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BACKGROUND: Atrial fibrillation is the most common complication after cardiac surgery and is associated with extended in-hospital stay and increased adverse outcomes, including death and stroke. Pericardial effusion is common after cardiac surgery and can trigger atrial fibrillation. We tested the hypothesis that posterior left pericardiotomy, a surgical manoeuvre that drains the pericardial space into the left pleural cavity, might reduce the incidence of atrial fibrillation after cardiac surgery. METHODS: In this adaptive, randomised, controlled trial, we recruited adult patients (aged ≥18 years) undergoing elective interventions on the coronary arteries, aortic valve, or ascending aorta, or a combination of these, performed by members of the Department of Cardiothoracic Surgery from Weill Cornell Medicine at the New York Presbyterian Hospital in New York, NY, USA. Patients were eligible if they had no history of atrial fibrillation or other arrhythmias or contraindications to the experimental intervention. Eligible patients were randomly assigned (1:1), stratified by CHA2DS2-VASc score and using a mixed-block randomisation approach (block sizes of 4, 6, and 8), to posterior left pericardiotomy or no intervention. Patients and assessors were blinded to treatment assignment. Patients were followed up until 30 days after hospital discharge. The primary outcome was the incidence of atrial fibrillation during postoperative in-hospital stay, which was assessed in the intention-to-treat (ITT) population. Safety was assessed in the as-treated population. This study is registered with ClinicalTrials.gov, NCT02875405, and is now complete. FINDINGS: Between Sept 18, 2017, and Aug 2, 2021, 3601 patients were screened and 420 were included and randomly assigned to the posterior left pericardiotomy group (n=212) or the no intervention group (n=208; ITT population). The median age was 61·0 years (IQR 53·0-70·0), 102 (24%) patients were female, and 318 (76%) were male, with a median CHA2DS2-VASc score of 2·0 (IQR 1·0-3·0). The two groups were balanced with respect to clinical and surgical characteristics. No patients were lost to follow-up and data completeness was 100%. Three patients in the posterior left pericardiotomy group did not receive the intervention. In the ITT population, the incidence of postoperative atrial fibrillation was significantly lower in the posterior left pericardiotomy group than in the no intervention group (37 [17%] of 212 vs 66 [32%] of 208 [p=0·0007]; odds ratio adjusted for the stratification variable 0·44 [95% CI 0·27-0·70; p=0·0005]). Two (1%) of 209 patients in the posterior left pericardiotomy group and one (<1%) of 211 in the no intervention group died within 30 days after hospital discharge. The incidence of postoperative pericardial effusion was lower in the posterior left pericardiotomy group than in the no intervention group (26 [12%] of 209 vs 45 [21%] of 211; relative risk 0·58 [95% CI 0·37-0·91]). Postoperative major adverse events occurred in six (3%) patients in the posterior left pericardiotomy group and in four (2%) in the no intervention group. No posterior left pericardiotomy related complications were seen. INTERPRETATION: Posterior left pericardiotomy is highly effective in reducing the incidence of atrial fibrillation after surgery on the coronary arteries, aortic valve, or ascending aorta, or a combination of these without additional risk of postoperative complications. FUNDING: None.
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Fibrilação Atrial , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Derrame Pericárdico , Pericardiectomia/efeitos adversos , Complicações Pós-Operatórias , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/prevenção & controle , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Cidade de Nova Iorque/epidemiologia , Derrame Pericárdico/epidemiologia , Derrame Pericárdico/prevenção & controle , Estudos Prospectivos , Resultado do TratamentoRESUMO
OBJECTIVES: No systematic studies on retractions in cardiothoracic and vascular anesthesia exist. The aim of this analysis was to identify characteristics and trends of retractions in this field over the past three decades. DESIGN: A search of the Retraction Watch Database for retracted articles published between 1990 and 2020 in the field of cardiothoracic and vascular anesthesia was performed. SETTING: A bibliometric study. PARTICIPANTS: Five thousand three hundred forty-four retractions with the term "medicine" in the subject code were selected. Retractions of full-length English articles reporting findings in cardiothoracic and vascular anesthesia were included. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 63 articles published in 31 journals from January 1990 to August 2020 were retracted. The majority were original articles (n = 60, 95.2%) and retracted for scientific misconduct (n = 50, 79.4%). The percentage of retractions due to misconduct increased from 2010, with a spike in 2011 (n = 26/50, 52.0%), and reached a plateau in 2014. The three most common reasons for retraction were misconduct by the author (n = 31, 49.2%), duplication (n = 12, 19.0%), and errors within the manuscript (n = 11, 17.5%). The median time from publication to retraction was 4.3 years (IQR: 1.7-9.4) and decreased significantly over time (p < 0.001). The median impact factor (IF) of the journals that published retracted articles was 3.5 (IQR 2.0-4.5) and decreased significantly over the study period (p < 0.001). CONCLUSION: Scientific misconduct represents the most common reason for retraction in cardiothoracic and vascular anesthesia. The median time to retraction and journal IF decreased significantly over time. While this is promising, future efforts should be made to screen for falsified data and standardize the processes after retraction to highlight problematic manuscripts.
