ACS Surgery News

Preventable emergency department visits and hospitalizations account for only a small portion of spending on high-cost Medicare patients, and strategies to control costs for these patients should be expanded to include efforts to reduce costs per episode of ED visits and hospitalizations, according to a study published in JAMA.

Most inpatient spending for high-cost Medicare patients is due to cancer, myocardial infarction, sepsis, and stroke, as well as orthopedic procedures such as hip replacement and spine surgery.

"Only a small percentage of costs appeared to be related to preventable ED visits and hospitalizations. The ability to lower costs for these patients through better outpatient care may be limited," stated Dr. Karen E. Joynt of Brigham and Women’s Hospital, Boston, and her colleagues.

The authors examined data from more than 1.1 million Medicare fee-for-service patients aged 65 years and older. They defined patients whose health care costs were in the highest decile in 2010 as high-cost patients; those with health care costs in the top decile for both 2010 and 2009 were categorized as persistently high-cost patients (JAMA 2013;309:2572-8).

Patients in the high-cost Medicare group were, on average, older than Medicare patients overall (78 vs. 77 years), and they were more likely to have chronic health conditions, including congestive heart failure (44% vs. 11%), diabetes (44% vs. 27%), and lung disease (38% vs. 13%). In addition, the high-cost patients were more likely to be male (45% vs. 42%) and African-American (9% vs. 7%).

To examine costs of preventable ED visits and hospitalizations, the authors used validated Agency for Healthcare Research and Quality (AHRQ) prevention quality algorithms. They concluded that high-cost Medicare patients accounted for 79% of overall inpatient costs of Medicare patients. In addition, the researchers discovered that 43% of ED visits by high-cost Medicare patients were considered preventable, compared with 44% of ED visits by the rest of the Medicare population. These preventable ED visits constituted 41% of ED costs for high-cost Medicare patients and 43% of ED costs for all other Medicare patients. Among the persistently high-cost patients, proportions of preventable ED spending and inpatient spending (43% and 14%, respectively) were comparable to those of high-cost patients.

Only 10% of hospital admissions for high-cost Medicare patients were due to preventable causes, compared with 17% of hospitalizations for the non–high-cost population. When the researchers combined costs of ED visits and hospitalizations, they concluded that only 10% of the costs for high-cost patients were categorized as preventable. The rest of the costs were due to what the authors described as "catastrophic events," such as myocardial infarction, sepsis, and stroke, as well as cancer, hip replacement, and spine surgery.

"Strategies [that are] focused on enhanced outpatient management of chronic disease, while critically important, may not be focused on the biggest and most expensive problems plaguing Medicare’s high-cost patients," the authors concluded.

These findings may explain why programs to improve outpatient services for patients with complex medical conditions have failed to reduce health care costs, the authors noted. "While disease management may yield cost savings, even a substantial reduction in these preventable hospitalizations is unlikely to have a large effect on overall spending levels within this cohort."

The authors also examined regional variability of health care spending for preventable acute care. They looked at costs for preventable acute care spending in various hospital referral regions (HRRs). They discovered that HRRs with the lowest supply of primary care physicians had average preventable acute care costs of $1,954 per capita, while HRRs with the highest supply of primary care physicians had average preventable acute care costs of $2,186 per capita. It was unclear whether this difference was due to a greater demand for ED visits and hospitalizations in areas with an ample supply of primary care physicians, or whether the greater supply of primary care physicians was a result of a sicker population of patients driving increased physician availability, Dr. Joynt and her colleagues stated.

They concluded that clinical leaders at health care systems may need to focus both on reducing preventable admissions and on lowering hospital costs for episodes of catastrophic and acute care in order to achieve meaningful savings in health care costs.

The Rx Foundation and the West Wireless Foundation funded the study. One coauthor, Dr. Atul A. Gawande, reported receiving income for teaching and lecturing on health care quality and safety topics, as well as earning royalties on books, other publications, and a documentary on health care system quality and performance. None of the other authors reported any conflicts of interest.

Preventable emergency department visits and hospitalizations account for only a small portion of spending on high-cost Medicare patients, and strategies to control costs for these patients should be expanded to include efforts to reduce costs per episode of ED visits and hospitalizations, according to a study published in JAMA.

Most inpatient spending for high-cost Medicare patients is due to cancer, myocardial infarction, sepsis, and stroke, as well as orthopedic procedures such as hip replacement and spine surgery.

"Only a small percentage of costs appeared to be related to preventable ED visits and hospitalizations. The ability to lower costs for these patients through better outpatient care may be limited," stated Dr. Karen E. Joynt of Brigham and Women’s Hospital, Boston, and her colleagues.

The authors examined data from more than 1.1 million Medicare fee-for-service patients aged 65 years and older. They defined patients whose health care costs were in the highest decile in 2010 as high-cost patients; those with health care costs in the top decile for both 2010 and 2009 were categorized as persistently high-cost patients (JAMA 2013;309:2572-8).

Patients in the high-cost Medicare group were, on average, older than Medicare patients overall (78 vs. 77 years), and they were more likely to have chronic health conditions, including congestive heart failure (44% vs. 11%), diabetes (44% vs. 27%), and lung disease (38% vs. 13%). In addition, the high-cost patients were more likely to be male (45% vs. 42%) and African-American (9% vs. 7%).

To examine costs of preventable ED visits and hospitalizations, the authors used validated Agency for Healthcare Research and Quality (AHRQ) prevention quality algorithms. They concluded that high-cost Medicare patients accounted for 79% of overall inpatient costs of Medicare patients. In addition, the researchers discovered that 43% of ED visits by high-cost Medicare patients were considered preventable, compared with 44% of ED visits by the rest of the Medicare population. These preventable ED visits constituted 41% of ED costs for high-cost Medicare patients and 43% of ED costs for all other Medicare patients. Among the persistently high-cost patients, proportions of preventable ED spending and inpatient spending (43% and 14%, respectively) were comparable to those of high-cost patients.

Only 10% of hospital admissions for high-cost Medicare patients were due to preventable causes, compared with 17% of hospitalizations for the non–high-cost population. When the researchers combined costs of ED visits and hospitalizations, they concluded that only 10% of the costs for high-cost patients were categorized as preventable. The rest of the costs were due to what the authors described as "catastrophic events," such as myocardial infarction, sepsis, and stroke, as well as cancer, hip replacement, and spine surgery.

"Strategies [that are] focused on enhanced outpatient management of chronic disease, while critically important, may not be focused on the biggest and most expensive problems plaguing Medicare’s high-cost patients," the authors concluded.

These findings may explain why programs to improve outpatient services for patients with complex medical conditions have failed to reduce health care costs, the authors noted. "While disease management may yield cost savings, even a substantial reduction in these preventable hospitalizations is unlikely to have a large effect on overall spending levels within this cohort."

The authors also examined regional variability of health care spending for preventable acute care. They looked at costs for preventable acute care spending in various hospital referral regions (HRRs). They discovered that HRRs with the lowest supply of primary care physicians had average preventable acute care costs of $1,954 per capita, while HRRs with the highest supply of primary care physicians had average preventable acute care costs of $2,186 per capita. It was unclear whether this difference was due to a greater demand for ED visits and hospitalizations in areas with an ample supply of primary care physicians, or whether the greater supply of primary care physicians was a result of a sicker population of patients driving increased physician availability, Dr. Joynt and her colleagues stated.

They concluded that clinical leaders at health care systems may need to focus both on reducing preventable admissions and on lowering hospital costs for episodes of catastrophic and acute care in order to achieve meaningful savings in health care costs.

The Rx Foundation and the West Wireless Foundation funded the study. One coauthor, Dr. Atul A. Gawande, reported receiving income for teaching and lecturing on health care quality and safety topics, as well as earning royalties on books, other publications, and a documentary on health care system quality and performance. None of the other authors reported any conflicts of interest.

Preventable emergency department visits and hospitalizations account for only a small portion of spending on high-cost Medicare patients, and strategies to control costs for these patients should be expanded to include efforts to reduce costs per episode of ED visits and hospitalizations, according to a study published in JAMA.

Most inpatient spending for high-cost Medicare patients is due to cancer, myocardial infarction, sepsis, and stroke, as well as orthopedic procedures such as hip replacement and spine surgery.

"Only a small percentage of costs appeared to be related to preventable ED visits and hospitalizations. The ability to lower costs for these patients through better outpatient care may be limited," stated Dr. Karen E. Joynt of Brigham and Women’s Hospital, Boston, and her colleagues.

The authors examined data from more than 1.1 million Medicare fee-for-service patients aged 65 years and older. They defined patients whose health care costs were in the highest decile in 2010 as high-cost patients; those with health care costs in the top decile for both 2010 and 2009 were categorized as persistently high-cost patients (JAMA 2013;309:2572-8).

Patients in the high-cost Medicare group were, on average, older than Medicare patients overall (78 vs. 77 years), and they were more likely to have chronic health conditions, including congestive heart failure (44% vs. 11%), diabetes (44% vs. 27%), and lung disease (38% vs. 13%). In addition, the high-cost patients were more likely to be male (45% vs. 42%) and African-American (9% vs. 7%).

To examine costs of preventable ED visits and hospitalizations, the authors used validated Agency for Healthcare Research and Quality (AHRQ) prevention quality algorithms. They concluded that high-cost Medicare patients accounted for 79% of overall inpatient costs of Medicare patients. In addition, the researchers discovered that 43% of ED visits by high-cost Medicare patients were considered preventable, compared with 44% of ED visits by the rest of the Medicare population. These preventable ED visits constituted 41% of ED costs for high-cost Medicare patients and 43% of ED costs for all other Medicare patients. Among the persistently high-cost patients, proportions of preventable ED spending and inpatient spending (43% and 14%, respectively) were comparable to those of high-cost patients.

Only 10% of hospital admissions for high-cost Medicare patients were due to preventable causes, compared with 17% of hospitalizations for the non–high-cost population. When the researchers combined costs of ED visits and hospitalizations, they concluded that only 10% of the costs for high-cost patients were categorized as preventable. The rest of the costs were due to what the authors described as "catastrophic events," such as myocardial infarction, sepsis, and stroke, as well as cancer, hip replacement, and spine surgery.

"Strategies [that are] focused on enhanced outpatient management of chronic disease, while critically important, may not be focused on the biggest and most expensive problems plaguing Medicare’s high-cost patients," the authors concluded.

These findings may explain why programs to improve outpatient services for patients with complex medical conditions have failed to reduce health care costs, the authors noted. "While disease management may yield cost savings, even a substantial reduction in these preventable hospitalizations is unlikely to have a large effect on overall spending levels within this cohort."

The authors also examined regional variability of health care spending for preventable acute care. They looked at costs for preventable acute care spending in various hospital referral regions (HRRs). They discovered that HRRs with the lowest supply of primary care physicians had average preventable acute care costs of $1,954 per capita, while HRRs with the highest supply of primary care physicians had average preventable acute care costs of $2,186 per capita. It was unclear whether this difference was due to a greater demand for ED visits and hospitalizations in areas with an ample supply of primary care physicians, or whether the greater supply of primary care physicians was a result of a sicker population of patients driving increased physician availability, Dr. Joynt and her colleagues stated.

They concluded that clinical leaders at health care systems may need to focus both on reducing preventable admissions and on lowering hospital costs for episodes of catastrophic and acute care in order to achieve meaningful savings in health care costs.

The Rx Foundation and the West Wireless Foundation funded the study. One coauthor, Dr. Atul A. Gawande, reported receiving income for teaching and lecturing on health care quality and safety topics, as well as earning royalties on books, other publications, and a documentary on health care system quality and performance. None of the other authors reported any conflicts of interest.

The likelihood of nodal metastases is increased in breast cancer patients whose tumors have breast cancer stem and progenitor cells with defects in PI3/Akt signaling.

The findings, drawn from an analysis of surgical specimens, "support embarking on a new way of approaching breast cancer diagnosis and treatment planning" and have potential implications for targeted treatment with PI3/Akt inhibitors currently being tested in clinical trials, Dr. Cory A. Donovan and his colleagues at the Oregon Health and Science University, Portland reported online July 24 in JAMA Surgery.

The researchers evaluated malignant and benign stem cells from 30 fresh surgical specimens of ductal breast cancers. Nine of the 10 specimens with mutations in breast cancer stem and progenitor cells (BCSCs) were associated with axillary lymph node micro- or macrometastases. Just 4 of the 20 tumors without mutations were associated with axillary lymph node metastases, the investigators said (JAMA Surg. 2013 July 17 [doi:10.1001/jamasurg.2013.3028]).

The tumor specimens were collected from patients with stage IA through IIIB cancers via cell sorting and were subjected to whole genomic amplification and subsequent screening for oncogene mutations. The 10 tumors with BCSC defects had AKT1, HRAS, or PIK3CA mutations.

"Three different mutations (E545k, N345k, and H1047R) were detected in PIK3CA, a single mutation was detected in AKT1, and a single mutation was detected in HRAS," the investigators wrote.

No difference in CD44 positivity was observed between BCSCs with and without mutations.

"When the presence of any BCSC mutation correlated with patient and breast cancer characteristics, no statistically significant correlations were found with patient age at diagnosis, tumor size, tumor histologic grade, estrogen receptor expression, progesterone receptor expression, or ERBB2 status. However, a statistically significant correlation was observed between the presence of BCSC mutations and axillary lymph node metastases. This significance was more pronounced when micrometastatic disease was included," they said.

At a mean follow-up of 29 months, disease had progressed after treatment in 3 of the 10 patients with BCSC mutations. Two patients died of disease; one had brain metastases. Conversely, there was no evidence of disease at a mean follow-up of 19 months in the patients with BCSCs without mutations.

Since 20% of patients without BCSC mutations had axillary lymph node metastases, it appears that a PI3K/Akt mutation in BCSC is not a requirement for metastases, but the link between PI3K and metastatic potential demonstrated in this study suggests that "micrometastases harboring PI3K/Akt mutations may carry a different risk for distant metastatic disease," Dr. Donovan and his associates noted.

"Longer patient follow-up periods and a larger sample size will determine if this subset of patients demonstrates an increased risk and may benefit from specifically designed use of adjuvant chemotherapy," the researchers added.

The existing evidence regarding the prognostic significance of specific PI3K/Akt signaling pathway mutations is conflicting, likely because of the variability of the mutations, the heterogeneity of the tumors, and the complexity of the pathway. Although the findings in BCSCs in the current study are consistent with others showing that PIK3CA and AKT mutations in breast cancers are associated with factors that may indicate poor prognosis and decreased survival, other studies have demonstrated improved survival, lower tumor grades, and increased rates of estrogen receptor positivity in patients with tumors that have PIK3CA mutations, they said.

"Our study findings indicate that the answer to this controversy may lie in identifying mutations in BCSCs, as well as mutations in the tumor as a whole," they said, adding that the findings support an evaluation of BCSCs along with overall breast cancer assessment.

"The analysis of BCSCs can generate specific information about tumor growth and metastatic potential that may not be obtained from analysis of the tumor progeny cells alone. Simultaneous molecular analyses of both the tumor and BCSCs may better identify patients who are likely to benefit from specific therapeutic regimens. Similarly, simultaneous BCSC and tumor analysis may increase the number of patients who might benefit from treatment but be missed by tumor analysis alone," Dr. Donovan and his coworkers said.

