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Postexposure prophylaxis may prevent Ebola disease development

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Postexposure prophylaxis may prevent Ebola disease development

A small group of health care workers at intermediate or high risk of developing Ebola virus disease after exposure to the virus did not develop the disease after being treated with postexposure prophylaxis, according to Dr. Michael Jacobs and his associates.

Of eight health care workers evacuated to the United Kingdom between January and March 2015 and assessed using an Ebola risk calculator, four were deemed to be at intermediate or high risk for developing Ebola virus disease (EVD) and were started on postexposure prophylaxis (PEP) using oral favipiravir over 10 days. In addition, two of the four also were treated with monoclonal antibodies to Ebola glycoproteins. The favipiravir, administered in high dosages, was tolerated well by the four patients, the investigators reported in Lancet Infectious Diseases.

Courtesy Wikimedia Commons/Thomas W. Geisbert/Creative Commons License

The second half of the eight-person study group had a low risk of EVD after assessment, and patients in this group were watched carefully, receiving no other form of treatment. No EVD developed in this low-risk group.

It cannot be known “whether or not PEP prevented the onset of Ebola virus disease in any of these individuals. However, two individuals had very high risk of Ebola virus transmission, and these are the first reported cases of transcutaneous, hollow-bore needlestick injuries contaminated with fresh blood that have not resulted in Ebola virus transmission,” noted Dr. Jacobs of the department of infection at Royal Free London NHS Foundation Trust and his associates.

In a related comment, Dr. Mark J. Mulligan and Dr. Paul N. Siebert said, “A needed next step is the development of a consensus risk determination algorithm devised by an expert panel, drawing on all available evidence, endorsed by health organizations, and disseminated to the field. The algorithm could be accompanied by a chart abstraction and case report form to standardize and organize data gathering.”

Dr. Mulligan and Dr. Siebert of the division of infectious diseases at Emory University in Atlanta added, “These data for recognized exposures in health care workers could be collated and analyzed in an international registry.”

Find the full study here: Lancet Infect Dis. 2015 Aug 26. doi: 10.1016/S1473-3099(15)00228-5.

lfranki@frontlinemedcom.com

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A small group of health care workers at intermediate or high risk of developing Ebola virus disease after exposure to the virus did not develop the disease after being treated with postexposure prophylaxis, according to Dr. Michael Jacobs and his associates.

Of eight health care workers evacuated to the United Kingdom between January and March 2015 and assessed using an Ebola risk calculator, four were deemed to be at intermediate or high risk for developing Ebola virus disease (EVD) and were started on postexposure prophylaxis (PEP) using oral favipiravir over 10 days. In addition, two of the four also were treated with monoclonal antibodies to Ebola glycoproteins. The favipiravir, administered in high dosages, was tolerated well by the four patients, the investigators reported in Lancet Infectious Diseases.

Courtesy Wikimedia Commons/Thomas W. Geisbert/Creative Commons License

The second half of the eight-person study group had a low risk of EVD after assessment, and patients in this group were watched carefully, receiving no other form of treatment. No EVD developed in this low-risk group.

It cannot be known “whether or not PEP prevented the onset of Ebola virus disease in any of these individuals. However, two individuals had very high risk of Ebola virus transmission, and these are the first reported cases of transcutaneous, hollow-bore needlestick injuries contaminated with fresh blood that have not resulted in Ebola virus transmission,” noted Dr. Jacobs of the department of infection at Royal Free London NHS Foundation Trust and his associates.

In a related comment, Dr. Mark J. Mulligan and Dr. Paul N. Siebert said, “A needed next step is the development of a consensus risk determination algorithm devised by an expert panel, drawing on all available evidence, endorsed by health organizations, and disseminated to the field. The algorithm could be accompanied by a chart abstraction and case report form to standardize and organize data gathering.”

Dr. Mulligan and Dr. Siebert of the division of infectious diseases at Emory University in Atlanta added, “These data for recognized exposures in health care workers could be collated and analyzed in an international registry.”

Find the full study here: Lancet Infect Dis. 2015 Aug 26. doi: 10.1016/S1473-3099(15)00228-5.

lfranki@frontlinemedcom.com

A small group of health care workers at intermediate or high risk of developing Ebola virus disease after exposure to the virus did not develop the disease after being treated with postexposure prophylaxis, according to Dr. Michael Jacobs and his associates.

Of eight health care workers evacuated to the United Kingdom between January and March 2015 and assessed using an Ebola risk calculator, four were deemed to be at intermediate or high risk for developing Ebola virus disease (EVD) and were started on postexposure prophylaxis (PEP) using oral favipiravir over 10 days. In addition, two of the four also were treated with monoclonal antibodies to Ebola glycoproteins. The favipiravir, administered in high dosages, was tolerated well by the four patients, the investigators reported in Lancet Infectious Diseases.

Courtesy Wikimedia Commons/Thomas W. Geisbert/Creative Commons License

The second half of the eight-person study group had a low risk of EVD after assessment, and patients in this group were watched carefully, receiving no other form of treatment. No EVD developed in this low-risk group.

It cannot be known “whether or not PEP prevented the onset of Ebola virus disease in any of these individuals. However, two individuals had very high risk of Ebola virus transmission, and these are the first reported cases of transcutaneous, hollow-bore needlestick injuries contaminated with fresh blood that have not resulted in Ebola virus transmission,” noted Dr. Jacobs of the department of infection at Royal Free London NHS Foundation Trust and his associates.

In a related comment, Dr. Mark J. Mulligan and Dr. Paul N. Siebert said, “A needed next step is the development of a consensus risk determination algorithm devised by an expert panel, drawing on all available evidence, endorsed by health organizations, and disseminated to the field. The algorithm could be accompanied by a chart abstraction and case report form to standardize and organize data gathering.”

Dr. Mulligan and Dr. Siebert of the division of infectious diseases at Emory University in Atlanta added, “These data for recognized exposures in health care workers could be collated and analyzed in an international registry.”

Find the full study here: Lancet Infect Dis. 2015 Aug 26. doi: 10.1016/S1473-3099(15)00228-5.

lfranki@frontlinemedcom.com

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Timely epinephrine for pediatric in-hospital cardiac arrest

Current guidelines upheld
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Timely epinephrine for pediatric in-hospital cardiac arrest

Delay in administering epinephrine is associated with significantly poorer outcomes among pediatric patients who have in-hospital cardiac arrest with an nonshockable rhythm, according to a report published online Aug. 25 in JAMA.

For the approximately 16,000 U.S. children and adolescents in this patient population each year, epinephrine is the recommended first-line pharmacologic therapy, even though no randomized placebo-controlled trials have ever been performed to support this practice.

It is highly unlikely that any such study will ever be done, given the ethical considerations, so to examine the effect of the timing of epinephrine therapy, investigators analyzed data from the Get With the Guidelines-Resuscitation registry concerning 1,558 patients aged 0-18 years who were treated during a 15-year period, said Dr. Lars W. Andersen of the department of emergency medicine at Beth Israel Deaconess Medical Center, Boston, and the department of anesthesiology at Aarhus (Denmark) University and his associates.

All the patients received chest compressions and at least one epinephrine bolus while pulseless with a documented nonshockable initial rhythm. The median age was 9 months, and the median time to first epinephrine dose was 1 minute (range, 0-20 minutes). A total of 37% of these patients received their first dose of epinephrine within 1 minute after loss of pulse was noted, and 15% received their first dose more than 5 minutes afterward.

Delay in epinephrine treatment was significantly associated with a lower chance of survival to hospital discharge (relative risk, 0.95 per minute of delay), the primary outcome measure of the study. In addition, longer time to epinephrine delivery was significantly associated with a decreased chance of return to spontaneous circulation (RR, 0.97 per minute of delay), for survival at 24 hours (RR, 0.97 per minute of delay), and for survival with favorable neurologic outcome (RR, 0.95 per minute of delay).

©Jupiterimages/thinkstockphotos.com

In a further analysis of the data, patients were divided into two groups according to the length of time before epinephrine administration. The 1,325 patients who received epinephrine within 5 minutes had a 33.1% rate of survival to hospital discharge, while the 233 who received epinephrine after 5 minutes had elapsed had a significantly lower 21.0% rate of survival to hospital discharge, Dr. Andersen and his associates said (JAMA. 2015 Aug 25. doi: 10.1001/jama.2015.9678).

These findings suggest, but cannot establish, that treatment delay causes poorer outcomes because an observational study cannot determine causality. Even though the data were adjusted to account for numerous patient and hospital characteristics, and even though the results remained robust through multiple sensitivity analyses, it remains possible that time to epinephrine administration is not a causal mediator but a marker of other aspects of the resuscitation process, the researchers added.

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Body

The findings by Dr. Andersen and his associates provide fairly strong evidence that following current guidelines for epinephrine timing is best practice, supporting an AHA class I strength of recommendation.

The investigators are correct to note that observational data cannot establish causality. Almost all of these cardiac arrests were witnessed; approximately two-thirds occurred in the pediatric intensive care unit, operating room, or postanesthesia setting; and half of the patients were receiving mechanical ventilation. So it is possible that the link between timing of epinephrine and outcomes may simply reflect factors such as the circumstances of the cardiac arrest, the presence of an airway and intravenous access, or the quality of chest compressions.

Dr. Robert C. Tasker and Dr. Adriennne G. Randolph are with the division of critical care medicine, department of anesthesia, perioperative, and pain medicine at Boston Children’s Hospital and the department of anesthesia at Harvard Medical School. Dr. Tasker is also with the department of neurology at both institutions and Dr. Randolph is also with the department of pediatrics at Harvard. Both authors reported having no relevant financial conflicts of interest. Dr. Tasker and Dr. Randolph made these remarks in an accompanying editorial (JAMA. 2015;314:776-7. doi: 10.1001/jama.2015.9527).

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Body

The findings by Dr. Andersen and his associates provide fairly strong evidence that following current guidelines for epinephrine timing is best practice, supporting an AHA class I strength of recommendation.

The investigators are correct to note that observational data cannot establish causality. Almost all of these cardiac arrests were witnessed; approximately two-thirds occurred in the pediatric intensive care unit, operating room, or postanesthesia setting; and half of the patients were receiving mechanical ventilation. So it is possible that the link between timing of epinephrine and outcomes may simply reflect factors such as the circumstances of the cardiac arrest, the presence of an airway and intravenous access, or the quality of chest compressions.

Dr. Robert C. Tasker and Dr. Adriennne G. Randolph are with the division of critical care medicine, department of anesthesia, perioperative, and pain medicine at Boston Children’s Hospital and the department of anesthesia at Harvard Medical School. Dr. Tasker is also with the department of neurology at both institutions and Dr. Randolph is also with the department of pediatrics at Harvard. Both authors reported having no relevant financial conflicts of interest. Dr. Tasker and Dr. Randolph made these remarks in an accompanying editorial (JAMA. 2015;314:776-7. doi: 10.1001/jama.2015.9527).

Body

The findings by Dr. Andersen and his associates provide fairly strong evidence that following current guidelines for epinephrine timing is best practice, supporting an AHA class I strength of recommendation.

The investigators are correct to note that observational data cannot establish causality. Almost all of these cardiac arrests were witnessed; approximately two-thirds occurred in the pediatric intensive care unit, operating room, or postanesthesia setting; and half of the patients were receiving mechanical ventilation. So it is possible that the link between timing of epinephrine and outcomes may simply reflect factors such as the circumstances of the cardiac arrest, the presence of an airway and intravenous access, or the quality of chest compressions.

Dr. Robert C. Tasker and Dr. Adriennne G. Randolph are with the division of critical care medicine, department of anesthesia, perioperative, and pain medicine at Boston Children’s Hospital and the department of anesthesia at Harvard Medical School. Dr. Tasker is also with the department of neurology at both institutions and Dr. Randolph is also with the department of pediatrics at Harvard. Both authors reported having no relevant financial conflicts of interest. Dr. Tasker and Dr. Randolph made these remarks in an accompanying editorial (JAMA. 2015;314:776-7. doi: 10.1001/jama.2015.9527).

Title
Current guidelines upheld
Current guidelines upheld

Delay in administering epinephrine is associated with significantly poorer outcomes among pediatric patients who have in-hospital cardiac arrest with an nonshockable rhythm, according to a report published online Aug. 25 in JAMA.

For the approximately 16,000 U.S. children and adolescents in this patient population each year, epinephrine is the recommended first-line pharmacologic therapy, even though no randomized placebo-controlled trials have ever been performed to support this practice.

It is highly unlikely that any such study will ever be done, given the ethical considerations, so to examine the effect of the timing of epinephrine therapy, investigators analyzed data from the Get With the Guidelines-Resuscitation registry concerning 1,558 patients aged 0-18 years who were treated during a 15-year period, said Dr. Lars W. Andersen of the department of emergency medicine at Beth Israel Deaconess Medical Center, Boston, and the department of anesthesiology at Aarhus (Denmark) University and his associates.

All the patients received chest compressions and at least one epinephrine bolus while pulseless with a documented nonshockable initial rhythm. The median age was 9 months, and the median time to first epinephrine dose was 1 minute (range, 0-20 minutes). A total of 37% of these patients received their first dose of epinephrine within 1 minute after loss of pulse was noted, and 15% received their first dose more than 5 minutes afterward.

Delay in epinephrine treatment was significantly associated with a lower chance of survival to hospital discharge (relative risk, 0.95 per minute of delay), the primary outcome measure of the study. In addition, longer time to epinephrine delivery was significantly associated with a decreased chance of return to spontaneous circulation (RR, 0.97 per minute of delay), for survival at 24 hours (RR, 0.97 per minute of delay), and for survival with favorable neurologic outcome (RR, 0.95 per minute of delay).

