Implementation of enhanced recovery in cardiac surgery: An experimental study with the control group.

INTRODUCTION: The Enhanced Recovery After Cardiac Surgery protocol is the most recent addition to cardiac treatment. In this paper, we aimed to test the safety and viability of this protocol in our hospital to improve our standard of care. METHODS: This study was conducted as an experimental study with a historical control at the Maritime Heart Center, Halifax, Nova Scotia, Canada. In order to quantify the success of this protocol, we measured the postoperative Length of Hospital Stay and three intensive care unit variables: time to extubation, time to ambulation, and opioid consumption. In the study, 100 patients were in the Enhanced Recovery After Cardiac Surgery group, and 103 patients were used as historic controls-selected by strenuous chart review and selection criteria. RESULTS: The primary outcome (Length of Hospital Stay) was reduced from a mean of 8.88 ± 3.50 days in the control group to a mean of 5.13 ± 1.34 days in the Enhanced Recovery After Cardiac Surgery group (p < 0.001). Likewise, we observed a significant reduction in intensive care unit variables: time to extubation was reduced from 10.54 ± 7.83 h in the control group to 6.69 ± 1.63 in the Enhanced Recovery After Cardiac Surgery group (p < 0.01), and time to ambulation was reduced from 36.27 ± 35.21 h in the control group to 9.78 ± 2.03 in the Enhanced Recovery After Cardiac Surgery group (p < 0.01) and opioid consumption was reduced from 50.58 ± 11.93 milligram morphine equivalent in the control group to 11.58 ± 4.43 milligram morphine equivalent in the Enhanced Recovery After Cardiac Surgery group (p < 0.01). CONCLUSION: Enhanced Recovery After Cardiac Surgery protocols were seamlessly integrated into selected cardiac surgical patients, contingent on a high level of interprofessional communication and collaboration.

Patient-prosthesis mismatch and surgical aortic valve replacement outcomes: Retrospective analysis of single-center surgical data.

BACKGROUND: Patient-prosthesis mismatch (PPM) has been identified as a risk factor for mortality and reoperation in patients undergoing surgical aortic valve replacement (SAVR). We present a retrospective analysis of risk factors for PPM and the effects of PPM on early postoperative outcomes after SAVR. METHODS: Chart review was conducted for patients (N = 3003) undergoing SAVR. PPM was calculated from valve reference orifice areas and patient body surface area. Logistic regression was used to analyze risk factors for PPM and develop a risk score from these results. Regression was also conducted to identify associations between projected PPM status and postoperative outcomes. RESULTS: Risk factors for PPM included female sex, higher body mass index (BMI), and use of the St. Jude Epic valve. Patients receiving St. Jude trifecta valves or mechanical valves were less likely to have predicted PPM. We developed a risk score using BMI, sex, and valve type, and retrospectively predicted PPM in our cohort. Mild PPM (odds ratio [OR] = 2.267), severe PPM (OR = 2.869), male sex (OR = 2.091), and younger age (OR = 0.940) were all predictors of SAVR reoperation, while aortic root replacement was associated with reduced reoperation rates (OR = 0.122). Severe PPM carried a risk of in-hospital mortality (OR = 3.599), and moderate PPM carried a smaller but significant risk (OR = 1.920). Other factors increasing postoperative morbidity and mortality included older age, renal failure, and diabetes. CONCLUSION: PPM could be retrospectively predicted in our cohort using a risk calculation from sex, BMI and valve type. We conclude that all degrees of PPM carry risk for mortality and reoperation.

Six-year follow-up of aortic valve reoperation rates: Carpentier-Edwards Perimount versus St. Jude Medical Trifecta.

BACKGROUND: The Carpentier-Edwards Perimount valves have a proven track record in aortic valve replacement: good durability, hemodynamic performance, rates of survival, and low rates of valve-related complications and prosthesis-patient mismatch. The St. Jude Medical Trifecta is a newer valve that has shown comparable early and midterm outcomes. Studies show reoperation rates of Trifecta are comparable with Perimount valves, with a few recent studies bringing into focus early structural valve deterioration (SVD), and increased midterm SVD in younger patients. Given that midterm data for Trifecta is still sparse, we wanted to confirm the early low reoperation rates of Trifecta persist over time compared with Perimount. METHODS: The Maritime Heart Centre Database was searched for AVR between 2011 and 2016, inclusive. The primary endpoint of the study was all-cause reoperation rate. RESULTS: In total, 711 Perimount and 453 Trifecta implantations were included. The reoperation hazards were determined for age: 0.96 (0.92-0.99; p = .02), female (vs. male): 0.35 (0.08-1.53; p = .16), smoker (vs. nonsmoker): 2.44 (0.85-7.02; p = .1), and Trifecta (vs. Perimount): 2.68 (0.97-7.39; p = .06). Kaplan-Meier survival analysis in subgroups-age <60, age ≥60, male, female, smoker, and nonsmoker-showed Perimount having lower reoperation rates than Trifecta in patients younger than 60 (p = .02) and current smokers (p < .01). CONCLUSIONS: The rates of reoperation of Perimount and Trifecta were comparable, with Trifecta showing higher rates in patients younger than 60 years, and current smokers. Continued diligence and further independent reporting of midterm reoperation and SVD rates of the Trifecta, including detailed echocardiographic follow-up, are needed to confirm these findings.