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Anestesia , Anestesiologia , Pesquisa Biomédica , Má Conduta Científica , Bibliometria , Bases de Dados Factuais , HumanosRESUMO
BACKGROUND: Deep sternal wound infections are rare but severe complications after median sternotomy and can be managed with sternal reconstruction. The use of pectoralis major flap (PMF) has traditionally been the first-line approach for flap reconstruction but the advantage in patients' survival when compared to the omental flap (OF) transposition is still not clear. We performed a study-level meta-analysis evaluating the association of the type of flap on postoperative outcomes. METHODS: A systematic search of the literature was performed to identify all studies comparing the postoperative outcomes of PMF versus OF for sternal reconstruction. The primary outcome was postoperative mortality. Secondary outcomes were the occurrence of sepsis, pneumonia, operative time, and length of stay. Binary outcomes were pooled using an inverse variance method and reported as odds ratio (OR) with corresponding 95% confidence interval (CI). Continuous outcomes were pooled using an inverse variance method and reported as standardized mean difference (SMD) with corresponding 95% CI. RESULTS: Four studies with a total of 528 patients were included in the analysis. Overall, 443 patients had PMF reconstruction, and 85 patients had OF reconstruction. Baseline characteristics were similar in both groups. There were no statistically significant differences between PMF patients and OF patients in mortality (OR 0.6 [0.16; 2.17]; p = .09), sepsis (OR 1.1 [0.49; 2.47]; p = .43), pneumonia (OR 0.72 [0.18; 2.8]; p = .11), length of stay (SMD -0.59 [-2.03; 0.85]; p < .01), and operative time (SMD 0.08 [-1.21; 1.57]; p < .01). CONCLUSION: Our analysis found no association between the type of flap and postoperative mortality, the incidence of pneumonia, sepsis, operation time, and length of stay.
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Mediastinite , Músculos Peitorais , Humanos , Músculos Peitorais/transplante , Mediastinite/etiologia , Mediastinite/cirurgia , Infecção da Ferida Cirúrgica/etiologia , Retalhos Cirúrgicos , Esterno/cirurgia , Esternotomia/efeitos adversos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Racial minorities account for 39.9% of the population in the United States, but are often underrepresented in clinical research. Results from studies predominantly enrolling White patients may not apply to racial minorities. The aim of this analysis is to assess the representation of racial minorities in cardiac surgery randomized clinical trials (RCTs). METHODS: A systematic search of the literature was performed. All RCTs published from 2000 to 2020 including at least 100 patients and comparing two or more adult cardiac surgery procedures were included. Meta-analytic estimates were calculated. RESULTS: Among 51 cardiac surgery RCTs published between 2000 and 2020, only 9 (17.6%) reported the race of patients and were included in the final analysis. All of them were multicentric, with a mean of 33 centers included. Six RCTs enrolled patients undergoing coronary artery bypass grafting (66.7%), while the remaining three were on valve surgery (33.3%). Overall, 9193 patients were included; of them, 8034 (87.4%) were White and 1026 (11.2%) nonWhite (386 [4.2%] Black, 191 [2.1%] Hispanic, 274 [3.0%] from other races, and 175 [1.9%] nonWhite patients of unspecified race). The proportion of nonWhite patients did not change over time. CONCLUSIONS: Only 9 (17.6%) of the 51 cardiac surgery RCTs published between 2000 and 2020 reported the race of the patients enrolled and only 11.2% of them were nonWhite patients. Given the association between race and clinical outcomes, future RCTs should either guarantee a balanced inclusion of racial minorities or be designed to specifically enroll them.
