Omission of Axillary Dissection Following Nodal Downstaging With Neoadjuvant Chemotherapy.

Importance: Data on oncological outcomes after omission of axillary lymph node dissection (ALND) in patients with breast cancer that downstages from node positive to negative with neoadjuvant chemotherapy are sparse. Additionally, the best axillary surgical staging technique in this scenario is unknown. Objective: To investigate oncological outcomes after sentinel lymph node biopsy (SLNB) with dual-tracer mapping or targeted axillary dissection (TAD), which combines SLNB with localization and retrieval of the clipped lymph node. Design, Setting, and Participants: In this multicenter retrospective cohort study that was conducted at 25 centers in 11 countries, 1144 patients with consecutive stage II to III biopsy-proven node-positive breast cancer were included between April 2013 and December 2020. The cumulative incidence rates of axillary, locoregional, and any invasive (locoregional or distant) recurrence were determined by competing risk analysis. Exposure: Omission of ALND after SLNB or TAD. Main Outcomes and Measures: The primary end points were the 3-year and 5-year rates of any axillary recurrence. Secondary end points included locoregional recurrence, any invasive (locoregional and distant) recurrence, and the number of lymph nodes removed. Results: A total of 1144 patients (median [IQR] age, 50 [41-59] years; 78 [6.8%] Asian, 105 [9.2%] Black, 102 [8.9%] Hispanic, and 816 [71.0%] White individuals; 666 SLNB [58.2%] and 478 TAD [41.8%]) were included. A total of 1060 patients (93%) had N1 disease, 619 (54%) had ERBB2 (formerly HER2)-positive illness, and 758 (66%) had a breast pathologic complete response. TAD patients were more likely to receive nodal radiation therapy (85% vs 78%; P = .01). The clipped node was successfully retrieved in 97% of TAD cases and 86% of SLNB cases (without localization). The mean (SD) number of sentinel lymph nodes retrieved was 3 (2) vs 4 (2) (P < .001), and the mean (SD) number of total lymph nodes removed was 3.95 (1.97) vs 4.44 (2.04) (P < .001) in the TAD and SLNB groups, respectively. The 5-year rates of any axillary, locoregional, and any invasive recurrence in the entire cohort were 1.0% (95% CI, 0.49%-2.0%), 2.7% (95% CI, 1.6%-4.1%), and 10% (95% CI, 8.3%-13%), respectively. The 3-year cumulative incidence of axillary recurrence did not differ between TAD and SLNB (0.5% vs 0.8%; P = .55). Conclusions and Relevance: The results of this cohort study showed that axillary recurrence was rare in this setting and was not significantly lower after TAD vs SLNB. These results support omission of ALND in this population.

Outpatient surgery benchmarks and practice variation patterns: Case controlled study.

BACKGROUND: Despite numerous potential benefits of outpatient surgery, there is currently a lack of national benchmarking data available for hospitals and surgeons to compare their own outcomes as they transition toward outpatient surgery. MATERIALS AND METHODS: Patients who underwent 14 common general surgery operations from 2016-2020 were identified in the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database. Operations were selected based on frequency and the ability to be performed both in- and outpatient. Postoperative complications and readmissions were compared between patients who underwent inpatient vs outpatient surgery. After adjusting for patient comorbidities, multivariable models assessed the effect of patient characteristics on the odds of experiencing postoperative complications. A separate multiinstitutional study of 21 affiliated hospitals assessed practice variation. RESULTS: In 13 of the 14 studied procedures, complications were lower for patients who were selected for outpatient surgery (all P<0.01); minimally invasive (MIS) adrenalectomy showed no difference (P=0.61). Multivariable analysis confirmed these findings; the odds of experiencing any adverse events were lower following outpatient surgery in all operations but MIS adrenalectomy (OR 0.97; 95% CI 0.47-2.02). Analysis of institutional practices demonstrated variation in the rate of outpatient surgery in certain breast, endocrine, and hernia repair operations. CONCLUSIONS: Institutional practice patterns may explain the national variation in the rate of outpatient surgery. While the present data does not support the adoption of outpatient surgery to less optimal candidates, addressing unexplained practice variations could result in improved utilization of outpatient surgery.

