Update of a Model to Predict Outcomes after Endovascular Aneurysm Repair.

BACKGROUND: Risk assessment models must be continuously validated and updated to ensure that predictions remain valid. Here, the Endovascular Aneurysm Repair Risk Assessment Model, developed in 2008, is updated and improved. METHODS: We used prospectively collected data from Australian patients who underwent elective endovascular aneurysm repair between 2009 and 2013 (n = 695). Data were provided by treating surgeons and the National Death Index. Key outcomes were early and midterm survival, early complications (endoleak, operative, and graft-related) and late complications (endoleak and graft-related). Multinomial logistic regression determined which preoperative variables best predicted each outcome. Area under Receiver Operating Characteristic curve (AUROC), model P-value and internal validation statistics were used to select the best model. RESULTS: Ten preoperative variables were included in the modeling for 10 key outcomes. The most valid outcomes with AUROC>0.7 were 1- and 3-year survival, 30 and 90-day mortality, early and late endoleak (types I, III and IV) and type II endoleak (with an increase in sac size ≥5 mm). The 10 preoperative variables that contributed to outcome models were self-reported fitness, American Society of Anesthesiologists physical status score, history of stroke/transient ischemic attack, age, aneurysm angle, infrarenal neck length, white cell count, respiratory assessment, diabetes and statin therapy. Fitness alone statistically significantly predicted 30 and 90-day deaths better than any other preoperative variable; achieving high AUROCs (0.78 and 0.80), and high odds ratios (12.8 [95% CI: 1.5-110.4] and 18.1 [95% CI: 2.2-149]). CONCLUSIONS: An updated interactive predictive model of outcomes after endovascular aneurysm repair has been created. Many of the variables used in the 2008 model continued to be significant, however, new variables including fitness and respiratory assessment, improved the model. The new model uses variables routinely collected preoperatively, and hence can better support surgeon-patient discussions prior to operation. Informing patients of potential risks or likely outcomes following elective surgery can assist with preoperative shared decision-making.

Circulating biomarkers are not associated with endoleaks after endovascular repair of abdominal aortic aneurysms.

OBJECTIVE: Endoleak is a common complication of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) but can be detected only through prolonged follow-up with repeated aortic imaging. This study examined the potential for circulating matrix metalloproteinase 9 (MMP9), osteoprotegerin (OPG), D-dimer, homocysteine (HCY), and C-reactive protein (CRP) to act as diagnostic markers for endoleak in AAA patients undergoing elective EVAR. METHODS: Linear mixed-effects models were constructed to assess differences in AAA diameter after EVAR between groups of patients who did and did not develop endoleak during follow-up, adjusting for potential confounders. Circulating MMP9, OPG, D-dimer, HCY, and CRP concentrations were measured in preoperative and postoperative plasma samples. The association of these markers with endoleak diagnosis was assessed using linear mixed effects adjusted as before. The potential for each marker to diagnose endoleak was assessed using receiver operating characteristic curves. RESULTS: Seventy-five patients were included in the study, 24 of whom developed an endoleak during follow-up. Patients with an endoleak had significantly larger AAA sac diameters than those who did not have an endoleak. None of the assessed markers showed a significant association with endoleak. This was confirmed through receiver operating characteristic curve analyses indicating poor diagnostic ability for all markers. CONCLUSIONS: Circulating concentrations of MMP9, OPG, D-dimer, HCY, and CRP were not associated with endoleak in patients undergoing EVAR in this study.

Fitness plus American Society of Anesthesiologists grade improve outcome prediction after endovascular aneurysm repair.

BACKGROUND: Although the American Society of Anesthesiologists (ASA) grade was established for statistical purposes, it is often used prognostically. However, older patients undergoing elective surgery are typically ASA III, which limits patient stratification. We look at the prognostic effect on early complications and survival of using ASA and self-reported physical fitness to stratify patients undergoing endovascular repair of abdominal aortic aneurysms. METHODS: Data were extracted from a trial database. All patients were assigned a fitness level (A (fit) or B (unfit)) based on their self-reported ability to walk briskly for 1 km or climb two flights of stairs. Fitness was used to stratify ASA III patients, with fitter patients assigned ASA IIIA and less fit patients ASA IIIB. Outcomes assessed included survival, reinterventions, endoleak, all early and late complications and early operative complications. RESULTS: A combined ASA/fitness scale (II, IIIA, IIIB and IV) correlated with 1- and 3-year survival (1-year P = 0.001, 3-year P = 0.001) and early and late complications (P = 0.001 and P = 0.05). On its own, ASA predicted early complications (P = 0.0004) and survival (1-year P = 0.01, 3-year P = 0.01). Fitness alone was predictive for survival (1-year P = 0.001, 3-year P = 0.001) and late complications (P = 0.009). CONCLUSION: This study shows that even a superficial assessment of fitness is reflected in surgical outcomes, with fitter ASA III patients showing survival patterns similar to ASA II patients. Physicians should be alert to differences in fitness between patients in the ASA III group, despite similarities based on preexisting severe systemic disease.

