One-time screening for abdominal aortic aneurysm in Ontario, Canada: a model-based cost-utility analysis.

BACKGROUND: Screening programs for abdominal aortic aneurysm (AAA) are not available in Canada. We sought to determine the effectiveness and costutility of AAA screening in Ontario. METHODS: We compared one-time ultrasonography-based AAA screening for people aged 65 years to no screening using a fully probabilistic Markov model with a lifetime horizon. We estimated life-years, quality-adjusted life-years (QALYs), AAA-related deaths, number needed to screen to prevent 1 AAA-related death and costs (in Canadian dollars) from the perspective of the Ontario Ministry of Health. We retrieved model inputs from literature, Statistics Canada, and the Ontario Case Costing Initiative. RESULTS: Screening reduced AAA-related deaths by 84.9% among males and 81.0% among females. Compared with no screening, screening resulted in 0.04 (18.96 v. 18.92) additional life-years and 0.04 (14.95 v. 14.91) additional QALYs at an incremental cost of $80 per person among males. Among females, screening resulted in 0.02 (21.25 v. 21.23) additional life-years and 0.01 (16.20 v. 16.19) additional QALYs at an incremental cost of $11 per person. At a willingness-to-pay of $50 000 per year, screening was cost-effective in 84% (males) and 90% (females) of model iterations. Screening was increasingly cost-effective with higher AAA prevalence. INTERPRETATION: Screening for AAA among people aged 65 years in Ontario was associated with fewer AAA-related deaths and favourable cost-effectiveness. To maximize QALY gains per dollar spent and AAA-related deaths prevented, AAA screening programs should be designed to ensure that populations with high prevalence of AAA participate.

ESC/EACTS vs. ACC/AHA guidelines for the management of severe aortic stenosis.

Aortic stenosis (AS) is a serious and complex condition, for which optimal management continues to evolve rapidly. An understanding of current clinical practice guidelines is critical to effective patient care and shared decision-making. This state of the art review of the 2021 European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines and 2020 American College of Cardiology/American Heart Association Guidelines compares their recommendations for AS based on the evidence to date. The European and American guidelines were generally congruent with the exception of three key distinctions. First, the European guidelines recommend intervening at a left ventricular ejection fraction of 55%, compared with 60% over serial imaging by the American guidelines for asymptomatic patients. Second, the European guidelines recommend a threshold of ≥65 years for surgical bioprosthesis, whereas the American guidelines employ multiple age categories, providing latitude for patient factors and preferences. Third, the guidelines endorse different age cut-offs for transcatheter vs. surgical aortic valve replacement, despite limited evidence. This review also discusses trends indicating a decreasing proportion of mechanical valve replacements. Finally, the review identifies gaps in the literature for areas including transcatheter aortic valve implantation in asymptomatic patients, the appropriateness of Ross procedures, concomitant coronary revascularization with aortic valve replacement, and bicuspid AS. To summarize, this state of the art review compares the latest European and American guidelines on the management of AS to highlight three areas of divergence: timing of intervention, valve selection, and surgical vs. transcatheter aortic valve replacement criteria.

Assessing the robustness of negative vascular surgery randomized controlled trials using their reverse fragility index.

OBJECTIVE: The reverse fragility index (RFI) describes the number of event conversions needed to convert a statistically nonsignificant dichotomous outcome to a significant one. The objective of the present study was to assess the RFI of vascular surgery randomized controlled trials (RCTs) comparing endovascular vs open surgery for the treatment of abdominal aortic aneurysms (AAAs), carotid artery stenosis (CAS), and peripheral artery disease (PAD). METHODS: MEDLINE and Embase were searched for RCTs that had investigated AAAs, CAS, or PAD with statistically nonsignificant binary primary outcomes. The primary outcome for the present study was the median RFI. Calculation of the RFI was performed by creating two-by-two contingency tables and subtracting events from the group with fewer events and adding nonevents to the same group until a two-tailed Fisher exact test had produced a statistically significant result (P ≤ .05). RESULTS: Of 4187 reports, 49 studies reporting 103 different primary end points were included. The overall median RFI was 7 (interquartile range [IQR], 5-13). The specific RFIs for AAA, CAS, and PAD were 10 (IQR, 6-15.5), 6 (IQR, 5-9.5), and 7 (IQR, 5.5-10), respectively. Of the 103 end points, 42 (47%) had had a loss to follow-up greater than the RFI, of which 10 were AAA trials (24%), 23 were CAS trials (55%), and 9 were PAD trials (21%). The Pearson correlation demonstrated a significant positive relationship between a study's RFI and the impact factor of its publishing journal (r = 0.38; 95% confidence interval [CI], 0.20-0.54; P < .01), length of follow-up (r = 0.43; 95% CI, 0.26-0.58; P < .01), and sample size (r = 0.28; 95% CI, 0.09-0.45; P < .01). CONCLUSIONS: A small number of events (median, 7) was required to change the outcome of negative RCTs from statistically nonsignificant to significant, with 47% of the studies having missing data that could have reversed the finding of its primary outcome. Reporting of the RFI relative to the loss to follow-up could be of benefit in future trials and provide confidence regarding the robustness of the P value.

