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Health care-associated infections in hospitals continue to decline
The rates of three major types of health care–associated infections have continued to decrease in U.S. hospitals, according to a new report from the Centers for Disease Control and Prevention.
The rate of central line–associated bloodstream infections (CLABSI) is down nationally by 41%, catheter-associated urinary tract infections (CAUTI) are down by 7%, and surgical site infections (SSI) for a combined 10 surgical procedures are down by 17%.
These declines are measured against the 2008 baseline rates of CLABSIs, CAUTIs and SSIs reported when the U.S. Department of Health and Human Services established its 5-year goals for reducing health care–associated infections by the end of 2013. The HHS goals include reducing CLABSIs by 50%, CAUTIs by 25%, and SSIs by 25%. The American College of Surgeons and the CDC have partnered to develop the means to report, measure, and prevent health care–associated infections, and the ACS has been instrumental in collecting and submitting standard SSI measure data and other data to the CDC’s National Healthcare Safety Network (NHSN) and the ACS’s National Surgical Quality Improvement Program (NSQIP).
“One thing these numbers show us is the complexity of achieving im provement,” said Dr. Clifford Y. Ko, MD, MS, FACS, Director of the American College of Surgeons (ACS) Division of Research and Optimal Patient Care. “The College’s recent effort with the Joint Commission Center for Transforming Healthcare to reduce SSI has shown us that SSIs are very multifactorial, and not every provider or facility has the same is sues to address.
“Similarly, even the measurement and analytical techniques used in this study can be improved upon,” Dr. Ko added. “While better than they used to be, we know through ACS NSQIP®[the College’s National Surgical Quality Improvement Program] that we can measure and feedback risk-adjusted infection rates on all procedures, not just 10. This is important for gaining traction with all providers because it will likely require the effort of all providers to achieve system- wide, sustained improvement.”
Paul J. Malpiedi and associates at the CDC reported the findings in the 2011 National and State Healthcare-Associated Infections Standard Infection Ratio Report. Mr. Malpiedi’s team compared the standard infection ratios (SIRs) between 2010 and 2011 to determine progress in preventing health care–associated infections.
Standard infection ratios developed at the national, state, and facility levels compare the number of infections that actually occurred to the number that would be expected based on the referent years: 2008 for CLABSIs and SSIs, and 2009 for CAUTIs. The standard infection ratios were adjusted to account for hospital type, hospital size (based on bed number), and hospital affiliation with a medical school.
Mr. Malpiedi’s team analyzed the data reported for the 2011 calendar year to the NHSN from 3,472 facilities for CLABSIs, 1,807 facilities for CAUTIs and 2,130 facilities for SSIs, based on reports submitted through Sept. 4, 2012. Non–acute care hospitals, outpatient dialysis facilities, inpatient dialysis wards, long-term care facilities, and outpatient surgical settings were excluded from the analysis.
A total of 18,113 CLABSIs were reported during 2011, compared with 30,617 that were predicted to occur based on the 2008 referent population, for an SIR of 0.592. This 41% reduction is an improvement over the 2010 reduction of 32%. With a median SIR of 0.469, half the reporting facilities in 2011 had reduced their CLABSIs by 53%. The lowest rate of CLABSIs was reported in ICUs, where the infections had declined 44% since 2008.
The number of facilities reporting infection data increased from 2010 to 2011. The 3,472 facilities in 50 states and the District of Columbia that reported data for CLABSIs represented a 55% increase from those reporting in 2010. The 2011 data came from 12,122 patient care locations, which included 5,722 ICUs (47%), 5,436 wards (45%) and 946 NICUs (8%).
The overall reduction in CAUTIs was less substantial, with no significant overall change since 2010. The 7% reduction in CAUTIs, with an SIR of 0.93, came from 14,315 reported CAUTIs, compared to the 15,398 predicted infections based on the 2009 referent population. Specifically, CAUTIs in wards declined about 15% while the infection rates in ICUs remained unchanged.
When only the 550 facilities that reported in both 2010 and 2011 were included in the analysis, the reduction since 2010 was statistically significant. A total of 1,807 facilities in 50 states and the District of Columbia reported CAUTI data, an 84% increase from the 2010 number of 981 reporting facilities. The 6,402 patient care locations included in the CAUTI data came from 2,633 ICUs (41%) and 3,769 wards (59%).
A total of 2,130 facilities from 48 states and the District of Columbia reported SSI data. Among the 748,192 surgical procedures included were 6,357 deep incisional and organ/space infections occurred, compared to the 7,683 SSIs that were predicted using the 2008 baseline, for an SIR of 0.827 .
This lower SIR represents a 17% decline in SSIs since 2008. SSIs declined for hip arthroplasty (10.4% decline), knee arthroplasty (14.3%), coronary artery bypass graft (22.1%), cardiac surgery (30.2%), peripheral vascular bypass surgery (25.5%), abdominal aortic aneurysm repair (45.7%), colon surgery (20.4%), rectal surgery (25.6%), abdominal hysterectomy (16.6%),and vaginal hysterectomy (13.3%).
The increase in reporting facilities in 2011 is partly a result of new state requirements for reporting health care–associated infections to the NHSN (30 states plus the District of Columbia as of December 2012) and from the federal requirement that all hospitals participating in the CMS Hospital Inpatient Quality Reporting Program report these infections to the NHSN.
The authors estimated that each CLABSI occurring in ICU patients cost the CMS approximately $26,000. However, the report did not have information on the insurance status of the patients with CLABSIs, so this figure would not apply to the private insurance patients.
The report was funded by the CDC, and no disclosures were noted.
The CDC report on health care–associated infections is great news. It shows that we have been making significant and substantial progress in the often preventable infections that occur in our hospitals. Reductions of 41% (CLABSI) are very impressive. This is a significant number of patients who did not get infected, receive otherwise unnecessary antibiotics and remain in the hospital longer than necessary. This also represents a significant cost savings. As we strive for improved value for our patients – higher quality care at lower costs – improvements like this are amazing.
One interesting finding is that, while there are reductions in CAUTIs and SSIs, they are not as significant as those with CLABSI. I think part of this has to do with the research into CLABSI and the fact that it lent itself well to the use of protocols and checklists, which are easily adopted by institutions. Peter Pronovost’s 2006 New England Journal of Medicine study detailed the 66% reduction in CLABSI throughout Michigan ICUs via the use of a simple checklist. SSIs also lend themselves to "protocol-ization." CAUTIs are slightly more difficult because a different human factor is introduced – the convenience and wishes of the patient. We need to continue educating our patients about CAUTIs and developing protocols that make the early removal of catheters the norm rather than the exception.
Physicians should be proud of their efforts in reducing health care–associated infections. We need to continue working hard to sustain these gains and identify other areas where similar interventions will yield positive outcomes. Sustained education and intervention will get us close to the HHS goals by the end of 2013, if not achieve them outright. One simple method of preventing health care–associated infections is to (a) implement a standardized checklist of proven steps to reduce said infections, and (b) empower members of the health care team to stop the provider when those steps are not being followed. A team approach, both in the development and implementation of these protocols, is essential to initial and sustained success.
Dr. Michael Pistoria is an internal medicine specialist and hospitalist at Allentown Hospital and Bethlehem Hospital in New Jersey. He is a senior fellow of the Society of Hospital Medicine and served as lead editor of the publication "Core Competencies in Hospital Medicine," which defined hospitalists’ roles. He made these comments in an e-mail interview with this news organization.
The CDC report on health care–associated infections is great news. It shows that we have been making significant and substantial progress in the often preventable infections that occur in our hospitals. Reductions of 41% (CLABSI) are very impressive. This is a significant number of patients who did not get infected, receive otherwise unnecessary antibiotics and remain in the hospital longer than necessary. This also represents a significant cost savings. As we strive for improved value for our patients – higher quality care at lower costs – improvements like this are amazing.
One interesting finding is that, while there are reductions in CAUTIs and SSIs, they are not as significant as those with CLABSI. I think part of this has to do with the research into CLABSI and the fact that it lent itself well to the use of protocols and checklists, which are easily adopted by institutions. Peter Pronovost’s 2006 New England Journal of Medicine study detailed the 66% reduction in CLABSI throughout Michigan ICUs via the use of a simple checklist. SSIs also lend themselves to "protocol-ization." CAUTIs are slightly more difficult because a different human factor is introduced – the convenience and wishes of the patient. We need to continue educating our patients about CAUTIs and developing protocols that make the early removal of catheters the norm rather than the exception.
Physicians should be proud of their efforts in reducing health care–associated infections. We need to continue working hard to sustain these gains and identify other areas where similar interventions will yield positive outcomes. Sustained education and intervention will get us close to the HHS goals by the end of 2013, if not achieve them outright. One simple method of preventing health care–associated infections is to (a) implement a standardized checklist of proven steps to reduce said infections, and (b) empower members of the health care team to stop the provider when those steps are not being followed. A team approach, both in the development and implementation of these protocols, is essential to initial and sustained success.
Dr. Michael Pistoria is an internal medicine specialist and hospitalist at Allentown Hospital and Bethlehem Hospital in New Jersey. He is a senior fellow of the Society of Hospital Medicine and served as lead editor of the publication "Core Competencies in Hospital Medicine," which defined hospitalists’ roles. He made these comments in an e-mail interview with this news organization.
The CDC report on health care–associated infections is great news. It shows that we have been making significant and substantial progress in the often preventable infections that occur in our hospitals. Reductions of 41% (CLABSI) are very impressive. This is a significant number of patients who did not get infected, receive otherwise unnecessary antibiotics and remain in the hospital longer than necessary. This also represents a significant cost savings. As we strive for improved value for our patients – higher quality care at lower costs – improvements like this are amazing.
One interesting finding is that, while there are reductions in CAUTIs and SSIs, they are not as significant as those with CLABSI. I think part of this has to do with the research into CLABSI and the fact that it lent itself well to the use of protocols and checklists, which are easily adopted by institutions. Peter Pronovost’s 2006 New England Journal of Medicine study detailed the 66% reduction in CLABSI throughout Michigan ICUs via the use of a simple checklist. SSIs also lend themselves to "protocol-ization." CAUTIs are slightly more difficult because a different human factor is introduced – the convenience and wishes of the patient. We need to continue educating our patients about CAUTIs and developing protocols that make the early removal of catheters the norm rather than the exception.
Physicians should be proud of their efforts in reducing health care–associated infections. We need to continue working hard to sustain these gains and identify other areas where similar interventions will yield positive outcomes. Sustained education and intervention will get us close to the HHS goals by the end of 2013, if not achieve them outright. One simple method of preventing health care–associated infections is to (a) implement a standardized checklist of proven steps to reduce said infections, and (b) empower members of the health care team to stop the provider when those steps are not being followed. A team approach, both in the development and implementation of these protocols, is essential to initial and sustained success.
Dr. Michael Pistoria is an internal medicine specialist and hospitalist at Allentown Hospital and Bethlehem Hospital in New Jersey. He is a senior fellow of the Society of Hospital Medicine and served as lead editor of the publication "Core Competencies in Hospital Medicine," which defined hospitalists’ roles. He made these comments in an e-mail interview with this news organization.
The rates of three major types of health care–associated infections have continued to decrease in U.S. hospitals, according to a new report from the Centers for Disease Control and Prevention.
The rate of central line–associated bloodstream infections (CLABSI) is down nationally by 41%, catheter-associated urinary tract infections (CAUTI) are down by 7%, and surgical site infections (SSI) for a combined 10 surgical procedures are down by 17%.
These declines are measured against the 2008 baseline rates of CLABSIs, CAUTIs and SSIs reported when the U.S. Department of Health and Human Services established its 5-year goals for reducing health care–associated infections by the end of 2013. The HHS goals include reducing CLABSIs by 50%, CAUTIs by 25%, and SSIs by 25%. The American College of Surgeons and the CDC have partnered to develop the means to report, measure, and prevent health care–associated infections, and the ACS has been instrumental in collecting and submitting standard SSI measure data and other data to the CDC’s National Healthcare Safety Network (NHSN) and the ACS’s National Surgical Quality Improvement Program (NSQIP).
“One thing these numbers show us is the complexity of achieving im provement,” said Dr. Clifford Y. Ko, MD, MS, FACS, Director of the American College of Surgeons (ACS) Division of Research and Optimal Patient Care. “The College’s recent effort with the Joint Commission Center for Transforming Healthcare to reduce SSI has shown us that SSIs are very multifactorial, and not every provider or facility has the same is sues to address.
“Similarly, even the measurement and analytical techniques used in this study can be improved upon,” Dr. Ko added. “While better than they used to be, we know through ACS NSQIP®[the College’s National Surgical Quality Improvement Program] that we can measure and feedback risk-adjusted infection rates on all procedures, not just 10. This is important for gaining traction with all providers because it will likely require the effort of all providers to achieve system- wide, sustained improvement.”
Paul J. Malpiedi and associates at the CDC reported the findings in the 2011 National and State Healthcare-Associated Infections Standard Infection Ratio Report. Mr. Malpiedi’s team compared the standard infection ratios (SIRs) between 2010 and 2011 to determine progress in preventing health care–associated infections.
Standard infection ratios developed at the national, state, and facility levels compare the number of infections that actually occurred to the number that would be expected based on the referent years: 2008 for CLABSIs and SSIs, and 2009 for CAUTIs. The standard infection ratios were adjusted to account for hospital type, hospital size (based on bed number), and hospital affiliation with a medical school.
Mr. Malpiedi’s team analyzed the data reported for the 2011 calendar year to the NHSN from 3,472 facilities for CLABSIs, 1,807 facilities for CAUTIs and 2,130 facilities for SSIs, based on reports submitted through Sept. 4, 2012. Non–acute care hospitals, outpatient dialysis facilities, inpatient dialysis wards, long-term care facilities, and outpatient surgical settings were excluded from the analysis.
A total of 18,113 CLABSIs were reported during 2011, compared with 30,617 that were predicted to occur based on the 2008 referent population, for an SIR of 0.592. This 41% reduction is an improvement over the 2010 reduction of 32%. With a median SIR of 0.469, half the reporting facilities in 2011 had reduced their CLABSIs by 53%. The lowest rate of CLABSIs was reported in ICUs, where the infections had declined 44% since 2008.
The number of facilities reporting infection data increased from 2010 to 2011. The 3,472 facilities in 50 states and the District of Columbia that reported data for CLABSIs represented a 55% increase from those reporting in 2010. The 2011 data came from 12,122 patient care locations, which included 5,722 ICUs (47%), 5,436 wards (45%) and 946 NICUs (8%).
