User login
Official Newspaper of the American College of Surgeons
Real-world data backs rivaroxaban for postop VTE prevention
NEW ORLEANS – In routine practice, rivaroxaban was superior to low-molecular-weight heparin for venous thromboembolism prevention in older adults undergoing hip or knee arthroplasty, without an increase in bleeding risk.
Among 24,321 patients, aged 66 years or older, the 30-day VTE event rate was 0.47% for rivaroxaban (Xarelto) (61 events) and 0.81% for low-molecular-weight heparin (LMWH) (93 events).
These findings resulted in an unadjusted relative risk of 0.58, which was statistically significant (P = .001) and did not change after adjustment for significant covariates, Dr. Alejandro Lazo-Langner said during an antithrombotic therapy session at the annual meeting of the American Society of Hematology.
There were 23 major bleeding events in both the rivaroxaban (0.18%) and LMWH (0.20%) groups. The unadjusted relative risk was 0.89 (P = .700) and did not change after adjustment in the population-based, retrospective cohort analysis.
Rivaroxaban has been the subject of numerous randomized controlled trials, but "We don’t have much real-life data in these patients," said Dr. Lazo-Langner, a hematologist specializing in thromboembolic diseases at Western University, London, Ontario, Canada.
In a meta-analysis of eight randomized rivaroxaban trials, the factor Xa inhibitor was associated with a significant 52% reduction in thrombosis after total hip or knee replacement, compared with enoxaparin (Lovenox) in roughly 14,000 patients (BMJ 2012;344:e3675 [doi:10.1136/bmj.e3675]). This came at a cost, however, of a slightly increased risk of clinically significant bleeding (relative risk, 1.25), he noted.
For the current analysis,the investigators used linked health care databases in Ontario to identify 24,321 patients who received an outpatient prescription for rivaroxaban or subcutaneous LMWH including dalteparin (Fragmin), tinzaparin (Innohep), or enoxaparin on discharge after total hip or knee arthroplasty between 2002 and 2012 across 121 hospitals.
Their average age was 74 years, 59% were women, and 12,850 received rivaroxaban. The anticoagulants were prescribed for a median of 14 days. Patients were excluded if they had other indications for anticoagulation, prosthetic mechanical heart valves, required dialysis, or lived in a long-term-care facility.
At 90 days, the VTE event rate was significantly lower in the rivaroxaban group than in the LMWH group (0.71% vs. 1.20%; adjusted RR, 0.59; P = .001). Once again, major bleeding events were similar (0.24% vs. 0.27%; adjusted RR, 0.63; P = .138), Dr. Lazo-Langner reported.
No differences were observed between the two groups at 30 or 90 days for hospitalization with endoscopy or hospitalization with major bleeding or endoscopy.
All-cause mortality was not estimable at 30 days but was lower with rivaroxaban at 90 days (16 deaths vs. 25 deaths; adjusted RR, 0.52; P = .058).
Additional analyses were conducted to test the robustness of the findings and no differences in rates of thrombosis were found when the analysis was restricted to 2009 to 2012, by type of joint replacement, or different low-molecular-weight heparins, he said.
Finally, a cost analysis was performed that showed a modest, but significant increase in direct drug costs to patients prescribed LMWH rather than rivaroxaban (Canadian $242 vs. $228; P less than .001) and home-care costs, likely from increased nursing ($1,082 vs. $959; P less than .001), Dr. Lazo-Langner said.
During a discussion of the results, he said there was no difference in novel anticoagulant use across surgeons or hospital settings, which was academic for 21% of LMWH patients and 15% of rivaroxaban patients.
Session comoderator Dr. Elaine Hylek, professor of medicine at Boston University, called this reassuring, but also urged caution in extrapolating conclusions on treatment effect outside a randomized trial.
Dr. Lazo-Langner reported research funding from Alexion, serving as a speaker for Pfizer, and honoraria from Pfizer, Leo Pharma, and Boehringer Ingelheim.
NEW ORLEANS – In routine practice, rivaroxaban was superior to low-molecular-weight heparin for venous thromboembolism prevention in older adults undergoing hip or knee arthroplasty, without an increase in bleeding risk.
Among 24,321 patients, aged 66 years or older, the 30-day VTE event rate was 0.47% for rivaroxaban (Xarelto) (61 events) and 0.81% for low-molecular-weight heparin (LMWH) (93 events).
These findings resulted in an unadjusted relative risk of 0.58, which was statistically significant (P = .001) and did not change after adjustment for significant covariates, Dr. Alejandro Lazo-Langner said during an antithrombotic therapy session at the annual meeting of the American Society of Hematology.
There were 23 major bleeding events in both the rivaroxaban (0.18%) and LMWH (0.20%) groups. The unadjusted relative risk was 0.89 (P = .700) and did not change after adjustment in the population-based, retrospective cohort analysis.
Rivaroxaban has been the subject of numerous randomized controlled trials, but "We don’t have much real-life data in these patients," said Dr. Lazo-Langner, a hematologist specializing in thromboembolic diseases at Western University, London, Ontario, Canada.
In a meta-analysis of eight randomized rivaroxaban trials, the factor Xa inhibitor was associated with a significant 52% reduction in thrombosis after total hip or knee replacement, compared with enoxaparin (Lovenox) in roughly 14,000 patients (BMJ 2012;344:e3675 [doi:10.1136/bmj.e3675]). This came at a cost, however, of a slightly increased risk of clinically significant bleeding (relative risk, 1.25), he noted.
For the current analysis,the investigators used linked health care databases in Ontario to identify 24,321 patients who received an outpatient prescription for rivaroxaban or subcutaneous LMWH including dalteparin (Fragmin), tinzaparin (Innohep), or enoxaparin on discharge after total hip or knee arthroplasty between 2002 and 2012 across 121 hospitals.
Their average age was 74 years, 59% were women, and 12,850 received rivaroxaban. The anticoagulants were prescribed for a median of 14 days. Patients were excluded if they had other indications for anticoagulation, prosthetic mechanical heart valves, required dialysis, or lived in a long-term-care facility.
At 90 days, the VTE event rate was significantly lower in the rivaroxaban group than in the LMWH group (0.71% vs. 1.20%; adjusted RR, 0.59; P = .001). Once again, major bleeding events were similar (0.24% vs. 0.27%; adjusted RR, 0.63; P = .138), Dr. Lazo-Langner reported.
No differences were observed between the two groups at 30 or 90 days for hospitalization with endoscopy or hospitalization with major bleeding or endoscopy.
All-cause mortality was not estimable at 30 days but was lower with rivaroxaban at 90 days (16 deaths vs. 25 deaths; adjusted RR, 0.52; P = .058).
Additional analyses were conducted to test the robustness of the findings and no differences in rates of thrombosis were found when the analysis was restricted to 2009 to 2012, by type of joint replacement, or different low-molecular-weight heparins, he said.
Finally, a cost analysis was performed that showed a modest, but significant increase in direct drug costs to patients prescribed LMWH rather than rivaroxaban (Canadian $242 vs. $228; P less than .001) and home-care costs, likely from increased nursing ($1,082 vs. $959; P less than .001), Dr. Lazo-Langner said.
During a discussion of the results, he said there was no difference in novel anticoagulant use across surgeons or hospital settings, which was academic for 21% of LMWH patients and 15% of rivaroxaban patients.
Session comoderator Dr. Elaine Hylek, professor of medicine at Boston University, called this reassuring, but also urged caution in extrapolating conclusions on treatment effect outside a randomized trial.
Dr. Lazo-Langner reported research funding from Alexion, serving as a speaker for Pfizer, and honoraria from Pfizer, Leo Pharma, and Boehringer Ingelheim.
NEW ORLEANS – In routine practice, rivaroxaban was superior to low-molecular-weight heparin for venous thromboembolism prevention in older adults undergoing hip or knee arthroplasty, without an increase in bleeding risk.
Among 24,321 patients, aged 66 years or older, the 30-day VTE event rate was 0.47% for rivaroxaban (Xarelto) (61 events) and 0.81% for low-molecular-weight heparin (LMWH) (93 events).
These findings resulted in an unadjusted relative risk of 0.58, which was statistically significant (P = .001) and did not change after adjustment for significant covariates, Dr. Alejandro Lazo-Langner said during an antithrombotic therapy session at the annual meeting of the American Society of Hematology.
There were 23 major bleeding events in both the rivaroxaban (0.18%) and LMWH (0.20%) groups. The unadjusted relative risk was 0.89 (P = .700) and did not change after adjustment in the population-based, retrospective cohort analysis.
Rivaroxaban has been the subject of numerous randomized controlled trials, but "We don’t have much real-life data in these patients," said Dr. Lazo-Langner, a hematologist specializing in thromboembolic diseases at Western University, London, Ontario, Canada.
In a meta-analysis of eight randomized rivaroxaban trials, the factor Xa inhibitor was associated with a significant 52% reduction in thrombosis after total hip or knee replacement, compared with enoxaparin (Lovenox) in roughly 14,000 patients (BMJ 2012;344:e3675 [doi:10.1136/bmj.e3675]). This came at a cost, however, of a slightly increased risk of clinically significant bleeding (relative risk, 1.25), he noted.
For the current analysis,the investigators used linked health care databases in Ontario to identify 24,321 patients who received an outpatient prescription for rivaroxaban or subcutaneous LMWH including dalteparin (Fragmin), tinzaparin (Innohep), or enoxaparin on discharge after total hip or knee arthroplasty between 2002 and 2012 across 121 hospitals.
Their average age was 74 years, 59% were women, and 12,850 received rivaroxaban. The anticoagulants were prescribed for a median of 14 days. Patients were excluded if they had other indications for anticoagulation, prosthetic mechanical heart valves, required dialysis, or lived in a long-term-care facility.
At 90 days, the VTE event rate was significantly lower in the rivaroxaban group than in the LMWH group (0.71% vs. 1.20%; adjusted RR, 0.59; P = .001). Once again, major bleeding events were similar (0.24% vs. 0.27%; adjusted RR, 0.63; P = .138), Dr. Lazo-Langner reported.
No differences were observed between the two groups at 30 or 90 days for hospitalization with endoscopy or hospitalization with major bleeding or endoscopy.
All-cause mortality was not estimable at 30 days but was lower with rivaroxaban at 90 days (16 deaths vs. 25 deaths; adjusted RR, 0.52; P = .058).
Additional analyses were conducted to test the robustness of the findings and no differences in rates of thrombosis were found when the analysis was restricted to 2009 to 2012, by type of joint replacement, or different low-molecular-weight heparins, he said.
Finally, a cost analysis was performed that showed a modest, but significant increase in direct drug costs to patients prescribed LMWH rather than rivaroxaban (Canadian $242 vs. $228; P less than .001) and home-care costs, likely from increased nursing ($1,082 vs. $959; P less than .001), Dr. Lazo-Langner said.
During a discussion of the results, he said there was no difference in novel anticoagulant use across surgeons or hospital settings, which was academic for 21% of LMWH patients and 15% of rivaroxaban patients.
Session comoderator Dr. Elaine Hylek, professor of medicine at Boston University, called this reassuring, but also urged caution in extrapolating conclusions on treatment effect outside a randomized trial.
Dr. Lazo-Langner reported research funding from Alexion, serving as a speaker for Pfizer, and honoraria from Pfizer, Leo Pharma, and Boehringer Ingelheim.
AT ASH 2013
Major finding: The 30-day VTE event rate was 0.47% for rivaroxaban and 0.81% for low molecular weight heparin (unadjusted RR, 0.58; P = .001).
Data source: Population-based, retrospective cohort study of 24,321 patients undergoing hip or knee arthroplasty
Disclosures: Dr. Lazo-Langner reported research funding from Alexion, serving as a speaker for Pfizer, and honoraria from Pfizer, Leo Pharma, and Boehringer Ingelheim.
Multiple revascularization ups risk of amputation, death
The risk of amputation and death appears to increase as the number of revascularization procedures increases, according to findings from a retrospective analysis of data.
The amputation risk was present among patients who underwent percutaneous transluminal angioplasty (PTA) only, as well as among subsets of patients who underwent lower extremity bypass (LEB) only, reported Dr. Alexander T. Hawkins of the Center for Surgery and Public Health, Boston, and his colleagues.
Among 11,190 patients with critical limb ischemia who underwent one, two, three, four, or five or more revascularization procedures, the 1-year estimated amputation rates were 23.3%, 27.1%, 30.3%, 26.7%, and 28.6%, and the 1-year estimated mortality rates were 18.7%, 21.1%, 26.3%, 23.6%, and 32.1%, respectively, the investigators reported. The findings were published in the January issue of Annals of Vascular Surgery.
The risk of amputation increased significantly for those with two vs. one revascularization procedures (hazard ratio, 1.22) and for those with three vs. two procedures (HR, 1.33). The risk for death at 1 year also increased significantly among those with two vs. one procedure (HR, 1.18) (Ann. Vasc. Surg. 2014;28:35-47).
Similar trends for amputation were seen in the PTA-only (1: 24.5%; 2: 26.1%; 3: 27.9%; 4: 31.3%; 5+: 26.8%), and LEB-only (1: 26.0%; 2: 32.5%; 3+: 45.5%) groups. "The increases did not appear to be exponential," they noted.
No changes were seen in the PTA-only and LEB-only groups with respect to 1-year estimates of in-hospital death.
A subgroup analysis further showed that timing between procedures was significantly associated with 1-year amputation risk; the risk was 27.2% for a 1-7 day interval, 36.4% for 8 days to 1 month, 19.4% for 1-6 months; and 22.2% for 6 months or more.
"There was also a difference in 1-year amputation rates between bypass patients who underwent bypass first and who underwent PTA followed by bypass" (21.8% vs. 30.7%), the researchers wrote.
Study subjects were adult patients with a mean age of 71 years who underwent revascularization between July 2007 and December 2009. The patients, including 6,225 men (55.9%), were identified from the California State Inpatient Database and had a high burden of comorbidities; 55.2% abused tobacco, 64.9% had coronary artery disease, 51.3% had hypertension, and 68% had diabetes.
Though limited by factors inherent in the use of an administrative database (such as potential inconsistencies in coding accuracy) and in a nonrandomized study (subject to confounding), the findings nonetheless provide "novel and useful information on the increasing risk of amputation and death in patients undergoing multiple revascularization procedures," the investigators said.
They stressed that they are "by no means making the claim that secondary revascularization is inappropriate," but rather, that they are presenting the risks associated with further procedures in an effort to inform the decision-making process.
Critical limb ischemia confers a high risk of limb loss without treatment, they said, noting that 16%-50% of revascularized patients require secondary revascularization. A "major proportion" of these patients will require further procedures, they noted.
"We emphasize continued communication between clinicians and patients on the true risks and benefits of these procedures," they concluded.
Dr. Hawkins and his coauthor, Dr. Stuart Lipsitz, are supported by a grant from the Brigham and Women’s Center for Surgery and Public Health Arthur Tracy Cabot Fellowship. Dr. Hawkins is also supported by the NIH NHLBI T32 Harvard/Longwood Vascular Surgery Training Program. Another author, Dr. Maria J. Schaumeier, is supported by a grant from the Freiwillige Akademische Gesellschaft, Basel, Switzerland.