Intravenous iron administration before cardiac surgery reduces red blood cell transfusion in patients without anaemia.

BACKGROUND: Reducing the need for blood transfusion among patients undergoing cardiac surgery FLA reduce postoperative complications and mortality. Our study aimed to assess the effects of administering preoperative i.v. ferric carboxymaltose on postoperative red cell transfusion requirements in patients without anaemia undergoing on-pump cardiac surgery. METHODS: This double-blind, randomised, placebo-controlled trial was conducted between October 2016 and November 2019, with a follow-up period of up to 6 weeks after surgery. Patients without anaemia who underwent on-pump cardiac surgery were included as participants and administered i.v. iron in the form of ferric carboxymaltose or placebo once, 24-72 h before surgery. The primary outcome was the number of red cell units transfused during the first four postoperative days, and the secondary outcome measures were blood haemoglobin concentrations at 4 days and 6 weeks after surgery. RESULTS: The 200 patients included were randomly assigned to the ferric carboxymaltose (n=102) and placebo (n=98) groups. By postoperative Day 4, a significantly lower mean number of red cell units were transfused in the ferric carboxymaltose than in the placebo group, 0.3 (0.8) vs 1.6 (4.4), respectively; P=0.007. The mean haemoglobin concentrations on postoperative Day 4 were 9.7 (1) g dl-1 and 9.3 (1) g dl-1, respectively (P=0.03). Corresponding values at 6 weeks after surgery were 12.6 (1.4) g dl-1 and 11.8 (1.5) g dl-1, respectively (P=0.012). CONCLUSIONS: In patients without anaemia undergoing on-pump cardiac surgery, treatment with a single dose of 1000 mg ferric carboxymaltose i.v. 1-3 days before surgery significantly reduced the need for red cell transfusions and increased the postoperative haemoglobin concentration. CLINICAL TRIAL REGISTRATION: NCT02939794.

The Impact of Heparin on Mortality Following Open Ruptured Abdominal Aortic Aneurysm Repair.

BACKGROUND: Systemic administration of heparin is widely used in patients undergoing open elective abdominal aortic aneurysm (AAA) repair. However, no clear consensus exists in the use of intraoperative heparin during open ruptured AAA (rAAA) repair. In this study, we assessed the safety of intravenous heparin administration in patients undergoing open rAAA repair. METHODS: A retrospective cohort study comparing patients who received and did not receive heparin during open rAAA repair in the Vascular Quality Initiative database between 2003 and 2020 was conducted. The primary outcomes were 30-day and 10-year mortality. The secondary outcomes included estimated blood loss, number of packed red blood cells transfused, early postoperative transfusions, and postsurgical complications. Propensity score matching was used to adjust for potentially confounding variables. The outcomes were compared between the 2 groups using relative risk for binary outcomes and paired t-test and the Wilcoxon rank-sum test for normally and non-normally distributed continuous variables, respectively. Survival was examined using Kaplan-Meier curves and compared using a Cox proportional hazards model. RESULTS: A total of 2,410 patients who underwent open rAAA repair between 2003 and 2020 were studied. Of the 2,410 patients, 1,853 patients received intraoperative heparin and 557 did not. Propensity score matching on 25 variables yielded 519 pairs for the heparin to no heparin comparison. Thirty-day mortality was lower in the heparin group (risk ratio: 0.74; 95% confidence interval [CI]: 0.66-0.84) and in-hospital was also lower in the heparin group (risk ratio: 0.68; 95% CI: 0.60-0.77). Furthermore, estimated blood loss was 910 mL (95% CI: 230 mL to 1,590 mL) lower in the heparin group and the mean number of packed red blood cells transfused intraoperatively and postoperatively were 17 units lower in the heparin group (95% CI: 8-42). Ten-year survival was higher for patients who received heparin, and their rate of survival was approximately 40% higher than those who did not receive heparin (hazard ratio: 0.62; 95% CI, 0.53-0.72; P < 0.0001). CONCLUSIONS: In patients who received systemic heparin administration at the time of open rAAA repair, there were significant short-term and long-term survival benefits within 30 days and at 10 years. Heparin administration may have afforded a mortality benefit or been a surrogate for healthier and less moribund patients at the time of the procedure.

