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OBJECTIVES: Clinical trials that are terminated prematurely may generate incomplete and potentially biased data and the reasons for premature trials termination are poorly understood. Our objective was to describe the incidence of premature trial termination and identify factors associated with it. METHODS: We performed a systematic search on ClinicalTrials.gov to identify all cardiac surgery trials from 1991 to 2023. Trials that were terminated prematurely were identified. Factors independently associated with premature termination were identified using multivariable logistic regression analysis. RESULTS: A total of 746 clinical trials were included; of them 577 were completed and 169 (22.6%) were terminated prematurely. Most of the trials originated from North America (294 [39.4%]), Europe (264 [35.4%]) or Asia (141 [18.9%]). Fourteen of the trials terminated prematurely (8.3%) were phase 1, 75 (44.4%) phase 2, 49 (29.0%) phase 3, and 31 (18.3%) phase 4. Fifty (29.6%) trials were terminated because of slow recruitment, 20 (11.8%) because of sponsor decision and 12 (7.1%) because lack of funding. Left ventricular assist device (LVAD) trials (odds ratio [OR] 3.65, 95% CI: [1.65-8.00] P = 0.001), valve surgery trials (OR 4.30, 95% CI: [2.33-8.00] P < 0.001), aortic surgery trials (OR 2.86 95% CI [1.22-6.43] P = 0.012), Phase 2 (OR 3.02, 95% CI [1.31-7.93] P = 0.015) and phase 4 trials (OR 3.62, 95% CI: [1.43-10.23] P = 0.010) were at higher risk of premature termination while trials performed in Asia (OR 0.18, 95% CI [0.07-0.39] P ≤ 0.001) and Europe (OR 0.49, 95% CI: [0.30-0.80] P = 0.004) were less likely to be terminated prematurely. CONCLUSIONS: Slow recruitment is the most common reason for premature termination of cardiac surgery trials. Trials on LVAD, valve surgery, aortic surgery, phase 2 trials and phase 4 trials are more likely to be terminated, while trials conducted in Asia and Europe are less likely to be terminated prematurely.
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OBJECTIVES: To determine the association of intraoperative pulmonary artery catheter (PAC) use with in-hospital outcomes in cardiac surgical patients. METHODS: MEDLINE, Embase, and Cochrane Library (Wiley) databases were screened for studies that compared cardiac surgical patients receiving intraoperative PAC with controls and reporting in-hospital mortality. Secondary outcomes included intensive care unit length of stay, cost of hospitalization, fluid volume administered, intubation time, inotropes use, acute kidney injury (AKI), stroke, myocardial infarction (MI), and infections. RESULTS: Seven studies (25 853 patients, 88.6% undergoing coronary artery bypass graft surgery) were included. In-hospital mortality was significantly increased with PAC use [odds ratio (OR) 1.57; 95% confidence interval (CI) 1.12-2.20, P = 0.04]; PAC use was also associated with greater intraoperative inotrope use (OR 2.61; 95% CI 1.54-4.41) and costs [standardized mean difference (SMD) = 0.20; 95% CI 0.16-0.23], longer intensive care unit stay (SMD = 0.29; 95% CI 0.25-0.33), and longer intubation time (SMD = 0.44; 95% CI 0.12-0.76). CONCLUSIONS: PAC use is associated with significantly increased odds of in-hospital mortality, but the amount and quality of the available evidence is limited. Prospective randomized trials testing the effect of PAC on the outcomes of cardiac surgical patients are urgently needed.