Type II Endoleak after Endovascular Aneurysm Repair: Natural History and Treatment Outcomes.

BACKGROUND: The natural history of type II endoleaks and linkage to aneurysm rupture is unclear. Likewise, treatment recommendations are controversial. The aim of this study was to examine the incidence, factors associated with type II endoleaks, and outcomes in an Australia cohort of patients who have undergone endovascular aneurysm repair (EVAR). METHODS: Data from 693 patients who underwent EVAR between 2009 and 2013 at multiple institutions across Australia were studied. Patients who developed (1) type II endoleak and (2) type II endoleak with sac expansion were compared for preoperative demographics, mortality, sac expansion, aneurysm rupture, and intervention rates. RESULTS: A total of 225 patients developed type II endoleak over a mean follow-up of 1.9 years (±1.0 years), out of which 133 spontaneously resolved, 37 were untreated unresolved, and 16 underwent intervention. Type I and III endoleaks occurred in 50 and 19 patients, respectively. Smoking (P = 0.002) and warfarin (P = 0.044) were protective factors for development of type II endoleak, whereas age (P = 0.034), right iliac artery tortuosity (P = 0.031), and right (P = 0.008) and left external iliac diameters (P = 0.028) were risk factors for endoleak. Three patients suffered aneurysm ruptures in the entire cohort. All ruptures occurred in type II endoleak patients, of which two occurred after reintervention and in the absence of sac expansion (>5 mm). Late type II endoleak occurred in 117 patients, out of which 26 had sac expansion. Of those without late type II endoleak, 25 have sac expansion. There was no statistically significant difference in survival between those with and without type II endoleak. Age (P < 0.0001) and smoking (P = 0.001) were significant independent predictive factors for survival in this patient sample. Treatment outcomes were encouraging with most cases involving endoleak resolution (15 of 16 patients) and no sac expansion after intervention (0 of 8 patients with complete follow-up info on sac size). CONCLUSIONS: Aneurysm rupture in patients with type II endoleak is uncommon in our series. Type II endoleak with sac expansion does not appear to be associated with aneurysm rupture. In this series, most aneurysm ruptures occurred in the absence of documented sac expansion and after reintervention.

Looking back at the John Mitchell Crouch Fellowship: the most prestigious research award of the Royal Australasian College of Surgeons.

The John Mitchell Crouch Fellowship is a generous endowment made to the Royal Australasian College of Surgeons (RACS) by the young neurosurgeon's family, following his death from a brain tumour. In this article, we examine the significance and legacy of the grant since its inception in 1979. This is the highest level of research fellowship awarded by the RACS recognizing early career excellence, as part of its significant research funding programme (over $1.7 million in 2015). John Mitchell Crouch recipients have been pioneers in various areas of medicine where they have developed new technologies, established research centres, improved patient safety and military surgery and embraced evidence-based medicine. The funds they received have directly contributed to research published in numerous highly respected peer-reviewed journals such as The New England Journal of Medicine; established new laboratories, helped fund clinical trials and allowed new directions of research to be pursued. Recipients of the John Mitchell Crouch Fellowship have been recognized with many awards including 11 Australian and New Zealand Honours to date. Many other significant research funds have been subsequently bestowed, including over 120 National Health Medical Research Council (NHMRC) grants to Australian and New Zealand recipients subsequent to their Fellowship. This article also shows the range of disciplines in which the award has supported cutting-edge research leading to benefits for patients and health care.

Self-reported fitness of American Society of Anesthesiologists class 3 patients undergoing endovascular aneurysm repair predicts patient survival.