Analysis of spin in vascular surgery randomized controlled trials with nonsignificant outcomes.

OBJECTIVE: Spin is the manipulation of language that distorts the interpretation of objective findings. The purpose of this study is to describe the characteristics of spin found in statistically nonsignificant randomized controlled trials (RCT) comparing carotid endarterectomy with carotid artery stenting for carotid artery stenosis (CS), and endovascular repair with open repair (OR) for abdominal aortic aneurysms (AAA). METHODS: A search of MEDLINE, EMBASE, and the Cochrane Controlled Register of Trials was performed in June 2020 for studies published describing AAA or CS. All phase III RCTs with nonsignificant primary outcomes comparing open repair with endovascular repair or carotid endarterectomy to carotid artery stenting were included. Studies were appraised for the characteristics and severity of spin using a validated tool. Binary logistic regression was performed to assess the association of spin grade to (1) funding source (commercial vs noncommercial) and (2) the publishing journal's impact factor. RESULTS: Thirty-one of 355 articles captured were included for analysis. Spin was identified in 9 abstracts (9/18) and 13 main texts (13/18) of AAA articles and 7 abstracts (7/13) and 10 main texts (10/13) of CS articles. For both AAA and CS articles, spin was most commonly found in the discussion section, with the most commonly used strategy being the interpretation of statistically nonsignificant primary results to show treatment equivalence or rule out adverse treatment effects. Increasing journal impact factor was associated with a statistically significant lower likelihood of spin in the study title or abstract conclusion (ß odds ratio, 0.96; 95% confidence interval, 0.94-0.98; P < .01); no significant association could be found with funding source (ß odds ratio, 1.33; 95% confidence interval, 0.30-5.92; P = .71). CONCLUSIONS: A large proportion of statistically nonsignificant RCTs contain interpretations that are inconsistent with their results. These findings should prompt authors and readers to appraise study findings independently and to limit the use of spin in study interpretations.

Impact of Transcatheter Aortic Valve Durability on Life Expectancy in Low-Risk Patients With Severe Aortic Stenosis.

BACKGROUND: Recent clinical trial results showed that transcatheter aortic valve replacement (TAVR) is noninferior and may be superior to surgical aortic valve replacement (SAVR) for mortality, stroke, and rehospitalization. However, the impact of transcatheter valve durability remains uncertain. METHODS: Discrete event simulation was used to model hypothetical scenarios of TAVR versus SAVR durability in which TAVR failure times were varied to determine the impact of TAVR valve durability on life expectancy in a cohort of low-risk patients similar to those in recent trials. Discrete event simulation modeling was used to estimate the tradeoff between a less invasive procedure with unknown valve durability (TAVR) and that of a more invasive procedure with known durability (SAVR). Standardized differences were calculated, and a difference >0.10 was considered clinically significant. In the base-case analysis, patients with structural valve deterioration requiring reoperation were assumed to undergo a valve-in-valve TAVR procedure. A sensitivity analysis was conducted to determine the impact of TAVR valve durability on life expectancy in younger age groups (40, 50, and 60 years). RESULTS: Our cohort consisted of patients with aortic stenosis at low surgical risk with a mean age of 73.4±5.9 years. In the base-case scenario, the standardized difference in life expectancy was <0.10 between TAVR and SAVR until transcatheter valve prosthesis failure time was 70% shorter than that of surgical prostheses. At a transcatheter valve failure time <30% compared with surgical valves, SAVR was the preferred option. In younger patients, life expectancy was reduced when TAVR durability was 30%, 40%, and 50% shorter than that of surgical valves in 40-, 50-, and 60-year-old patients, respectively. CONCLUSIONS: According to our simulation models, the durability of TAVR valves must be 70% shorter than that of surgical valves to result in reduced life expectancy in patients with demographics similar to those of recent trials. However, in younger patients, this threshold for TAVR valve durability was substantially higher. These findings suggest that durability concerns should not influence the initial treatment decision concerning TAVR versus SAVR in older low-risk patients on the basis of current evidence supporting TAVR valve durability. However, in younger low-risk patients, valve durability must be weighed against other patient factors such as life expectancy.

