General Surgery

Dose homogeneity with intensity-modulated radiotherapy reduced the risk of skin telangiectasia, resulting in superior overall cosmesis for early breast cancer patients in a 5-year single-center trial.

"This study should act as an evidence-based lever for change for radiotherapy centers that have yet to implement breast IMRT (intensity-modulated radiotherapy)," wrote Dr. Mukesh B. Mukesh of Cambridge (England) University Hospitals National Health Service Foundation Trust, and colleagues.

The Cambridge Breast IMRT Trial randomized 1,145 women with early breast cancer to receive either standard radiotherapy or simple intensity-modulated radiotherapy (IMRT), which uses additional irradiation fields to smooth out the dose to the target area.

In the multivariate analysis, significantly fewer patients in the IMRT arm had suboptimal overall cosmesis (OR, 0.65; 95% CI, 0.44 to 0.98; P = .038) and skin telangiectasia (OR, 0.57; 95% CI, 0.34 to 0.95; P = .031), according to data published online in the Journal of Clinical Oncology (doi:10.1200/JCO.2013.49.7842). However the two groups did not significantly differ based on photographically assessed breast shrinkage, clinically assessed edema, tumor bed induration or pigmentation, according to the researchers.

Also, there was no statistically significant difference in 5-year locoregional recurrence and overall survival rates.

Surgical cosmesis had a significant impact on outcomes, as patients with moderate to poor baseline surgical cosmesis were more likely to have suboptimal final cosmesis (OR, 8.15; 95% CI, 6.09 to 10.92; P < .001), tumor bed induration (OR, 1.80; 95% CI, 1.44 to 2.26; P < .001), and photographically assessed breast shrinkage (OR, 1.54; 95% CI, 1.21 to 1.96; P < .001).

Factors such as large breast volume and tumor bed boost were also associated with an increased risk of suboptimal overall cosmesis. Older patients, and those with postoperative breast infections, large breast volume, and tumor bed boost, were also more likely to develop skin telangiectasia.

The patients enrolled in the study all had operable unilateral, histologically confirmed invasive breast cancer or ductal carcinoma in situ requiring radiotherapy after breast-conservation surgery.

All patients were assigned a standard radiotherapy plan. Those with satisfactory dose homogeneity were not randomly assigned but treated with standard radiotherapy and followed up as if randomly assigned, while those whose plan had significant dose inhomogeneity (defined as > or = 2 cm³ volume receiving greater than 107% of the prescribed dose) were randomized between standard radiotherapy (control arm) and simple IMRT.

There were a significant number of patient withdrawals at the 5-year analysis due to factors such as travel difficulties, social issues, and personal choice, and cancer-related factors.

The researchers declared having no conflicts of interest.

Dose homogeneity with intensity-modulated radiotherapy reduced the risk of skin telangiectasia, resulting in superior overall cosmesis for early breast cancer patients in a 5-year single-center trial.

"This study should act as an evidence-based lever for change for radiotherapy centers that have yet to implement breast IMRT (intensity-modulated radiotherapy)," wrote Dr. Mukesh B. Mukesh of Cambridge (England) University Hospitals National Health Service Foundation Trust, and colleagues.

The Cambridge Breast IMRT Trial randomized 1,145 women with early breast cancer to receive either standard radiotherapy or simple intensity-modulated radiotherapy (IMRT), which uses additional irradiation fields to smooth out the dose to the target area.

In the multivariate analysis, significantly fewer patients in the IMRT arm had suboptimal overall cosmesis (OR, 0.65; 95% CI, 0.44 to 0.98; P = .038) and skin telangiectasia (OR, 0.57; 95% CI, 0.34 to 0.95; P = .031), according to data published online in the Journal of Clinical Oncology (doi:10.1200/JCO.2013.49.7842). However the two groups did not significantly differ based on photographically assessed breast shrinkage, clinically assessed edema, tumor bed induration or pigmentation, according to the researchers.

Also, there was no statistically significant difference in 5-year locoregional recurrence and overall survival rates.

Surgical cosmesis had a significant impact on outcomes, as patients with moderate to poor baseline surgical cosmesis were more likely to have suboptimal final cosmesis (OR, 8.15; 95% CI, 6.09 to 10.92; P < .001), tumor bed induration (OR, 1.80; 95% CI, 1.44 to 2.26; P < .001), and photographically assessed breast shrinkage (OR, 1.54; 95% CI, 1.21 to 1.96; P < .001).

Factors such as large breast volume and tumor bed boost were also associated with an increased risk of suboptimal overall cosmesis. Older patients, and those with postoperative breast infections, large breast volume, and tumor bed boost, were also more likely to develop skin telangiectasia.

The patients enrolled in the study all had operable unilateral, histologically confirmed invasive breast cancer or ductal carcinoma in situ requiring radiotherapy after breast-conservation surgery.

All patients were assigned a standard radiotherapy plan. Those with satisfactory dose homogeneity were not randomly assigned but treated with standard radiotherapy and followed up as if randomly assigned, while those whose plan had significant dose inhomogeneity (defined as > or = 2 cm³ volume receiving greater than 107% of the prescribed dose) were randomized between standard radiotherapy (control arm) and simple IMRT.

There were a significant number of patient withdrawals at the 5-year analysis due to factors such as travel difficulties, social issues, and personal choice, and cancer-related factors.

The researchers declared having no conflicts of interest.

Dose homogeneity with intensity-modulated radiotherapy reduced the risk of skin telangiectasia, resulting in superior overall cosmesis for early breast cancer patients in a 5-year single-center trial.

"This study should act as an evidence-based lever for change for radiotherapy centers that have yet to implement breast IMRT (intensity-modulated radiotherapy)," wrote Dr. Mukesh B. Mukesh of Cambridge (England) University Hospitals National Health Service Foundation Trust, and colleagues.

The Cambridge Breast IMRT Trial randomized 1,145 women with early breast cancer to receive either standard radiotherapy or simple intensity-modulated radiotherapy (IMRT), which uses additional irradiation fields to smooth out the dose to the target area.

In the multivariate analysis, significantly fewer patients in the IMRT arm had suboptimal overall cosmesis (OR, 0.65; 95% CI, 0.44 to 0.98; P = .038) and skin telangiectasia (OR, 0.57; 95% CI, 0.34 to 0.95; P = .031), according to data published online in the Journal of Clinical Oncology (doi:10.1200/JCO.2013.49.7842). However the two groups did not significantly differ based on photographically assessed breast shrinkage, clinically assessed edema, tumor bed induration or pigmentation, according to the researchers.

Also, there was no statistically significant difference in 5-year locoregional recurrence and overall survival rates.

Surgical cosmesis had a significant impact on outcomes, as patients with moderate to poor baseline surgical cosmesis were more likely to have suboptimal final cosmesis (OR, 8.15; 95% CI, 6.09 to 10.92; P < .001), tumor bed induration (OR, 1.80; 95% CI, 1.44 to 2.26; P < .001), and photographically assessed breast shrinkage (OR, 1.54; 95% CI, 1.21 to 1.96; P < .001).

Factors such as large breast volume and tumor bed boost were also associated with an increased risk of suboptimal overall cosmesis. Older patients, and those with postoperative breast infections, large breast volume, and tumor bed boost, were also more likely to develop skin telangiectasia.

The patients enrolled in the study all had operable unilateral, histologically confirmed invasive breast cancer or ductal carcinoma in situ requiring radiotherapy after breast-conservation surgery.

All patients were assigned a standard radiotherapy plan. Those with satisfactory dose homogeneity were not randomly assigned but treated with standard radiotherapy and followed up as if randomly assigned, while those whose plan had significant dose inhomogeneity (defined as > or = 2 cm³ volume receiving greater than 107% of the prescribed dose) were randomized between standard radiotherapy (control arm) and simple IMRT.

There were a significant number of patient withdrawals at the 5-year analysis due to factors such as travel difficulties, social issues, and personal choice, and cancer-related factors.

The researchers declared having no conflicts of interest.

SAN FRANCISCO – Regional recurrence and recurrence-free survival rates were statistically similar in subgroups of 730 patients who had sentinel lymph node–positive, invasive breast cancer and underwent total mastectomy.

The outcomes were comparable regardless of whether or not patients had a subsequent completion axillary lymph node dissection and radiation therapy. A marginally higher 10-year regional recurrence rate of 4.9% in patients who did not have completion lymphadenectomy was not significantly different from rates seen in patients who had completion lymphadenectomy but not radiation therapy (1.4% of whom had a regional recurrence) or in patients who had completion lymphadenectomy plus radiation therapy (3.1% had a regional recurrence), in the retrospective institutional study.

Recurrence-free survival rates also did not differ between groups, reported Dr. Elizabeth FitzSullivan and her associates.

Using the M.D. Anderson Cancer Center nomogram to predict whether lymph nodes other than the sentinel node will have cancer, the investigators predicted a significantly lower probability of additional lymph node positivity in the 98 patients who did not undergo completion lymphadenectomy (a median 10% probability), compared with the 632 patients who had a completion lymphadenectomy (23% probability), reported Dr. FitzSullivan of the University of Texas M.D. Anderson Cancer Center, Houston.

"In select patients with early-stage breast cancer treated with mastectomy with a positive sentinel lymph node biopsy, completion lymphadenectomy may be avoided without adversely affecting recurrence or recurrence-free survival," the investigators concluded in a poster presentation at a breast cancer symposium sponsored by the American Society of Clinical Oncology. The study won a Merit Award at the meeting.

The retrospective analysis of data from patients treated at the M.D. Anderson Cancer Center during 1994-2010 defined completion lymphadenectomy as removal of 10 or more lymph nodes. Median follow-up was 66 months.

In general, patients with early-stage breast cancer who are treated with conserving therapy and who have minimal axillary disease on sentinel lymph node biopsy often don’t undergo completion lymphadenectomy. The increasing rate of total mastectomies heightens the need to identify patients who undergo total mastectomy who may not benefit from completion lymphadenectomy and axillary radiation therapy, the researchers noted.

There were several baseline characteristics that differed significantly between patients who did or did not undergo completion lymphadenectomy in the study. Compared with patients who did have completion lymphadenectomy, those who did not undergo the additional axillary surgery were older (57 years vs. 53 years, respectively); had smaller tumors (a median of 2 cm vs. 2.3 cm); and were less likely to have stage T3 disease (8% vs. 17%), lymphovascular invasion (25% vs. 41%), or extranodal extension of disease (4% vs. 24%). The median size of sentinel node metastasis was smaller in patients who did not have completion lymphadenectomy (1.1 mm) compared with those who did (4 mm).

The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.

Dr. FitzSullivan reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Regional recurrence and recurrence-free survival rates were statistically similar in subgroups of 730 patients who had sentinel lymph node–positive, invasive breast cancer and underwent total mastectomy.

The outcomes were comparable regardless of whether or not patients had a subsequent completion axillary lymph node dissection and radiation therapy. A marginally higher 10-year regional recurrence rate of 4.9% in patients who did not have completion lymphadenectomy was not significantly different from rates seen in patients who had completion lymphadenectomy but not radiation therapy (1.4% of whom had a regional recurrence) or in patients who had completion lymphadenectomy plus radiation therapy (3.1% had a regional recurrence), in the retrospective institutional study.

Recurrence-free survival rates also did not differ between groups, reported Dr. Elizabeth FitzSullivan and her associates.