Assessment of the effect of the American Society of Breast Surgery guidelines on contralateral prophylactic mastectomy rates for unilateral breast cancer.

BACKGROUND: In July 2016, the American Society of Breast Surgeons published guidelines discouraging contralateral prophylactic mastectomy for average-risk women with unilateral breast cancer. We incorporated these into practice with structured patient counseling and aimed to assess the effect of this initiative on contralateral prophylactic mastectomy rates. METHODS: We evaluated female patients with unilateral breast cancer undergoing mastectomy at our institution from January 2011 to November 2022. Variables associated with contralateral prophylactic mastectomy and trends over time were analyzed using the Wilcoxon rank sum test or χ2 analysis as appropriate. RESULTS: Among 3,208 patients, (median age 54 years) 1,366 (43%) had a unilateral mastectomy, and 1,842 (57%) also had a concomitant contralateral prophylactic mastectomy. Across all patients, contralateral prophylactic mastectomy rates significantly decreased post-implementation from 2017 to 2019 (55%) vs 2015 to 2016 (62%) (P = .01) but increased from 2020 to 2022 (61%). Immediate breast reconstruction rate was 70% overall (81% with contralateral prophylactic mastectomy and 56% without contralateral prophylactic mastectomy, P < .001). Younger age, White race, mutation status, and earlier stage were also associated with contralateral prophylactic mastectomy. Genetic testing increased from 27% pre-guideline to 74% 2020 to 2022, as did the proportion of patients with a pathogenic variant (4% pre-guideline vs 11% from 2020-2022, P < .001), of whom 91% had a contralateral prophylactic mastectomy. Among tested patients without a pathogenic variant and patients not tested, contralateral prophylactic mastectomy rates declined from 78% to 67% and 48% to 38% pre -and post-guidelines, respectively, P < .001. CONCLUSION: Implementation of specific patient counseling was effective in decreasing contralateral prophylactic mastectomy rates. While recognizing that patient choice plays a significant role in the decision for contralateral prophylactic mastectomy, further educational efforts are warranted to affect contralateral prophylactic mastectomy rates, particularly in the setting of negative genetic testing.

Repeat sentinel lymph node surgery for locally recurrent breast cancer after prior mastectomy.

BACKGROUND AND OBJECTIVES: Current NCCN guidelines discourage repeat sentinel lymph node (SLN) surgery in patients with local recurrence (LR) of breast cancer following prior mastectomy. This study addresses the feasibility and therapeutic impact of this approach. METHODS: We identified 73 patients managed with repeat SLN surgery for post-mastectomy isolated LR. Lymphatic mapping was performed using radioisotope with or without lymphoscintigraphy and/or blue dye. Successful SLN surgery was defined as retrieval of ≥1 SLN. RESULTS: SLN surgery was successful in 65/73 (89%), identifying a median of 2 (range 1-4) SLNs, with 10/65 (15%) SLN-positive. Among these, 5/10 (50%) proceeded to ALND. In unsuccessful cases, 1/8 (13%) proceeded to ALND. Seven of 10 SLN-positive patients and 50/55 SLN-negative patients received adjuvant radiotherapy. Chemotherapy was administered in 31 (42%) and endocrine therapy in 50 of 57 HR+ patients (88%). After 28 months median follow-up, eight patients relapsed with the first site local in two, distant in five, and synchronous local/distant in one. No nodal recurrences were observed. CONCLUSIONS: SLN surgery for patients with LR post-mastectomy is feasible and informative. This approach appears oncologically sound, decreases axillary dissection rates and may be used to tailor adjuvant radiation target volumes and systemic therapies.

Lymph Node Positivity of Axillary Reverse Mapping Lymph Nodes at the Time of Axillary Lymph Node Dissection: Two-Site Prospective Trial.