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Objective: Bleeding is frequent during transcatheter aortic valve implantation (TAVI), especially when performed through a transapical approach (TA), and is associated with a worse prognosis. The present study aims to test the implication of red blood cell (RBC) transfusion and the optimal transfusion strategy in this context. Methods: Among 11,265 participants in the multicenter TRITAVI (Transfusion Requirements in Transcatheter Aortic Valve Implantation) registry, 548 patients (4.9%) who received TA-TAVI at 19 European centers were included. One-to-one propensity score matching was performed to reduce treatment selection bias and potential confounding among transfused versus non-transfused patients. The primary endpoint of the study was the 30-day occurrence of all-cause mortality. Results: 209 patients (38 %) received RBC transfusions. The primary endpoint occurred in 47 (8.6 %) patients. Propensity score matching identified 188 pairs of patients with and without RBC transfusion. In the propensity score-matched analysis, RBC transfusion was associated with increased 30-day mortality (HR 3.35, 95 % CI 1.51 - 7.39; p = 0.002). At multivariable cox regression analysis, RBC transfusion was an independent predictor of 30-day mortality (HR 3.07, 95 % CI 1.01-9.41, p = 0.048), as well as baseline ejection fraction (HR 0.96, 95 % CI 0.92-0.99, p = 0.043), and acute kidney injury (HR 3.95, 95 % CI 1.11-14.05, p = 0.034). Conclusions: RBC transfusion is an independent predictor of short-term mortality in patients undergoing TA-TAVI, regardless of major bleeding.Clinical trial registration: https://www.clinicaltrials.gov Unique identifier: NCT03740425.
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OBJECTIVES: This article identifies minimal clinically important differences (MCIDs) in quality of life (QoL) measures among patients who had coronary artery bypass grafting (CABG) and were enrolled in the arterial revascularization trial (ART). METHODS AND RESULTS: The European Quality of Life-5 Dimensions (EQ-5D) and the Short Form Health Survey 36-Item (SF-36) physical component (PC) and mental component (MC) scores were recorded at baseline, 5 years and 10 years in ART. The MCIDs were calculated as changes in QoL scores anchored to 1-class improvement in the New York Heart Association functional class and Canadian Cardiovascular Society scale at 5 years. Cox proportional hazard models were used to evaluate associations between MCIDs and mortality. Patient cohorts were examined for the SF-36 PC (N = 2671), SF-36 MC (N = 2815) and EQ-5D (N = 2943) measures, respectively. All QoL scores significantly improved after CABG compared to baseline. When anchored to the New York Heart Association, the MCID at 5 years was 17 (95% confidence interval: 17-20) for SF-36 PC, 14 (14-17) for the SF-36 MC and 0.12 (0.12-0.15) for EQ-5D. Using the Canadian Cardiovascular Society scale as an anchor, the MCID at 5 years was 15 (15-17) for the SF-36 PC, 12 (13-15) for the SF-36 MC and 0.12 (0.11-0.14) for the EQ-5D. The MCIDs for SF-36 PC and EQ-5D at 5 years were associated with a lower risk of mortality at the 10-year follow-up point after surgery. CONCLUSIONS: MCIDs for CABG patients have been identified. These thresholds may have direct clinical applications in monitoring patients during follow-up and in designing new trials that include QoL as a primary study outcome. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN46552265.