Using the M.D. Anderson Cancer Center nomogram to predict whether lymph nodes other than the sentinel node will have cancer, the investigators predicted a significantly lower probability of additional lymph node positivity in the 98 patients who did not undergo completion lymphadenectomy (a median 10% probability), compared with the 632 patients who had a completion lymphadenectomy (23% probability), reported Dr. FitzSullivan of the University of Texas M.D. Anderson Cancer Center, Houston.

"In select patients with early-stage breast cancer treated with mastectomy with a positive sentinel lymph node biopsy, completion lymphadenectomy may be avoided without adversely affecting recurrence or recurrence-free survival," the investigators concluded in a poster presentation at a breast cancer symposium sponsored by the American Society of Clinical Oncology. The study won a Merit Award at the meeting.

The retrospective analysis of data from patients treated at the M.D. Anderson Cancer Center during 1994-2010 defined completion lymphadenectomy as removal of 10 or more lymph nodes. Median follow-up was 66 months.

In general, patients with early-stage breast cancer who are treated with conserving therapy and who have minimal axillary disease on sentinel lymph node biopsy often don’t undergo completion lymphadenectomy. The increasing rate of total mastectomies heightens the need to identify patients who undergo total mastectomy who may not benefit from completion lymphadenectomy and axillary radiation therapy, the researchers noted.

There were several baseline characteristics that differed significantly between patients who did or did not undergo completion lymphadenectomy in the study. Compared with patients who did have completion lymphadenectomy, those who did not undergo the additional axillary surgery were older (57 years vs. 53 years, respectively); had smaller tumors (a median of 2 cm vs. 2.3 cm); and were less likely to have stage T3 disease (8% vs. 17%), lymphovascular invasion (25% vs. 41%), or extranodal extension of disease (4% vs. 24%). The median size of sentinel node metastasis was smaller in patients who did not have completion lymphadenectomy (1.1 mm) compared with those who did (4 mm).

The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.

Dr. FitzSullivan reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Regional recurrence and recurrence-free survival rates were statistically similar in subgroups of 730 patients who had sentinel lymph node–positive, invasive breast cancer and underwent total mastectomy.

The outcomes were comparable regardless of whether or not patients had a subsequent completion axillary lymph node dissection and radiation therapy. A marginally higher 10-year regional recurrence rate of 4.9% in patients who did not have completion lymphadenectomy was not significantly different from rates seen in patients who had completion lymphadenectomy but not radiation therapy (1.4% of whom had a regional recurrence) or in patients who had completion lymphadenectomy plus radiation therapy (3.1% had a regional recurrence), in the retrospective institutional study.

Recurrence-free survival rates also did not differ between groups, reported Dr. Elizabeth FitzSullivan and her associates.

Using the M.D. Anderson Cancer Center nomogram to predict whether lymph nodes other than the sentinel node will have cancer, the investigators predicted a significantly lower probability of additional lymph node positivity in the 98 patients who did not undergo completion lymphadenectomy (a median 10% probability), compared with the 632 patients who had a completion lymphadenectomy (23% probability), reported Dr. FitzSullivan of the University of Texas M.D. Anderson Cancer Center, Houston.

"In select patients with early-stage breast cancer treated with mastectomy with a positive sentinel lymph node biopsy, completion lymphadenectomy may be avoided without adversely affecting recurrence or recurrence-free survival," the investigators concluded in a poster presentation at a breast cancer symposium sponsored by the American Society of Clinical Oncology. The study won a Merit Award at the meeting.

The retrospective analysis of data from patients treated at the M.D. Anderson Cancer Center during 1994-2010 defined completion lymphadenectomy as removal of 10 or more lymph nodes. Median follow-up was 66 months.

In general, patients with early-stage breast cancer who are treated with conserving therapy and who have minimal axillary disease on sentinel lymph node biopsy often don’t undergo completion lymphadenectomy. The increasing rate of total mastectomies heightens the need to identify patients who undergo total mastectomy who may not benefit from completion lymphadenectomy and axillary radiation therapy, the researchers noted.

There were several baseline characteristics that differed significantly between patients who did or did not undergo completion lymphadenectomy in the study. Compared with patients who did have completion lymphadenectomy, those who did not undergo the additional axillary surgery were older (57 years vs. 53 years, respectively); had smaller tumors (a median of 2 cm vs. 2.3 cm); and were less likely to have stage T3 disease (8% vs. 17%), lymphovascular invasion (25% vs. 41%), or extranodal extension of disease (4% vs. 24%). The median size of sentinel node metastasis was smaller in patients who did not have completion lymphadenectomy (1.1 mm) compared with those who did (4 mm).

The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.

Dr. FitzSullivan reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Preoperative light transmission aggregometry assessments of platelet aggregation may help identify which patients on dual antiplatelet therapy are at greater risk of sustained bleeding from noncardiac surgery, a prospective study of 147 consecutive patients suggests.

The light transmission aggregometry (LTA) assessments of blood drawn immediately before noncardiac surgery were significantly lower in the 32% of patients with sustained bleeding than in the other patients.

All patients were on dual antiplatelet therapy, 95% of them on maintenance therapy with aspirin plus clopidogrel. The timing of the surgery was at the discretion of the surgeons. Treating physicians were blinded to LTA results. The average preoperative washout period for dual antiplatelet therapy was 1.5 days (range, 0-6 days).

The findings of the ongoing study might help define a "bleeding cutoff" measure by LTA to better individualize the timing of surgery, Dr. Wolfgang Toller and his associates suggested in a poster presentation at the annual meeting of the American Society of Anesthesiologists.

In general, approximately 5% of patients in their first year of dual antiplatelet therapy undergo noncardiac surgery, which creates a conundrum for management. Discontinuing dual antiplatelet therapy before noncardiac surgery has been associated with a 20% risk of major adverse cardiac events, but there’s a 20%-40% risk of moderate to severe bleeding if dual antiplatelet therapy is continued during noncardiac surgery, said Dr. Toller of the Medical University of Graz, Austria.

The 147 patients in the study underwent vascular surgery (76%), orthopedic surgery (10%), abdominal surgery (7%), or other surgical procedures (7%). All had been on P2Y12 receptor inhibitors within 7 days before surgery.

Investigators used the Chronolog 700 Lumi-Aggregometer to assess platelet aggregation in preoperative blood, using 5 mcm of adenosine diphosphate as the specific inductor for platelet aggregation.

Overall, they found an average 40% maximum change in light transmission from baseline after adding the adenosine diphosphate to blood samples. In patients with increased bleeding, however, the mean maximum change in light transmission was approximately 30% (suggesting less platelet aggregation), compared with a more than 40% change in patients who bled less from the surgery.

The study used a composite definition of increased bleeding that included TIMI (Thrombolysis in Myocardial Infarction) criteria for major or minor bleeding, any postoperative bleeding requiring reoperation, any platelet transfusion, or at least two packed red blood cells more than the average surgery-specific transfusion requirements at the surgical site.

Dr. Toller reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Preoperative light transmission aggregometry assessments of platelet aggregation may help identify which patients on dual antiplatelet therapy are at greater risk of sustained bleeding from noncardiac surgery, a prospective study of 147 consecutive patients suggests.

The light transmission aggregometry (LTA) assessments of blood drawn immediately before noncardiac surgery were significantly lower in the 32% of patients with sustained bleeding than in the other patients.

All patients were on dual antiplatelet therapy, 95% of them on maintenance therapy with aspirin plus clopidogrel. The timing of the surgery was at the discretion of the surgeons. Treating physicians were blinded to LTA results. The average preoperative washout period for dual antiplatelet therapy was 1.5 days (range, 0-6 days).

The findings of the ongoing study might help define a "bleeding cutoff" measure by LTA to better individualize the timing of surgery, Dr. Wolfgang Toller and his associates suggested in a poster presentation at the annual meeting of the American Society of Anesthesiologists.

In general, approximately 5% of patients in their first year of dual antiplatelet therapy undergo noncardiac surgery, which creates a conundrum for management. Discontinuing dual antiplatelet therapy before noncardiac surgery has been associated with a 20% risk of major adverse cardiac events, but there’s a 20%-40% risk of moderate to severe bleeding if dual antiplatelet therapy is continued during noncardiac surgery, said Dr. Toller of the Medical University of Graz, Austria.

The 147 patients in the study underwent vascular surgery (76%), orthopedic surgery (10%), abdominal surgery (7%), or other surgical procedures (7%). All had been on P2Y12 receptor inhibitors within 7 days before surgery.

Investigators used the Chronolog 700 Lumi-Aggregometer to assess platelet aggregation in preoperative blood, using 5 mcm of adenosine diphosphate as the specific inductor for platelet aggregation.

Overall, they found an average 40% maximum change in light transmission from baseline after adding the adenosine diphosphate to blood samples. In patients with increased bleeding, however, the mean maximum change in light transmission was approximately 30% (suggesting less platelet aggregation), compared with a more than 40% change in patients who bled less from the surgery.

The study used a composite definition of increased bleeding that included TIMI (Thrombolysis in Myocardial Infarction) criteria for major or minor bleeding, any postoperative bleeding requiring reoperation, any platelet transfusion, or at least two packed red blood cells more than the average surgery-specific transfusion requirements at the surgical site.

Dr. Toller reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Preoperative light transmission aggregometry assessments of platelet aggregation may help identify which patients on dual antiplatelet therapy are at greater risk of sustained bleeding from noncardiac surgery, a prospective study of 147 consecutive patients suggests.

The light transmission aggregometry (LTA) assessments of blood drawn immediately before noncardiac surgery were significantly lower in the 32% of patients with sustained bleeding than in the other patients.

All patients were on dual antiplatelet therapy, 95% of them on maintenance therapy with aspirin plus clopidogrel. The timing of the surgery was at the discretion of the surgeons. Treating physicians were blinded to LTA results. The average preoperative washout period for dual antiplatelet therapy was 1.5 days (range, 0-6 days).

The findings of the ongoing study might help define a "bleeding cutoff" measure by LTA to better individualize the timing of surgery, Dr. Wolfgang Toller and his associates suggested in a poster presentation at the annual meeting of the American Society of Anesthesiologists.

In general, approximately 5% of patients in their first year of dual antiplatelet therapy undergo noncardiac surgery, which creates a conundrum for management. Discontinuing dual antiplatelet therapy before noncardiac surgery has been associated with a 20% risk of major adverse cardiac events, but there’s a 20%-40% risk of moderate to severe bleeding if dual antiplatelet therapy is continued during noncardiac surgery, said Dr. Toller of the Medical University of Graz, Austria.

The 147 patients in the study underwent vascular surgery (76%), orthopedic surgery (10%), abdominal surgery (7%), or other surgical procedures (7%). All had been on P2Y12 receptor inhibitors within 7 days before surgery.

Investigators used the Chronolog 700 Lumi-Aggregometer to assess platelet aggregation in preoperative blood, using 5 mcm of adenosine diphosphate as the specific inductor for platelet aggregation.

Overall, they found an average 40% maximum change in light transmission from baseline after adding the adenosine diphosphate to blood samples. In patients with increased bleeding, however, the mean maximum change in light transmission was approximately 30% (suggesting less platelet aggregation), compared with a more than 40% change in patients who bled less from the surgery.

The study used a composite definition of increased bleeding that included TIMI (Thrombolysis in Myocardial Infarction) criteria for major or minor bleeding, any postoperative bleeding requiring reoperation, any platelet transfusion, or at least two packed red blood cells more than the average surgery-specific transfusion requirements at the surgical site.

Dr. Toller reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Patients with triple-negative breast cancer had no higher risk for metastases in the lymph nodes as compared with patients whose breast cancer was not triple-negative, a review of 2,957 cases found.