A comparative, population-based analysis of pituitary incidentalomas vs clinically manifesting sellar masses.

PURPOSE: Sellar masses may present either with clinical manifestations of mass effect/hormonal dysfunction (CMSM) or incidentally on imaging (pituitary incidentaloma (PI)). This novel population-based study compares these two entities. METHODS: Retrospective analysis of all patients within a provincial pituitary registry between January 2006 and June 2014. RESULTS: Nine hundred and three patients were included (681 CMSM, 222 PI). CMSM mainly presented with secondary hormone deficiencies (SHDs) or stalk compression (29.7%), whereas PIs were found in association with neurological complaints (34.2%) (P < 0.0001). PIs were more likely to be macroadenomas (70.7 vs 49.9%; P < 0.0001). The commonest pathologies among CMSM were prolactinomas (39.8%) and non-functioning adenomas (NFAs) (50%) in PI (P < 0.0001). SHDs were present in 41.3% CMSM and 31.1% PI patients (P < 0.0001) and visual field deficit in 24.2 and 29.3%, respectively (P = 0.16). CMSM were more likely to require surgery (62.9%) than PI (35.8%) (P < 0.0005). The commonest surgical indications were impaired vision and radiological evidence of optic nerve compression. Over a follow-up period of 5.7 years for CMSM and 5.0 years for PI, tumour growth/recurrence occurred in 7.8% of surgically treated CMSM and 2.6% without surgery and PI, 0 and 4.9%, respectively (P = 1.0). There were no significant differences in the risk of new-onset SHD in CMSM vs PI in those who underwent surgery (P = 0.7) and those who were followed without surgery (P = 0.58). CONCLUSIONS: This novel study compares the long-term trends of PI with CMSM, highlighting the need for comprehensive baseline and long-term radiological and hormonal evaluations in both entities.

Economic Evaluation of Lupus Nephritis in the Systemic Lupus International Collaborating Clinics Inception Cohort Using a Multistate Model Approach.

OBJECTIVE: Little is known about the long-term costs of lupus nephritis (LN). The costs were compared between patients with and without LN using multistate modeling. METHODS: Patients from 32 centers in 11 countries were enrolled in the Systemic Lupus International Collaborating Clinics inception cohort within 15 months of diagnosis and provided annual data on renal function, hospitalizations, medications, dialysis, and selected procedures. LN was diagnosed by renal biopsy or the American College of Rheumatology classification criteria. Renal function was assessed annually using the estimated glomerular filtration rate (GFR) or estimated proteinuria. A multistate model was used to predict 10-year cumulative costs by multiplying annual costs associated with each renal state by the expected state duration. RESULTS: A total of 1,545 patients participated; 89.3% were women, the mean ± age at diagnosis was 35.2 ± 13.4 years, 49% were white, and the mean followup duration was 6.3 ± 3.3 years. LN developed in 39.4% of these patients by the end of followup. Ten-year cumulative costs were greater in those with LN and an estimated glomerular filtration rate (GFR) <30 ml/minute ($310,579 2015 Canadian dollars versus $19,987 if no LN and estimated GFR >60 ml/minute) or with LN and estimated proteinuria >3 gm/day ($84,040 versus $20,499 if no LN and estimated proteinuria <0.25 gm/day). CONCLUSION: Patients with estimated GFR <30 ml/minute incurred 10-year costs 15-fold higher than those with normal estimated GFR. By estimating the expected duration in each renal state and incorporating associated annual costs, disease severity at presentation can be used to anticipate future health care costs. This is critical knowledge for cost-effectiveness evaluations of novel therapies.

Accuracy of kidney cancer diagnosis and histological subtype within Canadian cancer registry data.