P13K/Akt signaling pathway inhibitors are currently being evaluated in clinical trials and could prove useful for the treatment of patients with BCSC mutations, they noted, adding that this may be true even in cases without PIK/Akt mutation.

"The use of BCSC-specific and tumor-targeted chemotherapeutic agents may prove to be synergistic with each other, providing a novel therapeutic approach," they said.

This study was supported by a grant from the Janet E. Bowen Foundation. The authors reported having no disclosures.

The likelihood of nodal metastases is increased in breast cancer patients whose tumors have breast cancer stem and progenitor cells with defects in PI3/Akt signaling.

The findings, drawn from an analysis of surgical specimens, "support embarking on a new way of approaching breast cancer diagnosis and treatment planning" and have potential implications for targeted treatment with PI3/Akt inhibitors currently being tested in clinical trials, Dr. Cory A. Donovan and his colleagues at the Oregon Health and Science University, Portland reported online July 24 in JAMA Surgery.

The researchers evaluated malignant and benign stem cells from 30 fresh surgical specimens of ductal breast cancers. Nine of the 10 specimens with mutations in breast cancer stem and progenitor cells (BCSCs) were associated with axillary lymph node micro- or macrometastases. Just 4 of the 20 tumors without mutations were associated with axillary lymph node metastases, the investigators said (JAMA Surg. 2013 July 17 [doi:10.1001/jamasurg.2013.3028]).

The tumor specimens were collected from patients with stage IA through IIIB cancers via cell sorting and were subjected to whole genomic amplification and subsequent screening for oncogene mutations. The 10 tumors with BCSC defects had AKT1, HRAS, or PIK3CA mutations.

"Three different mutations (E545k, N345k, and H1047R) were detected in PIK3CA, a single mutation was detected in AKT1, and a single mutation was detected in HRAS," the investigators wrote.

No difference in CD44 positivity was observed between BCSCs with and without mutations.

"When the presence of any BCSC mutation correlated with patient and breast cancer characteristics, no statistically significant correlations were found with patient age at diagnosis, tumor size, tumor histologic grade, estrogen receptor expression, progesterone receptor expression, or ERBB2 status. However, a statistically significant correlation was observed between the presence of BCSC mutations and axillary lymph node metastases. This significance was more pronounced when micrometastatic disease was included," they said.

At a mean follow-up of 29 months, disease had progressed after treatment in 3 of the 10 patients with BCSC mutations. Two patients died of disease; one had brain metastases. Conversely, there was no evidence of disease at a mean follow-up of 19 months in the patients with BCSCs without mutations.

Since 20% of patients without BCSC mutations had axillary lymph node metastases, it appears that a PI3K/Akt mutation in BCSC is not a requirement for metastases, but the link between PI3K and metastatic potential demonstrated in this study suggests that "micrometastases harboring PI3K/Akt mutations may carry a different risk for distant metastatic disease," Dr. Donovan and his associates noted.

"Longer patient follow-up periods and a larger sample size will determine if this subset of patients demonstrates an increased risk and may benefit from specifically designed use of adjuvant chemotherapy," the researchers added.

The existing evidence regarding the prognostic significance of specific PI3K/Akt signaling pathway mutations is conflicting, likely because of the variability of the mutations, the heterogeneity of the tumors, and the complexity of the pathway. Although the findings in BCSCs in the current study are consistent with others showing that PIK3CA and AKT mutations in breast cancers are associated with factors that may indicate poor prognosis and decreased survival, other studies have demonstrated improved survival, lower tumor grades, and increased rates of estrogen receptor positivity in patients with tumors that have PIK3CA mutations, they said.

"Our study findings indicate that the answer to this controversy may lie in identifying mutations in BCSCs, as well as mutations in the tumor as a whole," they said, adding that the findings support an evaluation of BCSCs along with overall breast cancer assessment.

"The analysis of BCSCs can generate specific information about tumor growth and metastatic potential that may not be obtained from analysis of the tumor progeny cells alone. Simultaneous molecular analyses of both the tumor and BCSCs may better identify patients who are likely to benefit from specific therapeutic regimens. Similarly, simultaneous BCSC and tumor analysis may increase the number of patients who might benefit from treatment but be missed by tumor analysis alone," Dr. Donovan and his coworkers said.

P13K/Akt signaling pathway inhibitors are currently being evaluated in clinical trials and could prove useful for the treatment of patients with BCSC mutations, they noted, adding that this may be true even in cases without PIK/Akt mutation.

"The use of BCSC-specific and tumor-targeted chemotherapeutic agents may prove to be synergistic with each other, providing a novel therapeutic approach," they said.

This study was supported by a grant from the Janet E. Bowen Foundation. The authors reported having no disclosures.

The likelihood of nodal metastases is increased in breast cancer patients whose tumors have breast cancer stem and progenitor cells with defects in PI3/Akt signaling.

The findings, drawn from an analysis of surgical specimens, "support embarking on a new way of approaching breast cancer diagnosis and treatment planning" and have potential implications for targeted treatment with PI3/Akt inhibitors currently being tested in clinical trials, Dr. Cory A. Donovan and his colleagues at the Oregon Health and Science University, Portland reported online July 24 in JAMA Surgery.

The researchers evaluated malignant and benign stem cells from 30 fresh surgical specimens of ductal breast cancers. Nine of the 10 specimens with mutations in breast cancer stem and progenitor cells (BCSCs) were associated with axillary lymph node micro- or macrometastases. Just 4 of the 20 tumors without mutations were associated with axillary lymph node metastases, the investigators said (JAMA Surg. 2013 July 17 [doi:10.1001/jamasurg.2013.3028]).

The tumor specimens were collected from patients with stage IA through IIIB cancers via cell sorting and were subjected to whole genomic amplification and subsequent screening for oncogene mutations. The 10 tumors with BCSC defects had AKT1, HRAS, or PIK3CA mutations.

"Three different mutations (E545k, N345k, and H1047R) were detected in PIK3CA, a single mutation was detected in AKT1, and a single mutation was detected in HRAS," the investigators wrote.

No difference in CD44 positivity was observed between BCSCs with and without mutations.

"When the presence of any BCSC mutation correlated with patient and breast cancer characteristics, no statistically significant correlations were found with patient age at diagnosis, tumor size, tumor histologic grade, estrogen receptor expression, progesterone receptor expression, or ERBB2 status. However, a statistically significant correlation was observed between the presence of BCSC mutations and axillary lymph node metastases. This significance was more pronounced when micrometastatic disease was included," they said.

At a mean follow-up of 29 months, disease had progressed after treatment in 3 of the 10 patients with BCSC mutations. Two patients died of disease; one had brain metastases. Conversely, there was no evidence of disease at a mean follow-up of 19 months in the patients with BCSCs without mutations.

Since 20% of patients without BCSC mutations had axillary lymph node metastases, it appears that a PI3K/Akt mutation in BCSC is not a requirement for metastases, but the link between PI3K and metastatic potential demonstrated in this study suggests that "micrometastases harboring PI3K/Akt mutations may carry a different risk for distant metastatic disease," Dr. Donovan and his associates noted.

"Longer patient follow-up periods and a larger sample size will determine if this subset of patients demonstrates an increased risk and may benefit from specifically designed use of adjuvant chemotherapy," the researchers added.

The existing evidence regarding the prognostic significance of specific PI3K/Akt signaling pathway mutations is conflicting, likely because of the variability of the mutations, the heterogeneity of the tumors, and the complexity of the pathway. Although the findings in BCSCs in the current study are consistent with others showing that PIK3CA and AKT mutations in breast cancers are associated with factors that may indicate poor prognosis and decreased survival, other studies have demonstrated improved survival, lower tumor grades, and increased rates of estrogen receptor positivity in patients with tumors that have PIK3CA mutations, they said.

"Our study findings indicate that the answer to this controversy may lie in identifying mutations in BCSCs, as well as mutations in the tumor as a whole," they said, adding that the findings support an evaluation of BCSCs along with overall breast cancer assessment.

"The analysis of BCSCs can generate specific information about tumor growth and metastatic potential that may not be obtained from analysis of the tumor progeny cells alone. Simultaneous molecular analyses of both the tumor and BCSCs may better identify patients who are likely to benefit from specific therapeutic regimens. Similarly, simultaneous BCSC and tumor analysis may increase the number of patients who might benefit from treatment but be missed by tumor analysis alone," Dr. Donovan and his coworkers said.

P13K/Akt signaling pathway inhibitors are currently being evaluated in clinical trials and could prove useful for the treatment of patients with BCSC mutations, they noted, adding that this may be true even in cases without PIK/Akt mutation.

"The use of BCSC-specific and tumor-targeted chemotherapeutic agents may prove to be synergistic with each other, providing a novel therapeutic approach," they said.

This study was supported by a grant from the Janet E. Bowen Foundation. The authors reported having no disclosures.

LONDON – Improved pregnancy rates after fertility treatment were achieved by the surgical removal of ovarian cysts in a 10-year longitudinal study of women with endometriomas.

After surgery, 63% of women became pregnant after assisted conception methods whereas before surgery only 7% conceived; overall, 46% of women became pregnant at both time points combined.

"Endometrioma itself is associated with significantly reduced reproductive performance in the long term," said study investigator Dr. Saad Amer of the Royal Derby (England) Hospital.

However, "surgery does not seem to compromise the reproductive performance any further," he said at the annual meeting of the European Society of Human Reproduction and Embryology.

Sara Freeman/IMNG Medical Media

The rates of unassisted pregnancy were about the same before (48%) and after surgery (50%), with an overall rate of 65% in the surgical groups combined versus 98% for women without endometriomas but who had endometriosis (P = .001)

The rationale for the study was that evidence suggests that ovarian reserve is reduced after excision surgery (J. Clin. Endocrinol. Metab. 2012;97:3146-54), although the long-term impact of other types of surgery remains to be seen.

Between January 1999 and December 2009, 704 women with ovarian endometriosis who had surgery, of which 153 had surgery for endometriomas, were identified from hospital records.

Women who had endometriomas were sent a questionnaire and asked to attend an interview about their reproductive history. There was a 45% response rate (n = 151), with 68 women with endometriomas actually participating; they were compared with an age- and weight-matched control group of 68 apparently healthy women.

The median ages of women in both the study group and the control group were similar, at 40 and 41 years, respectively. A similar percentage of patients had a smoking history (8% and 10%), with a little more than half of all women having regular menstruation, and 75% and 84% in each group desiring to become pregnant.

Of the 68 women with endometriomas, 33 underwent excision (n = 27) or ablation (n = 6) procedures, with 21 women having oophorectomy and 14 having the cysts drained. The median diameter of the endometriomas was 6 cm. Surgery was performed by 10 consultant gynecologists, with 53% of procedures performed laparoscopically.

If the women who conceived spontaneously and those who became pregnant following fertility treatment were grouped together, the overall rates of pregnancy before and after endometrioma surgery were 50% and 71%, respectively, with a combined overall pregnancy rate of 80%. This compares well with the 98% of women who had spontaneous pregnancy in the control group, Dr. Amer noted.

A similar percentage of patients became pregnant after single (70%, n = 23) or multiple (73%, n = 15) surgical procedures, although the number of women included in the analysis was small.

There was a trend toward a lower pregnancy rate in women who had bilateral versus unilateral surgeries, at 67% vs. 77%, although the number of patients in this analysis was again small. There also was no significant difference in pregnancy rates when the type of surgery was considered.

"These findings are reassuring for patients with endometrioma who are seeking fertility and need surgery for their disease."

Importantly, surgery was not found to alter the timing or age of menopause, Dr. Amer said. Nine (13%) women who had surgery were postmenopausal, compared with six (9%) of those in the control group. The median age of menopause was 48 years in the surgical group overall versus 49 years in the control group.

The main conclusion of the study was that surgery itself does not appear to affect women’s long-term reproductive performance.

Although the findings are limited by the retrospective design of the study and further validation is needed, the results do suggest that endometriomas per se, rather than surgery, appear to be the main reason for reduced long-term reproductive function.

"These findings are reassuring for patients with endometrioma who are seeking fertility and need surgery for their disease," Dr. Amer said.

Dr. Amer reported having no relevant financial disclosures.

LONDON – Improved pregnancy rates after fertility treatment were achieved by the surgical removal of ovarian cysts in a 10-year longitudinal study of women with endometriomas.

After surgery, 63% of women became pregnant after assisted conception methods whereas before surgery only 7% conceived; overall, 46% of women became pregnant at both time points combined.

"Endometrioma itself is associated with significantly reduced reproductive performance in the long term," said study investigator Dr. Saad Amer of the Royal Derby (England) Hospital.

However, "surgery does not seem to compromise the reproductive performance any further," he said at the annual meeting of the European Society of Human Reproduction and Embryology.

Sara Freeman/IMNG Medical Media

The rates of unassisted pregnancy were about the same before (48%) and after surgery (50%), with an overall rate of 65% in the surgical groups combined versus 98% for women without endometriomas but who had endometriosis (P = .001)

The rationale for the study was that evidence suggests that ovarian reserve is reduced after excision surgery (J. Clin. Endocrinol. Metab. 2012;97:3146-54), although the long-term impact of other types of surgery remains to be seen.

Between January 1999 and December 2009, 704 women with ovarian endometriosis who had surgery, of which 153 had surgery for endometriomas, were identified from hospital records.

Women who had endometriomas were sent a questionnaire and asked to attend an interview about their reproductive history. There was a 45% response rate (n = 151), with 68 women with endometriomas actually participating; they were compared with an age- and weight-matched control group of 68 apparently healthy women.

The median ages of women in both the study group and the control group were similar, at 40 and 41 years, respectively. A similar percentage of patients had a smoking history (8% and 10%), with a little more than half of all women having regular menstruation, and 75% and 84% in each group desiring to become pregnant.

Of the 68 women with endometriomas, 33 underwent excision (n = 27) or ablation (n = 6) procedures, with 21 women having oophorectomy and 14 having the cysts drained. The median diameter of the endometriomas was 6 cm. Surgery was performed by 10 consultant gynecologists, with 53% of procedures performed laparoscopically.

If the women who conceived spontaneously and those who became pregnant following fertility treatment were grouped together, the overall rates of pregnancy before and after endometrioma surgery were 50% and 71%, respectively, with a combined overall pregnancy rate of 80%. This compares well with the 98% of women who had spontaneous pregnancy in the control group, Dr. Amer noted.

A similar percentage of patients became pregnant after single (70%, n = 23) or multiple (73%, n = 15) surgical procedures, although the number of women included in the analysis was small.

There was a trend toward a lower pregnancy rate in women who had bilateral versus unilateral surgeries, at 67% vs. 77%, although the number of patients in this analysis was again small. There also was no significant difference in pregnancy rates when the type of surgery was considered.

"These findings are reassuring for patients with endometrioma who are seeking fertility and need surgery for their disease."