The study included patients with invasive breast cancer treated surgically between January 2000 and May 2012. Immunohistochemical identification of markers showed that 2,201 (74%) had luminal A subtype breast cancer (estrogen receptor– and progesterone receptor–positive and HER2 negative), 344 (12%) had luminal B subtype (all three markers positive), 144 (5%) were HER2 positive but estrogen and progesterone receptors–negative, and 278 (9%) were negative for all three markers (the triple-negative group). The study excluded men, patients treated with neoadjuvant therapy, patients with distant metastases, and those who did not undergo nodal sampling.

At least one positive lymph node was found in 35% of patients, and four or more positive nodes were found in 10% of patients.

Patients in the triple-negative group were significantly younger at diagnosis and significantly more likely to have higher-grade tumors, compared with patients with other subtypes of breast cancer. Grade 3 cancer was seen in 87% of the triple-negative group and in 27% of the luminal A group, 51% of the luminal B group, and 80% of the HER2-positive group, Dr. Alexandra Gangi and her associates reported at a breast cancer symposium sponsored by the American Society of Clinical Oncology.

In multivariant analyses, younger age, higher tumor grade, larger tumor size, and lymphovascular invasion predicted increased likelihood of lymph node metastases. The triple-negative phenotype predicted neither a higher risk for lymph node positivity nor a greater likelihood of having four or more positive lymph nodes, which was found in 9% of the triple-negative group, 9% of the luminal A group, 14% of the luminal B group, and 19% of the HER2-positive group, reported Dr. Gangi of Cedars-Sinai Hospital, Los Angeles.

The likelihood of lymph node metastases was 50% higher in patients younger than 50 years as compared with older patients, 70% higher with grade 2 cancer as compared with grade 1 cancer, and 90% higher with grade 3 cancer as compared with grade 1 cancer. Lymphovascular invasion increased the likelihood of lymph node involvement four-fold. The risk of lymph node metastases was three times higher in patients with stage T2 breast cancer and 11 times higher in patients with stage T3 disease as compared with those with stage T1 breast cancer. All of these differences were statistically significant.

The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.

Dr. Gangi reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Patients with triple-negative breast cancer had no higher risk for metastases in the lymph nodes as compared with patients whose breast cancer was not triple-negative, a review of 2,957 cases found.

The study included patients with invasive breast cancer treated surgically between January 2000 and May 2012. Immunohistochemical identification of markers showed that 2,201 (74%) had luminal A subtype breast cancer (estrogen receptor– and progesterone receptor–positive and HER2 negative), 344 (12%) had luminal B subtype (all three markers positive), 144 (5%) were HER2 positive but estrogen and progesterone receptors–negative, and 278 (9%) were negative for all three markers (the triple-negative group). The study excluded men, patients treated with neoadjuvant therapy, patients with distant metastases, and those who did not undergo nodal sampling.

At least one positive lymph node was found in 35% of patients, and four or more positive nodes were found in 10% of patients.

Patients in the triple-negative group were significantly younger at diagnosis and significantly more likely to have higher-grade tumors, compared with patients with other subtypes of breast cancer. Grade 3 cancer was seen in 87% of the triple-negative group and in 27% of the luminal A group, 51% of the luminal B group, and 80% of the HER2-positive group, Dr. Alexandra Gangi and her associates reported at a breast cancer symposium sponsored by the American Society of Clinical Oncology.

In multivariant analyses, younger age, higher tumor grade, larger tumor size, and lymphovascular invasion predicted increased likelihood of lymph node metastases. The triple-negative phenotype predicted neither a higher risk for lymph node positivity nor a greater likelihood of having four or more positive lymph nodes, which was found in 9% of the triple-negative group, 9% of the luminal A group, 14% of the luminal B group, and 19% of the HER2-positive group, reported Dr. Gangi of Cedars-Sinai Hospital, Los Angeles.

The likelihood of lymph node metastases was 50% higher in patients younger than 50 years as compared with older patients, 70% higher with grade 2 cancer as compared with grade 1 cancer, and 90% higher with grade 3 cancer as compared with grade 1 cancer. Lymphovascular invasion increased the likelihood of lymph node involvement four-fold. The risk of lymph node metastases was three times higher in patients with stage T2 breast cancer and 11 times higher in patients with stage T3 disease as compared with those with stage T1 breast cancer. All of these differences were statistically significant.

The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.

Dr. Gangi reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Patients with triple-negative breast cancer had no higher risk for metastases in the lymph nodes as compared with patients whose breast cancer was not triple-negative, a review of 2,957 cases found.

The study included patients with invasive breast cancer treated surgically between January 2000 and May 2012. Immunohistochemical identification of markers showed that 2,201 (74%) had luminal A subtype breast cancer (estrogen receptor– and progesterone receptor–positive and HER2 negative), 344 (12%) had luminal B subtype (all three markers positive), 144 (5%) were HER2 positive but estrogen and progesterone receptors–negative, and 278 (9%) were negative for all three markers (the triple-negative group). The study excluded men, patients treated with neoadjuvant therapy, patients with distant metastases, and those who did not undergo nodal sampling.

At least one positive lymph node was found in 35% of patients, and four or more positive nodes were found in 10% of patients.

Patients in the triple-negative group were significantly younger at diagnosis and significantly more likely to have higher-grade tumors, compared with patients with other subtypes of breast cancer. Grade 3 cancer was seen in 87% of the triple-negative group and in 27% of the luminal A group, 51% of the luminal B group, and 80% of the HER2-positive group, Dr. Alexandra Gangi and her associates reported at a breast cancer symposium sponsored by the American Society of Clinical Oncology.

In multivariant analyses, younger age, higher tumor grade, larger tumor size, and lymphovascular invasion predicted increased likelihood of lymph node metastases. The triple-negative phenotype predicted neither a higher risk for lymph node positivity nor a greater likelihood of having four or more positive lymph nodes, which was found in 9% of the triple-negative group, 9% of the luminal A group, 14% of the luminal B group, and 19% of the HER2-positive group, reported Dr. Gangi of Cedars-Sinai Hospital, Los Angeles.

The likelihood of lymph node metastases was 50% higher in patients younger than 50 years as compared with older patients, 70% higher with grade 2 cancer as compared with grade 1 cancer, and 90% higher with grade 3 cancer as compared with grade 1 cancer. Lymphovascular invasion increased the likelihood of lymph node involvement four-fold. The risk of lymph node metastases was three times higher in patients with stage T2 breast cancer and 11 times higher in patients with stage T3 disease as compared with those with stage T1 breast cancer. All of these differences were statistically significant.

The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.

Dr. Gangi reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

ATLANTA – The addition of a comprehensive discharge protocol checklist and follow-up contact for bariatric surgery patients resulted in slightly longer hospital lengths of stay but significant reductions in readmissions.

"I feel the small amount of extra length of stay really supports the 46% overall decrease in readmissions. That’s pretty good," Sharon A. Krzyzanowski, RN, said at Obesity Week, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

To determine if the addition of discharge protocols had helped their bariatric surgery facility reduce the rate of 30-day readmissions, Ms. Krzyzanowski and her colleagues at the Celebration Health Florida Hospital in Orlando retrospectively analyzed patient data both pre- and post-implementation.

They compared the data of 224 Roux-en-Y gastric bypass (RYGB) patients before implementation of the protocols to 242 post-protocol RYGB patients; 125 pre-protocol laparoscopic gastric sleeve (LGS) patients to 178 post-protocol patients; and 100 gastric band patients admitted before the center had the protocols in place, vs. 50 such patients after the protocols.

Discharge protocols stipulated that patients must not be in extreme pain and were able to tolerate their pain medication; that they were not nauseous and were able to tolerate their nausea medication; and that they were able to comfortably drink a minimum of 30 ounces on the day of discharge. Respiratory values also had to be at "status quo," said Ms. Krzyzanowski. If patients did not meet any of those protocols, they were not discharged that day.

The second portion of the protocol that the researchers examined was post-discharge patient follow-up, either by phone or by e-mail. Under the protocol, a nurse contacted patients to discuss mental status, medications, postoperative regime, and any other questions the patients might have.

Patient readmissions were sorted according to reasons of technical concern, such as organ injury or leak; physical issues, such as an infection or a thromboembolic event; or general malaise, such as dehydration or benign abdominal pain.

The investigators determined that readmission rates in RYGB patients declined by 38.3%; 34.7% in LGS patients; and 100% in gastric banding patients.

The hospital length of stay in the RYGB group went from a pre-protocol average of 2.12 days to 2.50 days post protocol; in the LGS group, the average length of stay went from 1.93 to 2.10 average days.

The investigators found there was an overall reduction in readmissions of 46%. Readmissions associated with malaise were reduced from 6.5% to 2.9%; those associated with physical concerns were reduced from 2.9% to 2.1%, said Ms. Krzyzanowski. Technical readmissions did not change significantly.

During the question-and-answer portion of the presentation, Ms. Krzyzanowski said in response to a query about reimbursements for keeping patients an extra day, "As long as it’s documented why the patient is staying, insurance will review that and they will be fine. We have not had anybody denied for a third day."

Ms. Krzyzanowski, Dr. Kim, and Dr. Buffington reported no relevant disclosures.

[email protected]

ATLANTA – The addition of a comprehensive discharge protocol checklist and follow-up contact for bariatric surgery patients resulted in slightly longer hospital lengths of stay but significant reductions in readmissions.

"I feel the small amount of extra length of stay really supports the 46% overall decrease in readmissions. That’s pretty good," Sharon A. Krzyzanowski, RN, said at Obesity Week, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

To determine if the addition of discharge protocols had helped their bariatric surgery facility reduce the rate of 30-day readmissions, Ms. Krzyzanowski and her colleagues at the Celebration Health Florida Hospital in Orlando retrospectively analyzed patient data both pre- and post-implementation.

They compared the data of 224 Roux-en-Y gastric bypass (RYGB) patients before implementation of the protocols to 242 post-protocol RYGB patients; 125 pre-protocol laparoscopic gastric sleeve (LGS) patients to 178 post-protocol patients; and 100 gastric band patients admitted before the center had the protocols in place, vs. 50 such patients after the protocols.

Discharge protocols stipulated that patients must not be in extreme pain and were able to tolerate their pain medication; that they were not nauseous and were able to tolerate their nausea medication; and that they were able to comfortably drink a minimum of 30 ounces on the day of discharge. Respiratory values also had to be at "status quo," said Ms. Krzyzanowski. If patients did not meet any of those protocols, they were not discharged that day.

The second portion of the protocol that the researchers examined was post-discharge patient follow-up, either by phone or by e-mail. Under the protocol, a nurse contacted patients to discuss mental status, medications, postoperative regime, and any other questions the patients might have.

Patient readmissions were sorted according to reasons of technical concern, such as organ injury or leak; physical issues, such as an infection or a thromboembolic event; or general malaise, such as dehydration or benign abdominal pain.

The investigators determined that readmission rates in RYGB patients declined by 38.3%; 34.7% in LGS patients; and 100% in gastric banding patients.

The hospital length of stay in the RYGB group went from a pre-protocol average of 2.12 days to 2.50 days post protocol; in the LGS group, the average length of stay went from 1.93 to 2.10 average days.

The investigators found there was an overall reduction in readmissions of 46%. Readmissions associated with malaise were reduced from 6.5% to 2.9%; those associated with physical concerns were reduced from 2.9% to 2.1%, said Ms. Krzyzanowski. Technical readmissions did not change significantly.

During the question-and-answer portion of the presentation, Ms. Krzyzanowski said in response to a query about reimbursements for keeping patients an extra day, "As long as it’s documented why the patient is staying, insurance will review that and they will be fine. We have not had anybody denied for a third day."