The overall reduction in CAUTIs was less substantial, with no significant overall change since 2010. The 7% reduction in CAUTIs, with an SIR of 0.93, came from 14,315 reported CAUTIs, compared to the 15,398 predicted infections based on the 2009 referent population. Specifically, CAUTIs in wards declined about 15% while the infection rates in ICUs remained unchanged.
When only the 550 facilities that reported in both 2010 and 2011 were included in the analysis, the reduction since 2010 was statistically significant. A total of 1,807 facilities in 50 states and the District of Columbia reported CAUTI data, an 84% increase from the 2010 number of 981 reporting facilities. The 6,402 patient care locations included in the CAUTI data came from 2,633 ICUs (41%) and 3,769 wards (59%).
A total of 2,130 facilities from 48 states and the District of Columbia reported SSI data. Among the 748,192 surgical procedures included were 6,357 deep incisional and organ/space infections occurred, compared to the 7,683 SSIs that were predicted using the 2008 baseline, for an SIR of 0.827 .
This lower SIR represents a 17% decline in SSIs since 2008. SSIs declined for hip arthroplasty (10.4% decline), knee arthroplasty (14.3%), coronary artery bypass graft (22.1%), cardiac surgery (30.2%), peripheral vascular bypass surgery (25.5%), abdominal aortic aneurysm repair (45.7%), colon surgery (20.4%), rectal surgery (25.6%), abdominal hysterectomy (16.6%),and vaginal hysterectomy (13.3%).
The increase in reporting facilities in 2011 is partly a result of new state requirements for reporting health care–associated infections to the NHSN (30 states plus the District of Columbia as of December 2012) and from the federal requirement that all hospitals participating in the CMS Hospital Inpatient Quality Reporting Program report these infections to the NHSN.
The authors estimated that each CLABSI occurring in ICU patients cost the CMS approximately $26,000. However, the report did not have information on the insurance status of the patients with CLABSIs, so this figure would not apply to the private insurance patients.
The report was funded by the CDC, and no disclosures were noted.
The rates of three major types of health care–associated infections have continued to decrease in U.S. hospitals, according to a new report from the Centers for Disease Control and Prevention.
The rate of central line–associated bloodstream infections (CLABSI) is down nationally by 41%, catheter-associated urinary tract infections (CAUTI) are down by 7%, and surgical site infections (SSI) for a combined 10 surgical procedures are down by 17%.
These declines are measured against the 2008 baseline rates of CLABSIs, CAUTIs and SSIs reported when the U.S. Department of Health and Human Services established its 5-year goals for reducing health care–associated infections by the end of 2013. The HHS goals include reducing CLABSIs by 50%, CAUTIs by 25%, and SSIs by 25%. The American College of Surgeons and the CDC have partnered to develop the means to report, measure, and prevent health care–associated infections, and the ACS has been instrumental in collecting and submitting standard SSI measure data and other data to the CDC’s National Healthcare Safety Network (NHSN) and the ACS’s National Surgical Quality Improvement Program (NSQIP).
“One thing these numbers show us is the complexity of achieving im provement,” said Dr. Clifford Y. Ko, MD, MS, FACS, Director of the American College of Surgeons (ACS) Division of Research and Optimal Patient Care. “The College’s recent effort with the Joint Commission Center for Transforming Healthcare to reduce SSI has shown us that SSIs are very multifactorial, and not every provider or facility has the same is sues to address.
“Similarly, even the measurement and analytical techniques used in this study can be improved upon,” Dr. Ko added. “While better than they used to be, we know through ACS NSQIP®[the College’s National Surgical Quality Improvement Program] that we can measure and feedback risk-adjusted infection rates on all procedures, not just 10. This is important for gaining traction with all providers because it will likely require the effort of all providers to achieve system- wide, sustained improvement.”
Paul J. Malpiedi and associates at the CDC reported the findings in the 2011 National and State Healthcare-Associated Infections Standard Infection Ratio Report. Mr. Malpiedi’s team compared the standard infection ratios (SIRs) between 2010 and 2011 to determine progress in preventing health care–associated infections.
Standard infection ratios developed at the national, state, and facility levels compare the number of infections that actually occurred to the number that would be expected based on the referent years: 2008 for CLABSIs and SSIs, and 2009 for CAUTIs. The standard infection ratios were adjusted to account for hospital type, hospital size (based on bed number), and hospital affiliation with a medical school.
Mr. Malpiedi’s team analyzed the data reported for the 2011 calendar year to the NHSN from 3,472 facilities for CLABSIs, 1,807 facilities for CAUTIs and 2,130 facilities for SSIs, based on reports submitted through Sept. 4, 2012. Non–acute care hospitals, outpatient dialysis facilities, inpatient dialysis wards, long-term care facilities, and outpatient surgical settings were excluded from the analysis.
A total of 18,113 CLABSIs were reported during 2011, compared with 30,617 that were predicted to occur based on the 2008 referent population, for an SIR of 0.592. This 41% reduction is an improvement over the 2010 reduction of 32%. With a median SIR of 0.469, half the reporting facilities in 2011 had reduced their CLABSIs by 53%. The lowest rate of CLABSIs was reported in ICUs, where the infections had declined 44% since 2008.
The number of facilities reporting infection data increased from 2010 to 2011. The 3,472 facilities in 50 states and the District of Columbia that reported data for CLABSIs represented a 55% increase from those reporting in 2010. The 2011 data came from 12,122 patient care locations, which included 5,722 ICUs (47%), 5,436 wards (45%) and 946 NICUs (8%).
The overall reduction in CAUTIs was less substantial, with no significant overall change since 2010. The 7% reduction in CAUTIs, with an SIR of 0.93, came from 14,315 reported CAUTIs, compared to the 15,398 predicted infections based on the 2009 referent population. Specifically, CAUTIs in wards declined about 15% while the infection rates in ICUs remained unchanged.
When only the 550 facilities that reported in both 2010 and 2011 were included in the analysis, the reduction since 2010 was statistically significant. A total of 1,807 facilities in 50 states and the District of Columbia reported CAUTI data, an 84% increase from the 2010 number of 981 reporting facilities. The 6,402 patient care locations included in the CAUTI data came from 2,633 ICUs (41%) and 3,769 wards (59%).
A total of 2,130 facilities from 48 states and the District of Columbia reported SSI data. Among the 748,192 surgical procedures included were 6,357 deep incisional and organ/space infections occurred, compared to the 7,683 SSIs that were predicted using the 2008 baseline, for an SIR of 0.827 .
This lower SIR represents a 17% decline in SSIs since 2008. SSIs declined for hip arthroplasty (10.4% decline), knee arthroplasty (14.3%), coronary artery bypass graft (22.1%), cardiac surgery (30.2%), peripheral vascular bypass surgery (25.5%), abdominal aortic aneurysm repair (45.7%), colon surgery (20.4%), rectal surgery (25.6%), abdominal hysterectomy (16.6%),and vaginal hysterectomy (13.3%).
The increase in reporting facilities in 2011 is partly a result of new state requirements for reporting health care–associated infections to the NHSN (30 states plus the District of Columbia as of December 2012) and from the federal requirement that all hospitals participating in the CMS Hospital Inpatient Quality Reporting Program report these infections to the NHSN.
The authors estimated that each CLABSI occurring in ICU patients cost the CMS approximately $26,000. However, the report did not have information on the insurance status of the patients with CLABSIs, so this figure would not apply to the private insurance patients.
The report was funded by the CDC, and no disclosures were noted.
Major Finding: Since 2008, central line-associated bloodstream infections in facilities from all 50 states and the District of Columbia have declined 41% and surgical site infections have declined 17%, with catheter-associated urinary tract infections showing a decline of 7% since 2009.
Data Source: The data come from 3,472 facilities’ reports for central line-associated bloodstream infections, 1,807 facilities’ reports for catheter-associated urinary tract infections and 2,130 facilities’ reports for surgical site infections, which occurred during the 2011 calendar year, included in reports submitted up through Sept. 4, 2012.
Disclosures: The study was funded by the U.S. Centers for Disease Control and Prevention. No disclosures were noted.
Selective resection feasible for esophageal cancer
SAN FRANCISCO – Five-year survival rates for 41 patients with locoregionally advanced esophageal cancer who underwent induction chemotherapy and definitive chemoradiotherapy were 53% for patients with a clinical complete response who avoided surgery, 33% for patients with suspected residual disease, and 41% for patients with suspected residual disease who were able to undergo surgery.
The multicenter phase II Radiation Therapy Oncology Group (RTOG) 0246 trial suggests that the organ-preserving strategy of selective esophageal resection after definitive chemoradiation can be an effective approach, Dr. Stephen Swisher said at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology (ASCO).
Forty-one of the 43 patients enrolled with nonmetastatic resectable esophageal cancer had enough data to be included in the final analysis. Thirty-seven patients completed both induction chemotherapy and definitive chemoradiotherapy. Four patients died from problems associated with treatment (10%), two related to induction chemotherapy, one related to chemoradiation, and one related to surgery.
The overall 5-year survival rate after a median follow-up of 6.7 years was 37% in an intention-to-treat analysis, which is similar to results of trials of other treatment modalities for locoregionally advanced esophageal cancer, he said. Patients with a clinical complete response to chemoradiotherapy had a median survival of 66 months, compared with 15 months for all patients with suspected residual disease and 36 months for patients with suspected residual disease who were able to undergo surgery, reported Dr. Swisher of the University of Texas M.D. Anderson Cancer Center, Houston, and his associates.
During enrollment in 2003-2006, 15 patients came from the M.D. Anderson Cancer Center; 18 other sites contributed 1-3 patients each. Twenty-nine patients had adenocarcinomas (73%). Pretreatment clinical stages were T3 or greater in 31 patients (76%) and N1 in 29 patients (71%).
All underwent two cycles of induction chemotherapy with 5-fluorouracil (5-FU), cisplatin, and paclitaxel, followed by concurrent chemoradiation and daily 5-FU with cisplatin over the first 5 days.
After definitive chemoradiation, patients underwent chest and abdominal imaging to look for residual locoregional disease using CT scans, esophageal ultrasound, and optional PET scans. Those with no suspected residual disease were observed and monitored for recurrence every 3 months for the first 6 months, then every 6 months for the next 18 months, and then yearly. Patients with suspected residual disease were considered for immediate surgery.
Ultimately, 21 patients (51% of the total) underwent surgery: 17 had selective esophagectomies due to suspected residual cancer; 1 patient with a clinical complete response after chemoradiotherapy requested surgery; and 3 patients who were thought to have clinical complete responses underwent salvage esophagectomies due to recurrent cancer 5-15 months after chemoradiotherapy.
Besides the 17 patients with suspected residual cancer who underwent surgery, 4 others with a noncomplete response to chemoradiotherapy did not have esophagectomies because of metastatic disease in 3 patients and inoperable local disease in 1 patient.
The investigators previously reported preliminary results showing an overall 1-year survival rate of 71% in the study.
The meeting was cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
Dr. Swisher reported having no financial disclosures.
On Twitter @sherryboschert
This study provides a start toward "what we should be doing in cancer service delivery," which is creating a customized or tailored approach to delivery of services, Dr. Donald Low said. Eliminating esophagectomy when feasible is "probably appropriate, considering the historical perspective of bad outcomes in esophageal resection."
 |
Courtesy of the American Society of Clinical Oncology
|
The RTOG 0246 trial addresses an important clinical issue and looks at a new approach of neoadjuvant therapy and selective surgery. One of the study’s strengths is that surveillance was very scheduled and orchestrated – there was a branch point at which the decision was made to have or not have surgery. How that surveillance would fit into real-world practice is unclear and important to consider, he said. The long-term follow-up is another strength of the study.
On the other hand, it has several weaknesses. A large number of participating centers yielded a relatively limited number of study participants: 79% of the centers contributed fewer than two patients, and only the M.D. Anderson center contributed more than three patients. The cancers were mostly adenocarcinomas, but the study included some squamous cell cancers and esophageal or esophagogastric junction tumors – a mixed presentation that makes analysis of results more complex. There were no stage-by-stage comparisons of results, and the study included everything from T2 N0 to T3 N1 stage disease.
In addition, there was no reliable current methodology for accurately identifying complete pathological response without surgical resection. "Remember, that’s the important issue, because at some point you have to sit down with a physiologically intact person and give an impression as to whether they’ve had a complete response," he said.
Dr. Donald Low is head of the section on general thoracic surgery and thoracic oncology at Virginia Mason Medical Center, Seattle. This is a portion of his discussion of Dr. Swisher’s study at the meeting. Dr. Low has received honoraria from Boston Scientific.
This study provides a start toward "what we should be doing in cancer service delivery," which is creating a customized or tailored approach to delivery of services, Dr. Donald Low said. Eliminating esophagectomy when feasible is "probably appropriate, considering the historical perspective of bad outcomes in esophageal resection."
|
Courtesy of the American Society of Clinical Oncology
|
The RTOG 0246 trial addresses an important clinical issue and looks at a new approach of neoadjuvant therapy and selective surgery. One of the study’s strengths is that surveillance was very scheduled and orchestrated – there was a branch point at which the decision was made to have or not have surgery. How that surveillance would fit into real-world practice is unclear and important to consider, he said. The long-term follow-up is another strength of the study.
On the other hand, it has several weaknesses. A large number of participating centers yielded a relatively limited number of study participants: 79% of the centers contributed fewer than two patients, and only the M.D. Anderson center contributed more than three patients. The cancers were mostly adenocarcinomas, but the study included some squamous cell cancers and esophageal or esophagogastric junction tumors – a mixed presentation that makes analysis of results more complex. There were no stage-by-stage comparisons of results, and the study included everything from T2 N0 to T3 N1 stage disease.
In addition, there was no reliable current methodology for accurately identifying complete pathological response without surgical resection. "Remember, that’s the important issue, because at some point you have to sit down with a physiologically intact person and give an impression as to whether they’ve had a complete response," he said.
Dr. Donald Low is head of the section on general thoracic surgery and thoracic oncology at Virginia Mason Medical Center, Seattle. This is a portion of his discussion of Dr. Swisher’s study at the meeting. Dr. Low has received honoraria from Boston Scientific.
This study provides a start toward "what we should be doing in cancer service delivery," which is creating a customized or tailored approach to delivery of services, Dr. Donald Low said. Eliminating esophagectomy when feasible is "probably appropriate, considering the historical perspective of bad outcomes in esophageal resection."
|
Courtesy of the American Society of Clinical Oncology
|
The RTOG 0246 trial addresses an important clinical issue and looks at a new approach of neoadjuvant therapy and selective surgery. One of the study’s strengths is that surveillance was very scheduled and orchestrated – there was a branch point at which the decision was made to have or not have surgery. How that surveillance would fit into real-world practice is unclear and important to consider, he said. The long-term follow-up is another strength of the study.