Importantly, surgery was not found to alter the timing or age of menopause, Dr. Amer said. Nine (13%) women who had surgery were postmenopausal, compared with six (9%) of those in the control group. The median age of menopause was 48 years in the surgical group overall versus 49 years in the control group.

The main conclusion of the study was that surgery itself does not appear to affect women’s long-term reproductive performance.

Although the findings are limited by the retrospective design of the study and further validation is needed, the results do suggest that endometriomas per se, rather than surgery, appear to be the main reason for reduced long-term reproductive function.

"These findings are reassuring for patients with endometrioma who are seeking fertility and need surgery for their disease," Dr. Amer said.

Dr. Amer reported having no relevant financial disclosures.

LONDON – Improved pregnancy rates after fertility treatment were achieved by the surgical removal of ovarian cysts in a 10-year longitudinal study of women with endometriomas.

After surgery, 63% of women became pregnant after assisted conception methods whereas before surgery only 7% conceived; overall, 46% of women became pregnant at both time points combined.

"Endometrioma itself is associated with significantly reduced reproductive performance in the long term," said study investigator Dr. Saad Amer of the Royal Derby (England) Hospital.

However, "surgery does not seem to compromise the reproductive performance any further," he said at the annual meeting of the European Society of Human Reproduction and Embryology.

Sara Freeman/IMNG Medical Media

The rates of unassisted pregnancy were about the same before (48%) and after surgery (50%), with an overall rate of 65% in the surgical groups combined versus 98% for women without endometriomas but who had endometriosis (P = .001)

The rationale for the study was that evidence suggests that ovarian reserve is reduced after excision surgery (J. Clin. Endocrinol. Metab. 2012;97:3146-54), although the long-term impact of other types of surgery remains to be seen.

Between January 1999 and December 2009, 704 women with ovarian endometriosis who had surgery, of which 153 had surgery for endometriomas, were identified from hospital records.

Women who had endometriomas were sent a questionnaire and asked to attend an interview about their reproductive history. There was a 45% response rate (n = 151), with 68 women with endometriomas actually participating; they were compared with an age- and weight-matched control group of 68 apparently healthy women.

The median ages of women in both the study group and the control group were similar, at 40 and 41 years, respectively. A similar percentage of patients had a smoking history (8% and 10%), with a little more than half of all women having regular menstruation, and 75% and 84% in each group desiring to become pregnant.

Of the 68 women with endometriomas, 33 underwent excision (n = 27) or ablation (n = 6) procedures, with 21 women having oophorectomy and 14 having the cysts drained. The median diameter of the endometriomas was 6 cm. Surgery was performed by 10 consultant gynecologists, with 53% of procedures performed laparoscopically.

If the women who conceived spontaneously and those who became pregnant following fertility treatment were grouped together, the overall rates of pregnancy before and after endometrioma surgery were 50% and 71%, respectively, with a combined overall pregnancy rate of 80%. This compares well with the 98% of women who had spontaneous pregnancy in the control group, Dr. Amer noted.

A similar percentage of patients became pregnant after single (70%, n = 23) or multiple (73%, n = 15) surgical procedures, although the number of women included in the analysis was small.

There was a trend toward a lower pregnancy rate in women who had bilateral versus unilateral surgeries, at 67% vs. 77%, although the number of patients in this analysis was again small. There also was no significant difference in pregnancy rates when the type of surgery was considered.

"These findings are reassuring for patients with endometrioma who are seeking fertility and need surgery for their disease."

Importantly, surgery was not found to alter the timing or age of menopause, Dr. Amer said. Nine (13%) women who had surgery were postmenopausal, compared with six (9%) of those in the control group. The median age of menopause was 48 years in the surgical group overall versus 49 years in the control group.

The main conclusion of the study was that surgery itself does not appear to affect women’s long-term reproductive performance.

Although the findings are limited by the retrospective design of the study and further validation is needed, the results do suggest that endometriomas per se, rather than surgery, appear to be the main reason for reduced long-term reproductive function.

"These findings are reassuring for patients with endometrioma who are seeking fertility and need surgery for their disease," Dr. Amer said.

Dr. Amer reported having no relevant financial disclosures.

PHOENIX – Applying continuous negative pressure to the incisional wound sharply reduces the incidence of surgical site infection after open colorectal surgery, according to results from a retrospective study.

A team led by Dr. Allison M. Bonds, a general surgery resident at the University of Texas Southwestern Medical Center at Dallas, studied 254 patients who underwent open colorectal surgery, whether planned or converted from a laparoscopic procedure.

In 13% of the patients, surgeons used incisional negative-pressure wound therapy, which entails standard wound closure followed by placement of a wound vacuum device over the completed stapled skin closure.

Study results, reported at the annual meeting of the American Society of Colon and Rectal Surgeons, showed that relative to the group receiving usual wound care, patients receiving incisional negative-pressure wound therapy were two-thirds less likely to develop a surgical site infection.

"Our study, although a retrospective chart review, does seem to show that the use of incisional negative-pressure wound therapy is associated with a decreased risk of surgical site infection," Dr. Bonds asserted. "This finding is significant enough that we feel it further needs a randomized controlled trial to see if there is actually a significant effect in the colorectal population."

Several attendees wondered about the cost of the negative-pressure wound therapy and how that was covered in the study population.

"We didn’t do an official cost analysis," Dr. Bonds replied. "Normally, the device that we used is associated with about $200 extra initially and then ... another $500 a day to use. So it is a fairly expensive addition to the care of the patients." She said she did not have data on how this cost was covered.

Dr. Jason Hall of the Lahey Clinic in Burlington, Mass., asked, "What was the indication to use the vac in those 32 patients?" and further wondered whether the patients receiving this therapy differed in ways that may have confounded the results.

"Placement of the vacuum wound device was left to the discretion of the surgeons," Dr. Bonds replied. "It’s hard to know exactly which patients would have been chosen for the study. There is some chance that the surgeons would have chosen the patients that they didn’t think would have a high rate of infection risk. But from our talking with the surgeons who use this, we believe that most of the vacuum devices were placed on patients who they had a high suspicion were going to get surgical site infections."

She agreed that there might have been selection bias at play, despite the study’s use of multivariate analysis. "That’s exactly why we believe that a randomized controlled trial is really the only way to show whether this is going to be a good technique to use or not," she said.

Cost of the therapy and its coverage will be major issues going forward, according to session comoderator Dr. Mark Welton of Stanford (Calif.) University. "Any time you are talking about downstream benefit to the insurer, they really need to see robust data before they are going to start to pay for that. So, especially in today’s health care environment, it’s going to come back to the patient paying for it. If you could talk about driving the cost associated with the wound infection down significantly, then the insurance companies would pay for it."

"Interestingly, there are companies coming out producing less expensive and less cumbersome devices. So I think it’s actually a very exciting idea, it’s intriguing. But we have a long way to go, and we do get to this cost-benefit question, and who’s going to pay for it," he said in an interview.

Dr. Kim Rhoads, the other session comoderator, also of Stanford University, said that "it’s an interesting concept," but she would like to see a standardized protocol detailing, for example, whether the vacuum and dressing are changed at some point and how long it has to be used for benefit; additionally, the indication for use should be worked out.

Also, "what we didn’t hear is how much fluid actually comes out ... because if nothing is coming out, you have to ask, what’s happening here and would that patient not have otherwise been wound infection free," she said. "We don’t know."

Incisional negative-pressure wound therapy has been used in orthopedic surgery for several years, according to Dr. Bonds. "At UT Southwestern, we began using this in 2010 [in colorectal surgery], and anecdotally saw that it seemed to be decreasing the rate of infections in our patients, so we thought that this warranted further study," she explained.

With this therapy, surgeons close the incision with standard staples, apply a strip of bridge dressing (GranuFoam, made by KCI), and cover the area with clear occlusion tape. The vacuum device (V.A.C. Therapy, made by KCI) is then applied at 75 mm Hg of continuous suction; in patients having a stoma, the stoma is returned after the device is in place.

In the study, the vacuum device was left on until postoperative day 5 or 7, and was removed before patients were discharged, according to Dr. Bonds.

Overall, 27.2% of the patients developed a surgical site infection. The rate was 12.5% in the group given incisional negative-pressure wound therapy, compared with 29.3% in the group given standard care.

In a multivariate analysis, patients in the negative-pressure wound therapy group were 68% less likely to develop a surgical site infection (odds ratio, 0.32; P = .04).

The only other independent predictor of this outcome was diabetes mellitus, which was associated with roughly a doubling of risk (OR, 1.98; P = .03).

"There are several proposed mechanisms for why this therapy would work," Dr. Bonds noted. The device prevents the incision from coming into contact with the surrounding environment, and decreases patient mobility and shear forces on the wound.

"In addition, the continuous suction seems to remove infectious material and the interstitial fluid, thereby decreasing the wound edema. Studies have also shown that the wound vacuum device increases vascularity to the wound, which would seem to help it heal as well," she said.

Dr. Bonds disclosed no relevant conflicts of interest. One coinvestigator has an affiliation with KCI.

PHOENIX – Applying continuous negative pressure to the incisional wound sharply reduces the incidence of surgical site infection after open colorectal surgery, according to results from a retrospective study.

A team led by Dr. Allison M. Bonds, a general surgery resident at the University of Texas Southwestern Medical Center at Dallas, studied 254 patients who underwent open colorectal surgery, whether planned or converted from a laparoscopic procedure.

In 13% of the patients, surgeons used incisional negative-pressure wound therapy, which entails standard wound closure followed by placement of a wound vacuum device over the completed stapled skin closure.

Study results, reported at the annual meeting of the American Society of Colon and Rectal Surgeons, showed that relative to the group receiving usual wound care, patients receiving incisional negative-pressure wound therapy were two-thirds less likely to develop a surgical site infection.

"Our study, although a retrospective chart review, does seem to show that the use of incisional negative-pressure wound therapy is associated with a decreased risk of surgical site infection," Dr. Bonds asserted. "This finding is significant enough that we feel it further needs a randomized controlled trial to see if there is actually a significant effect in the colorectal population."

Several attendees wondered about the cost of the negative-pressure wound therapy and how that was covered in the study population.

"We didn’t do an official cost analysis," Dr. Bonds replied. "Normally, the device that we used is associated with about $200 extra initially and then ... another $500 a day to use. So it is a fairly expensive addition to the care of the patients." She said she did not have data on how this cost was covered.

Dr. Jason Hall of the Lahey Clinic in Burlington, Mass., asked, "What was the indication to use the vac in those 32 patients?" and further wondered whether the patients receiving this therapy differed in ways that may have confounded the results.

"Placement of the vacuum wound device was left to the discretion of the surgeons," Dr. Bonds replied. "It’s hard to know exactly which patients would have been chosen for the study. There is some chance that the surgeons would have chosen the patients that they didn’t think would have a high rate of infection risk. But from our talking with the surgeons who use this, we believe that most of the vacuum devices were placed on patients who they had a high suspicion were going to get surgical site infections."

She agreed that there might have been selection bias at play, despite the study’s use of multivariate analysis. "That’s exactly why we believe that a randomized controlled trial is really the only way to show whether this is going to be a good technique to use or not," she said.

Cost of the therapy and its coverage will be major issues going forward, according to session comoderator Dr. Mark Welton of Stanford (Calif.) University. "Any time you are talking about downstream benefit to the insurer, they really need to see robust data before they are going to start to pay for that. So, especially in today’s health care environment, it’s going to come back to the patient paying for it. If you could talk about driving the cost associated with the wound infection down significantly, then the insurance companies would pay for it."

"Interestingly, there are companies coming out producing less expensive and less cumbersome devices. So I think it’s actually a very exciting idea, it’s intriguing. But we have a long way to go, and we do get to this cost-benefit question, and who’s going to pay for it," he said in an interview.

Dr. Kim Rhoads, the other session comoderator, also of Stanford University, said that "it’s an interesting concept," but she would like to see a standardized protocol detailing, for example, whether the vacuum and dressing are changed at some point and how long it has to be used for benefit; additionally, the indication for use should be worked out.

Also, "what we didn’t hear is how much fluid actually comes out ... because if nothing is coming out, you have to ask, what’s happening here and would that patient not have otherwise been wound infection free," she said. "We don’t know."

Incisional negative-pressure wound therapy has been used in orthopedic surgery for several years, according to Dr. Bonds. "At UT Southwestern, we began using this in 2010 [in colorectal surgery], and anecdotally saw that it seemed to be decreasing the rate of infections in our patients, so we thought that this warranted further study," she explained.

With this therapy, surgeons close the incision with standard staples, apply a strip of bridge dressing (GranuFoam, made by KCI), and cover the area with clear occlusion tape. The vacuum device (V.A.C. Therapy, made by KCI) is then applied at 75 mm Hg of continuous suction; in patients having a stoma, the stoma is returned after the device is in place.

In the study, the vacuum device was left on until postoperative day 5 or 7, and was removed before patients were discharged, according to Dr. Bonds.

Overall, 27.2% of the patients developed a surgical site infection. The rate was 12.5% in the group given incisional negative-pressure wound therapy, compared with 29.3% in the group given standard care.

In a multivariate analysis, patients in the negative-pressure wound therapy group were 68% less likely to develop a surgical site infection (odds ratio, 0.32; P = .04).

The only other independent predictor of this outcome was diabetes mellitus, which was associated with roughly a doubling of risk (OR, 1.98; P = .03).

"There are several proposed mechanisms for why this therapy would work," Dr. Bonds noted. The device prevents the incision from coming into contact with the surrounding environment, and decreases patient mobility and shear forces on the wound.

"In addition, the continuous suction seems to remove infectious material and the interstitial fluid, thereby decreasing the wound edema. Studies have also shown that the wound vacuum device increases vascularity to the wound, which would seem to help it heal as well," she said.

Dr. Bonds disclosed no relevant conflicts of interest. One coinvestigator has an affiliation with KCI.

PHOENIX – Applying continuous negative pressure to the incisional wound sharply reduces the incidence of surgical site infection after open colorectal surgery, according to results from a retrospective study.

A team led by Dr. Allison M. Bonds, a general surgery resident at the University of Texas Southwestern Medical Center at Dallas, studied 254 patients who underwent open colorectal surgery, whether planned or converted from a laparoscopic procedure.

In 13% of the patients, surgeons used incisional negative-pressure wound therapy, which entails standard wound closure followed by placement of a wound vacuum device over the completed stapled skin closure.

Study results, reported at the annual meeting of the American Society of Colon and Rectal Surgeons, showed that relative to the group receiving usual wound care, patients receiving incisional negative-pressure wound therapy were two-thirds less likely to develop a surgical site infection.

"Our study, although a retrospective chart review, does seem to show that the use of incisional negative-pressure wound therapy is associated with a decreased risk of surgical site infection," Dr. Bonds asserted. "This finding is significant enough that we feel it further needs a randomized controlled trial to see if there is actually a significant effect in the colorectal population."

Several attendees wondered about the cost of the negative-pressure wound therapy and how that was covered in the study population.

"We didn’t do an official cost analysis," Dr. Bonds replied. "Normally, the device that we used is associated with about $200 extra initially and then ... another $500 a day to use. So it is a fairly expensive addition to the care of the patients." She said she did not have data on how this cost was covered.

