ACS Surgery News

Dalbavancin is the first drug with a Qualified Infectious Disease Product designation to be approved by the Food and Drug Administration.

On May 23, the agency approved dalbavancin (Dalvance) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus. The drug, which is given intravenously, is effective for methicillin-susceptible and methicillin-resistant strains as well as Streptococcus pyogenes.

Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, dalbavancin was granted Qualified Infectious Disease Product designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections, according to a statement issued by the FDA.

As part of its QIDP designation, dalbavancin was given priority review and qualifies for an additional 5 years of marketing exclusivity, in addition to the exclusivity period already provided by the Food, Drug and Cosmetic Act.

Dalbavancin was shown to be as safe and effective as vancomycin for the treatment of ABSSSI in two clinical trials with a total of 1,289 adults who had ABSSSI and were randomly assigned to one of the two drugs.

The most common side effects identified in the clinical trials were nausea, headache and diarrhea. More participants in the dalbavancin group had elevated liver enzymes.

Dalvance is marketed by Durata Therapeutics.

[email protected]

Dalbavancin is the first drug with a Qualified Infectious Disease Product designation to be approved by the Food and Drug Administration.

On May 23, the agency approved dalbavancin (Dalvance) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus. The drug, which is given intravenously, is effective for methicillin-susceptible and methicillin-resistant strains as well as Streptococcus pyogenes.

Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, dalbavancin was granted Qualified Infectious Disease Product designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections, according to a statement issued by the FDA.

As part of its QIDP designation, dalbavancin was given priority review and qualifies for an additional 5 years of marketing exclusivity, in addition to the exclusivity period already provided by the Food, Drug and Cosmetic Act.

Dalbavancin was shown to be as safe and effective as vancomycin for the treatment of ABSSSI in two clinical trials with a total of 1,289 adults who had ABSSSI and were randomly assigned to one of the two drugs.

The most common side effects identified in the clinical trials were nausea, headache and diarrhea. More participants in the dalbavancin group had elevated liver enzymes.

Dalvance is marketed by Durata Therapeutics.

[email protected]

Dalbavancin is the first drug with a Qualified Infectious Disease Product designation to be approved by the Food and Drug Administration.

On May 23, the agency approved dalbavancin (Dalvance) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus. The drug, which is given intravenously, is effective for methicillin-susceptible and methicillin-resistant strains as well as Streptococcus pyogenes.

Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, dalbavancin was granted Qualified Infectious Disease Product designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections, according to a statement issued by the FDA.

As part of its QIDP designation, dalbavancin was given priority review and qualifies for an additional 5 years of marketing exclusivity, in addition to the exclusivity period already provided by the Food, Drug and Cosmetic Act.

Dalbavancin was shown to be as safe and effective as vancomycin for the treatment of ABSSSI in two clinical trials with a total of 1,289 adults who had ABSSSI and were randomly assigned to one of the two drugs.

The most common side effects identified in the clinical trials were nausea, headache and diarrhea. More participants in the dalbavancin group had elevated liver enzymes.

Dalvance is marketed by Durata Therapeutics.

[email protected]

SAN DIEGO – Subsyndromal delirium was present in 86% of critically ill patients, results from a large observational study demonstrated. In addition, the duration of delirium was associated with increased odds of institutionalization, an association that was modified by the duration of delirium.

"In patients with less delirium, the effect of subsyndromal delirium on institutionalization was actually stronger," lead author Dr. Nathan E. Brummel said in an interview at an international conference of the American Thoracic Society, where the research was presented. "This identifies a cohort of people who previously were considered to have normal brain function, but it appears that this has long-term implications for their lives.

"Screening for delirium should occur not only in the ICU but on the wards as well. Patients who have delirium or delirium symptoms may benefit from measures used to prevent and treat this syndrome, such as the Hospital Elder Life Program, routine mobilization, and frequent reorientation through the use of nursing staff or even family members," he later added. This study data may help clinicians discuss long-term outcomes of critical illness with patients and their family members," he said.

For the study, Dr. Brummel, an instructor in medicine in the division of allergy, pulmonary and critical care medicine at Vanderbilt University Medical Center, Nashville, Tenn., and his associates evaluated 821 medical or surgical ICU patients with respiratory failure and/or shock who were enrolled in the BRAIN-ICU observational cohort study (N. Engl. J. Med. 2013;369:1306-16).

They used the Confusion Assessment Method for the ICU (CAM-ICU) to screen for delirium symptoms twice daily in the ICU and daily thereafter. The researchers considered delirium to be present if the CAM-ICU was positive. If the CAM-ICU was negative, they considered subsyndromal delirium (SSD) to be present if any delirium features were present or if inattention was present with or without other features of delirium.

SSD "is said to be present when a patient exhibits some delirium symptoms but does not meet the full delirium diagnostic criteria," the researchers wrote in their poster. "In patients without critical illness, SSD is associated with institutionalization, mortality, and cognitive decline, but these associations remain unclear in the critically ill."

The researchers tracked discharge location, mortality after hospital discharge and assessed for cognitive impairment at 3 and 12 months follow-up and used multivariate regression to determine the relationship between days of SSD and outcomes.

The mean age of the 821 patients was 61 years and their mean APACHE II score was 25. In all, 702 patients (86%) had SSD that lasted an average of 3 days. The most common SSU pattern based on the CAM-ICU was fluctuation of mental status (which occurred in 50% of assessments) and fluctuation in mental status plus altered level of consciousness (which occurred in 22% of assessments).

Dr. Brummel and his associates also found that the duration of SSD was independently associated with increased odds of institutionalization (odds ratio, 1.90), but SSD did not predict mortality or long-term cognitive impairment at 3 or 12 months. "We don’t yet understand the mechanism behind why subsyndromal delirium and institutionalization are associated," Dr. Brummel said. "It probably relates to an association between SSD and factors that drive institutionalization, such as physical disability and cognitive impairment. Once patients survived the hospital stay, subsyndromal delirium wasn’t associated with an increased risk of mortality. It may be the fact that this less severe form of brain dysfunction in the ICU does not have the same effect as the full syndrome of delirium."

He acknowledged certain limitations of the study, including the fact that the CAM-ICU only measures four features of delirium and that no assessments of cognitive or physical function were conducted at hospital discharge.

The study was supported by the National Institutes of Health, the Vanderbilt Clinical and Translational Scholars Program, and the Veterans Affairs Tennessee Valley Healthcare System Geriatric Research Education and Clinical Centers. Dr. Brummel said that he had no relevant financial conflicts to disclose.

[email protected]

SAN DIEGO – Subsyndromal delirium was present in 86% of critically ill patients, results from a large observational study demonstrated. In addition, the duration of delirium was associated with increased odds of institutionalization, an association that was modified by the duration of delirium.

"In patients with less delirium, the effect of subsyndromal delirium on institutionalization was actually stronger," lead author Dr. Nathan E. Brummel said in an interview at an international conference of the American Thoracic Society, where the research was presented. "This identifies a cohort of people who previously were considered to have normal brain function, but it appears that this has long-term implications for their lives.

"Screening for delirium should occur not only in the ICU but on the wards as well. Patients who have delirium or delirium symptoms may benefit from measures used to prevent and treat this syndrome, such as the Hospital Elder Life Program, routine mobilization, and frequent reorientation through the use of nursing staff or even family members," he later added. This study data may help clinicians discuss long-term outcomes of critical illness with patients and their family members," he said.

For the study, Dr. Brummel, an instructor in medicine in the division of allergy, pulmonary and critical care medicine at Vanderbilt University Medical Center, Nashville, Tenn., and his associates evaluated 821 medical or surgical ICU patients with respiratory failure and/or shock who were enrolled in the BRAIN-ICU observational cohort study (N. Engl. J. Med. 2013;369:1306-16).

They used the Confusion Assessment Method for the ICU (CAM-ICU) to screen for delirium symptoms twice daily in the ICU and daily thereafter. The researchers considered delirium to be present if the CAM-ICU was positive. If the CAM-ICU was negative, they considered subsyndromal delirium (SSD) to be present if any delirium features were present or if inattention was present with or without other features of delirium.

SSD "is said to be present when a patient exhibits some delirium symptoms but does not meet the full delirium diagnostic criteria," the researchers wrote in their poster. "In patients without critical illness, SSD is associated with institutionalization, mortality, and cognitive decline, but these associations remain unclear in the critically ill."

The researchers tracked discharge location, mortality after hospital discharge and assessed for cognitive impairment at 3 and 12 months follow-up and used multivariate regression to determine the relationship between days of SSD and outcomes.

The mean age of the 821 patients was 61 years and their mean APACHE II score was 25. In all, 702 patients (86%) had SSD that lasted an average of 3 days. The most common SSU pattern based on the CAM-ICU was fluctuation of mental status (which occurred in 50% of assessments) and fluctuation in mental status plus altered level of consciousness (which occurred in 22% of assessments).

Dr. Brummel and his associates also found that the duration of SSD was independently associated with increased odds of institutionalization (odds ratio, 1.90), but SSD did not predict mortality or long-term cognitive impairment at 3 or 12 months. "We don’t yet understand the mechanism behind why subsyndromal delirium and institutionalization are associated," Dr. Brummel said. "It probably relates to an association between SSD and factors that drive institutionalization, such as physical disability and cognitive impairment. Once patients survived the hospital stay, subsyndromal delirium wasn’t associated with an increased risk of mortality. It may be the fact that this less severe form of brain dysfunction in the ICU does not have the same effect as the full syndrome of delirium."

He acknowledged certain limitations of the study, including the fact that the CAM-ICU only measures four features of delirium and that no assessments of cognitive or physical function were conducted at hospital discharge.

The study was supported by the National Institutes of Health, the Vanderbilt Clinical and Translational Scholars Program, and the Veterans Affairs Tennessee Valley Healthcare System Geriatric Research Education and Clinical Centers. Dr. Brummel said that he had no relevant financial conflicts to disclose.