BACKGROUND: Most patients undergoing elective endovascular aneurysm repair (EVAR) are classified American Society of Anesthesiologists (ASA) 3. However, the severity of systemic disease among these patients can vary, resulting in markedly different levels of fitness. In this study, we explored the hypothesis that ASA 3 patients with good self-reported exercise tolerance have better survival after EVAR. METHODS: Data for EVAR patients classified ASA 3 were extracted retrospectively from a prospectively collected registry database. Patients were split into two groups according to fitness level, based on their self-reported ability to climb stairs or to walk briskly for 1 km. Patient survival for each group was assessed by Cox proportional hazards models. RESULTS: During follow-up of 392 patients for a mean of 1.9 years, there were 64 deaths (16.3%), 13.4% in the more physically able group and 21.6% in the less able group. Self-reported inability to walk or to climb stairs was associated with increased risk of all-cause mortality (hazard ratio, 3.55; P < .0001). Following risk adjustment for a number of possible confounding variables, fitness remained significant (hazard ratio, 3.03; P = .0011). CONCLUSIONS: This study has shown that among ASA 3 patients, self-reported exercise capacity is an excellent means of predicting survival. Physicians should consider the physical fitness of their ASA 3 patients when discussing treatment options.

International trends in patient selection for elective endovascular aneurysm repair: sicker patients with safer anatomy leading to improved 1-year survival.

BACKGROUND: To review the trends in patient selection and early death rate for patients undergoing elective endovascular repair of infrarenal abdominal aortic aneurysms (EVAR) in 3 countries. For this study, audit data from 4,163 patients who had undergone elective infrarenal EVAR were amalgamated. The data originated from Australia, Canada (Ontario), and England (London, Cambridge, and Leicester). METHODS: Statistical analyses were undertaken to determine whether patient characteristics and early death rate varied between and within study groups and over time. The study design was retrospective analysis of data collected prospectively between 1999 and 2012. RESULTS: One-year survival improved over time (P = 0.0013). Canadian patients were sicker than those in Australia or England (P < 0.001). American Society of Anesthesiologists classification (ASA) increased over time across all countries although more significantly in Canada. Age at operation remained constant, although older patients were treated more recently in London (P < 0.001). English centers treated larger aneurysms compared with Australia and Canada (P < 0.001). Australian centers treated a much larger proportion of aneurysms that were <55 mm than other countries. Preoperative creatinine levels decreased over time for all countries and centers (P < 0.001). Infrarenal neck angles have significantly decreased over time (P < 0.001). Recent data from London (UK) showed that operations were performed on longer (P < 0.001) and wider (P < 0.001) infrarenal necks than elsewhere. CONCLUSIONS: In this international comparison, several trends were noted including improved 1-year survival despite declining patient health (as measured by increasing ASA status). This may reflect greater knowledge regarding EVAR that centers from different countries have gained over the last decade and improved medical management of patients with aneurysmal disease.

Disparities in access to breast care nurses for breast surgeons: a National Breast Cancer Audit survey.

The involvement of a breast care nurse (BCN) in breast cancer treatment can improve the physical and psychological outcomes and provide the continuity of care and better information about the disease and treatment process. This survey examined the current status of BCNs access to determine the extent and how BCNs were accessed by breast surgeons across Australia and New Zealand in different geographical settings or health service sectors. The survey was disseminated in December 2006. Response rate was 91%. The results show that the majority of Australian and New Zealand breast surgeons either work with a BCN in their practice or can access a BCN outside their practice. Patients are more likely to have access to a BCN immediately after diagnosis while around a third of practices have access to a BCN more than once, usually "after diagnosis" and "after surgery". More public practices have direct access to a BCN than private practices, particularly in the metropolitan and regional areas while access to BCN is poor in rural public and private practices. The difference in overall access, either in the practice or external access (Yes or No but can access a BCN), to a BCN between public and private practices is smaller. Access to a BCN was best in metropolitan public practices and worst in rural private practices with one quarter rural private practices had no access to a BCN and no rural patients can access a BCN more than once in private practice. The results of this survey demonstrated some evidence of disparity in access to a BCN which needs to be reduced through more attention and/or extra resources in this area.

Patterns of surgical treatment for women with breast cancer in relation to age.

Although treatment recommendations have been advocated for all women with early breast cancer regardless of age, it is generally accepted that different treatments are preferred based on the age of the patient. The aim of this study was to assess the pattern of breast cancer surgery after adjusting for other major prognostic factors in relation to patient age. Data on cancer characteristics and surgical procedures in 31,298 patients with early breast cancer reported to the National Breast Cancer Audit between 1999 and 2006 were used for the study. There was a close association between age and surgical treatment pattern after adjusting for other prognostic factors, including tumor size, histologic grade, number of tumors, lymph node positivity, lymphovascular invasion (LVI), and extensive intraduct component. Breast Conserving Surgery (BCS) was highest among women aged 70 years (OR = 0.498, 95% CI: 0.455-0.545). Significantly more women aged 50 years (11.4-17.0%). Women aged >70 years were more likely to receive no surgical treatment, 3.5% versus 1.0-1.3% in all other age groups (70 years) more commonly undergo mastectomy and are more likely to receive no surgical treatment.