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Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria , Medición de Resultados Informados por el Paciente , Calidad de Vida , Humanos , Puente de Arteria Coronaria/métodos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Enfermedad de la Arteria Coronaria/cirugía , Diferencia Mínima Clínicamente Importante , Resultado del TratamientoRESUMEN
OBJECTIVE: To assess the effect of different antiplatelet strategies on clinical outcomes after coronary artery bypass grafting. DESIGN: Five year follow-up of randomised Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Grafting (DACAB) trial. SETTING: Six tertiary hospitals in China; enrolment between July 2014 and November 2015; completion of five year follow-up from August 2019 to June 2021. PARTICIPANTS: 500 patients aged 18-80 years (including 91 (18.2%) women) who had elective coronary artery bypass grafting surgery and completed the DACAB trial. INTERVENTIONS: Patients were randomised 1:1:1 to ticagrelor 90 mg twice daily plus aspirin 100 mg once daily (dual antiplatelet therapy; n=168), ticagrelor monotherapy 90 mg twice daily (n=166), or aspirin monotherapy 100 mg once daily (n=166) for one year after surgery. After the first year, antiplatelet therapy was prescribed according to standard of care by treating physicians. MAIN OUTCOME MEASURES: The primary outcome was major adverse cardiovascular events (a composite of all cause death, myocardial infarction, stroke, and coronary revascularisation), analysed using the intention-to-treat principle. Time-to-event analysis was used to compare the risk between treatment groups. Multiple post hoc sensitivity analyses examined the robustness of the findings. RESULTS: Follow-up at five years for major adverse cardiovascular events was completed for 477 (95.4%) of 500 patients; 148 patients had major adverse cardiovascular events, including 39 in the dual antiplatelet therapy group, 54 in the ticagrelor monotherapy group, and 55 in the aspirin monotherapy group. Risk of major adverse cardiovascular events at five years was significantly lower with dual antiplatelet therapy versus aspirin monotherapy (22.6% v 29.9%; hazard ratio 0.65, 95% confidence interval 0.43 to 0.99; P=0.04) and versus ticagrelor monotherapy (22.6% v 32.9%; 0.66, 0.44 to 1.00; P=0.05). Results were consistent in all sensitivity analyses. CONCLUSIONS: Treatment with ticagrelor dual antiplatelet therapy for one year after surgery reduced the risk of major adverse cardiovascular events at five years after coronary artery bypass grafting compared with aspirin monotherapy or ticagrelor monotherapy. TRIAL REGISTRATION: NCT03987373ClinicalTrials.gov NCT03987373.
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Aspirina , Puente de Arteria Coronaria , Inhibidores de Agregación Plaquetaria , Ticagrelor , Humanos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Inhibidores de Agregación Plaquetaria/administración & dosificación , Femenino , Masculino , Persona de Mediana Edad , Ticagrelor/uso terapéutico , Aspirina/uso terapéutico , Aspirina/administración & dosificación , Anciano , Estudios de Seguimiento , Adulto , Anciano de 80 o más Años , Quimioterapia Combinada , Adolescente , Complicaciones Posoperatorias/prevención & control , Resultado del Tratamiento , Adulto Joven , China , Terapia Antiplaquetaria Doble/métodosRESUMEN
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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BACKGROUND: Postoperative bleeding requiring re-exploration is a serious complication that occurs in 2.8% to 4.6% of patients undergoing cardiac surgery. Re-exploration has previously been associated with a higher risk of short-term mortality. However, a comprehensive analysis of long-term outcomes after re-exploration for bleeding has not been published. MATERIALS AND METHODS: We performed a systematic, three databases search to identify studies reporting long-term outcomes in patients who required re-exploration for bleeding after cardiac surgery compared to patients who did not, with at least 1 year of follow-up. Long-term survival was the primary outcome. Secondary outcomes were operative mortality, myocardial infarction, stroke, renal and respiratory complications, and hospital length of stay. Random-effects models was used. Individual patient survival data was extracted from available survival curves and reconstructed using restricted mean survival time. RESULTS: Six studies totaling 135,456 patients were included. The average follow-up was 5.5 years. In the individual patient data, patients who required re-exploration had a significantly higher risk of death compared with patients who did not (hazard ratio [HR]: 1.21; 95% confidence interval [CI]: 1.14-1.27; P<0.001), which was confirmed by the study-level survival analysis (HR: 1.32; 95% CI: 1.12-1.56; P<0.01). Re-exploration was also associated with a higher risk of operative mortality (odds ratio [OR]: 5.25, 95% CI, 4.74-5.82, P<0.0001), stroke (OR: 2.05, 95% CI, 1.72-2.43, P<0.0001), renal (OR: 4.13, 95% CI, 3.43-4.39 P<0.0001) respiratory complications (OR: 3.91, 95% CI, 2.96-5.17, P<0.0001), longer hospital length of stay (mean difference [MD]: 2.69, 95% CI, 1.68 to 3.69, P<0.0001), and myocardial infarction (OR: 1.85, 95% CI, 1.30-2.65, P=0.0007). CONCLUSION: Postoperative bleeding requiring re-exploration is associated with lower long-term survival and increased risk of short-term adverse events including operative mortality, stroke, renal and respiratory complications, and longer hospital length of stay. To improve both short- and long-term outcomes, strategies to prevent the need for re-exploration are necessary.