[email protected]

SAN DIEGO – Subsyndromal delirium was present in 86% of critically ill patients, results from a large observational study demonstrated. In addition, the duration of delirium was associated with increased odds of institutionalization, an association that was modified by the duration of delirium.

"In patients with less delirium, the effect of subsyndromal delirium on institutionalization was actually stronger," lead author Dr. Nathan E. Brummel said in an interview at an international conference of the American Thoracic Society, where the research was presented. "This identifies a cohort of people who previously were considered to have normal brain function, but it appears that this has long-term implications for their lives.

"Screening for delirium should occur not only in the ICU but on the wards as well. Patients who have delirium or delirium symptoms may benefit from measures used to prevent and treat this syndrome, such as the Hospital Elder Life Program, routine mobilization, and frequent reorientation through the use of nursing staff or even family members," he later added. This study data may help clinicians discuss long-term outcomes of critical illness with patients and their family members," he said.

For the study, Dr. Brummel, an instructor in medicine in the division of allergy, pulmonary and critical care medicine at Vanderbilt University Medical Center, Nashville, Tenn., and his associates evaluated 821 medical or surgical ICU patients with respiratory failure and/or shock who were enrolled in the BRAIN-ICU observational cohort study (N. Engl. J. Med. 2013;369:1306-16).

They used the Confusion Assessment Method for the ICU (CAM-ICU) to screen for delirium symptoms twice daily in the ICU and daily thereafter. The researchers considered delirium to be present if the CAM-ICU was positive. If the CAM-ICU was negative, they considered subsyndromal delirium (SSD) to be present if any delirium features were present or if inattention was present with or without other features of delirium.

SSD "is said to be present when a patient exhibits some delirium symptoms but does not meet the full delirium diagnostic criteria," the researchers wrote in their poster. "In patients without critical illness, SSD is associated with institutionalization, mortality, and cognitive decline, but these associations remain unclear in the critically ill."

The researchers tracked discharge location, mortality after hospital discharge and assessed for cognitive impairment at 3 and 12 months follow-up and used multivariate regression to determine the relationship between days of SSD and outcomes.

The mean age of the 821 patients was 61 years and their mean APACHE II score was 25. In all, 702 patients (86%) had SSD that lasted an average of 3 days. The most common SSU pattern based on the CAM-ICU was fluctuation of mental status (which occurred in 50% of assessments) and fluctuation in mental status plus altered level of consciousness (which occurred in 22% of assessments).

Dr. Brummel and his associates also found that the duration of SSD was independently associated with increased odds of institutionalization (odds ratio, 1.90), but SSD did not predict mortality or long-term cognitive impairment at 3 or 12 months. "We don’t yet understand the mechanism behind why subsyndromal delirium and institutionalization are associated," Dr. Brummel said. "It probably relates to an association between SSD and factors that drive institutionalization, such as physical disability and cognitive impairment. Once patients survived the hospital stay, subsyndromal delirium wasn’t associated with an increased risk of mortality. It may be the fact that this less severe form of brain dysfunction in the ICU does not have the same effect as the full syndrome of delirium."

He acknowledged certain limitations of the study, including the fact that the CAM-ICU only measures four features of delirium and that no assessments of cognitive or physical function were conducted at hospital discharge.

The study was supported by the National Institutes of Health, the Vanderbilt Clinical and Translational Scholars Program, and the Veterans Affairs Tennessee Valley Healthcare System Geriatric Research Education and Clinical Centers. Dr. Brummel said that he had no relevant financial conflicts to disclose.

[email protected]

CHICAGO – Treatment with an intragastric balloon before bariatric surgery produces significant weight loss in the morbidly obese, but at the cost of more surgical complications, according to the prospective randomized BIGPOM trial.

Preoperative weight loss is recommended, and in some cases mandated by third-party payer organizations, to improve comorbidities and postoperative outcomes in the morbidly obese. It’s also been suggested to be a predictive factor of postoperative weight loss, but overall the data are limited and methodological quality of prospective studies in this area poor, Dr. Benoit Coffin said at the annual Digestive Disease Week.

The prospective BIGPOM (Balloon Intra Gastrique Préopératoire Pour Obésité Morbide) study randomly assigned 60 patients to standard medical care and 55 to an air- or water-filled intragastric balloon (IGB) for 6 months before laparoscopic bypass surgery. Their average body mass index was 54.7 kg/m² and 53.9 kg/m², respectively. The average balloon insertion time was 17 minutes and average age in both groups was 40 years.

Weight loss in months 0-6 was significantly higher in the IGB group, compared with standard care (–10.3 kg vs. –3.0 kg; P less than .0001), but did not differ from months 6-12 (–30.4 kg vs. –35.1 kg) or overall from months 0-12 (–40.7 kg vs. –38.1 kg), said Dr. Coffin, of Hôpital Louis Mourier, Colombes, France.

There was no significant difference in weight loss between those treated with water- or air-filled balloons (P = .0.96).

"Preoperative weight loss is not a predictive factor of postoperative weight loss," he said.

Treatment with an IGB, compared with standard care, did not modify operative time (188 minutes vs. 175 minutes), ICU stays greater than 24 hours (71.4% vs. 76%), mean hospital stay (6.8 vs. 6.3 days), or need for laparotomy (2 vs. 1).

Surgical complications, however, were significantly higher with IGB (5 vs. 0; P = .02), and included digestive hemorrhage, intraperitoneal abscess, fistula, peritonitis, occlusion, and reintervention, Dr. Coffin said.

It is not possible to conclude if the increase in complications noted in the group of patients treated by intragastric balloon is the consequence of the balloon itself or the weight loss it induced, he said.

There were no deaths or medical complications in the IGB group, although two patients experienced complications during IGB removal and one patient required surgical removal of the balloon.

Dr. Coffin reported financial relationships with Shire Pharmaceuticals, Cephalon, Almirall, Gerson Lehrman Group, Mayoly-Spindler, and Mundipharma.

[email protected]

CHICAGO – Treatment with an intragastric balloon before bariatric surgery produces significant weight loss in the morbidly obese, but at the cost of more surgical complications, according to the prospective randomized BIGPOM trial.

Preoperative weight loss is recommended, and in some cases mandated by third-party payer organizations, to improve comorbidities and postoperative outcomes in the morbidly obese. It’s also been suggested to be a predictive factor of postoperative weight loss, but overall the data are limited and methodological quality of prospective studies in this area poor, Dr. Benoit Coffin said at the annual Digestive Disease Week.

The prospective BIGPOM (Balloon Intra Gastrique Préopératoire Pour Obésité Morbide) study randomly assigned 60 patients to standard medical care and 55 to an air- or water-filled intragastric balloon (IGB) for 6 months before laparoscopic bypass surgery. Their average body mass index was 54.7 kg/m² and 53.9 kg/m², respectively. The average balloon insertion time was 17 minutes and average age in both groups was 40 years.

Weight loss in months 0-6 was significantly higher in the IGB group, compared with standard care (–10.3 kg vs. –3.0 kg; P less than .0001), but did not differ from months 6-12 (–30.4 kg vs. –35.1 kg) or overall from months 0-12 (–40.7 kg vs. –38.1 kg), said Dr. Coffin, of Hôpital Louis Mourier, Colombes, France.

There was no significant difference in weight loss between those treated with water- or air-filled balloons (P = .0.96).

"Preoperative weight loss is not a predictive factor of postoperative weight loss," he said.

Treatment with an IGB, compared with standard care, did not modify operative time (188 minutes vs. 175 minutes), ICU stays greater than 24 hours (71.4% vs. 76%), mean hospital stay (6.8 vs. 6.3 days), or need for laparotomy (2 vs. 1).

Surgical complications, however, were significantly higher with IGB (5 vs. 0; P = .02), and included digestive hemorrhage, intraperitoneal abscess, fistula, peritonitis, occlusion, and reintervention, Dr. Coffin said.

It is not possible to conclude if the increase in complications noted in the group of patients treated by intragastric balloon is the consequence of the balloon itself or the weight loss it induced, he said.

There were no deaths or medical complications in the IGB group, although two patients experienced complications during IGB removal and one patient required surgical removal of the balloon.

Dr. Coffin reported financial relationships with Shire Pharmaceuticals, Cephalon, Almirall, Gerson Lehrman Group, Mayoly-Spindler, and Mundipharma.

[email protected]

CHICAGO – Treatment with an intragastric balloon before bariatric surgery produces significant weight loss in the morbidly obese, but at the cost of more surgical complications, according to the prospective randomized BIGPOM trial.

Preoperative weight loss is recommended, and in some cases mandated by third-party payer organizations, to improve comorbidities and postoperative outcomes in the morbidly obese. It’s also been suggested to be a predictive factor of postoperative weight loss, but overall the data are limited and methodological quality of prospective studies in this area poor, Dr. Benoit Coffin said at the annual Digestive Disease Week.

The prospective BIGPOM (Balloon Intra Gastrique Préopératoire Pour Obésité Morbide) study randomly assigned 60 patients to standard medical care and 55 to an air- or water-filled intragastric balloon (IGB) for 6 months before laparoscopic bypass surgery. Their average body mass index was 54.7 kg/m² and 53.9 kg/m², respectively. The average balloon insertion time was 17 minutes and average age in both groups was 40 years.

Weight loss in months 0-6 was significantly higher in the IGB group, compared with standard care (–10.3 kg vs. –3.0 kg; P less than .0001), but did not differ from months 6-12 (–30.4 kg vs. –35.1 kg) or overall from months 0-12 (–40.7 kg vs. –38.1 kg), said Dr. Coffin, of Hôpital Louis Mourier, Colombes, France.

There was no significant difference in weight loss between those treated with water- or air-filled balloons (P = .0.96).

"Preoperative weight loss is not a predictive factor of postoperative weight loss," he said.

Treatment with an IGB, compared with standard care, did not modify operative time (188 minutes vs. 175 minutes), ICU stays greater than 24 hours (71.4% vs. 76%), mean hospital stay (6.8 vs. 6.3 days), or need for laparotomy (2 vs. 1).

