Disease-free and overall survival after neoadjuvant chemotherapy in breast cancer: breast-conserving surgery compared to mastectomy in a large single-centre cohort study.

PURPOSE: The extended role of breast-conserving surgery (BCS) in the neoadjuvant setting may raise concerns on the oncologic safety of BCS compared to mastectomy. This study compared long-term outcomes after neoadjuvant chemotherapy (NAC) between patients treated with BCS and mastectomy. METHODS: All breast cancer patients treated with NAC from 2008 until 2017 at the Amphia Hospital (the Netherlands) were included. Disease-free and overall survival were compared between BCS and mastectomy with survival functions. Multivariable Cox proportional hazard regression was performed to determine prognostic variables for disease-free survival. RESULTS: 561 of 612 patients treated with NAC were eligible: 362 (64.5%) with BCS and 199 (35.5%) with mastectomy. Median follow-up was 6.8 years (0.9-11.9). Mastectomy patients had larger tumours and more frequently node-positive or lobular cancer. Unadjusted five-year disease-free survival was 90.9% for BCS versus 82.9% for mastectomy (p = .004). Unadjusted five-year overall survival was 95.3% and 85.9% (p < .001), respectively. In multivariable analysis, clinical T4 (cT4) (HR 3.336, 95% CI 1.214-9.165, p = .019) and triple negative disease (HR 5.946, 95% CI 2.703-13.081, p < .001) were negative predictors and pathologic complete response of the breast (HR 0.467, 95% CI 0.238-0.918, p = .027) and axilla (HR 0.332, 95% CI 0.193-0.572, p = .001) were positive predictors for disease-free survival. Mastectomy versus BCS was not a significant predictor for disease-free survival when adjusted for the former variables (unadjusted HR 2.13 (95%CI: 1.4-3.24), adjusted HR 1.31 (95%CI: 0.81-2.13)). In the BCS group, disease-free and overall survival did not differ significantly between cT1, cT2 or cT3 tumours. CONCLUSION: BCS does not impair disease-free and overall survival in patients treated with NAC. Tumour biology and treatment response are significant prognostic indicators.

Do Surgical Site Infections in Open Aortoiliac Surgery Differ Between Occlusive and Aneurysmal Arterial Disease?

BACKGROUND: Surgical site infections (SSI) are frequently seen after aortoiliac vascular surgery (2%-14%). Deep SSIs are associated with graft infection, sepsis, and mortality. This study evaluates the difference in incidence and nature of SSI following open aortoiliac surgery for aneurysmal disease compared to occlusive arterial disease. METHODS: A retrospective cohort study was conducted, including all consecutive patients who underwent open aortoiliac vascular surgery between January 2005 and December 2016 in the Amphia Hospital, Breda, the Netherlands. Patients were grouped by disease type, either aneurysmal or occlusive arterial disease. Data were gathered, including patient characteristics, potential risk factors, and development of SSI. Surgical site infections were defined in accordance with the criteria of the Centers for Disease Control. RESULTS: Between January 2005 and December 2016, a total of 756 patients underwent open aortoiliac surgery of which 517 had aortoiliac aneurysms and 225 had aortoiliac occlusive disease. The group with occlusive disease was younger, predominantly male, and had more smokers. After exclusion of 228 patients undergoing acute surgery, the SSI rate after elective surgery was 6.2%, with 10 of 301 SSIs in the aneurysmal group (3.0%) and 22 of 213 SSIs in the group with occlusive disease (10.3%, P < .001). Also, infection-related readmission and reintervention were higher after occlusive surgery, 6.6% versus 0.9% (P < .001) and 4.2% versus 0.9% (P = .003), respectively. Staphylococcus aureus was found as the most common pathogen, causing 64% of SSI in occlusive disease versus 10% in aneurysmal disease (P = .005). Logistic regression showed occlusive arterial disease and chronic renal disease were associated with SSI. CONCLUSION: Our study presents evidence for a higher rate of SSI in patients with aortoiliac occlusive disease compared to aortoiliac aneurysmal disease, in part due to inherent use of inguinal incision in patients with occlusive disease. All precautions to prevent SSI should be taken in patients undergoing vascular surgery for arterial occlusive disease.

