Difference Between Cardiopulmonary Bypass Time and Aortic Cross-Clamping Time as a Predictor of Complications After Coronary Artery Bypass Grafting.

INTRODUCTION: Along with cardiopulmonary bypass time, aortic cross-clamping time is directly related to the risk of complications after heart surgery. The influence of the time difference between cardiopulmonary bypass and cross-clamping times (TDC-C) remains poorly understood. OBJECTIVE: To assess the impact of cardiopulmonary bypass time in relation to cross-clamping time on immediate results after coronary artery bypass grafting in the Registro Paulista de Cirurgia Cardiovascular (REPLICCAR) II. METHODS: Analysis of 3,090 patients included in REPLICCAR II database was performed. The Society of Thoracic Surgeons outcomes were evaluated (mortality, kidney failure, deep wound infection, reoperation, cerebrovascular accident, and prolonged ventilation time). A cutoff point was adopted, from which the increase of this difference would affect each outcome. RESULTS: After a cutoff point determination, all patients were divided into Group 1 (cardiopulmonary bypass time < 140 min., TDC-C < 30 min.), Group 2 (cardiopulmonary bypass time < 140 min., TDC-C > 30 min.), Group 3 (cardiopulmonary bypass time > 140 min., TDC-C < 30 min.), and Group 4 (cardiopulmonary bypass time > 140 min., TDC-C > 30 min.). After univariate logistic regression, Group 2 showed significant association with reoperation (odds ratio: 1.64, 95% confidence interval: 1.01-2.66), stroke (odds ratio: 3.85, 95% confidence interval: 1.99-7.63), kidney failure (odds ratio: 1.90, 95% confidence interval: 1.32-2.74), and in-hospital mortality (odds ratio: 2.17, 95% confidence interval: 1.30-3.60). CONCLUSION: TDC-C serves as a predictive factor for complications following coronary artery bypass grafting. We strongly recommend that future studies incorporate this metric to improve the prediction of complications.

Difference Between Cardiopulmonary Bypass Time and Aortic Cross-Clamping Time as a Predictor of Complications After Coronary Artery Bypass Grafting

ABSTRACT Introduction: Along with cardiopulmonary bypass time, aortic cross-clamping time is directly related to the risk of complications after heart surgery. The influence of the time difference between cardiopulmonary bypass and cross-clamping times (TDC-C) remains poorly understood. Objective: To assess the impact of cardiopulmonary bypass time in relation to cross-clamping time on immediate results after coronary artery bypass grafting in the Registro Paulista de Cirurgia Cardiovascular (REPLICCAR) II. Methods: Analysis of 3,090 patients included in REPLICCAR II database was performed. The Society of Thoracic Surgeons outcomes were evaluated (mortality, kidney failure, deep wound infection, reoperation, cerebrovascular accident, and prolonged ventilation time). A cutoff point was adopted, from which the increase of this difference would affect each outcome. Results: After a cutoff point determination, all patients were divided into Group 1 (cardiopulmonary bypass time < 140 min., TDC-C < 30 min.), Group 2 (cardiopulmonary bypass time < 140 min., TDC-C > 30 min.), Group 3 (cardiopulmonary bypass time > 140 min., TDC-C < 30 min.), and Group 4 (cardiopulmonary bypass time > 140 min., TDC-C > 30 min.). After univariate logistic regression, Group 2 showed significant association with reoperation (odds ratio: 1.64, 95% confidence interval: 1.01-2.66), stroke (odds ratio: 3.85, 95% confidence interval: 1.99-7.63), kidney failure (odds ratio: 1.90, 95% confidence interval: 1.32-2.74), and in-hospital mortality (odds ratio: 2.17, 95% confidence interval: 1.30-3.60). Conclusion: TDC-C serves as a predictive factor for complications following coronary artery bypass grafting. We strongly recommend that future studies incorporate this metric to improve the prediction of complications.

Immediate Results after Multiple Arterial Grafts in Coronary Artery Bypass Graft Surgery in the São Paulo State: Cross Cohort Study. / Resultados Imediatos após Múltiplos Enxertos Arteriais em Cirurgia de Revascularização Miocárdica no Estado de São Paulo: Estudo de Coorte.