Surgical complications, however, were significantly higher with IGB (5 vs. 0; P = .02), and included digestive hemorrhage, intraperitoneal abscess, fistula, peritonitis, occlusion, and reintervention, Dr. Coffin said.

It is not possible to conclude if the increase in complications noted in the group of patients treated by intragastric balloon is the consequence of the balloon itself or the weight loss it induced, he said.

There were no deaths or medical complications in the IGB group, although two patients experienced complications during IGB removal and one patient required surgical removal of the balloon.

Dr. Coffin reported financial relationships with Shire Pharmaceuticals, Cephalon, Almirall, Gerson Lehrman Group, Mayoly-Spindler, and Mundipharma.

[email protected]

The Department of Health & Human Services says it is giving some $110 million to health care organizations that have come up with innovative ways to deliver high-quality care at lower cost.

The federal grants will last for 3 years and are part of the Health Care Innovation Awards program created by the Affordable Care Act and administered by the innovation center at the Centers for Medicare & Medicaid Services.

Last May, the department announced that it was seeking applicants for as much as $1 billion in federal money for the projects.

In addition to the $110 million awarded to 12 health care organizations, the agency is making $730 million available to states seeking to "design and test improvements to their public and private health care payment and delivery systems," according to a Health & Human Services (HHS) department press release. That money has not yet been awarded.

The 12 current recipients of the Health Care Innovation Awards, profiled here, are the Altarum Institute; American College of Cardiology Foundation; Association of American Medical Colleges; Avera Health; Children’s Home Society of Florida; Clifford W. Beers Guidance Clinic; Four Seasons Compassion for Life; Icahn School of Medicine at Mount Sinai; New York City Health and Hospitals Corporation; North Shore LIJ Health System; Regents of the University of California, San Francisco; and Regents of the University of Michigan.

Additional recipients will be announced in the coming months.

Projects funded include ways to provide better care for dementia patients, to improve coordination between specialists and primary care physicians, and to ensure that children in Medicaid and the Children’s Health Insurance Program get more rapid attention to dental problems.

The American College of Cardiology Foundation received one of the biggest grants – $15.8 million – for its project, called SMARTCare. The project will use a combination of clinical decision support, shared decision-making, patient engagement, and provider feedback tools designed to improve care for stable ischemic heart disease. Among the goals: a reduction of imaging procedures not meeting appropriate use criteria; a reduction in the percentage of percutaneous coronary interventions not meeting appropriate use criteria while achieving high levels of patient engagement and lower rates of complications; and an increase in the percentage of stable ischemic heart disease patients with optimal risk factor modification.

The ACC will test SMARTCare at five sites in Wisconsin and five sites in Florida. It was developed by cardiologists who belong to those states’ ACC chapters, along with other physicians at health systems and in primary care, payers and insurers, employer health coalitions, patient advisers, and payment reform advisers.

The SMARTCare goals are big, "but we have the right people at the table to make them a reality," said Dr. Thomas Lewandowski, SMARTCare project director and immediate past governor of the ACC’s Wisconsin Chapter, in a statement.

"We believe involving patients in an evidence-based decision-making process is the best way to improve outcomes while providing the highest value for the health care dollar," said ACC President Patrick T. O’Gara, in the statement. "This grant will give us an opportunity to demonstrate how data from clinical registries can be leveraged to enhance physician/patient communication," he said.

The biggest award, about $18 million, went to the New York City Health and Hospitals Corporation, to test out an Emergency Department Care Management model. Six hospitals will expand upon a pilot program that uses multidisciplinary teams to assess ED patients; create a care plan to avoid unnecessary hospitalization; and provide ongoing support after discharge, including medication management, education, and linkages with primary care providers.

The agency says there was great interest in the latest round of awards, but it could not say how many organizations had applied. For the first round, in which awards were given out in 2012, there were 3,000 applicants, and 107 winners.

The Center for Medicare & Medicaid Innovation (CMMI) has the authority to expand any program nationally if it looks like it is producing savings.

HHS also is making $730 million available under the State Innovation Models Initiative to states that apply for the funds.

"As a former governor, I understand the real sense of urgency states and local communities feel to improve the health of their populations while also reducing health care costs, and it’s critical that the many elements of health care in each state – including Medicaid, public health, and workforce training – work together," said HHS Secretary Kathleen Sebelius in a statement. "To help, HHS will continue to encourage and assist them in their efforts to transform health care."

The states can apply for either a Model Test award to assist in implementation or a Model Design award to develop or enhance a comprehensive State Health Care Innovation Plan. Up to 12 states will be chosen for Model Test awards, and up to 15 will be chosen for Model Design awards.

HHS said that current examples of state-led health innovations include development of advanced primary care networks supported by statewide health information technology systems, and models that coordinate care seamlessly across providers.

[email protected]

On Twitter @aliciaault

The Department of Health & Human Services says it is giving some $110 million to health care organizations that have come up with innovative ways to deliver high-quality care at lower cost.

The federal grants will last for 3 years and are part of the Health Care Innovation Awards program created by the Affordable Care Act and administered by the innovation center at the Centers for Medicare & Medicaid Services.

Last May, the department announced that it was seeking applicants for as much as $1 billion in federal money for the projects.

In addition to the $110 million awarded to 12 health care organizations, the agency is making $730 million available to states seeking to "design and test improvements to their public and private health care payment and delivery systems," according to a Health & Human Services (HHS) department press release. That money has not yet been awarded.

The 12 current recipients of the Health Care Innovation Awards, profiled here, are the Altarum Institute; American College of Cardiology Foundation; Association of American Medical Colleges; Avera Health; Children’s Home Society of Florida; Clifford W. Beers Guidance Clinic; Four Seasons Compassion for Life; Icahn School of Medicine at Mount Sinai; New York City Health and Hospitals Corporation; North Shore LIJ Health System; Regents of the University of California, San Francisco; and Regents of the University of Michigan.

Additional recipients will be announced in the coming months.

Projects funded include ways to provide better care for dementia patients, to improve coordination between specialists and primary care physicians, and to ensure that children in Medicaid and the Children’s Health Insurance Program get more rapid attention to dental problems.

The American College of Cardiology Foundation received one of the biggest grants – $15.8 million – for its project, called SMARTCare. The project will use a combination of clinical decision support, shared decision-making, patient engagement, and provider feedback tools designed to improve care for stable ischemic heart disease. Among the goals: a reduction of imaging procedures not meeting appropriate use criteria; a reduction in the percentage of percutaneous coronary interventions not meeting appropriate use criteria while achieving high levels of patient engagement and lower rates of complications; and an increase in the percentage of stable ischemic heart disease patients with optimal risk factor modification.

The ACC will test SMARTCare at five sites in Wisconsin and five sites in Florida. It was developed by cardiologists who belong to those states’ ACC chapters, along with other physicians at health systems and in primary care, payers and insurers, employer health coalitions, patient advisers, and payment reform advisers.

The SMARTCare goals are big, "but we have the right people at the table to make them a reality," said Dr. Thomas Lewandowski, SMARTCare project director and immediate past governor of the ACC’s Wisconsin Chapter, in a statement.

"We believe involving patients in an evidence-based decision-making process is the best way to improve outcomes while providing the highest value for the health care dollar," said ACC President Patrick T. O’Gara, in the statement. "This grant will give us an opportunity to demonstrate how data from clinical registries can be leveraged to enhance physician/patient communication," he said.

The biggest award, about $18 million, went to the New York City Health and Hospitals Corporation, to test out an Emergency Department Care Management model. Six hospitals will expand upon a pilot program that uses multidisciplinary teams to assess ED patients; create a care plan to avoid unnecessary hospitalization; and provide ongoing support after discharge, including medication management, education, and linkages with primary care providers.

The agency says there was great interest in the latest round of awards, but it could not say how many organizations had applied. For the first round, in which awards were given out in 2012, there were 3,000 applicants, and 107 winners.

The Center for Medicare & Medicaid Innovation (CMMI) has the authority to expand any program nationally if it looks like it is producing savings.

HHS also is making $730 million available under the State Innovation Models Initiative to states that apply for the funds.

"As a former governor, I understand the real sense of urgency states and local communities feel to improve the health of their populations while also reducing health care costs, and it’s critical that the many elements of health care in each state – including Medicaid, public health, and workforce training – work together," said HHS Secretary Kathleen Sebelius in a statement. "To help, HHS will continue to encourage and assist them in their efforts to transform health care."

The states can apply for either a Model Test award to assist in implementation or a Model Design award to develop or enhance a comprehensive State Health Care Innovation Plan. Up to 12 states will be chosen for Model Test awards, and up to 15 will be chosen for Model Design awards.

HHS said that current examples of state-led health innovations include development of advanced primary care networks supported by statewide health information technology systems, and models that coordinate care seamlessly across providers.

[email protected]

On Twitter @aliciaault

The Department of Health & Human Services says it is giving some $110 million to health care organizations that have come up with innovative ways to deliver high-quality care at lower cost.

The federal grants will last for 3 years and are part of the Health Care Innovation Awards program created by the Affordable Care Act and administered by the innovation center at the Centers for Medicare & Medicaid Services.

Last May, the department announced that it was seeking applicants for as much as $1 billion in federal money for the projects.

In addition to the $110 million awarded to 12 health care organizations, the agency is making $730 million available to states seeking to "design and test improvements to their public and private health care payment and delivery systems," according to a Health & Human Services (HHS) department press release. That money has not yet been awarded.

The 12 current recipients of the Health Care Innovation Awards, profiled here, are the Altarum Institute; American College of Cardiology Foundation; Association of American Medical Colleges; Avera Health; Children’s Home Society of Florida; Clifford W. Beers Guidance Clinic; Four Seasons Compassion for Life; Icahn School of Medicine at Mount Sinai; New York City Health and Hospitals Corporation; North Shore LIJ Health System; Regents of the University of California, San Francisco; and Regents of the University of Michigan.

Additional recipients will be announced in the coming months.

Projects funded include ways to provide better care for dementia patients, to improve coordination between specialists and primary care physicians, and to ensure that children in Medicaid and the Children’s Health Insurance Program get more rapid attention to dental problems.