A Comparison of Quality of Life in Elderly Patients with Intermittent Claudication and Chronic Limb-Threatening Ischemia.

BACKGROUND: Intermittent claudication (IC) and chronic limb-threatening ischemia (CLTI) are both associated with a decreased health status and possibly quality of life (QOL). A better understanding of the differences in QOL between patients with IC and CLTI could be of additional value in shared decision-making. The aim of this study was to compare the QOL at baseline between patients with IC and patients with CLTI. METHODS: The study population was based on 2 study cohorts, 1 cohort consisted of patients with IC (ELECT registry) and the other cohort of patients with CLTI (KOP-study). Patients with an age of ≥70 years were included. QOL at baseline was measured by the WHOQOL-BREF questionnaire. Nonresponders were excluded from data analyses. Student's t-tests and analysis of covariance (ANCOVA) analyses were used to compare QOL between the 2 groups. Outcomes of the ANCOVA analyses were expressed as estimated marginal means. RESULTS: In total, 308 patients were included, 115 patients with IC and 193 patients with CLTI. Patients with CLTI were older (median age 80 years vs. 75 years, P < 0.001) and had more comorbidities. Patients with IC had a statistically significant higher QOL regarding physical health (mean 13.7 [standard deviation (SD) 2.3] vs. 10.8 [SD 2.8], P < 0.001), psychological health (mean 15.3 [SD 2.1] vs. 14.1 [SD 2.4], P < 0.001), environment (mean 16.3 [SD 2.4] vs. 15.5 [SD 2.0], P < 0.002), and the overall domain (mean 3.5 [SD 0.7] vs. 3.1 [SD 0.9], P < 0.001). After correcting for the confounding effect of age and sex, patients with IC still had a statistically significant higher QOL in the physical, psychological, environment, and overall domain. CONCLUSIONS: Patients with IC had a significantly higher QOL in the physical, psychological, environment, and overall domains of the WHOQOL-BREF questionnaire compared with patients with CLTI. This underlines the importance of strategies that reduce disease progression as disease progression is associated with a decrease in QOL.

Abdominal aortic aneurysm patients remain at risk for delirium on the surgical ward after intensive care unit dismissal.

BACKGROUND: The incidence of delirium following open abdominal aortic aneurysm (AAA) surgery is significant, with incidence rates ranging from 12% to 33%. However, it remains unclear on what level of care a delirium develops in AAA patients. The aim of this study was to investigate the incidence of delirium in the ICU and on the surgical ward after AAA surgery. METHODS: A single-center retrospective cohort study was conducted that included all patients treated electively for an open AAA repair and patients who underwent emergency treatment for a ruptured AAA between 2013 and 2018. The diagnosis of delirium was verified by a psychiatrist or geriatrician using the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria. The incidence of delirium was calculated. Cox proportional hazards regression analyses were used to analyze 6- and 12-month survival. RESULTS: A total of 135 patients were included, 46 patients (34%) had a delirium during admission. Of these, 30 patients (65%) developed a delirium in the ICU and 16 patients (35%) on the surgical ward. There was no significant difference in six months and twelve months mortality between the ICU and ward delirium groups (HR=1.64, 95% CI: 0.33-8.13, and HR=1.12, 95% CI: 0.28-4.47, respectively). CONCLUSIONS: Delirium frequently occurs in patients who undergo AAA surgery. This study demonstrated that patients on the surgical ward remain at risk of developing a delirium after ICU dismissal. Patients with ICU delirium differ in clinical characteristics and outcomes from patients with a delirium on the surgical ward.

Post-EVAR aneurysm sac shrinkage is prognostically favorable, but does not justify withholding follow-up.