Ms. Krzyzanowski, Dr. Kim, and Dr. Buffington reported no relevant disclosures.

[email protected]

ATLANTA – The addition of a comprehensive discharge protocol checklist and follow-up contact for bariatric surgery patients resulted in slightly longer hospital lengths of stay but significant reductions in readmissions.

"I feel the small amount of extra length of stay really supports the 46% overall decrease in readmissions. That’s pretty good," Sharon A. Krzyzanowski, RN, said at Obesity Week, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

To determine if the addition of discharge protocols had helped their bariatric surgery facility reduce the rate of 30-day readmissions, Ms. Krzyzanowski and her colleagues at the Celebration Health Florida Hospital in Orlando retrospectively analyzed patient data both pre- and post-implementation.

They compared the data of 224 Roux-en-Y gastric bypass (RYGB) patients before implementation of the protocols to 242 post-protocol RYGB patients; 125 pre-protocol laparoscopic gastric sleeve (LGS) patients to 178 post-protocol patients; and 100 gastric band patients admitted before the center had the protocols in place, vs. 50 such patients after the protocols.

Discharge protocols stipulated that patients must not be in extreme pain and were able to tolerate their pain medication; that they were not nauseous and were able to tolerate their nausea medication; and that they were able to comfortably drink a minimum of 30 ounces on the day of discharge. Respiratory values also had to be at "status quo," said Ms. Krzyzanowski. If patients did not meet any of those protocols, they were not discharged that day.

The second portion of the protocol that the researchers examined was post-discharge patient follow-up, either by phone or by e-mail. Under the protocol, a nurse contacted patients to discuss mental status, medications, postoperative regime, and any other questions the patients might have.

Patient readmissions were sorted according to reasons of technical concern, such as organ injury or leak; physical issues, such as an infection or a thromboembolic event; or general malaise, such as dehydration or benign abdominal pain.

The investigators determined that readmission rates in RYGB patients declined by 38.3%; 34.7% in LGS patients; and 100% in gastric banding patients.

The hospital length of stay in the RYGB group went from a pre-protocol average of 2.12 days to 2.50 days post protocol; in the LGS group, the average length of stay went from 1.93 to 2.10 average days.

The investigators found there was an overall reduction in readmissions of 46%. Readmissions associated with malaise were reduced from 6.5% to 2.9%; those associated with physical concerns were reduced from 2.9% to 2.1%, said Ms. Krzyzanowski. Technical readmissions did not change significantly.

During the question-and-answer portion of the presentation, Ms. Krzyzanowski said in response to a query about reimbursements for keeping patients an extra day, "As long as it’s documented why the patient is staying, insurance will review that and they will be fine. We have not had anybody denied for a third day."

Ms. Krzyzanowski, Dr. Kim, and Dr. Buffington reported no relevant disclosures.

[email protected]

SAN FRANCISCO – Patients under general anesthesia may be getting insufficient neuromuscular blockade in 1%-45% of operations, depending on the definition, according to several studies presented in a joint session at the annual meeting of the American Society of Anesthesiologists.

Regardless of the exact definition, the findings suggest that the problem of insufficient blockade is considerably more common than expected, the anesthesiologists in attendance agreed.

A lack of clinical guidelines for neuromuscular blockade probably contributes to the problem, some speakers suggested. There is no established definition of insufficient neuromuscular blockade, which has been associated in prior studies with compromised surgical visualization, impaired ventilation leading to barotraumas, direct injury through unexpected movement, and other complications.

Investigators presented their results in posters and in a joint discussion session at the meeting. All studies were sponsored by Merck, which markets a neuromuscular blocking agent (rocuronium bromide, or Zemuron) and is seeking U.S. approval for a drug that rapidly reverses neuromuscular blockade (sugammadex, or Bridion).

One percent of 129,209 adults who underwent general anesthesia and received a nondepolarizing neuromuscular blockade agent in 2005-2013 experienced insufficient blockade in a way that interrupted surgery, either through undesired patient movement (0.3%) or an explicit request from the surgeon for additional muscle relaxation and administration of more neuromuscular blockade (0.7%), Dr. Timur Dubovoy and his associates reported.

They also found indirect evidence of insufficient neuromuscular blockade through two other criteria that were much more common, said Dr. Dubovoy of the University of Michigan, Ann Arbor. Anesthesiologists gave more neuromuscular blockade after documenting twitches on peripheral nerve stimulation (train-of-four monitoring) in 39% of patients, indicative of unintended recovery from neuromuscular blockade. Large or even "excessive" maintenance doses were given to 45% of patients, consistent with insufficient neuromuscular blockade, he said.

Those kinds of events typically don’t interrupt a procedure but can lead to residual neuromuscular blockade due to excessive dosing, potentially increasing complications and delaying recovery after anesthesia. The study looked only at the incidence of insufficient neuromuscular blockade, however, not outcomes.

"Current use of nondepolarizing neuromuscular blockade agents and subjective tactile train-of-four monitoring frequently exposes patients to inadequate neuromuscular blockade," Dr. Dubovoy said.

In a separate study, insufficient neuromuscular blockade affected 21%-28% of 48,315 adults undergoing abdominal, laparoscopic, and interventional neurovascular procedures at the Cleveland Clinic in 2005-2013, Dr. Brian D. Hesler and his associates reported.

"Our results suggest that insufficient block is relatively common, even in operations that are generally thought to require muscle relaxation," said Dr. Hesler of the Cleveland Clinic. "It is difficult to separate inadequate anesthesia from inadequate neuromuscular block, and both probably contributed in many cases."

He and his associates formed a panel of seven experienced anesthesiologists to identify anesthesiology actions that are indicative of episodes of insufficient neuromuscular block and searched for those criteria in patient records, with a three-person adjudication committee approving the search criteria through a random sample of at least 50 charts for each criterion.

Overall, 28% of operations had evidence of insufficient neuromuscular blockade, or 21% if the investigators excluded cases identified solely by electromyogram criteria.

In a separate analysis of the same cohort, Dr. Hesler and his associates searched for comments in the anesthetic records and found that insufficient blockade usually was identified more than 30 minutes before emergence, defined as the time when maintenance anesthesia was discontinued (106 cases), but 18% of the time it occurred 15-30 minutes before emergence (9 cases) or less than 15 minutes before emergence (14 cases).

The closer to the end of surgery, the more likely the anesthesiologist was to respond by deepening anesthesia instead of redosing the neuromuscular blocking agent, with other sedatives (opioids) used at a consistent rate in each time period.

A separate prospective, observational study of 448 patients undergoing elective laparoscopic or open abdominal surgical procedures at eight Canadian centers in 2011-2012 stratified residual neuromuscular blockade by train-of-four (TOF) ratios.

Lower TOF ratios at tracheal extubation and at arrival in the postanesthesia care unit (PACU) were associated with greater risk for complications and greater use of perioperative resources, Dr. Dolores McKeen and her associates reported.

Every 0.1-increment increase in the TOF ratio at tracheal extubation was associated with a 30% reduction in the odds of needing placement of an oral or nasal airway due to upper airway obstruction from the time of patient extubation to PACU discharge. Each 0.1-increment increase in the TOF ratio at tracheal extubation also was associated with 3% fewer bed visits by nurses, said Dr. McKeen of Dalhousie University, Halifax, N.S. Similar results were seen for TOF ratios upon arrival at the PACU.

This suggests that "more effective strategies to prevent and/or manage residual neuromuscular blockade are required to minimize the impact on the patient and health care provider," she said.

The incidence of postoperative residual neuromuscular blockade was 19% for patients with a TOF ratio less than 0.6 at tracheal extubation, 12% with a ratio of 0.6-0.7, 9% with a ratio of 0.7-0.8, 16% with a ratio of 0.8-0.9, and 44% with a ratio of 0.9 or greater. The incidence of residual blockade was 8% for patients with a TOF ratio less than 0.6 upon arrival to the PACU, 7% with a ratio of 0.6-0.7, 14% with a ratio of 0.7-0.8, 16% with a ratio of 0.8-0.9, and 56% with a ratio of 0.9 or greater.

In the United States, neostigmine, an acetylcholinesterase inhibitor, is the most common means of reversing neuromuscular blocking agents, according to Scott Devine, Ph.D., of Merck. Giving neostigmine too early can be ineffective, and giving it too late might induce skeletal muscle weakness.

He and his associates analyzed data from the Anesthesia Quality Institute’s National Anesthesia Clinical Outcomes Registry (NACOR) on 113,276 procedures utilizing rocuronium or vecuronium that were reversed with neostigmine in 2010-2012. The reversal agent was given a mean of 63 minutes after the last dose of a neuromuscular blocking agent, 7 minutes before surgical site closure, 14 minutes prior to emergence, and 29 minutes before the end of anesthesia time, though each administration time had a wide range, he reported.

A substantial number of patients would have spontaneously recovered from the effects of the neuromuscular blockers after 63 minutes, suggesting that neostigmine often may be given later than needed, he said. If neostigmine is given 7 minutes before surgical site closure, reversal of neuromuscular blockade could be well underway, resulting in increased muscle tension during surgical site closure, which could increase the risk of complications such as dehiscence or postsurgical hernias, he added.

The large variability in practice may be due to multiple factors and deserves further research, he said.

Merck, which markets a neuromuscular blockade agent, sponsored the studies and supplied at least one investigator for each study.

[email protected] On Twitter @sherryboschert

SAN FRANCISCO – Patients under general anesthesia may be getting insufficient neuromuscular blockade in 1%-45% of operations, depending on the definition, according to several studies presented in a joint session at the annual meeting of the American Society of Anesthesiologists.

Regardless of the exact definition, the findings suggest that the problem of insufficient blockade is considerably more common than expected, the anesthesiologists in attendance agreed.

A lack of clinical guidelines for neuromuscular blockade probably contributes to the problem, some speakers suggested. There is no established definition of insufficient neuromuscular blockade, which has been associated in prior studies with compromised surgical visualization, impaired ventilation leading to barotraumas, direct injury through unexpected movement, and other complications.

Investigators presented their results in posters and in a joint discussion session at the meeting. All studies were sponsored by Merck, which markets a neuromuscular blocking agent (rocuronium bromide, or Zemuron) and is seeking U.S. approval for a drug that rapidly reverses neuromuscular blockade (sugammadex, or Bridion).

One percent of 129,209 adults who underwent general anesthesia and received a nondepolarizing neuromuscular blockade agent in 2005-2013 experienced insufficient blockade in a way that interrupted surgery, either through undesired patient movement (0.3%) or an explicit request from the surgeon for additional muscle relaxation and administration of more neuromuscular blockade (0.7%), Dr. Timur Dubovoy and his associates reported.

They also found indirect evidence of insufficient neuromuscular blockade through two other criteria that were much more common, said Dr. Dubovoy of the University of Michigan, Ann Arbor. Anesthesiologists gave more neuromuscular blockade after documenting twitches on peripheral nerve stimulation (train-of-four monitoring) in 39% of patients, indicative of unintended recovery from neuromuscular blockade. Large or even "excessive" maintenance doses were given to 45% of patients, consistent with insufficient neuromuscular blockade, he said.

Those kinds of events typically don’t interrupt a procedure but can lead to residual neuromuscular blockade due to excessive dosing, potentially increasing complications and delaying recovery after anesthesia. The study looked only at the incidence of insufficient neuromuscular blockade, however, not outcomes.