BACKGROUND: The short-term results after using arterial grafts still raise questions and doubts for medical society. OBJECTIVE: To compare the immediate outcomes of patients undergoing single arterial graft versus multiple arterial grafts coronary artery bypass grafting surgery. METHODS: Cross-sectional cohort study in the São Paulo Registry of Cardiovascular Surgery II (REPLICCAR II). Perioperative data from 3122 patients were grouped by the number of arterial grafts used, and their outcomes were compared: reoperation, deep sternal wound infection (DSWI), stroke, acute kidney injury, prolonged intubation (>24 hours), short hospital stay (<6 days), prolonged hospital stay (>14 days), morbidity and mortality. Propensity Score Matching (PSM) matched 1062 patients, adjusted for the mortality risk. RESULTS: After PSM, the single arterial graft group showed patients with advanced age, more former smokers, hypertension, diabetes, stable angina, and previous myocardial infarction. In the multiple arterial grafts, there was a predominance of males, recent pneumonia, and urgent surgeries. After the procedure, there was a higher incidence of pleural effusion (p=0.042), pneumonia (p=0.01), reintubation (p=0.006), DSWI (p=0.007), and sternal debridement (p=0.015) in the multiple arterial grafts group, however, less need for blood transfusion (p=0.005), extremity infections (p=0.002) and shorter hospital stays (p=0.036). Bilateral use of the internal thoracic artery was not related to increased DSWI rate, but glycosylated hemoglobin >6.40% (p=0.048). CONCLUSION: Patients undergoing the multiarterial technique had a higher incidence of pulmonary complications, and DSWI, where glycosylated hemoglobin ≥6.40%, had a greater influence on the infectious outcome than the choice of grafts.

FUNDAMENTO: Os resultados a curto prazo após o uso de enxertos arteriais ainda suscitam questionamentos e dúvidas na sociedade médica. OBJETIVO: Comparar os resultados imediatos de pacientes submetidos à cirurgia de revascularização do miocárdio com enxerto arterial único versus enxertos arteriais múltiplos. MÉTODOS: Estudo de coorte transversal no Registro Paulista de Cirurgia Cardiovascular II (REPLICCAR II). Os dados perioperatórios de 3122 pacientes foram agrupados pelo número de enxertos arteriais utilizados e seus desfechos foram comparados: reoperação, infecção profunda da ferida torácica (IPFT), acidente vascular cerebral, lesão renal aguda, intubação prolongada (>24 horas), tempo de internação curta (<6 dias), tempo de internação prolongada (>14 dias), morbidade e mortalidade. O Propensity Score Matching (PSM) correspondeu a 1062 pacientes, ajustado para o risco de mortalidade. RESULTADOS: Após PSM, o grupo enxerto arterial único apresentou pacientes com idade avançada, mais ex-fumantes, hipertensos, diabéticos, portadores de angina estável e infarto do miocárdio prévio. Nos enxertos arteriais múltiplos houve predomínio do sexo masculino, pneumonia recente e cirurgias de urgência. Após o procedimento, houve maior incidência de derrame pleural (p=0,042), pneumonia (p=0,01), reintubação (p=0,006), IPFT (p=0,007) e desbridamento esternal (p=0,015) no grupo de enxertos multiarteriais, porém, menor necessidade de hemotransfusão (p=0,005), infecções de extremidades (p=0,002) e menor tempo de internação (p=0,036). O uso bilateral da artéria torácica interna não foi relacionado ao aumento da taxa de IPFT, e sim a hemoglobina glicosilada >6,40% (p=0,048). CONCLUSÃO: Pacientes submetidos a técnica multiarterial apresentaram maior incidência de complicações pulmonares e IPFT, sendo que a hemoglobina glicosilada ≥6,40% teve maior influência no resultado infeccioso do que a escolha dos enxertos.