On the other hand, it has several weaknesses. A large number of participating centers yielded a relatively limited number of study participants: 79% of the centers contributed fewer than two patients, and only the M.D. Anderson center contributed more than three patients. The cancers were mostly adenocarcinomas, but the study included some squamous cell cancers and esophageal or esophagogastric junction tumors – a mixed presentation that makes analysis of results more complex. There were no stage-by-stage comparisons of results, and the study included everything from T2 N0 to T3 N1 stage disease.
In addition, there was no reliable current methodology for accurately identifying complete pathological response without surgical resection. "Remember, that’s the important issue, because at some point you have to sit down with a physiologically intact person and give an impression as to whether they’ve had a complete response," he said.
Dr. Donald Low is head of the section on general thoracic surgery and thoracic oncology at Virginia Mason Medical Center, Seattle. This is a portion of his discussion of Dr. Swisher’s study at the meeting. Dr. Low has received honoraria from Boston Scientific.
SAN FRANCISCO – Five-year survival rates for 41 patients with locoregionally advanced esophageal cancer who underwent induction chemotherapy and definitive chemoradiotherapy were 53% for patients with a clinical complete response who avoided surgery, 33% for patients with suspected residual disease, and 41% for patients with suspected residual disease who were able to undergo surgery.
The multicenter phase II Radiation Therapy Oncology Group (RTOG) 0246 trial suggests that the organ-preserving strategy of selective esophageal resection after definitive chemoradiation can be an effective approach, Dr. Stephen Swisher said at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology (ASCO).
Forty-one of the 43 patients enrolled with nonmetastatic resectable esophageal cancer had enough data to be included in the final analysis. Thirty-seven patients completed both induction chemotherapy and definitive chemoradiotherapy. Four patients died from problems associated with treatment (10%), two related to induction chemotherapy, one related to chemoradiation, and one related to surgery.
The overall 5-year survival rate after a median follow-up of 6.7 years was 37% in an intention-to-treat analysis, which is similar to results of trials of other treatment modalities for locoregionally advanced esophageal cancer, he said. Patients with a clinical complete response to chemoradiotherapy had a median survival of 66 months, compared with 15 months for all patients with suspected residual disease and 36 months for patients with suspected residual disease who were able to undergo surgery, reported Dr. Swisher of the University of Texas M.D. Anderson Cancer Center, Houston, and his associates.
During enrollment in 2003-2006, 15 patients came from the M.D. Anderson Cancer Center; 18 other sites contributed 1-3 patients each. Twenty-nine patients had adenocarcinomas (73%). Pretreatment clinical stages were T3 or greater in 31 patients (76%) and N1 in 29 patients (71%).
All underwent two cycles of induction chemotherapy with 5-fluorouracil (5-FU), cisplatin, and paclitaxel, followed by concurrent chemoradiation and daily 5-FU with cisplatin over the first 5 days.
After definitive chemoradiation, patients underwent chest and abdominal imaging to look for residual locoregional disease using CT scans, esophageal ultrasound, and optional PET scans. Those with no suspected residual disease were observed and monitored for recurrence every 3 months for the first 6 months, then every 6 months for the next 18 months, and then yearly. Patients with suspected residual disease were considered for immediate surgery.
Ultimately, 21 patients (51% of the total) underwent surgery: 17 had selective esophagectomies due to suspected residual cancer; 1 patient with a clinical complete response after chemoradiotherapy requested surgery; and 3 patients who were thought to have clinical complete responses underwent salvage esophagectomies due to recurrent cancer 5-15 months after chemoradiotherapy.
Besides the 17 patients with suspected residual cancer who underwent surgery, 4 others with a noncomplete response to chemoradiotherapy did not have esophagectomies because of metastatic disease in 3 patients and inoperable local disease in 1 patient.
The investigators previously reported preliminary results showing an overall 1-year survival rate of 71% in the study.
The meeting was cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
Dr. Swisher reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Five-year survival rates for 41 patients with locoregionally advanced esophageal cancer who underwent induction chemotherapy and definitive chemoradiotherapy were 53% for patients with a clinical complete response who avoided surgery, 33% for patients with suspected residual disease, and 41% for patients with suspected residual disease who were able to undergo surgery.
The multicenter phase II Radiation Therapy Oncology Group (RTOG) 0246 trial suggests that the organ-preserving strategy of selective esophageal resection after definitive chemoradiation can be an effective approach, Dr. Stephen Swisher said at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology (ASCO).
Forty-one of the 43 patients enrolled with nonmetastatic resectable esophageal cancer had enough data to be included in the final analysis. Thirty-seven patients completed both induction chemotherapy and definitive chemoradiotherapy. Four patients died from problems associated with treatment (10%), two related to induction chemotherapy, one related to chemoradiation, and one related to surgery.
The overall 5-year survival rate after a median follow-up of 6.7 years was 37% in an intention-to-treat analysis, which is similar to results of trials of other treatment modalities for locoregionally advanced esophageal cancer, he said. Patients with a clinical complete response to chemoradiotherapy had a median survival of 66 months, compared with 15 months for all patients with suspected residual disease and 36 months for patients with suspected residual disease who were able to undergo surgery, reported Dr. Swisher of the University of Texas M.D. Anderson Cancer Center, Houston, and his associates.
During enrollment in 2003-2006, 15 patients came from the M.D. Anderson Cancer Center; 18 other sites contributed 1-3 patients each. Twenty-nine patients had adenocarcinomas (73%). Pretreatment clinical stages were T3 or greater in 31 patients (76%) and N1 in 29 patients (71%).
All underwent two cycles of induction chemotherapy with 5-fluorouracil (5-FU), cisplatin, and paclitaxel, followed by concurrent chemoradiation and daily 5-FU with cisplatin over the first 5 days.
After definitive chemoradiation, patients underwent chest and abdominal imaging to look for residual locoregional disease using CT scans, esophageal ultrasound, and optional PET scans. Those with no suspected residual disease were observed and monitored for recurrence every 3 months for the first 6 months, then every 6 months for the next 18 months, and then yearly. Patients with suspected residual disease were considered for immediate surgery.
Ultimately, 21 patients (51% of the total) underwent surgery: 17 had selective esophagectomies due to suspected residual cancer; 1 patient with a clinical complete response after chemoradiotherapy requested surgery; and 3 patients who were thought to have clinical complete responses underwent salvage esophagectomies due to recurrent cancer 5-15 months after chemoradiotherapy.
Besides the 17 patients with suspected residual cancer who underwent surgery, 4 others with a noncomplete response to chemoradiotherapy did not have esophagectomies because of metastatic disease in 3 patients and inoperable local disease in 1 patient.
The investigators previously reported preliminary results showing an overall 1-year survival rate of 71% in the study.
The meeting was cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
Dr. Swisher reported having no financial disclosures.
On Twitter @sherryboschert
AT THE ASCO GASTROINTESTINAL CANCERS SYMPOSIUM
Major finding: Five-year survival rates after definitive chemoradiotherapy were 53% with complete clinical responses to definitive chemoradiotherapy, 33% for those with noncomplete responses, and 41% for patients in the latter group who were able to undergo esophagectomy.
Data source: Prospective multicenter trial of selective surgery following definitive chemoradiotherapy in 41 patients with advanced locoregional esophageal cancer.
Disclosures: Dr. Swisher reported having no financial disclosures.
Kadcyla wins FDA approval for late-stage breast cancer
Ado-trastuzumab emtansine, a HER-2 targeted antibody-drug conjugate, has been approved by the Food and Drug Administration for treatment of women with HER2-positive, late-stage metastatic breast cancer, the agency announced Feb. 22.
Marketed as Kadcyla by Genentech, the treatment is a combination of an HER2-targeted antibody, trastuzumab, and DM1, a microtubule inhibitor, and is indicated as a single agent "for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination," according to the prescribing information. Patients should have either received previous therapy for metastatic disease, or had disease recurrence during or within 6 months of completing adjuvant therapy, according to the indication. The treatment is administered in an intravenous infusion every 3 weeks.
"Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth," Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research, said in a statement. "Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression, and prolong survival," he added.
Kadcyla is the fourth FDA-approved breast cancer treatment that targets the HER2 protein. The other three drugs approved for treating HER2-positive breast cancer are trastuzumab (Herceptin), approved in 1998; lapatinib (Tykerb), approved in 2007; and pertuzumab (Perjeta), approved in 2012.
Approval of Kadcyla was based on a randomized, open label, phase III study of 991 patients with HER2-positive, locally-advanced breast cancer or metastatic breast cancer who had previously been treated with trastuzumab and a taxane chemotherapy. The median progression-free survival was 9.6 months among those treated with Kadcyla, compared with 6.4 months in patients treated with lapatinib plus capecitabine. The median overall survival was 30.9 months among those treated with Kadcyla, compared with 25.1 months among those treated with lapatinib and capecitabine, according to statements from the FDA and Genentech. Overall survival and progression-free survival were the study’s primary endpoints.
The most common side effects associated with treatment (affecting more than 25% of patients) were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased transaminases, and constipation.
This accelerated approval was completed in 6 months instead of the usual 12-month review period, which is used for drugs that may provide safer and effective treatment when there is no satisfactory alternative treatment or when the treatment provides significant improvements over available treatments. Ado-trastuzumab emtansine has been referred to as T-DM1 during clinical trials.
Kadcyla will be available within 2 weeks of approval, according to the statement from Genentech, a member of the Roche group. The agent is currently under review by the European Medicines Agency for the same indication.
Serious adverse events associated with Kadcyla should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch. The prescribing information is available at www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427lbl.pdf.
Ado-trastuzumab emtansine, a HER-2 targeted antibody-drug conjugate, has been approved by the Food and Drug Administration for treatment of women with HER2-positive, late-stage metastatic breast cancer, the agency announced Feb. 22.
Marketed as Kadcyla by Genentech, the treatment is a combination of an HER2-targeted antibody, trastuzumab, and DM1, a microtubule inhibitor, and is indicated as a single agent "for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination," according to the prescribing information. Patients should have either received previous therapy for metastatic disease, or had disease recurrence during or within 6 months of completing adjuvant therapy, according to the indication. The treatment is administered in an intravenous infusion every 3 weeks.
"Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth," Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research, said in a statement. "Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression, and prolong survival," he added.
Kadcyla is the fourth FDA-approved breast cancer treatment that targets the HER2 protein. The other three drugs approved for treating HER2-positive breast cancer are trastuzumab (Herceptin), approved in 1998; lapatinib (Tykerb), approved in 2007; and pertuzumab (Perjeta), approved in 2012.
Approval of Kadcyla was based on a randomized, open label, phase III study of 991 patients with HER2-positive, locally-advanced breast cancer or metastatic breast cancer who had previously been treated with trastuzumab and a taxane chemotherapy. The median progression-free survival was 9.6 months among those treated with Kadcyla, compared with 6.4 months in patients treated with lapatinib plus capecitabine. The median overall survival was 30.9 months among those treated with Kadcyla, compared with 25.1 months among those treated with lapatinib and capecitabine, according to statements from the FDA and Genentech. Overall survival and progression-free survival were the study’s primary endpoints.
The most common side effects associated with treatment (affecting more than 25% of patients) were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased transaminases, and constipation.
This accelerated approval was completed in 6 months instead of the usual 12-month review period, which is used for drugs that may provide safer and effective treatment when there is no satisfactory alternative treatment or when the treatment provides significant improvements over available treatments. Ado-trastuzumab emtansine has been referred to as T-DM1 during clinical trials.
Kadcyla will be available within 2 weeks of approval, according to the statement from Genentech, a member of the Roche group. The agent is currently under review by the European Medicines Agency for the same indication.
Serious adverse events associated with Kadcyla should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch. The prescribing information is available at www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427lbl.pdf.
Ado-trastuzumab emtansine, a HER-2 targeted antibody-drug conjugate, has been approved by the Food and Drug Administration for treatment of women with HER2-positive, late-stage metastatic breast cancer, the agency announced Feb. 22.
Marketed as Kadcyla by Genentech, the treatment is a combination of an HER2-targeted antibody, trastuzumab, and DM1, a microtubule inhibitor, and is indicated as a single agent "for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination," according to the prescribing information. Patients should have either received previous therapy for metastatic disease, or had disease recurrence during or within 6 months of completing adjuvant therapy, according to the indication. The treatment is administered in an intravenous infusion every 3 weeks.
"Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth," Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research, said in a statement. "Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression, and prolong survival," he added.
Kadcyla is the fourth FDA-approved breast cancer treatment that targets the HER2 protein. The other three drugs approved for treating HER2-positive breast cancer are trastuzumab (Herceptin), approved in 1998; lapatinib (Tykerb), approved in 2007; and pertuzumab (Perjeta), approved in 2012.
Approval of Kadcyla was based on a randomized, open label, phase III study of 991 patients with HER2-positive, locally-advanced breast cancer or metastatic breast cancer who had previously been treated with trastuzumab and a taxane chemotherapy. The median progression-free survival was 9.6 months among those treated with Kadcyla, compared with 6.4 months in patients treated with lapatinib plus capecitabine. The median overall survival was 30.9 months among those treated with Kadcyla, compared with 25.1 months among those treated with lapatinib and capecitabine, according to statements from the FDA and Genentech. Overall survival and progression-free survival were the study’s primary endpoints.
The most common side effects associated with treatment (affecting more than 25% of patients) were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased transaminases, and constipation.
This accelerated approval was completed in 6 months instead of the usual 12-month review period, which is used for drugs that may provide safer and effective treatment when there is no satisfactory alternative treatment or when the treatment provides significant improvements over available treatments. Ado-trastuzumab emtansine has been referred to as T-DM1 during clinical trials.
Kadcyla will be available within 2 weeks of approval, according to the statement from Genentech, a member of the Roche group. The agent is currently under review by the European Medicines Agency for the same indication.
Serious adverse events associated with Kadcyla should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch. The prescribing information is available at www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427lbl.pdf.
'I never know when to call palliative care'
This morbidity and mortality conference was like any other: First, we reviewed the case of a patient with a complication from anticoagulation and then another with an anastomotic leak. Finally, we discussed an elderly patient who had a major emergent procedure to treat complications from an underlying life-limiting condition, only to die in hospital weeks later after developing insurmountable medical, surgical, and infectious complications.
This elderly patient was a man in his mid-70s recently diagnosed with recurrent melanoma. He came to our emergency department with peritonitis and hypotension. His wife of 52 years sat beside him. She was tearful and afraid. "We want everything done," she said. Eight weeks ago, he was working full time and playing golf. But, 6 weeks ago he became confused. A CT scan revealed brain metastasis. He spent 5 of the last 6 weeks in the ICU and in a step-down unit, or a nursing home after a series of complications from his brain biopsy. Now he was back in the hospital with a bowel perforation.