BACKGROUND: Axillary reverse mapping (ARM) was introduced in 2007 to identify and selectively preserve upper-extremity lymphatics during axillary lymph node surgery to decrease the risk of lymphedema. The patient population in which an ARM lymph node (LN) can be preserved during an axillary lymph node dissection (ALND) has not been established to date. This study aimed to determine the frequency of metastatic involvement of an ARM LN among patients undergoing ALND. METHODS: Patients undergoing ALND with or without immediate lymphatic reconstruction (ILR) were enrolled in a prospective trial at two institutional sites between April 2018 and Decemeber 2022. This report analyzes the ARM node positivity and total LN positivity rates during ALND for the cohort of patients enrolled in the ILR intervention arm of the study. RESULTS: The inclusion criteria were met by 139 patients, who made up the study population (133 with breast cancer and 6 with other disease). Of the breast cancer patients, 99.2% were female, 35.3% (47/133) were cT3 or greater, and 96.2% (128/133) had cN1 or greater disease. For 55 of the 133 patients (41.4%), the ARM nodes were marked and specified in the pathology report. Of the 55 patients, 39 (70.9%) had a positive LN at ALND. Of these 55 patients, 11 (20%) had positive ARM nodes. The ARM LN was the only positive node in 3 of the 11 patients. CONCLUSION: In the contemporary patient population undergoing ALND, the positivity rate of the ARM LN was relatively high, suggesting that leaving ARM LNs in patients undergoing ALND may not be oncologically safe.

Node Positivity Among Sonographically Suspicious but FNA-Negative Axillary Nodes.

BACKGROUND: Fine needle aspiration (FNA) of sonographically suspicious axillary lymph nodes is helpful to clinically stage patients and guide consideration of neoadjuvant therapy in breast cancer. However, data are limited for suspicious nodes that are FNA negative. Our goal is to compare the frequency of node positivity between patients with negative axillary ultrasound (AUSneg) versus suspicious AUS with negative FNA (FNAneg). METHODS: With IRB approval, we identified all clinically node-negative (cN0) patients with invasive breast cancer treated with upfront surgery at our tertiary care center between 2016 and 2021. AUS is routinely performed with FNA of suspicious lymph node(s). We compared clinicopathologic characteristics and nodal positivity rates between AUSneg and FNAneg groups. RESULTS: A total of 1580 cN0 patients with invasive breast cancer were analyzed, including 1240 AUSneg and 340 FNAneg patients. The FNAneg group was younger (median age 59.7 years versus 63.5 years, p < 0.001) and had higher clinical T (cT) category (29.1% versus 21.7% with cT2-cT4 disease, p = 0.005). Final axillary pathologic node positivity did not differ significantly between the AUSneg and FNAneg groups (16.5% versus 19.1%, p = 0.25). Among FNAneg patients, 58/340 (17.1%) had a clip placed, with retrieval confirmed in 28/58 (48.3%). Of the 28 retrieved clipped nodes, 27 were sentinel nodes. Final pathologic nodal status (pN+%) did not differ between patients in whom retrieval of the clipped node was confirmed versus not confirmed (28.6% versus 16.7%, p = 0.28). CONCLUSIONS: Both patients with sonographically suspicious node(s) and negative FNA and patients with negative AUS have a similarly low chance of positive nodes. Additionally, routine targeted excision of FNA-negative clipped nodes is not warranted.

Margin Width and Local Recurrence in Patients Undergoing Breast Conservation After Neoadjuvant Chemotherapy.

BACKGROUND: A margin of "no ink on tumor" has been established for primary breast conservation therapy (BCT), but the appropriate margin following neoadjuvant chemotherapy (NAC) remains controversial. We examined the impact of margin width on ipsilateral breast tumor recurrence (IBTR) in the NAC-BCT population. METHODS: Consecutive patients receiving NAC-BCT were identified from a prospective database. The associations between clinicopathologic characteristics, margin width, and isolated IBTR were evaluated. RESULTS: From 2013 to 2019 we identified 582 patients with 586 tumors who received NAC-BCT. The median age of the cohort was 54 years (IQR 45, 62); 84% of patients had cT1/T2 tumors and 61% were clinically node positive. The majority of tumors were HER2+ (38%) or triple negative (TN) (31%). Pathologic complete response was observed in 29%. Margin width was > 2 mm in 517 tumors (88%) and ≤ 2 mm in 69 (12%). At a median follow-up of 39 months, 14 patients had IBTR as a first event, with 64% occurring within 24 months of surgery. The 4-year IBTR rate was 2% (95% CI 1-4%), and there was no difference based on margin width (3% ≤ 2 mm vs 2% > 2 mm; p = not significant). On univariate analysis, clinical and pathologic T stage and receptor subtype, but not margin width, were associated with IBTR (p < 0.05). On multivariable analysis, TN subtype and higher pathologic T stage were associated with isolated IBTR (both p < 0.05). CONCLUSION: Pathologic features and tumor biology, not margin width, were associated with IBTR in NAC-BCT patients.