Health care costs of endovascular compared with open thoracoabdominal aortic aneurysm repair.

OBJECTIVE: To compare 1-year health care costs between endovascular and open thoracoabdominal aortic aneurysm (TAAA). METHODS: Population-based administrative health databases were used to capture TAAA repairs performed in Ontario, Canada, between January 2006 and February 2017. All health care costs incurred by the Ministry of Health from a single-payer universal health care system were included. Costs of the aortic endografts and ancillary devices for the index procedure were estimated as C$44,000 per endovascular case vs C$1000 for open cases, based on previous reports. Costs (2017 Canadian dollars) were calculated in phases (1, 1-3, 3-6, and 6-12 months from surgery) with censoring for death. For each phase, propensity score matching of endovascular and open cases based on preoperative patient and hospital characteristics was used. The association between preoperative characteristics (including repair approach) and the first month postprocedure cost was characterized through multivariable analysis. RESULTS: Overall 664 TAAA repairs were identified (open, n = 361 [54.5%] and endovascular, n = 303 [45.6%]). At 1 month, the median cost was higher for endovascular TAAA repair in the prematching cohort (C$64,892 vs C$36,647; P < .01). Similarly, in 241 well-balanced endovascular/open patient pairs after propensity score matching, the median health care costs were higher in endovascular TAAA cases during the first month (C$62,802 vs C$33,605; P < .01). The 1- to 3-month median cost was not statistically different between endovascular and open TAAA cases either before matching (C$2781 vs C$2618; P = .71) or after matching (C$2762 vs C$2092; P = .58). Likewise, in the 3- to 6-month and 6- to 12-month postprocedure intervals, there were no significant differences in the median health care costs between groups. On multivariable analysis, older age (5-year increments) (relative change [RC] in mean cost, 1.05; 95% confidence interval [CI], 1.04-1.06; P = .01), urgent procedures (RC, 1.29; 95% CI, 1.10-1.52; P < .01), and history of stroke (RC, 1.34; 95% CI, 1.00-1.78; P = .05) were associated with higher costs in the first postoperative month, whereas open relative to endovascular TAAA repair was associated with a decreased 1-month cost (RC, 0.65; 95% CI, 0.56-0.74; P < .01). CONCLUSIONS: TAAA repair is expensive regardless of technique. Compared with open TAAA repair, endovascular repair was associated with a higher early cost, owing to the upfront cost of the endograft and aortic ancillary devices. There was no difference in cost from 1 to 12 months after repair. A decrease in the cost of endovascular devices might allow equivalent costs between endovascular and open TAAA repair.

Derivation and validation of a clinical model to predict death or cardiac hospitalizations while on the cardiac surgery waitlist.

BACKGROUND: Waitlist management is a global challenge. For patients with severe cardiovascular diseases awaiting cardiac surgery, prolonged wait times are associated with unplanned hospitalizations. To facilitate evidence-based resource allocation, we derived and validated a clinical risk model to predict the composite outcome of death and cardiac hospitalization of patients on the waitlist for cardiac surgery. METHODS: We used the CorHealth Ontario Registry and linked ICES health care administrative databases, which have information on all Ontario residents. We included patients 18 years or older who waited at home for coronary artery bypass grafting, valvular or thoracic aorta surgeries between 2008 and 2019. The primary outcome was death or an unplanned cardiac hospitalizaton, defined as nonelective admission for heart failure, myocardial infarction, unstable angina or endocarditis. We randomly divided two-thirds of these patients into derivation and one-third into validation data sets. We derived the model using a multivariable Cox proportional hazard model with backward stepwise variable selection. RESULTS: Among 62 375 patients, 41 729 patients were part of the derivation data set and 20 583 were part of the validation data set. Of the total, 3033 (4.9%) died or had an unplanned cardiac hospitalization while waiting for surgery. The area under the curve of our model at 15, 30, 60 and 89 days was 0.85, 0.82, 0.81 and 0.80, respectively, in the derivation cohort and 0.83, 0.80, 0.78 and 0.78, respctively, in the validation cohort. The model calibrated well at all time points. INTERPRETATION: We derived and validated a clinical risk model that provides accurate prediction of the risk of death and unplanned cardiac hospitalization for patients on the cardiac surgery waitlist. Our model could be used for quality benchmarking and data-driven decision support for managing access to cardiac surgery.