Before our surgical team even saw him, he was told he needed surgery, or he would die. We discussed the surgical risks including the likelihood of a protracted ICU stay, and the high risk he would never go home. Still, he and his wife were unprepared for death and so we went to the operating room.
The following weeks were fraught with complications. His symptoms – including delirium, tumor headaches, and pain – were all difficult to manage on his cocktail of steroids, opiates, and antipsychotics. Occasionally, he would mumble something about dying but we couldn’t determine if he was lucid. His symptoms and "talk about death" were distressing for his family. All in all, our team spent almost an hour each day answering their questions and tending to their anxiety and suffering. It took a high emotional toll on our entire team, as we each worried to ourselves that we were doing more harm than good.
One organ system failed after the other. And finally, after two operations, 10 different consultants, and 3 weeks in the hospital, we stopped talking about organ systems and told the family that this man was dying. That day we consulted palliative care to help us with "goals of care." The next day, he became oliguric, and we shifted our focus to comfort. He died within hours surrounded by his loving extended family.
When we discussed this case at M&M, there were no objections to the decision to operate or how we managed his laundry list of complications. His death was deemed "nonpreventable." But, at then end of the discussion, a colleague asked, with some exasperation, "I never know when to call palliative care. How do you decide when the patient is dying?"
In retrospect, it is clear that this patient was dying when we met him in the emergency department. He was malnourished and disabled from his cancer and treatment. His bowel perforation was caused by the steroids prescribed to treat his underlying terminal disease. The best outcome we could hope for was a good quality of life in his last days, a peaceful and dignified death, and an uncomplicated bereavement for his survivors. Our emergency, life-saving surgery was, in fact, palliative. Death was near, but we just didn’t want him to die this way.
According to the American College of Surgeons code of professional conduct, surgeons play a pivotal role in facilitating the transition from curative to palliative treatment for the patients and the entire health care team. Furthermore, "effective palliation obligates sensitive discussion with patients and their families." These conversations can be particularly onerous for surgeons because we take on tremendous sense of personal responsibility for postoperative outcomes. Once we commit to operating on a patient, their death, especially if it follows complications, can be equated with personal defeat. We may benefit from consulting specialists who can help us set the stage, and smooth the transition for our patients and their families. Surgeons may also personally benefit from the support of other providers to help us cope with these emotionally difficult cases.
Palliative care is a multidisciplinary model of care to address the physical, intellectual, emotional, social, and spiritual needs of patients and families facing serious illness. The goal of palliative care is to support the best possible quality of life for patients at all stages of serious illness, through providing aggressive symptom management, psychosocial and spiritual care, and grief and bereavement counseling before and after death. Palliative care seeks to be life affirming and is based on the understanding of death as a normal life process. It can and should be delivered along with life-prolonging treatment.
In this case, palliative care should have been offered in the emergency department as soon as this patient was admitted to our service. The patient, and his family, would have benefited from a team of physicians, nurses, pharmacists, social workers, and chaplains with the time and expertise to manage distressing symptoms from his cancer, and attend to the grief and suffering that characterized his final weeks. Earlier palliative care may have also steered us away from the slog of high-burden treatments that ultimately offered him little benefit. For the surgeons, palliative care would have provided additional resources to take the best possible care of our patient who, whether or not he made it home, was near the end of his life from an advanced illness.
Dr. Zara Cooper is an ACS Fellow, and assistant professor of surgery, Harvard Medical School, and department of surgery, division of trauma, burns and critical care at Brigham and Women’s Hospital, Boston. Dr. Cooper has no disclosures relevant to this editorial.
This morbidity and mortality conference was like any other: First, we reviewed the case of a patient with a complication from anticoagulation and then another with an anastomotic leak. Finally, we discussed an elderly patient who had a major emergent procedure to treat complications from an underlying life-limiting condition, only to die in hospital weeks later after developing insurmountable medical, surgical, and infectious complications.
This elderly patient was a man in his mid-70s recently diagnosed with recurrent melanoma. He came to our emergency department with peritonitis and hypotension. His wife of 52 years sat beside him. She was tearful and afraid. "We want everything done," she said. Eight weeks ago, he was working full time and playing golf. But, 6 weeks ago he became confused. A CT scan revealed brain metastasis. He spent 5 of the last 6 weeks in the ICU and in a step-down unit, or a nursing home after a series of complications from his brain biopsy. Now he was back in the hospital with a bowel perforation.
Before our surgical team even saw him, he was told he needed surgery, or he would die. We discussed the surgical risks including the likelihood of a protracted ICU stay, and the high risk he would never go home. Still, he and his wife were unprepared for death and so we went to the operating room.
The following weeks were fraught with complications. His symptoms – including delirium, tumor headaches, and pain – were all difficult to manage on his cocktail of steroids, opiates, and antipsychotics. Occasionally, he would mumble something about dying but we couldn’t determine if he was lucid. His symptoms and "talk about death" were distressing for his family. All in all, our team spent almost an hour each day answering their questions and tending to their anxiety and suffering. It took a high emotional toll on our entire team, as we each worried to ourselves that we were doing more harm than good.
One organ system failed after the other. And finally, after two operations, 10 different consultants, and 3 weeks in the hospital, we stopped talking about organ systems and told the family that this man was dying. That day we consulted palliative care to help us with "goals of care." The next day, he became oliguric, and we shifted our focus to comfort. He died within hours surrounded by his loving extended family.
When we discussed this case at M&M, there were no objections to the decision to operate or how we managed his laundry list of complications. His death was deemed "nonpreventable." But, at then end of the discussion, a colleague asked, with some exasperation, "I never know when to call palliative care. How do you decide when the patient is dying?"
In retrospect, it is clear that this patient was dying when we met him in the emergency department. He was malnourished and disabled from his cancer and treatment. His bowel perforation was caused by the steroids prescribed to treat his underlying terminal disease. The best outcome we could hope for was a good quality of life in his last days, a peaceful and dignified death, and an uncomplicated bereavement for his survivors. Our emergency, life-saving surgery was, in fact, palliative. Death was near, but we just didn’t want him to die this way.
According to the American College of Surgeons code of professional conduct, surgeons play a pivotal role in facilitating the transition from curative to palliative treatment for the patients and the entire health care team. Furthermore, "effective palliation obligates sensitive discussion with patients and their families." These conversations can be particularly onerous for surgeons because we take on tremendous sense of personal responsibility for postoperative outcomes. Once we commit to operating on a patient, their death, especially if it follows complications, can be equated with personal defeat. We may benefit from consulting specialists who can help us set the stage, and smooth the transition for our patients and their families. Surgeons may also personally benefit from the support of other providers to help us cope with these emotionally difficult cases.
Palliative care is a multidisciplinary model of care to address the physical, intellectual, emotional, social, and spiritual needs of patients and families facing serious illness. The goal of palliative care is to support the best possible quality of life for patients at all stages of serious illness, through providing aggressive symptom management, psychosocial and spiritual care, and grief and bereavement counseling before and after death. Palliative care seeks to be life affirming and is based on the understanding of death as a normal life process. It can and should be delivered along with life-prolonging treatment.
In this case, palliative care should have been offered in the emergency department as soon as this patient was admitted to our service. The patient, and his family, would have benefited from a team of physicians, nurses, pharmacists, social workers, and chaplains with the time and expertise to manage distressing symptoms from his cancer, and attend to the grief and suffering that characterized his final weeks. Earlier palliative care may have also steered us away from the slog of high-burden treatments that ultimately offered him little benefit. For the surgeons, palliative care would have provided additional resources to take the best possible care of our patient who, whether or not he made it home, was near the end of his life from an advanced illness.
Dr. Zara Cooper is an ACS Fellow, and assistant professor of surgery, Harvard Medical School, and department of surgery, division of trauma, burns and critical care at Brigham and Women’s Hospital, Boston. Dr. Cooper has no disclosures relevant to this editorial.
This morbidity and mortality conference was like any other: First, we reviewed the case of a patient with a complication from anticoagulation and then another with an anastomotic leak. Finally, we discussed an elderly patient who had a major emergent procedure to treat complications from an underlying life-limiting condition, only to die in hospital weeks later after developing insurmountable medical, surgical, and infectious complications.
This elderly patient was a man in his mid-70s recently diagnosed with recurrent melanoma. He came to our emergency department with peritonitis and hypotension. His wife of 52 years sat beside him. She was tearful and afraid. "We want everything done," she said. Eight weeks ago, he was working full time and playing golf. But, 6 weeks ago he became confused. A CT scan revealed brain metastasis. He spent 5 of the last 6 weeks in the ICU and in a step-down unit, or a nursing home after a series of complications from his brain biopsy. Now he was back in the hospital with a bowel perforation.
Before our surgical team even saw him, he was told he needed surgery, or he would die. We discussed the surgical risks including the likelihood of a protracted ICU stay, and the high risk he would never go home. Still, he and his wife were unprepared for death and so we went to the operating room.
The following weeks were fraught with complications. His symptoms – including delirium, tumor headaches, and pain – were all difficult to manage on his cocktail of steroids, opiates, and antipsychotics. Occasionally, he would mumble something about dying but we couldn’t determine if he was lucid. His symptoms and "talk about death" were distressing for his family. All in all, our team spent almost an hour each day answering their questions and tending to their anxiety and suffering. It took a high emotional toll on our entire team, as we each worried to ourselves that we were doing more harm than good.
One organ system failed after the other. And finally, after two operations, 10 different consultants, and 3 weeks in the hospital, we stopped talking about organ systems and told the family that this man was dying. That day we consulted palliative care to help us with "goals of care." The next day, he became oliguric, and we shifted our focus to comfort. He died within hours surrounded by his loving extended family.
When we discussed this case at M&M, there were no objections to the decision to operate or how we managed his laundry list of complications. His death was deemed "nonpreventable." But, at then end of the discussion, a colleague asked, with some exasperation, "I never know when to call palliative care. How do you decide when the patient is dying?"
In retrospect, it is clear that this patient was dying when we met him in the emergency department. He was malnourished and disabled from his cancer and treatment. His bowel perforation was caused by the steroids prescribed to treat his underlying terminal disease. The best outcome we could hope for was a good quality of life in his last days, a peaceful and dignified death, and an uncomplicated bereavement for his survivors. Our emergency, life-saving surgery was, in fact, palliative. Death was near, but we just didn’t want him to die this way.
According to the American College of Surgeons code of professional conduct, surgeons play a pivotal role in facilitating the transition from curative to palliative treatment for the patients and the entire health care team. Furthermore, "effective palliation obligates sensitive discussion with patients and their families." These conversations can be particularly onerous for surgeons because we take on tremendous sense of personal responsibility for postoperative outcomes. Once we commit to operating on a patient, their death, especially if it follows complications, can be equated with personal defeat. We may benefit from consulting specialists who can help us set the stage, and smooth the transition for our patients and their families. Surgeons may also personally benefit from the support of other providers to help us cope with these emotionally difficult cases.
Palliative care is a multidisciplinary model of care to address the physical, intellectual, emotional, social, and spiritual needs of patients and families facing serious illness. The goal of palliative care is to support the best possible quality of life for patients at all stages of serious illness, through providing aggressive symptom management, psychosocial and spiritual care, and grief and bereavement counseling before and after death. Palliative care seeks to be life affirming and is based on the understanding of death as a normal life process. It can and should be delivered along with life-prolonging treatment.
In this case, palliative care should have been offered in the emergency department as soon as this patient was admitted to our service. The patient, and his family, would have benefited from a team of physicians, nurses, pharmacists, social workers, and chaplains with the time and expertise to manage distressing symptoms from his cancer, and attend to the grief and suffering that characterized his final weeks. Earlier palliative care may have also steered us away from the slog of high-burden treatments that ultimately offered him little benefit. For the surgeons, palliative care would have provided additional resources to take the best possible care of our patient who, whether or not he made it home, was near the end of his life from an advanced illness.
Dr. Zara Cooper is an ACS Fellow, and assistant professor of surgery, Harvard Medical School, and department of surgery, division of trauma, burns and critical care at Brigham and Women’s Hospital, Boston. Dr. Cooper has no disclosures relevant to this editorial.
Direct peritoneal resuscitation beneficial after damage control surgery
SCOTTSDALE, ARIZ. – Direct peritoneal resuscitation with 2.5% Delflex solution significantly reduced abdominal closure time and operative complications in patients with hemorrhagic shock undergoing damage control surgery, a prospective case-control study showed.
The time to definitive wound closure fell from 5.7 days with standard resuscitation to 3.6 days with the addition of direct peritoneal resuscitation (DPR) with 2.5% Delflex solution (P = .006).
In addition, the control group was 3.2 times more likely to develop an intra-abdominal complication than was the DPR group (odds ratio, 3.2; P = .03), Dr. Jason W. Smith reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma..
"DPR is a safe, simple, and inexpensive method of managing an open abdomen following damage control surgery," he said. "DPR may attenuate persistent hepatic injury following hemorrhagic shock."
Dr. Smith and his colleagues at the University of Louisville (Ky.) have been strong proponents of the technique, and previously reported that DPR with Delflex shortened abdominal closure by 2.7 days in a retrospective proof-of-concept study in 19 trauma patients (J. Am. Coll. Surg. 2010;210:658-67).
Vasodilators and heparin can be used to augment microvascular circulation and prevent blood clots, but in patients with hemorrhagic shock, this generally leads to bad results. Activated drotrecogin alfa (Xigris), which was pulled from the market in October 2011, was initially used, but the sepsis drug treats only the symptoms, Dr. Smith explained.
"We selected Delflex because of its ability to have an effect on microvascular permeability as well as microvascular blood flow," he said. "So really this is a new take on what is a very old medicine."
Between 2008 and 2011, the investigators prospectively enrolled 42 patients who underwent damage control surgery and conventional resuscitation plus DPR consisting of peritoneal lavage with an 800-mL bolus of 2.5% Delflex for the first hour and a 400-mL/hr infusion thereafter. A 19 Fr drain was placed along the root of the mesentery into the pelvis, and suction dressing was applied to drain fluid. The infusion was stopped when the abdomen was closed definitively either by primary closure or by the use of an absorbable or a biologic mesh.
The patients (average age, 30.6 years) were propensity matched against 42 case controls (average age, 29.1 years) who had undergone conventional resuscitation at the discretion of the treating surgeon after damage control surgery. All patients underwent blood product resuscitation in the first 24-48 hours of treatment.
The average Injury Severity Score was 19 among patients and 21 among controls. The hepatic Abbreviated Injury Scale (AIS) score was 3.4 in both groups, and roughly 40% of patients underwent a liver operation.