Dr. Jason Hall of the Lahey Clinic in Burlington, Mass., asked, "What was the indication to use the vac in those 32 patients?" and further wondered whether the patients receiving this therapy differed in ways that may have confounded the results.

"Placement of the vacuum wound device was left to the discretion of the surgeons," Dr. Bonds replied. "It’s hard to know exactly which patients would have been chosen for the study. There is some chance that the surgeons would have chosen the patients that they didn’t think would have a high rate of infection risk. But from our talking with the surgeons who use this, we believe that most of the vacuum devices were placed on patients who they had a high suspicion were going to get surgical site infections."

She agreed that there might have been selection bias at play, despite the study’s use of multivariate analysis. "That’s exactly why we believe that a randomized controlled trial is really the only way to show whether this is going to be a good technique to use or not," she said.

Cost of the therapy and its coverage will be major issues going forward, according to session comoderator Dr. Mark Welton of Stanford (Calif.) University. "Any time you are talking about downstream benefit to the insurer, they really need to see robust data before they are going to start to pay for that. So, especially in today’s health care environment, it’s going to come back to the patient paying for it. If you could talk about driving the cost associated with the wound infection down significantly, then the insurance companies would pay for it."

"Interestingly, there are companies coming out producing less expensive and less cumbersome devices. So I think it’s actually a very exciting idea, it’s intriguing. But we have a long way to go, and we do get to this cost-benefit question, and who’s going to pay for it," he said in an interview.

Dr. Kim Rhoads, the other session comoderator, also of Stanford University, said that "it’s an interesting concept," but she would like to see a standardized protocol detailing, for example, whether the vacuum and dressing are changed at some point and how long it has to be used for benefit; additionally, the indication for use should be worked out.

Also, "what we didn’t hear is how much fluid actually comes out ... because if nothing is coming out, you have to ask, what’s happening here and would that patient not have otherwise been wound infection free," she said. "We don’t know."

Incisional negative-pressure wound therapy has been used in orthopedic surgery for several years, according to Dr. Bonds. "At UT Southwestern, we began using this in 2010 [in colorectal surgery], and anecdotally saw that it seemed to be decreasing the rate of infections in our patients, so we thought that this warranted further study," she explained.

With this therapy, surgeons close the incision with standard staples, apply a strip of bridge dressing (GranuFoam, made by KCI), and cover the area with clear occlusion tape. The vacuum device (V.A.C. Therapy, made by KCI) is then applied at 75 mm Hg of continuous suction; in patients having a stoma, the stoma is returned after the device is in place.

In the study, the vacuum device was left on until postoperative day 5 or 7, and was removed before patients were discharged, according to Dr. Bonds.

Overall, 27.2% of the patients developed a surgical site infection. The rate was 12.5% in the group given incisional negative-pressure wound therapy, compared with 29.3% in the group given standard care.

In a multivariate analysis, patients in the negative-pressure wound therapy group were 68% less likely to develop a surgical site infection (odds ratio, 0.32; P = .04).

The only other independent predictor of this outcome was diabetes mellitus, which was associated with roughly a doubling of risk (OR, 1.98; P = .03).

"There are several proposed mechanisms for why this therapy would work," Dr. Bonds noted. The device prevents the incision from coming into contact with the surrounding environment, and decreases patient mobility and shear forces on the wound.

"In addition, the continuous suction seems to remove infectious material and the interstitial fluid, thereby decreasing the wound edema. Studies have also shown that the wound vacuum device increases vascularity to the wound, which would seem to help it heal as well," she said.

Dr. Bonds disclosed no relevant conflicts of interest. One coinvestigator has an affiliation with KCI.

When it comes to reducing health costs, physicians believe burden of responsibility lies primarily with plaintiffs attorneys, followed by insurers, hospitals, drug and device makers, patients, and, lastly, themselves.

Those conclusions are based on 2,438 responses from some 3,900 physicians randomly surveyed in 2012. Dr. Jon C. Tilburt of the Mayo Clinic, Rochester, Minn., and his colleagues reported their findings July 23 in JAMA.

When asked whether individual physicians should have a major responsibility in reducing health costs, 36% of respondents said yes. Sixty percent said that trial lawyers bore the major burden, with health insurers coming in a close second.

More than half said that drug and device companies, hospitals and health systems, and patients also should have major responsibility for cost containment. A total of 44% said the government had that responsibility (JAMA 2013;310:380-8 [doi:10.1001/jama.2013.8278]).

Physicians also were asked about their enthusiasm for various cost-control strategies and to examine their own role in cost containment by assessing their knowledge of prices of procedures and tests and their desire to personally curb costs in their practice. The authors asked about and analyzed potential barriers to physicians becoming more cost conscious, as well.

Doctors were very enthusiastic about improving the quality and efficiency of care, primarily through promoting continuity of care and going after fraud and abuse. Expanding access to preventive care was also warmly received. Physicians were also enthusiastic about limiting access to expensive treatments that had shown little benefit, using cost-effectiveness data to choose a therapy, and promoting head-to-head trials of competing therapies.

Just over half of respondents said that cutting pay for the highest-paid specialists should be embraced.

Eliminating fee for service altogether was rejected by 70% of respondents. Ninety percent said that they weren’t enthusiastic about letting the Medicare Sustainable Growth Rate cuts take effect. Two-thirds said that bundled pay and penalties for readmissions – both cost-control keystones advanced by the Obama administration – were not attractive.

Not surprisingly, increasing use of electronic health records also got a strong negative response, with 29% saying they were "not enthusiastic."

When it came to their own practice, 76% said they were aware of the costs of treatments or tests they recommended, and 84% said that cost is important whether a patient pays out of pocket or not.

When it comes to individual physicians’ responsibility for reducing health costs, the responses were very mixed.

The survey participants largely agreed that "trying to contain costs is the responsibility of every physician" (85%) and that physicians should take a more prominent role in eliminating unnecessary tests (89%). But by almost the same percentages, physicians also said that they should be devoted to their individual patients, even if a test or therapy was expensive, and that they should not deny services to their patients because someone else might need it more.

"This apparent inconsistency may reflect inherent tensions in professional roles to serve patients individually and society as a whole," Dr. Tilburt and colleagues wrote.

Finally, physicians overwhelmingly said that fear of malpractice had substantially decreased their enjoyment of practicing medicine. The authors rated that fear as a barrier to cost-conscious practice. They also found that 43% of physicians admitted they ordered more tests when they did not know the patient as well. Half said that being more cost conscious was the right thing to do, but large numbers said that it might not make a difference or could make things worse. A total of 40% said it would not limit unreasonable patient demands, and 28% said it could erode patients’ trust.

Dr. Tilburt and his colleagues pointed out that the findings should be viewed with caution in part because it could not fully reflect the opinions of all American physicians. Further, opinions could be in flux, given how much has changed since even a year ago.

They suggested that policy makers move slowly when it comes to changing payment models, and instead target areas where doctors seem to be enthusiastic, including improving quality of care and using comparative effectiveness data.

The study was funded by the Greenwall Foundation and the Mayo Clinic. The authors reported having no financial conflicts.

[email protected]

On Twitter @aliciaault

When it comes to reducing health costs, physicians believe burden of responsibility lies primarily with plaintiffs attorneys, followed by insurers, hospitals, drug and device makers, patients, and, lastly, themselves.

Those conclusions are based on 2,438 responses from some 3,900 physicians randomly surveyed in 2012. Dr. Jon C. Tilburt of the Mayo Clinic, Rochester, Minn., and his colleagues reported their findings July 23 in JAMA.

When asked whether individual physicians should have a major responsibility in reducing health costs, 36% of respondents said yes. Sixty percent said that trial lawyers bore the major burden, with health insurers coming in a close second.

More than half said that drug and device companies, hospitals and health systems, and patients also should have major responsibility for cost containment. A total of 44% said the government had that responsibility (JAMA 2013;310:380-8 [doi:10.1001/jama.2013.8278]).

Physicians also were asked about their enthusiasm for various cost-control strategies and to examine their own role in cost containment by assessing their knowledge of prices of procedures and tests and their desire to personally curb costs in their practice. The authors asked about and analyzed potential barriers to physicians becoming more cost conscious, as well.

Doctors were very enthusiastic about improving the quality and efficiency of care, primarily through promoting continuity of care and going after fraud and abuse. Expanding access to preventive care was also warmly received. Physicians were also enthusiastic about limiting access to expensive treatments that had shown little benefit, using cost-effectiveness data to choose a therapy, and promoting head-to-head trials of competing therapies.

Just over half of respondents said that cutting pay for the highest-paid specialists should be embraced.

Eliminating fee for service altogether was rejected by 70% of respondents. Ninety percent said that they weren’t enthusiastic about letting the Medicare Sustainable Growth Rate cuts take effect. Two-thirds said that bundled pay and penalties for readmissions – both cost-control keystones advanced by the Obama administration – were not attractive.

Not surprisingly, increasing use of electronic health records also got a strong negative response, with 29% saying they were "not enthusiastic."

When it came to their own practice, 76% said they were aware of the costs of treatments or tests they recommended, and 84% said that cost is important whether a patient pays out of pocket or not.

When it comes to individual physicians’ responsibility for reducing health costs, the responses were very mixed.

The survey participants largely agreed that "trying to contain costs is the responsibility of every physician" (85%) and that physicians should take a more prominent role in eliminating unnecessary tests (89%). But by almost the same percentages, physicians also said that they should be devoted to their individual patients, even if a test or therapy was expensive, and that they should not deny services to their patients because someone else might need it more.

"This apparent inconsistency may reflect inherent tensions in professional roles to serve patients individually and society as a whole," Dr. Tilburt and colleagues wrote.

Finally, physicians overwhelmingly said that fear of malpractice had substantially decreased their enjoyment of practicing medicine. The authors rated that fear as a barrier to cost-conscious practice. They also found that 43% of physicians admitted they ordered more tests when they did not know the patient as well. Half said that being more cost conscious was the right thing to do, but large numbers said that it might not make a difference or could make things worse. A total of 40% said it would not limit unreasonable patient demands, and 28% said it could erode patients’ trust.

Dr. Tilburt and his colleagues pointed out that the findings should be viewed with caution in part because it could not fully reflect the opinions of all American physicians. Further, opinions could be in flux, given how much has changed since even a year ago.

They suggested that policy makers move slowly when it comes to changing payment models, and instead target areas where doctors seem to be enthusiastic, including improving quality of care and using comparative effectiveness data.

The study was funded by the Greenwall Foundation and the Mayo Clinic. The authors reported having no financial conflicts.

[email protected]

On Twitter @aliciaault

When it comes to reducing health costs, physicians believe burden of responsibility lies primarily with plaintiffs attorneys, followed by insurers, hospitals, drug and device makers, patients, and, lastly, themselves.

Those conclusions are based on 2,438 responses from some 3,900 physicians randomly surveyed in 2012. Dr. Jon C. Tilburt of the Mayo Clinic, Rochester, Minn., and his colleagues reported their findings July 23 in JAMA.

When asked whether individual physicians should have a major responsibility in reducing health costs, 36% of respondents said yes. Sixty percent said that trial lawyers bore the major burden, with health insurers coming in a close second.

More than half said that drug and device companies, hospitals and health systems, and patients also should have major responsibility for cost containment. A total of 44% said the government had that responsibility (JAMA 2013;310:380-8 [doi:10.1001/jama.2013.8278]).

Physicians also were asked about their enthusiasm for various cost-control strategies and to examine their own role in cost containment by assessing their knowledge of prices of procedures and tests and their desire to personally curb costs in their practice. The authors asked about and analyzed potential barriers to physicians becoming more cost conscious, as well.

Doctors were very enthusiastic about improving the quality and efficiency of care, primarily through promoting continuity of care and going after fraud and abuse. Expanding access to preventive care was also warmly received. Physicians were also enthusiastic about limiting access to expensive treatments that had shown little benefit, using cost-effectiveness data to choose a therapy, and promoting head-to-head trials of competing therapies.

Just over half of respondents said that cutting pay for the highest-paid specialists should be embraced.

Eliminating fee for service altogether was rejected by 70% of respondents. Ninety percent said that they weren’t enthusiastic about letting the Medicare Sustainable Growth Rate cuts take effect. Two-thirds said that bundled pay and penalties for readmissions – both cost-control keystones advanced by the Obama administration – were not attractive.

Not surprisingly, increasing use of electronic health records also got a strong negative response, with 29% saying they were "not enthusiastic."

When it came to their own practice, 76% said they were aware of the costs of treatments or tests they recommended, and 84% said that cost is important whether a patient pays out of pocket or not.

When it comes to individual physicians’ responsibility for reducing health costs, the responses were very mixed.

The survey participants largely agreed that "trying to contain costs is the responsibility of every physician" (85%) and that physicians should take a more prominent role in eliminating unnecessary tests (89%). But by almost the same percentages, physicians also said that they should be devoted to their individual patients, even if a test or therapy was expensive, and that they should not deny services to their patients because someone else might need it more.

"This apparent inconsistency may reflect inherent tensions in professional roles to serve patients individually and society as a whole," Dr. Tilburt and colleagues wrote.

Finally, physicians overwhelmingly said that fear of malpractice had substantially decreased their enjoyment of practicing medicine. The authors rated that fear as a barrier to cost-conscious practice. They also found that 43% of physicians admitted they ordered more tests when they did not know the patient as well. Half said that being more cost conscious was the right thing to do, but large numbers said that it might not make a difference or could make things worse. A total of 40% said it would not limit unreasonable patient demands, and 28% said it could erode patients’ trust.

Dr. Tilburt and his colleagues pointed out that the findings should be viewed with caution in part because it could not fully reflect the opinions of all American physicians. Further, opinions could be in flux, given how much has changed since even a year ago.

They suggested that policy makers move slowly when it comes to changing payment models, and instead target areas where doctors seem to be enthusiastic, including improving quality of care and using comparative effectiveness data.

The study was funded by the Greenwall Foundation and the Mayo Clinic. The authors reported having no financial conflicts.

[email protected]

On Twitter @aliciaault

LONDON – Decompressive surgery dramatically increased the survival chances of older adult patients who had massive brain swelling after a middle cerebral artery stroke, according to the results of a randomized clinical trial.

After 1 year of follow-up, 57% of patients aged 61 years or older were still alive if they had undergone hemicraniectomy, compared with 24% (P less than .001) of those who received standard intensive care alone in the DESTINY II trial. The increase in survival did not lead to an increase in severe disability, study investigator Dr. Werner Hacke of the University of Heidelberg, Germany, reported at the annual European Stroke Conference.

Sara Freeman/IMNG Medical Media

"Malignant infarction of the middle cerebral artery [MCA] is the deadliest type of ischemic brain infarction," Dr. Hacke noted. It is associated with rapid neurological deterioration caused by cerebral edema (Postgrad. Med. J. 2010;86:235-42) and is responsible for 70%-80% of in-hospital mortality if treated conservatively using mechanical ventilation and intracranial pressure reduction.