Derivation and validation of predictive indices for 30-day mortality after coronary and valvular surgery in Ontario, Canada.

BACKGROUND: Coronary artery bypass grafting (CABG) and surgical aortic valve replacement (AVR) are the 2 most common cardiac surgery procedures in North America. We derived and externally validated clinical models to estimate the likelihood of death within 30 days of CABG, AVR or combined CABG + AVR. METHODS: We obtained data from the CorHealth Ontario Cardiac Registry and several linked population health administrative databases from Ontario, Canada. We derived multiple logistic regression models from all adult patients who underwent CABG, AVR or combined CABG + AVR from April 2017 to March 2019, and validated them in 2 temporally distinct cohorts (April 2015 to March 2017 and April 2019 to March 2020). RESULTS: The derivation cohorts included 13 435 patients who underwent CABG (30-d mortality 1.73%), 1970 patients who underwent AVR (30-d mortality 1.68%) and 1510 patients who underwent combined CABG + AVR (30-d mortality 3.05%). The final models for predicting 30-day mortality included 15 variables for patients undergoing CABG, 5 variables for patients undergoing AVR and 5 variables for patients undergoing combined CABG + AVR. Model discrimination was excellent for the CABG (c-statistic 0.888, optimism-corrected 0.866) AVR (c-statistic 0.850, optimism-corrected 0.762) and CABG + AVR (c-statistic 0.844, optimism-corrected 0.776) models, with similar results in the validation cohorts. INTERPRETATION: Our models, leveraging readily available, multidimensional data sources, computed accurate risk-adjusted 30-day mortality rates for CABG, AVR and combined CABG + AVR, with discrimination comparable to more complex American and European models. The ability to accurately predict perioperative mortality rates for these procedures will be valuable for quality improvement initiatives across institutions.

Decision analysis and personalized clinical tool for cerebrospinal fluid drains in thoracoabdominal aortic aneurysms repair.

BACKGROUND AND AIM: The routine use of cerebrospinal fluid (CSF) drainage in patients undergoing operative repair of thoracoabdominal aneurysms (TAAA) has been associated with decreased rates of spinal cord ischemia. The use of CSF drains is not without consequence, however with complications including subarachnoid hemorrhage, epidural hematoma, meningitis, and, in 1% of cases, death. To date, a decision analysis tool to help clinicians decide when to use and not to use a CSF drain does not exist. In this analysis, we set out to develop a decision analysis tool for CSF drain placement in patients undergoing operative repair of TAAA. METHODS: A Markov state-transition cohort model that compared TAAA repair with adjunctive CSF drain insertion to TAAA repair without drain insertion for the outcome of life expectancy was developed in TreeAge 2020. The cycle length was 1 month and the time horizon was 60 months. RESULTS: The use of a CSF drain was associated with improved 5-year life expectancy (3.21 ± 0.10 vs. 3.09 ± 0.11 life-years gained). In the sensitivity analysis that varied the effectiveness of a CSF drain (odds ratio closer to 1 = less effective), the use of a CSF drain resulted in higher life expectancy in almost all scenarios. CONCLUSIONS: The routine use of a CSF drain in patients undergoing TAAA repair is safe and effective, with few exceptions. This decision analysis tool can be used by clinicians to develop a personalized approach.

Arterial Grafts for Coronary Bypass: A Critical Review After the Publication of ART and RADIAL.

Observational and randomized evidence shows that arterial grafts have better patency rates than saphenous vein grafts (SVGs) in coronary artery bypass grafting. Observational studies suggest that the use of multiple arterial grafts is associated with longer postoperative survival, but this must be interpreted in the context of treatment allocation bias and hidden confounders intrinsic to the study designs. Recently, a pooled analysis of 6 randomized trials comparing the radial artery with the SVG as the second conduit and the largest randomized trial comparing the use of single and bilateral internal thoracic arteries have provided apparently divergent results about a clinical benefit with the use of >1 arterial conduit. However, both analyses have methodological limitations that may have influenced their results. At present, it is unclear whether the well-documented increased patency rate of arterial grafts translates into clinical benefits in the majority of patients undergoing coronary artery bypass grafting. A large randomized trial testing the arterial grafts hypothesis (ROMA [Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts]) is underway and will report the results in a few years.

