CONTINUING MEDICAL EDUCATION PROGRAM
February 2016 Featured Articles, Volume 222
Get credit right away by taking all CME tests online http://jacscme.facs.org Article 1: Breast
Is preoperative axillary imaging beneficial in identifying clinically node-negative patients requiring axillary lymph node dissection? Pilewskie M, Jochelson M, Gooch JC, et al. J Am Coll Surg 2016;222:138e145 Article 2: Gallbladder
Early cholecystectomy for acute cholecystitis offers the best outcomes at the least cost: a model-based cost-utility analysis. de Mestral C, Hoch JS, Laupacis A, et al. J Am Coll Surg 2016;222:185e194 Article 3: Surgical Oncology
Preoperative chemoprophylaxis is safe in major oncology operations and effective at preventing venous thromboembolism. Selby LV, Sovel M, Sjoberg DD, et al. J Am Coll Surg 2016;222:129e137
Objectives: After reading the featured articles published in this issue of the Journal of the American College of Surgeons (JACS) participants in this journal-based CME activity should be able to demonstrate increased understanding of the material specific to the article featured and be able to apply relevant information to clinical practice. A score of 75% is required to receive CME and Self-Assessment credit. The JACS Editor-in-Chief does not assign a manuscript for review to any person who discloses a conflict of interest with the content of the manuscript. Two articles are available each month in the print version, and up to 4 are available online for each monthly issue, going back 24 months.
ARTICLE 1 (Please consider how the content of this article may be applied to your practice.)
Is preoperative axillary imaging beneficial in identifying clinically node-negative patients requiring axillary lymph node dissection? Pilewskie M, Jochelson M, Gooch JC, et al J Am Coll Surg 2016;222:138e145 Learning Objectives: After review of this article, surgeons should be able to compare the rates of axillary lymph node dissection for pathologically nodepositive breast cancer patients with and without abnormal axillary imaging, and limit unnecessary imaging accordingly.
Accreditation: The American College of Surgeons is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Question 1 Among clinically node-negative breast cancer patients with a positive sentinel lymph node, who undergo preoperative axillary imaging:
Designation: The American College of Surgeons designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 Credit. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
ª 2016 Published by Elsevier Inc. on behalf of the American College of Surgeons.
a) The majority of women have 1 abnormal axillary lymph node identified on preoperative axillary ultrasound. b) The majority of women have >1 abnormal axillary lymph node identified on preoperative axillary ultrasound. c) Mammography frequently identifies radiologic suspicious axillary lymph nodes.
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d) The majority of women have no abnormal axillary lymph nodes identified on preoperative axillary imaging. e) MRI accurately identifies abnormal axillary lymph nodes in more than half of this population. Critique: Women meeting American College of Surgeons Oncology Group Z0011 criteria are at low risk for having high nodal disease burden. In this cohort of patients with a positive sentinel lymph node, only 17% required axillary lymph node dissection. Furthermore, this population of patients is at low risk for having abnormal axillary imaging, with no abnormal axillary lymph nodes identified on 93%, 75%, and 70% of preoperative mammograms, axillary ultrasounds, and MRIs, respectively. Among the minority of women who were found to have abnormal axillary lymph nodes by imaging, most women had 1 to 2 abnormal lymph nodes identified, with only 10 women in the entire cohort of 425 patients having >2 abnormal axillary lymph nodes identified on preoperative axillary imaging. Question 2 Negative preoperative axillary imaging in clinically node-negative patients: a) was mandatory for patient eligibility in the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial b) identifies a population of breast cancer patients not at risk for having >2 positive sentinel lymph nodes c) is uncommon among women with a positive sentinel lymph node d) is mandatory before proceeding with a sentinel lymph node biopsy e) is associated with a slightly lower rate of axillary lymph node dissection compared with that in patients with abnormal axillary imaging Critique: The ACOSOG Z0011 trial was practicechanging in that it proved the safety of sentinel lymph node biopsy alone for the management of clinically node-negative patients identified as having axillary nodal metastasis in 1 to 2 lymph nodes. Eligible patients for ACOSOG Z011 presented with cT1-2N0 invasive breast cancer by physical exam, underwent breast-conserving surgery, and underwent whole breast radiation therapy. This study shows that the majority of women meeting ACOSOG Z0011 criteria have negative preoperative axillary imaging and that axillary imaging results alone did not accurately identify women at risk for having >2 positive sentinel lymph
