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1.
J Cardiothorac Surg ; 19(1): 171, 2024 Apr 02.
Artículo en Inglés | MEDLINE | ID: mdl-38566106

RESUMEN

BACKGROUND: Acute Type A aortic dissection (ATAAD) is a life-threatening cardiovascular disease associated with high mortality rates, where surgical intervention remains the primary life-saving treatment. However, the mortality rate for ATAAD operations continues to be alarmingly high. To address this critical issue, our study aimed to assess the correlation between preoperative laboratory examination, clinical imaging data, and postoperative mortality in ATAAD patients. Additionally, we sought to establish a reliable prediction model for evaluating the risk of postoperative death. METHODS: In this study, a total of 384 patients with acute type A aortic dissection (ATAAD) who were admitted to the emergency department for surgical treatment were included. Based on preoperative laboratory examination and clinical imaging data of ATAAD patients, logistic analysis was used to obtain independent risk factors for postoperative in-hospital death. The survival prediction model was based on cox regression analysis and displayed as a nomogram. RESULTS: Logistic analysis identified several independent risk factors for postoperative in-hospital death, including Marfan syndrome, previous cardiac surgery history, previous renal dialysis history, direct bilirubin, serum phosphorus, D-dimer, white blood cell, multiple aortic ruptures and age. A survival prediction model based on cox regression analysis was established and presented as a nomogram. The model exhibited good discrimination and significantly improved the prediction of death risk in ATAAD patients. CONCLUSIONS: In this study, we developed a novel survival prediction model for acute type A aortic dissection based on preoperative clinical features. The model demonstrated good discriminatory power and improved accuracy in predicting the risk of death in ATAAD patients undergoing open surgery.


Asunto(s)
Disección Aórtica , Síndrome de Marfan , Humanos , Mortalidad Hospitalaria , Estudios Retrospectivos , Disección Aórtica/cirugía , Factores de Riesgo
2.
Trials ; 25(1): 250, 2024 Apr 10.
Artículo en Inglés | MEDLINE | ID: mdl-38600561

RESUMEN

BACKGROUND: Acute type A aortic dissection (aTAAD) is a critical and life-threatening condition. Previous research has demonstrated that the use of ketorolac not only reduces the progression, incidence, and severity of aortic aneurysms in animal models, but also decreases postoperative mortality and complications in patients undergoing open abdominal aortic aneurysm replacement. However, there is a lack of studies investigating the efficacy of ketorolac in treating aTAAD in humans. Therefore, we conducted a study to evaluate the safety and efficacy of ketorolac in patients with aTAAD. Our hypothesis was that ketorolac treatment for aTAAD patients would meet safety indicators and effectively improve patient prognosis. METHODS/DESIGN: This study is a single-center, randomized, double-blinded, and placebo-controlled study. A total of 120 patients with aTAAD will be recruited and will be randomized into the ketorolac group and placebo group with a ratio of 1:1. Ketorolac tromethamine 60 mg per 2 ml will be intramuscularly injected within 2 h before surgery, followed by intramuscular injections of 30 mg per 1 ml BID. on the first and second postoperative days in the Ketorolac group, while 0.9% saline will be administered at the same dose, dosage form, and time in the placebo group. This study aims to evaluate the safety and efficacy of ketorolac in improving the prognosis of aTAAD. The primary endpoint is the composite endpoint event concerning drug-related adverse events. Secondary endpoints include drug-related adverse events, laboratory examination of blood, diagnostic imaging tests, clinical biomarkers, etc. DISCUSSION: This study has been approved by the Medical Ethics Committee of Affiliated Nanjing Drum Tower Hospital, Nanjing University Medical College (approval number: 2023-197-02). This study is designed to evaluate the safety and efficacy of ketorolac in patients with aTAAD. All participating patients will sign an informed consent form, and the trial results will be published in international peer-reviewed journals. TRIAL REGISTRATION: The Chinese Clinical Trial Registry ( http://www.chictr.org.cn ) ChiCTR2300074394. Registered on 4 October 2023.