BACKGROUND: One of the main drawbacks of endovascular aortic aneurysm repair (EVAR) compared to open aortic surgery is the possibility of developing endoleaks and secondary aneurysm rupture, requiring frequent imaging follow-up. This study aims to identify prognostic factors that could be incorporated in follow-up protocols, which might lead to better personalized, lower cost and safe EVAR follow-up. METHODS: A retrospective study was performed including all patients who underwent elective EVAR from January 2000 to December 2015. Follow-up data were gathered by reviewing medical files for radiographic imaging. Linear and logistic regressions were used to assess predictive factors for aneurysm shrinkage. RESULTS: In 361 patients, aneurysm sac shrinkage of 10 mm or more was measured in 152 (42.1%) patients. Patients with ≥10-mm aneurysm shrinkage had fewer endoleaks (4.3% vs. 24.6%, P<0.0001) and fewer re-interventions for endoleak (3.0% vs. 10.1%, P=0.007). Aneurysm sac shrinkage was correlated with the absence of endoleak development (OR 0.36, 95% CI 0.19-0.66, P=0.001). In patients who had achieved ≥10-mm shrinkage of the aneurysm sac, no further significant growth was seen, compared to 38 (15.3%) patients who did not attain size reduction (P<0.001). CONCLUSIONS: Once patients achieve ≥10-mm aneurysm sac shrinkage, they are less prone to developing subsequent aneurysm growth and have significantly lower risk of requiring surgery for endoleaks. However, a small number of patients remain at risk of requiring endoleak surgery after aneurysm shrinkage. Therefore, we would not recommend ceasing life-long imaging follow-up after significant aneurysm sac shrinkage, though it might be safe to increase the interval of follow-up.

Adverse Cardiac Events and Mortality in Patients with Critical Limb Ischemia.

BACKGROUND: Both surgical and endovascular treatment in elderly patients with critical limb ischemia are associated with high mortality rates. Patients with critical limb ischemia are at increased risk of adverse cardiovascular events and subsequent cardiovascular death. Little is known about the incidence and consequences of these adverse events. The aim of this study was to investigate the effect of adverse cardiac events on mortality in patients with critical limb ischemia undergoing surgical or endovascular treatment. METHODS: A retrospective cohort study including all patients with critical limb ischemia aged ≥65 undergoing surgical or endovascular treatment for critical limb ischemia between January 2013 and June 2018 was conducted. Data on adverse cardiac events were collected from medical records. The effect of an adverse cardiac event on mortality during 6 months follow-up was analyzed with a multivariable cox proportional hazards model to adjust for confounders. Effects are displayed as hazard ratios (HR) with 95% confidence intervals (CI). RESULTS: A total number of 449 patients were included. Median age was 76 years, 52.8% of patients were male. In total, 51 patients (11%) developed an adverse cardiac event, 31 patients (10%) in the surgical group and 20 patients (14%) in the endovascular group. After adjustment for confounders, adverse cardiac events were associated with an increased risk of mortality (HR 3.5 95% CI 2.1-5.9). CONCLUSIONS: This study showed that adverse cardiac events commonly occur in elderly patients with critical limb ischemia. Adverse cardiac events continue to occur even months after treatment and are associated with an increased mortality risk. These findings justify routine cardiac evaluation in both surgical and endovascular treatment. Additionally, frequent postdischarge cardiac follow-up in the outpatient clinic may be helpful in limiting the occurrence of adverse cardiac events.

Incidence and Risk Factors for Delirium in Elderly Patients with Critical Limb Ischaemia.

OBJECTIVE: Delirium is associated with adverse outcomes, such as increased mortality and prolonged hospital stay. Information on the risk factors for delirium in elderly patients with critical limb ischaemia (CLI) is scarce. The aim of this study was to analyse the incidence of delirium and to identify risk factors for delirium in elderly patients undergoing surgical or endovascular treatment. METHODS: A retrospective cohort study was conducted including patients aged ≥ 65 years undergoing surgical or endovascular treatment for CLI between January 2013 and June 2018. Delirium was scored using the DOSS (Delirium Observation Screening Scale) and the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria. Risk factors for delirium were analysed using logistic regression. The discriminative ability of the model was calculated using the area under the receiver operating characteristics (AUROC) curve. RESULTS: In total, 392 patients were included, of which 70 (17.9%) developed delirium. Factors associated with an increased risk of delirium were: age, odds ratio (OR) 1.05 (95% confidence interval (CI) 1.0-1.1), history of femoral endarterectomy, OR 4.7 (95% CI 1.5-15), physical impairment, OR 2.2 (95% CI 1.1-4.5), history of delirium, OR 2.7 (95% CI 1.4-5.3), general anaesthesia, OR 2.6 (95% CI 1.2-5.7) and pre-operative anaemia, OR 5.9 (95% CI 2.3-15). The AUROC was .82 (95% CI 0.76-0.87, p < .001). Delirium was associated with more respiratory, renal and surgical complications, as well as a prolonged hospital stay and a more frequent discharge to a nursing home. CONCLUSION: Delirium occurs frequently in patients with critical limb ischaemia undergoing any type of invasive treatment. This study identified multiple risk factors for delirium that may be helpful to delineate patients susceptible to its development.