ASERNIP-S: international trend setting.

The Australian Safety and Efficacy Register of New Interventional Procedures--Surgical (ASERNIP-S) came into being 10 years ago to provide health technology assessments specifically tailored towards new surgical techniques and technologies. It was and remains the only organisation in the world to focus on this area of research. Most funding has been provided by the Australian Government Department of Health, and assessments have helped inform the introduction of new surgical techniques into Australia. ASERNIP-S is a project of the Royal Australasian College of Surgeons. The ASERNIP-S program employs a diverse range of methods including systematic reviews, technology overviews, assessments of new and emerging surgical technologies identified by horizon scanning, and audit. Support and guidance for the program is provided by Fellows of the Royal Australasian College of Surgeons. ASERNIP-S works closely with consumers to produce health technology assessments and audits, as well as consumer information to keep patients fully informed of research. Since its inception, the ASERNIP-S program has developed a strong international profile through the production of over 60 reports on evidence-based surgery, surgical technologies and audit. The work undertaken by ASERNIP-S has evolved from assessments of the safety and efficacy of procedures to include guidance on policies and surgical training programs. ASERNIP-S needs to secure funding so that it can continue to play an integral role in the improvement of quality of care both in Australia and internationally.

Trends in surgical treatment of younger patients with breast cancer in Australia and New Zealand.

BACKGROUND: The optimal surgical treatment of early breast cancer in young women is not fully determined, while past reports indicate a trend to the increased use of breast-conserving surgery (BCS). This study aims to assess the trend in Australia and New Zealand of BCS use between 1999 and 2006 and to determine pathological factors associated with it. METHODS: Data on cancer characteristics and surgical procedures in younger patients with early breast cancer reported to the National Breast Cancer Audit have been analysed. RESULTS: There was little change in the rate of BCS over the last 7 years with an overall rate of 53%. The main factors associated with the use of BCS are low histological grade, absence of extensive intraductal carcinoma (EIC), negative lymph node involvement, unifocal tumour and small tumour size. CONCLUSION: Between 1999 and 2006, the use of BCS for early breast cancer treatment in younger women was stable. These results show that surgeons contributing data to the National Breast Cancer Audit appear to use pathological factors that are known to increase the risk of local recurrence after BCS, in selecting mastectomy for younger women.

National Breast Cancer Audit: the use of multidisciplinary care teams by breast surgeons in Australia and New Zealand.

OBJECTIVE: To explore the involvement of members of the Royal Australasian College of Surgeons (RACS) Section of Breast Surgery in Australia and New Zealand in multidisciplinary care (MDC) teams. DESIGN AND SETTING: Questionnaire sent to all full members of the RACS Section of Breast Surgery in December 2006. PARTICIPANTS: 239 of 262 active full members of the RACS Section of Breast Surgery (response rate, 91.2%). MAIN OUTCOME MEASURES: Surgeons' use of, and the composition and functioning of, MDC teams in public and private practice, and in metropolitan, regional and rural settings. RESULTS: 85% of responding surgeons reported participating in at least one fully established MDC team. Public-sector teams were operationally more consistent and functional than private teams, and rural teams were less well developed than those in metropolitan and regional centres. The six core disciplines recommended by the National Breast Cancer Centre appear to be well represented in most teams. Patients and their general practitioners were not considered to be part of the treatment team by surgeons. CONCLUSIONS: MDC is supported by most breast surgeons, but there are deficits in rural areas, and in the private sector relative to the public sector.

Clinical audits: why and for whom.

Every surgical activity poses some element of risk to the public and should include a quality control initiative. Surgical audit is one strategy used to maintain and/or improve standards in surgical care. The Royal Australasian College of Surgeons is committed to ensuring best practice in surgical care and strongly endorses the use of audits to achieve this. This review provides an overview of clinical audit and its role in surgical practice.

National Breast Cancer Audit: ductal carcinoma in situ management in Australia and New Zealand.