Control patients had significantly elevated alanine transaminase levels at 48 (731 vs. 507 U/L) and 72 hours (791 vs. 501 U/L) post resuscitation, compared with DPR patients, and this difference continued up to 14 days after the initial injury (all P less than .01), Dr. Smith said.
International normalized ratio (INR) levels were persistently higher in the control group, reaching statistical significance at 72 hours (1.3 vs. 1.8; P = .03). Time to INR normalization was no different whether the red blood cell to fresh frozen plasma (FFP) ratio was 1:1 or 1:2, he said.
Controls achieved a slightly better transfusion ratio (1.57 vs. 1.76; P = .52), although DPR patients had significantly lower FFP requirements after 48 hours (P = .04), and received significantly fewer transfusions at 72 hours post admission (31 vs. 41; P = .007).
As observed in the pilot study, the primary fascial closure rate was significantly higher with DPR than conventional resuscitation alone (88% vs. 66%; P = .01), and mortality was similar (10% vs. 17%; P = .25), Dr. Smith said. There were no complications with DPR administration.
In a multivariate analysis, the two strongest predictors of persistent hepatic injury following hemorrhagic shock were hepatic AIS greater than 3 (OR, 3.18), followed by nonutilization of DPR (OR, 0.63).
Invited discussant Dr. Greta Piper of Yale University, New Haven, Conn., asked whether the results would have been even better with a higher infusion rate or concentration of Delflex since one effect of the infusion is continuous dialysis, with a potential reduction in total body salt and water content.
Dr. Smith replied that they have tried DPR with other agents such as mannitol and Delflex 1.5% and 4.25%, but said the 2.5% concentration "is kind of a Goldilocks dose," as 1.5% is too weak to do anything and 4.25% desiccates the intravascular space.
"The 2.5% doesn’t desiccate the intravascular space, but you still get all the benefits of microvascular augmentation," he added.
Dr. Smith noted that DPR with 2.5% Delflex has produced similar results in patients undergoing emergency surgery as well as in those with intestinal obstruction and significant bowel edema. The researchers are currently enrolling adult trauma patients into a prospective randomized trial that will evaluate changes in hepatic blood flow as well as the effect of DPR on the inflammatory process following hemorrhagic shock.
The National Institute of General Medicine Sciences supported this research. Dr. Smith and his coauthors reported no relevant financial disclosures.
SCOTTSDALE, ARIZ. – Direct peritoneal resuscitation with 2.5% Delflex solution significantly reduced abdominal closure time and operative complications in patients with hemorrhagic shock undergoing damage control surgery, a prospective case-control study showed.
The time to definitive wound closure fell from 5.7 days with standard resuscitation to 3.6 days with the addition of direct peritoneal resuscitation (DPR) with 2.5% Delflex solution (P = .006).
In addition, the control group was 3.2 times more likely to develop an intra-abdominal complication than was the DPR group (odds ratio, 3.2; P = .03), Dr. Jason W. Smith reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma..
"DPR is a safe, simple, and inexpensive method of managing an open abdomen following damage control surgery," he said. "DPR may attenuate persistent hepatic injury following hemorrhagic shock."
Dr. Smith and his colleagues at the University of Louisville (Ky.) have been strong proponents of the technique, and previously reported that DPR with Delflex shortened abdominal closure by 2.7 days in a retrospective proof-of-concept study in 19 trauma patients (J. Am. Coll. Surg. 2010;210:658-67).
Vasodilators and heparin can be used to augment microvascular circulation and prevent blood clots, but in patients with hemorrhagic shock, this generally leads to bad results. Activated drotrecogin alfa (Xigris), which was pulled from the market in October 2011, was initially used, but the sepsis drug treats only the symptoms, Dr. Smith explained.
"We selected Delflex because of its ability to have an effect on microvascular permeability as well as microvascular blood flow," he said. "So really this is a new take on what is a very old medicine."
Between 2008 and 2011, the investigators prospectively enrolled 42 patients who underwent damage control surgery and conventional resuscitation plus DPR consisting of peritoneal lavage with an 800-mL bolus of 2.5% Delflex for the first hour and a 400-mL/hr infusion thereafter. A 19 Fr drain was placed along the root of the mesentery into the pelvis, and suction dressing was applied to drain fluid. The infusion was stopped when the abdomen was closed definitively either by primary closure or by the use of an absorbable or a biologic mesh.
The patients (average age, 30.6 years) were propensity matched against 42 case controls (average age, 29.1 years) who had undergone conventional resuscitation at the discretion of the treating surgeon after damage control surgery. All patients underwent blood product resuscitation in the first 24-48 hours of treatment.
The average Injury Severity Score was 19 among patients and 21 among controls. The hepatic Abbreviated Injury Scale (AIS) score was 3.4 in both groups, and roughly 40% of patients underwent a liver operation.
Control patients had significantly elevated alanine transaminase levels at 48 (731 vs. 507 U/L) and 72 hours (791 vs. 501 U/L) post resuscitation, compared with DPR patients, and this difference continued up to 14 days after the initial injury (all P less than .01), Dr. Smith said.
International normalized ratio (INR) levels were persistently higher in the control group, reaching statistical significance at 72 hours (1.3 vs. 1.8; P = .03). Time to INR normalization was no different whether the red blood cell to fresh frozen plasma (FFP) ratio was 1:1 or 1:2, he said.
Controls achieved a slightly better transfusion ratio (1.57 vs. 1.76; P = .52), although DPR patients had significantly lower FFP requirements after 48 hours (P = .04), and received significantly fewer transfusions at 72 hours post admission (31 vs. 41; P = .007).
As observed in the pilot study, the primary fascial closure rate was significantly higher with DPR than conventional resuscitation alone (88% vs. 66%; P = .01), and mortality was similar (10% vs. 17%; P = .25), Dr. Smith said. There were no complications with DPR administration.
In a multivariate analysis, the two strongest predictors of persistent hepatic injury following hemorrhagic shock were hepatic AIS greater than 3 (OR, 3.18), followed by nonutilization of DPR (OR, 0.63).
Invited discussant Dr. Greta Piper of Yale University, New Haven, Conn., asked whether the results would have been even better with a higher infusion rate or concentration of Delflex since one effect of the infusion is continuous dialysis, with a potential reduction in total body salt and water content.
Dr. Smith replied that they have tried DPR with other agents such as mannitol and Delflex 1.5% and 4.25%, but said the 2.5% concentration "is kind of a Goldilocks dose," as 1.5% is too weak to do anything and 4.25% desiccates the intravascular space.
"The 2.5% doesn’t desiccate the intravascular space, but you still get all the benefits of microvascular augmentation," he added.
Dr. Smith noted that DPR with 2.5% Delflex has produced similar results in patients undergoing emergency surgery as well as in those with intestinal obstruction and significant bowel edema. The researchers are currently enrolling adult trauma patients into a prospective randomized trial that will evaluate changes in hepatic blood flow as well as the effect of DPR on the inflammatory process following hemorrhagic shock.
The National Institute of General Medicine Sciences supported this research. Dr. Smith and his coauthors reported no relevant financial disclosures.
SCOTTSDALE, ARIZ. – Direct peritoneal resuscitation with 2.5% Delflex solution significantly reduced abdominal closure time and operative complications in patients with hemorrhagic shock undergoing damage control surgery, a prospective case-control study showed.
The time to definitive wound closure fell from 5.7 days with standard resuscitation to 3.6 days with the addition of direct peritoneal resuscitation (DPR) with 2.5% Delflex solution (P = .006).
In addition, the control group was 3.2 times more likely to develop an intra-abdominal complication than was the DPR group (odds ratio, 3.2; P = .03), Dr. Jason W. Smith reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma..
"DPR is a safe, simple, and inexpensive method of managing an open abdomen following damage control surgery," he said. "DPR may attenuate persistent hepatic injury following hemorrhagic shock."
Dr. Smith and his colleagues at the University of Louisville (Ky.) have been strong proponents of the technique, and previously reported that DPR with Delflex shortened abdominal closure by 2.7 days in a retrospective proof-of-concept study in 19 trauma patients (J. Am. Coll. Surg. 2010;210:658-67).
Vasodilators and heparin can be used to augment microvascular circulation and prevent blood clots, but in patients with hemorrhagic shock, this generally leads to bad results. Activated drotrecogin alfa (Xigris), which was pulled from the market in October 2011, was initially used, but the sepsis drug treats only the symptoms, Dr. Smith explained.
"We selected Delflex because of its ability to have an effect on microvascular permeability as well as microvascular blood flow," he said. "So really this is a new take on what is a very old medicine."
Between 2008 and 2011, the investigators prospectively enrolled 42 patients who underwent damage control surgery and conventional resuscitation plus DPR consisting of peritoneal lavage with an 800-mL bolus of 2.5% Delflex for the first hour and a 400-mL/hr infusion thereafter. A 19 Fr drain was placed along the root of the mesentery into the pelvis, and suction dressing was applied to drain fluid. The infusion was stopped when the abdomen was closed definitively either by primary closure or by the use of an absorbable or a biologic mesh.
The patients (average age, 30.6 years) were propensity matched against 42 case controls (average age, 29.1 years) who had undergone conventional resuscitation at the discretion of the treating surgeon after damage control surgery. All patients underwent blood product resuscitation in the first 24-48 hours of treatment.
The average Injury Severity Score was 19 among patients and 21 among controls. The hepatic Abbreviated Injury Scale (AIS) score was 3.4 in both groups, and roughly 40% of patients underwent a liver operation.
Control patients had significantly elevated alanine transaminase levels at 48 (731 vs. 507 U/L) and 72 hours (791 vs. 501 U/L) post resuscitation, compared with DPR patients, and this difference continued up to 14 days after the initial injury (all P less than .01), Dr. Smith said.
International normalized ratio (INR) levels were persistently higher in the control group, reaching statistical significance at 72 hours (1.3 vs. 1.8; P = .03). Time to INR normalization was no different whether the red blood cell to fresh frozen plasma (FFP) ratio was 1:1 or 1:2, he said.
Controls achieved a slightly better transfusion ratio (1.57 vs. 1.76; P = .52), although DPR patients had significantly lower FFP requirements after 48 hours (P = .04), and received significantly fewer transfusions at 72 hours post admission (31 vs. 41; P = .007).
As observed in the pilot study, the primary fascial closure rate was significantly higher with DPR than conventional resuscitation alone (88% vs. 66%; P = .01), and mortality was similar (10% vs. 17%; P = .25), Dr. Smith said. There were no complications with DPR administration.
In a multivariate analysis, the two strongest predictors of persistent hepatic injury following hemorrhagic shock were hepatic AIS greater than 3 (OR, 3.18), followed by nonutilization of DPR (OR, 0.63).
Invited discussant Dr. Greta Piper of Yale University, New Haven, Conn., asked whether the results would have been even better with a higher infusion rate or concentration of Delflex since one effect of the infusion is continuous dialysis, with a potential reduction in total body salt and water content.
Dr. Smith replied that they have tried DPR with other agents such as mannitol and Delflex 1.5% and 4.25%, but said the 2.5% concentration "is kind of a Goldilocks dose," as 1.5% is too weak to do anything and 4.25% desiccates the intravascular space.
"The 2.5% doesn’t desiccate the intravascular space, but you still get all the benefits of microvascular augmentation," he added.
Dr. Smith noted that DPR with 2.5% Delflex has produced similar results in patients undergoing emergency surgery as well as in those with intestinal obstruction and significant bowel edema. The researchers are currently enrolling adult trauma patients into a prospective randomized trial that will evaluate changes in hepatic blood flow as well as the effect of DPR on the inflammatory process following hemorrhagic shock.
The National Institute of General Medicine Sciences supported this research. Dr. Smith and his coauthors reported no relevant financial disclosures.
AT THE EAST SCIENTIFIC ASSEMBLY
Major Finding: Time to definitive wound closure was 5.7 days with standard resuscitation vs. 3.6 days with the addition of direct peritoneal resuscitation with 2.5% Delflex (P = .006).
Data Source: Prospective, case-control study in 84 patients with hemorrhagic shock undergoing damage control surgery.
Disclosures: The National Institute of General Medicine Sciences supported this research. Dr. Smith and his coauthors reported no relevant financial disclosures.
Skin laser surgery lawsuits increasing
Patients and their families sued dermatologists in 21% of 174 lawsuits filed for injuries caused by cutaneous laser surgery from 1985 through 2011. Only plastic surgeons were more likely to be defendants, accounting for 26% of cases.
The incidence of lawsuits for cutaneous laser surgery injury generally is on the upswing, increasing from five or fewer cases per year in 1985-1999 to a peak of 22 cases in 2010, Dr. H. Ray Jalian and his associates reported.
The majority of the cases involved laser hair removal (36%) and rejuvenation procedures (25%). The rejuvenation procedures included conventional ablative resurfacing, nonablative resurfacing, intense pulsed light, and the use of both ablative and nonablative fractional lasers. Plaintiffs won an average of $380,700 each in 51% of the 120 cases that reached a decision or settlement. That’s more than the average $275,000 indemnity payment across all medical specialties in a 2011 report, but the two studies used different methodologies. Dr. Jalian and his associates analyzed cutaneous laser surgery cases in the national Westlaw Next database of public records that included some form of legal pleading (JAMA Dermatol. 2013;149:188-93). The previous data included all resolved claims (not only those with legal pleadings) in all specialties (N. Engl. J. Med. 2011;365:629-36).
The physicians being sued included at least 12 other kinds of specialists, suggesting that a significant number of physicians offer or supervise laser skin treatments outside the scope of their specialty, wrote Dr. Jalian, a clinical fellow at the Wellman Center for Photomedicine, Massachusetts General Hospital, Boston.
General surgeons, family physicians, ob.gyns., and otolaryngologists each accounted for 5% of cases. Others included ophthalmologists (3%), orthopedic surgeons (2%), and specialists in radiology, anesthesia, physical medicine and rehabilitation, preventative medicine, and vascular surgery (1% each). Physician extenders (including physician assistants, nurse practitioners, registered nurses, aestheticians, and technicians) were laser operators or supervisors in 20% of cases.
Notably, physicians were sued even when they weren’t operating the laser, but were responsible for supervising the operator. Nonphysician operators (including physician extenders, chiropractors, podiatrists, and others) comprised 38% of operators and 26% of defendants. Physicians comprised 58% of operators and 74% of defendants. The training status of 5% of operators was unknown. (Percentages were rounded.)
After hair removal and skin rejuvenation, the most often litigated cases involved treatment of vascular lesions and telangiectasia (8% of cases) or treatment of leg veins (another 8%). Seven percent of cases involved tattoo removal, 4% involved neoplasms, 3% stemmed from treatment of scars, 2% involved laser treatment of pigmentary disorders, 1% were the use of a laser to treat pigmented lesions, and 6% were other procedures.