The risk of amputation and death appears to increase as the number of revascularization procedures increases, according to findings from a retrospective analysis of data.
The amputation risk was present among patients who underwent percutaneous transluminal angioplasty (PTA) only, as well as among subsets of patients who underwent lower extremity bypass (LEB) only, reported Dr. Alexander T. Hawkins of the Center for Surgery and Public Health, Boston, and his colleagues.
Among 11,190 patients with critical limb ischemia who underwent one, two, three, four, or five or more revascularization procedures, the 1-year estimated amputation rates were 23.3%, 27.1%, 30.3%, 26.7%, and 28.6%, and the 1-year estimated mortality rates were 18.7%, 21.1%, 26.3%, 23.6%, and 32.1%, respectively, the investigators reported. The findings were published in the January issue of Annals of Vascular Surgery.
The risk of amputation increased significantly for those with two vs. one revascularization procedures (hazard ratio, 1.22) and for those with three vs. two procedures (HR, 1.33). The risk for death at 1 year also increased significantly among those with two vs. one procedure (HR, 1.18) (Ann. Vasc. Surg. 2014;28:35-47).
Similar trends for amputation were seen in the PTA-only (1: 24.5%; 2: 26.1%; 3: 27.9%; 4: 31.3%; 5+: 26.8%), and LEB-only (1: 26.0%; 2: 32.5%; 3+: 45.5%) groups. "The increases did not appear to be exponential," they noted.
No changes were seen in the PTA-only and LEB-only groups with respect to 1-year estimates of in-hospital death.
A subgroup analysis further showed that timing between procedures was significantly associated with 1-year amputation risk; the risk was 27.2% for a 1-7 day interval, 36.4% for 8 days to 1 month, 19.4% for 1-6 months; and 22.2% for 6 months or more.
"There was also a difference in 1-year amputation rates between bypass patients who underwent bypass first and who underwent PTA followed by bypass" (21.8% vs. 30.7%), the researchers wrote.
Study subjects were adult patients with a mean age of 71 years who underwent revascularization between July 2007 and December 2009. The patients, including 6,225 men (55.9%), were identified from the California State Inpatient Database and had a high burden of comorbidities; 55.2% abused tobacco, 64.9% had coronary artery disease, 51.3% had hypertension, and 68% had diabetes.
Though limited by factors inherent in the use of an administrative database (such as potential inconsistencies in coding accuracy) and in a nonrandomized study (subject to confounding), the findings nonetheless provide "novel and useful information on the increasing risk of amputation and death in patients undergoing multiple revascularization procedures," the investigators said.
They stressed that they are "by no means making the claim that secondary revascularization is inappropriate," but rather, that they are presenting the risks associated with further procedures in an effort to inform the decision-making process.
Critical limb ischemia confers a high risk of limb loss without treatment, they said, noting that 16%-50% of revascularized patients require secondary revascularization. A "major proportion" of these patients will require further procedures, they noted.
"We emphasize continued communication between clinicians and patients on the true risks and benefits of these procedures," they concluded.
Dr. Hawkins and his coauthor, Dr. Stuart Lipsitz, are supported by a grant from the Brigham and Women’s Center for Surgery and Public Health Arthur Tracy Cabot Fellowship. Dr. Hawkins is also supported by the NIH NHLBI T32 Harvard/Longwood Vascular Surgery Training Program. Another author, Dr. Maria J. Schaumeier, is supported by a grant from the Freiwillige Akademische Gesellschaft, Basel, Switzerland.
The risk of amputation and death appears to increase as the number of revascularization procedures increases, according to findings from a retrospective analysis of data.
The amputation risk was present among patients who underwent percutaneous transluminal angioplasty (PTA) only, as well as among subsets of patients who underwent lower extremity bypass (LEB) only, reported Dr. Alexander T. Hawkins of the Center for Surgery and Public Health, Boston, and his colleagues.
Among 11,190 patients with critical limb ischemia who underwent one, two, three, four, or five or more revascularization procedures, the 1-year estimated amputation rates were 23.3%, 27.1%, 30.3%, 26.7%, and 28.6%, and the 1-year estimated mortality rates were 18.7%, 21.1%, 26.3%, 23.6%, and 32.1%, respectively, the investigators reported. The findings were published in the January issue of Annals of Vascular Surgery.
The risk of amputation increased significantly for those with two vs. one revascularization procedures (hazard ratio, 1.22) and for those with three vs. two procedures (HR, 1.33). The risk for death at 1 year also increased significantly among those with two vs. one procedure (HR, 1.18) (Ann. Vasc. Surg. 2014;28:35-47).
Similar trends for amputation were seen in the PTA-only (1: 24.5%; 2: 26.1%; 3: 27.9%; 4: 31.3%; 5+: 26.8%), and LEB-only (1: 26.0%; 2: 32.5%; 3+: 45.5%) groups. "The increases did not appear to be exponential," they noted.
No changes were seen in the PTA-only and LEB-only groups with respect to 1-year estimates of in-hospital death.
A subgroup analysis further showed that timing between procedures was significantly associated with 1-year amputation risk; the risk was 27.2% for a 1-7 day interval, 36.4% for 8 days to 1 month, 19.4% for 1-6 months; and 22.2% for 6 months or more.
"There was also a difference in 1-year amputation rates between bypass patients who underwent bypass first and who underwent PTA followed by bypass" (21.8% vs. 30.7%), the researchers wrote.
Study subjects were adult patients with a mean age of 71 years who underwent revascularization between July 2007 and December 2009. The patients, including 6,225 men (55.9%), were identified from the California State Inpatient Database and had a high burden of comorbidities; 55.2% abused tobacco, 64.9% had coronary artery disease, 51.3% had hypertension, and 68% had diabetes.
Though limited by factors inherent in the use of an administrative database (such as potential inconsistencies in coding accuracy) and in a nonrandomized study (subject to confounding), the findings nonetheless provide "novel and useful information on the increasing risk of amputation and death in patients undergoing multiple revascularization procedures," the investigators said.
They stressed that they are "by no means making the claim that secondary revascularization is inappropriate," but rather, that they are presenting the risks associated with further procedures in an effort to inform the decision-making process.
Critical limb ischemia confers a high risk of limb loss without treatment, they said, noting that 16%-50% of revascularized patients require secondary revascularization. A "major proportion" of these patients will require further procedures, they noted.
"We emphasize continued communication between clinicians and patients on the true risks and benefits of these procedures," they concluded.
Dr. Hawkins and his coauthor, Dr. Stuart Lipsitz, are supported by a grant from the Brigham and Women’s Center for Surgery and Public Health Arthur Tracy Cabot Fellowship. Dr. Hawkins is also supported by the NIH NHLBI T32 Harvard/Longwood Vascular Surgery Training Program. Another author, Dr. Maria J. Schaumeier, is supported by a grant from the Freiwillige Akademische Gesellschaft, Basel, Switzerland.
FROM ANNALS OF VASCULAR SURGERY
Major finding: Amputation risk increased significantly for those with two revascularization procedures vs. one procedure (hazard ratio, 1.22) and for those with three vs. two procedures (HR, 1.33). The risk for death increased significantly among those with two vs. one procedure (HR, 1.18).
Data source: A retrospective analysis of 11,190 patients in an administrative database.
Disclosures: Dr. Hawkins and his coauthor, Dr. Stuart Lipsitz, are supported by a grant from the Brigham and Women’s Center for Surgery and Public Health Arthur Tracy Cabot Fellowship. Dr. Hawkins is also supported by the NIH NHLBI T32 Harvard/Longwood Vascular Surgery Training Program. Another author, Dr. Maria J. Schaumeier, is supported by a grant from the Freiwillige Akademische Gesellschaft, Basel, Switzerland.
Injury cause alone insufficient to justify CT scanning in children
Using computed tomographic imaging (CT scans) based only on a child’s method of injury in blunt trauma cases incurs more risks than benefits, according to a recent study.
The ionizing radiation from CT scanning has been linked to long-term risk of cancer, with an estimated risk of one cancer case per 10,000 CT scans, and the U.S. Environmental Protection Agency attributes 25% of all radiation in the United States to CT scanning.
"The benefit of identifying or excluding life-threatening injuries with a high sensitivity is an invaluable tool," wrote Dr. Hunter B. Moore and his colleagues at the University of Colorado at Denver, Aurora, in the Journal of Trauma and Acute Care Surgery. "However, application in the more radiosensitive pediatric population requires critical analysis."
Dr. Moore’s team found that the only clinically significant factor in determining the value of using CT scans was an abnormal Glasgow Coma Score (GCS). The GCS neurological scale rates patients from 3 to 14 on their level of consciousness; the highest score (14 on the original scale, 15 on the revised scale) refers to normal verbal, motor, and eye functioning. This study used the original scale, according to corresponding author Denis Bensard.
"Most concerning was that injured children imaged based on the mechanism of injury alone yielded no significant findings on CT imaging," the researchers wrote (J. Trauma Acute Care Surg. 2013;75:995-1001). "When anatomic or physiologic abnormalities were present, a serious CT finding was observed in more than 20% of the children imaged."
The researchers classified 174 patients, all meeting trauma team activation criteria at a Level 2 pediatric trauma center, into four groups to study the clinical value of CT scanning based on the children’s mechanism of injury. The patients, with a mean age of 7 years and a mean Injury Severity Score of 10, were admitted from January 2006 through December 2011.
The first group had normal GCS scores and normal vital signs and physical examinations. CT scanning for this group was considered to be done based on mechanism of injury alone. The second group had abnormal GCS scores but normal vital signs and physical exams. The third group had normal GCS scores but abnormal vital signs or exam findings. The fourth group had both abnormal GCS scores and abnormal findings in vital signs and/or exams.
Across all groups, motor vehicle collisions accounted for the most common injury causes, followed by being struck by autos as pedestrians, and falls. Positive CT scan findings included extra axial blood or parenchymal injury in the head; bony, vascular injury in the neck; great vessel injury in the chest; or solid organ or hollow visceral injury in the abdomen.
Of the 54 patients (82% of 66 children) in the group with normal exams, vital signs, and GCS scores who received CT scans, the patients were exposed to an average 17 mSv through an average 1.7 scans per child. The annual environmental dose limit for radiation is established at 1 mSv per year. "Remarkably, no patient imaged, based on [injury] mechanism alone, had a serious or life-threatening finding on CT scan," the researchers wrote.
All 25 patients in the group with abnormal GCS scores but normal exams and vital signs were scanned, with an average of 3.1 scans and 29 mSv of radiation per child. While 22% of the scans revealed a serious injury, the only surgeries required were one craniotomy and one nephrectomy.
Among the 57 children with normal GCS scores but abnormal exams or vital signs, 49 of them (86%) were scanned, with an average of two scans and 20 mSv per child. One splenectomy resulted from among the 23% of scans revealing significant findings.
All but 1 of the 26 children with abnormal GCS scores and abnormal vital signs or exams were scanned, with an average of 2.8 scans and 27 mSv per child. A quarter of the scans revealed significant findings, and two children required emergency craniotomies.
"We found that only one in four CT scans found a serious finding, but emergent operative interventions were required in less than 3% of injured children imaged," the researchers wrote. "Focused assessment with sonography for trauma [FAST] examination for the cohort was found to have a high specificity of 98%, but low sensitivity of 30%."
They determined the low sensitivity to result from the scans’ inability to identify injuries in solid organs without "detectable blood or retroperitoneal injury," though CT scans did appear valuable for identifying intra-abdominal hemorrhage. Abdominal CT scans were most likely to identify serious injuries when initial exams revealed anatomic or physiologic abnormalities, but chest scans had little to no utility.
The authors noted that current cancer risk estimates from CT scan radiation may be low because of the time it can take for cancers to manifest (up to 40 years) and the short time span (10 years) of the retrospective study that validated the 1 in 10,000 per CT scan risk. "Commentary on this article cautions that these preliminary data are similar to atomic bomb survivors, and the true incidence of cancer from CT scanning may be 10 times more after more time elapses following CT scans," they wrote.
The researchers did not use external funding. They reported no disclosures
Using computed tomographic imaging (CT scans) based only on a child’s method of injury in blunt trauma cases incurs more risks than benefits, according to a recent study.
The ionizing radiation from CT scanning has been linked to long-term risk of cancer, with an estimated risk of one cancer case per 10,000 CT scans, and the U.S. Environmental Protection Agency attributes 25% of all radiation in the United States to CT scanning.
"The benefit of identifying or excluding life-threatening injuries with a high sensitivity is an invaluable tool," wrote Dr. Hunter B. Moore and his colleagues at the University of Colorado at Denver, Aurora, in the Journal of Trauma and Acute Care Surgery. "However, application in the more radiosensitive pediatric population requires critical analysis."
Dr. Moore’s team found that the only clinically significant factor in determining the value of using CT scans was an abnormal Glasgow Coma Score (GCS). The GCS neurological scale rates patients from 3 to 14 on their level of consciousness; the highest score (14 on the original scale, 15 on the revised scale) refers to normal verbal, motor, and eye functioning. This study used the original scale, according to corresponding author Denis Bensard.
"Most concerning was that injured children imaged based on the mechanism of injury alone yielded no significant findings on CT imaging," the researchers wrote (J. Trauma Acute Care Surg. 2013;75:995-1001). "When anatomic or physiologic abnormalities were present, a serious CT finding was observed in more than 20% of the children imaged."
The researchers classified 174 patients, all meeting trauma team activation criteria at a Level 2 pediatric trauma center, into four groups to study the clinical value of CT scanning based on the children’s mechanism of injury. The patients, with a mean age of 7 years and a mean Injury Severity Score of 10, were admitted from January 2006 through December 2011.
The first group had normal GCS scores and normal vital signs and physical examinations. CT scanning for this group was considered to be done based on mechanism of injury alone. The second group had abnormal GCS scores but normal vital signs and physical exams. The third group had normal GCS scores but abnormal vital signs or exam findings. The fourth group had both abnormal GCS scores and abnormal findings in vital signs and/or exams.
Across all groups, motor vehicle collisions accounted for the most common injury causes, followed by being struck by autos as pedestrians, and falls. Positive CT scan findings included extra axial blood or parenchymal injury in the head; bony, vascular injury in the neck; great vessel injury in the chest; or solid organ or hollow visceral injury in the abdomen.
Of the 54 patients (82% of 66 children) in the group with normal exams, vital signs, and GCS scores who received CT scans, the patients were exposed to an average 17 mSv through an average 1.7 scans per child. The annual environmental dose limit for radiation is established at 1 mSv per year. "Remarkably, no patient imaged, based on [injury] mechanism alone, had a serious or life-threatening finding on CT scan," the researchers wrote.
All 25 patients in the group with abnormal GCS scores but normal exams and vital signs were scanned, with an average of 3.1 scans and 29 mSv of radiation per child. While 22% of the scans revealed a serious injury, the only surgeries required were one craniotomy and one nephrectomy.