The American College of Cardiology Foundation received one of the biggest grants – $15.8 million – for its project, called SMARTCare. The project will use a combination of clinical decision support, shared decision-making, patient engagement, and provider feedback tools designed to improve care for stable ischemic heart disease. Among the goals: a reduction of imaging procedures not meeting appropriate use criteria; a reduction in the percentage of percutaneous coronary interventions not meeting appropriate use criteria while achieving high levels of patient engagement and lower rates of complications; and an increase in the percentage of stable ischemic heart disease patients with optimal risk factor modification.

The ACC will test SMARTCare at five sites in Wisconsin and five sites in Florida. It was developed by cardiologists who belong to those states’ ACC chapters, along with other physicians at health systems and in primary care, payers and insurers, employer health coalitions, patient advisers, and payment reform advisers.

The SMARTCare goals are big, "but we have the right people at the table to make them a reality," said Dr. Thomas Lewandowski, SMARTCare project director and immediate past governor of the ACC’s Wisconsin Chapter, in a statement.

"We believe involving patients in an evidence-based decision-making process is the best way to improve outcomes while providing the highest value for the health care dollar," said ACC President Patrick T. O’Gara, in the statement. "This grant will give us an opportunity to demonstrate how data from clinical registries can be leveraged to enhance physician/patient communication," he said.

The biggest award, about $18 million, went to the New York City Health and Hospitals Corporation, to test out an Emergency Department Care Management model. Six hospitals will expand upon a pilot program that uses multidisciplinary teams to assess ED patients; create a care plan to avoid unnecessary hospitalization; and provide ongoing support after discharge, including medication management, education, and linkages with primary care providers.

The agency says there was great interest in the latest round of awards, but it could not say how many organizations had applied. For the first round, in which awards were given out in 2012, there were 3,000 applicants, and 107 winners.

The Center for Medicare & Medicaid Innovation (CMMI) has the authority to expand any program nationally if it looks like it is producing savings.

HHS also is making $730 million available under the State Innovation Models Initiative to states that apply for the funds.

"As a former governor, I understand the real sense of urgency states and local communities feel to improve the health of their populations while also reducing health care costs, and it’s critical that the many elements of health care in each state – including Medicaid, public health, and workforce training – work together," said HHS Secretary Kathleen Sebelius in a statement. "To help, HHS will continue to encourage and assist them in their efforts to transform health care."

The states can apply for either a Model Test award to assist in implementation or a Model Design award to develop or enhance a comprehensive State Health Care Innovation Plan. Up to 12 states will be chosen for Model Test awards, and up to 15 will be chosen for Model Design awards.

HHS said that current examples of state-led health innovations include development of advanced primary care networks supported by statewide health information technology systems, and models that coordinate care seamlessly across providers.

[email protected]

On Twitter @aliciaault

Obesity poses challenges to all modes of gynecologic surgery from open to minimally invasive to vaginal procedures. Operating on obese women results in more intraoperative and postoperative complications, particularly with regard to blood loss, wound infections, and venous thromboembolic disease, and contributes to increased length of hospital stay (J. Minim. Invasive Gynecol. 2014;21:259-65). Obesity has also been associated with longer operative and nonoperative times in laparoscopy, compared with those for normal-weight patients (J. Minim. Invasive Gynecol. 2012;19:701-7;Gynecol. Oncol. 2006;103:938-41; J. Minim. Invasive Gynecol. 2014;21:259-65).

While it was initially felt that obese patients were poor candidates for laparoscopic surgery, it is now widely supported that minimally invasive surgery is both feasible and may be the optimal approach in this population (Gynecol. Oncol. 2008;111:41-5; J. Minim. Invasive Gynecol. 2010;17:576-82). When obese patients are able to undergo minimally invasive procedures, the result is shorter hospitalizations, less postoperative pain, a faster return to activity, and fewer postoperative wound infections (10.5% vs. 1.3%) (Ann. Surg. 2006;243:181-8). These improved surgical outcomes are seen with both laparoscopic and robotic surgeries, compared with laparotomy in obese patients (Int. J. Gynecol. Cancer 2012;22:76-81; Ann. Surg. Oncol. 2007;14:2384-91; J. Clin. Oncol. 2009;27:5331-6).

Obesity affects most organ systems, resulting in several challenges for our anesthesiology colleagues. In addition to difficult airway management, hemodynamic concerns and metabolic changes must be considered (J. Anesth. 2012;26:758-65). Physiologically, obesity results in an increased oxygen requirement, which leads to increased cardiac output, increased stroke volume, decreased vascular resistance, and increased cardiac work. These physiologic changes result in a higher incidence of hypertension and cardiomegaly in obese patients. Both oxygen consumption and carbon dioxide production are more marked in obese patients. This requires increased ventilation. Because of the excess chest wall weight with subsequent reduced chest wall compliance, ventilation is even more difficult in obese patients.

In addition to the baseline physiology of obesity, minimally invasive surgery adds the additional obstacle of abdominal insufflation. Insufflation increases the intra-abdominal pressure, leading to venous stasis as well as a further lowering in chest wall compliance and increased airway pressure (Ann. Surg. 2005;241:219-26; Anesth. Analg. 2002;94:1345-50). Finally, the need for Trendelenburg positioning for pelvic surgery further complicates an already difficult to ventilate patient.

In addition to the anesthetic challenges, obesity poses multiple challenges for the surgeon. With regard to laparoscopic surgery, key challenges for surgeons include safe and effective patient positioning on the operating room table, access to the abdominal cavity, and difficulty with surgical field visualization. Optimal positioning of the patient remains crucial to avoid nerve injuries.

The depth of the abdominal wall makes safely accessing the abdominal cavity more challenging. The thickness of the abdominal wall can place more torque on laparoscopic ports and instruments, which can require contorted positioning on the part of the surgeon. The surgeon risks significant personal ergonomic strain operating on patients, particularly obese patients (Gynecol. Oncol. 2012;126:437-42). Lastly, visualization in obese patients is impaired regardless of mode of surgery. All of these challenges often can be overcome or at least optimized, particularly in the hands of skilled surgical teams.

In addition to making the surgery more challenging for the surgical team, obesity increases the cost of providing surgical care. In fact, hospital-associated surgical costs totaled an additional $160 million spent annually on the care of obese patients, compared with their nonobese counterparts receiving the same services (Ann. Surg. 2013;258:541-53). Given the continued rise in the number of obese patients, particularly those with a BMI greater than 40 kg/m², the surgical concerns addressed in this column will continue to pose challenges to surgeons.

Dr. Clark is a chief resident in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Clarke-Pearson is the chair and the Robert A. Ross Distinguished Professor of Obstetrics and Gynecology, and a professor in the division of gynecologic oncology, at the university. Dr. Clark and Dr. Clarke-Pearson said they had no relevant financial disclosures.

Obesity poses challenges to all modes of gynecologic surgery from open to minimally invasive to vaginal procedures. Operating on obese women results in more intraoperative and postoperative complications, particularly with regard to blood loss, wound infections, and venous thromboembolic disease, and contributes to increased length of hospital stay (J. Minim. Invasive Gynecol. 2014;21:259-65). Obesity has also been associated with longer operative and nonoperative times in laparoscopy, compared with those for normal-weight patients (J. Minim. Invasive Gynecol. 2012;19:701-7;Gynecol. Oncol. 2006;103:938-41; J. Minim. Invasive Gynecol. 2014;21:259-65).

While it was initially felt that obese patients were poor candidates for laparoscopic surgery, it is now widely supported that minimally invasive surgery is both feasible and may be the optimal approach in this population (Gynecol. Oncol. 2008;111:41-5; J. Minim. Invasive Gynecol. 2010;17:576-82). When obese patients are able to undergo minimally invasive procedures, the result is shorter hospitalizations, less postoperative pain, a faster return to activity, and fewer postoperative wound infections (10.5% vs. 1.3%) (Ann. Surg. 2006;243:181-8). These improved surgical outcomes are seen with both laparoscopic and robotic surgeries, compared with laparotomy in obese patients (Int. J. Gynecol. Cancer 2012;22:76-81; Ann. Surg. Oncol. 2007;14:2384-91; J. Clin. Oncol. 2009;27:5331-6).

Obesity affects most organ systems, resulting in several challenges for our anesthesiology colleagues. In addition to difficult airway management, hemodynamic concerns and metabolic changes must be considered (J. Anesth. 2012;26:758-65). Physiologically, obesity results in an increased oxygen requirement, which leads to increased cardiac output, increased stroke volume, decreased vascular resistance, and increased cardiac work. These physiologic changes result in a higher incidence of hypertension and cardiomegaly in obese patients. Both oxygen consumption and carbon dioxide production are more marked in obese patients. This requires increased ventilation. Because of the excess chest wall weight with subsequent reduced chest wall compliance, ventilation is even more difficult in obese patients.

In addition to the baseline physiology of obesity, minimally invasive surgery adds the additional obstacle of abdominal insufflation. Insufflation increases the intra-abdominal pressure, leading to venous stasis as well as a further lowering in chest wall compliance and increased airway pressure (Ann. Surg. 2005;241:219-26; Anesth. Analg. 2002;94:1345-50). Finally, the need for Trendelenburg positioning for pelvic surgery further complicates an already difficult to ventilate patient.

In addition to the anesthetic challenges, obesity poses multiple challenges for the surgeon. With regard to laparoscopic surgery, key challenges for surgeons include safe and effective patient positioning on the operating room table, access to the abdominal cavity, and difficulty with surgical field visualization. Optimal positioning of the patient remains crucial to avoid nerve injuries.

The depth of the abdominal wall makes safely accessing the abdominal cavity more challenging. The thickness of the abdominal wall can place more torque on laparoscopic ports and instruments, which can require contorted positioning on the part of the surgeon. The surgeon risks significant personal ergonomic strain operating on patients, particularly obese patients (Gynecol. Oncol. 2012;126:437-42). Lastly, visualization in obese patients is impaired regardless of mode of surgery. All of these challenges often can be overcome or at least optimized, particularly in the hands of skilled surgical teams.

