Decision analysis in cardiac surgery: a scoping review and methodological primer.

OBJECTIVES: Randomized controlled trials are the gold standard for evidence generation in medicine but are limited by their real-world generalizability, resource needs, shorter follow-up durations and inability to be conducted for all clinical questions. Decision analysis (DA) models may simulate trials and observational studies by using existing data and evidence- and expert-informed assumptions and extend analyses over longer time horizons, different study populations and specific scenarios, helping to translate population outcomes to patient-specific clinical and economic outcomes. Here, we present a scoping review and methodological primer on DA for cardiac surgery research. METHODS: A scoping review was performed using the PubMed/MEDLINE, EMBASE and Web of Science databases for cardiac surgery DA studies published until December 2021. Articles were summarized descriptively to quantify trends and ascertain methodological consistency. RESULTS: A total of 184 articles were identified, among which Markov models (N = 92, 50.0%) were the most commonly used models. The most common outcomes were costs (N = 107, 58.2%), quality-adjusted life-years (N = 96, 52.2%) and incremental cost-effectiveness ratios (N = 89, 48.4%). Most (N = 165, 89.7%) articles applied sensitivity analyses, most frequently in the form of deterministic sensitivity analyses (N = 128, 69.6%). Reporting of guidelines to inform the model development and/or reporting was present in 22.3% of articles. CONCLUSION: DA methods are increasing but remain limited and highly variable in cardiac surgery. A methodological primer is presented and may provide researchers with the foundation to start with or improve DA, as well as provide readers and reviewers with the fundamental concepts to review DA studies.

One-month DAPT with ticagrelor and aspirin for patients undergoing coronary artery bypass grafting: rationale and design of the randomised, multicentre, double-blind, placebo-controlled ODIN trial.

The optimal antiplatelet strategy after coronary artery bypass graft (CABG) surgery in patients with chronic coronary syndromes (CCS) is unclear. Adding the P2Y12 inhibitor, ticagrelor, to low-dose aspirin for 1 year is associated with a reduction in graft failure, particularly saphenous vein grafts, at the expense of an increased risk of clinically important bleeding. As the risk of thrombotic graft failure and ischaemic events is highest early after CABG surgery, a better risk-to-benefit profile may be attained with short-term dual antiplatelet therapy followed by single antiplatelet therapy. The One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients (ODIN) trial is a prospective, randomised, double-blind, placebo-controlled, international, multicentre study of 700 subjects that will evaluate the effect of short-term dual antiplatelet therapy with ticagrelor plus low-dose aspirin after CABG in patients with CCS. Patients will be randomised 1:1 to ticagrelor 90 mg twice daily or matching placebo, in addition to aspirin 75-150 mg once daily for 1 month; after the first month, antiplatelet therapy will be continued with aspirin alone. The primary endpoint is a hierarchical composite of all-cause death, stroke, myocardial infarction, revascularisation and graft failure at 1 year. The key secondary endpoint is a hierarchical composite of all-cause death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, revascularisation and graft failure at 1 year (net clinical benefit). ODIN will report whether the addition of ticagrelor to low-dose aspirin for 1 month after CABG reduces ischaemic events and provides a net clinical benefit in patients with CCS. (ClinicalTrials.gov: NCT05997693).

Do the Few Dictate Care for the Many? Revascularisation Considerations That Go Beyond the Guidelines.

The burden of coronary artery disease (CAD) is large and growing, commonly presenting with comorbidities and older age. Patients may benefit from coronary revascularisation with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), yet half of patients with CAD who would benefit from revascularisation fall outside the eligibility criteria of trials to date. As such, the choice of revascularisation procedures varies depending on the CAD anatomy and complexity, surgical risk and comorbidities, the patient's preferences and values, and the treating team's expertise. The recent American guidelines on coronary revascularisation are comprehensive in describing recommendations for PCI, CABG, or conservative management in patients with CAD. However, individual challenging patient presentations cannot be fully captured in guidelines. The aim of this narrative review is to summarise common clinical scenarios that are not sufficiently described by contemporary clinical guidelines and trials in order to inform heart team members and trainees about the nuanced considerations and available evidence to manage such cases. We discuss clinical cases that fall beyond the current guidelines and summarise the relevant evidence evaluating coronary revascularisation for these patients. In addition, we highlight gaps in knowledge based on a lack of research (eg, ineligibility of certain patient populations), underrepresentation in research (eg, underenrollment of female and non-White patients), and the surge in newer minimally invasive and hybrid techniques. We argue that ultimately, evidence-based medicine, patient preference, shared decision making, and effective heart team communications are necessary to best manage complex CAD presentations potentially benefitting from revascularisation with CABG or PCI.