INTRODUCTION: Provincial/territorial cancer registries (PTCRs) are the mainstay for Canadian population-based cancer statistics. Each jurisdiction captures this data in a population-based registry, including the Nova Scotia Cancer Registry (NSCR). The goal of this study was to describe data from the NSCR regarding renal cell carcinoma (RCC) pathology subtype and method of diagnosis and compare it to the actual pathology reports to determine the accuracy of diagnosis and histological subtype assignment. METHODS: This retrospective analysis included patients diagnosed with RCC in the NSCR from 2006-2010 with an ICD-O-3 code C64.9 seen or treated in the largest NS health district. From the NSCR, method of diagnosis and pathological diagnosis was recorded. All diagnoses of non-clear-cell RCC (nonccRCC) from NSCR were compared to the actual pathology report for descriptive comparison and reasons for discordance. RESULTS: 723 patients make up the study cohort. 81.3% of patients were diagnosed by nephrectomy, 11.1% radiography, 6.9 % biopsy, and 0.7% autopsy. By NSCR data, 52.8% had clear-cell (ccRCC), 20.5% RCC not otherwise specified (NOS), 12.7% papillary, 4% chromophobe, and the rest had other nonccRCC subtypes. By pathology reports, 69.5% had clear-cell, 15% papillary, 5% chromophobe, only 2.7% RCC NOS. There was a discordance rate of 15.4% between NSCR data and diagnosis from pathology report. Reasons for discordance were not enough information by the pathologist in 45.5%, misinterpretation of report by data coder in 22.2%, and true coding error in 32.3%. CONCLUSIONS: When using PTCR for RCC incidence data, it is important to understand how the diagnosis is made, as not all are based on pathological confirmation; in this cohort 11% were based on radiology. One must also be aware that clear-cell and non-clear-cell subtypes may differ between the PTCR data and pathology reports. In this study, ccRCC made up 52.8% of the registry diagnoses, but increased to 69.6% on pathology report review. Use of synoptic reporting and ongoing education may improve accuracy of registry data.

Analysis and natural history of pituitary incidentalomas.

OBJECTIVES: Pituitary incidentalomas (PI) are frequently found on brain imaging. Despite their high prevalence, little is known about their long-term natural history and there are limited guidelines on how to monitor them. METHODS: We conducted a retrospective study to compare epidemiological characteristics at presentation and the natural history of PI in population-based vs referral-based registries from two tertiary-care referral centers in Canada. RESULTS: A total of 328 patients with PI were included, of whom 73% had pituitary adenomas (PA) and 27% had non-pituitary sellar masses. The commonest indications for imaging were headache (28%), dizziness (12%) and stroke/transient ischemic attack (TIA) (9%). There was a slight female preponderance (52%) with a median age of 55 years at diagnosis; 71% presented as macroadenomas (>10mm). Of PA, 25% were functioning tumors and at presentation 36% of patients had evidence of secondary hormonal deficiency (SHD). Of the total cohort, 68% were treated medically or conservatively whereas 32% required surgery. Most tumors (87% in non-surgery and 68% in post-surgery group) remained stable during follow-up. Similarly, 84% of patients in the non-surgery and 73% in the surgery group did not develop additional SHD during follow-up. The diagnosis of non-functioning adenoma was a risk factor for tumor enlargement and a change in SHD status was associated with a change in tumor size. CONCLUSIONS: Our data suggest that most PI seen in tertiary-care referral centers present as macroadenomas and may frequently be functional, often requiring medical or surgical intervention.

A Longitudinal Analysis of Outcomes of Lupus Nephritis in an International Inception Cohort Using a Multistate Model Approach.

OBJECTIVE: To study bidirectional change and predictors of change in estimated glomerular filtration rate (GFR) and proteinuria in lupus nephritis (LN) using a multistate modeling approach. METHODS: Patients in the Systemic Lupus International Collaborating Clinics inception cohort were classified annually into estimated GFR state 1 (>60 ml/minute), state 2 (30-60 ml/minute), or state 3 (<30 ml/minute) and estimated proteinuria state 1 (<0.25 gm/day), state 2 (0.25-3.0 gm/day), or state 3 (>3.0 gm/day), or end-stage renal disease (ESRD) or death. Using multistate modeling, relative transition rates between states indicated improvement and deterioration. RESULTS: Of 1,826 lupus patients, 700 (38.3%) developed LN. During a mean ± SD follow-up of 5.2 ± 3.5 years, the likelihood of improvement in estimated GFR and estimated proteinuria was greater than the likelihood of deterioration. After 5 years, 62% of patients initially in estimated GFR state 3 and 11% of patients initially in estimated proteinuria state 3 transitioned to ESRD. The probability of remaining in the initial states 1, 2, and 3 was 85%, 11%, and 3%, respectively, for estimated GFR and 62%, 29%, and 4%, respectively, for estimated proteinuria. Male sex predicted improvement in estimated GFR states; older age, race/ethnicity, higher estimated proteinuria state, and higher renal biopsy chronicity scores predicted deterioration. For estimated proteinuria, race/ethnicity, earlier calendar years, damage scores without renal variables, and higher renal biopsy chronicity scores predicted deterioration; male sex, presence of lupus anticoagulant, class V nephritis, and mycophenolic acid use predicted less improvement. CONCLUSION: In LN, the expected improvement or deterioration in renal outcomes can be estimated by multistate modeling and is preceded by identifiable risk factors. New therapeutic interventions for LN should meet or exceed these expectations.