Resident-Championed Quality Improvement Provides Value: Confronting Prolonged Mechanical Ventilation.

BACKGROUND: The Quality In-Training Initiative (QITI) provides hands-on quality improvement education for residents. As our institution has ranked in the bottom quartile for prolonged mechanical ventilation (PMV) according to the National Surgical Quality Improvement Program (NSQIP), we sought to illustrate how our resident-led QITI could be used to determine perioperative contributors to PMV. MATERIALS AND METHODS: The Model for Improvement framework (developed by Associates in Process Improvement) was used to target postoperative ventilator management. However, baseline findings from our 2016 NSQIP data suggested that preoperative patient factors were more likely contributing to PMV. Subsequently, a retrospective one-to-one case-control study was developed, comparing preoperative NSQIP risk calculator profiles for PMV patients to case-matched patients for age, sex, procedure, and emergent case status. Chart review determined ventilator time, 30-d outcomes, and all-cause mortality. RESULTS: Forty-five patients with PMV (69% elective) had a median ventilator time of 134 h (interquartile range 87-254). The NSQIP calculator demonstrated increased preoperative risk percentages in PMV patients when compared to case-matched patients for any complication (includes PMV), predicted length of stay, and death (all P < 0.05). Thirty-day outcomes were worse for the PMV group in categories for sepsis, pneumonia, unplanned reoperation, 30-d mortality, rehab facility discharge, and length of stay (all P < 0.05). All-cause mortality was also significantly higher for PMV patients (P < 0.05). CONCLUSIONS: Resident-led QITI projects enhance resident education while exposing opportunities for improving care. Preoperative patient factors play a larger-than-anticipated role in PMV at our institution. Ongoing efforts are aimed toward preoperative identification and optimization of high-risk patients.

Preoperative Frailty and Surgical Outcomes Across Diverse Surgical Subspecialties in a Large Health Care System.

BACKGROUND: Frailty is an emerging risk factor for surgical outcomes; however, its application across large populations is not well defined. We hypothesized that frailty affects postoperative outcomes in a large health care system. STUDY DESIGN: Frailty was prospectively measured in elective surgery patients (January 2016 to June 2017) in a health care system (4 hospitals/901 beds). Frailty classifications-low (0), intermediate (1 to 2), high (3 to 5)-were assigned based on the modified Hopkins score. Operations were classified as inpatient (IP) vs outpatient (OP). Outcomes measured (30-day) included major morbidity, discharge location, emergency department (ED) visit, readmission, length of stay (LOS), mortality, and direct-cost/patient. RESULTS: There were 14,530 elective surgery patients (68.1% outpatient, 31.9% inpatient) preoperatively assessed (cardiothoracic 4%, colorectal 4%, general 29%, oral maxillofacial 2%, otolaryngology 8%, plastic surgery 13%, podiatry 6%, surgical oncology 5%, transplant 3%, urology 24%, vascular 2%). High frailty was found in 3.4% of patients (5.3% IP, 2.5% OP). Incidence of major morbidity, readmission, and mortality correlated with frailty classification in all patients (p < 0.05). In the IP cohort, length of stay in days (low 1.6, intermediate 2.3, high 4.1, p < 0.0001) and discharge to facility increased with frailty (p < 0.05). In the OP cohort, ED visits increased with frailty (p < 0.05). Frailty was associated with increased direct-cost in the IP cohort (low, $7,045; intermediate, $7,995; high, $8,599; p < 0.05). CONCLUSIONS: Frailty affects morbidity, mortality, and health care resource use in both IP and OP operations. Additionally, IP cost increased with frailty. The broad applicability of frailty (across surgical specialties) represents an opportunity for risk stratification and patient optimization across a large health care system.

Long-term growth outcomes in neonates diagnosed with necrotizing enterocolitis: a 20-year analysis.