Among the 57 children with normal GCS scores but abnormal exams or vital signs, 49 of them (86%) were scanned, with an average of two scans and 20 mSv per child. One splenectomy resulted from among the 23% of scans revealing significant findings.
All but 1 of the 26 children with abnormal GCS scores and abnormal vital signs or exams were scanned, with an average of 2.8 scans and 27 mSv per child. A quarter of the scans revealed significant findings, and two children required emergency craniotomies.
"We found that only one in four CT scans found a serious finding, but emergent operative interventions were required in less than 3% of injured children imaged," the researchers wrote. "Focused assessment with sonography for trauma [FAST] examination for the cohort was found to have a high specificity of 98%, but low sensitivity of 30%."
They determined the low sensitivity to result from the scans’ inability to identify injuries in solid organs without "detectable blood or retroperitoneal injury," though CT scans did appear valuable for identifying intra-abdominal hemorrhage. Abdominal CT scans were most likely to identify serious injuries when initial exams revealed anatomic or physiologic abnormalities, but chest scans had little to no utility.
The authors noted that current cancer risk estimates from CT scan radiation may be low because of the time it can take for cancers to manifest (up to 40 years) and the short time span (10 years) of the retrospective study that validated the 1 in 10,000 per CT scan risk. "Commentary on this article cautions that these preliminary data are similar to atomic bomb survivors, and the true incidence of cancer from CT scanning may be 10 times more after more time elapses following CT scans," they wrote.
The researchers did not use external funding. They reported no disclosures
Using computed tomographic imaging (CT scans) based only on a child’s method of injury in blunt trauma cases incurs more risks than benefits, according to a recent study.
The ionizing radiation from CT scanning has been linked to long-term risk of cancer, with an estimated risk of one cancer case per 10,000 CT scans, and the U.S. Environmental Protection Agency attributes 25% of all radiation in the United States to CT scanning.
"The benefit of identifying or excluding life-threatening injuries with a high sensitivity is an invaluable tool," wrote Dr. Hunter B. Moore and his colleagues at the University of Colorado at Denver, Aurora, in the Journal of Trauma and Acute Care Surgery. "However, application in the more radiosensitive pediatric population requires critical analysis."
Dr. Moore’s team found that the only clinically significant factor in determining the value of using CT scans was an abnormal Glasgow Coma Score (GCS). The GCS neurological scale rates patients from 3 to 14 on their level of consciousness; the highest score (14 on the original scale, 15 on the revised scale) refers to normal verbal, motor, and eye functioning. This study used the original scale, according to corresponding author Denis Bensard.
"Most concerning was that injured children imaged based on the mechanism of injury alone yielded no significant findings on CT imaging," the researchers wrote (J. Trauma Acute Care Surg. 2013;75:995-1001). "When anatomic or physiologic abnormalities were present, a serious CT finding was observed in more than 20% of the children imaged."
The researchers classified 174 patients, all meeting trauma team activation criteria at a Level 2 pediatric trauma center, into four groups to study the clinical value of CT scanning based on the children’s mechanism of injury. The patients, with a mean age of 7 years and a mean Injury Severity Score of 10, were admitted from January 2006 through December 2011.
The first group had normal GCS scores and normal vital signs and physical examinations. CT scanning for this group was considered to be done based on mechanism of injury alone. The second group had abnormal GCS scores but normal vital signs and physical exams. The third group had normal GCS scores but abnormal vital signs or exam findings. The fourth group had both abnormal GCS scores and abnormal findings in vital signs and/or exams.
Across all groups, motor vehicle collisions accounted for the most common injury causes, followed by being struck by autos as pedestrians, and falls. Positive CT scan findings included extra axial blood or parenchymal injury in the head; bony, vascular injury in the neck; great vessel injury in the chest; or solid organ or hollow visceral injury in the abdomen.
Of the 54 patients (82% of 66 children) in the group with normal exams, vital signs, and GCS scores who received CT scans, the patients were exposed to an average 17 mSv through an average 1.7 scans per child. The annual environmental dose limit for radiation is established at 1 mSv per year. "Remarkably, no patient imaged, based on [injury] mechanism alone, had a serious or life-threatening finding on CT scan," the researchers wrote.
All 25 patients in the group with abnormal GCS scores but normal exams and vital signs were scanned, with an average of 3.1 scans and 29 mSv of radiation per child. While 22% of the scans revealed a serious injury, the only surgeries required were one craniotomy and one nephrectomy.
Among the 57 children with normal GCS scores but abnormal exams or vital signs, 49 of them (86%) were scanned, with an average of two scans and 20 mSv per child. One splenectomy resulted from among the 23% of scans revealing significant findings.
All but 1 of the 26 children with abnormal GCS scores and abnormal vital signs or exams were scanned, with an average of 2.8 scans and 27 mSv per child. A quarter of the scans revealed significant findings, and two children required emergency craniotomies.
"We found that only one in four CT scans found a serious finding, but emergent operative interventions were required in less than 3% of injured children imaged," the researchers wrote. "Focused assessment with sonography for trauma [FAST] examination for the cohort was found to have a high specificity of 98%, but low sensitivity of 30%."
They determined the low sensitivity to result from the scans’ inability to identify injuries in solid organs without "detectable blood or retroperitoneal injury," though CT scans did appear valuable for identifying intra-abdominal hemorrhage. Abdominal CT scans were most likely to identify serious injuries when initial exams revealed anatomic or physiologic abnormalities, but chest scans had little to no utility.
The authors noted that current cancer risk estimates from CT scan radiation may be low because of the time it can take for cancers to manifest (up to 40 years) and the short time span (10 years) of the retrospective study that validated the 1 in 10,000 per CT scan risk. "Commentary on this article cautions that these preliminary data are similar to atomic bomb survivors, and the true incidence of cancer from CT scanning may be 10 times more after more time elapses following CT scans," they wrote.
The researchers did not use external funding. They reported no disclosures
FROM THE JOURNAL OF TRAUMA AND ACUTE CARE SURGERY
Major finding: A Glasgow Coma Score (GCS) of less than 14 (original scale; less than 15 on revised scale) was the only clinically significant variable for identifying positive findings with CT scans in pediatric blunt trauma patients.
Data source: The findings are based on an analysis of the cases (CT scans received, significant findings, surgeries, and radiation exposure) of 174 children who met trauma team activation criteria at a Level 2 pediatric trauma center between January 2006 and December 2011.
Disclosures: The researchers did not use external funding. They reported no disclosures.
Partial flail chest stabilization may suffice
NAPLES, FLA. – Partial repair of flail segment rib fractures may suffice in patients whose anatomy precludes full stabilization, a small study suggests.
After a median follow-up of 189 days, only predicted total lung capacity at 3 months (90% vs. 72%; P = .02) and 6 months (94% vs. 75%; P = .038) significantly differed between patients undergoing complete flail stabilization (CFS) vs. partial flail stabilization (PFS).
No other differences in pulmonary and clinical outcomes were observed between the 43 patients, Dr. Terry P. Nickerson reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
Flail chest is defined by two or more consecutive ribs fractured in two places and a segment of chest wall unable to contribute to respiratory mechanics.
Benefits of surgical stabilization of flail chest reported in the heterogeneous literature include decreased ICU stay, lower rates of pneumonia, increased return to work, improved quality of life, and low surgical morbidity, Dr. Nickerson noted.
The retrospective analysis, included all patients (aged 30-85 years) who underwent surgical rib fracture stabilization for flail chest from August 2009 through February 2013 at the Mayo Clinic Hospital, St. Marys Campus, Rochester, Minn. In all, 23 patients had CFS, defined as all fractures involved in a flail segment undergoing full fixation, and 20 had PFS or at least one flail segment not completely repaired.
The CFS and PFS groups were similar with respect to median age (63 years vs. 58 years), sex (52% male vs. 65% male), operating time (186 minutes vs. 183 minutes), Injury Severity Score (20 vs. 17), hospital length of stay (10 days for both), ICU stay (1 day vs. 2 days), and narcotic use at 1-month follow-up (50% vs. 47%), according to the poster presentation.
At 6 months, there were no significant differences between the CFS and PFS groups in predicted vital capacity (86% vs. 76%), forced vital capacity (85% vs. 77%), forced expiratory volume in 1 second (71% vs. 78%), and FVC/FEV1 ratio (68% vs. 74%).
Rates of pneumonia were also similar in the two groups (21% vs. 20%; P = .39), reported Dr. Nickerson, a general surgeon in Rochester.
No patient or provider observed a significant chest wall deformity in either group during follow-up and no reoperations were required for incomplete repair in the PFS.
"Despite advances in surgical technique, not all flail segment rib fractures are accessible for repair via standard thoracotomy," the authors wrote. "Our data suggest that PFS is acceptable and that extending or creating additional incisions for exposure for CFS is unwarranted."
Additional research assessing late complications, performance/functional outcomes, and perceived benefits of the operation is needed to determine whether partial repair is truly comparable with full stabilization, coauthor Dr. Brian Kim, associate medical director Mayo Clinic Trauma Center, Rochester, said in an interview.
In their experience, 6 months’ postoperative follow-up has been sufficient with respect to bony healing, convalescence from pain, and monitoring of chest wall integrity.
He noted that some surgeons may be dissuaded from pursuing or recommending operative stabilization of a flail segment with fractures deemed outside the boundaries of repair, particularly if the injury is in the elderly or obese patient.
"The results of our study lend support to the practice of repairing the most anatomically disrupted and/or symptomatic fractures within the flail segment," he said. "Age and/or BMI [body mass index] are not absolute contraindications for flail segment stabilization in our practice."
Poster session moderator Dr. Alexander Eastman of University of Texas Southwestern Medical Center in Dallas, said the low patient numbers and short follow-up in the study make it difficult to draw big conclusions, other than the need for further research.
His group uses surgical fixation of flail chest for patients with instability and pain management for those patients who are difficult to wean from the ventilator.
"I think many surgeons still are skeptical of the data supporting fixation of flail chest," he noted in an interview.
Dr. Nickerson and his coauthors reported having no financial disclosures.
NAPLES, FLA. – Partial repair of flail segment rib fractures may suffice in patients whose anatomy precludes full stabilization, a small study suggests.
After a median follow-up of 189 days, only predicted total lung capacity at 3 months (90% vs. 72%; P = .02) and 6 months (94% vs. 75%; P = .038) significantly differed between patients undergoing complete flail stabilization (CFS) vs. partial flail stabilization (PFS).
No other differences in pulmonary and clinical outcomes were observed between the 43 patients, Dr. Terry P. Nickerson reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
Flail chest is defined by two or more consecutive ribs fractured in two places and a segment of chest wall unable to contribute to respiratory mechanics.
Benefits of surgical stabilization of flail chest reported in the heterogeneous literature include decreased ICU stay, lower rates of pneumonia, increased return to work, improved quality of life, and low surgical morbidity, Dr. Nickerson noted.
The retrospective analysis, included all patients (aged 30-85 years) who underwent surgical rib fracture stabilization for flail chest from August 2009 through February 2013 at the Mayo Clinic Hospital, St. Marys Campus, Rochester, Minn. In all, 23 patients had CFS, defined as all fractures involved in a flail segment undergoing full fixation, and 20 had PFS or at least one flail segment not completely repaired.
The CFS and PFS groups were similar with respect to median age (63 years vs. 58 years), sex (52% male vs. 65% male), operating time (186 minutes vs. 183 minutes), Injury Severity Score (20 vs. 17), hospital length of stay (10 days for both), ICU stay (1 day vs. 2 days), and narcotic use at 1-month follow-up (50% vs. 47%), according to the poster presentation.
At 6 months, there were no significant differences between the CFS and PFS groups in predicted vital capacity (86% vs. 76%), forced vital capacity (85% vs. 77%), forced expiratory volume in 1 second (71% vs. 78%), and FVC/FEV1 ratio (68% vs. 74%).
Rates of pneumonia were also similar in the two groups (21% vs. 20%; P = .39), reported Dr. Nickerson, a general surgeon in Rochester.
No patient or provider observed a significant chest wall deformity in either group during follow-up and no reoperations were required for incomplete repair in the PFS.
"Despite advances in surgical technique, not all flail segment rib fractures are accessible for repair via standard thoracotomy," the authors wrote. "Our data suggest that PFS is acceptable and that extending or creating additional incisions for exposure for CFS is unwarranted."
Additional research assessing late complications, performance/functional outcomes, and perceived benefits of the operation is needed to determine whether partial repair is truly comparable with full stabilization, coauthor Dr. Brian Kim, associate medical director Mayo Clinic Trauma Center, Rochester, said in an interview.
In their experience, 6 months’ postoperative follow-up has been sufficient with respect to bony healing, convalescence from pain, and monitoring of chest wall integrity.
He noted that some surgeons may be dissuaded from pursuing or recommending operative stabilization of a flail segment with fractures deemed outside the boundaries of repair, particularly if the injury is in the elderly or obese patient.
"The results of our study lend support to the practice of repairing the most anatomically disrupted and/or symptomatic fractures within the flail segment," he said. "Age and/or BMI [body mass index] are not absolute contraindications for flail segment stabilization in our practice."
Poster session moderator Dr. Alexander Eastman of University of Texas Southwestern Medical Center in Dallas, said the low patient numbers and short follow-up in the study make it difficult to draw big conclusions, other than the need for further research.
His group uses surgical fixation of flail chest for patients with instability and pain management for those patients who are difficult to wean from the ventilator.
"I think many surgeons still are skeptical of the data supporting fixation of flail chest," he noted in an interview.
Dr. Nickerson and his coauthors reported having no financial disclosures.
NAPLES, FLA. – Partial repair of flail segment rib fractures may suffice in patients whose anatomy precludes full stabilization, a small study suggests.
After a median follow-up of 189 days, only predicted total lung capacity at 3 months (90% vs. 72%; P = .02) and 6 months (94% vs. 75%; P = .038) significantly differed between patients undergoing complete flail stabilization (CFS) vs. partial flail stabilization (PFS).
No other differences in pulmonary and clinical outcomes were observed between the 43 patients, Dr. Terry P. Nickerson reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
Flail chest is defined by two or more consecutive ribs fractured in two places and a segment of chest wall unable to contribute to respiratory mechanics.
Benefits of surgical stabilization of flail chest reported in the heterogeneous literature include decreased ICU stay, lower rates of pneumonia, increased return to work, improved quality of life, and low surgical morbidity, Dr. Nickerson noted.
The retrospective analysis, included all patients (aged 30-85 years) who underwent surgical rib fracture stabilization for flail chest from August 2009 through February 2013 at the Mayo Clinic Hospital, St. Marys Campus, Rochester, Minn. In all, 23 patients had CFS, defined as all fractures involved in a flail segment undergoing full fixation, and 20 had PFS or at least one flail segment not completely repaired.
The CFS and PFS groups were similar with respect to median age (63 years vs. 58 years), sex (52% male vs. 65% male), operating time (186 minutes vs. 183 minutes), Injury Severity Score (20 vs. 17), hospital length of stay (10 days for both), ICU stay (1 day vs. 2 days), and narcotic use at 1-month follow-up (50% vs. 47%), according to the poster presentation.