The most common injuries were burns (47%), scars (39%), and hypo- or hyperpigmentation (24%). Two percent of cases involved eye injuries, and at least two patients died due to complications of anesthesia.
The researchers offered several tips for physicians to reduce the risk of a lawsuit from skin laser surgery, including ensuring proper staff training and supervising delegated tasks. Be careful to evaluate skin type and select the correct laser parameters, they said. For some patients, it may be wise to do a test spot before starting laser treatment, even though solid data are lacking to support this. Follow guidelines from professional medical associations, such as the guidelines from the American Society for Laser Medicine, on delegating laser-related tasks to nonphysicians, the researchers added.
In general, federal regulations do not specify who can operate a laser, which procedures must be supervised by physicians, or where to perform procedures. Several states, including New York and Texas, do not require a license to perform laser hair removal, the most common type of laser skin surgery, the investigators noted. The lawsuits were filed in 30 states, the District of Columbia, and federal court, with the most cases in California (27), New York (23) and Texas (23).
Dr. Jalian reported having no financial disclosures. One of his coinvestigators has been a consultant and advisor for Zeltiq Aesthetics and a consultant for Unilever.
On Twitter @sherryboschert
Patients and their families sued dermatologists in 21% of 174 lawsuits filed for injuries caused by cutaneous laser surgery from 1985 through 2011. Only plastic surgeons were more likely to be defendants, accounting for 26% of cases.
The incidence of lawsuits for cutaneous laser surgery injury generally is on the upswing, increasing from five or fewer cases per year in 1985-1999 to a peak of 22 cases in 2010, Dr. H. Ray Jalian and his associates reported.
The majority of the cases involved laser hair removal (36%) and rejuvenation procedures (25%). The rejuvenation procedures included conventional ablative resurfacing, nonablative resurfacing, intense pulsed light, and the use of both ablative and nonablative fractional lasers. Plaintiffs won an average of $380,700 each in 51% of the 120 cases that reached a decision or settlement. That’s more than the average $275,000 indemnity payment across all medical specialties in a 2011 report, but the two studies used different methodologies. Dr. Jalian and his associates analyzed cutaneous laser surgery cases in the national Westlaw Next database of public records that included some form of legal pleading (JAMA Dermatol. 2013;149:188-93). The previous data included all resolved claims (not only those with legal pleadings) in all specialties (N. Engl. J. Med. 2011;365:629-36).
The physicians being sued included at least 12 other kinds of specialists, suggesting that a significant number of physicians offer or supervise laser skin treatments outside the scope of their specialty, wrote Dr. Jalian, a clinical fellow at the Wellman Center for Photomedicine, Massachusetts General Hospital, Boston.
General surgeons, family physicians, ob.gyns., and otolaryngologists each accounted for 5% of cases. Others included ophthalmologists (3%), orthopedic surgeons (2%), and specialists in radiology, anesthesia, physical medicine and rehabilitation, preventative medicine, and vascular surgery (1% each). Physician extenders (including physician assistants, nurse practitioners, registered nurses, aestheticians, and technicians) were laser operators or supervisors in 20% of cases.
Notably, physicians were sued even when they weren’t operating the laser, but were responsible for supervising the operator. Nonphysician operators (including physician extenders, chiropractors, podiatrists, and others) comprised 38% of operators and 26% of defendants. Physicians comprised 58% of operators and 74% of defendants. The training status of 5% of operators was unknown. (Percentages were rounded.)
After hair removal and skin rejuvenation, the most often litigated cases involved treatment of vascular lesions and telangiectasia (8% of cases) or treatment of leg veins (another 8%). Seven percent of cases involved tattoo removal, 4% involved neoplasms, 3% stemmed from treatment of scars, 2% involved laser treatment of pigmentary disorders, 1% were the use of a laser to treat pigmented lesions, and 6% were other procedures.
The most common injuries were burns (47%), scars (39%), and hypo- or hyperpigmentation (24%). Two percent of cases involved eye injuries, and at least two patients died due to complications of anesthesia.
The researchers offered several tips for physicians to reduce the risk of a lawsuit from skin laser surgery, including ensuring proper staff training and supervising delegated tasks. Be careful to evaluate skin type and select the correct laser parameters, they said. For some patients, it may be wise to do a test spot before starting laser treatment, even though solid data are lacking to support this. Follow guidelines from professional medical associations, such as the guidelines from the American Society for Laser Medicine, on delegating laser-related tasks to nonphysicians, the researchers added.
In general, federal regulations do not specify who can operate a laser, which procedures must be supervised by physicians, or where to perform procedures. Several states, including New York and Texas, do not require a license to perform laser hair removal, the most common type of laser skin surgery, the investigators noted. The lawsuits were filed in 30 states, the District of Columbia, and federal court, with the most cases in California (27), New York (23) and Texas (23).
Dr. Jalian reported having no financial disclosures. One of his coinvestigators has been a consultant and advisor for Zeltiq Aesthetics and a consultant for Unilever.
On Twitter @sherryboschert
Patients and their families sued dermatologists in 21% of 174 lawsuits filed for injuries caused by cutaneous laser surgery from 1985 through 2011. Only plastic surgeons were more likely to be defendants, accounting for 26% of cases.
The incidence of lawsuits for cutaneous laser surgery injury generally is on the upswing, increasing from five or fewer cases per year in 1985-1999 to a peak of 22 cases in 2010, Dr. H. Ray Jalian and his associates reported.
The majority of the cases involved laser hair removal (36%) and rejuvenation procedures (25%). The rejuvenation procedures included conventional ablative resurfacing, nonablative resurfacing, intense pulsed light, and the use of both ablative and nonablative fractional lasers. Plaintiffs won an average of $380,700 each in 51% of the 120 cases that reached a decision or settlement. That’s more than the average $275,000 indemnity payment across all medical specialties in a 2011 report, but the two studies used different methodologies. Dr. Jalian and his associates analyzed cutaneous laser surgery cases in the national Westlaw Next database of public records that included some form of legal pleading (JAMA Dermatol. 2013;149:188-93). The previous data included all resolved claims (not only those with legal pleadings) in all specialties (N. Engl. J. Med. 2011;365:629-36).
The physicians being sued included at least 12 other kinds of specialists, suggesting that a significant number of physicians offer or supervise laser skin treatments outside the scope of their specialty, wrote Dr. Jalian, a clinical fellow at the Wellman Center for Photomedicine, Massachusetts General Hospital, Boston.
General surgeons, family physicians, ob.gyns., and otolaryngologists each accounted for 5% of cases. Others included ophthalmologists (3%), orthopedic surgeons (2%), and specialists in radiology, anesthesia, physical medicine and rehabilitation, preventative medicine, and vascular surgery (1% each). Physician extenders (including physician assistants, nurse practitioners, registered nurses, aestheticians, and technicians) were laser operators or supervisors in 20% of cases.
Notably, physicians were sued even when they weren’t operating the laser, but were responsible for supervising the operator. Nonphysician operators (including physician extenders, chiropractors, podiatrists, and others) comprised 38% of operators and 26% of defendants. Physicians comprised 58% of operators and 74% of defendants. The training status of 5% of operators was unknown. (Percentages were rounded.)
After hair removal and skin rejuvenation, the most often litigated cases involved treatment of vascular lesions and telangiectasia (8% of cases) or treatment of leg veins (another 8%). Seven percent of cases involved tattoo removal, 4% involved neoplasms, 3% stemmed from treatment of scars, 2% involved laser treatment of pigmentary disorders, 1% were the use of a laser to treat pigmented lesions, and 6% were other procedures.
The most common injuries were burns (47%), scars (39%), and hypo- or hyperpigmentation (24%). Two percent of cases involved eye injuries, and at least two patients died due to complications of anesthesia.
The researchers offered several tips for physicians to reduce the risk of a lawsuit from skin laser surgery, including ensuring proper staff training and supervising delegated tasks. Be careful to evaluate skin type and select the correct laser parameters, they said. For some patients, it may be wise to do a test spot before starting laser treatment, even though solid data are lacking to support this. Follow guidelines from professional medical associations, such as the guidelines from the American Society for Laser Medicine, on delegating laser-related tasks to nonphysicians, the researchers added.
In general, federal regulations do not specify who can operate a laser, which procedures must be supervised by physicians, or where to perform procedures. Several states, including New York and Texas, do not require a license to perform laser hair removal, the most common type of laser skin surgery, the investigators noted. The lawsuits were filed in 30 states, the District of Columbia, and federal court, with the most cases in California (27), New York (23) and Texas (23).
Dr. Jalian reported having no financial disclosures. One of his coinvestigators has been a consultant and advisor for Zeltiq Aesthetics and a consultant for Unilever.
On Twitter @sherryboschert
FROM THE JOURNAL JAMA DERMATOLOGY
Major Finding: Plaintiffs and their families sued dermatologists in 21% of 174 lawsuits filed from 1985 through 2011 for injuries caused by cutaneous laser surgery.
Data Source: Retrospective review of records on 174 cases with legal pleadings in a national database.
Disclosures: Dr. Jalian reported having no financial disclosures. One of his coinvestigators has been a consultant and adviser for Zeltiq Aesthetics and a consultant for Unilever.
Clinical staging of early esophageal cancer unreliable
LOS ANGELES – Clinical staging of T2N0 esophageal cancer remains unreliable, despite advances in staging techniques, a study has shown.
The addition of endoscopic ultrasound and PET/CT has improved the ability to clinically stage esophageal cancer overall, but clinical staging of T2N0 disease has generally been less reliable than staging of more advanced disease. The subset of patients with T2N0 disease, which accounts for only a small portion of esophageal resections, has been a difficult group to study because single-center investigations involve a limited number of patients, Dr. Traves D. Crabtree said at the annual meeting of the Society of Thoracic Surgeons (STS), in the prestigious Richard E. Clark Paper for General Thoracic Surgery.
Dr. Crabtree of Washington University, St. Louis, and his colleagues examined the adequacy of clinical staging of T2N0 disease using the STS General Thoracic Surgery Database.
The researchers identified 810 patients clinically staged as T2N0 from 2002 to 2011 and excluded 58 because of inadequate pathologic staging data. Clinical stage, pathologic stage, and preoperative characteristics were recorded for each patient and multivariable analysis was used to identify factors associated with upstaging at the time of surgery.
Among 752 patients with clinically staged T2N0, the investigators found that 482 went directly to surgery. Of these, 27.4% (132) were confirmed as pathologic T2N0. A total of 25.9% (125) were downstaged (T1N0), while 46.7% (225) were upstaged (T3-4N0 or TanyN1-3). Tumor depth (pT3-4) accounted for 18.2% of upstaging while nodal upstaging occurred in approximately 82%. When logistic regression was used, male sex was associated with upstaging (odds ratio = 1.85, P = .024). By analyzing the part of the database that included tumor grade (between the years 2009 and 2011), the investigators found that a higher histologic grade was significantly associated with upstaging (P = .004).
"Over one-third of surgeons have opted to treat T2N0 disease with induction therapy, despite the fact that one-quarter of these patients will be pT1N0," he said.
"This is the first large-scale multi-institutional study of clinical T2N0 patients using the STS General Thoracic Surgery Database. These data highlight the inaccuracy associated with clinical staging of T2N0 esophageal cancer and may influence the surgeon’s decision-making process in choosing a treatment regimen for these patients," Dr. Crabtree added in an interview.
"Given the current limitations of clinical staging of T2N0 patients, the incidence of occult nodal disease, and the similar perioperative outcomes among patients treated with and without induction therapy, these patients may more likely be treated with induction therapy in the future. Additional studies are needed to compare long-term outcomes between patients receiving induction therapy, vs. those clinical T2N0 patients going directly to surgery, before a definitive recommendation can be made," he concluded.
Dr. Crabtree reported that he had no relevant financial disclosures.
LOS ANGELES – Clinical staging of T2N0 esophageal cancer remains unreliable, despite advances in staging techniques, a study has shown.
The addition of endoscopic ultrasound and PET/CT has improved the ability to clinically stage esophageal cancer overall, but clinical staging of T2N0 disease has generally been less reliable than staging of more advanced disease. The subset of patients with T2N0 disease, which accounts for only a small portion of esophageal resections, has been a difficult group to study because single-center investigations involve a limited number of patients, Dr. Traves D. Crabtree said at the annual meeting of the Society of Thoracic Surgeons (STS), in the prestigious Richard E. Clark Paper for General Thoracic Surgery.
Dr. Crabtree of Washington University, St. Louis, and his colleagues examined the adequacy of clinical staging of T2N0 disease using the STS General Thoracic Surgery Database.
The researchers identified 810 patients clinically staged as T2N0 from 2002 to 2011 and excluded 58 because of inadequate pathologic staging data. Clinical stage, pathologic stage, and preoperative characteristics were recorded for each patient and multivariable analysis was used to identify factors associated with upstaging at the time of surgery.
Among 752 patients with clinically staged T2N0, the investigators found that 482 went directly to surgery. Of these, 27.4% (132) were confirmed as pathologic T2N0. A total of 25.9% (125) were downstaged (T1N0), while 46.7% (225) were upstaged (T3-4N0 or TanyN1-3). Tumor depth (pT3-4) accounted for 18.2% of upstaging while nodal upstaging occurred in approximately 82%. When logistic regression was used, male sex was associated with upstaging (odds ratio = 1.85, P = .024). By analyzing the part of the database that included tumor grade (between the years 2009 and 2011), the investigators found that a higher histologic grade was significantly associated with upstaging (P = .004).
"Over one-third of surgeons have opted to treat T2N0 disease with induction therapy, despite the fact that one-quarter of these patients will be pT1N0," he said.
"This is the first large-scale multi-institutional study of clinical T2N0 patients using the STS General Thoracic Surgery Database. These data highlight the inaccuracy associated with clinical staging of T2N0 esophageal cancer and may influence the surgeon’s decision-making process in choosing a treatment regimen for these patients," Dr. Crabtree added in an interview.
"Given the current limitations of clinical staging of T2N0 patients, the incidence of occult nodal disease, and the similar perioperative outcomes among patients treated with and without induction therapy, these patients may more likely be treated with induction therapy in the future. Additional studies are needed to compare long-term outcomes between patients receiving induction therapy, vs. those clinical T2N0 patients going directly to surgery, before a definitive recommendation can be made," he concluded.
Dr. Crabtree reported that he had no relevant financial disclosures.
LOS ANGELES – Clinical staging of T2N0 esophageal cancer remains unreliable, despite advances in staging techniques, a study has shown.