©Jupiterimages/thinkstockphotos.com

In a further analysis of the data, patients were divided into two groups according to the length of time before epinephrine administration. The 1,325 patients who received epinephrine within 5 minutes had a 33.1% rate of survival to hospital discharge, while the 233 who received epinephrine after 5 minutes had elapsed had a significantly lower 21.0% rate of survival to hospital discharge, Dr. Andersen and his associates said (JAMA. 2015 Aug 25. doi: 10.1001/jama.2015.9678).

These findings suggest, but cannot establish, that treatment delay causes poorer outcomes because an observational study cannot determine causality. Even though the data were adjusted to account for numerous patient and hospital characteristics, and even though the results remained robust through multiple sensitivity analyses, it remains possible that time to epinephrine administration is not a causal mediator but a marker of other aspects of the resuscitation process, the researchers added.

Delay in administering epinephrine is associated with significantly poorer outcomes among pediatric patients who have in-hospital cardiac arrest with an nonshockable rhythm, according to a report published online Aug. 25 in JAMA.

For the approximately 16,000 U.S. children and adolescents in this patient population each year, epinephrine is the recommended first-line pharmacologic therapy, even though no randomized placebo-controlled trials have ever been performed to support this practice.

It is highly unlikely that any such study will ever be done, given the ethical considerations, so to examine the effect of the timing of epinephrine therapy, investigators analyzed data from the Get With the Guidelines-Resuscitation registry concerning 1,558 patients aged 0-18 years who were treated during a 15-year period, said Dr. Lars W. Andersen of the department of emergency medicine at Beth Israel Deaconess Medical Center, Boston, and the department of anesthesiology at Aarhus (Denmark) University and his associates.

All the patients received chest compressions and at least one epinephrine bolus while pulseless with a documented nonshockable initial rhythm. The median age was 9 months, and the median time to first epinephrine dose was 1 minute (range, 0-20 minutes). A total of 37% of these patients received their first dose of epinephrine within 1 minute after loss of pulse was noted, and 15% received their first dose more than 5 minutes afterward.

Delay in epinephrine treatment was significantly associated with a lower chance of survival to hospital discharge (relative risk, 0.95 per minute of delay), the primary outcome measure of the study. In addition, longer time to epinephrine delivery was significantly associated with a decreased chance of return to spontaneous circulation (RR, 0.97 per minute of delay), for survival at 24 hours (RR, 0.97 per minute of delay), and for survival with favorable neurologic outcome (RR, 0.95 per minute of delay).

©Jupiterimages/thinkstockphotos.com

In a further analysis of the data, patients were divided into two groups according to the length of time before epinephrine administration. The 1,325 patients who received epinephrine within 5 minutes had a 33.1% rate of survival to hospital discharge, while the 233 who received epinephrine after 5 minutes had elapsed had a significantly lower 21.0% rate of survival to hospital discharge, Dr. Andersen and his associates said (JAMA. 2015 Aug 25. doi: 10.1001/jama.2015.9678).

These findings suggest, but cannot establish, that treatment delay causes poorer outcomes because an observational study cannot determine causality. Even though the data were adjusted to account for numerous patient and hospital characteristics, and even though the results remained robust through multiple sensitivity analyses, it remains possible that time to epinephrine administration is not a causal mediator but a marker of other aspects of the resuscitation process, the researchers added.

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Timely epinephrine for pediatric in-hospital cardiac arrest
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Key clinical point: Delay in administering epinephrine was linked to poorer outcomes in pediatric in-hospital cardiac arrest.

Major finding: Delay in epinephrine treatment was significantly associated with a lower chance of survival to hospital discharge (RR, 0.95 per minute of delay).

Data source: A multicenter cohort study of 1,558 in-hospital cardiac arrests among pediatric patients across the United States during a 15-year period.

Disclosures: The National Heart, Lung, and Blood Institute and the American Heart Association supported the study. Dr. Andersen and his associates reported having no conflicts of interest.

CT scan utilization down in children’s hospitals

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CT scan utilization down in children’s hospitals

The use of computed tomography in children’s hospitals appears to be on the decline across the top 10 all-patient-refined, diagnosis-related groups (APR-DRGs), with alternate imaging processes increasing in utilization for 8 of those 10 groups.

New research examining the use of CT scans on children admitted to 33 pediatric tertiary-care hospitals participating in the Pediatric Health Information System between Jan. 1, 2004, and Dec. 31, 2012, reveals the decrease (Pediatrics 2015 Aug 24.[doi: 10.1542/peds.2015-0995]).

©picsfive/Fotolia.com

“This decrease occurred with a concomitant increase in alternative imaging modalities in 8 studied diagnostic groups, supporting the hypothesis that previously noted declines in CT utilization are associated with shifts to alternate modalities,” Dr. Michelle W. Parker of Children’s Hospital Medical Center in Cincinnati and her colleagues wrote.

The 10 APR-DRGs studies are:

• seizure.

• ventricular shunt procedures.

• appendectomy.

• craniotomy except for trauma.

• concussion, closed skull fracture, uncomplicated intracranial injury, coma less than 1 hour or no coma (concussion).

• head trauma with coma greater than 1 hour or hemorrhage (severe head trauma).

• infections of upper respiratory tract.

• nonbacterial gastroenteritis with nausea and vomiting (gastroenteritis).

• abdominal pain.

• other ear, nose, mouth, throat, and craniofacial diagnoses.

“The decrease was most noted for patients with an APR-DRG of seizure where CT utilization decreased almost 50%, and MRI utilization decreased by greater than 10%,” the authors wrote.

Severe head trauma had the largest reduction in CT utilization. “MRI utilization could not be evaluated for appendectomy, gastroenteritis, or infections of the upper respiratory tract because of limited study volume. Statistically significant changes in MRI use were noted across the remaining APR-DRGs,with marked increases for ventricular shunt procedures,” Dr. Parker and her colleagues reported.

“There were no ultrasound studies meeting inclusion criteria for seizures, concussion, or severe head trauma. Ultrasound use increased during the study period for all other APR-DRGs, with the greatest increase noted in appendectomy and gastroenteritis,” they said.

Dr. Parker and her colleagues suggested a number of reasons for the decrease, including a 2006 effort by the Alliance for Radiation Safety in Pediatric Imaging, an initiative within the Society for Pediatric Radiology that raised awareness on the number of pediatric CT scans and the use of adult dose protocols in pediatric imaging. They also mentioned other technological advances, such as electronic health records and the sharing of existing images, which may have contributed to the lower utilization of CT scans.

The authors note that the decrease does have public health implications, as lower CT utilization decreases exposure to hazardous ionizing radiation.“Therefore, the substitution of an imaging modality that does not confer ionizing radiation may affect lifetime cancer risk in children who receive diagnostic imaging.”

Dr. Parker and her colleagues reported no conflicts of interest or external funding sources for the research.

gtwachtman@frontlinemedcom.com

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The use of computed tomography in children’s hospitals appears to be on the decline across the top 10 all-patient-refined, diagnosis-related groups (APR-DRGs), with alternate imaging processes increasing in utilization for 8 of those 10 groups.

New research examining the use of CT scans on children admitted to 33 pediatric tertiary-care hospitals participating in the Pediatric Health Information System between Jan. 1, 2004, and Dec. 31, 2012, reveals the decrease (Pediatrics 2015 Aug 24.[doi: 10.1542/peds.2015-0995]).

©picsfive/Fotolia.com

“This decrease occurred with a concomitant increase in alternative imaging modalities in 8 studied diagnostic groups, supporting the hypothesis that previously noted declines in CT utilization are associated with shifts to alternate modalities,” Dr. Michelle W. Parker of Children’s Hospital Medical Center in Cincinnati and her colleagues wrote.

The 10 APR-DRGs studies are:

• seizure.

• ventricular shunt procedures.

• appendectomy.

• craniotomy except for trauma.

• concussion, closed skull fracture, uncomplicated intracranial injury, coma less than 1 hour or no coma (concussion).

• head trauma with coma greater than 1 hour or hemorrhage (severe head trauma).

• infections of upper respiratory tract.

• nonbacterial gastroenteritis with nausea and vomiting (gastroenteritis).

• abdominal pain.

• other ear, nose, mouth, throat, and craniofacial diagnoses.

“The decrease was most noted for patients with an APR-DRG of seizure where CT utilization decreased almost 50%, and MRI utilization decreased by greater than 10%,” the authors wrote.

Severe head trauma had the largest reduction in CT utilization. “MRI utilization could not be evaluated for appendectomy, gastroenteritis, or infections of the upper respiratory tract because of limited study volume. Statistically significant changes in MRI use were noted across the remaining APR-DRGs,with marked increases for ventricular shunt procedures,” Dr. Parker and her colleagues reported.

“There were no ultrasound studies meeting inclusion criteria for seizures, concussion, or severe head trauma. Ultrasound use increased during the study period for all other APR-DRGs, with the greatest increase noted in appendectomy and gastroenteritis,” they said.

Dr. Parker and her colleagues suggested a number of reasons for the decrease, including a 2006 effort by the Alliance for Radiation Safety in Pediatric Imaging, an initiative within the Society for Pediatric Radiology that raised awareness on the number of pediatric CT scans and the use of adult dose protocols in pediatric imaging. They also mentioned other technological advances, such as electronic health records and the sharing of existing images, which may have contributed to the lower utilization of CT scans.

The authors note that the decrease does have public health implications, as lower CT utilization decreases exposure to hazardous ionizing radiation.“Therefore, the substitution of an imaging modality that does not confer ionizing radiation may affect lifetime cancer risk in children who receive diagnostic imaging.”

Dr. Parker and her colleagues reported no conflicts of interest or external funding sources for the research.

gtwachtman@frontlinemedcom.com

The use of computed tomography in children’s hospitals appears to be on the decline across the top 10 all-patient-refined, diagnosis-related groups (APR-DRGs), with alternate imaging processes increasing in utilization for 8 of those 10 groups.

New research examining the use of CT scans on children admitted to 33 pediatric tertiary-care hospitals participating in the Pediatric Health Information System between Jan. 1, 2004, and Dec. 31, 2012, reveals the decrease (Pediatrics 2015 Aug 24.[doi: 10.1542/peds.2015-0995]).

©picsfive/Fotolia.com

“This decrease occurred with a concomitant increase in alternative imaging modalities in 8 studied diagnostic groups, supporting the hypothesis that previously noted declines in CT utilization are associated with shifts to alternate modalities,” Dr. Michelle W. Parker of Children’s Hospital Medical Center in Cincinnati and her colleagues wrote.

The 10 APR-DRGs studies are:

• seizure.

• ventricular shunt procedures.

• appendectomy.

• craniotomy except for trauma.

• concussion, closed skull fracture, uncomplicated intracranial injury, coma less than 1 hour or no coma (concussion).

• head trauma with coma greater than 1 hour or hemorrhage (severe head trauma).

• infections of upper respiratory tract.

• nonbacterial gastroenteritis with nausea and vomiting (gastroenteritis).

• abdominal pain.

• other ear, nose, mouth, throat, and craniofacial diagnoses.

“The decrease was most noted for patients with an APR-DRG of seizure where CT utilization decreased almost 50%, and MRI utilization decreased by greater than 10%,” the authors wrote.

Severe head trauma had the largest reduction in CT utilization. “MRI utilization could not be evaluated for appendectomy, gastroenteritis, or infections of the upper respiratory tract because of limited study volume. Statistically significant changes in MRI use were noted across the remaining APR-DRGs,with marked increases for ventricular shunt procedures,” Dr. Parker and her colleagues reported.

“There were no ultrasound studies meeting inclusion criteria for seizures, concussion, or severe head trauma. Ultrasound use increased during the study period for all other APR-DRGs, with the greatest increase noted in appendectomy and gastroenteritis,” they said.

Dr. Parker and her colleagues suggested a number of reasons for the decrease, including a 2006 effort by the Alliance for Radiation Safety in Pediatric Imaging, an initiative within the Society for Pediatric Radiology that raised awareness on the number of pediatric CT scans and the use of adult dose protocols in pediatric imaging. They also mentioned other technological advances, such as electronic health records and the sharing of existing images, which may have contributed to the lower utilization of CT scans.

The authors note that the decrease does have public health implications, as lower CT utilization decreases exposure to hazardous ionizing radiation.“Therefore, the substitution of an imaging modality that does not confer ionizing radiation may affect lifetime cancer risk in children who receive diagnostic imaging.”

Dr. Parker and her colleagues reported no conflicts of interest or external funding sources for the research.

gtwachtman@frontlinemedcom.com

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CT scan utilization down in children’s hospitals
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Key clinical point: The use of CT scans in children’s hospitals declined in the top 10 APR-DRGs.

Major finding: The decrease was greatest for patients with an APR-DRG of seizure with an almost 50% decrease in CT scans; MRI use decreased by greater than 10%.

Data source: Utilization of CT scans on children admitted to 33 pediatric tertiary-care hospitals participating in the Pediatric Health Information System between Jan.1, 2004, and Dec. 31, 2012.

Disclosures: Dr. Parker and her colleagues reported no conflicts of interest or external funding sources for the research.

Evidence-based practices can cut breast cancer costs

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Evidence-based practices can cut breast cancer costs

HOUSTON – There are at least three evidence-based practices for reducing the costs of locoregional therapy for early breast cancer without compromising the quality of care, according to Dr. Rachel Adams Greenup of the department of surgery at Duke University Medical Center, in Durham, North Carolina.