At 6 months, there were no significant differences between the CFS and PFS groups in predicted vital capacity (86% vs. 76%), forced vital capacity (85% vs. 77%), forced expiratory volume in 1 second (71% vs. 78%), and FVC/FEV1 ratio (68% vs. 74%).
Rates of pneumonia were also similar in the two groups (21% vs. 20%; P = .39), reported Dr. Nickerson, a general surgeon in Rochester.
No patient or provider observed a significant chest wall deformity in either group during follow-up and no reoperations were required for incomplete repair in the PFS.
"Despite advances in surgical technique, not all flail segment rib fractures are accessible for repair via standard thoracotomy," the authors wrote. "Our data suggest that PFS is acceptable and that extending or creating additional incisions for exposure for CFS is unwarranted."
Additional research assessing late complications, performance/functional outcomes, and perceived benefits of the operation is needed to determine whether partial repair is truly comparable with full stabilization, coauthor Dr. Brian Kim, associate medical director Mayo Clinic Trauma Center, Rochester, said in an interview.
In their experience, 6 months’ postoperative follow-up has been sufficient with respect to bony healing, convalescence from pain, and monitoring of chest wall integrity.
He noted that some surgeons may be dissuaded from pursuing or recommending operative stabilization of a flail segment with fractures deemed outside the boundaries of repair, particularly if the injury is in the elderly or obese patient.
"The results of our study lend support to the practice of repairing the most anatomically disrupted and/or symptomatic fractures within the flail segment," he said. "Age and/or BMI [body mass index] are not absolute contraindications for flail segment stabilization in our practice."
Poster session moderator Dr. Alexander Eastman of University of Texas Southwestern Medical Center in Dallas, said the low patient numbers and short follow-up in the study make it difficult to draw big conclusions, other than the need for further research.
His group uses surgical fixation of flail chest for patients with instability and pain management for those patients who are difficult to wean from the ventilator.
"I think many surgeons still are skeptical of the data supporting fixation of flail chest," he noted in an interview.
Dr. Nickerson and his coauthors reported having no financial disclosures.
AT THE EAST SCIENTIFIC ASSEMBLY
Major finding: Only predicted total lung capacity at 3 months (90% vs. 72%; P = .02) and 6 months (94% vs. 75%; P = .038) significantly differed between CFS and PFS patients.
Data source: A retrospective study of 43 patients undergoing surgical rib fracture stabilization for flail chest.
Disclosures: Dr. Nickerson and his coauthors reported having no financial disclosures.
Regionalized trauma care boosts TBI survival
NAPLES, FLA. – A regional trauma system decreased hospital mortality for traumatic brain injury patients by 21% overall and by 26% for severe brain injuries, according to a partially retrospective study.
"Regionalization represents an additional step in attempting to improve outcomes for trauma patients. It can be defined as a tiered, integrated system that attempts to get the right patient to the right place at the right time," Dr. Michael L. Kelly said at the annual meeting of the Eastern Association for the Surgery of Trauma.
A few American studies and several more outside the United States have shown that regionalization decreases mortality in the general trauma population, but similar studies in traumatic brain injury (TBI) patients are scarce.
The Northern Ohio Trauma System (NOTS) was organized in 2010 and includes a transfer line to the Level I trauma center, a nontrauma hospital transfer protocol, a pilot scene triage protocol for emergency medical services, as well as the creation of a trauma-specific ICU in the level I center, explained Dr. Kelly, a sixth-year neurosurgery resident at the Cleveland Clinic, Ohio. The network includes the Level I MetroHealth Medical Center trauma center, two Level II trauma centers, and 12 nontrauma hospitals.
The three-tiered system mandates that TBI patients with a Glasgow Coma Scale (GCS) score of less than 12 and a traumatic mechanism, any penetrating head injury, or any open/depressed skull fracture, be sent to the Level I trauma center if they can be transferred within 15 minutes.
Patients with a GCS of 12-14 and a penetrating mechanism can be transferred to any trauma center, while those with lesser head injuries can remain at their hospital, unless their condition worsens.
For the study, Dr. Kelly and his coauthors analyzed data from 2008 through 2012 for 11,220 patients more than 14 years old with a TBI in the NOTS database, which was populated prospectively beginning in mid-2010.
Level I admissions increased significantly after NOTS by 10% for all TBIs (36% vs. 46%) and by 15% for severe TBIs with a head Abbreviated Injury Scale (AIS) score of 3 or more, he said. The percentage of patients who underwent transfers between NOTS institutions also increased significantly by 7% (7% vs. 14%) and 11% (10% vs. 21%), respectively.
Hospital mortality declined from 6.2% to 4.9% post-NOTS for all TBI patients (P = .005) and from 19% to 14% for the subset with severe TBI (P less than .0001). Mortality for trauma patients in general in Ohio has consistently hovered at 4% to 5% for the last decade, despite efforts to improve outcomes, including a 2002 law requiring the transfer of trauma patients to a validated trauma center, Dr. Kelly said.
In the post-NOTS period, craniotomies increased significantly for all TBIs (2% vs. 3%; P = .003) and for severe TBIs (6% vs. 8%; P = .02). The use of any neurosurgical procedure and hospital length of stay, however, remained constant for both groups in both time periods.
At baseline, the 6,713 post-NOTS patients were significantly older than the 4,507 pre-NOTS patients (55 years vs. 52 years) and less likely to be male (63% vs. 66%) or black (23% vs. 34%). GCS scores were similar (15 for both), as were Injury Severity Scores (14 for both) and the percentage of patients with a head AIS of 3 or more (34% post- vs. 32% pre-).
Multivariate regression analysis showed that the NOTS time period was an independent predictor of survival for all TBIs, with an odds ratio of 0.76, representing a 24% mortality reduction, and odds ratio of 0.72 for severe TBIs, representing a 28% mortality reduction.
"Of some importance, the multivariate model actually strengthened the effect of NOTS on mortality in our patient population," Dr. Kelly said.
Invited discussant Deborah Stein, medical director of neurotrauma critical care at the R Adams Cowley Shock Trauma Center at the University of Maryland Medical Center in Baltimore, described the study as an important contribution to the growing body of literature demonstrating that regionalization of care is associated with improved outcomes.
Dr. Stein went on to congratulate the NOTS members for participating in what was, at times, likely a contentious and difficult process: to bring a diverse group of hospitals to consensus about the best way to care for injured patients.
"Effecting change is difficult enough in a single division, department, or hospital," she remarked.
Following the formal presentation, audience members questioned whether the change in mortality was accomplished by simply shifting patients to nursing homes to die or whether it reflects a more aggressive surgical approach to TBI or improved critical care.
Dr. Kelly said that the creation of a trauma-specific ICU at MetroHealth, the uptick in transfers to the Level I trauma center, and the increased craniotomy rate all likely affected the outcome. Patient disposition data are still being analyzed, but hospice rates remained similar after NOTS was implemented, he said.
Dr. Kelly and his coauthors reported having no financial disclosures.
For nearly 50 years, data has been accumulating regarding the effects of regionalized trauma systems on postinjury outcomes, and the verdict is clear: Having a system in place that is prepared to rapidly transport the severely injured to a trauma center provides the best opportunity to reduce morbidity and mortality in these patients. While this is true in a general sense, a penetrating injury to the torso is not the same as a TBI, with each requiring different resources and expertise for optimal management.
The group at Cleveland MetroHealth in Ohio sought to answer the question of whether or not regionalization of trauma services would demonstrate a benefit in patients with TBI. Reviewing 4 years' worth of data that coincided at its midpoint with the implementation of the Northern Ohio Trauma System (NOTS), the authors demonstrate a significant reduction in mortality in brain-injured patients, including a 28% reduction in patients with severe TBI on multivariate analysis.
![]() |
Dr. Robert Winfield |
In the end, the commendation from Dr. Stein regarding the ability of the NOTS group, which comprises three hospitals from two health systems, to coalesce into a highly functioning regional trauma system is prescient and reflective of an impressive achievement for the authors. It is a reminder that in a time of scarce resources and competition for health care dollars, maintaining a focus on patient care through a cooperative and collaborative approach will ultimately yield the best results for all involved.
Dr. Robert Winfield is an ACS Fellow and the chair of the ACS Resident and Associate Society, and assistant professor of trauma and acute and critical care surgery at Washington University, St. Louis.
For nearly 50 years, data has been accumulating regarding the effects of regionalized trauma systems on postinjury outcomes, and the verdict is clear: Having a system in place that is prepared to rapidly transport the severely injured to a trauma center provides the best opportunity to reduce morbidity and mortality in these patients. While this is true in a general sense, a penetrating injury to the torso is not the same as a TBI, with each requiring different resources and expertise for optimal management.
The group at Cleveland MetroHealth in Ohio sought to answer the question of whether or not regionalization of trauma services would demonstrate a benefit in patients with TBI. Reviewing 4 years' worth of data that coincided at its midpoint with the implementation of the Northern Ohio Trauma System (NOTS), the authors demonstrate a significant reduction in mortality in brain-injured patients, including a 28% reduction in patients with severe TBI on multivariate analysis.
![]() |
Dr. Robert Winfield |
In the end, the commendation from Dr. Stein regarding the ability of the NOTS group, which comprises three hospitals from two health systems, to coalesce into a highly functioning regional trauma system is prescient and reflective of an impressive achievement for the authors. It is a reminder that in a time of scarce resources and competition for health care dollars, maintaining a focus on patient care through a cooperative and collaborative approach will ultimately yield the best results for all involved.
Dr. Robert Winfield is an ACS Fellow and the chair of the ACS Resident and Associate Society, and assistant professor of trauma and acute and critical care surgery at Washington University, St. Louis.
For nearly 50 years, data has been accumulating regarding the effects of regionalized trauma systems on postinjury outcomes, and the verdict is clear: Having a system in place that is prepared to rapidly transport the severely injured to a trauma center provides the best opportunity to reduce morbidity and mortality in these patients. While this is true in a general sense, a penetrating injury to the torso is not the same as a TBI, with each requiring different resources and expertise for optimal management.
The group at Cleveland MetroHealth in Ohio sought to answer the question of whether or not regionalization of trauma services would demonstrate a benefit in patients with TBI. Reviewing 4 years' worth of data that coincided at its midpoint with the implementation of the Northern Ohio Trauma System (NOTS), the authors demonstrate a significant reduction in mortality in brain-injured patients, including a 28% reduction in patients with severe TBI on multivariate analysis.
![]() |
Dr. Robert Winfield |
In the end, the commendation from Dr. Stein regarding the ability of the NOTS group, which comprises three hospitals from two health systems, to coalesce into a highly functioning regional trauma system is prescient and reflective of an impressive achievement for the authors. It is a reminder that in a time of scarce resources and competition for health care dollars, maintaining a focus on patient care through a cooperative and collaborative approach will ultimately yield the best results for all involved.
Dr. Robert Winfield is an ACS Fellow and the chair of the ACS Resident and Associate Society, and assistant professor of trauma and acute and critical care surgery at Washington University, St. Louis.
NAPLES, FLA. – A regional trauma system decreased hospital mortality for traumatic brain injury patients by 21% overall and by 26% for severe brain injuries, according to a partially retrospective study.
"Regionalization represents an additional step in attempting to improve outcomes for trauma patients. It can be defined as a tiered, integrated system that attempts to get the right patient to the right place at the right time," Dr. Michael L. Kelly said at the annual meeting of the Eastern Association for the Surgery of Trauma.
A few American studies and several more outside the United States have shown that regionalization decreases mortality in the general trauma population, but similar studies in traumatic brain injury (TBI) patients are scarce.
The Northern Ohio Trauma System (NOTS) was organized in 2010 and includes a transfer line to the Level I trauma center, a nontrauma hospital transfer protocol, a pilot scene triage protocol for emergency medical services, as well as the creation of a trauma-specific ICU in the level I center, explained Dr. Kelly, a sixth-year neurosurgery resident at the Cleveland Clinic, Ohio. The network includes the Level I MetroHealth Medical Center trauma center, two Level II trauma centers, and 12 nontrauma hospitals.
The three-tiered system mandates that TBI patients with a Glasgow Coma Scale (GCS) score of less than 12 and a traumatic mechanism, any penetrating head injury, or any open/depressed skull fracture, be sent to the Level I trauma center if they can be transferred within 15 minutes.
Patients with a GCS of 12-14 and a penetrating mechanism can be transferred to any trauma center, while those with lesser head injuries can remain at their hospital, unless their condition worsens.
For the study, Dr. Kelly and his coauthors analyzed data from 2008 through 2012 for 11,220 patients more than 14 years old with a TBI in the NOTS database, which was populated prospectively beginning in mid-2010.
Level I admissions increased significantly after NOTS by 10% for all TBIs (36% vs. 46%) and by 15% for severe TBIs with a head Abbreviated Injury Scale (AIS) score of 3 or more, he said. The percentage of patients who underwent transfers between NOTS institutions also increased significantly by 7% (7% vs. 14%) and 11% (10% vs. 21%), respectively.
Hospital mortality declined from 6.2% to 4.9% post-NOTS for all TBI patients (P = .005) and from 19% to 14% for the subset with severe TBI (P less than .0001). Mortality for trauma patients in general in Ohio has consistently hovered at 4% to 5% for the last decade, despite efforts to improve outcomes, including a 2002 law requiring the transfer of trauma patients to a validated trauma center, Dr. Kelly said.
In the post-NOTS period, craniotomies increased significantly for all TBIs (2% vs. 3%; P = .003) and for severe TBIs (6% vs. 8%; P = .02). The use of any neurosurgical procedure and hospital length of stay, however, remained constant for both groups in both time periods.
At baseline, the 6,713 post-NOTS patients were significantly older than the 4,507 pre-NOTS patients (55 years vs. 52 years) and less likely to be male (63% vs. 66%) or black (23% vs. 34%). GCS scores were similar (15 for both), as were Injury Severity Scores (14 for both) and the percentage of patients with a head AIS of 3 or more (34% post- vs. 32% pre-).
Multivariate regression analysis showed that the NOTS time period was an independent predictor of survival for all TBIs, with an odds ratio of 0.76, representing a 24% mortality reduction, and odds ratio of 0.72 for severe TBIs, representing a 28% mortality reduction.
"Of some importance, the multivariate model actually strengthened the effect of NOTS on mortality in our patient population," Dr. Kelly said.
Invited discussant Deborah Stein, medical director of neurotrauma critical care at the R Adams Cowley Shock Trauma Center at the University of Maryland Medical Center in Baltimore, described the study as an important contribution to the growing body of literature demonstrating that regionalization of care is associated with improved outcomes.
Dr. Stein went on to congratulate the NOTS members for participating in what was, at times, likely a contentious and difficult process: to bring a diverse group of hospitals to consensus about the best way to care for injured patients.
"Effecting change is difficult enough in a single division, department, or hospital," she remarked.
Following the formal presentation, audience members questioned whether the change in mortality was accomplished by simply shifting patients to nursing homes to die or whether it reflects a more aggressive surgical approach to TBI or improved critical care.