The addition of endoscopic ultrasound and PET/CT has improved the ability to clinically stage esophageal cancer overall, but clinical staging of T2N0 disease has generally been less reliable than staging of more advanced disease. The subset of patients with T2N0 disease, which accounts for only a small portion of esophageal resections, has been a difficult group to study because single-center investigations involve a limited number of patients, Dr. Traves D. Crabtree said at the annual meeting of the Society of Thoracic Surgeons (STS), in the prestigious Richard E. Clark Paper for General Thoracic Surgery.
Dr. Crabtree of Washington University, St. Louis, and his colleagues examined the adequacy of clinical staging of T2N0 disease using the STS General Thoracic Surgery Database.
The researchers identified 810 patients clinically staged as T2N0 from 2002 to 2011 and excluded 58 because of inadequate pathologic staging data. Clinical stage, pathologic stage, and preoperative characteristics were recorded for each patient and multivariable analysis was used to identify factors associated with upstaging at the time of surgery.
Among 752 patients with clinically staged T2N0, the investigators found that 482 went directly to surgery. Of these, 27.4% (132) were confirmed as pathologic T2N0. A total of 25.9% (125) were downstaged (T1N0), while 46.7% (225) were upstaged (T3-4N0 or TanyN1-3). Tumor depth (pT3-4) accounted for 18.2% of upstaging while nodal upstaging occurred in approximately 82%. When logistic regression was used, male sex was associated with upstaging (odds ratio = 1.85, P = .024). By analyzing the part of the database that included tumor grade (between the years 2009 and 2011), the investigators found that a higher histologic grade was significantly associated with upstaging (P = .004).
"Over one-third of surgeons have opted to treat T2N0 disease with induction therapy, despite the fact that one-quarter of these patients will be pT1N0," he said.
"This is the first large-scale multi-institutional study of clinical T2N0 patients using the STS General Thoracic Surgery Database. These data highlight the inaccuracy associated with clinical staging of T2N0 esophageal cancer and may influence the surgeon’s decision-making process in choosing a treatment regimen for these patients," Dr. Crabtree added in an interview.
"Given the current limitations of clinical staging of T2N0 patients, the incidence of occult nodal disease, and the similar perioperative outcomes among patients treated with and without induction therapy, these patients may more likely be treated with induction therapy in the future. Additional studies are needed to compare long-term outcomes between patients receiving induction therapy, vs. those clinical T2N0 patients going directly to surgery, before a definitive recommendation can be made," he concluded.
Dr. Crabtree reported that he had no relevant financial disclosures.
AT THE ANNUAL MEETING OF THE SOCIETY OF THORACIC SURGESONS
Major Finding: Of 482 patients who went directly to surgery, 26% were downstaged, while 47% were upstaged.
Data Source: A retrospective, database analysis of 810 patients clinically staged as T2N0 from 2002 to 2011.
Disclosures: Dr. Crabtree reported that he had no relevant financial disclosures.
Survey: Most support transfusing to increase organ donation
SCOTTSDALE, ARIZ. – The majority of trauma surgeons would aggressively manage patients with a lethal brain injury for the purposes of organ donation.
Consensus on how best to transfuse these patients to protect their organs appears to be another matter, a survey of Eastern Association for the Surgery of Trauma (EAST) members reveals.
"Further investigation is needed to determine what the transfusion triggers and limits should be in order to maximize our donor conversion rates," said Dr. Stancie Rhodes and her colleagues at Robert Wood Johnson University Hospital, New Brunswick, N.J.
Many institutions have set up aggressive donor management protocols to help address the worldwide shortage of transplantable organs. At press time, 117,090 candidates were on the U.S. Department of Health and Human Services’ Organ Procurement and Transplantation Network waiting list, with just 25,785 transplants performed between January and November 2012.
Aggressive donor management (ADM) protocols typically include guidelines for invasive monitoring and correction of metabolic disturbances that follow brain death, but many continue to lack guidelines on when and in what quantity to transfuse potential organ donors, explained Dr. Rhodes, a trauma surgeon at Robert Wood Johnson.
To further develop these guidelines, the investigators electronically surveyed all trauma surgeons in EAST regarding their transfusion practices in patients with nonsurvivable brain injury. In all, 285 members responded (24.5%). Among these respondents, 53.5% currently transfuse these patients.
Almost three-fourths, 72.5%, of respondents agreed with aggressive medical management of patients with lethal brain injury in the hope they could donate organs, while 9.4% strongly disagreed, Dr. Rhodes reported in a poster at the EAST’s annual meeting.
Trauma surgeons practicing in a suburban setting were significantly more likely to agree with transfusion than were those in rural or urban settings (77% vs. 52% vs. 55%; P less than .04).
Before deciding to aggressively manage a potential organ donor, respondents were divided on whether the testing for declaration of brain death must already be underway (111 strongly agree/26 strongly disagree), the patient must be declared brain dead (11 strongly agree/84 strongly disagree), or consent for donation of organs must have been obtained (6 strongly agree/114 strongly disagree, Dr. Rhodes reported.
"I think the important piece is that respondents overwhelmingly agreed that they would not wait for declaration of brain death to begin to aggressively manage these patients," she said in an interview. "This is important, as these patients succumb to hypoperfusion, coagulopathy, and acidosis if their ongoing hemorrhage is uncontrolled early in their course."
The majority of respondents (75%) agreed that they have a limit to the amount of product they would administer.
If the potential donor was in hemorrhagic shock, 6 respondents strongly agreed and 12 agreed they would consider transfusing blood products, while 114 disagreed and 119 strongly disagreed with the practice.
Respondents were more likely to consider transfusing, however, if the potential donor was having coagulopathic bleeding. In all, 47 strongly agreed and 106 agreed with transfusing in this setting, while 30 disagreed and 15 strongly disagreed.
If either hemorrhagic shock or coagulopathic bleeding were present, most respondents would limit packed red blood cells and fresh frozen plasma to no more than 5-8 units, and platelets to no more than 1-4 units, the authors reported.
Of those surgeons surveyed, 42% were between the ages of 40 and 49 years, 10.2% practiced primarily in a rural setting, 15.1% practiced in an suburban setting – defined as a population less than 500,000 – and 45.6% were in an urban setting, defined by a population in excess of 500,000 residents.
Dr. Rhodes and her coauthors have nothing to disclose.
transfuse, survey, Eastern Association for the Surgery of Trauma, EAST, Dr. Stancie Rhodes, aggressive donor management protocols, worldwide shortage of transplantable organs, U.S. Department of Health and Human Services’ Organ Procurement and Transplantation Network waiting list,
SCOTTSDALE, ARIZ. – The majority of trauma surgeons would aggressively manage patients with a lethal brain injury for the purposes of organ donation.
Consensus on how best to transfuse these patients to protect their organs appears to be another matter, a survey of Eastern Association for the Surgery of Trauma (EAST) members reveals.
"Further investigation is needed to determine what the transfusion triggers and limits should be in order to maximize our donor conversion rates," said Dr. Stancie Rhodes and her colleagues at Robert Wood Johnson University Hospital, New Brunswick, N.J.
Many institutions have set up aggressive donor management protocols to help address the worldwide shortage of transplantable organs. At press time, 117,090 candidates were on the U.S. Department of Health and Human Services’ Organ Procurement and Transplantation Network waiting list, with just 25,785 transplants performed between January and November 2012.
Aggressive donor management (ADM) protocols typically include guidelines for invasive monitoring and correction of metabolic disturbances that follow brain death, but many continue to lack guidelines on when and in what quantity to transfuse potential organ donors, explained Dr. Rhodes, a trauma surgeon at Robert Wood Johnson.
To further develop these guidelines, the investigators electronically surveyed all trauma surgeons in EAST regarding their transfusion practices in patients with nonsurvivable brain injury. In all, 285 members responded (24.5%). Among these respondents, 53.5% currently transfuse these patients.
Almost three-fourths, 72.5%, of respondents agreed with aggressive medical management of patients with lethal brain injury in the hope they could donate organs, while 9.4% strongly disagreed, Dr. Rhodes reported in a poster at the EAST’s annual meeting.
Trauma surgeons practicing in a suburban setting were significantly more likely to agree with transfusion than were those in rural or urban settings (77% vs. 52% vs. 55%; P less than .04).
Before deciding to aggressively manage a potential organ donor, respondents were divided on whether the testing for declaration of brain death must already be underway (111 strongly agree/26 strongly disagree), the patient must be declared brain dead (11 strongly agree/84 strongly disagree), or consent for donation of organs must have been obtained (6 strongly agree/114 strongly disagree, Dr. Rhodes reported.
"I think the important piece is that respondents overwhelmingly agreed that they would not wait for declaration of brain death to begin to aggressively manage these patients," she said in an interview. "This is important, as these patients succumb to hypoperfusion, coagulopathy, and acidosis if their ongoing hemorrhage is uncontrolled early in their course."
The majority of respondents (75%) agreed that they have a limit to the amount of product they would administer.
If the potential donor was in hemorrhagic shock, 6 respondents strongly agreed and 12 agreed they would consider transfusing blood products, while 114 disagreed and 119 strongly disagreed with the practice.
Respondents were more likely to consider transfusing, however, if the potential donor was having coagulopathic bleeding. In all, 47 strongly agreed and 106 agreed with transfusing in this setting, while 30 disagreed and 15 strongly disagreed.
If either hemorrhagic shock or coagulopathic bleeding were present, most respondents would limit packed red blood cells and fresh frozen plasma to no more than 5-8 units, and platelets to no more than 1-4 units, the authors reported.
Of those surgeons surveyed, 42% were between the ages of 40 and 49 years, 10.2% practiced primarily in a rural setting, 15.1% practiced in an suburban setting – defined as a population less than 500,000 – and 45.6% were in an urban setting, defined by a population in excess of 500,000 residents.
Dr. Rhodes and her coauthors have nothing to disclose.
SCOTTSDALE, ARIZ. – The majority of trauma surgeons would aggressively manage patients with a lethal brain injury for the purposes of organ donation.
Consensus on how best to transfuse these patients to protect their organs appears to be another matter, a survey of Eastern Association for the Surgery of Trauma (EAST) members reveals.
"Further investigation is needed to determine what the transfusion triggers and limits should be in order to maximize our donor conversion rates," said Dr. Stancie Rhodes and her colleagues at Robert Wood Johnson University Hospital, New Brunswick, N.J.
Many institutions have set up aggressive donor management protocols to help address the worldwide shortage of transplantable organs. At press time, 117,090 candidates were on the U.S. Department of Health and Human Services’ Organ Procurement and Transplantation Network waiting list, with just 25,785 transplants performed between January and November 2012.
Aggressive donor management (ADM) protocols typically include guidelines for invasive monitoring and correction of metabolic disturbances that follow brain death, but many continue to lack guidelines on when and in what quantity to transfuse potential organ donors, explained Dr. Rhodes, a trauma surgeon at Robert Wood Johnson.
To further develop these guidelines, the investigators electronically surveyed all trauma surgeons in EAST regarding their transfusion practices in patients with nonsurvivable brain injury. In all, 285 members responded (24.5%). Among these respondents, 53.5% currently transfuse these patients.
Almost three-fourths, 72.5%, of respondents agreed with aggressive medical management of patients with lethal brain injury in the hope they could donate organs, while 9.4% strongly disagreed, Dr. Rhodes reported in a poster at the EAST’s annual meeting.
Trauma surgeons practicing in a suburban setting were significantly more likely to agree with transfusion than were those in rural or urban settings (77% vs. 52% vs. 55%; P less than .04).
Before deciding to aggressively manage a potential organ donor, respondents were divided on whether the testing for declaration of brain death must already be underway (111 strongly agree/26 strongly disagree), the patient must be declared brain dead (11 strongly agree/84 strongly disagree), or consent for donation of organs must have been obtained (6 strongly agree/114 strongly disagree, Dr. Rhodes reported.
"I think the important piece is that respondents overwhelmingly agreed that they would not wait for declaration of brain death to begin to aggressively manage these patients," she said in an interview. "This is important, as these patients succumb to hypoperfusion, coagulopathy, and acidosis if their ongoing hemorrhage is uncontrolled early in their course."
The majority of respondents (75%) agreed that they have a limit to the amount of product they would administer.
If the potential donor was in hemorrhagic shock, 6 respondents strongly agreed and 12 agreed they would consider transfusing blood products, while 114 disagreed and 119 strongly disagreed with the practice.
Respondents were more likely to consider transfusing, however, if the potential donor was having coagulopathic bleeding. In all, 47 strongly agreed and 106 agreed with transfusing in this setting, while 30 disagreed and 15 strongly disagreed.
If either hemorrhagic shock or coagulopathic bleeding were present, most respondents would limit packed red blood cells and fresh frozen plasma to no more than 5-8 units, and platelets to no more than 1-4 units, the authors reported.
Of those surgeons surveyed, 42% were between the ages of 40 and 49 years, 10.2% practiced primarily in a rural setting, 15.1% practiced in an suburban setting – defined as a population less than 500,000 – and 45.6% were in an urban setting, defined by a population in excess of 500,000 residents.
Dr. Rhodes and her coauthors have nothing to disclose.
transfuse, survey, Eastern Association for the Surgery of Trauma, EAST, Dr. Stancie Rhodes, aggressive donor management protocols, worldwide shortage of transplantable organs, U.S. Department of Health and Human Services’ Organ Procurement and Transplantation Network waiting list,
transfuse, survey, Eastern Association for the Surgery of Trauma, EAST, Dr. Stancie Rhodes, aggressive donor management protocols, worldwide shortage of transplantable organs, U.S. Department of Health and Human Services’ Organ Procurement and Transplantation Network waiting list,
EXPERT ANALYSIS FROM THE EAST ANNUAL MEETING
Major Finding: Among respondents, 72.5% agreed with aggressive medical management of patients with lethal brain injury for the sake of organ donation, but there was less consensus on when and how to manage these patients.
Data Source: Electronic survey of 285 trauma surgeons in the Eastern Association for the Surgery of Trauma.
Disclosures: Dr. Rhodes and her coauthors have nothing to disclose.
Neonates at highest risk for Ebstein's malformation treatment
LOS ANGELES – Ebstein’s malformation is a rare congenital cardiac anomaly. Surgery for Ebstein’s involves a range of procedures, and with low institutional volumes, the only available data on treatment are limited to individual reports demonstrating highly variable approaches. Neonates in particular are at risk for poor outcomes, showing significantly higher mortality than infants, children, and adults, according to a database study presented by Dr. Ryan R. Davies at the annual meeting of the Society of Thoracic Surgeons.
Dr. Davies of the Nemours/A.I. duPont Hospital for Children, Wilmington, Del., and his colleagues performed a retrospective study of procedures performed on patients with a primary diagnosis of Ebstein’s malformation (2002-2009) in the STS Congenital Heart Surgery Database.