Asunto(s)
Disección Aórtica , COVID-19 , Humanos , SARS-CoV-2 , Ketorolaco/efectos adversos , Pronóstico , Disección Aórtica/diagnóstico por imagen , Disección Aórtica/tratamiento farmacológico , Disección Aórtica/cirugía , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como Asunto
3.
J Cardiothorac Surg ; 19(1): 138, 2024 Mar 19.
Artículo en Inglés | MEDLINE | ID: mdl-38504265

RESUMEN

BACKGROUND: Postoperative hyper-inflammation is a frequent event in patients with acute Stanford type A aortic dissection (ATAAD) after surgical repair. This study's objective was to determine which inflammatory biomarkers could be used to make a better formula for identifying postoperative hyper-inflammation, and which risk factors were associated with hyper-inflammation. METHODS: A total of 405 patients were enrolled in this study from October 1, 2020 to April 1, 2023. Of these patients, 124 exhibited poor outcomes. In order to investigate the optimal cut-off values for poor outcomes, logistic and receiver operating characteristic analyses were performed on the following parameters on the first postoperative day: procalcitonin (PCT), C-reactive protein (CRP), interleukin-6 (IL-6), and systemic immune-inflammation index (SII). These cut-off points were used to separate the patients into hyper-inflammatory (n = 52) and control (n = 353) groups. Finally, the logistic were used to find the risk factors of hyper-inflammatory. RESULTS: PCT, CRP, IL-6, and SII were independent risk factors of poor outcomes in the multivariate logistic model. Cut-off points of these biomarkers were 2.18 ng/ml, 49.76 mg/L, 301.88 pg/ml, 2509.96 × 109/L respectively. These points were used to define postoperative hyper-inflammation (OR 2.97, 95% CI 1.35-6.53, P < 0.01). Cardiopulmonary bypass (CPB) > 180 min, and deep hypothermia circulatory arrest (DHCA) > 40 min were the independent risk factors for hyper-inflammation. CONCLUSIONS: PCT > 2.18, CRP > 49.76, IL-6 > 301.88, and SII < 2509.96 could be used to define postoperative hyper-inflammation which increased mortality and morbidity in patients after ATAAD surgery. Based on these findings, we found that CPB > 180 min and DHCA > 40 min were separate risk factors for postoperative hyper-inflammation.


Asunto(s)
Disección Aórtica , Interleucina-6 , Humanos , Disección Aórtica/cirugía , Inflamación , Biomarcadores , Factores de Riesgo , Polipéptido alfa Relacionado con Calcitonina , Proteína C-Reactiva , Estudios Retrospectivos
4.
J Inflamm Res ; 17: 591-601, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38318242

RESUMEN

Background: Sivelestat, a neutrophil elastase inhibitor, is specifically developed to mitigate the occurrence of acute lung injury (ALI) in individuals who are undergoing cardiovascular surgery. However, its impact on patients who are at a heightened risk of developing ALI after scheduled cardiac surgery has yet to be determined. In order to address this knowledge gap, we undertook a study to assess the efficacy of sivelestat in protecting the lungs of these patients. Methods: We conducted a prospective cohort study involving 718 patients who were at high risk of developing postoperative acute lung injury (ALI) and underwent scheduled cardiac surgery between April 25th, 2022, and September 7th, 2023. Among them, 52 patients received sivelestat (administered at a dosage of 0.2mg/kg/h for 3 days), while 666 patients served as controls, not receiving sivelestat. The control conditions were the same for all patients, including ventilation strategy, extubating time, and fluid management. Subsequently, a propensity-score matched cohort was established, consisting of 40 patients in both the sivelestat and control groups. The primary outcome measure encompassed a composite of adverse outcomes, including 30-day mortality, ALI, acute respiratory distress syndrome (ARDS), and others. Secondary outcomes assessed included pneumonia, ventricular arrhythmias, mechanical ventilation (MV) time, and more. Results: After conducting propensity matching in our study, we observed that there were no significant differences in 30-day mortality between the sivelestat and control groups (0% vs 2.5%, P=0.32). However, the use of sivelestat exhibited a significant reduction in the incidence of acute lung injury/acute respiratory distress syndrome (ALI/ARDS) compared to the control group (0% vs 55%, P<0.01), pneumonia (0 vs 37.5%, P<0.01), MV time (median:8 hours, IQR:4-14.8 hours vs median: 15.2 hours, IQR:14-16.3 hours, P<0.01). Compared to the control group, the sivelestat could significantly decrease white cell count (P<0.01), neutrophile percentage (P<0.01) and C-reactive protein (P<0.01) in the period of postoperative 5 days. Conclusion: The prophylactic administration of sivelestat has shown promising results in reducing the occurrence of acute lung injury/acute respiratory distress syndrome (ALI/ARDS) in patients with a heightened risk of developing these conditions after elective cardiac surgery. Our study findings indicate that sivelestat may provide protective effects by suppressing inflammation triggered by neutrophil activation, thereby safeguarding pulmonary function. Registration: ChiCTR2200059102, https://www.chictr.org.cn/showproj.html?proj=166643.