Dr. Kelly said that the creation of a trauma-specific ICU at MetroHealth, the uptick in transfers to the Level I trauma center, and the increased craniotomy rate all likely affected the outcome. Patient disposition data are still being analyzed, but hospice rates remained similar after NOTS was implemented, he said.
Dr. Kelly and his coauthors reported having no financial disclosures.
NAPLES, FLA. – A regional trauma system decreased hospital mortality for traumatic brain injury patients by 21% overall and by 26% for severe brain injuries, according to a partially retrospective study.
"Regionalization represents an additional step in attempting to improve outcomes for trauma patients. It can be defined as a tiered, integrated system that attempts to get the right patient to the right place at the right time," Dr. Michael L. Kelly said at the annual meeting of the Eastern Association for the Surgery of Trauma.
A few American studies and several more outside the United States have shown that regionalization decreases mortality in the general trauma population, but similar studies in traumatic brain injury (TBI) patients are scarce.
The Northern Ohio Trauma System (NOTS) was organized in 2010 and includes a transfer line to the Level I trauma center, a nontrauma hospital transfer protocol, a pilot scene triage protocol for emergency medical services, as well as the creation of a trauma-specific ICU in the level I center, explained Dr. Kelly, a sixth-year neurosurgery resident at the Cleveland Clinic, Ohio. The network includes the Level I MetroHealth Medical Center trauma center, two Level II trauma centers, and 12 nontrauma hospitals.
The three-tiered system mandates that TBI patients with a Glasgow Coma Scale (GCS) score of less than 12 and a traumatic mechanism, any penetrating head injury, or any open/depressed skull fracture, be sent to the Level I trauma center if they can be transferred within 15 minutes.
Patients with a GCS of 12-14 and a penetrating mechanism can be transferred to any trauma center, while those with lesser head injuries can remain at their hospital, unless their condition worsens.
For the study, Dr. Kelly and his coauthors analyzed data from 2008 through 2012 for 11,220 patients more than 14 years old with a TBI in the NOTS database, which was populated prospectively beginning in mid-2010.
Level I admissions increased significantly after NOTS by 10% for all TBIs (36% vs. 46%) and by 15% for severe TBIs with a head Abbreviated Injury Scale (AIS) score of 3 or more, he said. The percentage of patients who underwent transfers between NOTS institutions also increased significantly by 7% (7% vs. 14%) and 11% (10% vs. 21%), respectively.
Hospital mortality declined from 6.2% to 4.9% post-NOTS for all TBI patients (P = .005) and from 19% to 14% for the subset with severe TBI (P less than .0001). Mortality for trauma patients in general in Ohio has consistently hovered at 4% to 5% for the last decade, despite efforts to improve outcomes, including a 2002 law requiring the transfer of trauma patients to a validated trauma center, Dr. Kelly said.
In the post-NOTS period, craniotomies increased significantly for all TBIs (2% vs. 3%; P = .003) and for severe TBIs (6% vs. 8%; P = .02). The use of any neurosurgical procedure and hospital length of stay, however, remained constant for both groups in both time periods.
At baseline, the 6,713 post-NOTS patients were significantly older than the 4,507 pre-NOTS patients (55 years vs. 52 years) and less likely to be male (63% vs. 66%) or black (23% vs. 34%). GCS scores were similar (15 for both), as were Injury Severity Scores (14 for both) and the percentage of patients with a head AIS of 3 or more (34% post- vs. 32% pre-).
Multivariate regression analysis showed that the NOTS time period was an independent predictor of survival for all TBIs, with an odds ratio of 0.76, representing a 24% mortality reduction, and odds ratio of 0.72 for severe TBIs, representing a 28% mortality reduction.
"Of some importance, the multivariate model actually strengthened the effect of NOTS on mortality in our patient population," Dr. Kelly said.
Invited discussant Deborah Stein, medical director of neurotrauma critical care at the R Adams Cowley Shock Trauma Center at the University of Maryland Medical Center in Baltimore, described the study as an important contribution to the growing body of literature demonstrating that regionalization of care is associated with improved outcomes.
Dr. Stein went on to congratulate the NOTS members for participating in what was, at times, likely a contentious and difficult process: to bring a diverse group of hospitals to consensus about the best way to care for injured patients.
"Effecting change is difficult enough in a single division, department, or hospital," she remarked.
Following the formal presentation, audience members questioned whether the change in mortality was accomplished by simply shifting patients to nursing homes to die or whether it reflects a more aggressive surgical approach to TBI or improved critical care.
Dr. Kelly said that the creation of a trauma-specific ICU at MetroHealth, the uptick in transfers to the Level I trauma center, and the increased craniotomy rate all likely affected the outcome. Patient disposition data are still being analyzed, but hospice rates remained similar after NOTS was implemented, he said.
Dr. Kelly and his coauthors reported having no financial disclosures.
AT THE EAST SCIENTIFIC ASSEMBLY
Major finding: Hospital mortality was 6.2% pre-NOTS vs. 4.9% post-NOTS for all TBIs (P = .005) and 19% vs. 14% for severe TBIs (P less than .001).
Data source: A partially retrospective analysis of 11,220 TBI trauma patients.
Disclosures: Dr. Kelly and his coauthors reported having no financial disclosures.
Inpatient safety efforts yield mixed results
Adverse events decreased over the last decade for Medicare inpatients with acute myocardial infarction or heart failure but barely changed for those with pneumonia or conditions requiring surgery, according to an analysis of a Medicare database.
The improvements likely translated to 81,000 fewer adverse events for patients with acute MI (AMI) and heart failure (HF) from 2010 to 2011 alone, according to the study published Jan. 22 in the New England Journal of Medicine.
"Although this suggests that national efforts focused on patient safety have made some inroads, the lack of reductions across the board is disappointing," Yun Wang, Ph.D., of the Harvard School of Public Health, Boston, and his colleagues wrote.
The researchers examined whether hospitalized patients are any better off in light of the current focus on patient safety, including the launch of initiatives such as the American College of Surgeons’ National Surgical Quality Improvement Program and the federal government’s Surgical Infection Prevention Project.
They used three composite outcomes measures: the rate of occurrence for adverse events for which patients were at risk (for instance, only patients receiving warfarin were at risk for warfarin-related events); the proportion of patients with one or more adverse events; and the number of adverse events per 1,000 hospitalizations. They analyzed data on 61,523 patients who were discharged from 4,372 hospitals; the data were extracted from the Medicare Patient Safety Monitoring System database (N. Engl. J. Med. 2014:370;341-51).
The 61,523 patients included 11,399 with AMI, 15,374 with HF, 18,269 with pneumonia, and 16,481 with conditions requiring surgery. Postsurgical patients largely were being treated for joint replacement procedures and other osteoarthritis-related conditions, femur fracture, colon cancer, post-AMI procedures, or other forms of chronic ischemic heart disease.
From 2005-2006 to 2010-2011, AMI and HF patients saw a 1.3 percentage point decline in the rate of adverse events, from 5% to 3.7%. The proportion who had one or more such events decreased from 26% to 19%. The number of adverse events per 1,000 hospitalizations declined from 402 to 262 for AMI patients and from 235 to 167 for HF patients.
Infection-related and drug-related adverse events declined significantly in heart attack and HF patients. There was also a substantial improvement in postprocedure events in HF patients.
Postsurgical patients experienced slight increases in all three outcomes measures, in particular, increases in infection-related and postprocedural events such as venous thromboembolism, and cardiac and catheter-related events. The number of events per 1,000 hospitalizations for pneumonia patients increased insignificantly from 216 to 223. For postsurgical patients, the number of events increased insignificantly from 352/1,000 to 368/1,000.
Patients who had adverse events had significantly longer hospital stays and were at higher risk for death. As the number of adverse events increased, so did the risk of death.
The authors noted that declines in events for AMI and HF patients might be a reflection of the numerous efforts and initiatives to improve care in those two conditions.
But they also found that concerted efforts to improve safety did not necessarily work. There was an increase in pressure ulcers in postsurgical patients, and no decline in ventilator-associated pneumonia in most patients, even though there have been initiatives focused on those conditions.
"Our finding of an increased adverse-event rate among surgical patients indicates a continuing challenge and identifies an important target for patient-safety initiatives," the researchers said.
The study was supported by the Agency for Healthcare Research and Quality as well as academic and federal grants. Dr. Wang was a consultant to and other researchers were employees of the research firm Qualidigm and participated in the analysis. One of the researchers, Dr. Harlan M. Krumholz, disclosed being on a scientific advisory board for UnitedHealthcare and receiving grant money from Medtronic.
On Twitter @aliciaault
Adverse events decreased over the last decade for Medicare inpatients with acute myocardial infarction or heart failure but barely changed for those with pneumonia or conditions requiring surgery, according to an analysis of a Medicare database.
The improvements likely translated to 81,000 fewer adverse events for patients with acute MI (AMI) and heart failure (HF) from 2010 to 2011 alone, according to the study published Jan. 22 in the New England Journal of Medicine.
"Although this suggests that national efforts focused on patient safety have made some inroads, the lack of reductions across the board is disappointing," Yun Wang, Ph.D., of the Harvard School of Public Health, Boston, and his colleagues wrote.
The researchers examined whether hospitalized patients are any better off in light of the current focus on patient safety, including the launch of initiatives such as the American College of Surgeons’ National Surgical Quality Improvement Program and the federal government’s Surgical Infection Prevention Project.
They used three composite outcomes measures: the rate of occurrence for adverse events for which patients were at risk (for instance, only patients receiving warfarin were at risk for warfarin-related events); the proportion of patients with one or more adverse events; and the number of adverse events per 1,000 hospitalizations. They analyzed data on 61,523 patients who were discharged from 4,372 hospitals; the data were extracted from the Medicare Patient Safety Monitoring System database (N. Engl. J. Med. 2014:370;341-51).
The 61,523 patients included 11,399 with AMI, 15,374 with HF, 18,269 with pneumonia, and 16,481 with conditions requiring surgery. Postsurgical patients largely were being treated for joint replacement procedures and other osteoarthritis-related conditions, femur fracture, colon cancer, post-AMI procedures, or other forms of chronic ischemic heart disease.
From 2005-2006 to 2010-2011, AMI and HF patients saw a 1.3 percentage point decline in the rate of adverse events, from 5% to 3.7%. The proportion who had one or more such events decreased from 26% to 19%. The number of adverse events per 1,000 hospitalizations declined from 402 to 262 for AMI patients and from 235 to 167 for HF patients.
Infection-related and drug-related adverse events declined significantly in heart attack and HF patients. There was also a substantial improvement in postprocedure events in HF patients.
Postsurgical patients experienced slight increases in all three outcomes measures, in particular, increases in infection-related and postprocedural events such as venous thromboembolism, and cardiac and catheter-related events. The number of events per 1,000 hospitalizations for pneumonia patients increased insignificantly from 216 to 223. For postsurgical patients, the number of events increased insignificantly from 352/1,000 to 368/1,000.
Patients who had adverse events had significantly longer hospital stays and were at higher risk for death. As the number of adverse events increased, so did the risk of death.
The authors noted that declines in events for AMI and HF patients might be a reflection of the numerous efforts and initiatives to improve care in those two conditions.
But they also found that concerted efforts to improve safety did not necessarily work. There was an increase in pressure ulcers in postsurgical patients, and no decline in ventilator-associated pneumonia in most patients, even though there have been initiatives focused on those conditions.
"Our finding of an increased adverse-event rate among surgical patients indicates a continuing challenge and identifies an important target for patient-safety initiatives," the researchers said.
The study was supported by the Agency for Healthcare Research and Quality as well as academic and federal grants. Dr. Wang was a consultant to and other researchers were employees of the research firm Qualidigm and participated in the analysis. One of the researchers, Dr. Harlan M. Krumholz, disclosed being on a scientific advisory board for UnitedHealthcare and receiving grant money from Medtronic.
On Twitter @aliciaault
Adverse events decreased over the last decade for Medicare inpatients with acute myocardial infarction or heart failure but barely changed for those with pneumonia or conditions requiring surgery, according to an analysis of a Medicare database.
The improvements likely translated to 81,000 fewer adverse events for patients with acute MI (AMI) and heart failure (HF) from 2010 to 2011 alone, according to the study published Jan. 22 in the New England Journal of Medicine.
"Although this suggests that national efforts focused on patient safety have made some inroads, the lack of reductions across the board is disappointing," Yun Wang, Ph.D., of the Harvard School of Public Health, Boston, and his colleagues wrote.
The researchers examined whether hospitalized patients are any better off in light of the current focus on patient safety, including the launch of initiatives such as the American College of Surgeons’ National Surgical Quality Improvement Program and the federal government’s Surgical Infection Prevention Project.
They used three composite outcomes measures: the rate of occurrence for adverse events for which patients were at risk (for instance, only patients receiving warfarin were at risk for warfarin-related events); the proportion of patients with one or more adverse events; and the number of adverse events per 1,000 hospitalizations. They analyzed data on 61,523 patients who were discharged from 4,372 hospitals; the data were extracted from the Medicare Patient Safety Monitoring System database (N. Engl. J. Med. 2014:370;341-51).
The 61,523 patients included 11,399 with AMI, 15,374 with HF, 18,269 with pneumonia, and 16,481 with conditions requiring surgery. Postsurgical patients largely were being treated for joint replacement procedures and other osteoarthritis-related conditions, femur fracture, colon cancer, post-AMI procedures, or other forms of chronic ischemic heart disease.
From 2005-2006 to 2010-2011, AMI and HF patients saw a 1.3 percentage point decline in the rate of adverse events, from 5% to 3.7%. The proportion who had one or more such events decreased from 26% to 19%. The number of adverse events per 1,000 hospitalizations declined from 402 to 262 for AMI patients and from 235 to 167 for HF patients.
Infection-related and drug-related adverse events declined significantly in heart attack and HF patients. There was also a substantial improvement in postprocedure events in HF patients.
Postsurgical patients experienced slight increases in all three outcomes measures, in particular, increases in infection-related and postprocedural events such as venous thromboembolism, and cardiac and catheter-related events. The number of events per 1,000 hospitalizations for pneumonia patients increased insignificantly from 216 to 223. For postsurgical patients, the number of events increased insignificantly from 352/1,000 to 368/1,000.
Patients who had adverse events had significantly longer hospital stays and were at higher risk for death. As the number of adverse events increased, so did the risk of death.
The authors noted that declines in events for AMI and HF patients might be a reflection of the numerous efforts and initiatives to improve care in those two conditions.
But they also found that concerted efforts to improve safety did not necessarily work. There was an increase in pressure ulcers in postsurgical patients, and no decline in ventilator-associated pneumonia in most patients, even though there have been initiatives focused on those conditions.
"Our finding of an increased adverse-event rate among surgical patients indicates a continuing challenge and identifies an important target for patient-safety initiatives," the researchers said.
