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.

Risk of Bias in Randomized Clinical Trials Comparing Transcatheter and Surgical Aortic Valve Replacement: A Systematic Review and Meta-analysis.

Importance: Recent European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines highlighted some concerns about the randomized clinical trials (RCTs) comparing transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) for aortic stenosis. Quantification of these biases has not been previously performed. Objective: To assess whether randomization protects RCTs comparing TAVI and SAVR from biases other than nonrandom allocation. Data Sources: A systematic review of the literature between January 1, 2007, and June 6, 2022, on MEDLINE, Embase, and Cochrane Central Register of Controlled Trials was performed. Specialist websites were also checked for unpublished data. Study Selection: The study included RCTs with random allocation to TAVI or SAVR with a maximum 5-year follow-up. Data Extraction and Synthesis: Data extraction was performed by 2 independent investigators following the PRISMA guidelines. A random-effects meta-analysis was used for quantifying pooled rates and differential rates between treatments of deviation from random assigned treatment (DAT), loss to follow-up, and receipt of additional treatments. Main Outcomes and Measures: The primary outcomes were the proportion of DAT, loss to follow-up, and patients who were provided additional treatments and myocardial revascularization, together with their ratio between treatments. The measures were the pooled overall proportion of the primary outcomes and the risk ratio (RR) in the TAVI vs SAVR groups. Results: The search identified 8 eligible trials including 8849 participants randomly assigned to undergo TAVI (n = 4458) or SAVR (n = 4391). The pooled proportion of DAT among the sample was 4.2% (95% CI, 3.0%-5.6%), favoring TAVI (pooled RR vs SAVR, 0.16; 95% CI, 0.08-0.36; P < .001). The pooled proportion of loss to follow-up was 4.8% (95% CI, 2.7%-7.3%). Meta-regression showed a significant association between the proportion of participants lost to follow-up and follow-up time (slope, 0.042; 95% CI, 0.017-0.066; P < .001). There was an imbalance of loss to follow-up favoring TAVI (RR, 0.39; 95% CI, 0.28-0.55; P < .001). The pooled proportion of patients who had additional procedures was 10.4% (95% CI, 4.4%-18.5%): 4.6% (95% CI, 1.5%-9.3%) in the TAVI group and 16.5% (95% CI, 7.5%-28.1%) in the SAVR group (RR, 0.27; 95% CI, 0.15-0.50; P < .001). The imbalance between groups also favored TAVI for additional myocardial revascularization (RR, 0.40; 95% CI, 0.24-0.68; P < .001). Conclusions and Relevance: This study suggests that, in RCTs comparing TAVI vs SAVR, there are substantial proportions of DAT, loss to follow-up, and additional procedures together with systematic selective imbalance in the same direction characterized by significantly lower proportions of patients undergoing TAVI that might affect internal validity.

Perspectives in Training and Professional Practice of Cardiac Surgery in Latin America.

INTRODUCTION: There is a lack of information about cardiac surgery training and professional practice in Latin American (LATAM) countries. This study is the first comparative analysis of cardiac surgical training and professional practice across LATAM and provides the fundamentals for future academic projects of the Latin American Association of Cardiac and Endovascular Surgery (LACES). METHODS: International survey-based comparative analysis of the training and professional practice of cardiac surgeons across LATAM. Trainees (residents/fellows) and staf (graduated) surgeons from LATAM countries were included. RESULTS: A total of 289 respondents (staf surgeons N=221 [76.5%]; residents/fellows N=68 [23.5%]) from 18 different countries participated in the survey. Most surgeons (N=92 [45.3%]) reported being unsatisfied with their salaries. Most respondents (N=181 [62.6%]) stated that it was difficult to obtain a leadership position, and 149 (73.8%) stated that it was difficult to find a job after completing training. Only half of the trainee respondents (N=32 [47.1%]) reported that their program had all resident spots occupied. Only 22.1% (N=15) of residents/fellows were satisfied with their training programs. The majority (N=205 [70.9%]) of respondents would choose cardiac surgery as their specialty again. Most surgeons (N=129 [63.9%]) and residents/fellows (N=52 [76.5%]) indicated that the establishment of a LATAM cardiac surgery board examination would be beneficial. CONCLUSION: Modernization and standardization of training, as well as greater access to opportunities, may be required in LATAM to increase professional satisfaction of cardiac surgeons and to reduce disparities in the specialty. Such changes may enhance the regional response to the dynamic challenges in the feld.

Randomized evidence for reduction of perioperative mortality.