5.
J Inflamm Res ; 16: 3983-3996, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37719939

RESUMEN

Background: Early postoperative bacterial pneumonia and sepsis (ePOPS), which occurs within the first 48 hours after cardiovascular surgery, is a serious life-threatening complication. Diagnosis of ePOPS is extremely challenging, and the existing diagnostic tools are insufficient. The purpose of this study was to construct a novel diagnostic prediction model for ePOPS. Methods: Least Absolute Shrinkage and Selection Operator (LASSO) with logistic regression was used to construct a model to diagnose ePOPS based on patients' comorbidities, medical history, and laboratory findings. The area under the receiver operating characteristic curve (AUC) was used to evaluate the model discrimination. Results: A total of 1203 patients were recruited and randomly split into a training and validation set in a 7:3 ratio. By early morning on the 3rd postoperative day (POD3), 103 patients had experienced 133 episodes of bacterial pneumonia or sepsis (15 patients had both). LASSO logistic regression model showed that duration of mechanical ventilation (P=0.015), NYHA class ≥ III (P=0.001), diabetes (P<0.001), exudation on chest radiograph (P=0.011) and IL-6 on POD3 (P<0.001) were independent risk factors. Based on these factors, we created a nomogram named DICS-I with an AUC of 0.787 in the training set and 0.739 in the validation set. Conclusion: The DICS-I model may be used to predict the risk of ePOPS after cardiovascular surgery, and is also especially suitable for predicting the risk of IRAO. The DICS-I model could help clinicians to adjust antibiotics on the POD3.

6.
BMC Anesthesiol ; 23(1): 262, 2023 08 05.
Artículo en Inglés | MEDLINE | ID: mdl-37543588

RESUMEN

BACKGROUND: We sought to explore the relationship between dexmedetomidine as an anesthetic adjuvant in cardiac surgery and postoperative complications and length of stay (LOS) in the cardiac intensive care unit (CICU). METHODS: We conducted a retrospective study of patients aged 18 years and older who underwent heart valve surgery between October 2020 and June 2022. The primary endpoint of the study was major postoperative complications (cardiac arrest, atrial fibrillation, myocardial injury/infarction, heart failure) and the secondary endpoint was prolonged CICU LOS (defined as LOS > 90th percentile). Multivariate logistic regression analysis was performed for variables that were significant in the univariate analysis. RESULTS: A total of 856 patients entered our study. The 283 patients who experienced the primary and secondary endpoints were included in the adverse outcomes group, and the remaining 573 were included in the prognostic control group. Multivariate logistic regression analysis revealed that age > 60 years (odds ratio [OR], 1.68; 95% confidence interval [CI], 1.23-2.31; p < 0.01), cardiopulmonary bypass (CPB) > 180 min (OR, 1.62; 95% CI, 1.03-2.55; p = 0.04) and postoperative mechanical ventilation time > 10 h (OR, 1.84; 95% CI, 1.35-2.52; p < 0.01) were independent risk factors for major postoperative complications; Age > 60 years (OR, 3.20; 95% CI, 1.65-6.20; p < 0.01), preoperative NYHA class 4 (OR, 4.03; 95% CI, 1.74-9.33; p < 0.01), diabetes mellitus (OR, 2.57; 95% CI, 1.22-5.41; p = 0.01), Intraoperative red blood cell (RBC) transfusion > 650 ml (OR, 2.04; 95% CI, 1.13-3.66; p = 0.02), Intraoperative bleeding > 1200 ml (OR, 2.69; 95% CI, 1.42-5.12; p < 0.01) were independent risk factors for prolonged CICU length of stay. Intraoperative use of dexmedetomidine as an anesthetic adjunct was a protective factor for major complications (odds ratio, 0.51; 95% confidence interval, 0.35-0.74; p < 0.01) and prolonged CICU stay. (odds ratio, 0.37; 95% confidence interval, 0.19-0.73; p < 0.01). CONCLUSIONS: In patients undergoing heart valve surgery, age, duration of cardiopulmonary bypass, and duration of mechanical ventilation are associated with major postoperative complication. Age, preoperative NYHA classification 4, diabetes mellitus, intraoperative bleeding, and RBC transfusion are associated with increased CICU length of stay. Intraoperative use of dexmedetomidine may improve such clinical outcomes.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Dexmedetomidina , Diabetes Mellitus , Humanos , Dexmedetomidina/uso terapéutico , Tiempo de Internación , Estudios Retrospectivos , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Unidades de Cuidados Intensivos , Factores de Riesgo , Válvulas Cardíacas/cirugía , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología
8.
Front Immunol ; 14: 1082830, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36761773