In addition to making the surgery more challenging for the surgical team, obesity increases the cost of providing surgical care. In fact, hospital-associated surgical costs totaled an additional $160 million spent annually on the care of obese patients, compared with their nonobese counterparts receiving the same services (Ann. Surg. 2013;258:541-53). Given the continued rise in the number of obese patients, particularly those with a BMI greater than 40 kg/m², the surgical concerns addressed in this column will continue to pose challenges to surgeons.

Dr. Clark is a chief resident in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Clarke-Pearson is the chair and the Robert A. Ross Distinguished Professor of Obstetrics and Gynecology, and a professor in the division of gynecologic oncology, at the university. Dr. Clark and Dr. Clarke-Pearson said they had no relevant financial disclosures.

Obesity poses challenges to all modes of gynecologic surgery from open to minimally invasive to vaginal procedures. Operating on obese women results in more intraoperative and postoperative complications, particularly with regard to blood loss, wound infections, and venous thromboembolic disease, and contributes to increased length of hospital stay (J. Minim. Invasive Gynecol. 2014;21:259-65). Obesity has also been associated with longer operative and nonoperative times in laparoscopy, compared with those for normal-weight patients (J. Minim. Invasive Gynecol. 2012;19:701-7;Gynecol. Oncol. 2006;103:938-41; J. Minim. Invasive Gynecol. 2014;21:259-65).

While it was initially felt that obese patients were poor candidates for laparoscopic surgery, it is now widely supported that minimally invasive surgery is both feasible and may be the optimal approach in this population (Gynecol. Oncol. 2008;111:41-5; J. Minim. Invasive Gynecol. 2010;17:576-82). When obese patients are able to undergo minimally invasive procedures, the result is shorter hospitalizations, less postoperative pain, a faster return to activity, and fewer postoperative wound infections (10.5% vs. 1.3%) (Ann. Surg. 2006;243:181-8). These improved surgical outcomes are seen with both laparoscopic and robotic surgeries, compared with laparotomy in obese patients (Int. J. Gynecol. Cancer 2012;22:76-81; Ann. Surg. Oncol. 2007;14:2384-91; J. Clin. Oncol. 2009;27:5331-6).

Obesity affects most organ systems, resulting in several challenges for our anesthesiology colleagues. In addition to difficult airway management, hemodynamic concerns and metabolic changes must be considered (J. Anesth. 2012;26:758-65). Physiologically, obesity results in an increased oxygen requirement, which leads to increased cardiac output, increased stroke volume, decreased vascular resistance, and increased cardiac work. These physiologic changes result in a higher incidence of hypertension and cardiomegaly in obese patients. Both oxygen consumption and carbon dioxide production are more marked in obese patients. This requires increased ventilation. Because of the excess chest wall weight with subsequent reduced chest wall compliance, ventilation is even more difficult in obese patients.

In addition to the baseline physiology of obesity, minimally invasive surgery adds the additional obstacle of abdominal insufflation. Insufflation increases the intra-abdominal pressure, leading to venous stasis as well as a further lowering in chest wall compliance and increased airway pressure (Ann. Surg. 2005;241:219-26; Anesth. Analg. 2002;94:1345-50). Finally, the need for Trendelenburg positioning for pelvic surgery further complicates an already difficult to ventilate patient.

In addition to the anesthetic challenges, obesity poses multiple challenges for the surgeon. With regard to laparoscopic surgery, key challenges for surgeons include safe and effective patient positioning on the operating room table, access to the abdominal cavity, and difficulty with surgical field visualization. Optimal positioning of the patient remains crucial to avoid nerve injuries.

The depth of the abdominal wall makes safely accessing the abdominal cavity more challenging. The thickness of the abdominal wall can place more torque on laparoscopic ports and instruments, which can require contorted positioning on the part of the surgeon. The surgeon risks significant personal ergonomic strain operating on patients, particularly obese patients (Gynecol. Oncol. 2012;126:437-42). Lastly, visualization in obese patients is impaired regardless of mode of surgery. All of these challenges often can be overcome or at least optimized, particularly in the hands of skilled surgical teams.

In addition to making the surgery more challenging for the surgical team, obesity increases the cost of providing surgical care. In fact, hospital-associated surgical costs totaled an additional $160 million spent annually on the care of obese patients, compared with their nonobese counterparts receiving the same services (Ann. Surg. 2013;258:541-53). Given the continued rise in the number of obese patients, particularly those with a BMI greater than 40 kg/m², the surgical concerns addressed in this column will continue to pose challenges to surgeons.

Dr. Clark is a chief resident in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Clarke-Pearson is the chair and the Robert A. Ross Distinguished Professor of Obstetrics and Gynecology, and a professor in the division of gynecologic oncology, at the university. Dr. Clark and Dr. Clarke-Pearson said they had no relevant financial disclosures.

BOSTON – Preoperative comorbidities and postoperative complications are the most common reasons that patients are readmitted to a hospital within 30 days of thyroid or parathyroid surgery, but outpatient surgery was associated with a lower likelihood of readmission, investigators have found.

A review of data on more than 7,000 patients who underwent cervical endocrine resections showed that 4% were readmitted within a month of surgery, reported Dr. Matthew G. Mullen, a surgery resident at the University of Virginia Health System in Charlottesville.

"Identifying best practice patterns to avoid major postoperative complications will help reduce hospital readmission rates and improve the quality of patient care," Dr. Mullen said at the annual meeting of the American Association of Endocrine Surgeons.

Previous single-institution studies have shown readmission rates for patients undergoing thyroidectomy of 0.3%-3.9%. A 2010 study of readmission rates among elderly patients undergoing thyroidectomy for thyroid cancer found that 8% required readmission within a month of surgery, Dr. Mullen noted.

To see whether, as they suspected, patients with more medical comorbidities and postoperative complications are more likely to be back in the hospital within 30 days of surgery, the investigators reviewed the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) participant use data file, which includes records on 442,149 elective surgery cases from 315 U.S. hospitals. Data on a total of 7,069 total elective cases, including 3,711 thyroidectomies and 3,358 parathyroidectomies were reviewed.

They found an overall readmission rate of 4.0%, with a rate of 4.1% for patients undergoing thyroidectomy, and 3.8% for those undergoing parathyroidectomy.

Demographic factors significantly associated with a greater likelihood of readmission included diabetes (present in 18.6% of readmitted patients, vs. 12.5% of not readmitted patients; P = .003), severe chronic obstructive pulmonary disease (4.6% vs. 2.0%; P = .002), hemodialysis (11.8% vs. 2.2%; P = .001), and weight loss of more than 10% (1.8% vs. 0.5%; P = .005). Younger and heavier patients were more likely to be readmitted within 30 days than were slightly older and lighter-weight patients.

Complications predict readmission

Postoperative complications associated with readmission included wound complications (5% vs. 0.3%; P less than .001 for all following comparisons, unless noted), respiratory complications 5.4 vs. 0.2%), renal complications (2.1% vs. 0.3%), neurologic complications (0.7% vs. 0.1%; P = .008), and cardiovascular complications (4.6% vs. 0.2%).

In multivariate analysis, factors that were significantly associated with readmission were reoperation within 30 days (P less than .001), American Society of Anesthesiologists physical status class (P = .024), patient functional status (independent vs. partially or fully dependent, P = .007), renal insufficiency (P = .004), and hemodialysis (P = .005).

In contrast, patients who were discharged within 24 hours of surgery were significantly less likely to be readmitted (odds ratio, 0.63; P = .006).

The researchers also found that 63% of patients had a longer than 24-hour stay after surgery – a finding that Dr. Mullen said was surprising – and that patients undergoing surgery for malignant disease were significantly more likely to be readmitted than were patients with benign disease (11% vs. 2.6%, P less than .001). There was no difference in readmission rates of patients treated by general surgeons, compared with those treated by surgeons trained in otolaryngologic procedures.

Dr. Mullen noted that the study was limited by the lack of data on the reasons for each readmission and by a lack of information on many complications that are specific to endocrine surgery.

In the discussion, Dr. Samuel K. Snyder of Texas A & M University in Temple, commented on the lack of study specifics about the reasons for readmission making it hard to draw conclusions about how best to prevent readmissions.

Dr. Mullen responded that because some of the patients had treatable comorbidities such as renal insufficiency, medical augmentation could be a reasonable approach to reducing postoperative complications and risk of readmission.

The authors did not disclose the study funding source. Dr. Mullen and Dr. Snyder reported having no financial disclosures.

BOSTON – Preoperative comorbidities and postoperative complications are the most common reasons that patients are readmitted to a hospital within 30 days of thyroid or parathyroid surgery, but outpatient surgery was associated with a lower likelihood of readmission, investigators have found.

A review of data on more than 7,000 patients who underwent cervical endocrine resections showed that 4% were readmitted within a month of surgery, reported Dr. Matthew G. Mullen, a surgery resident at the University of Virginia Health System in Charlottesville.

"Identifying best practice patterns to avoid major postoperative complications will help reduce hospital readmission rates and improve the quality of patient care," Dr. Mullen said at the annual meeting of the American Association of Endocrine Surgeons.

Previous single-institution studies have shown readmission rates for patients undergoing thyroidectomy of 0.3%-3.9%. A 2010 study of readmission rates among elderly patients undergoing thyroidectomy for thyroid cancer found that 8% required readmission within a month of surgery, Dr. Mullen noted.

To see whether, as they suspected, patients with more medical comorbidities and postoperative complications are more likely to be back in the hospital within 30 days of surgery, the investigators reviewed the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) participant use data file, which includes records on 442,149 elective surgery cases from 315 U.S. hospitals. Data on a total of 7,069 total elective cases, including 3,711 thyroidectomies and 3,358 parathyroidectomies were reviewed.

They found an overall readmission rate of 4.0%, with a rate of 4.1% for patients undergoing thyroidectomy, and 3.8% for those undergoing parathyroidectomy.