"Current use of nondepolarizing neuromuscular blockade agents and subjective tactile train-of-four monitoring frequently exposes patients to inadequate neuromuscular blockade," Dr. Dubovoy said.

In a separate study, insufficient neuromuscular blockade affected 21%-28% of 48,315 adults undergoing abdominal, laparoscopic, and interventional neurovascular procedures at the Cleveland Clinic in 2005-2013, Dr. Brian D. Hesler and his associates reported.

"Our results suggest that insufficient block is relatively common, even in operations that are generally thought to require muscle relaxation," said Dr. Hesler of the Cleveland Clinic. "It is difficult to separate inadequate anesthesia from inadequate neuromuscular block, and both probably contributed in many cases."

He and his associates formed a panel of seven experienced anesthesiologists to identify anesthesiology actions that are indicative of episodes of insufficient neuromuscular block and searched for those criteria in patient records, with a three-person adjudication committee approving the search criteria through a random sample of at least 50 charts for each criterion.

Overall, 28% of operations had evidence of insufficient neuromuscular blockade, or 21% if the investigators excluded cases identified solely by electromyogram criteria.

In a separate analysis of the same cohort, Dr. Hesler and his associates searched for comments in the anesthetic records and found that insufficient blockade usually was identified more than 30 minutes before emergence, defined as the time when maintenance anesthesia was discontinued (106 cases), but 18% of the time it occurred 15-30 minutes before emergence (9 cases) or less than 15 minutes before emergence (14 cases).

The closer to the end of surgery, the more likely the anesthesiologist was to respond by deepening anesthesia instead of redosing the neuromuscular blocking agent, with other sedatives (opioids) used at a consistent rate in each time period.

A separate prospective, observational study of 448 patients undergoing elective laparoscopic or open abdominal surgical procedures at eight Canadian centers in 2011-2012 stratified residual neuromuscular blockade by train-of-four (TOF) ratios.

Lower TOF ratios at tracheal extubation and at arrival in the postanesthesia care unit (PACU) were associated with greater risk for complications and greater use of perioperative resources, Dr. Dolores McKeen and her associates reported.

Every 0.1-increment increase in the TOF ratio at tracheal extubation was associated with a 30% reduction in the odds of needing placement of an oral or nasal airway due to upper airway obstruction from the time of patient extubation to PACU discharge. Each 0.1-increment increase in the TOF ratio at tracheal extubation also was associated with 3% fewer bed visits by nurses, said Dr. McKeen of Dalhousie University, Halifax, N.S. Similar results were seen for TOF ratios upon arrival at the PACU.

This suggests that "more effective strategies to prevent and/or manage residual neuromuscular blockade are required to minimize the impact on the patient and health care provider," she said.

The incidence of postoperative residual neuromuscular blockade was 19% for patients with a TOF ratio less than 0.6 at tracheal extubation, 12% with a ratio of 0.6-0.7, 9% with a ratio of 0.7-0.8, 16% with a ratio of 0.8-0.9, and 44% with a ratio of 0.9 or greater. The incidence of residual blockade was 8% for patients with a TOF ratio less than 0.6 upon arrival to the PACU, 7% with a ratio of 0.6-0.7, 14% with a ratio of 0.7-0.8, 16% with a ratio of 0.8-0.9, and 56% with a ratio of 0.9 or greater.

In the United States, neostigmine, an acetylcholinesterase inhibitor, is the most common means of reversing neuromuscular blocking agents, according to Scott Devine, Ph.D., of Merck. Giving neostigmine too early can be ineffective, and giving it too late might induce skeletal muscle weakness.

He and his associates analyzed data from the Anesthesia Quality Institute’s National Anesthesia Clinical Outcomes Registry (NACOR) on 113,276 procedures utilizing rocuronium or vecuronium that were reversed with neostigmine in 2010-2012. The reversal agent was given a mean of 63 minutes after the last dose of a neuromuscular blocking agent, 7 minutes before surgical site closure, 14 minutes prior to emergence, and 29 minutes before the end of anesthesia time, though each administration time had a wide range, he reported.

A substantial number of patients would have spontaneously recovered from the effects of the neuromuscular blockers after 63 minutes, suggesting that neostigmine often may be given later than needed, he said. If neostigmine is given 7 minutes before surgical site closure, reversal of neuromuscular blockade could be well underway, resulting in increased muscle tension during surgical site closure, which could increase the risk of complications such as dehiscence or postsurgical hernias, he added.

The large variability in practice may be due to multiple factors and deserves further research, he said.

Merck, which markets a neuromuscular blockade agent, sponsored the studies and supplied at least one investigator for each study.

[email protected] On Twitter @sherryboschert

SAN FRANCISCO – Patients under general anesthesia may be getting insufficient neuromuscular blockade in 1%-45% of operations, depending on the definition, according to several studies presented in a joint session at the annual meeting of the American Society of Anesthesiologists.

Regardless of the exact definition, the findings suggest that the problem of insufficient blockade is considerably more common than expected, the anesthesiologists in attendance agreed.

A lack of clinical guidelines for neuromuscular blockade probably contributes to the problem, some speakers suggested. There is no established definition of insufficient neuromuscular blockade, which has been associated in prior studies with compromised surgical visualization, impaired ventilation leading to barotraumas, direct injury through unexpected movement, and other complications.

Investigators presented their results in posters and in a joint discussion session at the meeting. All studies were sponsored by Merck, which markets a neuromuscular blocking agent (rocuronium bromide, or Zemuron) and is seeking U.S. approval for a drug that rapidly reverses neuromuscular blockade (sugammadex, or Bridion).

One percent of 129,209 adults who underwent general anesthesia and received a nondepolarizing neuromuscular blockade agent in 2005-2013 experienced insufficient blockade in a way that interrupted surgery, either through undesired patient movement (0.3%) or an explicit request from the surgeon for additional muscle relaxation and administration of more neuromuscular blockade (0.7%), Dr. Timur Dubovoy and his associates reported.

They also found indirect evidence of insufficient neuromuscular blockade through two other criteria that were much more common, said Dr. Dubovoy of the University of Michigan, Ann Arbor. Anesthesiologists gave more neuromuscular blockade after documenting twitches on peripheral nerve stimulation (train-of-four monitoring) in 39% of patients, indicative of unintended recovery from neuromuscular blockade. Large or even "excessive" maintenance doses were given to 45% of patients, consistent with insufficient neuromuscular blockade, he said.

Those kinds of events typically don’t interrupt a procedure but can lead to residual neuromuscular blockade due to excessive dosing, potentially increasing complications and delaying recovery after anesthesia. The study looked only at the incidence of insufficient neuromuscular blockade, however, not outcomes.

"Current use of nondepolarizing neuromuscular blockade agents and subjective tactile train-of-four monitoring frequently exposes patients to inadequate neuromuscular blockade," Dr. Dubovoy said.

In a separate study, insufficient neuromuscular blockade affected 21%-28% of 48,315 adults undergoing abdominal, laparoscopic, and interventional neurovascular procedures at the Cleveland Clinic in 2005-2013, Dr. Brian D. Hesler and his associates reported.

"Our results suggest that insufficient block is relatively common, even in operations that are generally thought to require muscle relaxation," said Dr. Hesler of the Cleveland Clinic. "It is difficult to separate inadequate anesthesia from inadequate neuromuscular block, and both probably contributed in many cases."

He and his associates formed a panel of seven experienced anesthesiologists to identify anesthesiology actions that are indicative of episodes of insufficient neuromuscular block and searched for those criteria in patient records, with a three-person adjudication committee approving the search criteria through a random sample of at least 50 charts for each criterion.

Overall, 28% of operations had evidence of insufficient neuromuscular blockade, or 21% if the investigators excluded cases identified solely by electromyogram criteria.

In a separate analysis of the same cohort, Dr. Hesler and his associates searched for comments in the anesthetic records and found that insufficient blockade usually was identified more than 30 minutes before emergence, defined as the time when maintenance anesthesia was discontinued (106 cases), but 18% of the time it occurred 15-30 minutes before emergence (9 cases) or less than 15 minutes before emergence (14 cases).

The closer to the end of surgery, the more likely the anesthesiologist was to respond by deepening anesthesia instead of redosing the neuromuscular blocking agent, with other sedatives (opioids) used at a consistent rate in each time period.

A separate prospective, observational study of 448 patients undergoing elective laparoscopic or open abdominal surgical procedures at eight Canadian centers in 2011-2012 stratified residual neuromuscular blockade by train-of-four (TOF) ratios.

Lower TOF ratios at tracheal extubation and at arrival in the postanesthesia care unit (PACU) were associated with greater risk for complications and greater use of perioperative resources, Dr. Dolores McKeen and her associates reported.

Every 0.1-increment increase in the TOF ratio at tracheal extubation was associated with a 30% reduction in the odds of needing placement of an oral or nasal airway due to upper airway obstruction from the time of patient extubation to PACU discharge. Each 0.1-increment increase in the TOF ratio at tracheal extubation also was associated with 3% fewer bed visits by nurses, said Dr. McKeen of Dalhousie University, Halifax, N.S. Similar results were seen for TOF ratios upon arrival at the PACU.

This suggests that "more effective strategies to prevent and/or manage residual neuromuscular blockade are required to minimize the impact on the patient and health care provider," she said.

The incidence of postoperative residual neuromuscular blockade was 19% for patients with a TOF ratio less than 0.6 at tracheal extubation, 12% with a ratio of 0.6-0.7, 9% with a ratio of 0.7-0.8, 16% with a ratio of 0.8-0.9, and 44% with a ratio of 0.9 or greater. The incidence of residual blockade was 8% for patients with a TOF ratio less than 0.6 upon arrival to the PACU, 7% with a ratio of 0.6-0.7, 14% with a ratio of 0.7-0.8, 16% with a ratio of 0.8-0.9, and 56% with a ratio of 0.9 or greater.

In the United States, neostigmine, an acetylcholinesterase inhibitor, is the most common means of reversing neuromuscular blocking agents, according to Scott Devine, Ph.D., of Merck. Giving neostigmine too early can be ineffective, and giving it too late might induce skeletal muscle weakness.

He and his associates analyzed data from the Anesthesia Quality Institute’s National Anesthesia Clinical Outcomes Registry (NACOR) on 113,276 procedures utilizing rocuronium or vecuronium that were reversed with neostigmine in 2010-2012. The reversal agent was given a mean of 63 minutes after the last dose of a neuromuscular blocking agent, 7 minutes before surgical site closure, 14 minutes prior to emergence, and 29 minutes before the end of anesthesia time, though each administration time had a wide range, he reported.

A substantial number of patients would have spontaneously recovered from the effects of the neuromuscular blockers after 63 minutes, suggesting that neostigmine often may be given later than needed, he said. If neostigmine is given 7 minutes before surgical site closure, reversal of neuromuscular blockade could be well underway, resulting in increased muscle tension during surgical site closure, which could increase the risk of complications such as dehiscence or postsurgical hernias, he added.

The large variability in practice may be due to multiple factors and deserves further research, he said.

Merck, which markets a neuromuscular blockade agent, sponsored the studies and supplied at least one investigator for each study.

[email protected] On Twitter @sherryboschert

WASHINGTON – One year out from surgery, gastric bypass, gastric sleeve, and gastric banding all showed considerable reductions in cardiac risk factors, but gastric bypass showed the greatest risk reduction of all three, as well as greater improvement in body mass index, according to a study presented at this year’s annual clinical congress of the American College of Surgeons.

Baseline and 1-year postoperative data were collected on 1,398 consecutive bariatric surgery patients by Christopher S. Crowe and his colleagues at Stanford (Calif.) University. The investigators sought to evaluate each type of surgery’s effect on biochemical cardiovascular risk factors. The follow-up rate at 12 months was 77%.