The study was supported by the Agency for Healthcare Research and Quality as well as academic and federal grants. Dr. Wang was a consultant to and other researchers were employees of the research firm Qualidigm and participated in the analysis. One of the researchers, Dr. Harlan M. Krumholz, disclosed being on a scientific advisory board for UnitedHealthcare and receiving grant money from Medtronic.
On Twitter @aliciaault
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Major finding: At least 81,000 adverse events were avoided in a single year in patients hospitalized for acute MI and heart failure.
Data source: A retrospective analysis of data from 61,523 patients in the Medicare Patient Safety Monitoring System.
Disclosures: The study was supported by the Agency for Healthcare Research and Quality as well as academic and federal grants. Dr. Wang was a consultant to and other researchers were employees of the research firm Qualidigm and participated in the analysis. One of the researchers, Dr. Harlan M. Krumholz, disclosed being on a scientific advisory board for UnitedHealthcare and receiving grant money from Medtronic.
Give calcium before and after thyroidectomies in gastric bypass patients
Patients who’ve had roux-en-Y gastric bypasses have higher incidences of recalcitrant, symptomatic hypocalcemia after thyroidectomies and spend more time in the hospital afterward for intravenous calcium, according to investigators from the Massachusetts General Hospital in Boston.
Because of that, "it is necessary to ensure that all patients with prior RYGBPs [roux-en-Y gastric bypasses] [take] oral calcium supplements before thyroidectomy," and afterward "recalcitrant, postoperative hypocalcemia should be anticipated, calcium levels closely monitored, and early calcium and vitamin D supplementation initiated preemptively," said the researchers, led by endocrine surgery fellow Dr. Travis McKenzie (Surgery 2013;154:1300-6).
Based on the findings, "we recommend starting oral calcium as early as possible in the evaluation phase before thyroidectomy," supplementing with 1.5-2 gm/day of oral calcium, as per American Society for Metabolic and Bariatric Surgery guidelines. "We prefer calcium citrate, because it has better bioavailability when compared with calcium carbonate after RYGBP." Vitamin D–deficient patients should also get calcitriol (0.25 mcg orally twice daily) for 7 days before the operation, they said.
The team compared outcomes in 19 patients who underwent thyroidectomies an average of 53 months after gastric bypass to outcomes in 38 age-, sex-, and body mass index–matched controls, with pre-bypass BMI matched in the study group to pre-thyroidectomy BMI in the control group, about 45 kg/m2 in both cases. Almost all of the patients in both arms had total thyroidectomies, and thyroid malignancies were found in about half of each.
Overall, eight (42%) of the previous-bypass patients, but none of the controls, developed hypocalcemia after thyroid surgery (P less than .01) and four (21%) – but, again, no controls – required intravenous calcium (P less than .01). The need for intravenous calcium, in turn, led to longer hospital stays in the bypass group (2.2 vs. 1.2 days; P = .02). In the bypass group, about 4 patients, 20%, who were on calcium and vitamin D supplements before surgery developed postop symptomatic hypocalcemia, vs. 11 (58%) of those who were not on supplements (P = .18).
Among the 16 bypass patients and 33 controls who did not have intentional parathyroidectomies as part of their operations, both symptomatic postop hypocalcemia (6 patients; 38% vs 0%; P less than.01) and use of intravenous calcium (3 patients;19% vs. 0%; P = .03) were higher in the bypass group.
In addition to preop calcium supplements, all Mass General patients with previous RYGBPs are now started immediately on postop calcium citrate with vitamin D3 (200-mg elemental calcium/tablet), two tablets four times daily, which is continued indefinitely. "We do not feel that higher dosing will increase efficacy as absorption is limited beyond these doses." Patients also get post-op calcitriol (0.25 mcg orally twice daily) for at least a week, and stopped at that point only if there are no symptoms of hypocalcemia, the investigators said.
The problem "is likely multifactorial, including relative hypoparathyroidism after thyroidectomy in the setting of malabsorptive enteric anatomy and metabolic bone disease," they noted.
"An argument has been made that PTH [parathyroid hormone] testing may allow early identification of patients at risk for hypocalcemia after thyroidectomy, prompting early initiation of calcium and calcitriol when PTH is less than [10 mcg/L]. This finding would not change our immediate management since all patients after thyroidectomy in the setting of previous RYGBP are now maintained on both calcium and calcitriol postoperatively. Furthermore, following PTH levels in this unique patient population may not be accurate because secondary hyperparathyroidism is frequently present after RYGBP. In our study group, patients with symptomatic hypocalcemia had an average PTH of [34 mcg/L]," the investigators said.
Patients were, on average, about 50 years old in both study arms, and more than 90% of the subjects were women. No one developed permanent hypoparathyroidism in either arm.
The work was funded in part by the National Cancer Institute and the Massachusetts General Hospital Department of Surgery. Investigator disclosures were not available.
This article focuses on the challenges associated with the management of transient hypocalcemia after thyroidectomy in patients with a history of a gastric bypass. While for most patients, this is a transient problem, in a subset of patients, their hypoparathyroidism ends up being permanent. While, thankfully, permanent hypoparathyroidism is a rare complication after thyroidectomy, in this cohort of patients, it can be a disastrous situation. Because of the altered absorption of calcium and vitamin D, permanent hypoparathyroidism can be almost impossible to manage effectively in this population. This is something that both bariatric and endocrine surgeons need to know and think about.
![]() |
|
Our institution took care of a patient who had hypoparathyroidism following a thyroidectomy 10 years earlier. She was well managed on calcium and vitamin D, but then had a gastric bypass; the surgeon didn’t realize her past medical history made her a poor candidate. Afterward, she had to be repeatedly admitted for intravenous calcium, as her symptoms could not be controlled with even massive doses of calcium and vitamin D. Ultimately, she needed to have her gastric bypass reversed so she could absorb oral calcium more effectively.
For many patients with nodular thyroid disease, we need to decide whether to do a lobectomy or remove the whole thyroid. I think surgeons can get a bit cavalier about total thyroidectomies because the risk of hypoparathyroidism is very low in most patients, but the risk/benefit ratio is clearly different in this population. Because of this concern, we have a higher threshold to do total thyroidectomies in patients with a history of a gastric bypass. We specifically ask on our endocrine surgery in-take forms if patients have had a gastric bypass; we don’t assume patients will self-report, because it’s often something they want to keep private. When we see that have had a bypass, it frames our conversation about whether or not to have surgery, and the extent of surgery.
Dr. Rebecca Sippel is an associate professor and chief of the section of endocrine surgery at the University of Wisconsin (Madison). She is also an editorial adviser for Surgery News.
This article focuses on the challenges associated with the management of transient hypocalcemia after thyroidectomy in patients with a history of a gastric bypass. While for most patients, this is a transient problem, in a subset of patients, their hypoparathyroidism ends up being permanent. While, thankfully, permanent hypoparathyroidism is a rare complication after thyroidectomy, in this cohort of patients, it can be a disastrous situation. Because of the altered absorption of calcium and vitamin D, permanent hypoparathyroidism can be almost impossible to manage effectively in this population. This is something that both bariatric and endocrine surgeons need to know and think about.
![]() |
|
Our institution took care of a patient who had hypoparathyroidism following a thyroidectomy 10 years earlier. She was well managed on calcium and vitamin D, but then had a gastric bypass; the surgeon didn’t realize her past medical history made her a poor candidate. Afterward, she had to be repeatedly admitted for intravenous calcium, as her symptoms could not be controlled with even massive doses of calcium and vitamin D. Ultimately, she needed to have her gastric bypass reversed so she could absorb oral calcium more effectively.
For many patients with nodular thyroid disease, we need to decide whether to do a lobectomy or remove the whole thyroid. I think surgeons can get a bit cavalier about total thyroidectomies because the risk of hypoparathyroidism is very low in most patients, but the risk/benefit ratio is clearly different in this population. Because of this concern, we have a higher threshold to do total thyroidectomies in patients with a history of a gastric bypass. We specifically ask on our endocrine surgery in-take forms if patients have had a gastric bypass; we don’t assume patients will self-report, because it’s often something they want to keep private. When we see that have had a bypass, it frames our conversation about whether or not to have surgery, and the extent of surgery.
Dr. Rebecca Sippel is an associate professor and chief of the section of endocrine surgery at the University of Wisconsin (Madison). She is also an editorial adviser for Surgery News.
This article focuses on the challenges associated with the management of transient hypocalcemia after thyroidectomy in patients with a history of a gastric bypass. While for most patients, this is a transient problem, in a subset of patients, their hypoparathyroidism ends up being permanent. While, thankfully, permanent hypoparathyroidism is a rare complication after thyroidectomy, in this cohort of patients, it can be a disastrous situation. Because of the altered absorption of calcium and vitamin D, permanent hypoparathyroidism can be almost impossible to manage effectively in this population. This is something that both bariatric and endocrine surgeons need to know and think about.
![]() |
|
Our institution took care of a patient who had hypoparathyroidism following a thyroidectomy 10 years earlier. She was well managed on calcium and vitamin D, but then had a gastric bypass; the surgeon didn’t realize her past medical history made her a poor candidate. Afterward, she had to be repeatedly admitted for intravenous calcium, as her symptoms could not be controlled with even massive doses of calcium and vitamin D. Ultimately, she needed to have her gastric bypass reversed so she could absorb oral calcium more effectively.
For many patients with nodular thyroid disease, we need to decide whether to do a lobectomy or remove the whole thyroid. I think surgeons can get a bit cavalier about total thyroidectomies because the risk of hypoparathyroidism is very low in most patients, but the risk/benefit ratio is clearly different in this population. Because of this concern, we have a higher threshold to do total thyroidectomies in patients with a history of a gastric bypass. We specifically ask on our endocrine surgery in-take forms if patients have had a gastric bypass; we don’t assume patients will self-report, because it’s often something they want to keep private. When we see that have had a bypass, it frames our conversation about whether or not to have surgery, and the extent of surgery.
Dr. Rebecca Sippel is an associate professor and chief of the section of endocrine surgery at the University of Wisconsin (Madison). She is also an editorial adviser for Surgery News.
Patients who’ve had roux-en-Y gastric bypasses have higher incidences of recalcitrant, symptomatic hypocalcemia after thyroidectomies and spend more time in the hospital afterward for intravenous calcium, according to investigators from the Massachusetts General Hospital in Boston.
Because of that, "it is necessary to ensure that all patients with prior RYGBPs [roux-en-Y gastric bypasses] [take] oral calcium supplements before thyroidectomy," and afterward "recalcitrant, postoperative hypocalcemia should be anticipated, calcium levels closely monitored, and early calcium and vitamin D supplementation initiated preemptively," said the researchers, led by endocrine surgery fellow Dr. Travis McKenzie (Surgery 2013;154:1300-6).
Based on the findings, "we recommend starting oral calcium as early as possible in the evaluation phase before thyroidectomy," supplementing with 1.5-2 gm/day of oral calcium, as per American Society for Metabolic and Bariatric Surgery guidelines. "We prefer calcium citrate, because it has better bioavailability when compared with calcium carbonate after RYGBP." Vitamin D–deficient patients should also get calcitriol (0.25 mcg orally twice daily) for 7 days before the operation, they said.
The team compared outcomes in 19 patients who underwent thyroidectomies an average of 53 months after gastric bypass to outcomes in 38 age-, sex-, and body mass index–matched controls, with pre-bypass BMI matched in the study group to pre-thyroidectomy BMI in the control group, about 45 kg/m2 in both cases. Almost all of the patients in both arms had total thyroidectomies, and thyroid malignancies were found in about half of each.
Overall, eight (42%) of the previous-bypass patients, but none of the controls, developed hypocalcemia after thyroid surgery (P less than .01) and four (21%) – but, again, no controls – required intravenous calcium (P less than .01). The need for intravenous calcium, in turn, led to longer hospital stays in the bypass group (2.2 vs. 1.2 days; P = .02). In the bypass group, about 4 patients, 20%, who were on calcium and vitamin D supplements before surgery developed postop symptomatic hypocalcemia, vs. 11 (58%) of those who were not on supplements (P = .18).
Among the 16 bypass patients and 33 controls who did not have intentional parathyroidectomies as part of their operations, both symptomatic postop hypocalcemia (6 patients; 38% vs 0%; P less than.01) and use of intravenous calcium (3 patients;19% vs. 0%; P = .03) were higher in the bypass group.
In addition to preop calcium supplements, all Mass General patients with previous RYGBPs are now started immediately on postop calcium citrate with vitamin D3 (200-mg elemental calcium/tablet), two tablets four times daily, which is continued indefinitely. "We do not feel that higher dosing will increase efficacy as absorption is limited beyond these doses." Patients also get post-op calcitriol (0.25 mcg orally twice daily) for at least a week, and stopped at that point only if there are no symptoms of hypocalcemia, the investigators said.
The problem "is likely multifactorial, including relative hypoparathyroidism after thyroidectomy in the setting of malabsorptive enteric anatomy and metabolic bone disease," they noted.
"An argument has been made that PTH [parathyroid hormone] testing may allow early identification of patients at risk for hypocalcemia after thyroidectomy, prompting early initiation of calcium and calcitriol when PTH is less than [10 mcg/L]. This finding would not change our immediate management since all patients after thyroidectomy in the setting of previous RYGBP are now maintained on both calcium and calcitriol postoperatively. Furthermore, following PTH levels in this unique patient population may not be accurate because secondary hyperparathyroidism is frequently present after RYGBP. In our study group, patients with symptomatic hypocalcemia had an average PTH of [34 mcg/L]," the investigators said.
Patients were, on average, about 50 years old in both study arms, and more than 90% of the subjects were women. No one developed permanent hypoparathyroidism in either arm.
The work was funded in part by the National Cancer Institute and the Massachusetts General Hospital Department of Surgery. Investigator disclosures were not available.
Patients who’ve had roux-en-Y gastric bypasses have higher incidences of recalcitrant, symptomatic hypocalcemia after thyroidectomies and spend more time in the hospital afterward for intravenous calcium, according to investigators from the Massachusetts General Hospital in Boston.
Because of that, "it is necessary to ensure that all patients with prior RYGBPs [roux-en-Y gastric bypasses] [take] oral calcium supplements before thyroidectomy," and afterward "recalcitrant, postoperative hypocalcemia should be anticipated, calcium levels closely monitored, and early calcium and vitamin D supplementation initiated preemptively," said the researchers, led by endocrine surgery fellow Dr. Travis McKenzie (Surgery 2013;154:1300-6).
Based on the findings, "we recommend starting oral calcium as early as possible in the evaluation phase before thyroidectomy," supplementing with 1.5-2 gm/day of oral calcium, as per American Society for Metabolic and Bariatric Surgery guidelines. "We prefer calcium citrate, because it has better bioavailability when compared with calcium carbonate after RYGBP." Vitamin D–deficient patients should also get calcitriol (0.25 mcg orally twice daily) for 7 days before the operation, they said.
The team compared outcomes in 19 patients who underwent thyroidectomies an average of 53 months after gastric bypass to outcomes in 38 age-, sex-, and body mass index–matched controls, with pre-bypass BMI matched in the study group to pre-thyroidectomy BMI in the control group, about 45 kg/m2 in both cases. Almost all of the patients in both arms had total thyroidectomies, and thyroid malignancies were found in about half of each.