Dr. Rachel Adams Greenup

Management of axilla per the ACOSOG Z0011 study, adherence to joint Society of Surgical Oncology/American Society of Radiation Oncology (SSO/ASTRO) margin guidelines, and alternative radiation regimens following lumpectomy can all cut costs without compromsing quality of care, she said at the annual Society of Surgical Oncology Symposium.

The results of ACOSOG Z0011, published in 2010, were universally acknowledged to be practice changing. They showed that for women undergoing lumpectomy and radiation therapy for T1-2 invasive breast cancer and positive sentinel lymph node biopsy, completion axiallary dissection did not improve either disease-free or overall survival (DFS/OS). There were low rates of locoregional recurrence regardless of whether patients received axillary node dissection.

The potential savings from eliminating the routine practice of axillary dissection were estimated to be a 64% reduction in inpatient days, and an 18% decrease in perioperative costs.

The SSO/ASTRO margin guidelines, published in 2014, were developed by a multidisciplinary panel based on a meta-analysis of 33 studies involving more than 28,000 patients. The guidelines note that positive surgical margins are associated with a 2-fold increase in ipsilateral breast tumor recurrence, with “no ink on tumor” sufficient for a negative margin. The guidelines say that further margin width resections do not decrease same-breast recurrences.

In a related analysis of the cost implications, Dr. Greenup and colleagues noted that there are wide variations in clinical practice, and that 20% of women with close but negative margins were re-excised needlessly. Eliminating 25,000 unnecessary re-excisions annually would save $31 million dollars. These savings do not include cost reductions from an estimated 8% to 12% reduction in conversions to mastectomy that would be avoided, the authors calculated.

The costs of radiation following lumpectomy correlate directly with the number of delivered radiation fractions or treatment sessions, and also with the technique. Alternatives to standard radiation schedules include the following:

Per-patient costs for each of these options in 2011 ranged from $0 for no radiation, as in CALGB 9343, to $5342 for APBI, $9122 for HF-WBI, and $13m358 for conventionally fractionated WBI.

Dr Greenup and colleagues looked at data on 43,247 women in the National Cancer Data Base with T1-T2, NO invasive breast cancers treated with lumpectomy, and compared the actual costs of treatment with the evidence-based alternative. They found that 26% of patients were treated with the least cost-effective radiation, while nearly all of the remaining patients received more expensive radiation than necessary. If every patient were treated with the most cost-effective approach, there would be an estimated 39% reduction in costs, translating into a saving of $164 million over a single year, they reported in an abstract presented at the 2014 San Antonio Breast Cancer Symposium.

“We can’t make decisions based on cost alone, and value is certainly more important, but clinical trials, moving forward, should incorporate cost information. There is an opportunity to have small changes in clinical practice have the potential to make dramatic reductions in health care spending, and there are lots of opportunities in early stage breast cancer to practice evidence-based care while reducing health care spending,” Dr. Greenup concluded.

Dr. Greenup reported having no relevant financial disclosures.

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HOUSTON – There are at least three evidence-based practices for reducing the costs of locoregional therapy for early breast cancer without compromising the quality of care, according to Dr. Rachel Adams Greenup of the department of surgery at Duke University Medical Center, in Durham, North Carolina.

Dr. Rachel Adams Greenup

Management of axilla per the ACOSOG Z0011 study, adherence to joint Society of Surgical Oncology/American Society of Radiation Oncology (SSO/ASTRO) margin guidelines, and alternative radiation regimens following lumpectomy can all cut costs without compromsing quality of care, she said at the annual Society of Surgical Oncology Symposium.

The results of ACOSOG Z0011, published in 2010, were universally acknowledged to be practice changing. They showed that for women undergoing lumpectomy and radiation therapy for T1-2 invasive breast cancer and positive sentinel lymph node biopsy, completion axiallary dissection did not improve either disease-free or overall survival (DFS/OS). There were low rates of locoregional recurrence regardless of whether patients received axillary node dissection.

The potential savings from eliminating the routine practice of axillary dissection were estimated to be a 64% reduction in inpatient days, and an 18% decrease in perioperative costs.

The SSO/ASTRO margin guidelines, published in 2014, were developed by a multidisciplinary panel based on a meta-analysis of 33 studies involving more than 28,000 patients. The guidelines note that positive surgical margins are associated with a 2-fold increase in ipsilateral breast tumor recurrence, with “no ink on tumor” sufficient for a negative margin. The guidelines say that further margin width resections do not decrease same-breast recurrences.

In a related analysis of the cost implications, Dr. Greenup and colleagues noted that there are wide variations in clinical practice, and that 20% of women with close but negative margins were re-excised needlessly. Eliminating 25,000 unnecessary re-excisions annually would save $31 million dollars. These savings do not include cost reductions from an estimated 8% to 12% reduction in conversions to mastectomy that would be avoided, the authors calculated.

The costs of radiation following lumpectomy correlate directly with the number of delivered radiation fractions or treatment sessions, and also with the technique. Alternatives to standard radiation schedules include the following:

Per-patient costs for each of these options in 2011 ranged from $0 for no radiation, as in CALGB 9343, to $5342 for APBI, $9122 for HF-WBI, and $13m358 for conventionally fractionated WBI.

Dr Greenup and colleagues looked at data on 43,247 women in the National Cancer Data Base with T1-T2, NO invasive breast cancers treated with lumpectomy, and compared the actual costs of treatment with the evidence-based alternative. They found that 26% of patients were treated with the least cost-effective radiation, while nearly all of the remaining patients received more expensive radiation than necessary. If every patient were treated with the most cost-effective approach, there would be an estimated 39% reduction in costs, translating into a saving of $164 million over a single year, they reported in an abstract presented at the 2014 San Antonio Breast Cancer Symposium.

“We can’t make decisions based on cost alone, and value is certainly more important, but clinical trials, moving forward, should incorporate cost information. There is an opportunity to have small changes in clinical practice have the potential to make dramatic reductions in health care spending, and there are lots of opportunities in early stage breast cancer to practice evidence-based care while reducing health care spending,” Dr. Greenup concluded.

Dr. Greenup reported having no relevant financial disclosures.

HOUSTON – There are at least three evidence-based practices for reducing the costs of locoregional therapy for early breast cancer without compromising the quality of care, according to Dr. Rachel Adams Greenup of the department of surgery at Duke University Medical Center, in Durham, North Carolina.

Dr. Rachel Adams Greenup

Management of axilla per the ACOSOG Z0011 study, adherence to joint Society of Surgical Oncology/American Society of Radiation Oncology (SSO/ASTRO) margin guidelines, and alternative radiation regimens following lumpectomy can all cut costs without compromsing quality of care, she said at the annual Society of Surgical Oncology Symposium.

The results of ACOSOG Z0011, published in 2010, were universally acknowledged to be practice changing. They showed that for women undergoing lumpectomy and radiation therapy for T1-2 invasive breast cancer and positive sentinel lymph node biopsy, completion axiallary dissection did not improve either disease-free or overall survival (DFS/OS). There were low rates of locoregional recurrence regardless of whether patients received axillary node dissection.

The potential savings from eliminating the routine practice of axillary dissection were estimated to be a 64% reduction in inpatient days, and an 18% decrease in perioperative costs.

The SSO/ASTRO margin guidelines, published in 2014, were developed by a multidisciplinary panel based on a meta-analysis of 33 studies involving more than 28,000 patients. The guidelines note that positive surgical margins are associated with a 2-fold increase in ipsilateral breast tumor recurrence, with “no ink on tumor” sufficient for a negative margin. The guidelines say that further margin width resections do not decrease same-breast recurrences.

In a related analysis of the cost implications, Dr. Greenup and colleagues noted that there are wide variations in clinical practice, and that 20% of women with close but negative margins were re-excised needlessly. Eliminating 25,000 unnecessary re-excisions annually would save $31 million dollars. These savings do not include cost reductions from an estimated 8% to 12% reduction in conversions to mastectomy that would be avoided, the authors calculated.

The costs of radiation following lumpectomy correlate directly with the number of delivered radiation fractions or treatment sessions, and also with the technique. Alternatives to standard radiation schedules include the following:

Per-patient costs for each of these options in 2011 ranged from $0 for no radiation, as in CALGB 9343, to $5342 for APBI, $9122 for HF-WBI, and $13m358 for conventionally fractionated WBI.

Dr Greenup and colleagues looked at data on 43,247 women in the National Cancer Data Base with T1-T2, NO invasive breast cancers treated with lumpectomy, and compared the actual costs of treatment with the evidence-based alternative. They found that 26% of patients were treated with the least cost-effective radiation, while nearly all of the remaining patients received more expensive radiation than necessary. If every patient were treated with the most cost-effective approach, there would be an estimated 39% reduction in costs, translating into a saving of $164 million over a single year, they reported in an abstract presented at the 2014 San Antonio Breast Cancer Symposium.

“We can’t make decisions based on cost alone, and value is certainly more important, but clinical trials, moving forward, should incorporate cost information. There is an opportunity to have small changes in clinical practice have the potential to make dramatic reductions in health care spending, and there are lots of opportunities in early stage breast cancer to practice evidence-based care while reducing health care spending,” Dr. Greenup concluded.

Dr. Greenup reported having no relevant financial disclosures.

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More octogenarians muscling through emergent surgeries

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CHICAGO – An increasing number of octogenarians are undergoing emergent surgeries, but the mortality associated with these procedures has not changed significantly, a national ACS/NSQIP analysis found.

From 2005 to 2012, overall mortality among 5,016 octogenarians actually decreased slightly from 8.8% to 7.3%. This reduction was driven by declining death rates for appendectomy from 6.7% to 2.4%, ventral hernia repair from 11% to 4%, and cholecystectomy from 5% to 3%.

Only octogenarians undergoing a Hartmann’s procedure were more likely to die over the 7-year study period, increasing from 14.3% to 21.7%, Dr. Busayo Irojah, of Wellspan Health York (Pa.) Hospital, reported at the American College of Surgeons (ACS)/National Surgical Quality Improvement Program (NSQIP) National Conference.

In all, 1,440 patients, mean age 84 years, underwent appendectomy (35% open; 65% laparoscopic), 1,252 cholecystectomy (34% open; 66% laparoscopic), 1,197 ventral (umbilical/inguinal) hernia repair (96% open; 4% laparoscopic), and 1,127 Hartmann’s procedure.

Mortality was lower for laparoscopic than for open procedures; appendectomy (2.1% vs. 4.2%; P = .024), cholecystectomy (3.1% vs. 11.6%; P less than .0001), and hernia repair (1.9% vs. 5.8%; P = .22), Dr. Irojah reported.

In multivariate analysis that adjusted for 31 variables including patient characteristics, medical comorbidities, and hospital characteristics, significant predictors of mortality were: sepsis (Odds ratio, 2.5; P less than .01), DNR status (OR, 2.4; P less than .001), previous cardiac surgery (OR, 2.3; P = .003), postoperative renal failure (OR, 2.6; P = .03), poor functional health status (OR, 4.5; P less than .001), and disseminated cancer (OR 6.5; P = .01).

Super elders

Poor functional status was also a strong predictor of morbidity and mortality in the “super elderly” following cholecystectomy in a separate analysis, also led by Dr. Irojah.

The study involved 1,017 patients, aged 90 years and older, who underwent cholecystectomy from 2005 to 2012 in the ACS/NSQIP database. Of these cases, 78% were laparoscopic, 22% open, 80% emergent, and 20% elective.

Mortality was three times higher for an open than a laparoscopic procedure (12.2% vs. 3.8%; P less than .01) and twice as high for emergent than elective cases (10% vs. 4.5%; P less than .01).

In multivariate analysis that adjusted for 25 variables, significant independent predictors of mortality were: preoperative total dependence vs. functional independence (OR, 12.75), postoperative acute renal failure (OR 19.46), postoperative myocardial infarction (OR 71.16), and an open approach (OR, 5.44; all P values less than .00).

“Mortality following both elective and emergent cholecystectomy in patients ninety and over is higher than the general population; hence preoperative optimization is essential and nonoperative management might be reasonable in high-risk patients,” Dr. Irojah observed.

The odds of a complication were double for super elders undergoing open cholecystectomy (OR, 2.4; P less than .01) and at least four times higher for those with poor preoperative functional health status (OR, 4.2; P less than .01), undergoing emergency surgery (OR 4.3; P = .03), or who were Hispanic (OR 4.9; P less than .01), Dr. Irojah reported.

An outpatient procedure, however, was protective for morbidity (OR, 0.39: P = .03) in multivariate analysis adjusted for 13 variables.

“We are trying to educate primary care in our area on the need to avoid emergency operation and preemptively assess for elective operation. Secondarily, we are discussing palliative care with families of elderly higher-risk patients,” senior author and colleague Dr. Vanita Ahuja said in an interview.

The study authors reported having no disclosures.

pwendling@frontlinemedcom.com

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CHICAGO – An increasing number of octogenarians are undergoing emergent surgeries, but the mortality associated with these procedures has not changed significantly, a national ACS/NSQIP analysis found.

From 2005 to 2012, overall mortality among 5,016 octogenarians actually decreased slightly from 8.8% to 7.3%. This reduction was driven by declining death rates for appendectomy from 6.7% to 2.4%, ventral hernia repair from 11% to 4%, and cholecystectomy from 5% to 3%.

Only octogenarians undergoing a Hartmann’s procedure were more likely to die over the 7-year study period, increasing from 14.3% to 21.7%, Dr. Busayo Irojah, of Wellspan Health York (Pa.) Hospital, reported at the American College of Surgeons (ACS)/National Surgical Quality Improvement Program (NSQIP) National Conference.

In all, 1,440 patients, mean age 84 years, underwent appendectomy (35% open; 65% laparoscopic), 1,252 cholecystectomy (34% open; 66% laparoscopic), 1,197 ventral (umbilical/inguinal) hernia repair (96% open; 4% laparoscopic), and 1,127 Hartmann’s procedure.

