Ten years survival benefit and appropriateness of surgical versus percutaneous revascularization in synergy between percutaneous coronary intervention with taxus and cardiac surgery randomized trial.

OBJECTIVES: Average treatment effects from randomized trials do not reflect the heterogeneity of an individual's response to treatment. This study evaluates the appropriate proportions of patients for coronary artery bypass grafting, or percutaneous intervention based on the predicted/observed ratio of 10-year all-cause mortality in the SYNTAX population. METHODS: The study included 1800 randomized patients and 1275 patients in the nested percutaneous (n = 198) or surgical (n = 1077) registries. The primary end-point was 10-year all-cause mortality. The SYNTAX score II-2020 was validated internally in the randomized cohort and externally in the registry cohort. Proportions of patients with survival benefits from coronary artery bypass grafting or percutaneous intervention were determined using SYNTAX score II-2020. RESULTS: Ten-year mortality was 23.8% for coronary artery bypass grafting 28.6% for percutaneous intervention in the randomized cohort, 27.6% for coronary artery bypass grafting, and 55.4% for percutaneous intervention in the registries. In the coronary artery bypass grafting registry, the SYNTAX score II-2020 predicted 10-year mortality with helpful calibration and discrimination (C-index : 0.70, intercept : 0.00, slope : 0.76). The proportion of patients deriving a predicted survival benefit from coronary artery bypass grafting over percutaneous intervention was 82.4% (2143/2602) and 17.7% (459/2602) for the entire SYNTAX trial population; translating into a 4.7 to 1 appropriate ratio of treatment allocation to coronary artery bypass grafting and percutaneous intervention. CONCLUSIONS: Choosing a revascularization modality should depend on an individual's long-term prognosis rather than average treatment effects. Additionally, patients should be informed about their predicted prognosis. TRIAL REGISTRATION: Registered on clinicaltrial.govSYNTAXES: NCT03417050 (https://clinicaltrials.gov/ct2/show/NCT03417050);SYNTAX: NCT00114972 (https://www.clinicaltrials.gov/ct2/show/NCT00114972).

Conflicts of interest in clinical practice: lessons learned from cardiovascular medicine.

Cardiovascular diseases represent a major burden worldwide, and clinical trials are critical to define treatment improvements. Since various conflicts of interest (COIs) may influence trials at multiple levels, cardiovascular research represents a paradigmatic example to analyze their effects and manage them effectively to re-establish the centrality of evidence-based medicine.Despite the manifest role of industry, COIs may differently affect both sponsored and non-sponsored studies in many ways. COIs influence may start from the research question, data collection and adjudication, up to result reporting, including the spin phenomenon. Outcomes and endpoints (especially composite) choice and definitions also represent potential sources for COIs interference. Since large randomized controlled trials significantly influence international guidelines, thus impacting also clinical practice, their critical assessment for COIs is mandatory. Despite specific protocols aimed to mitigate COI influence, even scientific societies and guideline panels may not be totally free from COIs, negatively affecting their accountability and trustworthiness.Shared rules, awareness of COI mechanisms and transparency with external data access may help promoting evidence-based research and mitigate COIs impact. Managing COIs effectively should preserve public trust in the cardiovascular profession without compromising the positive relationships between investigators and industry.

Clinical cases referring to the 2023 EACTS/STS Guidelines for diagnosing and treating acute and chronic syndromes of the aortic organ.

Clinical cases referring to the EACTS/STS Guidelines for diagnosing and treating acute and chronic syndromes of the aortic organ aim to assist physicians in selecting the best management strategies for individual patients with a given condition. These expert opinions consider the impact on patient outcomes as well as the risk-benefit ratio of different diagnostic or therapeutic methods. These cases serve as a vital tool to aid physicians in making decisions in their daily practice. However, in essence, although these recommendations serve as a valuable resource to guide clinical practice, their application should be tailored to the needs of the individual patient. Each patient's case is unique, presenting its own set of variables and circumstances. This editorial is a tool designed to support, but not supersede, the decision-making process of physicians, based on their knowledge, expertise and understanding of their patients' individual situations. Furthermore, these clinical cases are based on the EACTS/STS Guidelines for diagnosing and treating acute and chronic syndromes of the aortic organ but should not be interpreted as legally binding documents. The legal responsibilities of healthcare professionals remain firmly grounded in applicable laws and regulations, and the guidelines and the clinical cases presented in this document do not alter these obligations.