OBJECTIVE: With more than 220 million major surgical procedures performed annually, perioperative interventions leading to even minor mortality reductions would save thousands of lives per year. This international consensus conference aimed to identify all nonsurgical interventions that increase or reduce perioperative mortality as suggested by randomized evidence. DESIGN AND SETTING: A web-based international consensus conference. PARTICIPANTS: More than 1,000 physicians from 77 countries participated in this web-based consensus conference. INTERVENTIONS: Systematic literature searches (MEDLINE/PubMed, June 8, 2011) were used to identify the papers with a statistically significant effect on mortality together with contacts with experts. Interventions were considered eligible for evaluation if they (1) were published in peer-reviewed journals, (2) dealt with a nonsurgical intervention (drug/technique/strategy) in adult patients undergoing surgery, and (3) provided a statistically significant mortality increase or reduction as suggested by a randomized trial or meta-analysis of randomized trials. MEASUREMENTS AND MAIN RESULTS: Fourteen interventions that might change perioperative mortality in adult surgery were identified. Interventions that might reduce mortality include chlorhexidine oral rinse, clonidine, insulin, intra-aortic balloon pump, leukodepletion, levosimendan, neuraxial anesthesia, noninvasive respiratory support, hemodynamic optimization, oxygen, selective decontamination of the digestive tract, and volatile anesthetics. In contrast, aprotinin and extended-release metoprolol might increase mortality. CONCLUSIONS: Future research and health care funding should be directed toward studying and evaluating these interventions.

Quality of Life after 114 months of follow-up following geometric reconstruction of the left ventricle by endoventriculoplasty with septal exclusion.

BACKGROUND: The purpose of this study was to present the surgical experience of the Institute of Cardiovascular Surgery of West of Paraná (ICCOP) with respect to the treatment of left ventricle aneurysms by endoventriculoplasty with septal exclusion (EVSE) and to evaluate the quality of life of these patients after a 114-month follow-up. METHODS: Between April 1999 and April 2006, 28 patients underwent EVSE. Preoperative, transoperative, and late postoperative clinical and echocardiographic variables were analyzed retrospectively. In addition, latepostoperative quality of life was evaluated with questionnaire SF-36 (Brazilian version). The mean age (+/-SD) of the group was 59.0 +/- 9.5 years, and 23 of the patients were male. Seventeen patients were in New York Heart Association functional class IV, and the mean preoperative EuroSCORE was 8.2 +/- 2.3. The mean preoperative values for the ejection fraction (EF) and the end-systolic and end-diastolic left ventricular volumes were 32.3% +/- 9.2%, 113.9 +/- 36.0 mL, and 179.2 +/- 48.4 mL, respectively. RESULTS: The in-hospital mortality rate was 14.3%, with the major causes of morbidity being low cardiac output syndrome and arrhythmias. The mean follow-up period was 5.9 +/- 3.4 years. The left ventricular EF and the aortic cross-clamping time were the significant factors for hospital and late mortality (P = .0222, and P = .0123, respectively). The actuarial survival curve showed survival rates of 82.1 +/- 7.2%, and 54.7 +/- 22.9%, before and after 107 months of follow-up. The overall score for the quality of life showed an improvement. CONCLUSION: EVSE surgery is an effective option for treating this group of patients, with improvement noted in left ventricular function and in the patients' quality of life, despite the high in-hospital mortality.

Global perspectives on cardiothoracic, cardiovascular, and cardiac surgical training.

OBJECTIVE: Various methods for cardiothoracic, cardiovascular, and cardiac surgical training exist across the globe, with the common goal of producing safe, independent surgeons. A comparative analysis of international training paradigms has not been undertaken, and our goal in doing so was to offer insights into how to best prepare future trainees and ensure the health of our specialty. METHODS: We performed a comparative analysis of available publications offering detailed descriptions of various cardiothoracic, cardiovascular, and cardiac surgical training paradigms. Corresponding authors from previous publications and other international collaborators were also reached directly for further data acquisition. RESULTS: We report various approaches to common challenges surrounding (1) selection of trainees and plans for the future surgical workforce; (2) trainee assessments and certification of competency before independent practice; and (3) challenges related to a changing practice landscape. CONCLUSIONS: Cardiothoracic surgery remains a dynamic and rewarding specialty. Current and future trainees face several challenges that transcend national borders. To foster collaboration and adoption of best practices, we highlight international strengths and weaknesses of various nations in terms of workforce selection, trainee operative experience and assessment, board certification, and preparation for future changes anticipated in cardiothoracic surgery.

Endovascular Treatment of the Ascending Aorta: is this the Last Frontier in Aortic Surgery?

Regardless the successful treatment of the descending aorta with endovascular prosthesis, for the ascending aorta segment, because of several anatomic and physiologic issues, this technique has been considered an alternative only for high-risk or inoperable patients. Despite restricted indications, hundreds of treatments have been performed worldwide, demonstrating its safety and reproducibility if it is done in high-quality centers. Therefore, understanding patients' selection criteria and technique limitations are critical to its application.