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Procedimentos Cirúrgicos Cardíacos , Minorias Étnicas e Raciais , Adulto , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Estados UnidosRESUMO
The use of the radial artery (RA) as a conduit in coronary artery bypass grafting (CABG) has been steadily increasing since the early 1990s and based on the most recent data may well become the standard of care for patients with multivessel coronary artery disease requiring multiple arterial grafts. The transradial access (TRA) approach for cardiac catherization has also increased steadily in use by interventional cardiologists owing to its reduction in bleeding and vascular complications when compared with the femoral approach and is now considered the preferred arterial access. However, prior use of TRA for cardiac catherization is a contraindication for the use of the RA for CABG because of high rates of structural damage to the vascular wall and potential for graft failure. In this issue of the Journal of Cardiac Surgery Clarke et al. examine the RA of two patients who had TRA for coronary angiography 8 and 12 years prior and note that both patients had chronic injury with dissection and obstruction of the lumen secondary to fibrosis suggesting that TRA causes long-term and irreversible damage rendering them unsuitable as conduits for CABG.
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Ponte de Artéria Coronária , Artéria Radial , Angiografia Coronária , Artéria Femoral , Humanos , Resultado do TratamentoRESUMO
INTRODUCTION: Post-infarction left ventricular remodeling is associated with increased mortality in patients with ischemic heart disease. Surgical ventricular reconstruction (SVR) in addition to coronary artery bypass grafting (CABG) has been proposed to reduce left ventricular volume and improve clinical outcomes. The Surgical Treatment for Ischemic Heart Failure (STICH) trial found that the addition of SVR to CABG did not reduce the rates of death or rehospitalization in the 5 years after surgery compared to CABG alone. Like all randomized trials, STICH has limitations and it has been hypothesized that it may have underestimated the treatment effect of SVR. The aim of this study is to evaluate the results of SVR in one of the largest contemporary single-center series and to compare the results with those of the STICH trial using individual patient's data. METHODS AND ANALYSIS: Individual data of patients who underwent SVR with or without CABG will be obtained from San Donato University Hospital in Milan. Using multivariable Cox regression analysis, significant prognostic indicators in this cohort will be identified. We will then compare the San Donato cohort to individual patient's data from the SVR arm of Hypothesis 2 of the STICH trial and from both arms of the STICH Extended Study (STICHES). To reduce confounders, propensity score adjustment will be used for this comparison. The primary endpoint will be all-cause mortality. Data will be merged and analyzed independently at Weill Cornell Medicine in New York.
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Insuficiência Cardíaca , Isquemia Miocárdica , Disfunção Ventricular Esquerda , Ponte de Artéria Coronária , Ventrículos do Coração/diagnóstico por imagem , Ventrículos do Coração/cirurgia , Humanos , Isquemia Miocárdica/cirurgia , New York , Resultado do TratamentoRESUMO
BACKGROUND AND AIM OF THE STUDY: Aortic stenosis (AS) has been associated with higher mortality in patients undergoing aortic root replacement (ARR). In this analysis, we compare the outcomes among patients with moderate to severe AS or aortic insufficiency (AI) undergoing ARR in a tertiary aortic center. METHODS: A total of 889 patients underwent ARR from 1997 to 2020, of whom 798 had AI and 91 had AS. We excluded valve-sparing procedures. The primary endpoint consisted of major adverse events (MAEs), including operative mortality, myocardial infarction, tracheostomy, new dialysis, and cerebrovascular accidents. All patients had either a mechanical or biologic composite valve-graft implanted using button and exclusion techniques. Propensity score matching (PSM) was used to compare outcomes. Long-term survival was estimated using the Kaplan-Meier method. RESULTS: Patients with AI had a higher incidence of connective tissue disorder (8.0% vs. 0.0%; p = .01) and were more likely to be classified as having an urgent or emergent procedure (22.4% vs. 8.8%; p = .004). PSM achieved a good balance between the groups. There was no difference in MAE rates, postoperatively (AI vs. AS, 1.6% vs. 1.6%; p = .85). Long-term survival was similar at 5 years in the matched cohorts (AI vs. AS, 75.9% vs. 95.5%; p = .36). CONCLUSION: In patients undergoing ARR, the presence of moderate to severe AI or AS does not impact operative outcomes. ARR can be carried out with excellent outcomes and low operative mortality when performed in specialized centers.