Overall, eight (42%) of the previous-bypass patients, but none of the controls, developed hypocalcemia after thyroid surgery (P less than .01) and four (21%) – but, again, no controls – required intravenous calcium (P less than .01). The need for intravenous calcium, in turn, led to longer hospital stays in the bypass group (2.2 vs. 1.2 days; P = .02). In the bypass group, about 4 patients, 20%, who were on calcium and vitamin D supplements before surgery developed postop symptomatic hypocalcemia, vs. 11 (58%) of those who were not on supplements (P = .18).
Among the 16 bypass patients and 33 controls who did not have intentional parathyroidectomies as part of their operations, both symptomatic postop hypocalcemia (6 patients; 38% vs 0%; P less than.01) and use of intravenous calcium (3 patients;19% vs. 0%; P = .03) were higher in the bypass group.
In addition to preop calcium supplements, all Mass General patients with previous RYGBPs are now started immediately on postop calcium citrate with vitamin D3 (200-mg elemental calcium/tablet), two tablets four times daily, which is continued indefinitely. "We do not feel that higher dosing will increase efficacy as absorption is limited beyond these doses." Patients also get post-op calcitriol (0.25 mcg orally twice daily) for at least a week, and stopped at that point only if there are no symptoms of hypocalcemia, the investigators said.
The problem "is likely multifactorial, including relative hypoparathyroidism after thyroidectomy in the setting of malabsorptive enteric anatomy and metabolic bone disease," they noted.
"An argument has been made that PTH [parathyroid hormone] testing may allow early identification of patients at risk for hypocalcemia after thyroidectomy, prompting early initiation of calcium and calcitriol when PTH is less than [10 mcg/L]. This finding would not change our immediate management since all patients after thyroidectomy in the setting of previous RYGBP are now maintained on both calcium and calcitriol postoperatively. Furthermore, following PTH levels in this unique patient population may not be accurate because secondary hyperparathyroidism is frequently present after RYGBP. In our study group, patients with symptomatic hypocalcemia had an average PTH of [34 mcg/L]," the investigators said.
Patients were, on average, about 50 years old in both study arms, and more than 90% of the subjects were women. No one developed permanent hypoparathyroidism in either arm.
The work was funded in part by the National Cancer Institute and the Massachusetts General Hospital Department of Surgery. Investigator disclosures were not available.
FROM SURGERY
Major finding: Almost half (42%) of patients who have had gastric bypasses develop recalcitrant, symptomatic hypocalcemia after thyroidectomies. Patients who have not had gastric bypasses do not become symptomatically hypocalcemic.
Data source: A retrospective study of 57 thyroidectomy patients
Disclosures: The work was funded in part by the National Cancer Institute and Massachusetts General Hospital. Investigator disclosures were not available.
Colorectal cancer incidence rising sharply among younger adults
SAN FRANCISCO – The incidence of colorectal cancer is rising sharply among younger adults in the United States, a study showed.
Researchers analyzed Surveillance, Epidemiology, and End Results (SEER) data for 383,241 patients in whom colorectal cancer was diagnosed between 1975 and 2010.
The results showed that the age-adjusted incidence rate of colorectal cancer fell steadily among patients aged 50 years and older at diagnosis, lead author Dr. Christina E. Bailey, a surgical oncology fellow at the M.D. Anderson Cancer Center in Houston, reported in a poster session at the annual Gastrointestinal Cancers Symposium. But the rate rose among younger patients.
The annual percentage change in the age-adjusted incidence rate of colorectal cancer during the 35-year period was a significant –0.92 in the cohort overall. In stratified analyses, the annual percentage change fell significantly among patients aged 50-74 at diagnosis (–0.97), and aged 75 years and older at diagnosis (–1.15). But it rose among patients aged 35-49 at diagnosis (0.41) and especially among patients aged 20-34 at diagnosis (1.99).
The findings were similar for colon cancer separately (with strongest results seen for disease that was distant at diagnosis) and for rectal/rectosigmoid cancer separately.
A predictive model suggested that if the observed trends persist between 2010 and 2030, the incidences of colon cancer and of rectal/rectosigmoid cancer will rise by 90% and 124%, respectively, among 20- to 34-year-olds, and by 28% and 46%, respectively, among 35- to 49-year-olds.
Much of the decreasing incidence among older adults "can be attributed to the fact that screening is recommended beginning at the age of 50," Dr. Bailey commented in an interview.
"We saw dramatic rises in the predicted incidences of both colon and rectal cancer in our younger cohort that point out that further studies need to be done to determine why this is happening and what can we do now to prevent this trajectory from occurring in the future," she said at the symposium, sponsored by the American Society of Clinical Oncology.
Likely explanations for this sharp uptick, she suggested, include increasing population levels of obesity and physical inactivity, and consumption of a diet high in fat and red meat – factors implicated as risks for colorectal cancer.
Another possibility is that primary care physicians are now more alert for this cancer in young patients with symptoms such as rectal bleeding, which previously may have been attributed to conditions such as hemorrhoids, delaying diagnosis until an older age.
Recommendations still call for routine colorectal cancer screening only in those patients younger than age 50 who have risk factors such as familial adenomatous polyposis and Lynch syndrome, Dr. Bailey noted. And even though the incidence is rising in the younger age groups, it is still considerably lower than it is among people aged 50 years and older.
Dr. Bailey said she had no relevant financial disclosures.
SAN FRANCISCO – The incidence of colorectal cancer is rising sharply among younger adults in the United States, a study showed.
Researchers analyzed Surveillance, Epidemiology, and End Results (SEER) data for 383,241 patients in whom colorectal cancer was diagnosed between 1975 and 2010.
The results showed that the age-adjusted incidence rate of colorectal cancer fell steadily among patients aged 50 years and older at diagnosis, lead author Dr. Christina E. Bailey, a surgical oncology fellow at the M.D. Anderson Cancer Center in Houston, reported in a poster session at the annual Gastrointestinal Cancers Symposium. But the rate rose among younger patients.
The annual percentage change in the age-adjusted incidence rate of colorectal cancer during the 35-year period was a significant –0.92 in the cohort overall. In stratified analyses, the annual percentage change fell significantly among patients aged 50-74 at diagnosis (–0.97), and aged 75 years and older at diagnosis (–1.15). But it rose among patients aged 35-49 at diagnosis (0.41) and especially among patients aged 20-34 at diagnosis (1.99).
The findings were similar for colon cancer separately (with strongest results seen for disease that was distant at diagnosis) and for rectal/rectosigmoid cancer separately.
A predictive model suggested that if the observed trends persist between 2010 and 2030, the incidences of colon cancer and of rectal/rectosigmoid cancer will rise by 90% and 124%, respectively, among 20- to 34-year-olds, and by 28% and 46%, respectively, among 35- to 49-year-olds.
Much of the decreasing incidence among older adults "can be attributed to the fact that screening is recommended beginning at the age of 50," Dr. Bailey commented in an interview.
"We saw dramatic rises in the predicted incidences of both colon and rectal cancer in our younger cohort that point out that further studies need to be done to determine why this is happening and what can we do now to prevent this trajectory from occurring in the future," she said at the symposium, sponsored by the American Society of Clinical Oncology.
Likely explanations for this sharp uptick, she suggested, include increasing population levels of obesity and physical inactivity, and consumption of a diet high in fat and red meat – factors implicated as risks for colorectal cancer.
Another possibility is that primary care physicians are now more alert for this cancer in young patients with symptoms such as rectal bleeding, which previously may have been attributed to conditions such as hemorrhoids, delaying diagnosis until an older age.
Recommendations still call for routine colorectal cancer screening only in those patients younger than age 50 who have risk factors such as familial adenomatous polyposis and Lynch syndrome, Dr. Bailey noted. And even though the incidence is rising in the younger age groups, it is still considerably lower than it is among people aged 50 years and older.
Dr. Bailey said she had no relevant financial disclosures.
SAN FRANCISCO – The incidence of colorectal cancer is rising sharply among younger adults in the United States, a study showed.
Researchers analyzed Surveillance, Epidemiology, and End Results (SEER) data for 383,241 patients in whom colorectal cancer was diagnosed between 1975 and 2010.
The results showed that the age-adjusted incidence rate of colorectal cancer fell steadily among patients aged 50 years and older at diagnosis, lead author Dr. Christina E. Bailey, a surgical oncology fellow at the M.D. Anderson Cancer Center in Houston, reported in a poster session at the annual Gastrointestinal Cancers Symposium. But the rate rose among younger patients.
The annual percentage change in the age-adjusted incidence rate of colorectal cancer during the 35-year period was a significant –0.92 in the cohort overall. In stratified analyses, the annual percentage change fell significantly among patients aged 50-74 at diagnosis (–0.97), and aged 75 years and older at diagnosis (–1.15). But it rose among patients aged 35-49 at diagnosis (0.41) and especially among patients aged 20-34 at diagnosis (1.99).
The findings were similar for colon cancer separately (with strongest results seen for disease that was distant at diagnosis) and for rectal/rectosigmoid cancer separately.
A predictive model suggested that if the observed trends persist between 2010 and 2030, the incidences of colon cancer and of rectal/rectosigmoid cancer will rise by 90% and 124%, respectively, among 20- to 34-year-olds, and by 28% and 46%, respectively, among 35- to 49-year-olds.
Much of the decreasing incidence among older adults "can be attributed to the fact that screening is recommended beginning at the age of 50," Dr. Bailey commented in an interview.
"We saw dramatic rises in the predicted incidences of both colon and rectal cancer in our younger cohort that point out that further studies need to be done to determine why this is happening and what can we do now to prevent this trajectory from occurring in the future," she said at the symposium, sponsored by the American Society of Clinical Oncology.
Likely explanations for this sharp uptick, she suggested, include increasing population levels of obesity and physical inactivity, and consumption of a diet high in fat and red meat – factors implicated as risks for colorectal cancer.
Another possibility is that primary care physicians are now more alert for this cancer in young patients with symptoms such as rectal bleeding, which previously may have been attributed to conditions such as hemorrhoids, delaying diagnosis until an older age.
Recommendations still call for routine colorectal cancer screening only in those patients younger than age 50 who have risk factors such as familial adenomatous polyposis and Lynch syndrome, Dr. Bailey noted. And even though the incidence is rising in the younger age groups, it is still considerably lower than it is among people aged 50 years and older.
Dr. Bailey said she had no relevant financial disclosures.
AT THE GASTROINTESTINAL CANCERS SYMPOSIUM
Major finding: Between 2010 and 2030, the incidences of colon and rectal/rectosigmoid cancer are predicted to rise by 90% and 124% among 20- to 34-year-olds and by 28% and 46% among 35- to 49-year-olds.
Data source: A retrospective cohort study of 383,241 patients with colorectal cancer diagnosed between 1975 and 2010.
Disclosures: Dr. Bailey reported no relevant financial conflicts.
Imaging, biomarkers, clinical findings guide approach to indeterminate pulmonary nodules
SAN DIEGO – About 30% of nodules detected by CT screening fit the criteria for an indeterminate pulmonary nodule. Very few of those nodules represent cancer, and the question is, what do you recommend for those patients in terms of follow-up?
"We’re encountering more and more patients with lung nodules in the clinic, and with the advance of screening, it will become even more of a problem. The numbers are tremendous," Dr. Pierre P. Massion stated at the Joint Conference on the Molecular Origins of Lung Cancer, sponsored by the American Association for Cancer Research and the International Association for the Study of Lung Cancer.
Dr. Massion, the Ingram Professor of Cancer Research at Vanderbilt-Ingram Cancer Center in Nashville, Tenn., said it’s important to differentiate – early, accurately, and noninvasively – benign lesions from cancer. "There is a race for early diagnosis, because surgery is the best chance for cure ... but we also need to decrease the number of thoracotomies performed for benign disease."
Data from eight large trials of lung cancer screening examined the relationship between lesion size and the probability of lung cancer (Chest 2007;132[3 Suppl]:94S-107S). The probability of cancer was 0-1% for lesions less than 5 mm in diameter; 6%-28% for those 5-10 mm, 33%-60% for those 11-20 mm, and 64%-82% for those 21-30 mm.
"The bigger the nodule, the greater the probability of cancer. In fact, however, the number of large nodules is very small," Dr. Massion said. "The indeterminate ones are between 5 and 15 mm in diameter, and these are the ones we struggle with how best to handle." The probability of cancer from indeterminate pulmonary nodules ranges from 6% to 60%, which is a large range.
The shape of the nodule provides additional information, Dr. Massion said. Triangular shape abutting a fissure and central calcification are generally indicators of benign disease and typically do not require follow-up. Alternatively, solid, noncalcified spiculated nodules have a high likelihood of being cancer. Part solid nodules are "very worrisome," he said. "These are most likely to contain malignancy. Nonsolid lesions, also called ground-glass opacities, are troublesome and difficult to assess. They represent about a 20% probability of disease."
The rate of growth of small nodules over time "is probably one of the best imaging markers, [but] for small nodules such as those 5 mm in diameter, the volumetric analysis has a large coefficient of variance," he said.
Prediction models are important to the evaluation of lung nodules, yet even with existing tools "we’re wrong about 30% of the time," he said. The best three prediction models come from studies of patients at the Mayo Clinic (Arch. Intern. Med. 1997;157:849-55) and the Veterans Affairs department (Chest 2007;131:383-88), and from patients enrolled in the PLCO (Prostate, Lung, Colorectal, and Ovarian) Cancer Screening Trial (N. Engl. J. Med. 2013;368:728-36). These prediction models are now recommended for use on nodules greater than 8 mm in diameter in the ACCP 2013 guidelines for evaluation of lung nodules (Chest 2013;143[5 Suppl]:e93S-120S).
"We have no models for never-smokers, which is a huge problem in the community at the moment."
Dr. Massion predicted that serum biomarkers might "come to the rescue" for deciding which patients with indeterminate pulmonary nodules might need to go for a biopsy or resection and which can be carefully watched over time.
In a separate study of 62 lung nodules that integrated clinical, imaging, and protein biomarker findings, clinical information alone resulted in about 50% sensitivity for predicting disease, "which is not great," said Dr. Massion, who was the principal investigator (Cancer Epidemiol. Biomarkers Prev. 2012;21:786-92). The addition of CT imaging increased the area under the curve to about 61%. Adding biomarkers in the blood raised the bar to about 69%.
"It’s not a panacea, but we show a trend toward improvement of classification of these nodules, which is where I think this field is going – integrating information from the clinic, imaging, and the discriminatory power of biomarkers."
Dr. Massion said that he had no relevant financial conflicts to disclose.
SAN DIEGO – About 30% of nodules detected by CT screening fit the criteria for an indeterminate pulmonary nodule. Very few of those nodules represent cancer, and the question is, what do you recommend for those patients in terms of follow-up?
"We’re encountering more and more patients with lung nodules in the clinic, and with the advance of screening, it will become even more of a problem. The numbers are tremendous," Dr. Pierre P. Massion stated at the Joint Conference on the Molecular Origins of Lung Cancer, sponsored by the American Association for Cancer Research and the International Association for the Study of Lung Cancer.