Demographic factors significantly associated with a greater likelihood of readmission included diabetes (present in 18.6% of readmitted patients, vs. 12.5% of not readmitted patients; P = .003), severe chronic obstructive pulmonary disease (4.6% vs. 2.0%; P = .002), hemodialysis (11.8% vs. 2.2%; P = .001), and weight loss of more than 10% (1.8% vs. 0.5%; P = .005). Younger and heavier patients were more likely to be readmitted within 30 days than were slightly older and lighter-weight patients.

Complications predict readmission

Postoperative complications associated with readmission included wound complications (5% vs. 0.3%; P less than .001 for all following comparisons, unless noted), respiratory complications 5.4 vs. 0.2%), renal complications (2.1% vs. 0.3%), neurologic complications (0.7% vs. 0.1%; P = .008), and cardiovascular complications (4.6% vs. 0.2%).

In multivariate analysis, factors that were significantly associated with readmission were reoperation within 30 days (P less than .001), American Society of Anesthesiologists physical status class (P = .024), patient functional status (independent vs. partially or fully dependent, P = .007), renal insufficiency (P = .004), and hemodialysis (P = .005).

In contrast, patients who were discharged within 24 hours of surgery were significantly less likely to be readmitted (odds ratio, 0.63; P = .006).

The researchers also found that 63% of patients had a longer than 24-hour stay after surgery – a finding that Dr. Mullen said was surprising – and that patients undergoing surgery for malignant disease were significantly more likely to be readmitted than were patients with benign disease (11% vs. 2.6%, P less than .001). There was no difference in readmission rates of patients treated by general surgeons, compared with those treated by surgeons trained in otolaryngologic procedures.

Dr. Mullen noted that the study was limited by the lack of data on the reasons for each readmission and by a lack of information on many complications that are specific to endocrine surgery.

In the discussion, Dr. Samuel K. Snyder of Texas A & M University in Temple, commented on the lack of study specifics about the reasons for readmission making it hard to draw conclusions about how best to prevent readmissions.

Dr. Mullen responded that because some of the patients had treatable comorbidities such as renal insufficiency, medical augmentation could be a reasonable approach to reducing postoperative complications and risk of readmission.

The authors did not disclose the study funding source. Dr. Mullen and Dr. Snyder reported having no financial disclosures.

BOSTON – Preoperative comorbidities and postoperative complications are the most common reasons that patients are readmitted to a hospital within 30 days of thyroid or parathyroid surgery, but outpatient surgery was associated with a lower likelihood of readmission, investigators have found.

A review of data on more than 7,000 patients who underwent cervical endocrine resections showed that 4% were readmitted within a month of surgery, reported Dr. Matthew G. Mullen, a surgery resident at the University of Virginia Health System in Charlottesville.

"Identifying best practice patterns to avoid major postoperative complications will help reduce hospital readmission rates and improve the quality of patient care," Dr. Mullen said at the annual meeting of the American Association of Endocrine Surgeons.

Previous single-institution studies have shown readmission rates for patients undergoing thyroidectomy of 0.3%-3.9%. A 2010 study of readmission rates among elderly patients undergoing thyroidectomy for thyroid cancer found that 8% required readmission within a month of surgery, Dr. Mullen noted.

To see whether, as they suspected, patients with more medical comorbidities and postoperative complications are more likely to be back in the hospital within 30 days of surgery, the investigators reviewed the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) participant use data file, which includes records on 442,149 elective surgery cases from 315 U.S. hospitals. Data on a total of 7,069 total elective cases, including 3,711 thyroidectomies and 3,358 parathyroidectomies were reviewed.

They found an overall readmission rate of 4.0%, with a rate of 4.1% for patients undergoing thyroidectomy, and 3.8% for those undergoing parathyroidectomy.

Demographic factors significantly associated with a greater likelihood of readmission included diabetes (present in 18.6% of readmitted patients, vs. 12.5% of not readmitted patients; P = .003), severe chronic obstructive pulmonary disease (4.6% vs. 2.0%; P = .002), hemodialysis (11.8% vs. 2.2%; P = .001), and weight loss of more than 10% (1.8% vs. 0.5%; P = .005). Younger and heavier patients were more likely to be readmitted within 30 days than were slightly older and lighter-weight patients.

Complications predict readmission

Postoperative complications associated with readmission included wound complications (5% vs. 0.3%; P less than .001 for all following comparisons, unless noted), respiratory complications 5.4 vs. 0.2%), renal complications (2.1% vs. 0.3%), neurologic complications (0.7% vs. 0.1%; P = .008), and cardiovascular complications (4.6% vs. 0.2%).

In multivariate analysis, factors that were significantly associated with readmission were reoperation within 30 days (P less than .001), American Society of Anesthesiologists physical status class (P = .024), patient functional status (independent vs. partially or fully dependent, P = .007), renal insufficiency (P = .004), and hemodialysis (P = .005).

In contrast, patients who were discharged within 24 hours of surgery were significantly less likely to be readmitted (odds ratio, 0.63; P = .006).

The researchers also found that 63% of patients had a longer than 24-hour stay after surgery – a finding that Dr. Mullen said was surprising – and that patients undergoing surgery for malignant disease were significantly more likely to be readmitted than were patients with benign disease (11% vs. 2.6%, P less than .001). There was no difference in readmission rates of patients treated by general surgeons, compared with those treated by surgeons trained in otolaryngologic procedures.

Dr. Mullen noted that the study was limited by the lack of data on the reasons for each readmission and by a lack of information on many complications that are specific to endocrine surgery.

In the discussion, Dr. Samuel K. Snyder of Texas A & M University in Temple, commented on the lack of study specifics about the reasons for readmission making it hard to draw conclusions about how best to prevent readmissions.

Dr. Mullen responded that because some of the patients had treatable comorbidities such as renal insufficiency, medical augmentation could be a reasonable approach to reducing postoperative complications and risk of readmission.

The authors did not disclose the study funding source. Dr. Mullen and Dr. Snyder reported having no financial disclosures.

Clearing an occluded central venous catheter with alteplase is just as effective as replacing the line, but costs significantly less.

A large, retrospective, industry-funded study has concluded that treatment with alteplase costs about $1,400 less than replacing the line. Differences in radiologic, nursing, and surgical costs accounted for most of that, Frank R. Ernst, Pharm.D., and his colleagues wrote online in the Journal of Hospital Medicine (J. Hosp. Med. 2014 May 14 [doi: 10.1002/jhm.2208]).

The additional finding that length of stay was not a main cost driver lends credence to the idea that alteplase could be a good choice whether patients only need line clearance, or are already in the hospital for other reasons, wrote Dr. Ernst of Premier Research Services, Charlotte, N.C., and his coauthors.

"If patients are admitted for a noncardiovascular condition and have central venous catheter occlusion, using alteplase to clear the ... occlusion, along with implementing strategies to manage the underlying disease to reduce the length of stay, becomes a powerful opportunity to impact cost," the investigators wrote.

"Among patients who may come to the hospital for just the ... occlusion, the length of stay should be short. There may be no significant opportunity to reduce the length of stay in those cases, but opportunities to decrease core hospital resource utilization with alteplase make this approach beneficial if the patient can tolerate it."

The retrospective study comprised data on 34,579 patients who had been treated for a central venous catheter (CVC) occlusion. Of these, 33,551 were treated with 2 mg alteplase. The other 1,028 had the CVC replaced.

More than half of the cohort were older than 65 years, but patients who got alteplase were an average of 2 years younger than those who had surgery (63 vs. 65 years). Significantly more of those in the alteplase group had serious comorbidities, including chronic obstructive pulmonary disease, liver and renal disease, and diabetes with complications. Catheter replacements were more commonly done in teaching hospitals than in nonteaching hospitals (58% vs. 42%). Larger hospitals also did more replacements: up to 42% of those with 300 or more beds, but no more than 12% for those with 299 or fewer beds.

After adjustment for baseline characteristics, the daily charge for patients treated with alteplase was $317 less than for those who had the line replaced. This translated to an average savings of $1,419 per patient.

Those savings accrued in different departments, and for different periods, the authors said. For example, in the preocclusion period, cardiology/electrocardiography costs were lower for those in the replacement group – but in the postocclusion period, they were lower in the alteplase group. Many other hospital charges were also lower for the replacement group during the preocclusion period (lab, nursing, surgical, pharmacy, radiology, and intensive care costs), but higher in the postocclusion period.

In an unadjusted analysis of readmissions, there were no statistically significant differences between groups in either the 30- or 90-day rates. Neither diagnoses of heart failure, heart attack, nor cancer altered this finding.

The authors, one of whom is Dr. Alpesh N. Amin, an adviser to Hospitalist News, noted that the findings are limited by the issues inherent in every retrospective database study, including an inability to access the clinical information that would have affected decision-making.

Genentech, which markets alteplase, funded the study. Dr. Ernst is an employee of Premier, which Genentech contracted to perform the study. Several of the coauthors reported financial relationships with Genentech.

[email protected]

Clearing an occluded central venous catheter with alteplase is just as effective as replacing the line, but costs significantly less.

A large, retrospective, industry-funded study has concluded that treatment with alteplase costs about $1,400 less than replacing the line. Differences in radiologic, nursing, and surgical costs accounted for most of that, Frank R. Ernst, Pharm.D., and his colleagues wrote online in the Journal of Hospital Medicine (J. Hosp. Med. 2014 May 14 [doi: 10.1002/jhm.2208]).

The additional finding that length of stay was not a main cost driver lends credence to the idea that alteplase could be a good choice whether patients only need line clearance, or are already in the hospital for other reasons, wrote Dr. Ernst of Premier Research Services, Charlotte, N.C., and his coauthors.

"If patients are admitted for a noncardiovascular condition and have central venous catheter occlusion, using alteplase to clear the ... occlusion, along with implementing strategies to manage the underlying disease to reduce the length of stay, becomes a powerful opportunity to impact cost," the investigators wrote.