Outcomes following coronary artery bypass grafting with multiple arterial grafting by pump status in men and women.

BACKGROUND: Multiple arterial grafting (MAG) and off-pump surgery are strategies proposed to improve outcomes with coronary artery bypass grafting (CABG). This study was conducted to determine the impact of off-pump surgery on outcomes after CABG with MAG in men and women. METHODS: This cohort study used population-based data to identify all Ontarians undergoing isolated CABG with MAG between October 2008 and September 2019. The primary outcome was all-cause mortality. Secondary outcomes included major adverse cardiac and cerebrovascular events (MACCE; hospitalization for stroke, myocardial infarction hospitalization or heart failure, or repeat revascularization). Analysis used propensity-score overlap-weighted cause-specific Cox proportional hazard regression. RESULTS: A total of 2989 women (1188 off-pump, 1801 on-pump) and 16,209 men (6065 off-pump, 10,144 on-pump) underwent MAG with a median follow-up of 5.0 years (interquartile range, 2.7-8.0) years. Compared to the on-pump approach, all-cause mortality was not changed with off-pump status (hazard ratio [HR] in women: 1.25 [95% CI, 0.83-1.88]; in men: 1.08 [95% CI, 0.85-1.37]). In women, the risk of MACCE was significantly higher off-pump (HR, 1.45; 95% CI, 1.04-2.03), with nonsignificantly increased risk observed for all component outcomes. CONCLUSIONS: In patients undergoing CABG with MAG, this population-based analysis found no association between pump status and survival in either men or women. However, it did suggest that off-pump MAG in women may be associated with an increased risk of MACCE.

Race and Ethnicity in Cardiac Surgery: A Missed Opportunity?

BACKGROUND: Patients' race and/or ethnicity are increasingly being associated with differential surgical access and outcomes in cardiac surgery. However, deriving evidence-based conclusions that can inform surgical care has been difficult because of poor diversity in study populations and conflicting research methodology and findings. Using a fictional patient example, this review identifies areas of concern in research engagement, methodology, and analyses, as well as potential steps to improve race and ethnicity considerations in cardiac surgical research. METHODS: A narrative literature review was performed using the PubMed/MEDLINE and Google Scholar databases, with a combination of cardiac surgery, race, ethnicity, and disparities keywords. RESULTS: Less than half of the published cardiac surgery randomized control trials report the race and/or ethnicity of research participants. Racial and/or ethnic minorities make up <20% of most study populations and are significantly underrepresented relative to their proportions of the general population. Further, race and/or ethnicity of research participants is variably categorized based on ancestry, geographic regions, cultural similarities, or minority status. There is growing consideration of analyzing interrelated and confounding variables, such as socioeconomic status, geographic location, or hospital quality, to better elucidate racial and/or ethnic disparities; however, intersectionality considerations remain limited in cardiac surgery research. CONCLUSIONS: Racial and/or ethnic disparities are increasingly being reported in research engagement, cardiac pathologies, and surgical outcomes. To promote equitable surgical care, tangible efforts are needed to recruit racially and/or ethnically minoritized patients to research studies, be transparent and consistent in their groupings, and elucidate the impact of their intersectional social identities.

The Call for the "Interventional/Hybrid" Aortic Surgeon: Open, Endovascular, and Hybrid Therapies of the Aortic Arch.

Aortic arch pathology is relatively rare but potentially highly fatal and associated with considerable comorbidity. Operative mortality and complication rates have improved over time but remain high. In response, aortic arch surgery is one of the most rapidly evolving areas of cardiac surgery in terms of surgical volume and improved outcomes. Moreover, there has been a surge in novel devices and techniques, many of which have been developed by or codeveloped with vascular surgeons and interventional radiologists. Nevertheless, the extent of arch surgery, the choice of nadir temperature, cannulation, and perfusion strategies, and the use of open, endovascular, or hybrid options vary according to country, centre, and surgeon. In this review article, we provide a technical overview of the surgical, total endovascular, and hybrid repair options for aortic arch pathology through historical developments and contemporary results. We highlight key information for surgeons, cardiologists, and trainees to understand the management of patients with aortic arch pathology. We conclude by discussing training paradigms, the role of aortic teams, and gaps in knowledge, arguing for the need for wire skills for the future "interventional aortic surgeon" and increased research into techniques and novel devices to continue improving outcomes for aortic arch surgery.

Research Concepts and Opportunities for Early-Career Investigators in Cardiac Surgery.

Basic, translational or clinic, research is a key component of cardiac surgery. Understanding basic cellular and molecular mechanisms is key to improving patient outcomes, and cardiac surgical procedures must be compared with nonsurgical alternatives. However, guidance for early-career investigators interested in cardiac surgery research is limited. This opinion piece aims at providing basic guidance and principles based on the authors' experience.