A mortality prediction model for elderly patients with critical limb ischemia.

OBJECTIVE: To aid physicians in the process of shared decision-making, many predictive models for critical limb ischemia (CLI) have been constructed. However, none of these models is in widespread use. Predicting survival outcomes for a specific individual may be used to guide treatment selection. The aim of this study was to construct a 6-month survival-predicting model representative of elderly patients with CLI undergoing surgical or endovascular treatment. METHODS: An observational cohort study including all patients with CLI aged ≥65 years who underwent surgical or endovascular treatment of CLI between January 2013 and June 2018 was conducted. The model to predict survival at 6 months was based on a multivariable Cox proportional hazards regression model and a penalized likelihood method. The performance of the model was judged by means of the area under the receiver operating characteristic curve. RESULTS: In total, 449 patients were included in the study population. The median age was 76 years (range, 65-97 years), and 52.8% of the population was male. Surgical treatment was performed in 303 patients (67.5%), and 146 underwent endovascular treatment (32.5%). The estimated 30-day survival was 92.7% (standard error [SE], 1.2%); 6-month survival, 80% (SE, 1.9%); and 12-month survival, 71% (SE, 2.1%). Variables with the strongest association with 6-month mortality were age, living in a nursing home, physical impairment, and American Society of Anesthesiologists class. The area under the receiver operating characteristic curve of the 6-month mortality model was 0.81 (95% confidence interval, 0.76-0.85; P < .001). CONCLUSIONS: A prediction model constructed for 6-month mortality of elderly patients undergoing surgical or endovascular treatment of CLI showed that age, living in a nursing home, physical impairment, and American Society of Anesthesiologists class have the highest association with an increase in mortality. These factors may be used to identify patients at risk for mortality in shared decision-making.

Marital quality and loneliness as predictors for subjective health status in cardiac rehabilitation patients following percutaneous coronary intervention.

BACKGROUND: Low marital quality is associated with adverse health outcomes and lower personal well-being. Loneliness increases the risk of cardiovascular disease and mortality and predicts poor quality of life. The aim of this study was to investigate the association between marital quality and loneliness and subjective health status in primary percutaneous coronary intervention (pPCI) patients who underwent cardiac rehabilitation (CR). DESIGN/METHODS: In a prospective cohort study, pPCI patients that followed CR were included between 2009-2011. A total of 223 patients responded to the Short Form 12 (SF-12) (subjective health status), Maudsley Marital Questionnaire (MMQ-6) (marital quality) and University of California, Los Angeles - Revised (UCLA-R) questionnaires at baseline (pre-CR) and at three months (post-CR) or at 12 months follow-up. Subjective health status is displayed by a physical component summary (PCS) score and a mental component summary (MCS) score. Generalized estimating equation (GEE) analyses were performed to test improvements in subjective health status. RESULTS: Changes over time in subjective health status scores were similar between patients with optimal marital quality vs patients with less optimal marital quality and non-lonely patients vs lonely patients. The MCS level at one-year follow-up of both patients with less optimal marital quality and lonely patients was lower compared with a healthy Dutch population (respectively; mean MCS score 47.3 (standard deviation (SD) 10.5); p = 0.013 and mean MCS score 46.1 (SD 11.2); p = 0.010). CONCLUSION: Both patients with less optimal marital quality and lonely patients did not reach the MCS level of a healthy Dutch population. Therefore, extra care and support should be given to these patients in a CR programme.