Carolina State Board of Dental Examiners v. Federal Trade Commission (719 F.3d 359 [4th Cir. 2013]). The case, currently under appeal, deals with the North Carolina State Board of Dental Examiners’ (NCSBDE) actions to forbid nondentists from providing teeth-whitening services to the public at spas, salons, and various retail outlets. NCSBDE also urged mall owners not to lease space to such providers. The FTC argued that most of the board members were practicing dentists rather than state employees; so, for purposes of the antitrust laws, the NCSBDE should be deemed a private person rather than part of a state government. Because North Carolina did not actively supervise its actions, the NCSBDE could not hide behind the protection of the "state action doctrine."

The United States Court of Appeals for the Fourth Circuit sided with the FTC, holding that NCSBDE could not restrain competition through means such as the use of cease and desist letters. The U.S. Supreme Court has agreed to hear the case, which has major implications for the regulatory authority of professional licensing boards.

A different recurring antitrust issue concerns the exclusion of doctors from a provider network. In Little Rock Cardiology Clinic v. Baptist Health (591 F.3d 591 [8th Cir. 2009]), the Little Rock (Ark.) Cardiology Clinic sued Baptist Health for entering into an exclusive contract with Blue Cross/Blue Shield of Arkansas in order to monopolize the market for cardiac care services. However, the trial court as well as the U.S. Court of Appeals for the Eighth Circuit held that the complaint failed to identify the relevant geographic area, product, or service market, without which it was impossible to reach a finding of monopolization.

Can a professional organization advise its members of pitfalls or drawbacks of health care plans? In International Healthcare Management v. Hawaii Coalition for Health (332 F.3d 600 [9th Cir. 2003]), the Hawaii Medical Association (HMA), the state’s medical organization, was sued for allegedly organizing a boycott of two managed care organizations when it advised its doctor members of certain problems with the proposed provider contracts. HMA argued that it neither forged an agreement to act in concert nor encouraged its members to participate in any boycott. It won a summary judgment in the U.S. District Court dismissing the suit, which the U.S. Court of Appeals for the Ninth Circuit affirmed.

Finally, antitrust prosecutions may be expected to increase under Obamacare, which advocates the efficient integration and consolidation of quality health services to achieve health cost savings. Any action taken, however, must still pass antitrust scrutiny.

One scenario is the trend toward hospital acquisitions of physician practices. The case of Idaho’s St. Luke Health Systems, a nonprofit, six-hospital system based in Boise and the largest in the state, is a prime example.

In a recent decision, a federal judge sided with the FTC in blocking St. Luke’s Health System from acquiring the 40-doctor Saltzer Medical Group – an acquisition made in the name of better "integrated health care." The FTC had alleged that the merger would give St. Luke a nearly 60% share of the primary-care market, resulting in diminished competition among primary care physicians. Idaho’s attorney general, as well as two other competitor health systems in Boise, also joined in the suit.

The federal court ruled against St. Luke’s, claiming that there was a legal and less anticompetitive way to achieve its goal of improving health care delivery in the area. The acquisition had in fact taken place more than a year ago, and St. Luke’s is now left with the task of dismantling the acquisition.

Antitrust law is complex and difficult, some issues and results may appear surprising and counterintuitive, and penalties can be severe (such as treble damages). All business transactions including those that touch on health care should therefore proactively examine whether they illegally affect free market competition.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk," and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].

Question: Which of the following is likely to run afoul of antitrust laws?

A. A medical center in a big city buys the practices of several retiring doctors.

B. The only two hospitals in a rural area agree to merge to integrate better delivery of health care at lower cost.

C. A medical association’s president advises members of the drawbacks of a new managed care health plan.

D. All of the above.

E. None of the above.

Answer: B. Choice B constitutes illegal monopolization, whereas A is not likely to wield market power and C, without more, does not amount to a boycott. This article, the last in the series on health care antitrust, will showcase several cases illustrative of recurring themes such as the "state action doctrine," exclusive dealings, and mergers.

One broad category of cases concerns the so-called "state action doctrine," which confers antitrust immunity to all state governmental agencies.

For doctors, the most dramatic example is probably Patrick v. Burget (108 S. Ct. 1658 [1988]), an adverse peer review action against a physician who challenged it as nothing less than an anticompetitive ploy. In 1973, Dr. Timothy Patrick, a surgeon, chose to leave the Astoria Clinic in Oregon to establish an independent practice in general and vascular surgery. He continued to have staff privileges at Columbia Memorial Hospital, Astoria, but experienced refusal of professional dealings by former colleagues who were still at the clinic. One of them lodged a complaint that Dr. Patrick had left a patient unattended following surgery. In due course, the hospital medical staff voted to revoke his privileges because of substandard care.