Dr. Massion, the Ingram Professor of Cancer Research at Vanderbilt-Ingram Cancer Center in Nashville, Tenn., said it’s important to differentiate – early, accurately, and noninvasively – benign lesions from cancer. "There is a race for early diagnosis, because surgery is the best chance for cure ... but we also need to decrease the number of thoracotomies performed for benign disease."
Data from eight large trials of lung cancer screening examined the relationship between lesion size and the probability of lung cancer (Chest 2007;132[3 Suppl]:94S-107S). The probability of cancer was 0-1% for lesions less than 5 mm in diameter; 6%-28% for those 5-10 mm, 33%-60% for those 11-20 mm, and 64%-82% for those 21-30 mm.
"The bigger the nodule, the greater the probability of cancer. In fact, however, the number of large nodules is very small," Dr. Massion said. "The indeterminate ones are between 5 and 15 mm in diameter, and these are the ones we struggle with how best to handle." The probability of cancer from indeterminate pulmonary nodules ranges from 6% to 60%, which is a large range.
The shape of the nodule provides additional information, Dr. Massion said. Triangular shape abutting a fissure and central calcification are generally indicators of benign disease and typically do not require follow-up. Alternatively, solid, noncalcified spiculated nodules have a high likelihood of being cancer. Part solid nodules are "very worrisome," he said. "These are most likely to contain malignancy. Nonsolid lesions, also called ground-glass opacities, are troublesome and difficult to assess. They represent about a 20% probability of disease."
The rate of growth of small nodules over time "is probably one of the best imaging markers, [but] for small nodules such as those 5 mm in diameter, the volumetric analysis has a large coefficient of variance," he said.
Prediction models are important to the evaluation of lung nodules, yet even with existing tools "we’re wrong about 30% of the time," he said. The best three prediction models come from studies of patients at the Mayo Clinic (Arch. Intern. Med. 1997;157:849-55) and the Veterans Affairs department (Chest 2007;131:383-88), and from patients enrolled in the PLCO (Prostate, Lung, Colorectal, and Ovarian) Cancer Screening Trial (N. Engl. J. Med. 2013;368:728-36). These prediction models are now recommended for use on nodules greater than 8 mm in diameter in the ACCP 2013 guidelines for evaluation of lung nodules (Chest 2013;143[5 Suppl]:e93S-120S).
"We have no models for never-smokers, which is a huge problem in the community at the moment."
Dr. Massion predicted that serum biomarkers might "come to the rescue" for deciding which patients with indeterminate pulmonary nodules might need to go for a biopsy or resection and which can be carefully watched over time.
In a separate study of 62 lung nodules that integrated clinical, imaging, and protein biomarker findings, clinical information alone resulted in about 50% sensitivity for predicting disease, "which is not great," said Dr. Massion, who was the principal investigator (Cancer Epidemiol. Biomarkers Prev. 2012;21:786-92). The addition of CT imaging increased the area under the curve to about 61%. Adding biomarkers in the blood raised the bar to about 69%.
"It’s not a panacea, but we show a trend toward improvement of classification of these nodules, which is where I think this field is going – integrating information from the clinic, imaging, and the discriminatory power of biomarkers."
Dr. Massion said that he had no relevant financial conflicts to disclose.
SAN DIEGO – About 30% of nodules detected by CT screening fit the criteria for an indeterminate pulmonary nodule. Very few of those nodules represent cancer, and the question is, what do you recommend for those patients in terms of follow-up?
"We’re encountering more and more patients with lung nodules in the clinic, and with the advance of screening, it will become even more of a problem. The numbers are tremendous," Dr. Pierre P. Massion stated at the Joint Conference on the Molecular Origins of Lung Cancer, sponsored by the American Association for Cancer Research and the International Association for the Study of Lung Cancer.
Dr. Massion, the Ingram Professor of Cancer Research at Vanderbilt-Ingram Cancer Center in Nashville, Tenn., said it’s important to differentiate – early, accurately, and noninvasively – benign lesions from cancer. "There is a race for early diagnosis, because surgery is the best chance for cure ... but we also need to decrease the number of thoracotomies performed for benign disease."
Data from eight large trials of lung cancer screening examined the relationship between lesion size and the probability of lung cancer (Chest 2007;132[3 Suppl]:94S-107S). The probability of cancer was 0-1% for lesions less than 5 mm in diameter; 6%-28% for those 5-10 mm, 33%-60% for those 11-20 mm, and 64%-82% for those 21-30 mm.
"The bigger the nodule, the greater the probability of cancer. In fact, however, the number of large nodules is very small," Dr. Massion said. "The indeterminate ones are between 5 and 15 mm in diameter, and these are the ones we struggle with how best to handle." The probability of cancer from indeterminate pulmonary nodules ranges from 6% to 60%, which is a large range.
The shape of the nodule provides additional information, Dr. Massion said. Triangular shape abutting a fissure and central calcification are generally indicators of benign disease and typically do not require follow-up. Alternatively, solid, noncalcified spiculated nodules have a high likelihood of being cancer. Part solid nodules are "very worrisome," he said. "These are most likely to contain malignancy. Nonsolid lesions, also called ground-glass opacities, are troublesome and difficult to assess. They represent about a 20% probability of disease."
The rate of growth of small nodules over time "is probably one of the best imaging markers, [but] for small nodules such as those 5 mm in diameter, the volumetric analysis has a large coefficient of variance," he said.
Prediction models are important to the evaluation of lung nodules, yet even with existing tools "we’re wrong about 30% of the time," he said. The best three prediction models come from studies of patients at the Mayo Clinic (Arch. Intern. Med. 1997;157:849-55) and the Veterans Affairs department (Chest 2007;131:383-88), and from patients enrolled in the PLCO (Prostate, Lung, Colorectal, and Ovarian) Cancer Screening Trial (N. Engl. J. Med. 2013;368:728-36). These prediction models are now recommended for use on nodules greater than 8 mm in diameter in the ACCP 2013 guidelines for evaluation of lung nodules (Chest 2013;143[5 Suppl]:e93S-120S).
"We have no models for never-smokers, which is a huge problem in the community at the moment."
Dr. Massion predicted that serum biomarkers might "come to the rescue" for deciding which patients with indeterminate pulmonary nodules might need to go for a biopsy or resection and which can be carefully watched over time.
In a separate study of 62 lung nodules that integrated clinical, imaging, and protein biomarker findings, clinical information alone resulted in about 50% sensitivity for predicting disease, "which is not great," said Dr. Massion, who was the principal investigator (Cancer Epidemiol. Biomarkers Prev. 2012;21:786-92). The addition of CT imaging increased the area under the curve to about 61%. Adding biomarkers in the blood raised the bar to about 69%.
"It’s not a panacea, but we show a trend toward improvement of classification of these nodules, which is where I think this field is going – integrating information from the clinic, imaging, and the discriminatory power of biomarkers."
Dr. Massion said that he had no relevant financial conflicts to disclose.
EXPERT ANALYSIS AT AN AACR-IASLC JOINT CONFERENCE
Memory fares better with laser ablation for epilepsy than with surgery
WASHINGTON – Stereotactic laser ablation resulted in better cognitive outcomes in patients with temporal lobe epilepsy than did treatment with standard open surgical approaches, Daniel Drane, Ph.D., reported at the annual meeting of the American Epilepsy Society.
In a study comparing pre- and posttreatment cognitive outcomes in 17 people with temporal lobe epilepsy, those treated with MRI-guided laser ablation had better outcomes on episodic memory measures 6 months after surgery than did the patients treated with standard surgical treatments, said Dr. Drane of the departments of neurology and pediatrics at Emory University, Atlanta. The results suggest that "memory decline requires broader damage to mesial temporal lobe structures or that epilepsy patients are able to reorganize memory more efficiently if structural damage is more selective," he concluded.
The study compared neuropsychological data before surgery and 6 months after surgery in 7 people who were treated with hippocampal laser ablation (5 left and 2 right resections) and 10 people who underwent surgery with standard or selective surgical approaches, including selective amygdalohippocampectomy (5 left and 5 right resections). Patients in both groups were similar in age (mean 36-39 years) and were on a mean of two antiepileptic drugs. Two patients in the surgery group and three in the laser ablation group had had seizures since they were 5 years or younger.
The investigators evaluated episodic memory with measures that included tasks of visual and verbal memory.
After treatment, there was evidence of a significant decline in one or both of the memory tasks in only 1 of the 7 patients treated with laser ablation, compared with 9 of the 10 surgical patients, a statistically significant difference, Dr. Drane said. In addition, six patients who had laser ablation showed a significant improvement in one or more memory measures after treatment, compared with four standard surgery patients.
In a statement issued during the meeting, Dr. Drane said that considering "the presumed importance of the hippocampus in episodic memory, we were surprised by the absence of any decline" in the laser ablation group. The results suggest that the function of the hippocampus may not be completely understood "and that being able to perform such a precise resection may help us learn more about brain regions in a manner that was never before possible in humans," he added.
During a press briefing held during the meeting, Dr. Drane pointed out that laser ablation benefits patients with less pain and a short hospital stay lasting a median of 1 day with no time spent in the intensive care unit.
Another possible benefit of the less invasive procedure is a positive effect on mood, he said. He described a patient in her early 60s with chronic epilepsy and chronic depression who was completely seizure free after laser ablation. But the most striking result of treatment was that she was no longer depressed and was off all antidepressants for the first time since she was a teenager.
This is just one case, but mood may benefit "from not cutting so many regions," he noted.
Dr. Drane said he received funding from the National Institutes of Health to conduct the study.
WASHINGTON – Stereotactic laser ablation resulted in better cognitive outcomes in patients with temporal lobe epilepsy than did treatment with standard open surgical approaches, Daniel Drane, Ph.D., reported at the annual meeting of the American Epilepsy Society.
In a study comparing pre- and posttreatment cognitive outcomes in 17 people with temporal lobe epilepsy, those treated with MRI-guided laser ablation had better outcomes on episodic memory measures 6 months after surgery than did the patients treated with standard surgical treatments, said Dr. Drane of the departments of neurology and pediatrics at Emory University, Atlanta. The results suggest that "memory decline requires broader damage to mesial temporal lobe structures or that epilepsy patients are able to reorganize memory more efficiently if structural damage is more selective," he concluded.
The study compared neuropsychological data before surgery and 6 months after surgery in 7 people who were treated with hippocampal laser ablation (5 left and 2 right resections) and 10 people who underwent surgery with standard or selective surgical approaches, including selective amygdalohippocampectomy (5 left and 5 right resections). Patients in both groups were similar in age (mean 36-39 years) and were on a mean of two antiepileptic drugs. Two patients in the surgery group and three in the laser ablation group had had seizures since they were 5 years or younger.
The investigators evaluated episodic memory with measures that included tasks of visual and verbal memory.
After treatment, there was evidence of a significant decline in one or both of the memory tasks in only 1 of the 7 patients treated with laser ablation, compared with 9 of the 10 surgical patients, a statistically significant difference, Dr. Drane said. In addition, six patients who had laser ablation showed a significant improvement in one or more memory measures after treatment, compared with four standard surgery patients.
In a statement issued during the meeting, Dr. Drane said that considering "the presumed importance of the hippocampus in episodic memory, we were surprised by the absence of any decline" in the laser ablation group. The results suggest that the function of the hippocampus may not be completely understood "and that being able to perform such a precise resection may help us learn more about brain regions in a manner that was never before possible in humans," he added.
During a press briefing held during the meeting, Dr. Drane pointed out that laser ablation benefits patients with less pain and a short hospital stay lasting a median of 1 day with no time spent in the intensive care unit.
Another possible benefit of the less invasive procedure is a positive effect on mood, he said. He described a patient in her early 60s with chronic epilepsy and chronic depression who was completely seizure free after laser ablation. But the most striking result of treatment was that she was no longer depressed and was off all antidepressants for the first time since she was a teenager.
This is just one case, but mood may benefit "from not cutting so many regions," he noted.
Dr. Drane said he received funding from the National Institutes of Health to conduct the study.
WASHINGTON – Stereotactic laser ablation resulted in better cognitive outcomes in patients with temporal lobe epilepsy than did treatment with standard open surgical approaches, Daniel Drane, Ph.D., reported at the annual meeting of the American Epilepsy Society.
In a study comparing pre- and posttreatment cognitive outcomes in 17 people with temporal lobe epilepsy, those treated with MRI-guided laser ablation had better outcomes on episodic memory measures 6 months after surgery than did the patients treated with standard surgical treatments, said Dr. Drane of the departments of neurology and pediatrics at Emory University, Atlanta. The results suggest that "memory decline requires broader damage to mesial temporal lobe structures or that epilepsy patients are able to reorganize memory more efficiently if structural damage is more selective," he concluded.
The study compared neuropsychological data before surgery and 6 months after surgery in 7 people who were treated with hippocampal laser ablation (5 left and 2 right resections) and 10 people who underwent surgery with standard or selective surgical approaches, including selective amygdalohippocampectomy (5 left and 5 right resections). Patients in both groups were similar in age (mean 36-39 years) and were on a mean of two antiepileptic drugs. Two patients in the surgery group and three in the laser ablation group had had seizures since they were 5 years or younger.
The investigators evaluated episodic memory with measures that included tasks of visual and verbal memory.
After treatment, there was evidence of a significant decline in one or both of the memory tasks in only 1 of the 7 patients treated with laser ablation, compared with 9 of the 10 surgical patients, a statistically significant difference, Dr. Drane said. In addition, six patients who had laser ablation showed a significant improvement in one or more memory measures after treatment, compared with four standard surgery patients.
In a statement issued during the meeting, Dr. Drane said that considering "the presumed importance of the hippocampus in episodic memory, we were surprised by the absence of any decline" in the laser ablation group. The results suggest that the function of the hippocampus may not be completely understood "and that being able to perform such a precise resection may help us learn more about brain regions in a manner that was never before possible in humans," he added.
During a press briefing held during the meeting, Dr. Drane pointed out that laser ablation benefits patients with less pain and a short hospital stay lasting a median of 1 day with no time spent in the intensive care unit.
Another possible benefit of the less invasive procedure is a positive effect on mood, he said. He described a patient in her early 60s with chronic epilepsy and chronic depression who was completely seizure free after laser ablation. But the most striking result of treatment was that she was no longer depressed and was off all antidepressants for the first time since she was a teenager.
This is just one case, but mood may benefit "from not cutting so many regions," he noted.
Dr. Drane said he received funding from the National Institutes of Health to conduct the study.
AT AES 2013
Major finding: After undergoing stereotactic laser ablation, 1 in 7 patients had significant drop in one of two memory tasks, compared with 9 of the 10 who underwent standard surgery, a significant difference.
Data source: A comparison of visual and verbal memory before and after treatment with MRI-guided stereotactic laser ablation or standard surgery in a group of 17 patients with temporal lobe epilepsy.
Disclosures: Dr. Drane received funding from the National Institutes of Health to conduct the study.