Evidence supporting decompressive surgery

Previous pooled research, including the DESTINY I study (Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery), showed that relieving the pressure on the brain by temporarily removing part of the skull within the first 48 hours of ischemic injury reduces the risk of death and poor clinical outcome by almost 50% in patients under the age of 60 years (Lancet Neurol. 2007;6:215-22). The DESTINY II data now show that older patients also can benefit from decompressive surgery, perhaps as much as their younger counterparts.

A total of 112 patients with malignant MCA infarction aged 61 years and older were recruited into the study and randomized to receive maximum conservative treatment alone or in addition to hemicraniectomy within 48 hours after symptom onset (Int. J. Stroke 2011;6:79-86). The mean age was 70 years, and 60%-67% had infarctions affecting the nondominant cerebral hemisphere. The mean National Institutes of Health Stroke Scale (NIHSS) score was 20-22 at admission.

The primary endpoint was the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-4 versus 5-6 at 6 months. A score of 6 on this scale signifies death and a score of 5 represents severe disability, such as being bedridden and incontinent and requiring constant nursing care and attention.

Dr. Hacke noted that the trial’s data and safety monitoring board halted the trial at the 6-month assessment after reviewing data on 82 patients. The exact reasons were undisclosed, but part of the study’s protocol was to stop the trial once statistical significance was reached. At the time the trial has halted, a further 30 patients had already been randomized and were included in the intention-to-treat analysis (ITT).

DESTINY II results

Significantly more patients who underwent surgery had a mRS of 0-4 than did those who had standard intensive care treatment (40.5% vs. 18.6%, P = .039) using the DSMB data set. The percentages of surgically and conservatively treated patients with an mRS of 5 or 6 were 59.5% and 81.4%, respectively. Performing an ITT analysis did not change the findings.

The number needed to treat was just 4, Dr. Hacke reported.

At 12 months in the ITT population, he noted that 38% of surgically and 16% of conservatively managed patients with an mRS of 0-4 were alive, as were 62% versus 84% of those, respectively, who had a mRS of 5-6 (P =.009).

An ITT analysis of multiple secondary endpoints at 1 year – which included the NIHSS score, Barthel Activities of Daily Living Index, Short Form-36 physical and mental domains, Hamilton Rating Scale for Depression, and the EuroQoL-5D – was also significantly in favor of early hemicraniectomy. This was perhaps a statistical artifact, Dr. Hacke observed, as the significance disappeared when data were examined in only the patients who had survived to 1 year.

Retrospective consent to surgery

When survivors and their caregivers were asked if they would undergo the same procedure again, given the knowledge of the final outcome, the majority of both surgically treated (77%, n = 27) and conservatively managed survivors (73%, n = 15) said that they would.

This finding shows that most patients, including those with moderately severe disability (mRS of 4) would rather have the procedures than be dead.

Dr. Christine Roffe, professor of medicine at Keele University in Stoke-on-Trent, England, commented that a person’s point of view of disability often changes after having a stroke.

"We’ve always assumed that if you asked someone before they had a stroke, ‘Would you rather have a stroke or be dead?’ that people would say, ‘I’d rather be dead,’ " she said in an interview. It’s not unreasonable that most people would probably say they would rather be dead than be severely incapacitated for the rest of their lives, she added.

However, after having a stroke, people often report that they are able to continue to live their lives reasonably happily despite often being quite disabled and having lost their independence.

The DESTINY II data show that people who had surgery were quite happy despite any disability, and this was at a similar level to those who were treated conservatively but with higher survival rates, Dr. Roffe noted.

The ethical implications of this could be considerable, she suggested. It shows that people who have living wills or who decide that they do not want treatment in the event of a stroke could live just as happy a life after the event as before. It therefore begs the question of whether patients should be allowed to decide on this aspect of their care, she added.

The German Research Foundation and the German Ministry of Science and Education financially supported the study. Dr. Hacke had no disclosures. Dr. Roffe was not involved in the study and had no relevant conflicts of interest.

LONDON – Decompressive surgery dramatically increased the survival chances of older adult patients who had massive brain swelling after a middle cerebral artery stroke, according to the results of a randomized clinical trial.

After 1 year of follow-up, 57% of patients aged 61 years or older were still alive if they had undergone hemicraniectomy, compared with 24% (P less than .001) of those who received standard intensive care alone in the DESTINY II trial. The increase in survival did not lead to an increase in severe disability, study investigator Dr. Werner Hacke of the University of Heidelberg, Germany, reported at the annual European Stroke Conference.

Sara Freeman/IMNG Medical Media

"Malignant infarction of the middle cerebral artery [MCA] is the deadliest type of ischemic brain infarction," Dr. Hacke noted. It is associated with rapid neurological deterioration caused by cerebral edema (Postgrad. Med. J. 2010;86:235-42) and is responsible for 70%-80% of in-hospital mortality if treated conservatively using mechanical ventilation and intracranial pressure reduction.

Evidence supporting decompressive surgery

Previous pooled research, including the DESTINY I study (Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery), showed that relieving the pressure on the brain by temporarily removing part of the skull within the first 48 hours of ischemic injury reduces the risk of death and poor clinical outcome by almost 50% in patients under the age of 60 years (Lancet Neurol. 2007;6:215-22). The DESTINY II data now show that older patients also can benefit from decompressive surgery, perhaps as much as their younger counterparts.

A total of 112 patients with malignant MCA infarction aged 61 years and older were recruited into the study and randomized to receive maximum conservative treatment alone or in addition to hemicraniectomy within 48 hours after symptom onset (Int. J. Stroke 2011;6:79-86). The mean age was 70 years, and 60%-67% had infarctions affecting the nondominant cerebral hemisphere. The mean National Institutes of Health Stroke Scale (NIHSS) score was 20-22 at admission.

The primary endpoint was the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-4 versus 5-6 at 6 months. A score of 6 on this scale signifies death and a score of 5 represents severe disability, such as being bedridden and incontinent and requiring constant nursing care and attention.

Dr. Hacke noted that the trial’s data and safety monitoring board halted the trial at the 6-month assessment after reviewing data on 82 patients. The exact reasons were undisclosed, but part of the study’s protocol was to stop the trial once statistical significance was reached. At the time the trial has halted, a further 30 patients had already been randomized and were included in the intention-to-treat analysis (ITT).

DESTINY II results

Significantly more patients who underwent surgery had a mRS of 0-4 than did those who had standard intensive care treatment (40.5% vs. 18.6%, P = .039) using the DSMB data set. The percentages of surgically and conservatively treated patients with an mRS of 5 or 6 were 59.5% and 81.4%, respectively. Performing an ITT analysis did not change the findings.

The number needed to treat was just 4, Dr. Hacke reported.

At 12 months in the ITT population, he noted that 38% of surgically and 16% of conservatively managed patients with an mRS of 0-4 were alive, as were 62% versus 84% of those, respectively, who had a mRS of 5-6 (P =.009).

An ITT analysis of multiple secondary endpoints at 1 year – which included the NIHSS score, Barthel Activities of Daily Living Index, Short Form-36 physical and mental domains, Hamilton Rating Scale for Depression, and the EuroQoL-5D – was also significantly in favor of early hemicraniectomy. This was perhaps a statistical artifact, Dr. Hacke observed, as the significance disappeared when data were examined in only the patients who had survived to 1 year.

Retrospective consent to surgery

When survivors and their caregivers were asked if they would undergo the same procedure again, given the knowledge of the final outcome, the majority of both surgically treated (77%, n = 27) and conservatively managed survivors (73%, n = 15) said that they would.

This finding shows that most patients, including those with moderately severe disability (mRS of 4) would rather have the procedures than be dead.

Dr. Christine Roffe, professor of medicine at Keele University in Stoke-on-Trent, England, commented that a person’s point of view of disability often changes after having a stroke.

"We’ve always assumed that if you asked someone before they had a stroke, ‘Would you rather have a stroke or be dead?’ that people would say, ‘I’d rather be dead,’ " she said in an interview. It’s not unreasonable that most people would probably say they would rather be dead than be severely incapacitated for the rest of their lives, she added.

However, after having a stroke, people often report that they are able to continue to live their lives reasonably happily despite often being quite disabled and having lost their independence.

The DESTINY II data show that people who had surgery were quite happy despite any disability, and this was at a similar level to those who were treated conservatively but with higher survival rates, Dr. Roffe noted.

The ethical implications of this could be considerable, she suggested. It shows that people who have living wills or who decide that they do not want treatment in the event of a stroke could live just as happy a life after the event as before. It therefore begs the question of whether patients should be allowed to decide on this aspect of their care, she added.

The German Research Foundation and the German Ministry of Science and Education financially supported the study. Dr. Hacke had no disclosures. Dr. Roffe was not involved in the study and had no relevant conflicts of interest.

LONDON – Decompressive surgery dramatically increased the survival chances of older adult patients who had massive brain swelling after a middle cerebral artery stroke, according to the results of a randomized clinical trial.

After 1 year of follow-up, 57% of patients aged 61 years or older were still alive if they had undergone hemicraniectomy, compared with 24% (P less than .001) of those who received standard intensive care alone in the DESTINY II trial. The increase in survival did not lead to an increase in severe disability, study investigator Dr. Werner Hacke of the University of Heidelberg, Germany, reported at the annual European Stroke Conference.

Sara Freeman/IMNG Medical Media

"Malignant infarction of the middle cerebral artery [MCA] is the deadliest type of ischemic brain infarction," Dr. Hacke noted. It is associated with rapid neurological deterioration caused by cerebral edema (Postgrad. Med. J. 2010;86:235-42) and is responsible for 70%-80% of in-hospital mortality if treated conservatively using mechanical ventilation and intracranial pressure reduction.

Evidence supporting decompressive surgery

Previous pooled research, including the DESTINY I study (Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery), showed that relieving the pressure on the brain by temporarily removing part of the skull within the first 48 hours of ischemic injury reduces the risk of death and poor clinical outcome by almost 50% in patients under the age of 60 years (Lancet Neurol. 2007;6:215-22). The DESTINY II data now show that older patients also can benefit from decompressive surgery, perhaps as much as their younger counterparts.

A total of 112 patients with malignant MCA infarction aged 61 years and older were recruited into the study and randomized to receive maximum conservative treatment alone or in addition to hemicraniectomy within 48 hours after symptom onset (Int. J. Stroke 2011;6:79-86). The mean age was 70 years, and 60%-67% had infarctions affecting the nondominant cerebral hemisphere. The mean National Institutes of Health Stroke Scale (NIHSS) score was 20-22 at admission.

The primary endpoint was the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-4 versus 5-6 at 6 months. A score of 6 on this scale signifies death and a score of 5 represents severe disability, such as being bedridden and incontinent and requiring constant nursing care and attention.

Dr. Hacke noted that the trial’s data and safety monitoring board halted the trial at the 6-month assessment after reviewing data on 82 patients. The exact reasons were undisclosed, but part of the study’s protocol was to stop the trial once statistical significance was reached. At the time the trial has halted, a further 30 patients had already been randomized and were included in the intention-to-treat analysis (ITT).

DESTINY II results

Significantly more patients who underwent surgery had a mRS of 0-4 than did those who had standard intensive care treatment (40.5% vs. 18.6%, P = .039) using the DSMB data set. The percentages of surgically and conservatively treated patients with an mRS of 5 or 6 were 59.5% and 81.4%, respectively. Performing an ITT analysis did not change the findings.

The number needed to treat was just 4, Dr. Hacke reported.

At 12 months in the ITT population, he noted that 38% of surgically and 16% of conservatively managed patients with an mRS of 0-4 were alive, as were 62% versus 84% of those, respectively, who had a mRS of 5-6 (P =.009).

An ITT analysis of multiple secondary endpoints at 1 year – which included the NIHSS score, Barthel Activities of Daily Living Index, Short Form-36 physical and mental domains, Hamilton Rating Scale for Depression, and the EuroQoL-5D – was also significantly in favor of early hemicraniectomy. This was perhaps a statistical artifact, Dr. Hacke observed, as the significance disappeared when data were examined in only the patients who had survived to 1 year.

Retrospective consent to surgery

When survivors and their caregivers were asked if they would undergo the same procedure again, given the knowledge of the final outcome, the majority of both surgically treated (77%, n = 27) and conservatively managed survivors (73%, n = 15) said that they would.

This finding shows that most patients, including those with moderately severe disability (mRS of 4) would rather have the procedures than be dead.

Dr. Christine Roffe, professor of medicine at Keele University in Stoke-on-Trent, England, commented that a person’s point of view of disability often changes after having a stroke.

"We’ve always assumed that if you asked someone before they had a stroke, ‘Would you rather have a stroke or be dead?’ that people would say, ‘I’d rather be dead,’ " she said in an interview. It’s not unreasonable that most people would probably say they would rather be dead than be severely incapacitated for the rest of their lives, she added.

However, after having a stroke, people often report that they are able to continue to live their lives reasonably happily despite often being quite disabled and having lost their independence.

The DESTINY II data show that people who had surgery were quite happy despite any disability, and this was at a similar level to those who were treated conservatively but with higher survival rates, Dr. Roffe noted.

The ethical implications of this could be considerable, she suggested. It shows that people who have living wills or who decide that they do not want treatment in the event of a stroke could live just as happy a life after the event as before. It therefore begs the question of whether patients should be allowed to decide on this aspect of their care, she added.

The German Research Foundation and the German Ministry of Science and Education financially supported the study. Dr. Hacke had no disclosures. Dr. Roffe was not involved in the study and had no relevant conflicts of interest.

NEW YORK – Physicians at Boston Children’s Hospital have replaced the mitral valves of eight infants with irreparable mitral valve disease with a valve that offers the opportunity of sequential expansion as the child grows, according to Dr. Sitaram M. Emani, who described the results at the 2013 Mitral Valve Conclave.

"The Melody valve retains its competence if you expand it before putting it in. We asked whether the valve retains the ability to maintain competence even if expansion is performed after implantation as the patient grows," said Dr. Emani, a pediatric cardiac surgeon at Boston Children’s Hospital.

According to Dr. Emani, the current options for infants with damaged mitral valves that are beyond repair are replacement with mechanical or bioprosthetic valves or the Ross mitral procedure. Perhaps the main disadvantage of these options is the lack of a prosthetic valve small enough for an infant, one that is less than 12 mm in diameter. Another problem is the possibility of stenosis developing as the child grows, since the diameters of the prosthetics are fixed. Other drawbacks are that supra-annular fixation is generally associated with poor outcomes and that annular fixation limits the ability to upsize at reoperation.

The Melody valve is an externally stented bovine jugular vein graft that was designed for transcatheter pulmonary valve replacement. In this study, the valve was inserted surgically. The valve maintains competence over a range of sizes up to 22 mm. Although this valve is not approved for use for mitral valve replacement, the hope of using such a prosthetic is that it can be enlarged in the catheterization laboratory as the child grows.

Dr. Emani conducted a retrospective study of his experience with the Melody valve for mitral valve replacement in eight infants less than 12 months of age. The median age at implantation was 6 months (range, 1-9 months). Four infants had an atrioventricular canal (AVC) defect and four had congenital mitral valve stenosis. Most of the children had two prior operations for mitral valve repair. The longest follow-up to date has been 2 years.