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OBJECTIVES: The association between obesity and graft failure after coronary artery bypass grafting has not been previously investigated. METHODS: We pooled individual patient data from randomized clinical trials with systematic postoperative coronary imaging to evaluate the association between obesity and graft failure at the individual graft and patient levels. Penalized cubic regression splines and mixed-effects multivariable logistic regression models were performed. RESULTS: Six trials comprising 3928 patients and 12 048 grafts were included. The median time to imaging was 1.03 (interquartile range 1.00-1.09) years. By body mass index (BMI) category, 800 (20.4%) patients were normal weight (BMI 18.5-24.9), 1668 (42.5%) were overweight (BMI 25-29.9), 983 (25.0%) were obesity class 1 (BMI 30-34.9), 344 (8.8%) were obesity class 2 (BMI 35-39.9) and 116 (2.9%) were obesity class 3 (BMI 40+). As a continuous variable, BMI was associated with reduced graft failure [adjusted odds ratio (aOR) 0.98 (95% confidence interval (CI) 0.97-0.99)] at the individual graft level. Compared to normal weight patients, graft failure at the individual graft level was reduced in overweight [aOR 0.79 (95% CI 0.64-0.96)], obesity class 1 [aOR 0.81 (95% CI 0.64-1.01)] and obesity class 2 [aOR 0.61 (95% CI 0.45-0.83)] patients, but not different compared to obesity class 3 [aOR 0.94 (95% CI 0.62-1.42)] patients. Findings were similar, but did not reach significance, at the patient level. CONCLUSIONS: In a pooled individual patient data analysis of randomized clinical trials, BMI and obesity appear to be associated with reduced graft failure at 1 year after coronary artery bypass grafting.
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Índice de Masa Corporal , Puente de Arteria Coronaria , Obesidad , Sobrepeso , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Puente de Arteria Coronaria/efectos adversos , Obesidad/complicaciones , Sobrepeso/complicaciones , Sobrepeso/epidemiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de RiesgoRESUMEN
Background: The Society of Thoracic Surgeons and European System for Cardiac Operative Risk Evaluation (EuroSCORE) II risk scores are the most commonly used risk prediction models for in-hospital mortality after adult cardiac surgery. However, they are prone to miscalibration over time and poor generalization across data sets; thus, their use remains controversial. Despite increased interest, a gap in understanding the effect of data set drift on the performance of machine learning (ML) over time remains a barrier to its wider use in clinical practice. Data set drift occurs when an ML system underperforms because of a mismatch between the data it was developed from and the data on which it is deployed. Objective: In this study, we analyzed the extent of performance drift using models built on a large UK cardiac surgery database. The objectives were to (1) rank and assess the extent of performance drift in cardiac surgery risk ML models over time and (2) investigate any potential influence of data set drift and variable importance drift on performance drift. Methods: We conducted a retrospective analysis of prospectively, routinely gathered data on adult patients undergoing cardiac surgery in the United Kingdom between 2012 and 2019. We temporally split the data 70:30 into a training and validation set and a holdout set. Five novel ML mortality prediction models were developed and assessed, along with EuroSCORE II, for relationships between and within variable importance drift, performance drift, and actual data set drift. Performance was assessed using a consensus metric. Results: A total of 227,087 adults underwent cardiac surgery during the study period, with a mortality rate of 2.76% (n=6258). There was strong evidence of a decrease in overall performance across all models (P<.0001). Extreme gradient boosting (clinical effectiveness metric [CEM] 0.728, 95% CI 0.728-0.729) and random forest (CEM 0.727, 95% CI 0.727-0.728) were the overall best-performing models, both temporally and nontemporally. EuroSCORE II performed the worst across all comparisons. Sharp changes in variable importance and data set drift from October to December 2017, from June to July 2018, and from December 2018 to February 2019 mirrored the effects of performance decrease across models. Conclusions: All models show a decrease in at least 3 of the 5 individual metrics. CEM and variable importance drift detection demonstrate the limitation of logistic regression methods used for cardiac surgery risk prediction and the effects of data set drift. Future work will be required to determine the interplay between ML models and whether ensemble models could improve on their respective performance advantages.