BACKGROUND: Ductal carcinoma in situ (DCIS) is a significant issue in Australia and New Zealand with rising incidence because of the implementation of mammographic screening. Current information on its natural history is unable to accurately predict progression to invasive cancer. In 2003, the National Breast Cancer Centre in Australia published recommendations for DCIS. In Australia and New Zealand, the National Breast Cancer Audit collects information on DCIS cases. This article will examine these recommendations and provide information from the audit on current DCIS management. METHODS: Three thousand six hundred and twenty-nine cases of DCIS were entered by 274 breast surgeons between January 1998 and December 2004. Data items in the National Breast Cancer Audit database that were covered in the National Breast Cancer Centre recommendations were reviewed. Information was available on the following: diagnostic biopsy rates for all cases and mammographically positive cases and rates of breast conserving surgery (BCS), clear margins following BCS, postoperative radiotherapy following BCS for groups at high risk of recurrence as well as axillary procedures and tamoxifen prescription. RESULTS: Close adherence was found in diagnostic biopsy, BCS and clear margin rates. Some high-risk groups received radiotherapy, although women with 'close' margins did not in 33% of cases. Axillary procedures were conducted in 23% of cases and most (81%) patients were not prescribed tamoxifen. CONCLUSION: There was predominantly close adherence to recommendations with three possible areas of improvement: fewer axillary procedures, an appraisal of radiotherapy practice following BCS and more investigation into tamoxifen prescription practices for DCIS.

The outcome of endovascular repair of small abdominal aortic aneurysms.

OBJECTIVE: To assess the outcome of endovascular repair (EVAR) of small abdominal aortic aneurysms (AAA,

National breast cancer audit: overview of invasive breast cancer management.

BACKGROUND: The National Breast Cancer Audit is an initiative of the Breast Section of the Royal Australasian College of Surgeons collecting surgical information in early breast cancer. It is managed in conjunction with the Australian Safety and Efficacy Register of New Interventional Procedures - Surgical. An overview of results for invasive breast cancer from January 1999 until December 2004 is presented to provide preliminary data for participating surgeons. METHODS: Invasive breast cancer cases were retrieved from the National Breast Cancer Audit database for the 274 participating breast surgeons in Australia and New Zealand. Data for a variety of clinical parameters were analysed to provide an overview of the diagnostic, histological, surgical and adjuvant therapy management issues. RESULTS: There were 25,026 cases of invasive breast cancer. Annual percentages of mammographically detected cancers from 1999 to 2004 did not differ significantly. Breast-conserving surgery rates also remained stable at 60%. Margins were involved in 5% of patients; an additional 9% had final margins of less than 1 mm. Radiotherapy followed breast-conserving surgery in most cases (86%). Patients undergoing mastectomy with large tumours (>5 cm) underwent radiotherapy in 71% of cases. When at least four lymph nodes were positive, radiotherapy followed mastectomy in the majority (75%) of cases. The most frequently carried out axillary procedure was a level 2 dissection. Chemotherapy was received by 78% of oestrogen receptor negative, axillary node positive, postmenopausal patients. Tamoxifen was used in the majority (83%) of oestrogen receptor positive cases. CONCLUSION: Surgeons contributing their invasive breast cancer data show a high quality of treatment. Some further improvement may be possibly related to excision margins and tamoxifen prescription for oestrogen receptor negative cancers. Chemotherapy prescription might also warrant further investigation.

National Breast Cancer Audit: establishing a web-based data system.

BACKGROUND: An audit of surgical treatment of early breast cancer was introduced nationally in 1999. In August 2002, the Australian Safety and Efficacy Register of New Interventional Procedures - Surgical, under the auspices of the Royal Australasian College of Surgeons, assumed responsibility for managing this audit. This article provides an update of audit activities, now known formally as the National Breast Cancer Audit (NBCA), including a description of the new governance structure and the development of a secure online surgical audit system. METHODS: Major changes have taken place in the design and governance of the NBCA during the last two years. Two committees have been established to oversee the audit. A clinical advisory committee comprises experts from a number of fields including breast surgery, oncology, government, and from peak breast cancer and consumer bodies. A technical advisory committee oversees many of the technical issues that have arisen with the development of an online data entry system. The online system of data entry was developed and launched to surgeons in May 2004. RESULTS: There are now 28,000 cases of primary breast surgery in the audit. Around 250 surgeons are currently participating, an increase of over 50 surgeons since May 2004. Surgeons can review their data using the online system and compare their own results by generating reports which graph their own results against national aggregate data. CONCLUSIONS: There has been a significant increase in the volume of data received since the launch of the secure online system. The governing committees are working towards creating a clinical audit which will provide an improved data entry system and better reporting for all participating surgeons. The NBCA can also serve as a template on which to base other surgical audits.