RESUMEN

Background: The sivelestat is a neutrophil elastase inhibitor thought to have an effect against acute lung injury (ALI) in patients after scheduled cardiac surgery. However, the beneficial effect of sivelestat in patients undergoing emergent cardiovascular surgery remains unclear. We aim to evaluate the effect of sivelestat on pulmonary protection in patients with ALI after emergent cardiovascular surgery. Methods: Firstly, a case-control study in 665 patients undergoing emergent cardiovascular surgery from January 1st, 2020 to October 26th, 2022 was performed. 52 patients who received sivelestat (0.2mg/kg/h for 3 days) and 613 age- and sex-matched controls. Secondly, a propensity-score matched cohort (sivelestat vs control: 50 vs 50) was performed in these 665 patients. The primary outcome was a composite of adverse outcomes, including 30-day mortality, ECMO, continuous renal replacement therapy (CRRT) and IABP, etc. The secondary outcome included pneumonia, ventricular arrhythmias and mechanical ventilation time, etc. Results: In propensity-matched patients, the 30-day mortality (16% vs 24%, P=0.32), stroke (2% vs 8%, P=0.17), ECMO(6% vs 10%, P=0.46), IABP(4% vs 8%, P=0.40) and CRRT(8% vs 20%, P=0.08) had no differences between sivelestat and control group; sivelestat could significantly decrease pneumonia (40% vs 62%, P=0.03), mechanical ventilation time (median: 96hours, IQR:72-120hours vs median:148hours, IQR:110-186hours, P<0.01), bilateral pulmonary infiltrates (P<0.01), oxygen index (P<0.01), interleukin-6(P=0.02), procalcitonin(P<0.01) and C-reactive protein(P<0.01). Conclusion: Administration of sivelestat might improve postoperative outcomes in patients with ALI after emergent cardiovascular surgery. Our results show that sivelestat may be considered to protect pulmonary function against inflammatory injury by CPB. Registration: http://www.chictr.org.cn/showproj.aspx?proj=166643, identifier ChiCTR2200059102.


Asunto(s)
Lesión Pulmonar Aguda , Puente Cardiopulmonar , Humanos , Puente Cardiopulmonar/efectos adversos , Proteínas Inhibidoras de Proteinasas Secretoras/uso terapéutico , Estudios de Casos y Controles , Lesión Pulmonar Aguda/tratamiento farmacológico , Lesión Pulmonar Aguda/etiología , Lesión Pulmonar Aguda/prevención & control
9.
Crit Care ; 27(1): 49, 2023 02 07.
Artículo en Inglés | MEDLINE | ID: mdl-36747296