At a median follow-up of 8 months, regurgitation on the echocardiogram was considered to be mild or less in all patients. The median gradient was 3 mm Hg (range, 2-7 mm Hg) on the immediate postoperative echocardiogram. Three patients developed a mild paravalvular leak; one of these patients had undergone aggressive stent resection, a modification Dr. Emani does not recommend. One patient developed left ventricular outflow tract obstruction (LVOTO), which Dr. Emani attributed to the lack of distal stent fixation in this patient. Another patient with an AVC defect developed complete heart block.

One patient who died 3 days postoperatively had heterotaxy, severe mitral regurgitation, and prior ventricular failure on extracorporeal membrane oxygenation support. That patient had undergone valve implantation as a last resort.

Three patients underwent sequential expansion about 6 months after implantation. After valve expansion, the median balloon size was 12 mm, ranging from 12 to 16 mm. None of the patients developed worsening valvular function and all had relief of obstruction. Transcatheter intervention was used to correct a paravalvular leak in one patient and to treat a left ventricular outflow tract problem in another. None of the patients developed endocarditis or a strut fracture, "although I worry about strut fracture if aggressive stent resection and manipulation is performed," Dr. Emani said at the meeting, which was sponsored by the American Association for Thoracic Surgery.

Dr. Emani offered some procedural tips. First, the Melody valve must be optimized for surgical implantation in infants. The length of the valve must be reduced by trimming it to reduce the chance of LVOTO or pulmonary vein obstruction. He recommends sizing the valves by echocardiogram and fixating the distal stent to the inferior free wall of the ventricle.

Although he has used both circumferential and four-point fixation, Dr. Emani has learned all that is really needed to prevent leakage is friction of the stent against the annulus. Early on he used a pericardial cuff to anchor to the annulus, particularly in patients who had undergone failed AVC repair. He tries to preserve at least part of the anterior leaflet to facilitate suture placement and create a "stand-off" from the LVOTO.

Dr. Emani also advised limiting intraoperative dilation to no more than 1 mm greater than the measured annulus. "Try not to overdilate at implantation to avoid heart block, LVOTO, and coronary compression. The nice thing is you don’t have to decide then and there what size you want. You can go back to the cath lab and, under direct visualization with the coronary view, you can dilate it under more controlled circumstances.

"The hope is that we will be able to dilate these valves as the patients grow into adolescence. If we can dilate them up to 22 mm, hopefully we will decrease the number of repeat replacements, delay the time to reoperation, and perhaps modify our thresholds for tolerating significant disease after unsuccessful repairs," he said. The investigators continue to accumulate experience with this device and hope to design a multicenter trial evaluating its safety and efficacy for this indication.

Dr. Emani had no relevant financial disclosures.

[email protected]

NEW YORK – Physicians at Boston Children’s Hospital have replaced the mitral valves of eight infants with irreparable mitral valve disease with a valve that offers the opportunity of sequential expansion as the child grows, according to Dr. Sitaram M. Emani, who described the results at the 2013 Mitral Valve Conclave.

"The Melody valve retains its competence if you expand it before putting it in. We asked whether the valve retains the ability to maintain competence even if expansion is performed after implantation as the patient grows," said Dr. Emani, a pediatric cardiac surgeon at Boston Children’s Hospital.

According to Dr. Emani, the current options for infants with damaged mitral valves that are beyond repair are replacement with mechanical or bioprosthetic valves or the Ross mitral procedure. Perhaps the main disadvantage of these options is the lack of a prosthetic valve small enough for an infant, one that is less than 12 mm in diameter. Another problem is the possibility of stenosis developing as the child grows, since the diameters of the prosthetics are fixed. Other drawbacks are that supra-annular fixation is generally associated with poor outcomes and that annular fixation limits the ability to upsize at reoperation.

The Melody valve is an externally stented bovine jugular vein graft that was designed for transcatheter pulmonary valve replacement. In this study, the valve was inserted surgically. The valve maintains competence over a range of sizes up to 22 mm. Although this valve is not approved for use for mitral valve replacement, the hope of using such a prosthetic is that it can be enlarged in the catheterization laboratory as the child grows.

Dr. Emani conducted a retrospective study of his experience with the Melody valve for mitral valve replacement in eight infants less than 12 months of age. The median age at implantation was 6 months (range, 1-9 months). Four infants had an atrioventricular canal (AVC) defect and four had congenital mitral valve stenosis. Most of the children had two prior operations for mitral valve repair. The longest follow-up to date has been 2 years.

At a median follow-up of 8 months, regurgitation on the echocardiogram was considered to be mild or less in all patients. The median gradient was 3 mm Hg (range, 2-7 mm Hg) on the immediate postoperative echocardiogram. Three patients developed a mild paravalvular leak; one of these patients had undergone aggressive stent resection, a modification Dr. Emani does not recommend. One patient developed left ventricular outflow tract obstruction (LVOTO), which Dr. Emani attributed to the lack of distal stent fixation in this patient. Another patient with an AVC defect developed complete heart block.

One patient who died 3 days postoperatively had heterotaxy, severe mitral regurgitation, and prior ventricular failure on extracorporeal membrane oxygenation support. That patient had undergone valve implantation as a last resort.

Three patients underwent sequential expansion about 6 months after implantation. After valve expansion, the median balloon size was 12 mm, ranging from 12 to 16 mm. None of the patients developed worsening valvular function and all had relief of obstruction. Transcatheter intervention was used to correct a paravalvular leak in one patient and to treat a left ventricular outflow tract problem in another. None of the patients developed endocarditis or a strut fracture, "although I worry about strut fracture if aggressive stent resection and manipulation is performed," Dr. Emani said at the meeting, which was sponsored by the American Association for Thoracic Surgery.

Dr. Emani offered some procedural tips. First, the Melody valve must be optimized for surgical implantation in infants. The length of the valve must be reduced by trimming it to reduce the chance of LVOTO or pulmonary vein obstruction. He recommends sizing the valves by echocardiogram and fixating the distal stent to the inferior free wall of the ventricle.

Although he has used both circumferential and four-point fixation, Dr. Emani has learned all that is really needed to prevent leakage is friction of the stent against the annulus. Early on he used a pericardial cuff to anchor to the annulus, particularly in patients who had undergone failed AVC repair. He tries to preserve at least part of the anterior leaflet to facilitate suture placement and create a "stand-off" from the LVOTO.

Dr. Emani also advised limiting intraoperative dilation to no more than 1 mm greater than the measured annulus. "Try not to overdilate at implantation to avoid heart block, LVOTO, and coronary compression. The nice thing is you don’t have to decide then and there what size you want. You can go back to the cath lab and, under direct visualization with the coronary view, you can dilate it under more controlled circumstances.

"The hope is that we will be able to dilate these valves as the patients grow into adolescence. If we can dilate them up to 22 mm, hopefully we will decrease the number of repeat replacements, delay the time to reoperation, and perhaps modify our thresholds for tolerating significant disease after unsuccessful repairs," he said. The investigators continue to accumulate experience with this device and hope to design a multicenter trial evaluating its safety and efficacy for this indication.

Dr. Emani had no relevant financial disclosures.

[email protected]

NEW YORK – Physicians at Boston Children’s Hospital have replaced the mitral valves of eight infants with irreparable mitral valve disease with a valve that offers the opportunity of sequential expansion as the child grows, according to Dr. Sitaram M. Emani, who described the results at the 2013 Mitral Valve Conclave.

"The Melody valve retains its competence if you expand it before putting it in. We asked whether the valve retains the ability to maintain competence even if expansion is performed after implantation as the patient grows," said Dr. Emani, a pediatric cardiac surgeon at Boston Children’s Hospital.

According to Dr. Emani, the current options for infants with damaged mitral valves that are beyond repair are replacement with mechanical or bioprosthetic valves or the Ross mitral procedure. Perhaps the main disadvantage of these options is the lack of a prosthetic valve small enough for an infant, one that is less than 12 mm in diameter. Another problem is the possibility of stenosis developing as the child grows, since the diameters of the prosthetics are fixed. Other drawbacks are that supra-annular fixation is generally associated with poor outcomes and that annular fixation limits the ability to upsize at reoperation.

The Melody valve is an externally stented bovine jugular vein graft that was designed for transcatheter pulmonary valve replacement. In this study, the valve was inserted surgically. The valve maintains competence over a range of sizes up to 22 mm. Although this valve is not approved for use for mitral valve replacement, the hope of using such a prosthetic is that it can be enlarged in the catheterization laboratory as the child grows.

Dr. Emani conducted a retrospective study of his experience with the Melody valve for mitral valve replacement in eight infants less than 12 months of age. The median age at implantation was 6 months (range, 1-9 months). Four infants had an atrioventricular canal (AVC) defect and four had congenital mitral valve stenosis. Most of the children had two prior operations for mitral valve repair. The longest follow-up to date has been 2 years.

At a median follow-up of 8 months, regurgitation on the echocardiogram was considered to be mild or less in all patients. The median gradient was 3 mm Hg (range, 2-7 mm Hg) on the immediate postoperative echocardiogram. Three patients developed a mild paravalvular leak; one of these patients had undergone aggressive stent resection, a modification Dr. Emani does not recommend. One patient developed left ventricular outflow tract obstruction (LVOTO), which Dr. Emani attributed to the lack of distal stent fixation in this patient. Another patient with an AVC defect developed complete heart block.

One patient who died 3 days postoperatively had heterotaxy, severe mitral regurgitation, and prior ventricular failure on extracorporeal membrane oxygenation support. That patient had undergone valve implantation as a last resort.

Three patients underwent sequential expansion about 6 months after implantation. After valve expansion, the median balloon size was 12 mm, ranging from 12 to 16 mm. None of the patients developed worsening valvular function and all had relief of obstruction. Transcatheter intervention was used to correct a paravalvular leak in one patient and to treat a left ventricular outflow tract problem in another. None of the patients developed endocarditis or a strut fracture, "although I worry about strut fracture if aggressive stent resection and manipulation is performed," Dr. Emani said at the meeting, which was sponsored by the American Association for Thoracic Surgery.

Dr. Emani offered some procedural tips. First, the Melody valve must be optimized for surgical implantation in infants. The length of the valve must be reduced by trimming it to reduce the chance of LVOTO or pulmonary vein obstruction. He recommends sizing the valves by echocardiogram and fixating the distal stent to the inferior free wall of the ventricle.

Although he has used both circumferential and four-point fixation, Dr. Emani has learned all that is really needed to prevent leakage is friction of the stent against the annulus. Early on he used a pericardial cuff to anchor to the annulus, particularly in patients who had undergone failed AVC repair. He tries to preserve at least part of the anterior leaflet to facilitate suture placement and create a "stand-off" from the LVOTO.

Dr. Emani also advised limiting intraoperative dilation to no more than 1 mm greater than the measured annulus. "Try not to overdilate at implantation to avoid heart block, LVOTO, and coronary compression. The nice thing is you don’t have to decide then and there what size you want. You can go back to the cath lab and, under direct visualization with the coronary view, you can dilate it under more controlled circumstances.

"The hope is that we will be able to dilate these valves as the patients grow into adolescence. If we can dilate them up to 22 mm, hopefully we will decrease the number of repeat replacements, delay the time to reoperation, and perhaps modify our thresholds for tolerating significant disease after unsuccessful repairs," he said. The investigators continue to accumulate experience with this device and hope to design a multicenter trial evaluating its safety and efficacy for this indication.

Dr. Emani had no relevant financial disclosures.

[email protected]

SAN DIEGO – Patients who underwent adhesiolysis within 24 hours of hospital admission for acute small bowel obstruction had a significant reduction in 30-day major morbidity, mortality, and hospital length of stay, compared with those who underwent adhesiolysis after 24 hours, results from an analysis of national data showed.

"Historically, the teaching was that surgeons should never let the sun rise and set on a complete small bowel obstruction," Dr. Kristin N. Kelly said at the national conference of the American College of Surgeons/National Surgical Quality Improvement Program. "The consequences of bowel ischemia, perforation, and peritonitis were feared. Interestingly, over the past 2 decades, practice patterns have shifted."

For example, she said, a recent study of data from the 2009 Nationwide Inpatient Sample researchers found that only 18% of patients with small bowel obstruction received surgical intervention and the rest were managed with conservative measures including intravenous fluid and nasogastric decompression (J. Trauma Acute Care Surg. 2013;74:181-7).

In addition, recently released guidelines (World J. Emerg. Surg. 2011;6:5) "have suggested that without peritoneal signs or evidence of bowel ischemia, nonoperative management can be extended for 3-5 days before contrast studies or surgery [is] recommended," said Dr. Kelly of the Surgical Health Outcomes and Research Enterprise (SHORE) and the department of surgery at the University of Rochester (N.Y.) Medical Center. "The concern remains that surgery may be difficult or dangerous or promote additional adhesion formation. Alternatively, delaying surgical treatment may increase morbidity and mortality. We wondered if perhaps we’ve moved too far toward conservative management. We sought to address if there is a benefit to a prompt surgical approach. Our aim was to examine whether adhesiolysis within 24 hours of admission for acute small bowel obstruction is associated with improved 30-day morbidity and mortality compared with those undergoing later adhesiolysis."

She and her associates searched the 2005-2010 American College of Surgeons/National Surgical Quality Improvement Program database for patients who had a diagnosis of adhesive small bowel obstruction. They limited their analysis to patients who were operated on within 1 week of admission. The time from admission to operation was classified as early (within 24 hours) or late (after 24 hours). The groups were compared using univariate and multivariate analysis to examine the association between numerous patient and operative factors.

Of the 8,912 patients who met inclusion criteria, 3,240 (36%) underwent early adhesiolysis while the remaining 5,692 (64%) underwent the procedure late. The mean time to surgery was 1.7 days, while about three-quarters of patients in the late group had surgery between 1 and 3 days after admission.

Compared with patients in the late adhesiolysis group, those in the early adhesiolysis group had higher rates of emergency operations (60% vs. 45%, respectively; P less than .0001), and more laparoscopic operations (19% vs. 13%; P less than .0001), but both groups had similar operative times (a mean of 93 vs. 89 minutes) and similar rates of small bowel resection (27% vs. 28%). The mean postoperative length of stay was about 2 days shorter in the early group (7.4 days vs. 9.5 days; P less than .0001).

"Patients in the early group were slightly younger, had fewer comorbodities, and better functional status," Dr. Kelly added. "But the rates of preoperative sepsis and systemic inflammatory response syndrome were similar."

On multivariate analysis patients in the early adhesiolysis group had 17% fewer major complications (odds ratio, 0.83; P = .005) and a 26% lower mortality rate (OR, 0.74; P = .041) at 30 days, compared with their counterparts in the late adhesiolysis group. The three most common complications were respiratory complications (28%), sepsis/septic shock (25%), and unexpected return to the operating room (18%).

Dr. Kelly acknowledged certain limitations of the study, including the potential for selection bias and that "perhaps surgeons postpone operating on patients with many comorbodities and poorer functional status, or perhaps it takes several days for a surgical referral," she said. "We are also limited because we do not have information regarding all of the clinical, personal, and administrative factors that may go into any individual surgeon’s decision to take a patient to the OR. Finally, we don’t have data on the case difficulty or any intraoperative occurrences. These would be useful in evaluating whether the timing really affected how challenging the case might be." Nevertheless, the findings "support early surgeon involvement and an expeditious approach to small bowel obstruction," she concluded.