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BACKGROUND: We compared the outcomes of aortic root replacement by composite valve grafts (CVG) and valve-sparing root replacement (VSRR) operations, with an emphasis on postoperative conduction block and the need for permanent pacemaker implantation (PPM). METHODS: From 1997 to 2023, 1712 consecutive patients underwent ARR by VSRR (501 [29%]) or CVG (1211 [71%]) at a high-volume aortic center. RESULTS: Patients undergoing CVG were older (59 ± 14 vs 49 ± 14 years, P < .001), with more cardiovascular comorbidities. Compared with CVG, there were more women undergoing VSRR (17% vs. 13%, P = .042) and more patients with connective tissue disease (22% vs 7.3%, P < .001). Multivariable analysis found that the risk for PPM was higher after CVG compared with VSRR (6.5% vs 1.2%; odds ratio [OR], 2.83; 95% CI, 1.23-7.69; P = .024). Other variables associated with PPM include older age (OR, 1.03; 95% CI, 1.01-1.05; P = .006) preoperative renal impairment (OR, 2.69; 95% CI, 1.24-5.6; P = .010), previous operation (OR, 2.76; 95% CI, 1.29-5.62; P = .007), and bicuspid aortic valve (OR, 3.63; 95% CI, 2.13-6.33; P < .001). Among the CVG population, patients who are at increased risk are especially those with some degree of aortic stenosis (OR, 2.06; 95% CI, 1.18-3.61; P = .011). Patients who required PPM had no additive risk for long-term mortality (hazard ratio, 1.01; 95% CI, 0.47-2.17; P = .986); however, they were more likely to have reduced ejection fraction (29.3% vs 16%, P = .014). CONCLUSIONS: The incidence of PPM after ARR is low, but rates were higher after CVG compared with VSRR.
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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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To develop risk scoring models predicting long-term survival and major adverse cardiovascular and cerebrovascular events (MACCEs), including myocardial infarction and stroke after coronary artery bypass grafting (CABG). All 4,821 consecutive patients who underwent isolated CABG at Lankenau between January 2005 and July 2021 were included. MACCE was defined as all-cause mortality + myocardial infarction + stroke. Variable selection for both outcomes was obtained using a double-selection logit least absolute shrinkage and selection operator with adaptive selection. Model performance was internally evaluated by calibration and accuracy using bootstrap cross-validation. Mortality and MACCEs were compared in patients split into 3 groups based on the predicted risk scores for all-cause mortality and MACCEs. An external validation of our database was performed with 665 patients from the University of Brescia, Italy. Preoperative risk predictors were found to be predictors for all-cause mortality and MACCEs. In addition, being of African-American ethnicity is a significant predictor for MACCEs after isolated CABG. The areas under the curve (AUCs), which measures the discrimination of the models, were 80.4%, 79.1%, 81.3%, and 79.2% for mortality at 1, 2, 3, and 5 years follow-up. The AUCs for MACCEs were 75%, 72.5%, 73.8%, and 72.7% at 1, 2, 3, and 5 years follow-up. For external validation, the AUCs for all-cause mortality and MACCEs at 1, 2, 3, and 5 years were 73.7%, 70.8%, 68.7%, and 72.2% and 72.3%, 68.2%, 65.6%, and 69.6%, respectively. The Advanced (AD) Coronary Risk Score for All-Cause Mortality and MACCE provide good discrimination of long-term mortality and MACCEs after isolated CABG. External validation observed a more AUCs greater than 70%.