Canadian Cardiovascular Society/Canadian Association of Interventional Cardiology 2023 Focused Update of the Guidelines for the Use of Antiplatelet Therapy.

Antiplatelet therapy (APT) is the foundation of treatment and prevention of atherothrombotic events in patients with atherosclerotic cardiovascular disease. Selecting the optimal APT strategies to reduce major adverse cardiovascular events, while balancing bleeding risk, requires ongoing review of clinical trials. Appended, the focused update of the Canadian Cardiovascular Society/Canadian Association of Interventional Cardiology guidelines for the use of APT provides recommendations on the following topics: (1) use of acetylsalicylic acid in primary prevention of atherosclerotic cardiovascular disease; (2) dual APT (DAPT) duration after percutaneous coronary intervention (PCI) in patients at high bleeding risk; (3) potent DAPT (P2Y12 inhibitor) choice in patients who present with an acute coronary syndrome (ACS) and possible DAPT de-escalation strategies after PCI; (4) choice and duration of DAPT in ACS patients who are medically treated without revascularization; (5) pretreatment with DAPT (P2Y12 inhibitor) before elective or nonelective coronary angiography; (6) perioperative and longer-term APT management in patients who require coronary artery bypass grafting surgery; and (7) use of APT in patients with atrial fibrillation who require oral anticoagulation after PCI or medically managed ACS. These recommendations are all on the basis of systematic reviews and meta-analyses conducted as part of the development of these guidelines, provided in the Supplementary Material.

Barriers to Access to Cardiac Surgery: Canadian Situation and Global Context.

Cardiovascular disease is the leading cause of morbidity and mortality worldwide. Cardiovascular care spans primary, secondary, and tertiary prevention and care, whereby tertiary care is particularly prone to disparities in care. Challenges in access to care especially affect low- and middle-income countries (LMICs), however, multiple barriers also exist and persist across high-income countries. Canada is lauded for its universal health coverage but is faced with health care system challenges and substantial geographic barriers. Canada possesses 203 active cardiac surgeons, or 5.02 per million population, ranging from 3.70 per million in Newfoundland and Labrador to 7.48 in Nova Scotia. As such, Canada possesses fewer cardiac surgeons per million population than the average among high-income countries (7.15 per million), albeit more than the global average (1.64 per million) and far higher than the low-income country average (0.04 per million). In Canada, adult cardiac surgeons are active across 32 cardiac centres, representing 0.79 cardiac centres per million population, which is just above the global average (0.73 per million). In addition to centre and workforce variations, barriers to care exist in the form of waiting times, sociodemographic characteristics, insufficient virtual care infrastructure and electronic health record interoperability, and health care governance fragmentation. Meanwhile, Canada has highly favourable surgical outcomes, well established postacute cardiac care infrastructure, considerable spending on health, robust health administrative data, and effective health technology assessment agencies, which provides a foundation for continued improvements in care. In this narrative review, we describe successes and challenges surrounding access to cardiac surgery in Canada and globally.

Revascularization strategies for multivessel coronary artery disease based on sex and age.

OBJECTIVES: This study describes coronary revascularization strategies used by sex and age in the USA. METHODS: A sex-stratified cohort study from the National Inpatient Sample from the Agency for Healthcare Research and Quality (USA) including patients admitted for coronary revascularization with primary or secondary diagnoses of chronic coronary syndrome or non-ST elevation myocardial infarction who underwent ≥3-vessel coronary artery bypass grafting or percutaneous coronary intervention from January 2019 to December 2020. The primary outcome was the use rate of coronary artery bypass grafting or multivessel percutaneous coronary intervention. Prespecified subgroups included age and non-ST elevation myocardial infarction. RESULTS: Among 121 150 patients (21.7% women), there were no sex differences in age (women: 66.6 [66.5-66.7], men: 67.6 [67.5-67.7], standardized mean difference: 0.1) or non-ST elevation myocardial infarction incidence (women: 37.4%, men: 45.7%, standardized mean difference: 0.17). The majority of women (74.2%) and men (84.9%) underwent bypass grafting, which was unaffected by age, race or non-ST elevation myocardial infarction. Women were less likely to undergo bypass grafting than percutaneous intervention (adjusted odds ratio 0.49, 95% confidence interval 0.44-0.54; P < 0.001) and a disparity most pronounced in patients >80 years old (adjusted odds ratio 0.31, 95% confidence interval 0.22-0.45; P < 0.001). CONCLUSIONS: Most patients with multivessel coronary artery disease needing revascularization undergo bypass grafting, irrespective of sex, age or clinical presentation. The sex disparity in the use of bypass grafting is mostly seen among patients >80 years old.