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Valvopatia Aórtica , Insuficiência da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/cirurgia , Humanos , Diálise Renal , Estudos Retrospectivos , Resultado do TratamentoRESUMO
Background: Subclinical hypothyroidism (SCH) is associated with major adverse cardiovascular events. Despite the recognized negative impact of SCH on cardiovascular health, research on cardiac postoperative outcomes with SCH has yielded conflicting results, and patients are not currently treated for SCH before cardiac surgery procedures. Methods: We performed a study-level meta-analysis on the impact of SCH on patients undergoing nonurgent cardiac surgery, including coronary artery bypass grafting and valve and aortic surgery. The primary outcome was operative mortality. Secondary outcomes were hospital length of stay (LOS), intensive care unit (ICU) stay, postoperative atrial fibrillation (POAF), intra-aortic balloon pump (IABP) use, renal complications, and long-term all-cause mortality. Results: Seven observational studies, with a total of 3445 patients, including 851 [24.7%] diagnosed with SCH and 2594 [75.3%] euthyroid patients) were identified. Compared to euthyroid patients, the patients with SCH had higher rates of operative mortality (odds ratio [OR], 2.57; 95% confidence interval [CI], 1.09-6.04; P = .03), prolonged hospital LOS (standardized mean difference, 0.32; 95% CI, 0.02-0.62; P = .04), a higher rate of renal complications (OR, 2.53; 95% CI, 1.74-3.69; P < .0001), but no significant differences in ICU stay, POAF, or IABP use. At mean follow-up of 49.3 months, the presence of SCH was associated with a higher rate of all-cause mortality (incidence rate ratio, 1.82; 95% CI, 1.18-2.83; P = .02). Conclusions: Patients with SCH have higher operative mortality, prolonged hospital LOS, and increased renal complications after cardiac surgery. Achieving and maintaining a euthyroid state prior to and after cardiac surgery procedures might improve outcomes in these patients.
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INTRODUCTION: Lipoprotein(a) (Lp[a]) is a variant of low-density lipoprotein (LDL) and has been associated with increased risk of vascular inflammation and thrombosis. Coronary artery bypass grafting (CABG) has been associated with local inflammation of the myocardium. It is plausible, therefore, that patients with elevated baseline Lp(a) may be prone to unfavorable clinical outcomes following CABG. We evaluate differences in outcomes between CABG patients with high and low serum Lp(a) in this meta-analysis. EVIDENCE ACQUISITION: A comprehensive literature search was performed to identify studies reporting outcomes in CABG patients stratified by preoperative Lp(a) level. When possible, the outcomes were pooled in a meta-analysis. We assessed post-operative mortality, major cardiovascular events, stroke occurrence and saphenous graft occlusion. EVIDENCE SYNTHESIS: Eight studies involving 8681 patients were included. Articles used varying cut-offs for high versus low Lp(a), and outcomes varied. In the three studies evaluating mortality, two showed no statistically significant difference between groups while one reported increased mortality associated with high Lp(a) level. Both studies investigating major adverse cardiovascular events reported higher risk in patients with high Lp(a). A study-level meta-analysis of four studies reporting saphenous vein graft occlusion incidence after CABG was performed. High (≥30 mg/dL) preoperative Lp(a) was not associated with an increased risk of graft occlusion compared with low (<30 mg/dL) preoperative Lp(a) (OR=1.88, 95% CI: 0.66-5.36; P=0.15). CONCLUSIONS: Studies evaluating the impact of Lp(a) on outcomes in CABG patients are few, with heterogenous cut-offs and outcomes. In the limited published studies, Lp(a) level was not associated with graft occlusion.