An assessment of the quality of current clinical meta-analyses.

BACKGROUND: The objective of this study was to assess the overall quality of study-level meta-analyses in high-ranking journals using commonly employed guidelines and standards for systematic reviews and meta-analyses. METHODS: 100 randomly selected study-level meta-analyses published in ten highest-ranking clinical journals in 2016-2017 were evaluated by medical librarians against 4 assessments using a scale of 0-100: the Peer Review of Electronic Search Strategies (PRESS), Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), Institute of Medicine's (IOM) Standards for Systematic Reviews, and quality items from the Cochrane Handbook. Multiple regression was performed to assess meta-analyses characteristics' associated with quality scores. RESULTS: The overall median (interquartile range) scores were: PRESS 62.5(45.8-75.0), PRISMA 92.6(88.9-96.3), IOM 81.3(76.6-85.9), and Cochrane 66.7(50.0-83.3). Involvement of librarians was associated with higher PRESS and IOM scores on multiple regression. Compliance with journal guidelines was associated with higher PRISMA and IOM scores. CONCLUSION: This study raises concerns regarding the reporting and methodological quality of published MAs in high impact journals Early involvement of information specialists, stipulation of detailed author guidelines, and strict adherence to them may improve quality of published meta-analyses.

Variability in opioid prescribing practices among cardiac surgeons and trainees.

BACKGROUND AND AIM: The opioid epidemic has become a major public health crisis in recent years. Discharge opioid prescription following cardiac surgery has been associated with opioid use disorder; however, ideal practices remain unclear. Our aim was to examine current practices in discharge opioid prescription among cardiac surgeons and trainees. METHODS: A survey instrument with open- and closed-ended questions, developed through a 3-round Delphi method, was circulated to cardiac surgeons and trainees via the Canadian Society of Cardiac Surgeons. Survey questions focused on routine prescription practices including type, dosage and duration. Respondents were also asked about their perceptions of current education and guidelines surrounding opioid medication. RESULTS: Eighty-one percent of respondents reported prescribing opioids at discharge following routine sternotomy-based procedures, however, there remained significant variability in the type and dose of medication prescribed. The median (interquartile range) number of pills prescribed was 30 (20-30) with a median total dose of 135 (113-200) Morphine Milligram Equivalents. Informal teaching was the most commonly reported primary influence on prescribing habits and a lack of formal education regarding opioid prescription was associated with a higher number of pills prescribed. A majority of respondents (91%) felt that there would be value in establishing practice guidelines for opioid prescription following cardiac surgery. CONCLUSIONS: Significant variability exists with respect to routine opioid prescription at discharge following cardiac surgery. Education has come predominantly from informal sources and there is a desire for guidelines. Standardization in this area may have a role in combatting the opioid epidemic.

Multiple Arterial Grafting Is Associated With Better Outcomes for Coronary Artery Bypass Grafting Patients.

