Statistical primer: Composite endpoints and competing risks analysis.

Composite end-points are common primary outcomes in clinical trials. Their main benefit of utilizing a composite outcome is increasing the number of primary outcome events meaning fewer participants are required to deliver an adequately powered trial. By combining multiple important end-points in the primary outcome rather than having to select only one, composite end-points potentially make clinically meaningful benefits easier to detect and avoid ranking outcomes hierarchically. However there are a number of important considerations when designing and interpreting clinical trials that utilize composite end-points. In this Statistical Primer, issues with composite end-points such as competing events, halo effect, risk of bias, time to event limitations and the win ratio are discussed in the context of real world clinical trials.

Early anticoagulation after aortic valve replacement with porcine bioprosthesis randomized control trial(ANTIPRO). 3 years follow-up.

BACKGROUND: Most evidence for anticoagulation in aortic bioprosthesis is centered on embolic events, bleeding and re-intervention risk. The effect of anticoagulation on hemodynamics has not been previously assessed. Our hypothesis was that patients with anticoagulation (AC) early after aortic valve replacement (AVR) with porcine bioprosthesis have better hemodynamics at 3 years of follow-up. METHODS: This is a follow-up evaluation of the ANTIPRO trial. All patients undergoing AVR with porcine bioprosthesis were consecutively recruited. The AC group received warfarin+aspirin and the non-AC(control) only aspirin. The primary outcome was mean gradient after 3 years of AVR and change in New York Heart Association (NYHA) class. Secondary outcomes were major and minor bleeding and embolic events. RESULTS: Of 140 participants in the study, 71 were assigned to the AC group and 69 to the control group. Mean age of the overall population was 72.4(SD: 7.1) years. Global euroSCORE was 7.65(SD: 5.73). At 3 years the mean gradient was similar between both groups (19.4(SD: 9.6 mmHg) and 18.6(SD: 8.2 mmHg) in the control and AC group respectively, p = 0.7). No differences in functional class at 3 years were found among groups. No differences were found among groups in the secondary outcomes. CONCLUSIONS: The addition of 3 months of oral anticoagulation to anti-aggregation treatment did not affect bioprosthetic hemodynamics nor functional class at years after AVR.

The ISCHEMIA trial revisited: setting the record straight on the benefits of coronary bypass surgery and the misinterpretation of a landmark trial.

OBJECTIVES: The ISCHEMIA trial is a landmark study that has been the subject of heated debate within the cardiovascular community. In this analysis of the ISCHEMIA trial, we aim to set the record straight on the benefits of coronary artery bypass grafting (CABG) and the misinterpretation of this landmark trial. We sought to clarify and reorient this misinterpretation. METHODS: We herein analyse the ISCHEMIA trial in detail and describe how its misinterpretation has led to an erroneous guideline recommendation downgrading for prognosis-altering surgical therapy in these at-risk patients. RESULTS: The interim ISCHEMIA trial findings align with previous evidence where CABG reduces the long-term risks of myocardial infarction and mortality in advanced coronary artery disease. The trial outcomes of a significantly lower rate of cardiovascular mortality and a higher rate of non-cardiovascular mortality with the invasive strategy are explained according to landmark evidence. CONCLUSIONS: The ISCHEMIA trial findings are aligned with previous evidence and should not be used to downgrade recommendations in recent guidelines for the indisputable benefits of CABG.

Coronary surgery provides better survival than drug-eluting stent: A pooled meta-analysis of Kaplan- Meier-derived individual patient data.

OBJECTIVES: We explored the current evidence on coronary disease treatment comparing the survival of 2 therapeutic strategies: coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) with drug-eluting stent (DES). METHODS: PubMed, Embase, and Google Scholar were searched for randomized clinical trials comparing CABG versus PCI with DES. The end point was overall mortality. Two statistical approaches were used: the generic inverse variance method, which was used to pool the incident rate ratios, and the pooled meta-analysis of Kaplan-Meier-derived individual patient data. RESULTS: Eight randomized clinical trials comparing 4975 patients undergoing CABG and 4992 patients undergoing PCI were included in our meta-analysis. Generic inverse variance method showed a statistically significant survival benefit of the CABG group (incident rate ratio, 1.21; 95% confidence interval, 1.09-1.35; P < .01). The Kaplan-Meier estimates of survival at 1, 5, and 10 years of the CABG group were 97.1%, 90.3%, and 80.3%, respectively. The Kaplan-Meier estimates of survival at 1, 5, and 10 years of the PCI group were 97.0%, 87.7%, and 76.4%, respectively. The log-rank analysis confirmed a statistically significant benefit in term of overall mortality of the CABG group (hazard ratio, 1.24; 95% confidence interval, 1.11-1.38; P = .0001). CONCLUSIONS: The present meta-analysis suggests that CABG provides a consistent survival benefit over PCI with DES.

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.

2021 Coronary Revascularization Guidelines-Lessons in the Importance of Data Scrutiny and Reappraisal of Evidence.

This Viewpoint discusses whether or not the evidence cited in the 2021 American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography & Interventions guidelines for coronary artery revascularization support downgrading coronary artery bypass grafting relative to medical therapy.

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.

Early anticoagulation after aortic valve replacement with porcine bioprosthesis randomized control trial (ANTIPRO).