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OBJECTIVE: To evaluate the association between sternal wound complications (SWC) and long-term mortality in the Arterial Revascularization Trial. METHODS: Participants in the Arterial Revascularization Trial were stratified according to the occurrence of postoperative SWC. The primary outcome was all-cause mortality at long-term follow-up. The secondary outcome was major adverse cardiovascular events. RESULTS: Three thousand one hundred two patients were included in the analysis; the median follow-up was 10 years. 115 patients (3.7%) had postoperative SWC: 85 (73.9%) deep sternal wound infections and 30 (26.1%) sterile SWC that required sternal reconstruction. Independent predictors of SWC included diabetes (odds ratio [OR], 2.77; 95% CI, 1.79-4.30; P < .001), female sex (OR, 2.73; 95% CI, 1.71-4.38; P < .001), prior stroke (OR, 2.59; 95% CI, 1.12-5.98; P = .03), chronic obstructive pulmonary disease (OR, 2.44; 95% CI, 1.60-3.71; P < .001), and use of bilateral internal thoracic artery (OR, 1.70; 95% CI, 1.12-2.59; P = .01). Postoperative SWC was significantly associated with long-term mortality. The Kaplan-Meier survival estimate was 91.3% at 5 years and 79.4% at 10 years in patients without SWC, and 86.1% and 64.3% in patients with SWC (log rank P < .001). The rate of major adverse cardiovascular events was also higher among patients who had SWC (n = 51 [44.3%] vs 758 [25.4%]; P < .001). Using multivariable analysis, the occurrence of SWC was independently associated with long-term mortality (hazard ratio, 1.81; 95% CI, 1.30-2.54; P < .001). CONCLUSIONS: In the Arterial Revascularization Trial, postoperative SWC although uncommon were significantly associated with long-term mortality.
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Doença da Artéria Coronariana , Diabetes Mellitus , Artéria Torácica Interna , Feminino , Humanos , Ponte de Artéria Coronária/efeitos adversos , Doença da Artéria Coronariana/cirurgia , Diabetes Mellitus/epidemiologia , Artéria Torácica Interna/transplante , Complicações Pós-Operatórias/epidemiologia , Estudos Retrospectivos , Fatores de Risco , Infecção da Ferida Cirúrgica/epidemiologia , Resultado do TratamentoRESUMO
Randomized clinical trials (RCTs) have a key role in progressing biomedical research and guiding clinical decision making, but premature termination remains high (up to 30%), raising concerns regarding funding expenditure and resource allocation. This brief report sought to identify variables associated with RCTs' premature termination and completion.
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Pesquisa Biomédica , Humanos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Postoperative atrial fibrillation (POAF) is the most frequent complication of cardiac surgery. Despite clinical and economic implications, ample variability in POAF assessment method and definition exist across studies. We performed a study-level meta-analysis to evaluate the influence of POAF assessment method and definition on its incidence and association with clinical outcomes. METHODS AND RESULTS: A systematic literature search was conducted to identify studies comparing the outcomes of patients with and without POAF after cardiac surgery that also reported POAF assessment method. The primary outcome was POAF incidence. The secondary outcomes were in-hospital mortality, stroke, intensive care unit length of stay, and postoperative length of stay. Fifty-nine studies totaling 197 774 patients were included. POAF cumulative incidence was 26% (range: 7.3%-53.1%). There were no differences in POAF incidence among assessment methods (27%, [range: 7.3%-53.1%] for continuous telemetry, 27% [range: 7.9%-50%] for telemetry plus daily ECG, and 19% [range: 7.8%-42.4%] for daily ECG only; P>0.05 for all comparisons). No differences in in-hospital mortality, stroke, intensive care unit length of stay, and postoperative length of stay were found between assessment methods. No differences in POAF incidence or any other outcomes were found between POAF definitions. Continuous telemetry and telemetry plus daily ECG were associated with higher POAF incidence compared with daily ECG in studies including only patients undergoing isolated coronary artery bypass grafting. CONCLUSIONS: POAF incidence after cardiac surgery remains high, and detection rates are variable among studies. POAF incidence and its association with adverse outcomes are not influenced by the assessment method and definition used, except in patients undergoing isolated coronary artery bypass grafting.