Dr. Kelly said she had no relevant financial disclosures.

[email protected]

SAN DIEGO – Patients who underwent adhesiolysis within 24 hours of hospital admission for acute small bowel obstruction had a significant reduction in 30-day major morbidity, mortality, and hospital length of stay, compared with those who underwent adhesiolysis after 24 hours, results from an analysis of national data showed.

"Historically, the teaching was that surgeons should never let the sun rise and set on a complete small bowel obstruction," Dr. Kristin N. Kelly said at the national conference of the American College of Surgeons/National Surgical Quality Improvement Program. "The consequences of bowel ischemia, perforation, and peritonitis were feared. Interestingly, over the past 2 decades, practice patterns have shifted."

For example, she said, a recent study of data from the 2009 Nationwide Inpatient Sample researchers found that only 18% of patients with small bowel obstruction received surgical intervention and the rest were managed with conservative measures including intravenous fluid and nasogastric decompression (J. Trauma Acute Care Surg. 2013;74:181-7).

In addition, recently released guidelines (World J. Emerg. Surg. 2011;6:5) "have suggested that without peritoneal signs or evidence of bowel ischemia, nonoperative management can be extended for 3-5 days before contrast studies or surgery [is] recommended," said Dr. Kelly of the Surgical Health Outcomes and Research Enterprise (SHORE) and the department of surgery at the University of Rochester (N.Y.) Medical Center. "The concern remains that surgery may be difficult or dangerous or promote additional adhesion formation. Alternatively, delaying surgical treatment may increase morbidity and mortality. We wondered if perhaps we’ve moved too far toward conservative management. We sought to address if there is a benefit to a prompt surgical approach. Our aim was to examine whether adhesiolysis within 24 hours of admission for acute small bowel obstruction is associated with improved 30-day morbidity and mortality compared with those undergoing later adhesiolysis."

She and her associates searched the 2005-2010 American College of Surgeons/National Surgical Quality Improvement Program database for patients who had a diagnosis of adhesive small bowel obstruction. They limited their analysis to patients who were operated on within 1 week of admission. The time from admission to operation was classified as early (within 24 hours) or late (after 24 hours). The groups were compared using univariate and multivariate analysis to examine the association between numerous patient and operative factors.

Of the 8,912 patients who met inclusion criteria, 3,240 (36%) underwent early adhesiolysis while the remaining 5,692 (64%) underwent the procedure late. The mean time to surgery was 1.7 days, while about three-quarters of patients in the late group had surgery between 1 and 3 days after admission.

Compared with patients in the late adhesiolysis group, those in the early adhesiolysis group had higher rates of emergency operations (60% vs. 45%, respectively; P less than .0001), and more laparoscopic operations (19% vs. 13%; P less than .0001), but both groups had similar operative times (a mean of 93 vs. 89 minutes) and similar rates of small bowel resection (27% vs. 28%). The mean postoperative length of stay was about 2 days shorter in the early group (7.4 days vs. 9.5 days; P less than .0001).

"Patients in the early group were slightly younger, had fewer comorbodities, and better functional status," Dr. Kelly added. "But the rates of preoperative sepsis and systemic inflammatory response syndrome were similar."

On multivariate analysis patients in the early adhesiolysis group had 17% fewer major complications (odds ratio, 0.83; P = .005) and a 26% lower mortality rate (OR, 0.74; P = .041) at 30 days, compared with their counterparts in the late adhesiolysis group. The three most common complications were respiratory complications (28%), sepsis/septic shock (25%), and unexpected return to the operating room (18%).

Dr. Kelly acknowledged certain limitations of the study, including the potential for selection bias and that "perhaps surgeons postpone operating on patients with many comorbodities and poorer functional status, or perhaps it takes several days for a surgical referral," she said. "We are also limited because we do not have information regarding all of the clinical, personal, and administrative factors that may go into any individual surgeon’s decision to take a patient to the OR. Finally, we don’t have data on the case difficulty or any intraoperative occurrences. These would be useful in evaluating whether the timing really affected how challenging the case might be." Nevertheless, the findings "support early surgeon involvement and an expeditious approach to small bowel obstruction," she concluded.

Dr. Kelly said she had no relevant financial disclosures.

[email protected]

SAN DIEGO – Patients who underwent adhesiolysis within 24 hours of hospital admission for acute small bowel obstruction had a significant reduction in 30-day major morbidity, mortality, and hospital length of stay, compared with those who underwent adhesiolysis after 24 hours, results from an analysis of national data showed.

"Historically, the teaching was that surgeons should never let the sun rise and set on a complete small bowel obstruction," Dr. Kristin N. Kelly said at the national conference of the American College of Surgeons/National Surgical Quality Improvement Program. "The consequences of bowel ischemia, perforation, and peritonitis were feared. Interestingly, over the past 2 decades, practice patterns have shifted."

For example, she said, a recent study of data from the 2009 Nationwide Inpatient Sample researchers found that only 18% of patients with small bowel obstruction received surgical intervention and the rest were managed with conservative measures including intravenous fluid and nasogastric decompression (J. Trauma Acute Care Surg. 2013;74:181-7).

In addition, recently released guidelines (World J. Emerg. Surg. 2011;6:5) "have suggested that without peritoneal signs or evidence of bowel ischemia, nonoperative management can be extended for 3-5 days before contrast studies or surgery [is] recommended," said Dr. Kelly of the Surgical Health Outcomes and Research Enterprise (SHORE) and the department of surgery at the University of Rochester (N.Y.) Medical Center. "The concern remains that surgery may be difficult or dangerous or promote additional adhesion formation. Alternatively, delaying surgical treatment may increase morbidity and mortality. We wondered if perhaps we’ve moved too far toward conservative management. We sought to address if there is a benefit to a prompt surgical approach. Our aim was to examine whether adhesiolysis within 24 hours of admission for acute small bowel obstruction is associated with improved 30-day morbidity and mortality compared with those undergoing later adhesiolysis."

She and her associates searched the 2005-2010 American College of Surgeons/National Surgical Quality Improvement Program database for patients who had a diagnosis of adhesive small bowel obstruction. They limited their analysis to patients who were operated on within 1 week of admission. The time from admission to operation was classified as early (within 24 hours) or late (after 24 hours). The groups were compared using univariate and multivariate analysis to examine the association between numerous patient and operative factors.

Of the 8,912 patients who met inclusion criteria, 3,240 (36%) underwent early adhesiolysis while the remaining 5,692 (64%) underwent the procedure late. The mean time to surgery was 1.7 days, while about three-quarters of patients in the late group had surgery between 1 and 3 days after admission.

Compared with patients in the late adhesiolysis group, those in the early adhesiolysis group had higher rates of emergency operations (60% vs. 45%, respectively; P less than .0001), and more laparoscopic operations (19% vs. 13%; P less than .0001), but both groups had similar operative times (a mean of 93 vs. 89 minutes) and similar rates of small bowel resection (27% vs. 28%). The mean postoperative length of stay was about 2 days shorter in the early group (7.4 days vs. 9.5 days; P less than .0001).

"Patients in the early group were slightly younger, had fewer comorbodities, and better functional status," Dr. Kelly added. "But the rates of preoperative sepsis and systemic inflammatory response syndrome were similar."

On multivariate analysis patients in the early adhesiolysis group had 17% fewer major complications (odds ratio, 0.83; P = .005) and a 26% lower mortality rate (OR, 0.74; P = .041) at 30 days, compared with their counterparts in the late adhesiolysis group. The three most common complications were respiratory complications (28%), sepsis/septic shock (25%), and unexpected return to the operating room (18%).

Dr. Kelly acknowledged certain limitations of the study, including the potential for selection bias and that "perhaps surgeons postpone operating on patients with many comorbodities and poorer functional status, or perhaps it takes several days for a surgical referral," she said. "We are also limited because we do not have information regarding all of the clinical, personal, and administrative factors that may go into any individual surgeon’s decision to take a patient to the OR. Finally, we don’t have data on the case difficulty or any intraoperative occurrences. These would be useful in evaluating whether the timing really affected how challenging the case might be." Nevertheless, the findings "support early surgeon involvement and an expeditious approach to small bowel obstruction," she concluded.

Dr. Kelly said she had no relevant financial disclosures.

[email protected]

SAN DIEGO – Patients who undergo dialysis before cholecystectomy face a significantly higher risk for postoperative morbidity but not mortality, results from a large analysis of national data showed.

"We hope that these data will allow surgeons to quantitate the risks that are associated with operating on these patients and help them to relay that information to their patients preoperatively," Sophia F. Tam said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference. "We also would like to further study why these adverse outcomes are occurring, and any preoperative or preventive measures that we can make in order to avoid these adverse outcomes."

Although cholecystectomy is one of the most commonly performed surgical procedures in the United States, there is a lack of quantitative data on the postoperative risks of the procedure in patients who are undergoing dialysis, said Ms. Tam, a third-year medical student at the State University of New York Downstate Medical Center, Brooklyn.

To examine postoperative outcomes following cholecystectomy in dialysis patients, she and her associates evaluated data from the public use file of the American College of Surgeons National Surgical Quality Improvement Program. The sample included 93,703 patients aged 16 or older who underwent cholecystectomy identified by CPT codes during 2006-2010. Of these, 551 were on chronic dialysis. The researchers used ICD-9 codes to exclude cases caused by trauma and selected a matched control group of 530 nondialysis patients based on age, sex, and surgical approach. Outcomes of interest were morbidity, mortality, and hospital length of stay.

Morbidity was defined as having one or more of the following after cholecystectomy: wound infection, wound disruption, pneumonia, unplanned intubation, pulmonary embolism, being on a ventilator for more than 48 hours, cardiac arrest, myocardial infarction, bleeding requiring transfusion, deep vein thrombosis, sepsis, septic shock, and unplanned return to the operating room.

With univariate analysis, the researchers found that in comparison with nondialysis patients, dialysis patients had higher rates of at least one morbidity (14% vs. 3.6%, respectively), mortality (4.2% vs. 0.3%), and mean hospital length of stay (4.3 vs. 1.2 days). All differences were statistically significant with a P value of less than.0001. Compared with nondialysis patients, dialysis patients had higher rates of infectious, pulmonary, and cardiovascular complications, as well as returns to the OR (all significant with a P value of less than .05).

With multivariate logistic regression adjusted for confounding variables, dialysis patients were more likely than were nondialysis patients to experience at least one morbidity (13.8% vs. 4.7%; adjusted odds ratio 2.3), but there was no difference in mortality between the two groups. Hospital length of stay continued to be significantly higher among dialysis patients, compared with their nondialysis counterparts (a mean of 4.3 vs. 1.4 days; adjusted OR 2.0).

Ms. Tam had no disclosures.

[email protected]

SAN DIEGO – Patients who undergo dialysis before cholecystectomy face a significantly higher risk for postoperative morbidity but not mortality, results from a large analysis of national data showed.

"We hope that these data will allow surgeons to quantitate the risks that are associated with operating on these patients and help them to relay that information to their patients preoperatively," Sophia F. Tam said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference. "We also would like to further study why these adverse outcomes are occurring, and any preoperative or preventive measures that we can make in order to avoid these adverse outcomes."

Although cholecystectomy is one of the most commonly performed surgical procedures in the United States, there is a lack of quantitative data on the postoperative risks of the procedure in patients who are undergoing dialysis, said Ms. Tam, a third-year medical student at the State University of New York Downstate Medical Center, Brooklyn.

To examine postoperative outcomes following cholecystectomy in dialysis patients, she and her associates evaluated data from the public use file of the American College of Surgeons National Surgical Quality Improvement Program. The sample included 93,703 patients aged 16 or older who underwent cholecystectomy identified by CPT codes during 2006-2010. Of these, 551 were on chronic dialysis. The researchers used ICD-9 codes to exclude cases caused by trauma and selected a matched control group of 530 nondialysis patients based on age, sex, and surgical approach. Outcomes of interest were morbidity, mortality, and hospital length of stay.

Morbidity was defined as having one or more of the following after cholecystectomy: wound infection, wound disruption, pneumonia, unplanned intubation, pulmonary embolism, being on a ventilator for more than 48 hours, cardiac arrest, myocardial infarction, bleeding requiring transfusion, deep vein thrombosis, sepsis, septic shock, and unplanned return to the operating room.

With univariate analysis, the researchers found that in comparison with nondialysis patients, dialysis patients had higher rates of at least one morbidity (14% vs. 3.6%, respectively), mortality (4.2% vs. 0.3%), and mean hospital length of stay (4.3 vs. 1.2 days). All differences were statistically significant with a P value of less than.0001. Compared with nondialysis patients, dialysis patients had higher rates of infectious, pulmonary, and cardiovascular complications, as well as returns to the OR (all significant with a P value of less than .05).

With multivariate logistic regression adjusted for confounding variables, dialysis patients were more likely than were nondialysis patients to experience at least one morbidity (13.8% vs. 4.7%; adjusted odds ratio 2.3), but there was no difference in mortality between the two groups. Hospital length of stay continued to be significantly higher among dialysis patients, compared with their nondialysis counterparts (a mean of 4.3 vs. 1.4 days; adjusted OR 2.0).

Ms. Tam had no disclosures.

[email protected]

SAN DIEGO – Patients who undergo dialysis before cholecystectomy face a significantly higher risk for postoperative morbidity but not mortality, results from a large analysis of national data showed.

"We hope that these data will allow surgeons to quantitate the risks that are associated with operating on these patients and help them to relay that information to their patients preoperatively," Sophia F. Tam said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference. "We also would like to further study why these adverse outcomes are occurring, and any preoperative or preventive measures that we can make in order to avoid these adverse outcomes."

Although cholecystectomy is one of the most commonly performed surgical procedures in the United States, there is a lack of quantitative data on the postoperative risks of the procedure in patients who are undergoing dialysis, said Ms. Tam, a third-year medical student at the State University of New York Downstate Medical Center, Brooklyn.

To examine postoperative outcomes following cholecystectomy in dialysis patients, she and her associates evaluated data from the public use file of the American College of Surgeons National Surgical Quality Improvement Program. The sample included 93,703 patients aged 16 or older who underwent cholecystectomy identified by CPT codes during 2006-2010. Of these, 551 were on chronic dialysis. The researchers used ICD-9 codes to exclude cases caused by trauma and selected a matched control group of 530 nondialysis patients based on age, sex, and surgical approach. Outcomes of interest were morbidity, mortality, and hospital length of stay.

Morbidity was defined as having one or more of the following after cholecystectomy: wound infection, wound disruption, pneumonia, unplanned intubation, pulmonary embolism, being on a ventilator for more than 48 hours, cardiac arrest, myocardial infarction, bleeding requiring transfusion, deep vein thrombosis, sepsis, septic shock, and unplanned return to the operating room.