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nodes who require axillary lymph node dissection. Among women with negative preoperative axillary imaging by mammogram, ultrasound, or MRI, 15%, 12%, and 13%, respectively, had >2 positive sentinel lymph nodes and required completion axillary lymph node dissection. Although women with abnormal axillary imaging were statistically more likely to require axillary lymph node dissection, the need for additional axillary surgery among women with abnormal lymph nodes identified by ultrasound or MRI was only 34%. Question 3 Potential harm of using preoperative axillary imaging with ultrasound as a guide to direct the need for axillary lymph node dissection (ALND) in clinically node-negative breast cancer patients meeting American College of Surgeons Oncology Group (ACOSOG) Z0011 criteria includes all of the following EXCEPT: a) b) c) d) e)
increased medical care costs potential for delay in treatment unnecessary axillary lymph node dissection removal of fewer sentinel lymph nodes increased risk for lymphedema
Critique: When practicing according to ACOSOG Z0011, axillary ultrasound is beneficial only if it accurately identifies patients with >2 positive lymph nodes who would require an axillary lymph node dissection. As shown in this study, axillary ultrasound did not accurately identify women requiring axillary lymph node dissection. If surgeons use axillary imaging results to recommend axillary lymph node dissection, patients are exposed to potentially unnecessary surgical harm. In this cohort of patients, if all women with abnormal axillary imaging were triaged to axillary lymph node dissection, 68% to 73% would have been overtreated and subjected to unnecessary surgical morbidity resulting from ALND. Question 4 In clinical practice, surgeons should consider preoperative axillary imaging: a) in women with palpable axillary adenopathy b) among obese patients c) before proceeding with a sentinel lymph node biopsy d) to safely omit axillary surgery e) in all breast cancer patients Critique: Before ordering an imaging test, it is important to acknowledge if and how the results would change practice. Among clinically node-negative breast
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cancer patients meeting American College of Surgeons Oncology Group (ACOSOG) Z0011 criteria, axillary imaging is unable to accurately predict the need for axillary lymph node dissection and therefore is unnecessary before proceeding with a sentinel lymph node biopsy. ACOSOG Z0011 included only clinically node-negative patients and therefore women with palpable adenopathy, those undergoing partial breast radiation, or those undergoing neoadjuvant chemotherapy warrant additional treatment if pathologically node positive.
ARTICLE 2 (Please consider how the content of this article may be applied to your practice.)
Early cholecystectomy for acute cholecystitis offers the best outcomes at the least cost: a model-based cost-utility analysis de Mestral C, Hoch JS, Laupacis A, et al J Am Coll Surg 2016;222:185e194 Learning Objectives: After study of this article, the reader should be aware of the relative cost and quality-adjusted life-years associated with early cholecystectomy, delayed cholecystectomy, and watchful waiting for patients with acute cholecystitis. Question 1 When comparing early with delayed elective laparoscopic cholecystectomy for acute cholecystitis, which one of the following statements is TRUE? a) Early operation (7 days from presentation) is associated with a lower rate of conversion to open cholecystectomy. b) Early operation (7 days from presentation) is associated with a lower risk of major bile duct injury requiring operative repair. c) Early and delayed operation have equivalent total hospital lengths of stay. d) Fewer than 5% of patients suffer recurrent gallstone symptoms before delayed elective cholecystectomy. e) A 2013 Cochrane meta-analysis of single-center trials comparing the clinical outcomes of early and delayed laparoscopic cholecystectomy represents an up-to-date synthesis of best available evidence. Critique: A multicenter randomized trial and population-based analyses published in 2013 and 2014 offer novel evidence supplementing data from single-center trials published in the late 1990s and early 2000s. Taken together, these data support the
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clinical benefit of early over delayed cholecystectomy across a number of outcomes. Specifically, early cholecystectomy (within up to 7 days of symptom onset) is associated with a lower risk of major bile duct injury, a similar risk of conversion from laparoscopic to open cholecystectomy, a shorter total hospital length of stay and, unlike delaying operation, does not leave the patient at risk of recurrent gallstone symptoms. In the delayed cholecystectomy strategy, 17.4% of patients suffered recurrent gallstone-related symptoms before elective delayed cholecystectomy. In the watchful-waiting strategy, 47.7% of patients suffered recurrent gallstone-related symptoms. The extra average cost of delayed compared with early operation is driven by a longer total hospital stay due to a second admission or day operation for cholecystectomy. Question 2 In a model-based economic evaluation, the model structure and its input values should reflect all important clinical consequences and costs associated with the disease process and the defined management strategies. In this cost-utility analysis, the model did NOT include: a) a chance of preoperative mortality b) added cost of endoscopic retrograde