Sellar Masses: An Epidemiological Study.

BACKGROUND: Sellar masses (SM) are mostly benign growths of pituitary or nonpituitary origin that are increasingly encountered in clinical practice. To date, no comprehensive population-based study has reported the epidemiology of SM from North America. AIM: To determine the epidemiology of SM in the province of Nova Scotia, Canada. METHODS: Data from all pituitary-related referrals within the province were prospectively collected in interlinked computerized registries starting in November 2005. We conducted a retrospective analysis on all patients with SM seen within the province between November 2005 and December 2013. RESULTS: A total of 1107 patients were identified, of which 1005 were alive and residing within the province. The mean age at presentation was 44.6±18 years, with an overall female preponderance (62%) and a population prevalence rate of 0.1%. Of patients with SM, 837 (83%) had pituitary adenomas and 168 (17%) had nonpituitary lesions. The relative prevalence and standardized incidence ratio, respectively, of various SM were: nonfunctioning adenomas (38.4%; 2.34), prolactinomas (34.3%; 2.22), Rathke's cyst (6.5%; 0.5), growth hormone-secreting adenomas (6.5%; 0.3), craniopharyngiomas (4.5%; 0.2), adrenocorticotropic hormone-secreting adenomas (3.8%; 0.2), meningiomas (1.9%), and others (3.9%; 0.21). At presentation, 526 (52.3%) had masses ≥1 cm, 318 (31.6%) at <1 cm, and 11 (1.1%) had functioning pituitary adenomas without discernible tumor, whereas tumor size data were unavailable in 150 (14.9%) patients. The specific pathologies and their most common presenting features were: nonfunctioning adenoma (incidental, headaches, and vision loss), prolactinomas (galactorrhea, menstrual irregularity, and headache), growth hormone-secreting adenomas (enlarging extremities and sweating), adrenocorticotropic hormone-secreting adenoma (easy bruising, muscle wasting, and weight gain) and nonpituitary lesions (incidental, headaches, and vision problems). Secondary hormonal deficiencies were common, ranging from 19.6% to 65.7%; secondary hypogonadism, hypothyroidism, and growth hormone deficiencies constituted the majority of these abnormalities. CONCLUSIONS: This is the largest North American study to date to assess the epidemiology of SM in a large stable population. Given their significant prevalence in the general population, more studies are needed to evaluate the natural history of these masses and to help allocate appropriate resources for their management.

Routine cardiac evaluation in patients with early-stage breast cancer before adjuvant chemotherapy.

INTRODUCTION: This population-based study of women diagnosed with early-stage breast cancer aimed to (i) determine the current utilization pattern of multigated acquisition (MUGA) scans before adjuvant chemotherapy (AdjC) treatment, and (ii) examine the impact of MUGA scan results on AdjC decision making. METHODS: All women who underwent curative-intent surgery for stage I-III breast cancer between October 2005 and September 2006 in Nova Scotia, Canada, were identified through the provincial cancer registry. A retrospective chart review was performed to abstract all relevant clinical-pathologic variables, including baseline cardiac risk factors. The association between MUGA scan utilization and clinical-pathologic variables, as well as receipt and type of AdjC, was examined through univariate and multivariate analyses. RESULTS: The study included 593 women, of whom 238 (40%) received AdjC (94% anthracycline vs. 6% nonanthracycline) and 198 (33%) underwent baseline MUGA scans. Of those received AdjC, 80% underwent MUGA scans. MUGA scan utilization was associated with AdjC treatment (yes vs. no; P < .0001), Her-2/neu status (positive vs. negative vs. not tested; P < .0001), and AdjC regimen (anthracycline vs. nonanthracycline; P < .0001). Abnormal MUGA results were observed in 5 (2.5%) of 198; all were smokers, and 4 were >65 years of age. In the 1 patient <50 years old, subsequent echocardiograms indicated normal cardiac function. CONCLUSIONS: Routine baseline MUGA scans before AdjC were abnormal and changed the AdjC treatment decision in only 2.5% and 2.0% of patients, respectively. Routine MUGA scans before anthracycline-based AdjC without trastuzumab, however, did not influence AdjC decisions for younger patients <65 years of age without underlying cardiac risk factors.