PURPOSE: Limited data exists for longitudinal growth outcomes in neonates with a history of necrotizing enterocolitis (NEC). We aimed to study 20-year growth outcomes in NEC survivors. METHODS: A retrospective matched cohort study included neonates diagnosed with NEC and control subjects matched for birth year, birth weight, and gestational age who had at least one post-discharge follow-up. The primary outcome was growth, measured by length and weight until 20 years. Logistic regression was used to test the change in growth from birth until most recent encounter. RESULTS: Five hundred twenty-seven neonates were included: 294 with NEC, and 233 controls. Sixty-eight percent of NEC cases were Bell's stage I, 25% were stage II, and 7% were stage III. Median gestational age was 29 weeks, and median birth weight was 1237 g. Infants with NEC had a longer NICU stay (p < 0.0001) and increased number of comorbidities (p < 0.0001). Compared to overall and sex-matched controls, infants with NEC had a significantly slower growth rate in terms of weight (p < 0.0068) but not length (p = 0.09). Neither group exhibited failure to thrive. CONCLUSIONS: These results suggest that non-surgical NEC may have a more profound impact on long-term growth than previously considered. TYPE OF STUDY: Retrospective Cohort-Matched Study. LEVEL OF EVIDENCE: Level III.

Implementation of a standardized handoff protocol for post-operative admissions to the surgical intensive care unit.

BACKGROUND: The transfer of critically ill patients from the operating room (OR) to the surgical intensive care unit (SICU) involves handoffs between multiple providers. Incomplete handoffs lead to poor communication, a major contributor to sentinel events. Our aim was to determine whether handoff standardization led to improvements in caregiver involvement and communication. METHODS: A prospective intervention study was designed to observe thirty one patient handoffs from OR to SICU for 49 critical parameters including caregiver presence, peri-operative details, and time required to complete key steps. Following a six month implementation period, thirty one handoffs were observed to determine improvement. RESULTS: A significant improvement in presence of physician providers including intensivists and surgeons was observed (p = 0.0004 and p < 0.0001, respectively). Critical details were communicated more consistently, including procedure performed (p = 0.0048), complications (p < 0.0001), difficult airways (p < 0.0001), ventilator settings (p < 0.0001) and pressor requirements (p = 0.0134). Conversely, handoff duration did not increase significantly (p = 0.22). CONCLUSIONS: Implementation of a standardized protocol for handoffs between OR and SICU significantly improved caregiver involvement and reduced information omission without affecting provider time commitment.

Impact of complications on length of stay in elective laparoscopic colectomies.

BACKGROUND: Length of hospital stay (LOS) is an indirect measure of surgical quality and a surrogate for cost. The impact of postoperative complications on LOS following elective colorectal surgery is not well defined. The purpose of this study is to determine the contribution of specific complications towards LOS in elective laparoscopic colectomy patients. MATERIALS AND METHODS: American College of Surgeon's National Surgical Quality Improvement Program database (2011-2014) was queried for patients undergoing elective laparoscopic partial colectomy with primary anastomosis. Demographics, specific 30 d postoperative complications and LOS, were evaluated. A negative binomial regression adjusting for demographic variables and complications was performed to explore the impact of individual complications on LOS, significance set at P < 0.05. RESULTS: A total of 42,365 patients were evaluated, with an overall median LOS 4.0 d (interquartile range, 3.0-5.0). Unplanned reoperation and pneumonia each increase LOS by 50%; superficial surgical site infections (SSIs), organ space SSI sepsis, urinary tract infection, ventilation >48 h, pulmonary embolism, and myocardial infarction each increase LOS by at least 25% (P < 0.0001). When accounting for additional LOS and rate of complications, unplanned reoperation, bleeding requiring transfusion within 72 h, and superficial SSIs were the highest impact complications. CONCLUSIONS: In laparoscopic colectomy, each complication uniquely impacts LOS, and therefore cost. Utilizing this model, individual hospitals can implement pathways targeting specific complication profiles to improve care and minimize health care cost.

NSQIP-Based Quality Improvement Curriculum for Surgical Residents.