Dr. Patrick’s lawsuit alleged that the staff’s true purpose was to eliminate him as a competitor, rather than to improve quality. The U.S. Court of Appeals for the Ninth Circuit found that the state of Oregon had articulated a policy in favor of peer review and had supervised the process. It therefore held that the "state action doctrine" exemption protected the hospital staff from antitrust liability even if the peer review proceedings were abused to disadvantage a competitor.

However, in a unanimous decision, the U.S. Supreme Court reversed, finding that the "active supervision" requirement was not satisfied, because that required Oregon to exercise ultimate control over the conduct of peer review, not simply some state involvement or monitoring. The state’s agencies were the Oregon Board of Medical Examiners and the Health Division, neither of which had the authority to expressly supervise the peer review process.

In a recent merger case, Federal Trade Commission v. Phoebe Putney Health System Inc. (133 S. Ct. 1003 [2013]) the U.S. Supreme Court again refuted the use of the "state action doctrine" defense.

The state of Georgia had claimed immunity when county-owned Phoebe Putney Memorial Hospital, Albany, Ga., made a bid to purchase Palmyra Park Hospital, also in Albany, its chief competitor. The Eleventh Circuit acknowledged that the challenged transaction would substantially lessen competition. However, the court reasoned that the transaction was exempted from the antitrust laws because the legislature, under the Georgia Hospital Authorities Law, had given hospital authorities the power to acquire or lease out hospitals despite potential anticompetitive effects.

However, the U.S. Supreme Court disagreed and reversed, holding the doctrine inapplicable because the general grant of power to the hospital authority did not clearly articulate the state’s intent to restrict competition.

Another remarkable example of the "state action doctrine" at play is North Carolina State Board of Dental Examiners v. Federal Trade Commission (719 F.3d 359 [4th Cir. 2013]). The case, currently under appeal, deals with the North Carolina State Board of Dental Examiners’ (NCSBDE) actions to forbid nondentists from providing teeth-whitening services to the public at spas, salons, and various retail outlets. NCSBDE also urged mall owners not to lease space to such providers. The FTC argued that most of the board members were practicing dentists rather than state employees; so, for purposes of the antitrust laws, the NCSBDE should be deemed a private person rather than part of a state government. Because North Carolina did not actively supervise its actions, the NCSBDE could not hide behind the protection of the "state action doctrine."

The United States Court of Appeals for the Fourth Circuit sided with the FTC, holding that NCSBDE could not restrain competition through means such as the use of cease and desist letters. The U.S. Supreme Court has agreed to hear the case, which has major implications for the regulatory authority of professional licensing boards.

A different recurring antitrust issue concerns the exclusion of doctors from a provider network. In Little Rock Cardiology Clinic v. Baptist Health (591 F.3d 591 [8th Cir. 2009]), the Little Rock (Ark.) Cardiology Clinic sued Baptist Health for entering into an exclusive contract with Blue Cross/Blue Shield of Arkansas in order to monopolize the market for cardiac care services. However, the trial court as well as the U.S. Court of Appeals for the Eighth Circuit held that the complaint failed to identify the relevant geographic area, product, or service market, without which it was impossible to reach a finding of monopolization.

Can a professional organization advise its members of pitfalls or drawbacks of health care plans? In International Healthcare Management v. Hawaii Coalition for Health (332 F.3d 600 [9th Cir. 2003]), the Hawaii Medical Association (HMA), the state’s medical organization, was sued for allegedly organizing a boycott of two managed care organizations when it advised its doctor members of certain problems with the proposed provider contracts. HMA argued that it neither forged an agreement to act in concert nor encouraged its members to participate in any boycott. It won a summary judgment in the U.S. District Court dismissing the suit, which the U.S. Court of Appeals for the Ninth Circuit affirmed.

Finally, antitrust prosecutions may be expected to increase under Obamacare, which advocates the efficient integration and consolidation of quality health services to achieve health cost savings. Any action taken, however, must still pass antitrust scrutiny.

One scenario is the trend toward hospital acquisitions of physician practices. The case of Idaho’s St. Luke Health Systems, a nonprofit, six-hospital system based in Boise and the largest in the state, is a prime example.

In a recent decision, a federal judge sided with the FTC in blocking St. Luke’s Health System from acquiring the 40-doctor Saltzer Medical Group – an acquisition made in the name of better "integrated health care." The FTC had alleged that the merger would give St. Luke a nearly 60% share of the primary-care market, resulting in diminished competition among primary care physicians. Idaho’s attorney general, as well as two other competitor health systems in Boise, also joined in the suit.

The federal court ruled against St. Luke’s, claiming that there was a legal and less anticompetitive way to achieve its goal of improving health care delivery in the area. The acquisition had in fact taken place more than a year ago, and St. Luke’s is now left with the task of dismantling the acquisition.

Antitrust law is complex and difficult, some issues and results may appear surprising and counterintuitive, and penalties can be severe (such as treble damages). All business transactions including those that touch on health care should therefore proactively examine whether they illegally affect free market competition.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk," and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].