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Fibrilação Atrial , Procedimentos Cirúrgicos Cardíacos , Acidente Vascular Cerebral , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/etiologia , Incidência , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Ponte de Artéria Coronária/efeitos adversos , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/complicações , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Fatores de RiscoRESUMO
OBJECTIVES: The aim of this study was to perform a meta-analysis of studies reporting outcomes in patients with liver dysfunction addressed by the model of end-stage liver disease and Child-Turcotte-Pugh scores undergoing cardiac surgery. METHODS: A systematic literature search was conducted to identify contemporary studies reporting short- and long-term outcomes in patients with liver dysfunction compared to patients with no or mild liver dysfunction undergoing cardiac surgery (stratified in high and low score group based on the study cut-offs). Primary outcome was perioperative mortality. Secondary outcomes were perioperative neurological events, prolonged ventilation, sepsis, bleeding and/or need for transfusion, acute kidney injury and long-term mortality. RESULTS: A total of 33 studies with 48 891 patients were included. Compared with the low score group, being in the high score group was associated with significantly higher risk of perioperative mortality [odds ratio (OR) 3.72, 95% confidence interval (CI) 2.75-5.03, P < 0.001]. High score group was also associated with a significantly higher rate of perioperative neurological events (OR 1.49, 95% CI 1.30-1.71, P < 0.001), prolonged ventilation (OR 2.45, 95% CI 1.94-3.09, P < 0.001), sepsis (OR 3.88, 95% CI 2.07-7.26, P < 0.001), bleeding and/or need for transfusion (OR 1.95, 95% CI 1.43-2.64, P < 0.001), acute kidney injury (OR 3.84, 95% CI 2.12-6.98, P < 0.001) and long-term mortality (incidence risk ratio 1.29, 95% CI 1.14-1.46, P < 0.001). CONCLUSIONS: The analysis suggests that liver dysfunction in patients undergoing cardiac surgery is independently associated with higher risk of short and long-term mortality and also with an increased occurrence of various perioperative adverse events.
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Procedimentos Cirúrgicos Cardíacos , Hepatopatias , Humanos , Hepatopatias/complicações , Hepatopatias/cirurgia , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , HemorragiaRESUMO
Postoperative atrial fibrillation (POAF) is the most common complication after cardiac surgery. Patients who develop POAF are more likely to experience adverse outcomes, including increased rates of death, stroke, heart failure, and hospitalizations, and higher hospital costs. Understanding the mechanisms underlying POAF is important to improve patients' outcome and optimize health systems' efficiency. Beyond classic pathogenic hypotheses, emerging evidence suggests that postoperative pericardial effusion and localized pericardial inflammation may trigger POAF. This hypothesis is supported by data from nonhuman animal models and a growing body of evidence showing that reducing postoperative pericardial effusion might reduce POAF incidence. In this review, we summarize the classic pathophysiology theories of POAF following cardiac surgery and discuss new etiologic mechanisms with a specific focus on the role of pericardial effusion and inflammation.
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Fibrilação Atrial , Procedimentos Cirúrgicos Cardíacos , Derrame Pericárdico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/etiologia , Fibrilação Atrial/prevenção & controle , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Humanos , Inflamação/etiologia , Derrame Pericárdico/epidemiologia , Derrame Pericárdico/etiologia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Fatores de Risco , Resultado do TratamentoRESUMO
BACKGROUND: Retractions of erroneous and fraudulent papers from the biomedical literature continue to be a major concern. The aim of this analysis is to summarize trends of retractions in the cardiovascular literature over the past four decades. METHODS: A review of the Retraction Watch database for retracted articles published between 1978 and 2020 in the cardiovascular literature was performed. Retractions with the term "medicine" in the subject code were selected. Titles and abstracts were reviewed and only retractions of articles in cardiovascular medicine and surgery were included. RESULTS: 459 retraction notices published in 228 journals were identified. The number of retractions increased with time from 1 in 1991 to 48 at the end of 2019 (P < 0.001). Overall, the yearly percentage of retraction increased during the study period (P < 0.001) but decreased after 2015. China had the highest percentage of retractions when compared to other countries (P < 0.001). The majority of articles were retracted for scientific misconduct (n = 289, 63.0%); retractions due to scientific misconduct increased significantly over the study period (P = 0.04) but decreased after 2015. The median time from publication to retraction was 1.4 years (interquartile range [IQR]: 0.6-3.8) and decreased significantly over time (P < 0.001). The median number of citations of retracted articles was 8.0. CONCLUSIONS: The number of retractions and the yearly percentage of retraction in the cardiovascular literature increased significantly during the study period, although a decrease was seen after 2015. Scientific misconduct represents the most common reason for retraction, although a reduction has been observed in the last five years.