Mortality was lower for laparoscopic than for open procedures; appendectomy (2.1% vs. 4.2%; P = .024), cholecystectomy (3.1% vs. 11.6%; P less than .0001), and hernia repair (1.9% vs. 5.8%; P = .22), Dr. Irojah reported.

In multivariate analysis that adjusted for 31 variables including patient characteristics, medical comorbidities, and hospital characteristics, significant predictors of mortality were: sepsis (Odds ratio, 2.5; P less than .01), DNR status (OR, 2.4; P less than .001), previous cardiac surgery (OR, 2.3; P = .003), postoperative renal failure (OR, 2.6; P = .03), poor functional health status (OR, 4.5; P less than .001), and disseminated cancer (OR 6.5; P = .01).

Super elders

Poor functional status was also a strong predictor of morbidity and mortality in the “super elderly” following cholecystectomy in a separate analysis, also led by Dr. Irojah.

The study involved 1,017 patients, aged 90 years and older, who underwent cholecystectomy from 2005 to 2012 in the ACS/NSQIP database. Of these cases, 78% were laparoscopic, 22% open, 80% emergent, and 20% elective.

Mortality was three times higher for an open than a laparoscopic procedure (12.2% vs. 3.8%; P less than .01) and twice as high for emergent than elective cases (10% vs. 4.5%; P less than .01).

In multivariate analysis that adjusted for 25 variables, significant independent predictors of mortality were: preoperative total dependence vs. functional independence (OR, 12.75), postoperative acute renal failure (OR 19.46), postoperative myocardial infarction (OR 71.16), and an open approach (OR, 5.44; all P values less than .00).

“Mortality following both elective and emergent cholecystectomy in patients ninety and over is higher than the general population; hence preoperative optimization is essential and nonoperative management might be reasonable in high-risk patients,” Dr. Irojah observed.

The odds of a complication were double for super elders undergoing open cholecystectomy (OR, 2.4; P less than .01) and at least four times higher for those with poor preoperative functional health status (OR, 4.2; P less than .01), undergoing emergency surgery (OR 4.3; P = .03), or who were Hispanic (OR 4.9; P less than .01), Dr. Irojah reported.

An outpatient procedure, however, was protective for morbidity (OR, 0.39: P = .03) in multivariate analysis adjusted for 13 variables.

“We are trying to educate primary care in our area on the need to avoid emergency operation and preemptively assess for elective operation. Secondarily, we are discussing palliative care with families of elderly higher-risk patients,” senior author and colleague Dr. Vanita Ahuja said in an interview.

The study authors reported having no disclosures.

pwendling@frontlinemedcom.com

CHICAGO – An increasing number of octogenarians are undergoing emergent surgeries, but the mortality associated with these procedures has not changed significantly, a national ACS/NSQIP analysis found.

From 2005 to 2012, overall mortality among 5,016 octogenarians actually decreased slightly from 8.8% to 7.3%. This reduction was driven by declining death rates for appendectomy from 6.7% to 2.4%, ventral hernia repair from 11% to 4%, and cholecystectomy from 5% to 3%.

Only octogenarians undergoing a Hartmann’s procedure were more likely to die over the 7-year study period, increasing from 14.3% to 21.7%, Dr. Busayo Irojah, of Wellspan Health York (Pa.) Hospital, reported at the American College of Surgeons (ACS)/National Surgical Quality Improvement Program (NSQIP) National Conference.

In all, 1,440 patients, mean age 84 years, underwent appendectomy (35% open; 65% laparoscopic), 1,252 cholecystectomy (34% open; 66% laparoscopic), 1,197 ventral (umbilical/inguinal) hernia repair (96% open; 4% laparoscopic), and 1,127 Hartmann’s procedure.

Mortality was lower for laparoscopic than for open procedures; appendectomy (2.1% vs. 4.2%; P = .024), cholecystectomy (3.1% vs. 11.6%; P less than .0001), and hernia repair (1.9% vs. 5.8%; P = .22), Dr. Irojah reported.

In multivariate analysis that adjusted for 31 variables including patient characteristics, medical comorbidities, and hospital characteristics, significant predictors of mortality were: sepsis (Odds ratio, 2.5; P less than .01), DNR status (OR, 2.4; P less than .001), previous cardiac surgery (OR, 2.3; P = .003), postoperative renal failure (OR, 2.6; P = .03), poor functional health status (OR, 4.5; P less than .001), and disseminated cancer (OR 6.5; P = .01).

Super elders

Poor functional status was also a strong predictor of morbidity and mortality in the “super elderly” following cholecystectomy in a separate analysis, also led by Dr. Irojah.

The study involved 1,017 patients, aged 90 years and older, who underwent cholecystectomy from 2005 to 2012 in the ACS/NSQIP database. Of these cases, 78% were laparoscopic, 22% open, 80% emergent, and 20% elective.

Mortality was three times higher for an open than a laparoscopic procedure (12.2% vs. 3.8%; P less than .01) and twice as high for emergent than elective cases (10% vs. 4.5%; P less than .01).

In multivariate analysis that adjusted for 25 variables, significant independent predictors of mortality were: preoperative total dependence vs. functional independence (OR, 12.75), postoperative acute renal failure (OR 19.46), postoperative myocardial infarction (OR 71.16), and an open approach (OR, 5.44; all P values less than .00).

“Mortality following both elective and emergent cholecystectomy in patients ninety and over is higher than the general population; hence preoperative optimization is essential and nonoperative management might be reasonable in high-risk patients,” Dr. Irojah observed.

The odds of a complication were double for super elders undergoing open cholecystectomy (OR, 2.4; P less than .01) and at least four times higher for those with poor preoperative functional health status (OR, 4.2; P less than .01), undergoing emergency surgery (OR 4.3; P = .03), or who were Hispanic (OR 4.9; P less than .01), Dr. Irojah reported.

An outpatient procedure, however, was protective for morbidity (OR, 0.39: P = .03) in multivariate analysis adjusted for 13 variables.

“We are trying to educate primary care in our area on the need to avoid emergency operation and preemptively assess for elective operation. Secondarily, we are discussing palliative care with families of elderly higher-risk patients,” senior author and colleague Dr. Vanita Ahuja said in an interview.

The study authors reported having no disclosures.

pwendling@frontlinemedcom.com

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OR-focused effort cuts catheter use, surgical UTIs

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CHICAGO – A novel effort to change the prevailing culture toward overuse of catheters in surgical patients appears to be paying off for one Midwestern hospital.

The goal was to decrease catheter utilization by 5%, but 6 months after implementation, the number of catheters placed per day in the operating room in surgeries lasting less than 3 hours declined 9% (mean 14.2/day vs. 12.9/day) and overall catheter utilization in these short cases by 12% (mean 23.7% vs. 20.6%).

Removal of catheters in the OR after surgery decreased by 15% (18.3% vs. 21%), Dr. Anthony D. Yang, of Northwestern Memorial Hospital, reported at the American College of Surgeons (ACS)/National Surgical Quality Improvement Program (NSQIP) National Conference.

Dr. Anthony D. Yang

Catheter-associated urinary tract infection (CAUTI) rates before the intervention put the Chicago-based hospital in the bottom 10% of ACS NSQIP hospitals.

Post-intervention, the number of CAUTIs in patients whose catheters were inserted in the OR declined 89% from a mean of 2.75 to 0.3 per month. In 4 out of 6 post-intervention months, no CAUTIs were reported, Dr. Yang observed.

Efforts to improve CAUTIs typically focus on removing catheters in surgical patients promptly after transfer to the floor, but the assembled multidisciplinary team chose the less-studied approach of decreasing overall utilization of catheters in the OR.

Using the DMAIC (Define, Measure, Analyze, Improve and Control) method of process improvement, the team identified and instituted two major interventions. First, all catheters have to be inserted with a two-person technique to identify previously unnoticed breaks in sterile technique. Second, OR staff routinely address the necessity for catheters with the surgical team at the beginning of the procedure and with the attending surgeon in the OR before the end of surgery in all cases.

To help change culture, educational programs were instituted with all perioperative services staff and house-staff physicians in all surgical departments, awareness was raised about the project and its justification, and the intervention was mandated to permit tracking.

A total of 465 catheters were inserted in the OR in cases less than 3 hours in the month prior to the intervention, compared with 391, 348, 409, 387, 382, and 427, respectively, in the first six months after the intervention, team leader Dr. Yang, with the hospital’s department of surgery and surgical oncology, said.

Adherence to the two-person sterile technique for OR catheter placement was 80% in the first month, reached 100% for the second and third months, but dropped to around 70% for months four through six. Data for the latter months was fed back to OR staff with encouragement to redouble efforts and increase compliance. It’s thought the problem is actually with documentation because at the time, the fields to document two-person technique in the electronic medical record were not required to be filled in before closing the file, he said.

Compliance with catheter status with the attending surgeon at sign-out was 88% in the first month, dipped slightly in months 2 and 3, and reached and has been maintained at about 85% in months 4 through 6.

“With any intervention it is expected to see periodic decreases in performance,” Dr. Yang said in an interview. “This is why using the DMAIC method becomes important, because the Control part of the methodology calls for continuously monitoring for drops in performance and includes a plan to respond to them. In our plan, the Control plan was to feedback data to the OR staff as the initial step.”

Future steps are to utilize the hospital’s Enterprise Data Warehouse report for monthly performance audits to identify any problem areas, develop a detailed Control plan and consensus criteria for catheter insertion in short cases, and to continue to provide feedback data to relevant stakeholders.

pwendling@frontlinemedcom.com

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CHICAGO – A novel effort to change the prevailing culture toward overuse of catheters in surgical patients appears to be paying off for one Midwestern hospital.

The goal was to decrease catheter utilization by 5%, but 6 months after implementation, the number of catheters placed per day in the operating room in surgeries lasting less than 3 hours declined 9% (mean 14.2/day vs. 12.9/day) and overall catheter utilization in these short cases by 12% (mean 23.7% vs. 20.6%).

Removal of catheters in the OR after surgery decreased by 15% (18.3% vs. 21%), Dr. Anthony D. Yang, of Northwestern Memorial Hospital, reported at the American College of Surgeons (ACS)/National Surgical Quality Improvement Program (NSQIP) National Conference.

Dr. Anthony D. Yang

Catheter-associated urinary tract infection (CAUTI) rates before the intervention put the Chicago-based hospital in the bottom 10% of ACS NSQIP hospitals.

Post-intervention, the number of CAUTIs in patients whose catheters were inserted in the OR declined 89% from a mean of 2.75 to 0.3 per month. In 4 out of 6 post-intervention months, no CAUTIs were reported, Dr. Yang observed.

Efforts to improve CAUTIs typically focus on removing catheters in surgical patients promptly after transfer to the floor, but the assembled multidisciplinary team chose the less-studied approach of decreasing overall utilization of catheters in the OR.

Using the DMAIC (Define, Measure, Analyze, Improve and Control) method of process improvement, the team identified and instituted two major interventions. First, all catheters have to be inserted with a two-person technique to identify previously unnoticed breaks in sterile technique. Second, OR staff routinely address the necessity for catheters with the surgical team at the beginning of the procedure and with the attending surgeon in the OR before the end of surgery in all cases.

To help change culture, educational programs were instituted with all perioperative services staff and house-staff physicians in all surgical departments, awareness was raised about the project and its justification, and the intervention was mandated to permit tracking.

A total of 465 catheters were inserted in the OR in cases less than 3 hours in the month prior to the intervention, compared with 391, 348, 409, 387, 382, and 427, respectively, in the first six months after the intervention, team leader Dr. Yang, with the hospital’s department of surgery and surgical oncology, said.

Adherence to the two-person sterile technique for OR catheter placement was 80% in the first month, reached 100% for the second and third months, but dropped to around 70% for months four through six. Data for the latter months was fed back to OR staff with encouragement to redouble efforts and increase compliance. It’s thought the problem is actually with documentation because at the time, the fields to document two-person technique in the electronic medical record were not required to be filled in before closing the file, he said.

Compliance with catheter status with the attending surgeon at sign-out was 88% in the first month, dipped slightly in months 2 and 3, and reached and has been maintained at about 85% in months 4 through 6.

“With any intervention it is expected to see periodic decreases in performance,” Dr. Yang said in an interview. “This is why using the DMAIC method becomes important, because the Control part of the methodology calls for continuously monitoring for drops in performance and includes a plan to respond to them. In our plan, the Control plan was to feedback data to the OR staff as the initial step.”

Future steps are to utilize the hospital’s Enterprise Data Warehouse report for monthly performance audits to identify any problem areas, develop a detailed Control plan and consensus criteria for catheter insertion in short cases, and to continue to provide feedback data to relevant stakeholders.

pwendling@frontlinemedcom.com

CHICAGO – A novel effort to change the prevailing culture toward overuse of catheters in surgical patients appears to be paying off for one Midwestern hospital.

The goal was to decrease catheter utilization by 5%, but 6 months after implementation, the number of catheters placed per day in the operating room in surgeries lasting less than 3 hours declined 9% (mean 14.2/day vs. 12.9/day) and overall catheter utilization in these short cases by 12% (mean 23.7% vs. 20.6%).

Removal of catheters in the OR after surgery decreased by 15% (18.3% vs. 21%), Dr. Anthony D. Yang, of Northwestern Memorial Hospital, reported at the American College of Surgeons (ACS)/National Surgical Quality Improvement Program (NSQIP) National Conference.

Dr. Anthony D. Yang

Catheter-associated urinary tract infection (CAUTI) rates before the intervention put the Chicago-based hospital in the bottom 10% of ACS NSQIP hospitals.