"Among patients who may come to the hospital for just the ... occlusion, the length of stay should be short. There may be no significant opportunity to reduce the length of stay in those cases, but opportunities to decrease core hospital resource utilization with alteplase make this approach beneficial if the patient can tolerate it."

The retrospective study comprised data on 34,579 patients who had been treated for a central venous catheter (CVC) occlusion. Of these, 33,551 were treated with 2 mg alteplase. The other 1,028 had the CVC replaced.

More than half of the cohort were older than 65 years, but patients who got alteplase were an average of 2 years younger than those who had surgery (63 vs. 65 years). Significantly more of those in the alteplase group had serious comorbidities, including chronic obstructive pulmonary disease, liver and renal disease, and diabetes with complications. Catheter replacements were more commonly done in teaching hospitals than in nonteaching hospitals (58% vs. 42%). Larger hospitals also did more replacements: up to 42% of those with 300 or more beds, but no more than 12% for those with 299 or fewer beds.

After adjustment for baseline characteristics, the daily charge for patients treated with alteplase was $317 less than for those who had the line replaced. This translated to an average savings of $1,419 per patient.

Those savings accrued in different departments, and for different periods, the authors said. For example, in the preocclusion period, cardiology/electrocardiography costs were lower for those in the replacement group – but in the postocclusion period, they were lower in the alteplase group. Many other hospital charges were also lower for the replacement group during the preocclusion period (lab, nursing, surgical, pharmacy, radiology, and intensive care costs), but higher in the postocclusion period.

In an unadjusted analysis of readmissions, there were no statistically significant differences between groups in either the 30- or 90-day rates. Neither diagnoses of heart failure, heart attack, nor cancer altered this finding.

The authors, one of whom is Dr. Alpesh N. Amin, an adviser to Hospitalist News, noted that the findings are limited by the issues inherent in every retrospective database study, including an inability to access the clinical information that would have affected decision-making.

Genentech, which markets alteplase, funded the study. Dr. Ernst is an employee of Premier, which Genentech contracted to perform the study. Several of the coauthors reported financial relationships with Genentech.

[email protected]

Clearing an occluded central venous catheter with alteplase is just as effective as replacing the line, but costs significantly less.

A large, retrospective, industry-funded study has concluded that treatment with alteplase costs about $1,400 less than replacing the line. Differences in radiologic, nursing, and surgical costs accounted for most of that, Frank R. Ernst, Pharm.D., and his colleagues wrote online in the Journal of Hospital Medicine (J. Hosp. Med. 2014 May 14 [doi: 10.1002/jhm.2208]).

The additional finding that length of stay was not a main cost driver lends credence to the idea that alteplase could be a good choice whether patients only need line clearance, or are already in the hospital for other reasons, wrote Dr. Ernst of Premier Research Services, Charlotte, N.C., and his coauthors.

"If patients are admitted for a noncardiovascular condition and have central venous catheter occlusion, using alteplase to clear the ... occlusion, along with implementing strategies to manage the underlying disease to reduce the length of stay, becomes a powerful opportunity to impact cost," the investigators wrote.

"Among patients who may come to the hospital for just the ... occlusion, the length of stay should be short. There may be no significant opportunity to reduce the length of stay in those cases, but opportunities to decrease core hospital resource utilization with alteplase make this approach beneficial if the patient can tolerate it."

The retrospective study comprised data on 34,579 patients who had been treated for a central venous catheter (CVC) occlusion. Of these, 33,551 were treated with 2 mg alteplase. The other 1,028 had the CVC replaced.

More than half of the cohort were older than 65 years, but patients who got alteplase were an average of 2 years younger than those who had surgery (63 vs. 65 years). Significantly more of those in the alteplase group had serious comorbidities, including chronic obstructive pulmonary disease, liver and renal disease, and diabetes with complications. Catheter replacements were more commonly done in teaching hospitals than in nonteaching hospitals (58% vs. 42%). Larger hospitals also did more replacements: up to 42% of those with 300 or more beds, but no more than 12% for those with 299 or fewer beds.

After adjustment for baseline characteristics, the daily charge for patients treated with alteplase was $317 less than for those who had the line replaced. This translated to an average savings of $1,419 per patient.

Those savings accrued in different departments, and for different periods, the authors said. For example, in the preocclusion period, cardiology/electrocardiography costs were lower for those in the replacement group – but in the postocclusion period, they were lower in the alteplase group. Many other hospital charges were also lower for the replacement group during the preocclusion period (lab, nursing, surgical, pharmacy, radiology, and intensive care costs), but higher in the postocclusion period.

In an unadjusted analysis of readmissions, there were no statistically significant differences between groups in either the 30- or 90-day rates. Neither diagnoses of heart failure, heart attack, nor cancer altered this finding.

The authors, one of whom is Dr. Alpesh N. Amin, an adviser to Hospitalist News, noted that the findings are limited by the issues inherent in every retrospective database study, including an inability to access the clinical information that would have affected decision-making.

Genentech, which markets alteplase, funded the study. Dr. Ernst is an employee of Premier, which Genentech contracted to perform the study. Several of the coauthors reported financial relationships with Genentech.

[email protected]

President Obama’s choice to be the new Secretary of the Department of Health & Human Services moved one step closer to that position with a Senate panel voting in favor of the nominee.

The Senate Finance Committee voted 21-3 May 21 to approve Sylvia Mathews Burwell as the new chief of HHS. She will replace Kathleen Sebelius, who has said she will step down when there is a new secretary in place.

"Ms. Burwell is highly qualified and well respected by Democrats and Republicans in government and in the private sector," said Sen. Ron Wyden (D-Ore.), chairman of the Finance Committee. "My view is that she will hit the ground running at the Department of Health & Human Services," he said.

Alicia Ault/Frontline Medical News

At a Finance Committee hearing May 14, Ms. Burwell promised to be responsive to Congress, particularly in addressing issues related to the Affordable Care Act. She also said she was eager to work on a replacement for Medicare’s Sustainable Growth Rate factor.

Ms. Burwell is currently the director of the White House Office of Management and Budget.

Sen. Johnny Isakson (R-Ga.) said that at that earlier hearing, he found Ms. Burwell to be "forthright, and she was honest." He added, "I didn’t support the Affordable Care Act, but I believe with her in place, we’ll get answers to questions when they are asked, we’ll get accountability and honesty in the management of the department, and that’s a step in the right direction."

He said that he would vote for Ms. Burwell when the full Senate took up her nomination.

"I think we have a chance at having a really great administrator," said Sen. Orrin Hatch (R-Utah) of Ms. Burwell. "I very much support her."

Three Republican committee members voted against the nomination: Pat Roberts (Kan.), John Cornyn (Texas), and John Thune (S.D.).

The full Senate likely will vote on her nomination soon, possibly before the Senate recesses for a week beginning May 23.

[email protected]

On Twitter @aliciaault

President Obama’s choice to be the new Secretary of the Department of Health & Human Services moved one step closer to that position with a Senate panel voting in favor of the nominee.

The Senate Finance Committee voted 21-3 May 21 to approve Sylvia Mathews Burwell as the new chief of HHS. She will replace Kathleen Sebelius, who has said she will step down when there is a new secretary in place.

"Ms. Burwell is highly qualified and well respected by Democrats and Republicans in government and in the private sector," said Sen. Ron Wyden (D-Ore.), chairman of the Finance Committee. "My view is that she will hit the ground running at the Department of Health & Human Services," he said.

Alicia Ault/Frontline Medical News

At a Finance Committee hearing May 14, Ms. Burwell promised to be responsive to Congress, particularly in addressing issues related to the Affordable Care Act. She also said she was eager to work on a replacement for Medicare’s Sustainable Growth Rate factor.

Ms. Burwell is currently the director of the White House Office of Management and Budget.

Sen. Johnny Isakson (R-Ga.) said that at that earlier hearing, he found Ms. Burwell to be "forthright, and she was honest." He added, "I didn’t support the Affordable Care Act, but I believe with her in place, we’ll get answers to questions when they are asked, we’ll get accountability and honesty in the management of the department, and that’s a step in the right direction."

He said that he would vote for Ms. Burwell when the full Senate took up her nomination.

"I think we have a chance at having a really great administrator," said Sen. Orrin Hatch (R-Utah) of Ms. Burwell. "I very much support her."

Three Republican committee members voted against the nomination: Pat Roberts (Kan.), John Cornyn (Texas), and John Thune (S.D.).

The full Senate likely will vote on her nomination soon, possibly before the Senate recesses for a week beginning May 23.

[email protected]

On Twitter @aliciaault

President Obama’s choice to be the new Secretary of the Department of Health & Human Services moved one step closer to that position with a Senate panel voting in favor of the nominee.

The Senate Finance Committee voted 21-3 May 21 to approve Sylvia Mathews Burwell as the new chief of HHS. She will replace Kathleen Sebelius, who has said she will step down when there is a new secretary in place.

"Ms. Burwell is highly qualified and well respected by Democrats and Republicans in government and in the private sector," said Sen. Ron Wyden (D-Ore.), chairman of the Finance Committee. "My view is that she will hit the ground running at the Department of Health & Human Services," he said.

Alicia Ault/Frontline Medical News

At a Finance Committee hearing May 14, Ms. Burwell promised to be responsive to Congress, particularly in addressing issues related to the Affordable Care Act. She also said she was eager to work on a replacement for Medicare’s Sustainable Growth Rate factor.

Ms. Burwell is currently the director of the White House Office of Management and Budget.

Sen. Johnny Isakson (R-Ga.) said that at that earlier hearing, he found Ms. Burwell to be "forthright, and she was honest." He added, "I didn’t support the Affordable Care Act, but I believe with her in place, we’ll get answers to questions when they are asked, we’ll get accountability and honesty in the management of the department, and that’s a step in the right direction."

He said that he would vote for Ms. Burwell when the full Senate took up her nomination.

"I think we have a chance at having a really great administrator," said Sen. Orrin Hatch (R-Utah) of Ms. Burwell. "I very much support her."

Three Republican committee members voted against the nomination: Pat Roberts (Kan.), John Cornyn (Texas), and John Thune (S.D.).