Impact of the COVID-19 Outbreak on Coronary Artery Bypass Grafting in Brazil

Abstract Background The COVID-19 pandemic has disrupted the routine of emergency centers around the world, including in Brazil, where the crisis has affected the volume of major cardiac surgeries such as coronary artery bypass grafting. Objective To analyze the impact of the COVID-19 pandemic on the number of surgical procedures for coronary artery bypass grafting in Brazil. Methods An ecological, cross-sectional, quantitative, and descriptive study was conducted. Data for the period from July 2018 to June 2019 and from July 2020 to June 2021 were collected from SIHSUS using DATASUS/Tabwin. Results A global reduction of 26.58% was observed in the analyzed population, with on-pump coronary artery bypass grafting decreasing by 28.10%, and off-pump coronary artery bypass grafting reduced by only 10.31%. Conclusion During the pandemic, there was a 26.58% reduction in the number of surgical procedures for myocardial revascularization in Brazil.

Perspectives in Training and Professional Practice of Cardiac Surgery in Latin America

ABSTRACT Introduction: There is a lack of information about cardiac surgery training and professional practice in Latin American (LATAM) countries. This study is the first comparative analysis of cardiac surgical training and professional practice across LATAM and provides the fundamentals for future academic projects of the Latin American Association of Cardiac and Endovascular Surgery (LACES). Methods: International survey-based comparative analysis of the training and professional practice of cardiac surgeons across LATAM. Trainees (residents/fellows) and staf (graduated) surgeons from LATAM countries were included. Results: A total of 289 respondents (staf surgeons N=221 [76.5%]; residents/fellows N=68 [23.5%]) from 18 different countries participated in the survey. Most surgeons (N=92 [45.3%]) reported being unsatisfied with their salaries. Most respondents (N=181 [62.6%]) stated that it was difficult to obtain a leadership position, and 149 (73.8%) stated that it was difficult to find a job after completing training. Only half of the trainee respondents (N=32 [47.1%]) reported that their program had all resident spots occupied. Only 22.1% (N=15) of residents/fellows were satisfied with their training programs. The majority (N=205 [70.9%]) of respondents would choose cardiac surgery as their specialty again. Most surgeons (N=129 [63.9%]) and residents/fellows (N=52 [76.5%]) indicated that the establishment of a LATAM cardiac surgery board examination would be beneficial. Conclusion: Modernization and standardization of training, as well as greater access to opportunities, may be required in LATAM to increase professional satisfaction of cardiac surgeons and to reduce disparities in the specialty. Such changes may enhance the regional response to the dynamic challenges in the feld.

Benefit from using recycling red blood cells in cardiovascular surgery.

OBJECTIVE: To show if blood salvage is indicated in all patients submitted to cardiovascular surgery with cardiopulmonary bypass. METHODS: We studied 77 consecutive patients submitted to cardiac surgery with use of blood salvage and cardiopulmonary bypass from November 2010 to June 2012. The sample was divided in three groups, depending on the time of cardiopulmonary bypass. In group A, the time of cardiopulmonary bypass was smaller than 45, in group B from 45 to 90 and in group C greater than 90 minutes. We analyzed the volume of red cells recovered and infused, the pre, intra and post-operative hemoglobin, the number of packed red cells units which were transfused and hematocrit and hemoglobin blood infused. RESULTS: The average group age was 60.44±12.09 years old, of whom 71.43% were males. The group A was formed by 5.19% of the patients, B by 81.82% and C by 12.99%. The volume of erythrocytes recovered and infused was respectively 1,360.50±511.37 ml and 339.75±87.71 ml in group A, 1,436.63±516.06 ml and 518.83±183.0 ml in B and 2,137.00±925.04 ml and 526.20±227.15 ml in C. About packed red cells transfusions, in group A 1,00±2,00 packed red cells were transfused, in B 1.27±1.85 packed red cells and in C 2.56±2.01 packed red cells. The infused blood had a hematocrit of 50.97±12.06% and hemoglobin of 19.57±8.35 g/dl. CONCLUSION: That blood salvage can be used in patients submitted to cardiovascular surgery with cardiopulmonary bypass. However, it is only cost-effective in surgeries in which the time of cardiopulmonary bypass is greater than 45 minutes.

Endovascular treatment of the ascending aorta: is this the last frontier in aortic surgery?

Abstract Regardless the successful treatment of the descending aorta with endovascular prosthesis, for the ascending aorta segment, because of several anatomic and physiologic issues, this technique has been considered an alternative only for high-risk or inoperable patients. Despite restricted indications, hundreds of treatments have been performed worldwide, demonstrating its safety and reproducibility if it is done in high-quality centers. Therefore, understanding patients' selection criteria and technique limitations are critical to its application.