OBJECTIVES: Most evidence for anticoagulation (AC) in aortic bioprosthesis is centred on embolic events, bleeding and reintervention risk. The effect of AC on haemodynamics has not been previously assessed. Our hypothesis was that patients with early AC after aortic valve replacement (AVR) with porcine bioprosthesis have better haemodynamics at 1 year of follow-up. METHODS: Prospective, randomized, open-label trial conducted at 2 cardiac surgery centres. All patients undergoing AVR with porcine bioprosthesis were consecutively recruited. The anticoagulated group received warfarin + aspirin and the non-anticoagulated (control) only aspirin. The primary outcome was mean gradient after 1 year of AVR and change in New York Heart Association class. Secondary outcomes were major and minor bleeding, embolic events and prosthetic leak. RESULTS: Of 140 participants in the study, 71 were assigned to the anticoagulated group and 69 to the control group. The mean age of the overall population was 72.4 (SD: 7.1) years. Global EuroSCORE was 7.65 (SD: 5.73). At 1 year, the mean gradient was similar between both groups [18.6 (SD: 1.1 mmHg) and 18.1 (SD: 1.0 mmHg) in the control and anticoagulated groups, respectively, P = 0.701]. No differences in functional class at 3 months or 1 year were found among groups. No differences were found among groups in the secondary outcomes. CONCLUSIONS: The addition of 3 months of oral AC to anti-aggregation treatment was not detected to affect bioprosthetic haemodynamics nor functional class at 1 year after AVR. Likewise, AC does not lead to the higher incidence of complications.

Joint Recommendations From The Latin American Association of Cardiac and Endovascular Surgery (LACES) and The Cardiovascular Anesthesia Committee of The Latin American Confederation of Anesthesia Societies (CLASA) on the Timing for Cardiac Surgery After COVID-19 Infection

ABSTRACT Introduction: Since the coronavirus disease 2019 (COVID-19) pandemic, cardiac surgeries in patients with previous infection by COVID-19 were suspended or postponed, which led to surgeries performed in patients with an advanced stage of their disease and an increase in the waiting list. There is a heterogeneous attitude in Latin America on the optimal timing to cardiac surgery in patients with previous COVID-19 infection due to scarce data on its outcome. Two Latin American associations joined to establish common suggestions on the optimal timing of surgery in patients with previous COVID-19 infection. Methods: Data collection was performed using a pre-established form, which included year of publication, objective, type of study (prospective/retrospective, descriptive/analytical), number of patients, year of study, waiting time between infection and surgery, type of surgery, morbidity, mortality, and conclusions regarding the association between mortality and morbidity. Final recommendations were approved by the board of directors of Latin American Association of Cardiac and Endovascular Surgery (LACES) and Latin American Confederation of Anesthesia Societies (CLASA). Results: Of the initial 1,016 articles, 11 comprised the final selection. Only six of them included patients who underwent cardiac surgery. According to the analyzed literature, optimal timing for cardiac surgery needs to consider the following aspects: deferable surgery, symptomatic COVID-19 infection, completeness of COVID-19 vaccination. Conclusion: These recommendations derive from the analysis of the scarce literature published at present on outcomes after cardiac surgery in patients with previous COVID-19 infection. These are to be taken as a dynamic recommendation in which Latin American reality was taken into consideration.

Joint Recommendations From The Latin American Association of Cardiac and Endovascular Surgery (LACES) and The Cardiovascular Anesthesia Committee of The Latin American Confederation of Anesthesia Societies (CLASA) on the Timing for Cardiac Surgery After COVID-19 Infection.

INTRODUCTION: Since the coronavirus disease 2019 (COVID-19) pandemic, cardiac surgeries in patients with previous infection by COVID-19 were suspended or postponed, which led to surgeries performed in patients with an advanced stage of their disease and an increase in the waiting list. There is a heterogeneous attitude in Latin America on the optimal timing to cardiac surgery in patients with previous COVID-19 infection due to scarce data on its outcome. Two Latin American associations joined to establish common suggestions on the optimal timing of surgery in patients with previous COVID-19 infection. METHODS: Data collection was performed using a pre-established form, which included year of publication, objective, type of study (prospective/retrospective, descriptive/analytical), number of patients, year of study, waiting time between infection and surgery, type of surgery, morbidity, mortality, and conclusions regarding the association between mortality and morbidity. Final recommendations were approved by the board of directors of Latin American Association of Cardiac and Endovascular Surgery (LACES) and Latin American Confederation of Anesthesia Societies (CLASA). RESULTS: Of the initial 1,016 articles, 11 comprised the final selection. Only six of them included patients who underwent cardiac surgery. According to the analyzed literature, optimal timing for cardiac surgery needs to consider the following aspects: deferable surgery, symptomatic COVID-19 infection, completeness of COVID-19 vaccination. CONCLUSION: These recommendations derive from the analysis of the scarce literature published at present on outcomes after cardiac surgery in patients with previous COVID-19 infection. These are to be taken as a dynamic recommendation in which Latin American reality was taken into consideration.

Declaración de la Latinoamerican Association of Cardiac & Endovascular Surgery (LACES) sobre las guías de la AHA/ACC para el manejo de la enfermedad valvular 2020 / Latin American Association of Cardiac and Endovascular Surgery statement regarding the 2020 ACC/AHA guidelines for the management of valvular heart disease

Resumen Se han publicado ya las nuevas guías 2020 de recomendación clínica de la AHA/ACC para el tratamiento de pacientes con valvulopatía. Luego de un análisis profundo, con base en los más grandes estudios clínicos y en la situación en los países de Latinoamérica, la Latinoamerican Association of Cardiac & Endovascular Surgery (LACES) redactó una declaración en relación con algunas de las nuevas recomendaciones.

Abstract The new clinical guidelines of the AHA/ACC for the treatment of patients with Valvulopathy 2020 have been published. After an in-depth analysis, based on the largest clinical trials and taking into account the situation in our countries in Latin America, the Latinoamerican Association of Cardiac & Endovascular Surgery (LACES) drafting a statement on some of the new recommendations.