The full Senate likely will vote on her nomination soon, possibly before the Senate recesses for a week beginning May 23.

[email protected]

On Twitter @aliciaault

Fear seems to be a major driver of contralateral prophylactic mastectomy after initial breast cancer surgery.

Almost two-thirds of those who had the procedure had no clinical indication for it, Sarah T. Hawley, Ph.D., and her colleagues wrote in the May 21 online issue of JAMA Surgery (doi:10.1001/jamasurg.2013.5689). The women choosing contralateral prophylactic mastectomy (CPM) for which there was no clinical indication were more highly educated than were those who didn’t elect the surgery, more likely to be white, and two to four times more likely to be worried about a recurrence.

Fear of recurrence was a "powerful nonclinical factor" in the analysis, wrote Dr. Hawley of the University of Michigan, Ann Arbor – and education may be the best way to overcome it.

"A patient’s decision to undergo contralateral prophylactic mastectomy based on a strong fear of recurrence in the absence of clinical indications presents an important clinical challenge for surgeons," she and her colleagues wrote. "Growing literature supports the notion that patients have a difficult time assessing and interpreting their own risk and that fear and anxiety related to disease recurrence often supersede accurate risk perceptions to drive health decisions."

Dr. Hawley and her coinvestigators extracted their data from the Surveillance, Epidemiology, and End Results (SEER) registries for Los Angeles and Detroit. They included records from 1,447 women aged 20-79 years who had been diagnosed with a first incident primary ductal carcinoma in situ or invasive breast cancer of stages I-IIIa.

About half of the sample was white; 21% was black, and 30% Hispanic. Other groups made up the balance. More than half (59%) had achieved some college-level education.

About half the respondents (57%) underwent breast-conserving surgery (BCS). Other surgical treatments included unilateral mastectomy (UM; 34%), and contralateral prophylactic mastectomy (8%).

CPM was pondered more frequently than it was an executed, the investigators said, with 19% of the entire sample considering it "strongly or very strongly."

Most of the women who had CPM said that they did it to prevent recurrence, with 78% citing that worry as a very important driver of their decision. However, the authors said, of the 106 women who underwent CPM, only 31% had clinical indications, while the majority (67%) did not.

A multivariate analysis determined the relationships between patient characteristics and breast surgery,

Those with some college-level education were five times more likely to have CPM than UM, and four times more likely to have that than BCS. Those with high worry were almost three times more likely to have CPM than UM, and four times more likely to have CPM than BCS.

Women who had positive genetic testing were 10 times more likely to have contralateral prophylactic mastectomy than unilateral mastectomy, and 19 times more likely to have CPM than BCS. But those with negative results were still twice as likely to have the CPM as either of the other surgeries.

Having at least two close relatives with breast or ovarian cancer also significantly increased the likelihood of a CMP vs. UM (relative risk = 5) or BCS (RR = 4). Having had a diagnostic MRI doubled the chance of having CPM, compared with the other surgeries.

"Our results provide evidence that decisions about CPM represent a clear case in which better strategies to increase patient knowledge about their own risk of developing contralateral cancer as well as the net benefit of treatment are needed and should be made only after patients are accurately informed about these issues," Dr. Hawley and her coauthors said, adding that such patients need to clearly understand the consequences of CMP, "including lengthy recovery time and increased risk for serious operative complications."

The National Institutes of Health and the University of Michigan supported the study. Neither Dr. Hawley nor her coauthors had any financial disclosures.

[email protected]

On Twitter @alz_gal

Fear seems to be a major driver of contralateral prophylactic mastectomy after initial breast cancer surgery.

Almost two-thirds of those who had the procedure had no clinical indication for it, Sarah T. Hawley, Ph.D., and her colleagues wrote in the May 21 online issue of JAMA Surgery (doi:10.1001/jamasurg.2013.5689). The women choosing contralateral prophylactic mastectomy (CPM) for which there was no clinical indication were more highly educated than were those who didn’t elect the surgery, more likely to be white, and two to four times more likely to be worried about a recurrence.

Fear of recurrence was a "powerful nonclinical factor" in the analysis, wrote Dr. Hawley of the University of Michigan, Ann Arbor – and education may be the best way to overcome it.

"A patient’s decision to undergo contralateral prophylactic mastectomy based on a strong fear of recurrence in the absence of clinical indications presents an important clinical challenge for surgeons," she and her colleagues wrote. "Growing literature supports the notion that patients have a difficult time assessing and interpreting their own risk and that fear and anxiety related to disease recurrence often supersede accurate risk perceptions to drive health decisions."

Dr. Hawley and her coinvestigators extracted their data from the Surveillance, Epidemiology, and End Results (SEER) registries for Los Angeles and Detroit. They included records from 1,447 women aged 20-79 years who had been diagnosed with a first incident primary ductal carcinoma in situ or invasive breast cancer of stages I-IIIa.

About half of the sample was white; 21% was black, and 30% Hispanic. Other groups made up the balance. More than half (59%) had achieved some college-level education.

About half the respondents (57%) underwent breast-conserving surgery (BCS). Other surgical treatments included unilateral mastectomy (UM; 34%), and contralateral prophylactic mastectomy (8%).

CPM was pondered more frequently than it was an executed, the investigators said, with 19% of the entire sample considering it "strongly or very strongly."

Most of the women who had CPM said that they did it to prevent recurrence, with 78% citing that worry as a very important driver of their decision. However, the authors said, of the 106 women who underwent CPM, only 31% had clinical indications, while the majority (67%) did not.

A multivariate analysis determined the relationships between patient characteristics and breast surgery,

Those with some college-level education were five times more likely to have CPM than UM, and four times more likely to have that than BCS. Those with high worry were almost three times more likely to have CPM than UM, and four times more likely to have CPM than BCS.

Women who had positive genetic testing were 10 times more likely to have contralateral prophylactic mastectomy than unilateral mastectomy, and 19 times more likely to have CPM than BCS. But those with negative results were still twice as likely to have the CPM as either of the other surgeries.

Having at least two close relatives with breast or ovarian cancer also significantly increased the likelihood of a CMP vs. UM (relative risk = 5) or BCS (RR = 4). Having had a diagnostic MRI doubled the chance of having CPM, compared with the other surgeries.

"Our results provide evidence that decisions about CPM represent a clear case in which better strategies to increase patient knowledge about their own risk of developing contralateral cancer as well as the net benefit of treatment are needed and should be made only after patients are accurately informed about these issues," Dr. Hawley and her coauthors said, adding that such patients need to clearly understand the consequences of CMP, "including lengthy recovery time and increased risk for serious operative complications."

The National Institutes of Health and the University of Michigan supported the study. Neither Dr. Hawley nor her coauthors had any financial disclosures.

[email protected]

On Twitter @alz_gal

Fear seems to be a major driver of contralateral prophylactic mastectomy after initial breast cancer surgery.

Almost two-thirds of those who had the procedure had no clinical indication for it, Sarah T. Hawley, Ph.D., and her colleagues wrote in the May 21 online issue of JAMA Surgery (doi:10.1001/jamasurg.2013.5689). The women choosing contralateral prophylactic mastectomy (CPM) for which there was no clinical indication were more highly educated than were those who didn’t elect the surgery, more likely to be white, and two to four times more likely to be worried about a recurrence.

Fear of recurrence was a "powerful nonclinical factor" in the analysis, wrote Dr. Hawley of the University of Michigan, Ann Arbor – and education may be the best way to overcome it.

"A patient’s decision to undergo contralateral prophylactic mastectomy based on a strong fear of recurrence in the absence of clinical indications presents an important clinical challenge for surgeons," she and her colleagues wrote. "Growing literature supports the notion that patients have a difficult time assessing and interpreting their own risk and that fear and anxiety related to disease recurrence often supersede accurate risk perceptions to drive health decisions."

Dr. Hawley and her coinvestigators extracted their data from the Surveillance, Epidemiology, and End Results (SEER) registries for Los Angeles and Detroit. They included records from 1,447 women aged 20-79 years who had been diagnosed with a first incident primary ductal carcinoma in situ or invasive breast cancer of stages I-IIIa.

About half of the sample was white; 21% was black, and 30% Hispanic. Other groups made up the balance. More than half (59%) had achieved some college-level education.

About half the respondents (57%) underwent breast-conserving surgery (BCS). Other surgical treatments included unilateral mastectomy (UM; 34%), and contralateral prophylactic mastectomy (8%).

CPM was pondered more frequently than it was an executed, the investigators said, with 19% of the entire sample considering it "strongly or very strongly."

Most of the women who had CPM said that they did it to prevent recurrence, with 78% citing that worry as a very important driver of their decision. However, the authors said, of the 106 women who underwent CPM, only 31% had clinical indications, while the majority (67%) did not.

A multivariate analysis determined the relationships between patient characteristics and breast surgery,

Those with some college-level education were five times more likely to have CPM than UM, and four times more likely to have that than BCS. Those with high worry were almost three times more likely to have CPM than UM, and four times more likely to have CPM than BCS.

Women who had positive genetic testing were 10 times more likely to have contralateral prophylactic mastectomy than unilateral mastectomy, and 19 times more likely to have CPM than BCS. But those with negative results were still twice as likely to have the CPM as either of the other surgeries.

Having at least two close relatives with breast or ovarian cancer also significantly increased the likelihood of a CMP vs. UM (relative risk = 5) or BCS (RR = 4). Having had a diagnostic MRI doubled the chance of having CPM, compared with the other surgeries.

"Our results provide evidence that decisions about CPM represent a clear case in which better strategies to increase patient knowledge about their own risk of developing contralateral cancer as well as the net benefit of treatment are needed and should be made only after patients are accurately informed about these issues," Dr. Hawley and her coauthors said, adding that such patients need to clearly understand the consequences of CMP, "including lengthy recovery time and increased risk for serious operative complications."

The National Institutes of Health and the University of Michigan supported the study. Neither Dr. Hawley nor her coauthors had any financial disclosures.

[email protected]

On Twitter @alz_gal