Resultados Imediatos após Múltiplos Enxertos Arteriais em Cirurgia de Revascularização Miocárdica no Estado de São Paulo: Estudo de Coorte / Immediate Results after Multiple Arterial Grafts in Coronary Artery Bypass Graft Surgery in the São Paulo State: Cross Cohort Study

Resumo Fundamento Os resultados a curto prazo após o uso de enxertos arteriais ainda suscitam questionamentos e dúvidas na sociedade médica. Objetivo Comparar os resultados imediatos de pacientes submetidos à cirurgia de revascularização do miocárdio com enxerto arterial único versus enxertos arteriais múltiplos. Métodos Estudo de coorte transversal no Registro Paulista de Cirurgia Cardiovascular II (REPLICCAR II). Os dados perioperatórios de 3122 pacientes foram agrupados pelo número de enxertos arteriais utilizados e seus desfechos foram comparados: reoperação, infecção profunda da ferida torácica (IPFT), acidente vascular cerebral, lesão renal aguda, intubação prolongada (>24 horas), tempo de internação curta (<6 dias), tempo de internação prolongada (>14 dias), morbidade e mortalidade. O Propensity Score Matching (PSM) correspondeu a 1062 pacientes, ajustado para o risco de mortalidade. Resultados Após PSM, o grupo enxerto arterial único apresentou pacientes com idade avançada, mais ex-fumantes, hipertensos, diabéticos, portadores de angina estável e infarto do miocárdio prévio. Nos enxertos arteriais múltiplos houve predomínio do sexo masculino, pneumonia recente e cirurgias de urgência. Após o procedimento, houve maior incidência de derrame pleural (p=0,042), pneumonia (p=0,01), reintubação (p=0,006), IPFT (p=0,007) e desbridamento esternal (p=0,015) no grupo de enxertos multiarteriais, porém, menor necessidade de hemotransfusão (p=0,005), infecções de extremidades (p=0,002) e menor tempo de internação (p=0,036). O uso bilateral da artéria torácica interna não foi relacionado ao aumento da taxa de IPFT, e sim a hemoglobina glicosilada >6,40% (p=0,048). Conclusão Pacientes submetidos a técnica multiarterial apresentaram maior incidência de complicações pulmonares e IPFT, sendo que a hemoglobina glicosilada ≥6,40% teve maior influência no resultado infeccioso do que a escolha dos enxertos.

Abstract Background The short-term results after using arterial grafts still raise questions and doubts for medical society. Objective To compare the immediate outcomes of patients undergoing single arterial graft versus multiple arterial grafts coronary artery bypass grafting surgery. Methods Cross-sectional cohort study in the São Paulo Registry of Cardiovascular Surgery II (REPLICCAR II). Perioperative data from 3122 patients were grouped by the number of arterial grafts used, and their outcomes were compared: reoperation, deep sternal wound infection (DSWI), stroke, acute kidney injury, prolonged intubation (>24 hours), short hospital stay (<6 days), prolonged hospital stay (>14 days), morbidity and mortality. Propensity Score Matching (PSM) matched 1062 patients, adjusted for the mortality risk. Results After PSM, the single arterial graft group showed patients with advanced age, more former smokers, hypertension, diabetes, stable angina, and previous myocardial infarction. In the multiple arterial grafts, there was a predominance of males, recent pneumonia, and urgent surgeries. After the procedure, there was a higher incidence of pleural effusion (p=0.042), pneumonia (p=0.01), reintubation (p=0.006), DSWI (p=0.007), and sternal debridement (p=0.015) in the multiple arterial grafts group, however, less need for blood transfusion (p=0.005), extremity infections (p=0.002) and shorter hospital stays (p=0.036). Bilateral use of the internal thoracic artery was not related to increased DSWI rate, but glycosylated hemoglobin >6.40% (p=0.048). Conclusion Patients undergoing the multiarterial technique had a higher incidence of pulmonary complications, and DSWI, where glycosylated hemoglobin ≥6.40%, had a greater influence on the infectious outcome than the choice of grafts.

Adherence to the cardiac surgery checklist decreased mortality at a teaching hospital: A retrospective cohort study.

OBJECTIVE: To evaluate the impact of adherence to the cardiac surgical checklist on mortality at the teaching hospital. METHODS: A retrospective cohort study after the implementation of the cardiac surgical safety checklist in a reference hospital in Latin America. All patients undergoing coronary artery bypass surgery and/or heart valve surgery from 2013 to 2019 were analyzed. After the implementation of the project InCor-Checklist "Five steps to safe cardiac surgery" in 2015, the correlation between adherence and completeness of this instrument with surgical mortality was assessed. The EuroSCORE II was used as a reference to assess the risk of expected mortality for patients. Cross-sectional questionnaires were during the implementation of the InCor-Checklist. To perform the correlation, Pearson's coefficient was calculated using R software. RESULTS: Since 2013, data from 8139 patients have been analyzed. The average annual mortality was 5.98%. In 2015, the instrument was used in only 58% of patients; in contrast, it was used in 100% of patients in 2019. There was a decrease in surgical mortality from 8.22% to 3.13% for the same group of procedures. The results indicate that the greater the checklist use, the lower the surgical mortality (r = 88.9%). In addition, the greater the InCor-Checklist completeness, the lower the surgical mortality (r = 94.1%). CONCLUSION: In the formation of the surgical patient safety culture, the implementation and adherence to the InCor-Checklist "Five steps to safe cardiac surgery" was associated with decreased mortality after cardiac surgery.