A total of 595 operations on patients with Ebstein’s were included: 116 on neonates (19%), 122 on infants (21%), 264 on children (44%), and 93 on adults (16%). The authors found that average annual institutional case volumes were low (median, 1 case/year), and procedures varied according to age. Neonates had a high rate of palliative procedures: tricuspid valve (TV) closure (16%) and systemic-to-pulmonary shunts with or without TV closure (37%) and isolated TV closure (8.6%), with Ebstein’s repair or TV valvuloplasty performed in 32%.
Infants usually underwent superior cavopulmonary connections (52%).
Among older patients, procedures were mostly in three categories: TV surgery (children, 55%; adults, 69%), arrhythmia procedures (children, 9%; adults, 17%), and Fontan (children, 16%). In-hospital mortality was higher among neonatal patients (23%) than in infants (4%), children (0.8%), and adults (1.1%).
Among neonates, 36 subsequent procedures were performed during the same hospitalization in 27 patients (23%); including TV closure (11%); shunt (15%); Ebstein’s repair (17%) or TV replacement (15%); and heart transplantation (7.4%). Mortality was similar among neonates who had a second procedure and those who did not (27% vs. 23%, respectively). ECMO (extracorporeal membrane oxygenation) was used in 9% of neonates but in less than 2% of patients in other age groups.
"This study represents a broad overview of the diverse options for surgical treatment of Ebstein’s anomaly. It shows the challenges faced in caring for extremely ill neonatal patients. We have also shown that repair of Ebstein’s anomaly is performed infrequently at most centers, limiting the ability of individual series to define optimal management strategies," Dr. Davies said in an interview.
"Unfortunately, currently available databases do not contain information that may be important in defining such strategies (both surgical and nonsurgical), including anatomic and physiologic variables – whether they are neonates presenting in severe heart failure or older patients presenting for tricuspid valve repair or replacement," he added.
"We feel that in this setting, a prospective multi-institutional study would be of significant value. It should include operative and nonoperative patients, as well as precise diagnostic information and procedural details, to evaluate long-term outcomes including survival, reoperation and other reinterventions, as well as neurodevelopmental outcomes, functional health status, and quality of life," Dr. Davies concluded.
Dr. Davies and his colleagues reported having no relevant disclosures.
LOS ANGELES – Ebstein’s malformation is a rare congenital cardiac anomaly. Surgery for Ebstein’s involves a range of procedures, and with low institutional volumes, the only available data on treatment are limited to individual reports demonstrating highly variable approaches. Neonates in particular are at risk for poor outcomes, showing significantly higher mortality than infants, children, and adults, according to a database study presented by Dr. Ryan R. Davies at the annual meeting of the Society of Thoracic Surgeons.
Dr. Davies of the Nemours/A.I. duPont Hospital for Children, Wilmington, Del., and his colleagues performed a retrospective study of procedures performed on patients with a primary diagnosis of Ebstein’s malformation (2002-2009) in the STS Congenital Heart Surgery Database.
A total of 595 operations on patients with Ebstein’s were included: 116 on neonates (19%), 122 on infants (21%), 264 on children (44%), and 93 on adults (16%). The authors found that average annual institutional case volumes were low (median, 1 case/year), and procedures varied according to age. Neonates had a high rate of palliative procedures: tricuspid valve (TV) closure (16%) and systemic-to-pulmonary shunts with or without TV closure (37%) and isolated TV closure (8.6%), with Ebstein’s repair or TV valvuloplasty performed in 32%.
Infants usually underwent superior cavopulmonary connections (52%).
Among older patients, procedures were mostly in three categories: TV surgery (children, 55%; adults, 69%), arrhythmia procedures (children, 9%; adults, 17%), and Fontan (children, 16%). In-hospital mortality was higher among neonatal patients (23%) than in infants (4%), children (0.8%), and adults (1.1%).
Among neonates, 36 subsequent procedures were performed during the same hospitalization in 27 patients (23%); including TV closure (11%); shunt (15%); Ebstein’s repair (17%) or TV replacement (15%); and heart transplantation (7.4%). Mortality was similar among neonates who had a second procedure and those who did not (27% vs. 23%, respectively). ECMO (extracorporeal membrane oxygenation) was used in 9% of neonates but in less than 2% of patients in other age groups.
"This study represents a broad overview of the diverse options for surgical treatment of Ebstein’s anomaly. It shows the challenges faced in caring for extremely ill neonatal patients. We have also shown that repair of Ebstein’s anomaly is performed infrequently at most centers, limiting the ability of individual series to define optimal management strategies," Dr. Davies said in an interview.
"Unfortunately, currently available databases do not contain information that may be important in defining such strategies (both surgical and nonsurgical), including anatomic and physiologic variables – whether they are neonates presenting in severe heart failure or older patients presenting for tricuspid valve repair or replacement," he added.
"We feel that in this setting, a prospective multi-institutional study would be of significant value. It should include operative and nonoperative patients, as well as precise diagnostic information and procedural details, to evaluate long-term outcomes including survival, reoperation and other reinterventions, as well as neurodevelopmental outcomes, functional health status, and quality of life," Dr. Davies concluded.
Dr. Davies and his colleagues reported having no relevant disclosures.
LOS ANGELES – Ebstein’s malformation is a rare congenital cardiac anomaly. Surgery for Ebstein’s involves a range of procedures, and with low institutional volumes, the only available data on treatment are limited to individual reports demonstrating highly variable approaches. Neonates in particular are at risk for poor outcomes, showing significantly higher mortality than infants, children, and adults, according to a database study presented by Dr. Ryan R. Davies at the annual meeting of the Society of Thoracic Surgeons.
Dr. Davies of the Nemours/A.I. duPont Hospital for Children, Wilmington, Del., and his colleagues performed a retrospective study of procedures performed on patients with a primary diagnosis of Ebstein’s malformation (2002-2009) in the STS Congenital Heart Surgery Database.
A total of 595 operations on patients with Ebstein’s were included: 116 on neonates (19%), 122 on infants (21%), 264 on children (44%), and 93 on adults (16%). The authors found that average annual institutional case volumes were low (median, 1 case/year), and procedures varied according to age. Neonates had a high rate of palliative procedures: tricuspid valve (TV) closure (16%) and systemic-to-pulmonary shunts with or without TV closure (37%) and isolated TV closure (8.6%), with Ebstein’s repair or TV valvuloplasty performed in 32%.
Infants usually underwent superior cavopulmonary connections (52%).
Among older patients, procedures were mostly in three categories: TV surgery (children, 55%; adults, 69%), arrhythmia procedures (children, 9%; adults, 17%), and Fontan (children, 16%). In-hospital mortality was higher among neonatal patients (23%) than in infants (4%), children (0.8%), and adults (1.1%).
Among neonates, 36 subsequent procedures were performed during the same hospitalization in 27 patients (23%); including TV closure (11%); shunt (15%); Ebstein’s repair (17%) or TV replacement (15%); and heart transplantation (7.4%). Mortality was similar among neonates who had a second procedure and those who did not (27% vs. 23%, respectively). ECMO (extracorporeal membrane oxygenation) was used in 9% of neonates but in less than 2% of patients in other age groups.
"This study represents a broad overview of the diverse options for surgical treatment of Ebstein’s anomaly. It shows the challenges faced in caring for extremely ill neonatal patients. We have also shown that repair of Ebstein’s anomaly is performed infrequently at most centers, limiting the ability of individual series to define optimal management strategies," Dr. Davies said in an interview.
"Unfortunately, currently available databases do not contain information that may be important in defining such strategies (both surgical and nonsurgical), including anatomic and physiologic variables – whether they are neonates presenting in severe heart failure or older patients presenting for tricuspid valve repair or replacement," he added.
"We feel that in this setting, a prospective multi-institutional study would be of significant value. It should include operative and nonoperative patients, as well as precise diagnostic information and procedural details, to evaluate long-term outcomes including survival, reoperation and other reinterventions, as well as neurodevelopmental outcomes, functional health status, and quality of life," Dr. Davies concluded.
Dr. Davies and his colleagues reported having no relevant disclosures.
AT THE STS ANNUAL MEETING
Major Finding: In-hospital mortality was higher among neonatal patients (23%) than in infants (4%), children (0.8%), and adults (1.1%).
Data Source: A retrospective database analysis of 595 operations on patients with Ebstein’s malformation.
Disclosures: Dr. Davies and his colleagues reported having no relevant disclosures.
Sandwich technique bests coil embolization for complex AAA
MIAMI BEACH – Hypogastric artery endorevascularization using the sandwich technique was associated with fewer complications than was hypogastric artery exclusion by coil embolization for the treatment of abdominal aortic aneurysm with concomitant bilateral common iliac artery aneurysm in a series of 79 patients.
A total of 158 common iliac artery aneurysms were treated using either the same technique bilaterally or a different technique in each side. In the first group, 40 hypogastric artery endorevascularization procedures were performed using the sandwich technique, including 6 bilateral procedures. In the second group, 118 hypogastric artery exclusion procedures were performed using coil embolization followed by positioning of a limb extension to the external iliac artery, including 45 bilateral procedures, Dr. Armando C. Lobato reported at the International Symposium on Endovascular Therapy 2013.
At a mean of 37 months’ follow-up, permanent buttock claudication rates were significantly higher in group two (12.7% vs. 2.5%), as were late type II endoleak rates (15.5% vs. 2.5%), said Dr. Lobato of the Sao Paulo Vascular and Endovascular Surgery Institute, Beneficencia Portuguesa Hospital, Sao Paulo, Brazil.
The technical success rate was 100% in both groups, and related mortality and postoperative aneurysm rupture rates did not differ significantly between the groups. Early mortality was 0% and 1.4% in groups one and two, respectively; late mortality was 0% and 2.8% in the groups, respectively; and the postoperative aneurysm rupture rate was 0% and 1.4% in the groups, respectively, he said.
Rates of iliac limb migration, late type IB endoleak, type III endoleak, iliac limb occlusion, and reintervention also were similar in the two groups.
On multivariate regression analysis, bilateral hypogastric artery exclusion by coil embolization was significantly associated with permanent buttock claudication and late type II endoleak, he noted.
The findings provide further validation of the sandwich technique, which was developed by Dr. Lobato to overcome anatomical and device-related constraints encountered during endovascular aneurysm repair (EVAR). The technique has shown promise in prior studies and earlier reports from Dr. Lobato’s case series.
Dr. Lobato reported having no disclosures.
MIAMI BEACH – Hypogastric artery endorevascularization using the sandwich technique was associated with fewer complications than was hypogastric artery exclusion by coil embolization for the treatment of abdominal aortic aneurysm with concomitant bilateral common iliac artery aneurysm in a series of 79 patients.
A total of 158 common iliac artery aneurysms were treated using either the same technique bilaterally or a different technique in each side. In the first group, 40 hypogastric artery endorevascularization procedures were performed using the sandwich technique, including 6 bilateral procedures. In the second group, 118 hypogastric artery exclusion procedures were performed using coil embolization followed by positioning of a limb extension to the external iliac artery, including 45 bilateral procedures, Dr. Armando C. Lobato reported at the International Symposium on Endovascular Therapy 2013.
At a mean of 37 months’ follow-up, permanent buttock claudication rates were significantly higher in group two (12.7% vs. 2.5%), as were late type II endoleak rates (15.5% vs. 2.5%), said Dr. Lobato of the Sao Paulo Vascular and Endovascular Surgery Institute, Beneficencia Portuguesa Hospital, Sao Paulo, Brazil.
The technical success rate was 100% in both groups, and related mortality and postoperative aneurysm rupture rates did not differ significantly between the groups. Early mortality was 0% and 1.4% in groups one and two, respectively; late mortality was 0% and 2.8% in the groups, respectively; and the postoperative aneurysm rupture rate was 0% and 1.4% in the groups, respectively, he said.
Rates of iliac limb migration, late type IB endoleak, type III endoleak, iliac limb occlusion, and reintervention also were similar in the two groups.
On multivariate regression analysis, bilateral hypogastric artery exclusion by coil embolization was significantly associated with permanent buttock claudication and late type II endoleak, he noted.
The findings provide further validation of the sandwich technique, which was developed by Dr. Lobato to overcome anatomical and device-related constraints encountered during endovascular aneurysm repair (EVAR). The technique has shown promise in prior studies and earlier reports from Dr. Lobato’s case series.
Dr. Lobato reported having no disclosures.
MIAMI BEACH – Hypogastric artery endorevascularization using the sandwich technique was associated with fewer complications than was hypogastric artery exclusion by coil embolization for the treatment of abdominal aortic aneurysm with concomitant bilateral common iliac artery aneurysm in a series of 79 patients.
A total of 158 common iliac artery aneurysms were treated using either the same technique bilaterally or a different technique in each side. In the first group, 40 hypogastric artery endorevascularization procedures were performed using the sandwich technique, including 6 bilateral procedures. In the second group, 118 hypogastric artery exclusion procedures were performed using coil embolization followed by positioning of a limb extension to the external iliac artery, including 45 bilateral procedures, Dr. Armando C. Lobato reported at the International Symposium on Endovascular Therapy 2013.
At a mean of 37 months’ follow-up, permanent buttock claudication rates were significantly higher in group two (12.7% vs. 2.5%), as were late type II endoleak rates (15.5% vs. 2.5%), said Dr. Lobato of the Sao Paulo Vascular and Endovascular Surgery Institute, Beneficencia Portuguesa Hospital, Sao Paulo, Brazil.
The technical success rate was 100% in both groups, and related mortality and postoperative aneurysm rupture rates did not differ significantly between the groups. Early mortality was 0% and 1.4% in groups one and two, respectively; late mortality was 0% and 2.8% in the groups, respectively; and the postoperative aneurysm rupture rate was 0% and 1.4% in the groups, respectively, he said.
Rates of iliac limb migration, late type IB endoleak, type III endoleak, iliac limb occlusion, and reintervention also were similar in the two groups.
On multivariate regression analysis, bilateral hypogastric artery exclusion by coil embolization was significantly associated with permanent buttock claudication and late type II endoleak, he noted.
The findings provide further validation of the sandwich technique, which was developed by Dr. Lobato to overcome anatomical and device-related constraints encountered during endovascular aneurysm repair (EVAR). The technique has shown promise in prior studies and earlier reports from Dr. Lobato’s case series.
Dr. Lobato reported having no disclosures.
AT ISET 2013
Major finding: Permanent buttock claudication rates were significantly higher in the coil group, compared with the sandwich group (12.7% vs. 2.5%), as were late type II endoleak rates (15.5% vs. 2.5%).
Data source: A case series involving 79 patients with a total of 158 common iliac artery aneurysms.
Disclosures: Dr. Lobato reported having no disclosures.