BACKGROUND: General surgery training has historically lacked a standardized approach to resident quality improvement (QI) education aside from traditional morbidity and mortality conference. In 2013, the ACGME formalized QI as a component of residency training. Our residency chose the NSQIP Quality In-Training Initiative (QITI) as the foundation for our QI training. We hypothesized that a focused curriculum based on outcomes would produce change in culture and improve the quality of patient care. STUDY DESIGN: Quality improvement curriculum design and implementation were retrospectively reviewed. Institutional NSQIP data pre-, during, and post-curriculum implementation were reviewed for improvement. RESULTS: A QITI project committee designed a 2-year curriculum, with 3 parts: didactics, focused on methods of data collection, QI processes, and techniques; review of current institutional performance, practice, and complication rates; and QI breakout groups tasked with creating "best practice" guidelines addressing common complications in our NSQIP semi-annual reports. Educational presentations were given to the surgical department addressing reduction of cardiac complications, pneumonia, surgical site infections (SSIs), and urinary tract infections (UTIs). Twenty-four residents completed both years of the QITI curriculum. National NSQIP decile ranks improved in known high outlier areas: cardiac complications, ninth to fourth decile; pneumonia, eighth to first decile; SSIs, tenth to second decile; and UTIs, eighth to third decile. Pneumonia and SSI rates demonstrated statistical improvement after curriculum implementation (p < 0.003). CONCLUSIONS: Implementing a QITI curriculum with a full resident complement is feasible and can positively affect surgical morbidity and nationally benchmarked performance. Resident QI education is essential to future success in delivering high quality surgical care.

Impact of obesity on postoperative 30-day outcomes in emergent open ventral hernia repairs.

BACKGROUND: Anecdotally, obese patients experience increased morbidity with emergent ventral hernia repair (VHR). We hypothesized obese patients are over-represented in emergent VHRs and experience increased 30-day morbidity. METHODS: American College of Surgeons National Surgical Quality Improvement Program database (2011 to 2013) was queried for patients undergoing open VHR. Patients were stratified by body mass index (BMI) categories: underweight, normal weight, overweight, and obesity classes I, II, and III; 30-day postoperative complications (surgical site infections, return to operating room, dehiscence, death) were evaluated across BMI for elective vs emergent VHR. RESULTS: In all, 39,822 patients were included: 7.3% emergent. Obese classes I to III represented higher percent of emergent VHRs (55.8% vs 68.9%). Complication rate doubled for emergent group (7.2% vs 14.5%), and likelihood of at least one complication increased with BMI for emergent vs normal weight-elective VHR (overweight odds ratio, 2.2; 95% confidence interval, 1.4 to 3.4; class III odds ratio, 4.0; 95% confidence interval, 2.9 to 5.5). CONCLUSIONS: Selection bias exists with obese patients and ventral hernias. Emergent VHR have increased complications. Elective BMI cutoffs require re-evaluation.

Tailoring surgical approach for elective ventral hernia repair based on obesity and National Surgical Quality Improvement Program outcomes.

BACKGROUND: Obesity's influence on postoperative complications in either laparoscopic ventral hernia repair (LVHR) or open ventral hernia repair (OVHR) has yet to be defined. Although 30-day postoperative complications increase with higher body mass index (BMI), we propose LVHR minimizes surgical site infections (SSIs) and surgical site occurrences (SSOs) for given BMI categories. METHODS: Retrospective review of the American College of Surgeons National Surgical Quality Improvement Program database (2009 to 2012) for patients aged 18 years or more undergoing elective ventral hernia repair. Exclusion criteria included immunosuppression, disseminated malignancy, advanced liver disease, or pregnancy. Patients were stratified by BMI (20 to 25, 25 to 30, 30 to 35, 35 to 40, and >40 kg/m(2)), and 30-day SSOs evaluated across BMI groups for LVHR vs OVHR. RESULTS: A total of 106,968 patients met inclusion criteria, with 60% patients obese. LVHR decreased SSO for all patients (odds ratio, .4; confidence interval, .19 to .60). Obesity classes I/II/III have increased odds of superficial SSI, deep SSI, and dehiscence for OVHR compared with LVHR. Only obesity class III has increased odds of organ space SSI and reoperation for OVHR vs LVHR (P < .05). CONCLUSIONS: Obese patients are over-represented in VHRs. Thirty-day postoperative wound complications increase with higher BMI. LVHR minimizes both SSIs and SSOs, especially in higher obesity classes.