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Puente de Arteria Coronaria , Complicaciones Posoperatorias , Humanos , Masculino , Femenino , Persona de Mediana Edad , Medición de Riesgo/métodos , Anciano , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/mortalidad , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/mortalidad , Factores de Riesgo , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , Tasa de Supervivencia/tendencias , Causas de Muerte/tendencias , Infarto del Miocardio/epidemiología , Infarto del Miocardio/mortalidad , Estudios Retrospectivos , Trastornos Cerebrovasculares/mortalidad , Trastornos Cerebrovasculares/epidemiologíaRESUMEN
BACKGROUND: Dialysis is a rare but serious complication after transcatheter aortic valve replacement. We analyzed the large multicenter TRITAVI (transfusion requirements in transcatheter aortic valve implantation) registry in order to develop and validate a clinical score assessing this risk. METHODS AND RESULTS: A total of 10 071 consecutive patients were enrolled in 19 European centers. Patients were randomly assigned (2:1) to a derivation and validation cohort. Two scores were developed, 1 including only preprocedural variables (TRITAVIpre) and 1 also including procedural variables (TRITAVIpost). In the 6714 patients of the derivation cohort (age 82±6 years, 48% men), preprocedural factors independently associated with dialysis and included in the TRITAVIpre score were male sex, diabetes, prior coronary artery bypass graft, anemia, nonfemoral access, and creatinine clearance <30 mL/min per m2. Additional independent predictors among procedural features were volume of contrast, need for transfusion, and major vascular complications. Both scores showed a good discrimination power for identifying risk for dialysis with C-statistic 0.78 for TRITAVIpre and C-statistic 0.88 for TRITAVIpost score. Need for dialysis increased from the lowest to the highest of 3 risk score groups (from 0.3% to 3.9% for TRITAVIpre score and from 0.1% to 6.2% for TRITAVIpost score). Analysis of the 3357 patients of the validation cohort (age 82±7 years, 48% men) confirmed the good discrimination power of both scores (C-statistic 0.80 for TRITAVIpre and 0.81 for TRITAVIpost score). Need for dialysis was associated with a significant increase in 1-year mortality (from 6.9% to 54.4%; P=0.0001). CONCLUSIONS: A simple preprocedural clinical score can help predict the risk of dialysis after transcatheter aortic valve replacement.
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Estenosis de la Válvula Aórtica , Diabetes Mellitus , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Sistema de Registros , Diálisis Renal , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento , Estudios Multicéntricos como AsuntoRESUMEN
OBJECTIVES: This nationwide retrospective cohort study assessed the impact of the explanted valve type on reoperative outcomes in aortic valve surgery within the UK over a 23-year period. METHODS: Data were sourced from the National Institute for Cardiovascular Outcomes Research (NICOR) database. All patients undergoing first-time isolated reoperative aortic valve replacement between 1996 and 2019 in the UK were included. Concomitant procedures, homograft implantation or aortic root enlargement were excluded. Propensity score matching was utilized to compare outcomes and risk factors for in-hospital mortality was evaluated through multivariable logistic regression. Final model selection was conducted using Akaike Information Criterion through bootstrapping. The primary end point was in-hospital mortality, and secondary end points included postoperative morbidities. RESULTS: Out of 2371 patients, 24.9% had mechanical and 75% had bioprosthetic valves implanted during the primary procedure. Propensity matched groups of 324 patients each, were compared. In-hospital mortality for mechanical and bioprosthetic valve explants was 7.1% and 5.9%, respectively (P = 0.632). On multivariable logistic regression analysis, valve type was not a risk factor for mortality [odds ratio (OR) 0.62, 95% confidence interval (CI) 0.37-1.05; P = 0.1]. Age (OR 1.03, 95% CI 1.01-1.05; P < 0.05), left ventricular ejection fraction (OR 1.62, 95% CI 1.08-2.42; P < 0.05), creatinine ≥ 200 mg/dl (OR 2.21, 95% CI 1.17-4.04; P < 0.05) and endocarditis (OR 2.66, 95% CI 1.71-4.14; P < 0.05) emerged as risk factors for mortality. CONCLUSIONS: The type of valve initially implanted (mechanical or bioprosthetic) did not determine mortality. Instead, age, left ventricular ejection fraction, renal impairment and endocarditis were significant risk factors for in-hospital mortality.