RESUMEN

BACKGROUND: Recent high-quality trials have shown that the anti-inflammatory effects of colchicine reduce the risk of cardiovascular events in patients suffering post-myocardial infarction and chronic coronary disease. The effect of colchicine in patients undergoing non-coronary artery bypass grafting (non-CABG) with cardiopulmonary bypass remains unclear. We aim to evaluate the effect of colchicine on myocardial protection in patients who underwent non-CABG cardiac surgery. METHOD: Patients were randomly assigned to colchicine or placebo groups starting 72 h before scheduled cardiac surgery and for 5 days thereafter (0.5 mg daily).The primary outcome was the level of cardiac troponin T (cTnT) at postoperative 48 h. The secondary outcomes included troponin I (cTnI) and creatine kinase-MB (CK-MB), inflammatory biomarkers (procalcitonin and interleukin-6, etc.), and adverse events (30-day mortality, stroke, ECMO and IABP use, etc.). RESULTS: A total of 132 patients underwent non-CAGB cardiac surgery, 11were excluded because of diarrhea (n = 6) and long aortic cross-clamp time > 2 h (n = 5), 59 were assigned to the colchicine group and 62 to the placebo group. Compared with the placebo group, cTnT (median: 0.3 µg/L, IQR 0.2-0.4 µg/L vs. median: 0.4 µg/L, IQR 0.3-0.6 µg/L, P < 0.01), cardiac troponin I (median: 0.9 ng/ml, IQR 0.4-1.7 ng/ml vs. median: 1.3 ng/ml, IQR 0.6-2.3 ng/ml, P = 0.02), CK-MB (median: 1.9 ng/ml, IQR 0.7-3.2 ng/ml vs. median: 4.4 ng/ml, IQR 1.5-8.2 ng/ml, P < 0.01), and interleukin-6 (median: 73.5 pg/ml, IQR 49.6-125.8 pg/ml vs. median: 101 pg/ml, IQR 57.5-164.7 pg/ml, P = 0.048) were significantly reduced in colchicine group at postoperative 48 h. For safety evaluation, the colchicine (n = 65) significantly decreased post-pericardiotomy syndrome (3.08% vs. 17.7%, P < 0.01) and increased the rate of diarrhea (9.23% vs. 0, P = 0.01) compared with the placebo group (n = 62). No significant difference was observed in other adverse events between the two groups. CONCLUSION: A short perioperative course of low-dose colchicine was effective to attenuate the postoperative biomarkers of myocardial injury and inflammation, and to decrease the postoperative syndrome compared with the placebo. Trial registration ChiCTR2000040129. Registered 22nd Nov. 2020. This trial was registered before the first participant was enrolled. http://www.chictr.org.cn/showproj.aspx?proj=64370 .


Asunto(s)
Infarto del Miocardio , Troponina I , Humanos , Colchicina/farmacología , Colchicina/uso terapéutico , Interleucina-6 , Forma MB de la Creatina-Quinasa , Troponina T , Biomarcadores
10.
BMC Cardiovasc Disord ; 22(1): 306, 2022 07 07.
Artículo en Inglés | MEDLINE | ID: mdl-35794529

RESUMEN

BACKGROUND: Postoperative pneumonia (PP) is one of the most common complications after cardiac surgery. This study was designed to access the diagnostic value of interleukin-6 (IL-6) for pneumonia within the first 5 days after cardiac surgery in adults. METHOD: This prospective observational study enrolled 694 patients who admitted to our center from 10 October 2020 to 30 June 2021. Blood samples were collected after admission and on five consecutive days after surgery to measure IL-6, procalcitonin (PCT), C-reactive protein (CRP) and white blood cells (WBC) respectively. Combined with clinical data, we assessed the diagnostic performance of different biomarkers using univariate and multifactorial analyses as well as receiver operating characteristic curves (ROC) and the area under the curve (AUC). RESULT: Finally, 68 patients were diagnosed with PP (PP Group). In addition, 626 cases were assigned to the control group (Non-PP Group). From postoperative day 1 (POD1) to day 5, IL-6 and PCT levels showed higher diagnostic value (P < 0.001, P < 0.05, respectively); meanwhile, there was no difference in white blood cell counts between the two groups; CRP showed some value from POD2 onwards (P < 0.001). Among these biomarkers, IL-6 on POD1 [AUC: 0.78, 95% confidence interval (CI): 0.71-0.83], IL-6 on POD2 (AUC: 0.77, 95% CI: 0.71-0.82) and CRP levels on POD3 (AUC: 0.77, 95% CI: 0.70-0.84) had the highest diagnostic value. Multivariate analysis found that smoking status [odds ratio(OR): 7.79, 95% CI: 3.05, 19.88, p < 0.001], drinking status (OR: 22.68, 95% CI: 9.29, 55.37, p < 0.001) and hypertension (OR: 2.85, 95% CI: 1.28, 6.35, p = 0.011), IL-6 on POD2 (OR: 1.01, 95% CI: 1.00, 1.01, p = 0.018), mechanical ventilation time (OR: 1.03, 95% CI: 1.00, 1.05, p = 0.040) and intensive care unit stay time (OR: 1.01, 95% CI: 1.00, 1.02, p < 0.001) were independent risk factors for postoperative pneumonia. CONCLUSION: Smoking, drinking, hypertension, prolonged duration of mechanical ventilation and intensive care unit stay, and IL-6 on POD2 were independent risk factors for pneumonia after cardiovascular surgery. IL-6 level on POD2 may serve as a promising indicator, better than WBC, PCT and CRP.