Post-intervention, the number of CAUTIs in patients whose catheters were inserted in the OR declined 89% from a mean of 2.75 to 0.3 per month. In 4 out of 6 post-intervention months, no CAUTIs were reported, Dr. Yang observed.

Efforts to improve CAUTIs typically focus on removing catheters in surgical patients promptly after transfer to the floor, but the assembled multidisciplinary team chose the less-studied approach of decreasing overall utilization of catheters in the OR.

Using the DMAIC (Define, Measure, Analyze, Improve and Control) method of process improvement, the team identified and instituted two major interventions. First, all catheters have to be inserted with a two-person technique to identify previously unnoticed breaks in sterile technique. Second, OR staff routinely address the necessity for catheters with the surgical team at the beginning of the procedure and with the attending surgeon in the OR before the end of surgery in all cases.

To help change culture, educational programs were instituted with all perioperative services staff and house-staff physicians in all surgical departments, awareness was raised about the project and its justification, and the intervention was mandated to permit tracking.

A total of 465 catheters were inserted in the OR in cases less than 3 hours in the month prior to the intervention, compared with 391, 348, 409, 387, 382, and 427, respectively, in the first six months after the intervention, team leader Dr. Yang, with the hospital’s department of surgery and surgical oncology, said.

Adherence to the two-person sterile technique for OR catheter placement was 80% in the first month, reached 100% for the second and third months, but dropped to around 70% for months four through six. Data for the latter months was fed back to OR staff with encouragement to redouble efforts and increase compliance. It’s thought the problem is actually with documentation because at the time, the fields to document two-person technique in the electronic medical record were not required to be filled in before closing the file, he said.

Compliance with catheter status with the attending surgeon at sign-out was 88% in the first month, dipped slightly in months 2 and 3, and reached and has been maintained at about 85% in months 4 through 6.

“With any intervention it is expected to see periodic decreases in performance,” Dr. Yang said in an interview. “This is why using the DMAIC method becomes important, because the Control part of the methodology calls for continuously monitoring for drops in performance and includes a plan to respond to them. In our plan, the Control plan was to feedback data to the OR staff as the initial step.”

Future steps are to utilize the hospital’s Enterprise Data Warehouse report for monthly performance audits to identify any problem areas, develop a detailed Control plan and consensus criteria for catheter insertion in short cases, and to continue to provide feedback data to relevant stakeholders.

pwendling@frontlinemedcom.com

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Key clinical point: An OR-focused multidisciplinary effort decreased catheter use in the operating room and catheter-associated UTIs.

Major finding: Catheter utilization in short cases declined 9% and surgical CAUTI by 89%.

Data source: Observational analysis of 2,809 surgical catheters placed.

Disclosures: The authors reported having no financial disclosures.

Longer hospitalization after bariatric surgery ups readmission risk

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Patients who stayed in hospital for at least 3 days after bariatric surgery were up to four times as likely to be readmitted as were patients who were discharged within a day, according to a study in the August issue of Surgery.

Short length of stay (LOS) after bariatric surgery might not be a risk factor for readmission as long as clinical decisions reflect the individual needs of patients, said Alex W. Lois of the Medical College of Wisconsin, and his associates.

“The goal of a program or response to this study should not be to strive to discharge all patients in 1 day or less – the key is to discharge the right patients in the right circumstances in 1 day when feasible,” the researchers said.

Fast-tracking patients after laparoscopic bariatric surgery is controversial. Some papers have described successful programs, while others have described increased risk of morbidity or mortality without careful patient selection, the researchers noted. “Although discharge in 1 day or less is certainly possible, median duration of stay is closer to 2 days for most patients,” they noted (Surgery. 2015 Aug;158[2]:501-7).

To examine the risks of fast-tracking bariatric surgery patients, the researchers performed a multicenter database analysis of 95,294 such patients who were treated from January 2009 to December 2013. The average age of the patients was 44 years, and more than three-quarters were female. Most procedures were laparoscopic Roux en-Y gastric bypass (LRYGB) surgeries, the investigators noted.

In all, 5,423 patients (5.7%) were readmitted before the end of the study period, and 83 (0.1%) died, said the investigators. Patients with 3-day and more than 3-day LOS after bariatric surgery had double and quadruple the risk of readmission, compared with patients with 1-day LOS, respectively (P less than .001 for both). Other significant predictors of readmission included LRYGB surgery, increased postoperative complications, and more comorbidities at initial admission, they said.

Preventing readmissions is not always realistic, the researchers emphasized. “Not all readmissions are avoidable. Not all readmissions represent poor quality care, either,” they said. “The decision to readmit a patient who was recently discharged is often the best option for appropriate care.” They pointed to a recent analysis of Medicare patients that found that low readmission rates after pancreaticoduodenectomy were linked with the highest rates of mortality.

But hospitals that are able to efficiently discharge bariatric surgery patients also might have other attributes that prevent readmissions but were not discernable from the study database, the investigators said. “Patients who are successfully discharged earlier also may be different than those who ultimately stay longer,” they noted. “In addition to prolonged duration of stay, complications, gastric bypass, and increased number of comorbidities also are associated with an increased risk of readmission. Targeted interventions for patients with specific risk factors for readmission may be an effective strategy for reducing readmissions after bariatric surgery.”

The study did not examine care protocols and pathways, which can affect readmission rates, and the database included administrative billing records, which differ from clinical databases when calculating readmissions. “Clinical databases like the National Surgical Quality Improvement Program more accurately capture these data,” said the researchers. “[But] regardless of these shortcomings, we believe that the size of the dataset (nearly 100,000 bariatric surgery patients) provides significant statistical power for evaluating the relationship between duration of stay and readmission rates.” Future analyses of the NSQIP dataset or the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program could further study risk factors and preventive strategies, they noted.

The Medical College of Wisconsin and the National Institutes of Health supported the study. Two coauthors disclosed consulting relationships with the University HealthSystem Consortium and Torax Medical.

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Patients who stayed in hospital for at least 3 days after bariatric surgery were up to four times as likely to be readmitted as were patients who were discharged within a day, according to a study in the August issue of Surgery.

Short length of stay (LOS) after bariatric surgery might not be a risk factor for readmission as long as clinical decisions reflect the individual needs of patients, said Alex W. Lois of the Medical College of Wisconsin, and his associates.

“The goal of a program or response to this study should not be to strive to discharge all patients in 1 day or less – the key is to discharge the right patients in the right circumstances in 1 day when feasible,” the researchers said.

Fast-tracking patients after laparoscopic bariatric surgery is controversial. Some papers have described successful programs, while others have described increased risk of morbidity or mortality without careful patient selection, the researchers noted. “Although discharge in 1 day or less is certainly possible, median duration of stay is closer to 2 days for most patients,” they noted (Surgery. 2015 Aug;158[2]:501-7).

To examine the risks of fast-tracking bariatric surgery patients, the researchers performed a multicenter database analysis of 95,294 such patients who were treated from January 2009 to December 2013. The average age of the patients was 44 years, and more than three-quarters were female. Most procedures were laparoscopic Roux en-Y gastric bypass (LRYGB) surgeries, the investigators noted.

In all, 5,423 patients (5.7%) were readmitted before the end of the study period, and 83 (0.1%) died, said the investigators. Patients with 3-day and more than 3-day LOS after bariatric surgery had double and quadruple the risk of readmission, compared with patients with 1-day LOS, respectively (P less than .001 for both). Other significant predictors of readmission included LRYGB surgery, increased postoperative complications, and more comorbidities at initial admission, they said.

Preventing readmissions is not always realistic, the researchers emphasized. “Not all readmissions are avoidable. Not all readmissions represent poor quality care, either,” they said. “The decision to readmit a patient who was recently discharged is often the best option for appropriate care.” They pointed to a recent analysis of Medicare patients that found that low readmission rates after pancreaticoduodenectomy were linked with the highest rates of mortality.

But hospitals that are able to efficiently discharge bariatric surgery patients also might have other attributes that prevent readmissions but were not discernable from the study database, the investigators said. “Patients who are successfully discharged earlier also may be different than those who ultimately stay longer,” they noted. “In addition to prolonged duration of stay, complications, gastric bypass, and increased number of comorbidities also are associated with an increased risk of readmission. Targeted interventions for patients with specific risk factors for readmission may be an effective strategy for reducing readmissions after bariatric surgery.”

The study did not examine care protocols and pathways, which can affect readmission rates, and the database included administrative billing records, which differ from clinical databases when calculating readmissions. “Clinical databases like the National Surgical Quality Improvement Program more accurately capture these data,” said the researchers. “[But] regardless of these shortcomings, we believe that the size of the dataset (nearly 100,000 bariatric surgery patients) provides significant statistical power for evaluating the relationship between duration of stay and readmission rates.” Future analyses of the NSQIP dataset or the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program could further study risk factors and preventive strategies, they noted.

The Medical College of Wisconsin and the National Institutes of Health supported the study. Two coauthors disclosed consulting relationships with the University HealthSystem Consortium and Torax Medical.

Patients who stayed in hospital for at least 3 days after bariatric surgery were up to four times as likely to be readmitted as were patients who were discharged within a day, according to a study in the August issue of Surgery.

Short length of stay (LOS) after bariatric surgery might not be a risk factor for readmission as long as clinical decisions reflect the individual needs of patients, said Alex W. Lois of the Medical College of Wisconsin, and his associates.

“The goal of a program or response to this study should not be to strive to discharge all patients in 1 day or less – the key is to discharge the right patients in the right circumstances in 1 day when feasible,” the researchers said.

Fast-tracking patients after laparoscopic bariatric surgery is controversial. Some papers have described successful programs, while others have described increased risk of morbidity or mortality without careful patient selection, the researchers noted. “Although discharge in 1 day or less is certainly possible, median duration of stay is closer to 2 days for most patients,” they noted (Surgery. 2015 Aug;158[2]:501-7).

To examine the risks of fast-tracking bariatric surgery patients, the researchers performed a multicenter database analysis of 95,294 such patients who were treated from January 2009 to December 2013. The average age of the patients was 44 years, and more than three-quarters were female. Most procedures were laparoscopic Roux en-Y gastric bypass (LRYGB) surgeries, the investigators noted.

In all, 5,423 patients (5.7%) were readmitted before the end of the study period, and 83 (0.1%) died, said the investigators. Patients with 3-day and more than 3-day LOS after bariatric surgery had double and quadruple the risk of readmission, compared with patients with 1-day LOS, respectively (P less than .001 for both). Other significant predictors of readmission included LRYGB surgery, increased postoperative complications, and more comorbidities at initial admission, they said.

Preventing readmissions is not always realistic, the researchers emphasized. “Not all readmissions are avoidable. Not all readmissions represent poor quality care, either,” they said. “The decision to readmit a patient who was recently discharged is often the best option for appropriate care.” They pointed to a recent analysis of Medicare patients that found that low readmission rates after pancreaticoduodenectomy were linked with the highest rates of mortality.

But hospitals that are able to efficiently discharge bariatric surgery patients also might have other attributes that prevent readmissions but were not discernable from the study database, the investigators said. “Patients who are successfully discharged earlier also may be different than those who ultimately stay longer,” they noted. “In addition to prolonged duration of stay, complications, gastric bypass, and increased number of comorbidities also are associated with an increased risk of readmission. Targeted interventions for patients with specific risk factors for readmission may be an effective strategy for reducing readmissions after bariatric surgery.”

The study did not examine care protocols and pathways, which can affect readmission rates, and the database included administrative billing records, which differ from clinical databases when calculating readmissions. “Clinical databases like the National Surgical Quality Improvement Program more accurately capture these data,” said the researchers. “[But] regardless of these shortcomings, we believe that the size of the dataset (nearly 100,000 bariatric surgery patients) provides significant statistical power for evaluating the relationship between duration of stay and readmission rates.” Future analyses of the NSQIP dataset or the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program could further study risk factors and preventive strategies, they noted.

The Medical College of Wisconsin and the National Institutes of Health supported the study. Two coauthors disclosed consulting relationships with the University HealthSystem Consortium and Torax Medical.

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Longer hospitalization after bariatric surgery ups readmission risk
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Key clinical point: Short length of hospital stay after bariatric surgery was not a risk factor for readmission.

Major finding: Patients who were hospitalized for 3 days and longer were two to four times as likely to be readmitted than were patients with 1-day stays (P less than .001 for both).

Data source: Multicenter database analysis of postoperative outcomes for 95,294 bariatric surgery patients.

Disclosures: The Medical College of Wisconsin and the National Institutes of Health supported the research. Two coauthors disclosed consulting relationships with the University HealthSystem Consortium and Torax Medical.

3-D–printed devices mitigate pediatric tracheobronchomalacia

The move to a 4-D paradigm
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3-D–printed devices mitigate pediatric tracheobronchomalacia

Immediate and continued life-sustaining improvement was seen in three pediatric patients implanted with 3-D–printed tracheobronchial splints as a treatment for terminal tracheobronchomalacia (TBM), a condition of excessive collapse of the airways during respiration leading to cardiopulmonary arrest.

The particular value of such 3-D–printable biomaterials to pediatric surgery is their ability to adopt a 4-D modality – to exhibit specifically engineered shape changes in response to surrounding tissue growth over a defined time period. In addition to their malleability, these devices also are designed to biodegrade. These features have proven especially useful as seen in this medical device emergency use exemption study performed at the University of Michigan, according to a report published in Science Translational Medicine (2015 Apr 29. [doi: 10.1126/scitranslmed.3010825]).

“Our multidisciplinary team designed an archetype device to allow radial expansion of the affected airway over the critical growth period while resisting external compression and intrinsic collapse,” wrote Dr. Robert J. Morrison of the University of Michigan, Ann Arbor, and his colleagues.