The Effects of Corticosteroids on Survival in Pediatric and Nonelderly Adult Patients Undergoing Cardiac Surgery: A Meta-analysis of Randomized Studies.

OBJECTIVE: Cardiac surgery can be complicated by the development of a systemic inflammatory response syndrome related to cardiopulmonary bypass. This potentially contributes to the occurrence of postoperative morbidity and mortality. Corticosteroids can be used to reduce such inflammation, but the overall balance between potential harm and benefit is unknown and may be age-dependent. The present meta-analysis aims to evaluate the effects of prophylactic corticosteroids in pediatric and non-elderly adult cardiac surgery patients. DESIGN: Systematic review and meta-analysis of randomized trials. SETTING: Cardiac surgery with cardiopulmonary bypass. PARTICIPANTS: Patients younger than 65 years old (pediatric and non-elderly adults). INTERVENTIONS: Perioperative use of corticosteroids versus placebo or standard care. MEASUREMENTS AND MAIN RESULTS: Two independent investigators searched PubMed, EMBASE and the Cochrane Library from inception to January 20, 2024. The primary outcome was mortality at the longest follow-up available. Secondary outcomes included acute kidney injury, atrial fibrillation, myocardial injury, cerebrovascular events, and infections. Our search strategy identified a total of 17 randomized trials involving 6,598 patients. Mortality was significantly reduced in the corticosteroid group (78/3321 [2.3%] vs. 116/3277 [3.5%]; risk ratio = 0.69; 95% confidence interval, 0.52 to 0.92; P = 0.01; I2 = 0%; NNT = 91). Moreover, the highest postoperative vasoactive inotropic score (VIS) was significantly lower in corticosteroid group (MD: -2.07, 95% CI -3.69 to -0.45, P = 0.01, I2 = 0%). No significant differences in secondary outcomes between the two treatment groups were recorded. CONCLUSIONS: This meta-analysis of randomized trials highlights the potential benefits of corticosteroids on survival in cardiac surgery for patients younger than 65 years old.

Same evidence different recommendations: a methodological assessment of transatlantic guidelines for the management of valvular heart disease.

OBJECTIVES: The aim of this study was to identify methodological variations leading to varied recommendations between the American College of Cardiology (ACC)/American Heart Association (AHA) and the European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) valvular heart disease guidelines and to suggest foundational steps towards standardizing guideline development. METHODS: An in-depth analysis was conducted to evaluate the methodologies used in developing the transatlantic guidelines for managing valvular heart disease. The evaluation was benchmarked against the standards proposed by the Institute of Medicine. RESULTS: Substantial discrepancies were noted in the methodologies utilized in development processes, including Writing Committee composition, evidence evaluation, conflict of interest management and voting processes. Furthermore, despite their mutual differences, both methodologies demonstrate notable deviations from the Institute of Medicine standards in several essential areas, including literature review and evidence grading. These dual variances likely influenced divergent treatment recommendations. For example, the ESC/EACTS recommends transcatheter edge-to-edge repair for patients with chronic severe mitral regurgitation ineligible for mitral valve surgery, while the ACC/AHA recommends transcatheter edge-to-edge repair based on anatomy, regardless of surgical risk. ESC/EACTS guidelines recommend a mechanical aortic prosthesis for patients under 60, while ACC/AHA guidelines recommend it for patients under 50. Notably, the ACC/AHA and ESC/EACTS guidelines have differing age cut-offs for surgical over transcatheter aortic valve replacement (<65 and <75 years, respectively). CONCLUSIONS: Variations in methodologies for developing clinical practice guidelines have resulted in different treatment recommendations that may significantly impact global practice patterns. Standardization of essential processes is vital to increase the uniformity and credibility of clinical practice guidelines, ultimately improving healthcare quality, reducing variability and enhancing trust in modern medicine.