Expert systematic review on the choice of conduits for coronary artery bypass grafting: endorsed by the European Association for Cardio-Thoracic Surgery (EACTS) and The Society of Thoracic Surgeons (STS).

PREAMBLE: The finalized document was endorsed by the EACTS Council and STS Executive Committee before being simultaneously published in the European Journal of Cardio-thoracic Surgery (EJCTS) and The Annals of Thoracic Surgery (The Annals) and the Journal of Thoracic and Cardiovascular Surgery (JTCVS).

Impact of Complete Revascularization in the ISCHEMIA Trial.

BACKGROUND: Anatomic complete revascularization (ACR) and functional complete revascularization (FCR) have been associated with reduced death and myocardial infarction (MI) in some prior studies. The impact of complete revascularization (CR) in patients undergoing an invasive (INV) compared with a conservative (CON) management strategy has not been reported. OBJECTIVES: Among patients with chronic coronary disease without prior coronary artery bypass grafting randomized to INV vs CON management in the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial, we examined the following: 1) the outcomes of ACR and FCR compared with incomplete revascularization; and 2) the potential impact of achieving CR in all INV patients compared with CON management. METHODS: ACR and FCR in the INV group were assessed at an independent core laboratory. Multivariable-adjusted outcomes of CR were examined in INV patients. Inverse probability weighted modeling was then performed to estimate the treatment effect had CR been achieved in all INV patients compared with CON management. RESULTS: ACR and FCR were achieved in 43.4% and 58.4% of 1,824 INV patients. ACR was associated with reduced 4-year rates of cardiovascular death or MI compared with incomplete revascularization. By inverse probability weighted modeling, ACR in all 2,296 INV patients compared with 2,498 CON patients was associated with a lower 4-year rate of cardiovascular death or MI (difference -3.5; 95% CI: -7.2% to 0.0%). In comparison, the event rate difference of cardiovascular death or MI for INV minus CON in the overall ISCHEMIA trial was -2.4%. Results were similar but less pronounced with FCR. CONCLUSIONS: The outcomes of an INV strategy may be improved if CR (especially ACR) is achieved. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches [ISCHEMIA]; NCT01471522).

Graft Failure After Coronary Artery Bypass Grafting and Its Association With Patient Characteristics and Clinical Events: A Pooled Individual Patient Data Analysis of Clinical Trials With Imaging Follow-Up.

BACKGROUND: Graft patency is the postulated mechanism for the benefits of coronary artery bypass grafting (CABG). However, systematic graft imaging assessment after CABG is rare, and there is a lack of contemporary data on the factors associated with graft failure and on the association between graft failure and clinical events after CABG. METHODS: We pooled individual patient data from randomized clinical trials with systematic CABG graft imaging to assess the incidence of graft failure and its association with clinical risk factors. The primary outcome was the composite of myocardial infarction or repeat revascularization occurring after CABG and before imaging. A 2-stage meta-analytic approach was used to evaluate the association between graft failure and the primary outcome. We also assessed the association between graft failure and myocardial infarction, repeat revascularization, or all-cause death occurring after imaging. RESULTS: Seven trials were included comprising 4413 patients (mean age, 64.4±9.1 years; 777 [17.6%] women; 3636 [82.4%] men) and 13 163 grafts (8740 saphenous vein grafts and 4423 arterial grafts). The median time to imaging was 1.02 years (interquartile range [IQR], 1.00-1.03). Graft failure occurred in 1487 (33.7%) patients and in 2190 (16.6%) grafts. Age (adjusted odds ratio [aOR], 1.08 [per 10-year increment] [95% CI, 1.01-1.15]; P=0.03), female sex (aOR, 1.27 [95% CI, 1.08-1.50]; P=0.004), and smoking (aOR, 1.20 [95% CI, 1.04-1.38]; P=0.01) were independently associated with graft failure, whereas statins were associated with a protective effect (aOR, 0.74 [95% CI, 0.63-0.88]; P<0.001). Graft failure was associated with an increased risk of myocardial infarction or repeat revascularization occurring between CABG and imaging assessment (8.0% in patients with graft failure versus 1.7% in patients without graft failure; aOR, 3.98 [95% CI, 3.54-4.47]; P<0.001). Graft failure was also associated with an increased risk of myocardial infarction or repeat revascularization occurring after imaging (7.8% versus 2.0%; aOR, 2.59 [95% CI, 1.86-3.62]; P<0.001). All-cause death after imaging occurred more frequently in patients with graft failure compared with patients without graft failure (11.0% versus 2.1%; aOR, 2.79 [95% CI, 2.01-3.89]; P<0.001). CONCLUSIONS: In contemporary practice, graft failure remains common among patients undergoing CABG and is strongly associated with adverse cardiac events.