BACKGROUND: Observational studies have shown better survival in patients undergoing coronary artery bypass grafting (CABG) with 2 arterial grafts compared with 1. However, whether a third arterial graft is associated with incremental benefit remains uncertain. We sought to analyze the outcomes of 3 versus 2 arterial grafts during CABG. As a secondary objective, we compared CABG with 2 or 3 arterial grafts (multiple arterial grafts [MAG]) with CABG using a single arterial graft (SAG). METHODS: Retrospective cohort analyses of all patients undergoing primary isolated CABG in Ontario, Canada, from October 2008 to March 2016. Propensity score matching was performed between patients with 3 arterial grafts (3Art group) versus 2 (2Art group). The primary outcome was time to first event of a composite of death, myocardial infarction, stroke, and repeat revascularization (major adverse cardiac and cerebrovascular events). Additional analyses were performed to evaluate the association between MAG versus SAG and long-term outcomes using propensity score matching. RESULTS: Fifty thousand, two hundred thirty patients underwent isolated CABG during our study period; 3044 (6.1%) and 8253 (16.4%) patients had 3 and 2 arterial grafts, respectively, resulting in 2789 propensity score matching pairs for the primary analyses. Mean and maximum follow-up was 4.2 and 8.5 years, respectively. Radial artery grafting was more common in the 3Art versus 2Art group (79.3% versus 65.6%, P<0.01). In-hospital outcomes were not significantly different, including death (3Art 0.8% versus 2Art 0.5%, P=0.26). Up to 8 years, there were no differences in major adverse cardiac and cerebrovascular events (3Art 27%, 95% confidence interval [CI], 24% to 30% versus 2Art 25%, 95% CI, 22% to 28%; hazard ratio [HR], 1.08, 95% CI, 0.94-1.25), death (HR, 1.08; 95% CI, 0.90-1.29), myocardial infarction (HR, 1.15; 95% CI, 0.87-1.51), stroke (HR, 1.39; 95% CI, 0.95-2.06), or repeat revascularization (HR, 1.04; 95% CI, 0.82-1.32). When evaluating MAG versus SAG, 8629 patient pairs were formed using propensity score matching. At 8 years, cumulative incidences of major adverse cardiac and cerebrovascular events (HR, 0.82, 95% CI, 0.77-0.88), survival (HR, 0.80; 95% CI, 0.73-0.88), repeat revascularization (HR, 0.79; 95% CI, 0.69-0.90), and myocardial infarction (HR, 0.83; 95% CI, 0.72-0.97) were superior in the MAG group. CONCLUSIONS: CABG with 3 arterial grafts was not associated with increased in-hospital death nor with better clinical outcomes at 8-year follow-up, compared with CABG with 2 arterial grafts. MAG was associated with superior outcomes compared with SAG.

Bilateral versus single internal thoracic artery for coronary artery bypass grafting with end-stage renal disease: A systematic review and meta-analysis.

BACKGROUND: The incidence of severe coronary artery disease (CAD) in patients with end-stage renal disease (ESRD) on dialysis is high. Coronary artery bypass grafting (CABG) is the preferred treatment in those with severe CAD. Bilateral internal thoracic artery (BITA) vs single internal thoracic artery (SITA) grafting has been shown to improve late survival in other high-risk populations. In ESRD, comparative studies are limited by sample size to detect outcome differences. We sought to determine the late survival and early outcomes of BITA compared with SITA in patients with ESRD. METHODS: MEDLINE and EMBASE were searched from inception to 2017 for studies directly comparing BITA to SITA in patients with ESRD undergoing CABG. The primary outcome was late survival; secondary outcomes were in-hospital/30-day mortality, stroke, and deep sternal wound infection (DSWI). Kaplan-Meier curve reconstruction for late mortality was performed. RESULTS: Five studies (three adjusted [n = 197] and two unadjusted observational studies [n = 231]) were included in the analysis. Reported ITA skeletonization ranged from 83% to 100% (median: 100%). There was no difference in in-hospital mortality (risk risk [RR], 0.84; 95% confidence interval [95%CI], 0.36,1.98; P = 0.70), perioperative stroke (RR, 1.97; 95%CI, 0.58,6.66; P = 0.28), and DSWI (RR, 1.56; 95%CI, 0.60,4.07; P = 0.36) between BITA and SITA. All studies reported adjusted late mortality, which was similar between BITA and SITA (incident rate ratio, 0.81; 95%CI, 0.59,1.11) at mean 3.7-year follow-up. CONCLUSIONS: BITA grafting is safe in patients with ESRD although there was no survival benefit at 3.7 years. Additional studies with longer follow-up are required to determine the potential late benefits of BITA grafting in patients with ESRD.

Clinical trials in valvular surgery: a 2018 update.

PURPOSE OF REVIEW: There is a growing emphasis on the conduct of large-scale, multicenter randomized controlled trials (RCTs) to guide decision-making in cardiac surgery. Here we review recent landmark RCTs in cardiac valvular surgery. RECENT FINDINGS: RCTs are the gold-standard level of data in medicine. However, there are unique challenges of conducting large-scale surgical trials including funding, blinding, generalizability, nonstandardization of the surgical technique, crossover, among others. Thus, the vast majority of clinical outcomes data in cardiac surgery are mainly from observational studies and most prospective data are small, single-center trials. The Cardiothoracic Surgery Network is the largest platform focused on the conduct of high-quality, multicenter cardiac surgical trials, which has already produced several seminal guideline-changing and practice-changing contributions to the surgical approach to functional mitral regurgitation, aortic stenosis, atrial fibrillation, and neuroprotective surgical adjuncts. SUMMARY: There continues to be great interest in the conduct of high-quality, RCTs to help guide surgical management of patients with valvular heart disease.