The values measured were hemoglobin A_1c, fasting insulin, high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, triglycerides, high-sensitivity C-reactive protein (CRP), homocysteine, and lipoprotein (a).

Across the three groups, bypass patients tended to be younger by 1-2 years (mean age of this group was 44.3 years), and they had a higher baseline body mass index on average.

Excess weight loss after 1 year averaged 75% in the bypass patients, 55% in the patients with a sleeve, and 40% in those with a band.

When analyzing laboratory values for each group, the investigators found that fasting insulin levels were notably improved in all three groups; but at an improvement rate of 67.0%, the bypass patients had more than double the improvement of the gastric-band patients, while the gastric-sleeve patients showed a 63.7% improvement rate.

The CRP levels also improved dramatically in the bypass patients (67.1%), especially when compared with the band (21.2%) and sleeve (26.3%) groups. In addition, the ratio between triglycerides and HDL, a strong predictor of cardiovascular events, was differentially most improved in the bypass patients (38.5%), although improvement was also seen in both band (20.6%) and sleeve (35.2%) groups.

The investigators also sought to correlate each bariatric procedure’s resultant weight loss to improvement in specific cardiac risk factors. Only bypass was found to have a correlate between weight loss and total cholesterol and LDL reduction.

The triglyceride/HDL ratio improved with weight loss in both the bypass and band surgical groups. However, patients over age 50 and with a BMI greater than 50 kg/m² had the least improvement in this ratio.

Reduction in CRP level was not found to be related to weight loss for any of the procedures, although CRP did improve substantially after all three operations, primarily in bypass patients. In response to a question from an audience member, Mr. Crowe, a medical student, said this was probably because of changes in patient lifestyle, diet, and medications, as well as smoking cessation, postoperatively.

"When someone comes in for a bariatric procedure, they’re not just receiving the surgery, they are changing a lot about their life," said Mr. Crowe. "Those changes could, in effect, decrease the CRP levels after surgery, without it being weight loss–dependent."

Mr. Crowe reported no relevant disclosures. His coinvestigators reported serving as consultants to Ethicon and Covidien.

[email protected]

WASHINGTON – One year out from surgery, gastric bypass, gastric sleeve, and gastric banding all showed considerable reductions in cardiac risk factors, but gastric bypass showed the greatest risk reduction of all three, as well as greater improvement in body mass index, according to a study presented at this year’s annual clinical congress of the American College of Surgeons.

Baseline and 1-year postoperative data were collected on 1,398 consecutive bariatric surgery patients by Christopher S. Crowe and his colleagues at Stanford (Calif.) University. The investigators sought to evaluate each type of surgery’s effect on biochemical cardiovascular risk factors. The follow-up rate at 12 months was 77%.

The values measured were hemoglobin A_1c, fasting insulin, high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, triglycerides, high-sensitivity C-reactive protein (CRP), homocysteine, and lipoprotein (a).

Across the three groups, bypass patients tended to be younger by 1-2 years (mean age of this group was 44.3 years), and they had a higher baseline body mass index on average.

Excess weight loss after 1 year averaged 75% in the bypass patients, 55% in the patients with a sleeve, and 40% in those with a band.

When analyzing laboratory values for each group, the investigators found that fasting insulin levels were notably improved in all three groups; but at an improvement rate of 67.0%, the bypass patients had more than double the improvement of the gastric-band patients, while the gastric-sleeve patients showed a 63.7% improvement rate.

The CRP levels also improved dramatically in the bypass patients (67.1%), especially when compared with the band (21.2%) and sleeve (26.3%) groups. In addition, the ratio between triglycerides and HDL, a strong predictor of cardiovascular events, was differentially most improved in the bypass patients (38.5%), although improvement was also seen in both band (20.6%) and sleeve (35.2%) groups.

The investigators also sought to correlate each bariatric procedure’s resultant weight loss to improvement in specific cardiac risk factors. Only bypass was found to have a correlate between weight loss and total cholesterol and LDL reduction.

The triglyceride/HDL ratio improved with weight loss in both the bypass and band surgical groups. However, patients over age 50 and with a BMI greater than 50 kg/m² had the least improvement in this ratio.

Reduction in CRP level was not found to be related to weight loss for any of the procedures, although CRP did improve substantially after all three operations, primarily in bypass patients. In response to a question from an audience member, Mr. Crowe, a medical student, said this was probably because of changes in patient lifestyle, diet, and medications, as well as smoking cessation, postoperatively.

"When someone comes in for a bariatric procedure, they’re not just receiving the surgery, they are changing a lot about their life," said Mr. Crowe. "Those changes could, in effect, decrease the CRP levels after surgery, without it being weight loss–dependent."

Mr. Crowe reported no relevant disclosures. His coinvestigators reported serving as consultants to Ethicon and Covidien.

[email protected]

WASHINGTON – One year out from surgery, gastric bypass, gastric sleeve, and gastric banding all showed considerable reductions in cardiac risk factors, but gastric bypass showed the greatest risk reduction of all three, as well as greater improvement in body mass index, according to a study presented at this year’s annual clinical congress of the American College of Surgeons.

Baseline and 1-year postoperative data were collected on 1,398 consecutive bariatric surgery patients by Christopher S. Crowe and his colleagues at Stanford (Calif.) University. The investigators sought to evaluate each type of surgery’s effect on biochemical cardiovascular risk factors. The follow-up rate at 12 months was 77%.

The values measured were hemoglobin A_1c, fasting insulin, high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, triglycerides, high-sensitivity C-reactive protein (CRP), homocysteine, and lipoprotein (a).

Across the three groups, bypass patients tended to be younger by 1-2 years (mean age of this group was 44.3 years), and they had a higher baseline body mass index on average.

Excess weight loss after 1 year averaged 75% in the bypass patients, 55% in the patients with a sleeve, and 40% in those with a band.

When analyzing laboratory values for each group, the investigators found that fasting insulin levels were notably improved in all three groups; but at an improvement rate of 67.0%, the bypass patients had more than double the improvement of the gastric-band patients, while the gastric-sleeve patients showed a 63.7% improvement rate.

The CRP levels also improved dramatically in the bypass patients (67.1%), especially when compared with the band (21.2%) and sleeve (26.3%) groups. In addition, the ratio between triglycerides and HDL, a strong predictor of cardiovascular events, was differentially most improved in the bypass patients (38.5%), although improvement was also seen in both band (20.6%) and sleeve (35.2%) groups.

The investigators also sought to correlate each bariatric procedure’s resultant weight loss to improvement in specific cardiac risk factors. Only bypass was found to have a correlate between weight loss and total cholesterol and LDL reduction.

The triglyceride/HDL ratio improved with weight loss in both the bypass and band surgical groups. However, patients over age 50 and with a BMI greater than 50 kg/m² had the least improvement in this ratio.

Reduction in CRP level was not found to be related to weight loss for any of the procedures, although CRP did improve substantially after all three operations, primarily in bypass patients. In response to a question from an audience member, Mr. Crowe, a medical student, said this was probably because of changes in patient lifestyle, diet, and medications, as well as smoking cessation, postoperatively.

"When someone comes in for a bariatric procedure, they’re not just receiving the surgery, they are changing a lot about their life," said Mr. Crowe. "Those changes could, in effect, decrease the CRP levels after surgery, without it being weight loss–dependent."

Mr. Crowe reported no relevant disclosures. His coinvestigators reported serving as consultants to Ethicon and Covidien.

[email protected]

Clinicians appear to be too quick to perform antireflux procedures in infants, compared with older children, according to a report published online Nov. 6 in JAMA Surgery.

In a retrospective cohort study involving 141,190 pediatric and adolescent hospitalizations for gastroesophageal reflux disease (GERD) across the country over an 8-year period, the proportional hazard ratio of undergoing antireflux surgery was markedly decreased for those aged 7 months to 4 years (0.63) or 5-17 years (0.43), compared with those aged 0-2 months or 2-6 months.

The reasons for this strong difference are not yet known for certain, but the data showed a lack of objective diagnostic studies preceding the surgery in all pediatric age groups, and most strikingly in the youngest patients. It may well be that clinicians are confusing physiologic regurgitation – which is common, benign, and self-resolving in infancy – with a more pathologic process, said Dr. Jarod McAteer of the division of pediatric general and thoracic surgery, Seattle Children’s Hospital, and his associates.

At the very least, it appears that many infants aren’t given an adequate trial of medical management, since most cases of gastroesophageal reflux in infancy will resolve with that alone within 3-6 months, they noted.

"Referral for surgical treatment of GERD is generally presumed to be a last resort after failure of medical management, with optimal candidates having undergone specific preoperative evaluations," the authors wrote. Diagnostic and treatment guidelines are well delineated for adults, but not so for children.

For example, "upper GI fluoroscopy is frequently used in the preoperative workup among children with GERD," even though it has been clearly demonstrated to be a poor predictor of pathologic reflux, the investigators said.

In what they described as the first study to examine the influence of patient age on progression to antireflux procedures, Dr. McAteer and his colleagues analyzed data from the Pediatric Health Information System database, which includes demographic and clinical information from 41 children’s hospitals that cover 85% of major metropolitan areas in the U.S.

Out of 141,190 patients aged 0-7 years who were hospitalized with gastroesophageal reflux or GERD, 64% were younger than 1 year of age, and 53% were younger than 6 months. These numbers highlight how common the diagnosis is in babies, they said.

They also "suggest that physicians may be more likely to apply the diagnosis in this patient group because of diagnostic uncertainty or because other characteristics of these hospitalized infants make it more likely that any regurgitation is perceived as pathologic and indicative of GERD."

Examples of such "other characteristics" include comorbidities such as neurodevelopmental delay, cardiopulmonary disorders, seizures, asthma, and cerebral palsy.

A total of 11,621 of the study population underwent antireflux procedures, of which 52.7% were aged 6 months or younger. Only 14% of these patients had first undergone upper GI endoscopy, 0.2% esophageal manometry, 1.3% a 24-hour esophageal pH study, 65% upper GI fluoroscopy, and 17.1% a gastric emptying study, the investigators said (JAMA Surg. 2013 Nov. 6 [doi: 10.1001/jamasurg.2013.2685]).

The study findings show that the threshold for performing antireflux procedures is lower in infants than in older children. And "despite the fact that expert guidelines urge the use of objective studies in the diagnosis of GERD and despite evidence that supports the use of objective studies before performing antireflux procedures, such a standardized evaluation is not common practice.

"A greater effort is needed to develop and disseminate best-practice standards for the diagnosis and treatment of children, especially infants, with possible GERD. We must clarify the indications for antireflux procedures," Dr. McAteer and his associates said.

No financial conflicts of interest were reported.

Clinicians appear to be too quick to perform antireflux procedures in infants, compared with older children, according to a report published online Nov. 6 in JAMA Surgery.

In a retrospective cohort study involving 141,190 pediatric and adolescent hospitalizations for gastroesophageal reflux disease (GERD) across the country over an 8-year period, the proportional hazard ratio of undergoing antireflux surgery was markedly decreased for those aged 7 months to 4 years (0.63) or 5-17 years (0.43), compared with those aged 0-2 months or 2-6 months.

The reasons for this strong difference are not yet known for certain, but the data showed a lack of objective diagnostic studies preceding the surgery in all pediatric age groups, and most strikingly in the youngest patients. It may well be that clinicians are confusing physiologic regurgitation – which is common, benign, and self-resolving in infancy – with a more pathologic process, said Dr. Jarod McAteer of the division of pediatric general and thoracic surgery, Seattle Children’s Hospital, and his associates.