The study population involved three infant boys, aged 3 months, 5 months, and 16 months at time of treatment. In each patient, a sternotomy exposed their affected airways. The 3-D–printed splint, consisting of conjoined rib-like C-shaped arches was placed around the affected airway and secured with polypropylene sutures. The splint counters external pressure on the airway and holds it open. Because the splint is malleable, with an expandable opening placed opposite to the main collapsing pressure, it is capable of expanding as the airway grows.

Examination of the airway immediately after placement demonstrated patency, which was confirmed 1 month later. Results showed the benefit of the splints for all three patients, although total results were complicated by additional comorbidities:

• Patient 1: Blood gases returned to normal immediately after implantation and remained normal at 3 months’ follow-up. A week after implantation, weaning from mechanical ventilation was initiated and, 3 weeks after the procedure, the child was discharged to home. Repeat imaging at 1, 3, 6, 12, and 39 months postoperatively demonstrated continued resolution of the TBM, with evidence of fragmentation and degradation of the splint at 39 months.

• Patient 2: Immediately after implantation of the device, blood gases improved greatly and the left lung perfused. The patient had opioid and benzodiazepine dependence from long-term ventilator support, requiring a longer controlled wean from the ventilator. Four weeks after surgery, the patient was transitioned to a portable ventilator system, completely weaned at 15 weeks, and discharged from the hospital to home for the first time in his life.

• Patient 3: After implantation, the patient ceased experiencing life-threatening desaturation episodes and showed sustained improvement in blood gases. Imaging showed continued patency of the left main bronchus with resolution of left-lung air trapping. However, at 14 months post implantation, he remained on permanent ventilator support, “presumably because of distal left segmental bronchomalacia beyond what the splint was designed to address,” according to Dr. Morrison and his colleagues.

“We report successful implantation of patient-specific bioresorbable airway splints for the treatment of severe TBM. The personalized splints conformed to the patients’ individual geometries and expanded with airway growth (in the ‘fourth dimension’),” the researchers summarized.

“The three pediatric patients implanted with these 3-D–printed airway splints had a terminal form of TBM. The clinical improvement in each case was immediate and sustained, suggesting that improvement is not attributable to the natural history of the disease alone,” they concluded.

The study was funded by the National Institutes of Health. Two of the study authors were coinventors of the device for which they have filed a patent. There were no other disclosures.

mlesney@frontlinemedcom.com

Body

As illustrated in this article, the investigators demonstrate the potential for the future of 3-D–printing in medicine. While there have been numerous reports of utilizing 3-D–printing for a generation of personalized prostheses, these have been used in static circumstances in which the prosthesis is not required to change over time. In pediatric applications, as the child grows, the prosthesis also needs to adapt to this growth, thereby necessitating “4-D” printing.

 

Dr. Sai Yendamuri

In three patients, the authors have applied this 4-D–printing paradigm to devise external bronchial splints to alleviate life-threatening tracheobronchomalacia using a novel design and a bioresorbable material, resulting in superb medium-term outcomes for patients with an otherwise dire prognosis.

Dr. Sai Yendamuri is an attending surgeon at the department of thoracic surgery, and director, Thoracic Surgery Research Laboratory, and an associate professor of oncology at Roswell Park Cancer Institute, Buffalo, N.Y. He is also an associate medical editor for Thoracic Surgery News.

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As illustrated in this article, the investigators demonstrate the potential for the future of 3-D–printing in medicine. While there have been numerous reports of utilizing 3-D–printing for a generation of personalized prostheses, these have been used in static circumstances in which the prosthesis is not required to change over time. In pediatric applications, as the child grows, the prosthesis also needs to adapt to this growth, thereby necessitating “4-D” printing.

 

Dr. Sai Yendamuri

In three patients, the authors have applied this 4-D–printing paradigm to devise external bronchial splints to alleviate life-threatening tracheobronchomalacia using a novel design and a bioresorbable material, resulting in superb medium-term outcomes for patients with an otherwise dire prognosis.

Dr. Sai Yendamuri is an attending surgeon at the department of thoracic surgery, and director, Thoracic Surgery Research Laboratory, and an associate professor of oncology at Roswell Park Cancer Institute, Buffalo, N.Y. He is also an associate medical editor for Thoracic Surgery News.

Body

As illustrated in this article, the investigators demonstrate the potential for the future of 3-D–printing in medicine. While there have been numerous reports of utilizing 3-D–printing for a generation of personalized prostheses, these have been used in static circumstances in which the prosthesis is not required to change over time. In pediatric applications, as the child grows, the prosthesis also needs to adapt to this growth, thereby necessitating “4-D” printing.

 

Dr. Sai Yendamuri

In three patients, the authors have applied this 4-D–printing paradigm to devise external bronchial splints to alleviate life-threatening tracheobronchomalacia using a novel design and a bioresorbable material, resulting in superb medium-term outcomes for patients with an otherwise dire prognosis.

Dr. Sai Yendamuri is an attending surgeon at the department of thoracic surgery, and director, Thoracic Surgery Research Laboratory, and an associate professor of oncology at Roswell Park Cancer Institute, Buffalo, N.Y. He is also an associate medical editor for Thoracic Surgery News.

Title
The move to a 4-D paradigm
The move to a 4-D paradigm

Immediate and continued life-sustaining improvement was seen in three pediatric patients implanted with 3-D–printed tracheobronchial splints as a treatment for terminal tracheobronchomalacia (TBM), a condition of excessive collapse of the airways during respiration leading to cardiopulmonary arrest.

The particular value of such 3-D–printable biomaterials to pediatric surgery is their ability to adopt a 4-D modality – to exhibit specifically engineered shape changes in response to surrounding tissue growth over a defined time period. In addition to their malleability, these devices also are designed to biodegrade. These features have proven especially useful as seen in this medical device emergency use exemption study performed at the University of Michigan, according to a report published in Science Translational Medicine (2015 Apr 29. [doi: 10.1126/scitranslmed.3010825]).

“Our multidisciplinary team designed an archetype device to allow radial expansion of the affected airway over the critical growth period while resisting external compression and intrinsic collapse,” wrote Dr. Robert J. Morrison of the University of Michigan, Ann Arbor, and his colleagues.

The study population involved three infant boys, aged 3 months, 5 months, and 16 months at time of treatment. In each patient, a sternotomy exposed their affected airways. The 3-D–printed splint, consisting of conjoined rib-like C-shaped arches was placed around the affected airway and secured with polypropylene sutures. The splint counters external pressure on the airway and holds it open. Because the splint is malleable, with an expandable opening placed opposite to the main collapsing pressure, it is capable of expanding as the airway grows.

Examination of the airway immediately after placement demonstrated patency, which was confirmed 1 month later. Results showed the benefit of the splints for all three patients, although total results were complicated by additional comorbidities:

• Patient 1: Blood gases returned to normal immediately after implantation and remained normal at 3 months’ follow-up. A week after implantation, weaning from mechanical ventilation was initiated and, 3 weeks after the procedure, the child was discharged to home. Repeat imaging at 1, 3, 6, 12, and 39 months postoperatively demonstrated continued resolution of the TBM, with evidence of fragmentation and degradation of the splint at 39 months.

• Patient 2: Immediately after implantation of the device, blood gases improved greatly and the left lung perfused. The patient had opioid and benzodiazepine dependence from long-term ventilator support, requiring a longer controlled wean from the ventilator. Four weeks after surgery, the patient was transitioned to a portable ventilator system, completely weaned at 15 weeks, and discharged from the hospital to home for the first time in his life.

• Patient 3: After implantation, the patient ceased experiencing life-threatening desaturation episodes and showed sustained improvement in blood gases. Imaging showed continued patency of the left main bronchus with resolution of left-lung air trapping. However, at 14 months post implantation, he remained on permanent ventilator support, “presumably because of distal left segmental bronchomalacia beyond what the splint was designed to address,” according to Dr. Morrison and his colleagues.

“We report successful implantation of patient-specific bioresorbable airway splints for the treatment of severe TBM. The personalized splints conformed to the patients’ individual geometries and expanded with airway growth (in the ‘fourth dimension’),” the researchers summarized.

“The three pediatric patients implanted with these 3-D–printed airway splints had a terminal form of TBM. The clinical improvement in each case was immediate and sustained, suggesting that improvement is not attributable to the natural history of the disease alone,” they concluded.

The study was funded by the National Institutes of Health. Two of the study authors were coinventors of the device for which they have filed a patent. There were no other disclosures.

mlesney@frontlinemedcom.com

Immediate and continued life-sustaining improvement was seen in three pediatric patients implanted with 3-D–printed tracheobronchial splints as a treatment for terminal tracheobronchomalacia (TBM), a condition of excessive collapse of the airways during respiration leading to cardiopulmonary arrest.

The particular value of such 3-D–printable biomaterials to pediatric surgery is their ability to adopt a 4-D modality – to exhibit specifically engineered shape changes in response to surrounding tissue growth over a defined time period. In addition to their malleability, these devices also are designed to biodegrade. These features have proven especially useful as seen in this medical device emergency use exemption study performed at the University of Michigan, according to a report published in Science Translational Medicine (2015 Apr 29. [doi: 10.1126/scitranslmed.3010825]).

“Our multidisciplinary team designed an archetype device to allow radial expansion of the affected airway over the critical growth period while resisting external compression and intrinsic collapse,” wrote Dr. Robert J. Morrison of the University of Michigan, Ann Arbor, and his colleagues.

The study population involved three infant boys, aged 3 months, 5 months, and 16 months at time of treatment. In each patient, a sternotomy exposed their affected airways. The 3-D–printed splint, consisting of conjoined rib-like C-shaped arches was placed around the affected airway and secured with polypropylene sutures. The splint counters external pressure on the airway and holds it open. Because the splint is malleable, with an expandable opening placed opposite to the main collapsing pressure, it is capable of expanding as the airway grows.

Examination of the airway immediately after placement demonstrated patency, which was confirmed 1 month later. Results showed the benefit of the splints for all three patients, although total results were complicated by additional comorbidities:

• Patient 1: Blood gases returned to normal immediately after implantation and remained normal at 3 months’ follow-up. A week after implantation, weaning from mechanical ventilation was initiated and, 3 weeks after the procedure, the child was discharged to home. Repeat imaging at 1, 3, 6, 12, and 39 months postoperatively demonstrated continued resolution of the TBM, with evidence of fragmentation and degradation of the splint at 39 months.

• Patient 2: Immediately after implantation of the device, blood gases improved greatly and the left lung perfused. The patient had opioid and benzodiazepine dependence from long-term ventilator support, requiring a longer controlled wean from the ventilator. Four weeks after surgery, the patient was transitioned to a portable ventilator system, completely weaned at 15 weeks, and discharged from the hospital to home for the first time in his life.

• Patient 3: After implantation, the patient ceased experiencing life-threatening desaturation episodes and showed sustained improvement in blood gases. Imaging showed continued patency of the left main bronchus with resolution of left-lung air trapping. However, at 14 months post implantation, he remained on permanent ventilator support, “presumably because of distal left segmental bronchomalacia beyond what the splint was designed to address,” according to Dr. Morrison and his colleagues.

“We report successful implantation of patient-specific bioresorbable airway splints for the treatment of severe TBM. The personalized splints conformed to the patients’ individual geometries and expanded with airway growth (in the ‘fourth dimension’),” the researchers summarized.

“The three pediatric patients implanted with these 3-D–printed airway splints had a terminal form of TBM. The clinical improvement in each case was immediate and sustained, suggesting that improvement is not attributable to the natural history of the disease alone,” they concluded.

The study was funded by the National Institutes of Health. Two of the study authors were coinventors of the device for which they have filed a patent. There were no other disclosures.

mlesney@frontlinemedcom.com

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Key clinical point: The use of 3-D–printed airway implants mitigated life-threatening tracheobronchomalacia (TBM) in three infants.

Major finding: Three infants with a terminal form of TBM ceased exhibiting life-threatening airway disease and showed continued growth of pulmonary airways after 3-D tracheal implants.

Data source: A study performed at the University of Michigan, Ann Arbor, of three infants with terminal TBM who received a medical device emergency use exemption for a 3-D tracheal implant.

Disclosures: The study was funded by the National Institutes of Health. Two of the study authors were coinventors of the device for which they have filed a patent. There were no other disclosures.

Reduced invasive recurrence after DCIS does not reduce mortality

Reboot needed on DCIS treatment
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Reduced invasive recurrence after DCIS does not reduce mortality

Radiotherapy after breast-conserving surgery for ductal carcinoma in situ reduces the risk of ipsilateral invasive recurrence but does not reduce breast cancer mortality, new research shows.

Analysis of data from 108,196 women diagnosed with ductal carcinoma in situ (DCIS), who were included in the Surveillance, Epidemiology, and End Results (SEER) 18 registries database, showed radiotherapy significantly reduced the risk of ipsilateral invasive recurrence at 10 years (adjusted hazard, 0.47; 95% confidence interval, 0.42-0.53; P less than .001) but only achieved a nonsignificant reduction in breast cancer mortality (adjusted HR, 0.81; 95% CI, 0.63-1.04; P = .10).

“The finding of greatest clinical importance was that prevention of ipsilateral invasive recurrence did not prevent death from breast cancer,” wrote Dr. Steven A. Narod and his colleagues from the Women’s College Hospital and the University of Toronto.

Though it is often stated that DCIS is a preinvasive neoplastic lesion that is not lethal in itself, these results suggest that this interpretation should be revisited, they said in the report, published online August 20 in JAMA Oncology.