Adherence to the cardiac surgery checklist decreased mortality at a teaching hospital: A retrospective cohort study

Abstract Objectives To evaluate the impact of adherence to the cardiac surgical checklist on mortality at the teaching hospital. Methods A retrospective cohort study after the implementation of the cardiac surgical safety checklist in a reference hospital in Latin America. All patients undergoing coronary artery bypass surgery and/or heart valve surgery from 2013 to 2019 were analyzed. After the implementation of the project InCor-Checklist "Five steps to safe cardiac surgery" in 2015, the correlation between adherence and completeness of this instrument with surgical mortality was assessed. The EuroSCORE II was used as a reference to assess the risk of expected mortality for patients. Cross-sectional questionnaires were during the implementation of the InCor-Checklist. To perform the correlation, Pearson's coefficient was calculated using R software. Results Since 2013, data from 8139 patients have been analyzed. The average annual mortality was 5.98%. In 2015, the instrument was used in only 58% of patients; in contrast, it was used in 100% of patients in 2019. There was a decrease in surgical mortality from 8.22% to 3.13% for the same group of procedures. The results indicate that the greater the checklist use, the lower the surgical mortality (r = 88.9%). In addition, the greater the InCor-Checklist completeness, the lower the surgical mortality (r = 94.1%). Conclusion In the formation of the surgical patient safety culture, the implementation and adherence to the InCor-Checklist "Five steps to safe cardiac surgery" was associated with decreased mortality after cardiac surgery. HIGHLIGHTS Checklists avoid human errors and are commonly used in high-reliability industries. The "InCor Checklist" was associated with decreased mortality over time. Adherence, completeness, and sustainability within public policies are necessary.

Multivessel Woven Coronary Artery Disease.

Woven coronary disease is a rare pathology with unknown etiology. Although initially considered benign, recent publications report myocardial ischemia caused by the affected vessel. Since most patients are asymptomatic, long-term follow-up to understand its behavior is mandatory. We report a multivessel woven disease case with documented ischemia that was submitted to coronary artery bypass grafting and remained asymptomatic for two years of follow-up.

Multivessel woven coronary artery disease

Abstract Woven coronary disease is a rare pathology with unknown etiology. Although initially considered benign, recent publications report myocardial ischemia caused by the affected vessel. Since most patients are asymptomatic, long-term follow-up to understand its behavior is mandatory. We report a multivessel woven disease case with documented ischemia that was submitted to coronary artery bypass grafting and remained asymptomatic for two years of follow-up.

Pericardial-Peritoneal Window as an Alternative Treatment for Large and Recurrent Pericardial Effusion Post-Pericardiotomy

Abstract Introduction: The presence of mild to moderate pericardial effusion after cardiac surgery is common and oral medical therapy is usually able to treat it. Larger effusions are less frequent and surgical intervention is usually necessary. However, there are some rare cases of large effusions that are recurrent even after intervention and become challenging to treat. Methods: We describe the case of a patient submitted to coronary artery bypass grafting (CABG) without any intraoperative complications, who was regularly discharged from the hospital. She was referred to our emergency department twice after surgery with large pericardial effusion that was drained. Even after those two interventions and with adequate oral medication, the large effusion recurred. Results: During follow-up, the patient had her symptoms resolved, with no need for further hospital admission. Her echocardiograms after the last intervention showed no pericardial effusion. The present surgical technique demonstrated to be easy to perform, thus it should be considered as a treatment option for these rare cases of large and repetitive effusions, which do not respond to the traditional methods. Conclusions: In challenging cases of recurrent and large pericardial effusions, the pericardial-peritoneal window is an alternative surgical technique that brings clinical improvement and diminishes the risk of cardiac tamponade.