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Pesquisa Biomédica , Má Conduta Científica , China , Bases de Dados Factuais , HumanosRESUMO
OBJECTIVE: The role of surgical ventricular reconstruction (SVR) in patients with ischemic cardiomyopathy is controversial. Observational series and the Surgical Treatment of IsChemic Heart failure (STICH) trial reported contradictory results. SVR is highly dependent on operator experience. The aim of this study is to compare the long-term results of SVR between a high-volume SVR institution and the STICH trial using individual patient data. METHODS: Patients undergoing SVR at San Donato Hospital (Milan) were compared with patients undergoing SVR in STICH (as-treated principle) by inverse probability treatment-weighted Cox regression. The primary outcome was all-cause mortality. RESULTS: The San Donato cohort included 725 patients, whereas the STICH cohort included 501. Compared with the STICH-SVR cohort, San Donato patients were older (66.0, lower quartile, upper quartile [Q1, Q3: 58.0, 72.0] vs 61.9 [Q1, Q3: 55.1, 68.8], P < .001) and with lower left ventricular end-systolic volume index at baseline (LVESVI: 77.0 [Q1, Q3: 59.0, 97.0] vs 80.8 [Q1, Q3: 58.5, 106.8], P = .02). Propensity score weighting yielded 2 similar cohorts. At 4-year follow-up, mortality was significantly lower in the San Donato cohort compared with the STICH-SVR cohort (adjusted hazard ratio, 0.71; 95% confidence interval, 0.53-0.95; P = .001). Greater postoperative LVESVI was independently associated with mortality (hazard ratio, 1.02; 95% confidence interval, 1.01-1.03). At 4 to 6 months of follow-up, the mean reduction of LVESVI in the San Donato cohort was 39.6%, versus 10.7% in the STICH-SVR cohort (P < .001). CONCLUSIONS: Patients with postinfarction LV remodeling undergoing SVR at a high-volume SVR institution had better long-term results than those reported in the STICH trial, suggesting that a new trial testing the SVR hypothesis may be warranted.
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Importance: Recent evidence has suggested that skeletonization of the internal thoracic artery (ITA) is associated with worse clinical outcomes in patients undergoing coronary artery bypass surgery (CABG). Objective: To compare the long-term clinical outcomes of skeletonized and pedicled ITA for CABG. Design, Setting, and Participants: The Arterial Revascularization Trial (ART) was a 2-group, multicenter trial comparing the use of a bilateral ITA vs a single ITA for CABG at 10 years. Patients in the ART trial were stratified by ITA harvesting technique: skeletonized vs pedicled. Data were collected from June 2004 to December 2017, and data were analyzed from June to July 2021. Interventions: In this analysis, the 10-year clinical outcomes were compared between patients who received skeletonized vs pedicled ITAs. Main Outcomes and Measures: The primary outcome was all-cause mortality. The secondary outcomes were a composite of major adverse cardiac events (MACE) including all-cause mortality, myocardial infarction, and repeated revascularization and a composite including MACE and sternal wound complication (SWC). Cox regression and propensity score matching were used. Results: Of 2161 included patients, 295 (13.7%) were female, and the median (interquartile range) age was 65.0 (58.0-70.0) years. At 10 years, the risk of all-cause mortality was not significantly different between the pedicled and skeletonized groups (hazard ratio [HR], 1.12; 95% CI, 0.92-1.36; P = .27). However, the long-term risks of the secondary outcomes were significantly higher in the skeletonized group compared with the pedicled group (MACE: HR, 1.25; 95% CI, 1.06-1.47; P = .01; MACE and SWC: HR, 1.22; 95% CI, 1.05-1.43; P = .01). The difference was not seen when considering only patients operated on by surgeons who enrolled 51 patients or more in the trial (MACE: HR, 1.07; 95% CI, 0.82-1.39; P = .62; MACE and SWC: HR, 1.04; 95% CI, 0.80-1.34; P = .78). Conclusions and Relevance: While the long-term survival of patients was not different between groups, the rate of adverse cardiovascular events was consistently higher in the skeletonized group and the difference was associated with surgeon-related factors. Further evidence on the outcome of skeletonized ITA is needed.