At the very least, it appears that many infants aren’t given an adequate trial of medical management, since most cases of gastroesophageal reflux in infancy will resolve with that alone within 3-6 months, they noted.

"Referral for surgical treatment of GERD is generally presumed to be a last resort after failure of medical management, with optimal candidates having undergone specific preoperative evaluations," the authors wrote. Diagnostic and treatment guidelines are well delineated for adults, but not so for children.

For example, "upper GI fluoroscopy is frequently used in the preoperative workup among children with GERD," even though it has been clearly demonstrated to be a poor predictor of pathologic reflux, the investigators said.

In what they described as the first study to examine the influence of patient age on progression to antireflux procedures, Dr. McAteer and his colleagues analyzed data from the Pediatric Health Information System database, which includes demographic and clinical information from 41 children’s hospitals that cover 85% of major metropolitan areas in the U.S.

Out of 141,190 patients aged 0-7 years who were hospitalized with gastroesophageal reflux or GERD, 64% were younger than 1 year of age, and 53% were younger than 6 months. These numbers highlight how common the diagnosis is in babies, they said.

They also "suggest that physicians may be more likely to apply the diagnosis in this patient group because of diagnostic uncertainty or because other characteristics of these hospitalized infants make it more likely that any regurgitation is perceived as pathologic and indicative of GERD."

Examples of such "other characteristics" include comorbidities such as neurodevelopmental delay, cardiopulmonary disorders, seizures, asthma, and cerebral palsy.

A total of 11,621 of the study population underwent antireflux procedures, of which 52.7% were aged 6 months or younger. Only 14% of these patients had first undergone upper GI endoscopy, 0.2% esophageal manometry, 1.3% a 24-hour esophageal pH study, 65% upper GI fluoroscopy, and 17.1% a gastric emptying study, the investigators said (JAMA Surg. 2013 Nov. 6 [doi: 10.1001/jamasurg.2013.2685]).

The study findings show that the threshold for performing antireflux procedures is lower in infants than in older children. And "despite the fact that expert guidelines urge the use of objective studies in the diagnosis of GERD and despite evidence that supports the use of objective studies before performing antireflux procedures, such a standardized evaluation is not common practice.

"A greater effort is needed to develop and disseminate best-practice standards for the diagnosis and treatment of children, especially infants, with possible GERD. We must clarify the indications for antireflux procedures," Dr. McAteer and his associates said.

No financial conflicts of interest were reported.

Clinicians appear to be too quick to perform antireflux procedures in infants, compared with older children, according to a report published online Nov. 6 in JAMA Surgery.

In a retrospective cohort study involving 141,190 pediatric and adolescent hospitalizations for gastroesophageal reflux disease (GERD) across the country over an 8-year period, the proportional hazard ratio of undergoing antireflux surgery was markedly decreased for those aged 7 months to 4 years (0.63) or 5-17 years (0.43), compared with those aged 0-2 months or 2-6 months.

The reasons for this strong difference are not yet known for certain, but the data showed a lack of objective diagnostic studies preceding the surgery in all pediatric age groups, and most strikingly in the youngest patients. It may well be that clinicians are confusing physiologic regurgitation – which is common, benign, and self-resolving in infancy – with a more pathologic process, said Dr. Jarod McAteer of the division of pediatric general and thoracic surgery, Seattle Children’s Hospital, and his associates.

At the very least, it appears that many infants aren’t given an adequate trial of medical management, since most cases of gastroesophageal reflux in infancy will resolve with that alone within 3-6 months, they noted.

"Referral for surgical treatment of GERD is generally presumed to be a last resort after failure of medical management, with optimal candidates having undergone specific preoperative evaluations," the authors wrote. Diagnostic and treatment guidelines are well delineated for adults, but not so for children.

For example, "upper GI fluoroscopy is frequently used in the preoperative workup among children with GERD," even though it has been clearly demonstrated to be a poor predictor of pathologic reflux, the investigators said.

In what they described as the first study to examine the influence of patient age on progression to antireflux procedures, Dr. McAteer and his colleagues analyzed data from the Pediatric Health Information System database, which includes demographic and clinical information from 41 children’s hospitals that cover 85% of major metropolitan areas in the U.S.

Out of 141,190 patients aged 0-7 years who were hospitalized with gastroesophageal reflux or GERD, 64% were younger than 1 year of age, and 53% were younger than 6 months. These numbers highlight how common the diagnosis is in babies, they said.

They also "suggest that physicians may be more likely to apply the diagnosis in this patient group because of diagnostic uncertainty or because other characteristics of these hospitalized infants make it more likely that any regurgitation is perceived as pathologic and indicative of GERD."

Examples of such "other characteristics" include comorbidities such as neurodevelopmental delay, cardiopulmonary disorders, seizures, asthma, and cerebral palsy.

A total of 11,621 of the study population underwent antireflux procedures, of which 52.7% were aged 6 months or younger. Only 14% of these patients had first undergone upper GI endoscopy, 0.2% esophageal manometry, 1.3% a 24-hour esophageal pH study, 65% upper GI fluoroscopy, and 17.1% a gastric emptying study, the investigators said (JAMA Surg. 2013 Nov. 6 [doi: 10.1001/jamasurg.2013.2685]).

The study findings show that the threshold for performing antireflux procedures is lower in infants than in older children. And "despite the fact that expert guidelines urge the use of objective studies in the diagnosis of GERD and despite evidence that supports the use of objective studies before performing antireflux procedures, such a standardized evaluation is not common practice.

"A greater effort is needed to develop and disseminate best-practice standards for the diagnosis and treatment of children, especially infants, with possible GERD. We must clarify the indications for antireflux procedures," Dr. McAteer and his associates said.

No financial conflicts of interest were reported.

The addition of a transversus abdominis plane block to standard enhanced recovery pathway protocols decreased lengths of stay to less than 3 days in roughly two-thirds of patients who underwent laparoscopic colectomy, findings from a small study showed.

To determine the impact of a TAP block on rates of discharge for colorectal laparoscopic surgery, researchers at University Hospitals Case Medical Center in Cleveland observed 100 consecutive patients who underwent the elective procedure performed over a 1-year period by the same experienced laparoscopic colorectal surgeon. The TAP block was administered at the conclusion of the laparoscopic procedure.

The mean age of the study population was 60.5 years, and 62 were female. The mean body mass index was 28.4 kg/m². Surgical indications in two-thirds of patients included colorectal cancer or polyp. One-third of patients had an inflammatory condition such as diverticulitis, ulcerative colitis, or Crohn’s disease, said Dr. Joanne Favuzza and Dr. Conor P. Delaney (J. Am. Coll. Surg. 2013;217:503-6).

The investigators found that 62% of patients were discharged within 48 hours, with 27% being discharged on day 1. No operative mortality was reported, and only one patient experienced a complication post discharge. Two patients were readmitted, both having had lengths of stay exceeding 48 hours.

Incidence rates of complication or readmission were not significantly affected by the block. Eight patients experienced postoperative complications: one patient on the second day post surgery, another patient on the third day, and the rest after the fourth day. Three patients had complications involving the ileus or lower-bowel obstruction, four patients had anastomotic or gastrointestinal bleed, and one had a urinary tract infection.

"This study demonstrated that the addition of a TAP block to an established ERP can reproducibly reduce length of stay to less than 3 days," wrote Dr. Favuzza and Dr. Delaney, who also noted that a prospective randomized controlled trial is underway to further evaluate the benefits of TAP blocks to ERP in colorectal surgery.

Dr. Favuzza reported no relevant disclosures. Dr. Delaney is a paid a consultant to Adolor Corp., Ferring Pharmaceuticals, and Pacira Pharmaceuticals.

[email protected]

The addition of a transversus abdominis plane block to standard enhanced recovery pathway protocols decreased lengths of stay to less than 3 days in roughly two-thirds of patients who underwent laparoscopic colectomy, findings from a small study showed.

To determine the impact of a TAP block on rates of discharge for colorectal laparoscopic surgery, researchers at University Hospitals Case Medical Center in Cleveland observed 100 consecutive patients who underwent the elective procedure performed over a 1-year period by the same experienced laparoscopic colorectal surgeon. The TAP block was administered at the conclusion of the laparoscopic procedure.

The mean age of the study population was 60.5 years, and 62 were female. The mean body mass index was 28.4 kg/m². Surgical indications in two-thirds of patients included colorectal cancer or polyp. One-third of patients had an inflammatory condition such as diverticulitis, ulcerative colitis, or Crohn’s disease, said Dr. Joanne Favuzza and Dr. Conor P. Delaney (J. Am. Coll. Surg. 2013;217:503-6).

The investigators found that 62% of patients were discharged within 48 hours, with 27% being discharged on day 1. No operative mortality was reported, and only one patient experienced a complication post discharge. Two patients were readmitted, both having had lengths of stay exceeding 48 hours.

Incidence rates of complication or readmission were not significantly affected by the block. Eight patients experienced postoperative complications: one patient on the second day post surgery, another patient on the third day, and the rest after the fourth day. Three patients had complications involving the ileus or lower-bowel obstruction, four patients had anastomotic or gastrointestinal bleed, and one had a urinary tract infection.

"This study demonstrated that the addition of a TAP block to an established ERP can reproducibly reduce length of stay to less than 3 days," wrote Dr. Favuzza and Dr. Delaney, who also noted that a prospective randomized controlled trial is underway to further evaluate the benefits of TAP blocks to ERP in colorectal surgery.

Dr. Favuzza reported no relevant disclosures. Dr. Delaney is a paid a consultant to Adolor Corp., Ferring Pharmaceuticals, and Pacira Pharmaceuticals.

[email protected]

The addition of a transversus abdominis plane block to standard enhanced recovery pathway protocols decreased lengths of stay to less than 3 days in roughly two-thirds of patients who underwent laparoscopic colectomy, findings from a small study showed.

To determine the impact of a TAP block on rates of discharge for colorectal laparoscopic surgery, researchers at University Hospitals Case Medical Center in Cleveland observed 100 consecutive patients who underwent the elective procedure performed over a 1-year period by the same experienced laparoscopic colorectal surgeon. The TAP block was administered at the conclusion of the laparoscopic procedure.

The mean age of the study population was 60.5 years, and 62 were female. The mean body mass index was 28.4 kg/m². Surgical indications in two-thirds of patients included colorectal cancer or polyp. One-third of patients had an inflammatory condition such as diverticulitis, ulcerative colitis, or Crohn’s disease, said Dr. Joanne Favuzza and Dr. Conor P. Delaney (J. Am. Coll. Surg. 2013;217:503-6).

The investigators found that 62% of patients were discharged within 48 hours, with 27% being discharged on day 1. No operative mortality was reported, and only one patient experienced a complication post discharge. Two patients were readmitted, both having had lengths of stay exceeding 48 hours.

Incidence rates of complication or readmission were not significantly affected by the block. Eight patients experienced postoperative complications: one patient on the second day post surgery, another patient on the third day, and the rest after the fourth day. Three patients had complications involving the ileus or lower-bowel obstruction, four patients had anastomotic or gastrointestinal bleed, and one had a urinary tract infection.

"This study demonstrated that the addition of a TAP block to an established ERP can reproducibly reduce length of stay to less than 3 days," wrote Dr. Favuzza and Dr. Delaney, who also noted that a prospective randomized controlled trial is underway to further evaluate the benefits of TAP blocks to ERP in colorectal surgery.