With univariate analysis, the researchers found that in comparison with nondialysis patients, dialysis patients had higher rates of at least one morbidity (14% vs. 3.6%, respectively), mortality (4.2% vs. 0.3%), and mean hospital length of stay (4.3 vs. 1.2 days). All differences were statistically significant with a P value of less than.0001. Compared with nondialysis patients, dialysis patients had higher rates of infectious, pulmonary, and cardiovascular complications, as well as returns to the OR (all significant with a P value of less than .05).

With multivariate logistic regression adjusted for confounding variables, dialysis patients were more likely than were nondialysis patients to experience at least one morbidity (13.8% vs. 4.7%; adjusted odds ratio 2.3), but there was no difference in mortality between the two groups. Hospital length of stay continued to be significantly higher among dialysis patients, compared with their nondialysis counterparts (a mean of 4.3 vs. 1.4 days; adjusted OR 2.0).

Ms. Tam had no disclosures.

[email protected]

Should bariatric surgery be performed in certified centers only? Medicare officials think the answer might be "no."

In a proposed decision memo issued in June, the Centers for Medicare and Medicaid Services said the evidence was sufficient to end the certification requirement and that continuing the current requirements would not improve health outcomes for Medicare beneficiaries.

While some physician experts support the proposal as improving access to bariatric surgery, others express concerns that quality and data collection efforts will suffer.

The proposal does not change which procedures are covered by Medicare. The agency will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a body-mass index of 35 kg/m² or greater who have at least one comorbidity related to obesity and have been unsuccessful with medical treatment for obesity.

If the proposal is accepted, it would reverse the requirements the CMS put in place in February 2006. Since then, Medicare has covered only bariatric procedures performed at facilities that were certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center or by the American Society for Metabolic and Bariatric Surgery as a Bariatric Surgery Center of Excellence.

CMS officials reviewed eight studies to determine if facility certification meaningfully improved health outcomes for Medicare beneficiaries. The studies had "mixed" results, the agency said, but overall, the evidence showed "no consistent statistical or clinically meaningful difference" and there was nothing in the literature to suggest a worsening of outcomes.

The factors that led to the original certification requirements – the rapid growth in bariatric procedures and concerns about higher mortality rates – have changed.

"Since that 2006 determination, bariatric surgery has experienced a trend toward less invasive procedures and lower mortality and complication rates," according to the proposed decision memo.

The policy switch was requested by a trio of health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the university’s Center for Healthcare Outcomes and Policy. They asserted that certified hospitals were no safer than other facilities and that mortality and serious complication rates for bariatric surgery had declined across the country.

They called on the CMS to scrap the certification requirements but to encourage bariatric surgeons to participate in registry programs through their professional societies or through payer-supported collaborative improvement programs such as the one supported by Blue Cross Blue Shield of Michigan.

The Michigan researchers suggested that the agency incentivize physicians to participate in these quality improvement activities by tying them to programs such as the Physician Quality Reporting System.

Dr. Birkmeyer pointed to a study published earlier this year showing that the current certification policy has not led to better outcomes for patients (JAMA 2013;309:792-9). In the study, which Dr. Birkmeyer coauthored, the researchers found no statistically significant improvements in complications or reoperation rates after implementation of the CMS certification requirements after accounting for patient factors, changes in procedure type, and pre-existing time trends toward improved outcomes.

"There is absolutely no controversy about the fact that [the policy] didn’t steer people to safer hospitals," Dr. Birkmeyer said.

Access could improve under the proposed decision memo, Dr. Birkmeyer said. The current certification framework makes it harder for some Medicare patients to undergo bariatric surgery without traveling hours from home. The policy may also be disproportionately affecting minorities and low-income beneficiaries, Dr. Birkmeyer said.

The American College of Surgeons and the American Society for Metabolic and Bariatric Surgery continue to support certification; however, they are working to revise their processes to create a single, unified program that will include a lower volume threshold for certification, dropping from a minimum of 125 cases a year to 50 cases a year, according to Dr. Jaime Ponce, president of the American Society for Metabolic and Bariatric Surgery and a bariatric surgeon in Chattanooga, Tenn.

The volume change should help to address some of the concerns about access by opening up certification to more programs, he said.

But Dr. Ponce said his group plans to fight the "dangerous" CMS proposal to drop certification requirements completely.

"We do believe that this could be very harmful for Medicare patients because if a patient that is very sick shows up in a community hospital that doesn’t have the right structure to take care of obese patients ... accidents are going to start happening again," he said.

The majority of the literature supports facility certification for bariatric surgery, Dr. Ponce said. As for those studies showing no difference in outcomes, the results weren’t reliable because the studies were conducted at a time when most of the facilities included were pursuing certification, he noted. Even those facilities that fell short of meeting certification requirements would have been developing a culture of safety and would likely have met many of the standards.

Dr. Ponce singled out a 2011 study in Annals of Surgery, which evaluated mortality among Medicare patients before and after the certification requirements took effect (Ann. Surg. 2011;254: 860-5). The study, which used Medicare data from 2004-2008, showed that mortality, readmission, and reoperation rates all declined after the coverage decision was implemented. The 90-day mortality rate dropped from 1.5% to 0.7%, while 90-day readmission rates decreased from 19.9% to 15.4%. The researchers also noted a decrease in payments for the procedures.

But gains in safety and cost-effectiveness could be lost if the CMS removes the certification requirements, Dr. Ponce said. Without clear requirements in place, hospitals will be unlikely to make the investments they are making today in equipment, personnel, and training, he said.

Another issue is what will happen to data collection if certification requirements are eliminated. Dr. Ponce said he’s concerned that data collection efforts would dry up without those mandates from the CMS.

"We will not have that data in order to improve the quality that we need to," he said.

A final decision on the coverage memo is expected in the fall.

[email protected]

Should bariatric surgery be performed in certified centers only? Medicare officials think the answer might be "no."

In a proposed decision memo issued in June, the Centers for Medicare and Medicaid Services said the evidence was sufficient to end the certification requirement and that continuing the current requirements would not improve health outcomes for Medicare beneficiaries.

While some physician experts support the proposal as improving access to bariatric surgery, others express concerns that quality and data collection efforts will suffer.

The proposal does not change which procedures are covered by Medicare. The agency will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a body-mass index of 35 kg/m² or greater who have at least one comorbidity related to obesity and have been unsuccessful with medical treatment for obesity.

If the proposal is accepted, it would reverse the requirements the CMS put in place in February 2006. Since then, Medicare has covered only bariatric procedures performed at facilities that were certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center or by the American Society for Metabolic and Bariatric Surgery as a Bariatric Surgery Center of Excellence.

CMS officials reviewed eight studies to determine if facility certification meaningfully improved health outcomes for Medicare beneficiaries. The studies had "mixed" results, the agency said, but overall, the evidence showed "no consistent statistical or clinically meaningful difference" and there was nothing in the literature to suggest a worsening of outcomes.

The factors that led to the original certification requirements – the rapid growth in bariatric procedures and concerns about higher mortality rates – have changed.

"Since that 2006 determination, bariatric surgery has experienced a trend toward less invasive procedures and lower mortality and complication rates," according to the proposed decision memo.

The policy switch was requested by a trio of health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the university’s Center for Healthcare Outcomes and Policy. They asserted that certified hospitals were no safer than other facilities and that mortality and serious complication rates for bariatric surgery had declined across the country.

They called on the CMS to scrap the certification requirements but to encourage bariatric surgeons to participate in registry programs through their professional societies or through payer-supported collaborative improvement programs such as the one supported by Blue Cross Blue Shield of Michigan.

The Michigan researchers suggested that the agency incentivize physicians to participate in these quality improvement activities by tying them to programs such as the Physician Quality Reporting System.

Dr. Birkmeyer pointed to a study published earlier this year showing that the current certification policy has not led to better outcomes for patients (JAMA 2013;309:792-9). In the study, which Dr. Birkmeyer coauthored, the researchers found no statistically significant improvements in complications or reoperation rates after implementation of the CMS certification requirements after accounting for patient factors, changes in procedure type, and pre-existing time trends toward improved outcomes.

"There is absolutely no controversy about the fact that [the policy] didn’t steer people to safer hospitals," Dr. Birkmeyer said.

Access could improve under the proposed decision memo, Dr. Birkmeyer said. The current certification framework makes it harder for some Medicare patients to undergo bariatric surgery without traveling hours from home. The policy may also be disproportionately affecting minorities and low-income beneficiaries, Dr. Birkmeyer said.

The American College of Surgeons and the American Society for Metabolic and Bariatric Surgery continue to support certification; however, they are working to revise their processes to create a single, unified program that will include a lower volume threshold for certification, dropping from a minimum of 125 cases a year to 50 cases a year, according to Dr. Jaime Ponce, president of the American Society for Metabolic and Bariatric Surgery and a bariatric surgeon in Chattanooga, Tenn.

The volume change should help to address some of the concerns about access by opening up certification to more programs, he said.

But Dr. Ponce said his group plans to fight the "dangerous" CMS proposal to drop certification requirements completely.

"We do believe that this could be very harmful for Medicare patients because if a patient that is very sick shows up in a community hospital that doesn’t have the right structure to take care of obese patients ... accidents are going to start happening again," he said.

The majority of the literature supports facility certification for bariatric surgery, Dr. Ponce said. As for those studies showing no difference in outcomes, the results weren’t reliable because the studies were conducted at a time when most of the facilities included were pursuing certification, he noted. Even those facilities that fell short of meeting certification requirements would have been developing a culture of safety and would likely have met many of the standards.

Dr. Ponce singled out a 2011 study in Annals of Surgery, which evaluated mortality among Medicare patients before and after the certification requirements took effect (Ann. Surg. 2011;254: 860-5). The study, which used Medicare data from 2004-2008, showed that mortality, readmission, and reoperation rates all declined after the coverage decision was implemented. The 90-day mortality rate dropped from 1.5% to 0.7%, while 90-day readmission rates decreased from 19.9% to 15.4%. The researchers also noted a decrease in payments for the procedures.

But gains in safety and cost-effectiveness could be lost if the CMS removes the certification requirements, Dr. Ponce said. Without clear requirements in place, hospitals will be unlikely to make the investments they are making today in equipment, personnel, and training, he said.

Another issue is what will happen to data collection if certification requirements are eliminated. Dr. Ponce said he’s concerned that data collection efforts would dry up without those mandates from the CMS.

"We will not have that data in order to improve the quality that we need to," he said.

A final decision on the coverage memo is expected in the fall.

[email protected]

Should bariatric surgery be performed in certified centers only? Medicare officials think the answer might be "no."

In a proposed decision memo issued in June, the Centers for Medicare and Medicaid Services said the evidence was sufficient to end the certification requirement and that continuing the current requirements would not improve health outcomes for Medicare beneficiaries.

While some physician experts support the proposal as improving access to bariatric surgery, others express concerns that quality and data collection efforts will suffer.

The proposal does not change which procedures are covered by Medicare. The agency will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a body-mass index of 35 kg/m² or greater who have at least one comorbidity related to obesity and have been unsuccessful with medical treatment for obesity.

If the proposal is accepted, it would reverse the requirements the CMS put in place in February 2006. Since then, Medicare has covered only bariatric procedures performed at facilities that were certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center or by the American Society for Metabolic and Bariatric Surgery as a Bariatric Surgery Center of Excellence.

CMS officials reviewed eight studies to determine if facility certification meaningfully improved health outcomes for Medicare beneficiaries. The studies had "mixed" results, the agency said, but overall, the evidence showed "no consistent statistical or clinically meaningful difference" and there was nothing in the literature to suggest a worsening of outcomes.

The factors that led to the original certification requirements – the rapid growth in bariatric procedures and concerns about higher mortality rates – have changed.

"Since that 2006 determination, bariatric surgery has experienced a trend toward less invasive procedures and lower mortality and complication rates," according to the proposed decision memo.

The policy switch was requested by a trio of health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the university’s Center for Healthcare Outcomes and Policy. They asserted that certified hospitals were no safer than other facilities and that mortality and serious complication rates for bariatric surgery had declined across the country.

They called on the CMS to scrap the certification requirements but to encourage bariatric surgeons to participate in registry programs through their professional societies or through payer-supported collaborative improvement programs such as the one supported by Blue Cross Blue Shield of Michigan.

The Michigan researchers suggested that the agency incentivize physicians to participate in these quality improvement activities by tying them to programs such as the Physician Quality Reporting System.

Dr. Birkmeyer pointed to a study published earlier this year showing that the current certification policy has not led to better outcomes for patients (JAMA 2013;309:792-9). In the study, which Dr. Birkmeyer coauthored, the researchers found no statistically significant improvements in complications or reoperation rates after implementation of the CMS certification requirements after accounting for patient factors, changes in procedure type, and pre-existing time trends toward improved outcomes.

"There is absolutely no controversy about the fact that [the policy] didn’t steer people to safer hospitals," Dr. Birkmeyer said.

Access could improve under the proposed decision memo, Dr. Birkmeyer said. The current certification framework makes it harder for some Medicare patients to undergo bariatric surgery without traveling hours from home. The policy may also be disproportionately affecting minorities and low-income beneficiaries, Dr. Birkmeyer said.

The American College of Surgeons and the American Society for Metabolic and Bariatric Surgery continue to support certification; however, they are working to revise their processes to create a single, unified program that will include a lower volume threshold for certification, dropping from a minimum of 125 cases a year to 50 cases a year, according to Dr. Jaime Ponce, president of the American Society for Metabolic and Bariatric Surgery and a bariatric surgeon in Chattanooga, Tenn.

The volume change should help to address some of the concerns about access by opening up certification to more programs, he said.

But Dr. Ponce said his group plans to fight the "dangerous" CMS proposal to drop certification requirements completely.

"We do believe that this could be very harmful for Medicare patients because if a patient that is very sick shows up in a community hospital that doesn’t have the right structure to take care of obese patients ... accidents are going to start happening again," he said.

The majority of the literature supports facility certification for bariatric surgery, Dr. Ponce said. As for those studies showing no difference in outcomes, the results weren’t reliable because the studies were conducted at a time when most of the facilities included were pursuing certification, he noted. Even those facilities that fell short of meeting certification requirements would have been developing a culture of safety and would likely have met many of the standards.

Dr. Ponce singled out a 2011 study in Annals of Surgery, which evaluated mortality among Medicare patients before and after the certification requirements took effect (Ann. Surg. 2011;254: 860-5). The study, which used Medicare data from 2004-2008, showed that mortality, readmission, and reoperation rates all declined after the coverage decision was implemented. The 90-day mortality rate dropped from 1.5% to 0.7%, while 90-day readmission rates decreased from 19.9% to 15.4%. The researchers also noted a decrease in payments for the procedures.

But gains in safety and cost-effectiveness could be lost if the CMS removes the certification requirements, Dr. Ponce said. Without clear requirements in place, hospitals will be unlikely to make the investments they are making today in equipment, personnel, and training, he said.

Another issue is what will happen to data collection if certification requirements are eliminated. Dr. Ponce said he’s concerned that data collection efforts would dry up without those mandates from the CMS.

"We will not have that data in order to improve the quality that we need to," he said.

A final decision on the coverage memo is expected in the fall.

[email protected]