cholangiopancreatography for a bile leak c) patients’ out of pocket costs for mediations after hospital discharge d) a difference in postoperative quality of life during recovering from open vs laparoscopic cholecystectomy e) nongallstone-related mortality Critique: All important sources of quality-adjusted life-year gains and cost (from the perspective of the Ontario Ministry of Health and Long Term Care) that would differ between management strategies were modelled. Costs were considered from the perspective of a third party payer, the Ontario Ministry of Health and Long Term Care, and included hospital costs (emergency room, inpatient, day operation) and physician services. Patients’ out-of-pocket costs in Ontario would be minimal and were not included in the analysis. The model was structured to include the initial cholecystitis admission, subsequent day operation or admission for delayed elective cholecystectomy, the possibility of an emergency room visit or admission for recurrent gallstone-related symptoms, the possibility of complications resulting from cholecystectomy, and the possibility of death. As modelled, cholecystectomy could be undertaken via a laparoscopic or open
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approach and 4 cholecystectomy-related outcomes were incorporated: major bile duct injury requiring operative reconstruction, bile leak requiring endoscopic intervention, other complications, and no complication. Question 3 This cost-utility analysis comparing early operation, delayed elective cholecystectomy, and watchful waiting (deferring operation unless recurrent gallstone symptoms arise) showed that: a) Watchful waiting has the greatest average qualityadjusted life-years because some patients avoid undergoing surgery all together. b) Delayed cholecystectomy has the greatest average cost, driven up by the added cost of a second hospital visit for operation and by approximately 20% of patients with an unplanned readmission for recurrent gallstone-symptoms before delayed elective cholecystectomy. c) Operative morbidity had an important impact on the relative cost of each management strategy. d) Early operation has the highest average cost because all patients undergo emergency operation that may occur after hours. e) Patients with acute cholecystitis and ultrasoundconfirmed concurrent common bile duct stone should be managed with early cholecystectomy, intraoperative cholangiogram, and laparoscopic bile duct clearance. Critique: Early operation is the most efficient approach to treat acute cholecystitis, minimize total hospital length of stay, and preclude the risk of recurrent gallstone symptoms. Although major bile duct injury requiring operative repair has been shown to be lower with early operation, operative morbidity does not differ sufficiently between management strategies to drive a difference in average cost. The cost-utility analysis model did account for a higher proportion of after-hours cholecystectomy with early
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operation. This cost-utility analysis excluded patients with concurrent biliary tract obstruction at the time of initial presentation with acute cholecystitis. The extra average cost of delayed over early operation is driven by a longer total hospital stay due to a second admission or day surgery for cholecystectomy. Question 4 Extrapolating from this data, which of the following statements may NOT be TRUE? a) Early cholecystectomy is likely to be economically attractive from the perspective of a patient. b) Early cholecystectomy is likely to be economically attractive outside of Canada. c) Early cholecystectomy is likely to be economically attractive from the perspective of a single-payer regional health care system. d) Early cholecystectomy is likely to be economically attractive from the perspective of an insurance company. e) Early cholecystectomy is likely to be economically attractive from the perspective of an individual hospital. Critique: For most patients with acute cholecystitis, early operation minimizes operative morbidity, avoids the need for a second hospital visit, and precludes recurrent gallstone symptoms. The magnitude of the economic benefit will differ based on the perspective of the analysis (eg, single patient, hospital, singlepayer regional health care system, insurance company) and the context (eg, city, country). However, multiple published comparisons of efficacy, effectiveness, and cost consistently support the benefit of early cholecystectomy on first presenting admission. Delayed cholecystectomy or watchful waiting may not appear as economically unattractive if the negative impact of a second visit to hospital and recurrent gallstone symptoms are not considered (eg, a hospital with a policy of delayed cholecystectomy that refers all patients elsewhere for day surgery after discharge).
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February 2016 Featured Articles, Volume 222 Is preoperative axillary imaging beneficial in identifying clinically node-negative patients requiring axillary lymph node dissection? Pilewskie M, Jochelson M, Gooch JC, et al. J Am Coll Surg 2016;222:138e145 Early cholecystectomy for acute cholecystitis offers the best outcomes at the least cost: a modelbased cost-utility analysis de Mestral C, Hoch JS, Laupacis A, et al. J Am Coll Surg 2016;222:185e194