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Bioprótesis , Endocarditis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Humanos , Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Estudios Retrospectivos , Volumen Sistólico , Función Ventricular Izquierda , Prótesis Valvulares Cardíacas/efectos adversos , Reoperación , Endocarditis/cirugía , Reino Unido/epidemiología , Bioprótesis/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: Women undergoing coronary artery bypass grafting (CABG) have higher operative mortality than men. OBJECTIVES: The purpose of this study was to evaluate the relationship between intraoperative anemia (nadir intraoperative hematocrit), CABG operative mortality, and sex. METHODS: This was a cohort study of 1,434,225 isolated primary CABG patients (344,357 women) from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (2011-2022). The primary outcome was operative mortality. The attributable risk (AR) (the risk-adjusted strength of the association of female sex with CABG outcomes) for the primary outcome was calculated. Causal mediation analysis derived the total effect of female sex on operative mortality risk and the proportion of that effect mediated by intraoperative anemia. RESULTS: Women had lower median nadir intraoperative hematocrit (22.0% [Q1-Q3: 20.0%-25.0%] vs 27.0% [Q1-Q3: 24.0%-30.0%], standardized mean difference 97.0%) than men. Women had higher operative mortality than men (2.8% vs 1.7%; P < 0.001; adjusted OR: 1.36; 95% CI: 1.30-1.41). The AR of female sex for operative mortality was 1.21 (95% CI: 1.17-1.24). After adjusting for nadir intraoperative hematocrit, AR was reduced by 43% (1.12; 95% CI: 1.09-1.16). Intraoperative anemia mediated 38.5% of the increased mortality risk associated with female sex (95% CI: 32.3%-44.7%). Spline regression showed a stronger association between operative mortality and nadir intraoperative hematocrit at hematocrit values <22.0% (P < 0.001). CONCLUSIONS: The association of female sex with increased CABG operative mortality is mediated to a large extent by intraoperative anemia. Avoiding nadir intraoperative hematocrit values below 22.0% may reduce sex differences in CABG operative mortality.
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Anemia , Procedimientos Quirúrgicos Cardíacos , Adulto , Humanos , Femenino , Masculino , Estudios de Cohortes , Puente de Arteria Coronaria/efectos adversos , Anemia/epidemiología , Hematócrito , Factores de Riesgo , Resultado del Tratamiento , Estudios RetrospectivosRESUMEN
[This corrects the article DOI: 10.3389/fsurg.2023.1205396.].
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Esophagectomy for esophageal cancer is associated with high morbidity. It remains unclear whether prehabilitation, a strategy aimed at optimizing patients' physical and mental functioning prior to surgery, improves postoperative outcomes. A systematic review and meta-analysis was conducted to evaluate the effect of prehabilitation on post-operative outcomes after esophagectomy. Data sources included Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, and PEDro, with information from 1 January 2000 to 5 August 2023. The analysis included randomized controlled trials and observational studies that compared prehabilitation interventions to standard care prior to esophagectomy. A random effects model was used to generate a pooled estimate for pairwise meta-analysis, meta-analysis of proportions, and meta-analysis of means. A total of 1803 patients were included with 584 in randomized controlled trials (RCTs) and 1219 in observational studies. In the randomized evidence, there were no significant differences between prehabilitation and control in the odds of postoperative pneumonia (15.0 vs. 18.9%, odds ratio (OR) 1.06 [95% confidence interval (CI): 0.66;1.72]) or pulmonary complications (14 vs. 25.6%, OR 0.68 [95% CI: 0.32;1.45]). In the observational data, there was a reduction in both postoperative pneumonia (22.5 vs. 32.9%, OR 0.48 [95% CI: 0.28;0.83]) and pulmonary complications (26.1 vs. 52.3%, OR 0.35 [95% CI: 0.17;0.75]) with prehabilitation. Hospital and intensive care unit length of stay (days), operative mortality, and severe complications (Clavien-Dindo ≥ 3) did not differ between groups in both the randomized data and observational data. Prehabilitation demonstrated reductions in postoperative pneumonia and pulmonary complications in observational studies, but not RCTs. The overall certainty of these findings is limited by the low quality of the available evidence.