Dr. Favuzza reported no relevant disclosures. Dr. Delaney is a paid a consultant to Adolor Corp., Ferring Pharmaceuticals, and Pacira Pharmaceuticals.

[email protected]

The article by Weiner et al recently published in JAMA focuses on data derived from seven Blue Cross Insurance plans on patients who underwent bariatric surgery versus case-matched individuals in that plan who did not ("Studies question bariatric surgery health cost savings, October 2013, p. 1). The study found that although the patients who underwent surgery had lower non-hospital costs for the 6-year follow-up period overall, these costs did not overcome the initial expenditure for the operation and postoperative care or for other postoperative costs after surgery.

My initial reaction was: Why would we expect bariatric surgery to save money, or why must it? Name me three operations that are expected to save health care costs. Here are some procedures to consider:

• Joint replacements? Well, they certainly get people back on their feet but do we expect them to cut medical costs? No

• Hernia repairs? These operations may allow people to work more effectively, but actually cut health care costs?? I’ve never seen that study.

• Cataract surgery? These operations may or may not end up reducing health costs but they are not evaluated on cost savings

• Lung resections for cancer? Well, no but after all we are dealing with cancer. It’s not like obesity can kill you, right?

So why do we expect bariatric surgery to be cost effective? Who set that standard? Is it because of the innate societal bias against obesity as being a byproduct of character flaws and not a disease? Yet even though the American Medical Association and CMS have declared that obesity is a disease, treatment is under special scrutiny for cost savings. Even if bariatric surgery does not achieve cost effectiveness, I agree with the final conclusion of this paper that "studies should focus on the improved health and well-being of persons undergoing the procedure."

Bariatric surgery certainly does promote health and well-being in patients. It improves survival, decreases the incidence of cancer, puts most cases of type 2 diabetes into remission, decreases the need for multiple medications for hypertension, hypercholesterolemia, degenerative joint disease, and dramatically improves the overall quality of life for severely obese patients. Its benefits are well documented and undisputable.

And what about obesity? Dieting hasn’t been very effective against a disease that is rated the number two health threat in the U.S. today after cardiovascular disease. Recent news reports in fact said obesity may be the leading childhood risk factor for future cardiovascular disease. It certainly has increased the incidence of diabetes, renal failure, colon, breast, and prostate cancer as well as others. Today’s youth may live shorter lives than their parents due solely to this disease.

Since the data from this study were first collected, the incidence of postoperative death after bariatric surgery has dropped to one-fourth its level a decade ago. Large databases now demonstrate the fact that outcomes for bariatric surgery are much improved in the last decade. A significant percentage of the operations in this study were done using an open surgical approach, whereas today almost all metabolic and bariatric surgery is done with a laparoscopic approach. Laparoscopy is associated with lower morbidity, mortality, faster recovery, and shorter hospitalization. It is surprising that the transition to laparoscopic surgery did not show an improvement in costs when analyzed as an individual procedure compared to open surgery. Perhaps the double digit inflation of hospital costs over the years of the study may be a factor.

One also might contemplate the fact that an American can fly to some European and Asian countries, have a laparoscopic gastric bypass, stay for 2 weeks of convalescence afterward, and fly home all for less cost than for the hospital bill alone generated by most U.S. hospitals. Why is that? It would appear that even as our bariatric outcomes improve, our way of paying for health care in the United States system does not.

Many insurance companies do not cover bariatric surgery. As the Affordable Care Act is getting underway, it is not clear that even a majority of the states will have metabolic and bariatric surgery as a guaranteed part of the health insurance coverage. Yet scientific evidence shows that bariatric and metabolic surgery improve life expectancy and quality, and improve or put into remission many of the co-morbid medical problems associated with obesity. It does work for to the benefit of individuals.

We need to be asking the correct question about bariatric surgery. This operation may not save money, but it does save lives. So the question asked should not be whether it saves money but why it isn’t routinely covered by insurance plans?

Dr. Schirmer is an ACS Fellow and the Stephen H. Watts Professor of Surgery, University of Virginia Health Sciences Center, Charlottesville.
 

The article by Weiner et al recently published in JAMA focuses on data derived from seven Blue Cross Insurance plans on patients who underwent bariatric surgery versus case-matched individuals in that plan who did not ("Studies question bariatric surgery health cost savings, October 2013, p. 1). The study found that although the patients who underwent surgery had lower non-hospital costs for the 6-year follow-up period overall, these costs did not overcome the initial expenditure for the operation and postoperative care or for other postoperative costs after surgery.

My initial reaction was: Why would we expect bariatric surgery to save money, or why must it? Name me three operations that are expected to save health care costs. Here are some procedures to consider:

• Joint replacements? Well, they certainly get people back on their feet but do we expect them to cut medical costs? No

• Hernia repairs? These operations may allow people to work more effectively, but actually cut health care costs?? I’ve never seen that study.

• Cataract surgery? These operations may or may not end up reducing health costs but they are not evaluated on cost savings

• Lung resections for cancer? Well, no but after all we are dealing with cancer. It’s not like obesity can kill you, right?

So why do we expect bariatric surgery to be cost effective? Who set that standard? Is it because of the innate societal bias against obesity as being a byproduct of character flaws and not a disease? Yet even though the American Medical Association and CMS have declared that obesity is a disease, treatment is under special scrutiny for cost savings. Even if bariatric surgery does not achieve cost effectiveness, I agree with the final conclusion of this paper that "studies should focus on the improved health and well-being of persons undergoing the procedure."

Bariatric surgery certainly does promote health and well-being in patients. It improves survival, decreases the incidence of cancer, puts most cases of type 2 diabetes into remission, decreases the need for multiple medications for hypertension, hypercholesterolemia, degenerative joint disease, and dramatically improves the overall quality of life for severely obese patients. Its benefits are well documented and undisputable.

And what about obesity? Dieting hasn’t been very effective against a disease that is rated the number two health threat in the U.S. today after cardiovascular disease. Recent news reports in fact said obesity may be the leading childhood risk factor for future cardiovascular disease. It certainly has increased the incidence of diabetes, renal failure, colon, breast, and prostate cancer as well as others. Today’s youth may live shorter lives than their parents due solely to this disease.

Since the data from this study were first collected, the incidence of postoperative death after bariatric surgery has dropped to one-fourth its level a decade ago. Large databases now demonstrate the fact that outcomes for bariatric surgery are much improved in the last decade. A significant percentage of the operations in this study were done using an open surgical approach, whereas today almost all metabolic and bariatric surgery is done with a laparoscopic approach. Laparoscopy is associated with lower morbidity, mortality, faster recovery, and shorter hospitalization. It is surprising that the transition to laparoscopic surgery did not show an improvement in costs when analyzed as an individual procedure compared to open surgery. Perhaps the double digit inflation of hospital costs over the years of the study may be a factor.

One also might contemplate the fact that an American can fly to some European and Asian countries, have a laparoscopic gastric bypass, stay for 2 weeks of convalescence afterward, and fly home all for less cost than for the hospital bill alone generated by most U.S. hospitals. Why is that? It would appear that even as our bariatric outcomes improve, our way of paying for health care in the United States system does not.

Many insurance companies do not cover bariatric surgery. As the Affordable Care Act is getting underway, it is not clear that even a majority of the states will have metabolic and bariatric surgery as a guaranteed part of the health insurance coverage. Yet scientific evidence shows that bariatric and metabolic surgery improve life expectancy and quality, and improve or put into remission many of the co-morbid medical problems associated with obesity. It does work for to the benefit of individuals.

We need to be asking the correct question about bariatric surgery. This operation may not save money, but it does save lives. So the question asked should not be whether it saves money but why it isn’t routinely covered by insurance plans?

Dr. Schirmer is an ACS Fellow and the Stephen H. Watts Professor of Surgery, University of Virginia Health Sciences Center, Charlottesville.
 

The article by Weiner et al recently published in JAMA focuses on data derived from seven Blue Cross Insurance plans on patients who underwent bariatric surgery versus case-matched individuals in that plan who did not ("Studies question bariatric surgery health cost savings, October 2013, p. 1). The study found that although the patients who underwent surgery had lower non-hospital costs for the 6-year follow-up period overall, these costs did not overcome the initial expenditure for the operation and postoperative care or for other postoperative costs after surgery.

My initial reaction was: Why would we expect bariatric surgery to save money, or why must it? Name me three operations that are expected to save health care costs. Here are some procedures to consider:

• Joint replacements? Well, they certainly get people back on their feet but do we expect them to cut medical costs? No

• Hernia repairs? These operations may allow people to work more effectively, but actually cut health care costs?? I’ve never seen that study.

• Cataract surgery? These operations may or may not end up reducing health costs but they are not evaluated on cost savings

• Lung resections for cancer? Well, no but after all we are dealing with cancer. It’s not like obesity can kill you, right?

So why do we expect bariatric surgery to be cost effective? Who set that standard? Is it because of the innate societal bias against obesity as being a byproduct of character flaws and not a disease? Yet even though the American Medical Association and CMS have declared that obesity is a disease, treatment is under special scrutiny for cost savings. Even if bariatric surgery does not achieve cost effectiveness, I agree with the final conclusion of this paper that "studies should focus on the improved health and well-being of persons undergoing the procedure."

Bariatric surgery certainly does promote health and well-being in patients. It improves survival, decreases the incidence of cancer, puts most cases of type 2 diabetes into remission, decreases the need for multiple medications for hypertension, hypercholesterolemia, degenerative joint disease, and dramatically improves the overall quality of life for severely obese patients. Its benefits are well documented and undisputable.

And what about obesity? Dieting hasn’t been very effective against a disease that is rated the number two health threat in the U.S. today after cardiovascular disease. Recent news reports in fact said obesity may be the leading childhood risk factor for future cardiovascular disease. It certainly has increased the incidence of diabetes, renal failure, colon, breast, and prostate cancer as well as others. Today’s youth may live shorter lives than their parents due solely to this disease.

Since the data from this study were first collected, the incidence of postoperative death after bariatric surgery has dropped to one-fourth its level a decade ago. Large databases now demonstrate the fact that outcomes for bariatric surgery are much improved in the last decade. A significant percentage of the operations in this study were done using an open surgical approach, whereas today almost all metabolic and bariatric surgery is done with a laparoscopic approach. Laparoscopy is associated with lower morbidity, mortality, faster recovery, and shorter hospitalization. It is surprising that the transition to laparoscopic surgery did not show an improvement in costs when analyzed as an individual procedure compared to open surgery. Perhaps the double digit inflation of hospital costs over the years of the study may be a factor.

One also might contemplate the fact that an American can fly to some European and Asian countries, have a laparoscopic gastric bypass, stay for 2 weeks of convalescence afterward, and fly home all for less cost than for the hospital bill alone generated by most U.S. hospitals. Why is that? It would appear that even as our bariatric outcomes improve, our way of paying for health care in the United States system does not.

Many insurance companies do not cover bariatric surgery. As the Affordable Care Act is getting underway, it is not clear that even a majority of the states will have metabolic and bariatric surgery as a guaranteed part of the health insurance coverage. Yet scientific evidence shows that bariatric and metabolic surgery improve life expectancy and quality, and improve or put into remission many of the co-morbid medical problems associated with obesity. It does work for to the benefit of individuals.

We need to be asking the correct question about bariatric surgery. This operation may not save money, but it does save lives. So the question asked should not be whether it saves money but why it isn’t routinely covered by insurance plans?

Dr. Schirmer is an ACS Fellow and the Stephen H. Watts Professor of Surgery, University of Virginia Health Sciences Center, Charlottesville.