“Some cases of DCIS have an inherent potential for distant metastatic spread. It is therefore appropriate to consider these as de facto breast cancers and not as preinvasive markers predictive of a subsequent invasive cancer,” they said.

KGH/Wikimedia Commons/CC BY-SA

The mean age at diagnosis of DCIS for the women in the database was 53.8 (range, 15-69) years, and the mean duration of follow-up was 7.5 (range, 0-23.9) years. Overall, the 20-year breast cancer–specific mortality rate following a diagnosis of DCIS was 3.3% (95% CI, 3.0%-3.6%).

Just over 1% of the 42,250 women treated with lumpectomy and radiotherapy developed an ipsilateral invasive recurrence in the follow-up period and 163 women (0.4%) died of breast cancer. Of the 19,762 women who were treated with lumpectomy without radiotherapy, 595 women (3%) developed an ipsilateral invasive recurrence and 102 women (0.5%) died of breast cancer, Dr. Narod and his associates reported (JAMA Oncology. 2015 Aug. 20 doi: 10.1001/jamaoncol.2015.2510).

Among the 956 women who died of breast cancer in the follow-up period, over half (517) did not experience an in-breast invasive recurrence prior to death. Of the 163 women who were treated with lumpectomy and radiotherapy and then died of breast cancer, 57.7% (94) did not experience an in-breast invasive recurrence prior to death. Among the 102 women treated with lumpectomy without radiotherapy who died of breast cancer, 51 did not experience an in-breast invasive recurrence prior to death (50.0%). Among the 154 women treated with a mastectomy (unilateral or bilateral) who died of breast cancer, 112 did not experience an in-breast invasive recurrence prior to death (72.7%), the investigators reported.

They found that young age at diagnosis and black ethnicity were predictors of breast cancer mortality. Young women diagnosed with ductal carcinoma in situ before the age of 35 years had a more than twofold greater risk of dying from breast cancer than older women (7.8% vs. 3.2%; HR 2.58, 95% CI, 1.85-3.60; P less than .001). Black women also had a much greater risk of dying from breast cancer than non-Hispanic whites (7.0% vs. 3.0%; HR, 2.55, 95% CI, 2.17-3.01; P less than .001).

“If DCIS were truly a (noninvasive) precursor of breast cancer, then a woman with DCIS should not die of breast cancer without first experiencing an invasive breast cancer (ipsilateral or contralateral), and the prevention of an invasive recurrence should prevent her death from breast cancer. Surprisingly, the majority of women with DCIS in the cohort who died of breast cancer did not experience an invasive in-breast recurrence (ipsilateral or contralateral) prior to death (54.1%),” the investigators said.

“The outcome of breast cancer mortality for DCIS patients is of importance in itself and potential treatments that affect mortality are deserving of study,” they concluded.

No relevant conflicts of interest were declared.

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The analysis by Dr. Narod and his associates fuels a growing concern that we should rethink our strategy for the detection and treatment of DCIS. Given the low breast cancer mortality risk, we should stop telling women that DCIS is an emergency and that they should schedule definitive surgery within 2 weeks of diagnosis. For the lowest-risk lesions, observation and prevention interventions alone should be tested. High-risk lesions (such as HER2 positive, those in patients aged less than 40 years, hormone-receptor negative, large size) should still be aggressively treated, but this analysis suggests that our current approach of surgical removal and radiation therapy may not suffice for the rare cases that lead to breast cancer mortality, so new approaches are needed.

We should continue to better understand the biological characteristics of the highest-risk DCIS and test targeted approaches to reduce death from breast cancer.

Dr. Laura Esserman and Christina Yau, Ph.D., are with the department of surgery at the University of California, San Francisco. These comments were taken from an accompanying editorial (JAMA Oncology. 2015 Aug. 20 doi: 10.1001/jamaoncol.2015.2607). No conflicts of interest were declared.

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Body

The analysis by Dr. Narod and his associates fuels a growing concern that we should rethink our strategy for the detection and treatment of DCIS. Given the low breast cancer mortality risk, we should stop telling women that DCIS is an emergency and that they should schedule definitive surgery within 2 weeks of diagnosis. For the lowest-risk lesions, observation and prevention interventions alone should be tested. High-risk lesions (such as HER2 positive, those in patients aged less than 40 years, hormone-receptor negative, large size) should still be aggressively treated, but this analysis suggests that our current approach of surgical removal and radiation therapy may not suffice for the rare cases that lead to breast cancer mortality, so new approaches are needed.

We should continue to better understand the biological characteristics of the highest-risk DCIS and test targeted approaches to reduce death from breast cancer.

Dr. Laura Esserman and Christina Yau, Ph.D., are with the department of surgery at the University of California, San Francisco. These comments were taken from an accompanying editorial (JAMA Oncology. 2015 Aug. 20 doi: 10.1001/jamaoncol.2015.2607). No conflicts of interest were declared.

Body

The analysis by Dr. Narod and his associates fuels a growing concern that we should rethink our strategy for the detection and treatment of DCIS. Given the low breast cancer mortality risk, we should stop telling women that DCIS is an emergency and that they should schedule definitive surgery within 2 weeks of diagnosis. For the lowest-risk lesions, observation and prevention interventions alone should be tested. High-risk lesions (such as HER2 positive, those in patients aged less than 40 years, hormone-receptor negative, large size) should still be aggressively treated, but this analysis suggests that our current approach of surgical removal and radiation therapy may not suffice for the rare cases that lead to breast cancer mortality, so new approaches are needed.

We should continue to better understand the biological characteristics of the highest-risk DCIS and test targeted approaches to reduce death from breast cancer.

Dr. Laura Esserman and Christina Yau, Ph.D., are with the department of surgery at the University of California, San Francisco. These comments were taken from an accompanying editorial (JAMA Oncology. 2015 Aug. 20 doi: 10.1001/jamaoncol.2015.2607). No conflicts of interest were declared.

Title
Reboot needed on DCIS treatment
Reboot needed on DCIS treatment

Radiotherapy after breast-conserving surgery for ductal carcinoma in situ reduces the risk of ipsilateral invasive recurrence but does not reduce breast cancer mortality, new research shows.

Analysis of data from 108,196 women diagnosed with ductal carcinoma in situ (DCIS), who were included in the Surveillance, Epidemiology, and End Results (SEER) 18 registries database, showed radiotherapy significantly reduced the risk of ipsilateral invasive recurrence at 10 years (adjusted hazard, 0.47; 95% confidence interval, 0.42-0.53; P less than .001) but only achieved a nonsignificant reduction in breast cancer mortality (adjusted HR, 0.81; 95% CI, 0.63-1.04; P = .10).

“The finding of greatest clinical importance was that prevention of ipsilateral invasive recurrence did not prevent death from breast cancer,” wrote Dr. Steven A. Narod and his colleagues from the Women’s College Hospital and the University of Toronto.

Though it is often stated that DCIS is a preinvasive neoplastic lesion that is not lethal in itself, these results suggest that this interpretation should be revisited, they said in the report, published online August 20 in JAMA Oncology.

“Some cases of DCIS have an inherent potential for distant metastatic spread. It is therefore appropriate to consider these as de facto breast cancers and not as preinvasive markers predictive of a subsequent invasive cancer,” they said.

KGH/Wikimedia Commons/CC BY-SA

The mean age at diagnosis of DCIS for the women in the database was 53.8 (range, 15-69) years, and the mean duration of follow-up was 7.5 (range, 0-23.9) years. Overall, the 20-year breast cancer–specific mortality rate following a diagnosis of DCIS was 3.3% (95% CI, 3.0%-3.6%).

Just over 1% of the 42,250 women treated with lumpectomy and radiotherapy developed an ipsilateral invasive recurrence in the follow-up period and 163 women (0.4%) died of breast cancer. Of the 19,762 women who were treated with lumpectomy without radiotherapy, 595 women (3%) developed an ipsilateral invasive recurrence and 102 women (0.5%) died of breast cancer, Dr. Narod and his associates reported (JAMA Oncology. 2015 Aug. 20 doi: 10.1001/jamaoncol.2015.2510).

Among the 956 women who died of breast cancer in the follow-up period, over half (517) did not experience an in-breast invasive recurrence prior to death. Of the 163 women who were treated with lumpectomy and radiotherapy and then died of breast cancer, 57.7% (94) did not experience an in-breast invasive recurrence prior to death. Among the 102 women treated with lumpectomy without radiotherapy who died of breast cancer, 51 did not experience an in-breast invasive recurrence prior to death (50.0%). Among the 154 women treated with a mastectomy (unilateral or bilateral) who died of breast cancer, 112 did not experience an in-breast invasive recurrence prior to death (72.7%), the investigators reported.

They found that young age at diagnosis and black ethnicity were predictors of breast cancer mortality. Young women diagnosed with ductal carcinoma in situ before the age of 35 years had a more than twofold greater risk of dying from breast cancer than older women (7.8% vs. 3.2%; HR 2.58, 95% CI, 1.85-3.60; P less than .001). Black women also had a much greater risk of dying from breast cancer than non-Hispanic whites (7.0% vs. 3.0%; HR, 2.55, 95% CI, 2.17-3.01; P less than .001).

“If DCIS were truly a (noninvasive) precursor of breast cancer, then a woman with DCIS should not die of breast cancer without first experiencing an invasive breast cancer (ipsilateral or contralateral), and the prevention of an invasive recurrence should prevent her death from breast cancer. Surprisingly, the majority of women with DCIS in the cohort who died of breast cancer did not experience an invasive in-breast recurrence (ipsilateral or contralateral) prior to death (54.1%),” the investigators said.

“The outcome of breast cancer mortality for DCIS patients is of importance in itself and potential treatments that affect mortality are deserving of study,” they concluded.

No relevant conflicts of interest were declared.

Radiotherapy after breast-conserving surgery for ductal carcinoma in situ reduces the risk of ipsilateral invasive recurrence but does not reduce breast cancer mortality, new research shows.

Analysis of data from 108,196 women diagnosed with ductal carcinoma in situ (DCIS), who were included in the Surveillance, Epidemiology, and End Results (SEER) 18 registries database, showed radiotherapy significantly reduced the risk of ipsilateral invasive recurrence at 10 years (adjusted hazard, 0.47; 95% confidence interval, 0.42-0.53; P less than .001) but only achieved a nonsignificant reduction in breast cancer mortality (adjusted HR, 0.81; 95% CI, 0.63-1.04; P = .10).

“The finding of greatest clinical importance was that prevention of ipsilateral invasive recurrence did not prevent death from breast cancer,” wrote Dr. Steven A. Narod and his colleagues from the Women’s College Hospital and the University of Toronto.

Though it is often stated that DCIS is a preinvasive neoplastic lesion that is not lethal in itself, these results suggest that this interpretation should be revisited, they said in the report, published online August 20 in JAMA Oncology.

“Some cases of DCIS have an inherent potential for distant metastatic spread. It is therefore appropriate to consider these as de facto breast cancers and not as preinvasive markers predictive of a subsequent invasive cancer,” they said.

KGH/Wikimedia Commons/CC BY-SA

The mean age at diagnosis of DCIS for the women in the database was 53.8 (range, 15-69) years, and the mean duration of follow-up was 7.5 (range, 0-23.9) years. Overall, the 20-year breast cancer–specific mortality rate following a diagnosis of DCIS was 3.3% (95% CI, 3.0%-3.6%).

Just over 1% of the 42,250 women treated with lumpectomy and radiotherapy developed an ipsilateral invasive recurrence in the follow-up period and 163 women (0.4%) died of breast cancer. Of the 19,762 women who were treated with lumpectomy without radiotherapy, 595 women (3%) developed an ipsilateral invasive recurrence and 102 women (0.5%) died of breast cancer, Dr. Narod and his associates reported (JAMA Oncology. 2015 Aug. 20 doi: 10.1001/jamaoncol.2015.2510).

Among the 956 women who died of breast cancer in the follow-up period, over half (517) did not experience an in-breast invasive recurrence prior to death. Of the 163 women who were treated with lumpectomy and radiotherapy and then died of breast cancer, 57.7% (94) did not experience an in-breast invasive recurrence prior to death. Among the 102 women treated with lumpectomy without radiotherapy who died of breast cancer, 51 did not experience an in-breast invasive recurrence prior to death (50.0%). Among the 154 women treated with a mastectomy (unilateral or bilateral) who died of breast cancer, 112 did not experience an in-breast invasive recurrence prior to death (72.7%), the investigators reported.

They found that young age at diagnosis and black ethnicity were predictors of breast cancer mortality. Young women diagnosed with ductal carcinoma in situ before the age of 35 years had a more than twofold greater risk of dying from breast cancer than older women (7.8% vs. 3.2%; HR 2.58, 95% CI, 1.85-3.60; P less than .001). Black women also had a much greater risk of dying from breast cancer than non-Hispanic whites (7.0% vs. 3.0%; HR, 2.55, 95% CI, 2.17-3.01; P less than .001).

“If DCIS were truly a (noninvasive) precursor of breast cancer, then a woman with DCIS should not die of breast cancer without first experiencing an invasive breast cancer (ipsilateral or contralateral), and the prevention of an invasive recurrence should prevent her death from breast cancer. Surprisingly, the majority of women with DCIS in the cohort who died of breast cancer did not experience an invasive in-breast recurrence (ipsilateral or contralateral) prior to death (54.1%),” the investigators said.

“The outcome of breast cancer mortality for DCIS patients is of importance in itself and potential treatments that affect mortality are deserving of study,” they concluded.

No relevant conflicts of interest were declared.

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Key clinical point: Radiotherapy after ductal carcinoma in situ reduces the risk of ipsilateral invasive recurrence but does not reduce breast cancer mortality.