Asunto(s)
Hipertensión , Interleucina-6 , Neumonía , Adulto , Biomarcadores/sangre , Proteína C-Reactiva/análisis , Calcitonina/análisis , Progresión de la Enfermedad , Humanos , Hipertensión/sangre , Interleucina-6/sangre , Neumonía/sangre , Neumonía/diagnóstico , Complicaciones Posoperatorias/sangre , Polipéptido alfa Relacionado con Calcitonina/sangre , Estudios Prospectivos , Precursores de Proteínas/sangre
11.
BMC Anesthesiol ; 22(1): 135, 2022 05 03.
Artículo en Inglés | MEDLINE | ID: mdl-35501683

RESUMEN

STUDY OBJECTIVE: The purpose of the present study was to evaluate the efficacy of levosimendan in patients with acute myocardial infarction related ventricular septal rupture (AMI-VSR) underwent cardiac surgery. DESIGN: Prospective observational cohort study with propensity score analysis. PATIENTS: There were 261 patients with AMI-VSR in our study. After 1:1 propensity matching, 106 patients (53 levosimendan and 53 control) were selected in the matched cohort. INTERVENTIONS: None. MEASUREMENTS: Patients who received levosimendan were assigned to the levosimendan group (n = 164). The patients who were not received were levosimendan assigned to the control group (n = 97). The levosimendan was initiated immediately after cardiopulmonary bypass. Then, it has been maintained during the postoperative 3 days. The poor outcomes were identified as follows: death and postoperative complications (postoperative stroke, low cardiac output syndromeneeded mechanical circulatory support after surgery, acute kidney injury (≥ stage III), postoperative infection or septic shock, new developed atrial fibrillation or ventricular arrhythmias). MAIN RESULTS: Before matching, the control group had more length of ICU stay (6.69 ± 3.90 d vs. 5.20 ± 2.24 d, p < 0.001) and longer mechanical ventilation time (23 h, IQR: 16-53 h vs. 16 h, IQR: 11-23 h, p < 0.001). Other postoperative outcomes have not shown significant differences between two groups. After matching, no significant difference was found between both groups for all postoperative outcomes. The Kaplan-Meier survivul estimate and log-rank test showed that the 90-day survival had no significant differences between two groups before and after matching. CONCLUSION: Our study found that a low-dose infusion of levosimendan in AMI-VSR patients underwent surgical repair did not associated with positively affect to postoperative outcomes.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Infarto del Miocardio , Piridazinas , Rotura Septal Ventricular , Enfermedad Aguda , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Cardiotónicos , Femenino , Humanos , Hidrazonas/uso terapéutico , Masculino , Infarto del Miocardio/complicaciones , Infarto del Miocardio/tratamiento farmacológico , Complicaciones Posoperatorias , Puntaje de Propensión , Estudios Prospectivos , Piridazinas/uso terapéutico , Simendán , Rotura Septal Ventricular/tratamiento farmacológico
12.
BMJ Open ; 12(5): e056264, 2022 05 06.
Artículo en Inglés | MEDLINE | ID: mdl-35523485