Asunto(s)
Neoplasias Esofágicas , Neumonía , Humanos , Neoplasias Esofágicas/cirugía , Esofagectomía/efectos adversos , Unidades de Cuidados Intensivos , Neumonía/epidemiología , Neumonía/etiología , Neumonía/prevención & control , Ejercicio Preoperatorio , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Observacionales como AsuntoRESUMEN
BACKGROUND: Both valve-sparing root replacement and composite valve graft (CVG) are acceptable options in aortic root replacement. We compare outcomes of these 2 approaches and durability of the aortic valve. METHODS: A consecutive 1635 patients without acute dissection underwent primary aortic root replacement from 1997 to 2022; 473 (29%) underwent valve-sparing root replacement, and 1162 (71%) received CVG. Propensity score matching was used to reduce baseline differences. RESULTS: The CVG group was older (59 ± 14 years vs 49 ± 14 years; P < .001) with more comorbidities, such as hypertension (88.4% vs 66.4%; P < .001), diabetes (7% vs 1.7%; P < .001), ischemic heart disease (5.1% vs 1.3%; P = .001), pulmonary disease (6.6% vs 1.3%; P < .001), renal impairment (8.6% vs 1.3%; P < .001), class III-IV heart failure (35% vs 9.2%; P < .001), bicuspid aortic valves (44.8% vs 24.1%; P < .001), and severe aortic insufficiency (50.2% vs 13.2%; P < .001). Operative mortality was 0.4% (0% in valve sparing); incidence of major postoperative complications was 2.9% (3.6% vs 1.1%; P = .009). Ten-year survival was 93.1% (91.2% vs 97.7%; hazard ratio [HR], 1.7; 95% CI, 0.9-3.3; P = .120). Mean follow-up was 65 ± 60 months; aortic valve reoperations were similar (5.8% vs 5.7%; HR, 0.8; 95% CI, 0.4-1.4; P = .401). Recurrent moderate-severe aortic insufficiency was less prevalent in CVG (6.1% vs 11.1%; HR, 0.14; 95% CI, 0.07-0.27; P < .001). Propensity score matching identified 225 pairs. There was no difference in 10-year survival or reoperations. Recurrent moderate-severe aortic insufficiency was higher with valve sparing. CONCLUSIONS: Both valve-sparing operations and CVG provide excellent early and late outcomes out to 10 years. Valve sparing is associated with a higher risk for development of aortic insufficiency but no difference in reoperations.
Asunto(s)
Insuficiencia de la Válvula Aórtica , Enfermedad de la Válvula Aórtica Bicúspide , Implantación de Prótesis de Válvulas Cardíacas , Humanos , Puntaje de Propensión , Resultado del Tratamiento , Válvula Aórtica/cirugía , Aorta/cirugía , Enfermedad de la Válvula Aórtica Bicúspide/cirugía , Insuficiencia de la Válvula Aórtica/cirugía , Estudios RetrospectivosRESUMEN
Basic, translational or clinic, research is a key component of cardiac surgery. Understanding basic cellular and molecular mechanisms is key to improving patient outcomes, and cardiac surgical procedures must be compared with nonsurgical alternatives. However, guidance for early-career investigators interested in cardiac surgery research is limited. This opinion piece aims at providing basic guidance and principles based on the authors' experience.