Major finding: Radiotherapy after DCIS halves the risk of recurrence but does not significantly impact the risk of death from breast cancer.

Data source: Observational study of data from 108,196 women diagnosed with ductal carcinoma in situ in the SEER18 registries.

Disclosures: No conflicts of interest were declared.

Surgeon volume may affect choice of surgery type for NSCLC

Surgeons can argue either way
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Surgeon volume may affect choice of surgery type for NSCLC

A surgeon’s comfort level with a favored operation for non–small cell lung cancer can strongly influence whether the patient will have that operation, which, in turn, can affect the patient’s outcome and long-term survival, according to an analysis of a population-linked database. For patients whose surgeons have lower levels of experience, that could mean a greater chance they will have more invasive total lung removal rather than more difficult operations that spare part of the affected lung, according to investigators at McMaster University in Hamilton, Ontario.

“If a surgeon with high surgical volumes is less likely to perform higher-risk pneumonectomy procedures than one with lower volumes, this may translate to a significant reduction in adverse events,” said lead author Dr. Christian Finley and coauthors online in the Journal of Thoracic and Cardiovascular Surgery (2015 Jun 30 [doi: 10.1016/j.jtcvs.2015.04.060]). “Surgeon volume should be considered an important component in how care is delivered in this population.”

The McMaster investigators evaluated 8,070 patients in an Ontario population-based linked database who underwent surgical resection for non–small cell lung cancer during 2004-2011, including pneumonectomy, or total lung removal (842 patients), lobectomy (6,212 patients), and wedge resection (1,002 patients). Over the years of the study, the proportion of patients who underwent pneumonectomy fell by more than half, from 14.8% in 2004 to 7.6% in 2011.

Of the three procedures, pneumonectomy carries a threefold greater mortality and while the procedure is often avoidable, there may be cases where it’s necessary because of the location of the tumor, Dr. Finley and his colleagues said. Lobectomy is desirable because it spares the parenchyma and has lower recurrence rates than laser resections.

The study investigators aimed to explore the hypothesis that surgeons with less expertise are more inclined to perform the higher-risk pneumonectomy or sublobar resections such as a segmentectomy or a wedge resection than a lobectomy, the rationale being that these procedures can be less challenging than a standard or sleeve lobectomy. The study analyzed results from 124 different physicians at 45 institutions in Ontario.

Data analysis showed that physician volume, age, year of procedure, sex, and comorbidities were predictive of the surgeon performing a pneumonectomy. “Adjusting for these variables, the results indicated that for each 10-unit increase in physician volume, the relative risk of performing a pneumonectomy decreased by 9.1%,” Dr. Finley and his colleagues wrote. They also found no significant difference in stage distribution among low-, medium-, and high-volume surgeons.

“This is meaningful as pneumonectomy is known to have the highest mortality rate of lung cancer resection, found in this study to be 12.6%, demonstrating a potentially large impact on patient survival,” Dr. Finley and his colleagues said.

This analysis cites an earlier study that surgeon volume for many procedures was a key determinant in the link between hospital volume and operative mortality (N Engl J Med. 2003 Nov 27;349[2]:2117-27.). “This study suggests that a patient may improve their chance of survival substantially, even at high-volume institutions, by selecting surgeons who perform operations more frequently,” Dr. Finley and his colleagues said.

They said that despite their study’s limitations, the findings on how surgeon experience can influence the choice of lung resection for cancer warrant further study.

McMaster University, Division of Thoracic Surgery, provided funding for the study. The study authors had no disclosures.

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Because the McMaster University study derived the reported outcomes from registry data, determining the reasons that influenced surgeons’ choices of lung resection is impossible, Dr. Eric Lim of the Imperial College of Medicine, London, said in his invited commentary (J Thorac Cardiovasc Surg. 2015 May 21 [doi:10.1016/j.jtcvs.2015.05.048]).

The study authors noted that lower-volume surgeons were more inclined to perform pneumonectomy, and, Dr. Lim noted, previous studies have found that higher-volume centers tended to see more patients with advanced-stage cancers and increased morbidities. “An alternative explanation is that higher-volume surgeons have better skill sets to undertake procedures such as sleeve lobectomies that would lower the pneumonectomy rates and possibly more segmentectomies to lower the wedge-resection rate,” Dr. Lim said.

Until better evidence exists on what procedure is best for central and peripheral tumors, “surgeons can argue either way,” Dr. Lim said. The questions that follow from the study should concentrate on the relative harm of each procedure and the level of practice variation that’s unacceptable.

“As a surgical community, it is incumbent on us to continue to evaluate surgical treatments generating the highest levels of evidence possible (randomized trials) and have sufficient humility to cross refer to colleagues when appropriate to ensure the best care for our patients,” Dr. Lim concluded.

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Because the McMaster University study derived the reported outcomes from registry data, determining the reasons that influenced surgeons’ choices of lung resection is impossible, Dr. Eric Lim of the Imperial College of Medicine, London, said in his invited commentary (J Thorac Cardiovasc Surg. 2015 May 21 [doi:10.1016/j.jtcvs.2015.05.048]).

The study authors noted that lower-volume surgeons were more inclined to perform pneumonectomy, and, Dr. Lim noted, previous studies have found that higher-volume centers tended to see more patients with advanced-stage cancers and increased morbidities. “An alternative explanation is that higher-volume surgeons have better skill sets to undertake procedures such as sleeve lobectomies that would lower the pneumonectomy rates and possibly more segmentectomies to lower the wedge-resection rate,” Dr. Lim said.

Until better evidence exists on what procedure is best for central and peripheral tumors, “surgeons can argue either way,” Dr. Lim said. The questions that follow from the study should concentrate on the relative harm of each procedure and the level of practice variation that’s unacceptable.

“As a surgical community, it is incumbent on us to continue to evaluate surgical treatments generating the highest levels of evidence possible (randomized trials) and have sufficient humility to cross refer to colleagues when appropriate to ensure the best care for our patients,” Dr. Lim concluded.

Body

Because the McMaster University study derived the reported outcomes from registry data, determining the reasons that influenced surgeons’ choices of lung resection is impossible, Dr. Eric Lim of the Imperial College of Medicine, London, said in his invited commentary (J Thorac Cardiovasc Surg. 2015 May 21 [doi:10.1016/j.jtcvs.2015.05.048]).

The study authors noted that lower-volume surgeons were more inclined to perform pneumonectomy, and, Dr. Lim noted, previous studies have found that higher-volume centers tended to see more patients with advanced-stage cancers and increased morbidities. “An alternative explanation is that higher-volume surgeons have better skill sets to undertake procedures such as sleeve lobectomies that would lower the pneumonectomy rates and possibly more segmentectomies to lower the wedge-resection rate,” Dr. Lim said.

Until better evidence exists on what procedure is best for central and peripheral tumors, “surgeons can argue either way,” Dr. Lim said. The questions that follow from the study should concentrate on the relative harm of each procedure and the level of practice variation that’s unacceptable.

“As a surgical community, it is incumbent on us to continue to evaluate surgical treatments generating the highest levels of evidence possible (randomized trials) and have sufficient humility to cross refer to colleagues when appropriate to ensure the best care for our patients,” Dr. Lim concluded.

Title
Surgeons can argue either way
Surgeons can argue either way

A surgeon’s comfort level with a favored operation for non–small cell lung cancer can strongly influence whether the patient will have that operation, which, in turn, can affect the patient’s outcome and long-term survival, according to an analysis of a population-linked database. For patients whose surgeons have lower levels of experience, that could mean a greater chance they will have more invasive total lung removal rather than more difficult operations that spare part of the affected lung, according to investigators at McMaster University in Hamilton, Ontario.

“If a surgeon with high surgical volumes is less likely to perform higher-risk pneumonectomy procedures than one with lower volumes, this may translate to a significant reduction in adverse events,” said lead author Dr. Christian Finley and coauthors online in the Journal of Thoracic and Cardiovascular Surgery (2015 Jun 30 [doi: 10.1016/j.jtcvs.2015.04.060]). “Surgeon volume should be considered an important component in how care is delivered in this population.”

The McMaster investigators evaluated 8,070 patients in an Ontario population-based linked database who underwent surgical resection for non–small cell lung cancer during 2004-2011, including pneumonectomy, or total lung removal (842 patients), lobectomy (6,212 patients), and wedge resection (1,002 patients). Over the years of the study, the proportion of patients who underwent pneumonectomy fell by more than half, from 14.8% in 2004 to 7.6% in 2011.

Of the three procedures, pneumonectomy carries a threefold greater mortality and while the procedure is often avoidable, there may be cases where it’s necessary because of the location of the tumor, Dr. Finley and his colleagues said. Lobectomy is desirable because it spares the parenchyma and has lower recurrence rates than laser resections.

The study investigators aimed to explore the hypothesis that surgeons with less expertise are more inclined to perform the higher-risk pneumonectomy or sublobar resections such as a segmentectomy or a wedge resection than a lobectomy, the rationale being that these procedures can be less challenging than a standard or sleeve lobectomy. The study analyzed results from 124 different physicians at 45 institutions in Ontario.

Data analysis showed that physician volume, age, year of procedure, sex, and comorbidities were predictive of the surgeon performing a pneumonectomy. “Adjusting for these variables, the results indicated that for each 10-unit increase in physician volume, the relative risk of performing a pneumonectomy decreased by 9.1%,” Dr. Finley and his colleagues wrote. They also found no significant difference in stage distribution among low-, medium-, and high-volume surgeons.

“This is meaningful as pneumonectomy is known to have the highest mortality rate of lung cancer resection, found in this study to be 12.6%, demonstrating a potentially large impact on patient survival,” Dr. Finley and his colleagues said.

This analysis cites an earlier study that surgeon volume for many procedures was a key determinant in the link between hospital volume and operative mortality (N Engl J Med. 2003 Nov 27;349[2]:2117-27.). “This study suggests that a patient may improve their chance of survival substantially, even at high-volume institutions, by selecting surgeons who perform operations more frequently,” Dr. Finley and his colleagues said.

They said that despite their study’s limitations, the findings on how surgeon experience can influence the choice of lung resection for cancer warrant further study.

McMaster University, Division of Thoracic Surgery, provided funding for the study. The study authors had no disclosures.

A surgeon’s comfort level with a favored operation for non–small cell lung cancer can strongly influence whether the patient will have that operation, which, in turn, can affect the patient’s outcome and long-term survival, according to an analysis of a population-linked database. For patients whose surgeons have lower levels of experience, that could mean a greater chance they will have more invasive total lung removal rather than more difficult operations that spare part of the affected lung, according to investigators at McMaster University in Hamilton, Ontario.

“If a surgeon with high surgical volumes is less likely to perform higher-risk pneumonectomy procedures than one with lower volumes, this may translate to a significant reduction in adverse events,” said lead author Dr. Christian Finley and coauthors online in the Journal of Thoracic and Cardiovascular Surgery (2015 Jun 30 [doi: 10.1016/j.jtcvs.2015.04.060]). “Surgeon volume should be considered an important component in how care is delivered in this population.”

The McMaster investigators evaluated 8,070 patients in an Ontario population-based linked database who underwent surgical resection for non–small cell lung cancer during 2004-2011, including pneumonectomy, or total lung removal (842 patients), lobectomy (6,212 patients), and wedge resection (1,002 patients). Over the years of the study, the proportion of patients who underwent pneumonectomy fell by more than half, from 14.8% in 2004 to 7.6% in 2011.

Of the three procedures, pneumonectomy carries a threefold greater mortality and while the procedure is often avoidable, there may be cases where it’s necessary because of the location of the tumor, Dr. Finley and his colleagues said. Lobectomy is desirable because it spares the parenchyma and has lower recurrence rates than laser resections.

The study investigators aimed to explore the hypothesis that surgeons with less expertise are more inclined to perform the higher-risk pneumonectomy or sublobar resections such as a segmentectomy or a wedge resection than a lobectomy, the rationale being that these procedures can be less challenging than a standard or sleeve lobectomy. The study analyzed results from 124 different physicians at 45 institutions in Ontario.

Data analysis showed that physician volume, age, year of procedure, sex, and comorbidities were predictive of the surgeon performing a pneumonectomy. “Adjusting for these variables, the results indicated that for each 10-unit increase in physician volume, the relative risk of performing a pneumonectomy decreased by 9.1%,” Dr. Finley and his colleagues wrote. They also found no significant difference in stage distribution among low-, medium-, and high-volume surgeons.

“This is meaningful as pneumonectomy is known to have the highest mortality rate of lung cancer resection, found in this study to be 12.6%, demonstrating a potentially large impact on patient survival,” Dr. Finley and his colleagues said.

This analysis cites an earlier study that surgeon volume for many procedures was a key determinant in the link between hospital volume and operative mortality (N Engl J Med. 2003 Nov 27;349[2]:2117-27.). “This study suggests that a patient may improve their chance of survival substantially, even at high-volume institutions, by selecting surgeons who perform operations more frequently,” Dr. Finley and his colleagues said.

They said that despite their study’s limitations, the findings on how surgeon experience can influence the choice of lung resection for cancer warrant further study.

McMaster University, Division of Thoracic Surgery, provided funding for the study. The study authors had no disclosures.

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Key clinical point: Surgeon volume is a predictor of procedure selection for lung cancer surgery and has implications on outcomes.

Major finding: For each 10 unit increase in physician volume, the relative risk of performing a pneumonectomy decreased by 9.1%.

Data source: Dataset of 8,070 patients constructed from Ontario population-based linked databases accessed via the Institute for Clinical Evaluate Sciences.

Disclosures: McMaster University, Division of Thoracic Surgery, provided study funding. The authors had no disclosures.