Systematic review and meta-analysis in cardiac surgery: a primer.

PURPOSE OF REVIEW: The purpose of this article is to review the strengths and weaknesses of systematic reviews and meta-analyses to inform our current understanding of cardiac surgery. RECENT FINDINGS: A systematic review and meta-analysis of a focused topic can provide a quantitative estimate for the effect of a treatment intervention or exposure. In cardiac surgery, observational studies and small, single-center prospective trials provide most of the clinical outcomes that form the evidence base for patient management and guideline recommendations. As such, meta-analyses can be particularly valuable in synthesizing the literature for a particular focused surgical question. Since the year 2000, there are over 800 meta-analysis-related publications in our field. There are some limitations to this technique, including clinical, methodological and statistical heterogeneity, among other challenges. Despite these caveats, results of meta-analyses have been useful in forming treatment recommendations or in providing guidance in the design of future clinical trials. SUMMARY: There is a growing number of meta-analyses in the field of cardiac surgery. Knowledge translation via meta-analyses will continue to guide and inform cardiac surgical practice and our practice guidelines.

Management of patients with end-stage renal disease: coronary artery bypass graft surgery versus percutaneous coronary intervention.

PURPOSE OF REVIEW: Coronary artery disease is common in patients with end-stage renal disease (ESRD) on hemodialysis. ESRD patients are prone to atherosclerosis and are likely to present with advanced CAD requiring coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI). RECENT FINDINGS: Individual observational studies and aggregated results comparing PCI to CABG have shown an increased risk of early postoperative mortality in the CABG group followed by a decrease in late mortality and cardiovascular events. Drug eluting stents are preferred to bare metal stents in patients undergoing PCI. Bilateral versus single internal thoracic arterial grafting strategies showed no difference in survival, freedom from cardiac death or freedom from cardiac events. There was no clear survival advantage to off-pump CABG over on-pump CABG in ESRD patients. Evidence to support either CABG or PCI was limited to retrospective observational studies that were at risk for treatment allocation bias. SUMMARY: CABG carries an upfront risk of increased perioperative mortality while demonstrating late survival benefit compared with PCI. Thus, in the context of balancing these competing risks and benefits, deciding on the most appropriate treatment in this high-risk cohort is challenging. Comprehensive patient evaluation by a multidisciplinary team is strongly recommended.

Transcatheter valve-in-valve versus redo surgical aortic valve replacement for the treatment of degenerated bioprosthetic aortic valve: A systematic review and meta-analysis.

OBJECTIVE: To determine the safety and efficacy of valve-in-valve transcatheter aortic valve replacement (ViV) versus redo surgical aortic valve replacement (SAVR) for the treatment of previously failed aortic bioprostheses. BACKGROUND: Valve-in-valve has emerged as a treatment option for patients with a failed aortic bioprosthesis. Evidence for safety and efficacy remains limited to small studies. METHODS: Medline and Embase were searched to 2017 for studies that directly compared ViV to redo SAVR. A random effects meta-analysis was performed. RESULTS: Four unadjusted (n = 298) and two propensity-matched (n = 200) observational studies were included. Valve-in-valve patients were 2.85-years older (P = 0.03) and were 23% higher in predicted mortality risk (ratio of means: 1.23, 95% confidence interval (95%CI): 1.02-1.48). There was no difference in peri-operative mortality (4.4% vs. 5.7%, P = 0.83;I2 = 0%) or late mortality, reported at median one year follow-up (incident rate ratio (IRR) 0.93, 95%CI: 0.74-1.16, P = 0.51, I2 = 0%) between ViV and redo SAVR. The incidence of permanent pacemaker implantation (8.3% vs 14.6%; P = 0.05;I2 = 0%) and dialysis (3.2% vs. 10.3%; P = 0.03; I2 = 0%) were lower in ViV. There was a reduction in the incidence of severe patient-prosthesis mismatch (3.3% vs 13.5%; P = 0.03; I2 = 0%) and mild or greater paravalvular leak (5.5% vs 21.1%; P = 0.03; I2 = 37%) in the redo SAVR group compared to ViV. CONCLUSIONS: Despite higher predicted surgical risk of ViV patients, there was no difference in mortality but less permanent pacemaker implantation and dialysis compared to redo SAVR. Choice of treatment must be individualized for both anatomical and patient risk factors; in high risk patients with favorable previous prosthesis size, valve-in-valve may be preferred.