Bentall-de Bono procedure for acute aortic dissection.

We present a patient with an acute type A aortic dissection that involves the aortic root. The high mortality of patients with this condition is often associated with operations performed by surgeons with minimal experience dealing with aortic diseases. Therefore, less-experienced surgeons often opt for less complicated techniques like supracoronary ascending aortic replacement. However, according to the latest guidelines for the management of aortic diseases, the aortic root should be replaced when it is compromised by the dissection. The Bentall-de Bono technique treats the aortic root and demands less experience than valve-sparing aortic surgery.

Pericardial-Peritoneal Window as an Alternative Treatment for Large and Recurrent Pericardial Effusion Post-Pericardiotomy.

INTRODUCTION: The presence of mild to moderate pericardial effusion after cardiac surgery is common and oral medical therapy is usually able to treat it. Larger effusions are less frequent and surgical intervention is usually necessary. However, there are some rare cases of large effusions that are recurrent even after intervention and become challenging to treat. METHODS: We describe the case of a patient submitted to coronary artery bypass grafting (CABG) without any intraoperative complications, who was regularly discharged from the hospital. She was referred to our emergency department twice after surgery with large pericardial effusion that was drained. Even after those two interventions and with adequate oral medication, the large effusion recurred. RESULTS: During follow-up, the patient had her symptoms resolved, with no need for further hospital admission. Her echocardiograms after the last intervention showed no pericardial effusion. The present surgical technique demonstrated to be easy to perform, thus it should be considered as a treatment option for these rare cases of large and repetitive effusions, which do not respond to the traditional methods. CONCLUSIONS: In challenging cases of recurrent and large pericardial effusions, the pericardial-peritoneal window is an alternative surgical technique that brings clinical improvement and diminishes the risk of cardiac tamponade.

Coronary artery bypass graft during the covid-19 pandemic

Abstract Since the beginning of the coronavirus disease (COVID-19) pandemic, in March 2020, the number of people infected with COVID-19 worldwide increases continuously. Brazil is being followed with great concern in the international media, as it can, very soon, be the epicenter of the pandemic. Initial surgical data suggest that patients who acquire COVID-19 in the perioperative period are prone to a higher morbidity and mortality, however, evidence in cardiac surgery is still scarce. This article aims to aggregate to the growing evidence suggesting that perioperative infection with severe acute respiratory syndrome coronavirus 2 contributes to a more morbid evolution of the case.

Coronary Artery Bypass Graft During the COVID-19 Pandemic.

Since the beginning of the coronavirus disease (COVID-19) pandemic, in March 2020, the number of people infected with COVID-19 worldwide increases continuously. Brazil is being followed with great concern in the international media, as it can, very soon, be the epicenter of the pandemic. Initial surgical data suggest that patients who acquire COVID-19 in the perioperative period are prone to a higher morbidity and mortality, however, evidence in cardiac surgery is still scarce. This article aims to aggregate to the growing evidence suggesting that perioperative infection with severe acute respiratory syndrome coronavirus 2 contributes to a more morbid evolution of the case.

Validation and quality measurements for STS, EuroSCORE II and a regional risk model in Brazilian patients.

OBJECTIVES: The objectives of this study were to describe a novel statewide registry for cardiac surgery in Brazil (REPLICCAR), to compare a regional risk model (SPScore) with EuroSCORE II and STS, and to understand where quality improvement and safety initiatives can be implemented. METHODS: A total of 11 sites in the state of São Paulo, Brazil, formed an online registry platform to capture information on risk factors and outcomes after cardiac surgery procedures for all consecutive patients. EuroSCORE II and STS values were calculated for each patient. An SPScore model was designed and compared with EuroSCORE II and STS to predict 30-day outcomes: death, reoperation, readmission, and any morbidity. RESULTS: A total of 5222 patients were enrolled in this study between November 2013 and December 2017. The observed 30-day mortality rate was 7.6%. Most patients were older, overweight, and classified as New York Heart Association (NYHA) functional class III; 14.5% of the patient population had a positive diagnosis of rheumatic heart disease, 10.9% had insulin-dependent diabetes, and 19 individuals had a positive diagnosis of Chagas disease. When evaluating the prediction performance, we found that SPScore outperformed EuroSCORE II and STS in the prediction of mortality (0.90 vs. 0.76 and 0.77), reoperation (0.84 vs. 0.60 and 0.56), readmission (0.84 vs. 0.55 and 0.51), and any morbidity (0.80 vs. 0.65 and 0.64), respectively (p<0.001). CONCLUSIONS: The REPLICCAR registry might stimulate the creation of other cardiac surgery registries in developing countries, ultimately improving the regional quality of care provided to patients.

Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: Study Protocol for the FRAGILE Multicenter Randomized Controlled Trial.

INTRODUCTION: Advances in modern medicine have led to people living longer and healthier lives. Frailty is an emerging concept in medicine yet to be explored as a risk factor in cardiac surgery. When it comes to CABG surgery, randomized controlled clinical trials have primarily focused on low-risk (ROOBY, CORONARY), elevated-risk (GOPCABE) or high-risk patients (BBS), but not on frail patients. Therefore, we believe that off-pump CABG could be an important technique in patients with limited functional capacity to respond to surgical stress. In this study, the authors introduce the new national, multicenter, randomized, controlled trial "FRAGILE", to be developed in the main cardiac surgery centers of Brazil, to clarify the potential benefit of off-pump CABG in frail patients. METHODS: FRAGILE is a two-arm, parallel-group, multicentre, individually randomized (1:1) controlled trial which will enroll 630 patients with blinded outcome assessment (at 30 days, 6 months, 1 year, 2 years and 3 years), which aims to compare adverse cardiac and cerebrovascular events after off-pump versus on-pump CABG in pre-frail and frail patients. Primary outcomes will be all-cause mortality, acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome/cardiogenic shock, stroke, and coronary reintervention. Secondary outcomes will be major adverse cardiac and cerebrovascular events, operative time, mechanical ventilation time, hyperdynamic shock, new onset of atrial fibrillation, renal replacement therapy, reoperation for bleeding, pneumonia, length of stay in intensive care unit, length of stay in hospital, number of units of blood transfused, graft patency, rate of complete revascularization, neurobehavioral outcomes after cardiac surgery, quality of life after cardiac surgery and costs. DISCUSSION: FRAGILE trial will determine whether off-pump CABG is superior to conventional on-pump CABG in the surgical treatment of pre-frail and frail patients. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02338947. Registered on August 29th 2014; last updated on March 21st 2016.

Off-pump versus on-pump coronary artery bypass grafting in frail patients: study protocol for the fragile multicenter randomized controlled trial

Abstract Introduction: Advances in modern medicine have led to people living longer and healthier lives. Frailty is an emerging concept in medicine yet to be explored as a risk factor in cardiac surgery. When it comes to CABG surgery, randomized controlled clinical trials have primarily focused on low-risk (ROOBY, CORONARY), elevated-risk (GOPCABE) or high-risk patients (BBS), but not on frail patients. Therefore, we believe that off-pump CABG could be an important technique in patients with limited functional capacity to respond to surgical stress. In this study, the authors introduce the new national, multicenter, randomized, controlled trial "FRAGILE", to be developed in the main cardiac surgery centers of Brazil, to clarify the potential benefit of off-pump CABG in frail patients. Methods: FRAGILE is a two-arm, parallel-group, multicentre, individually randomized (1:1) controlled trial which will enroll 630 patients with blinded outcome assessment (at 30 days, 6 months, 1 year, 2 years and 3 years), which aims to compare adverse cardiac and cerebrovascular events after off-pump versus on-pump CABG in pre-frail and frail patients. Primary outcomes will be all-cause mortality, acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome/cardiogenic shock, stroke, and coronary reintervention. Secondary outcomes will be major adverse cardiac and cerebrovascular events, operative time, mechanical ventilation time, hyperdynamic shock, new onset of atrial fibrillation, renal replacement therapy, reoperation for bleeding, pneumonia, length of stay in intensive care unit, length of stay in hospital, number of units of blood transfused, graft patency, rate of complete revascularization, neurobehavioral outcomes after cardiac surgery, quality of life after cardiac surgery and costs. Discussion: FRAGILE trial will determine whether off-pump CABG is superior to conventional on-pump CABG in the surgical treatment of pre-frail and frail patients. Trial registration: ClinicalTrials.gov, ID: NCT02338947. Registered on August 29th 2014; last updated on March 21st 2016.