RESUMEN

INTRODUCTION: Heart failure (HF) is a growing global public health burden. However, due to the very limited regenerative capacity of mature cardiomyocytes in the adult mammalian heart, conventional treatments can only improve the symptoms of HF but fail to restore cardiac function. Heart transplantation is limited by a severe shortage of donors. Cell-based transplantation for the treatment of HF has become a promising strategy. Human-induced-pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) have been tested in animal models to assess safety and efficacy. This study aims at evaluating the safety and efficacy of epicardial injection of hiPSC-CMs in patients with advanced HF during coronary artery bypass grafting (CABG) surgery. METHODS: This study is a dose-escalation, placebo-controlled, single-centre phase I/IIa clinical trial. Dose escalation will be guided by a modified 3+3 design for three doses (1×108, 2×108 and 4×108 cells, sequentially). Patients with advanced heart failure will be enrolled and randomly allocated to receive epicardial injection of hiPSC-CMs during CABG surgery or CABG surgery alone, followed by a 12-month follow-up investigation. The primary endpoint is to assess the safety of hiPSC-CMs transplantation, including haemodynamic compromised sustained ventricular arrhythmias and newly formed tumours during 6 months postoperatively. The secondary endpoint is to evaluate the efficacy of epicardial injection of hiPSC-CMs and CABG surgery combination by comparison with CABG surgery alone. ETHICS AND DISSEMINATION: The study protocol has been approved by the Institutional Ethical Committee of Nanjing Drum Tower Hospital (No. SC202000102) and approved by National Health Commission of the PRC (MR-32-21-014649). Findings will be disseminated to the academic community through peer-reviewed publications and presentation at national and international meetings. TRIAL REGISTRATION NUMBER: NCT03763136.


Asunto(s)
Insuficiencia Cardíaca , Trasplante de Células Madre Hematopoyéticas , Células Madre Pluripotentes Inducidas , Ensayos Clínicos Fase I como Asunto , Ensayos Clínicos Fase II como Asunto , Puente de Arteria Coronaria , Insuficiencia Cardíaca/cirugía , Humanos , Células Madre Pluripotentes Inducidas/patología , Células Madre Pluripotentes Inducidas/trasplante , Miocitos Cardíacos/patología , Ensayos Clínicos Controlados Aleatorios como Asunto
13.
BMJ Open ; 12(2): e050577, 2022 Feb 01.
Artículo en Inglés | MEDLINE | ID: mdl-35105570

RESUMEN

INTRODUCTION: Inflammation and myocardial damage caused by cardiovascular surgery with cardiopulmonary bypass (CPB) have been shown to be the major contributors to postoperative morbidity and mortality. Colchicine can reduce myocardial ischaemia-reperfusion injury in patients with chronic coronary artery disease. However, there is a lack of evidence whether colchicine could reduce myocardial injury after cardiovascular surgery. In this study, we aim to evaluate the effect of low-dose colchicine on myocardial protection during perioperative period in patients who undergo cardiovascular surgery with CPB. METHODS AND ANALYSIS: In this randomised controlled trial, a total of 132 patients will be recruited from the Department of Cardio-Thoracic Surgery, Nanjing Drum Tower Hospital. Patients will be randomised into the colchicine treatment group and control group with a ratio of 1:1. Patients in the colchicine treatment group will receive 0.5 mg of colchicine daily for 3 days before surgery and 0.5 mg of colchicine daily for 5 days after surgery. Patients in the control group will receive placebo instead of colchicine for the same schedule. Level of postoperative myocardial injury will be assessed as the primary outcome. The secondary outcomes are biomarker levels for myocardial injury (such as creatine kinase-MB, cardiac troponin I, myohaemoglobin, type B natriuretic peptide, D-dimer) and inflammatory response markers (white blood cell, procalcitonin, interleukin-6, C reactive protein) for 5 consecutive days after surgery and poor postoperative outcomes. ETHICS AND DISSEMINATION: This study has been approved by Medical Ethics Committee of Affiliated Nanjing Drum Tower Hospital, Nanjing University Medical College (approval number: 2020-293-01). Study results will be disseminated through publication in an open access journal. TRIAL REGISTRATION NUMBER: ChiCTR2000040129.


Asunto(s)
Isquemia Miocárdica , Daño por Reperfusión Miocárdica , Procedimientos Quirúrgicos Torácicos , Puente Cardiopulmonar/efectos adversos , Colchicina/uso terapéutico , Humanos , Isquemia Miocárdica/etiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento
14.
J Cardiothorac Surg ; 16(1): 326, 2021 Nov 07.
Artículo en Inglés | MEDLINE | ID: mdl-34743732

RESUMEN

BACKGROUND: Cannulation strategy in surgery for acute type A aortic dissection (ATAAD) remains controversial. We aimed to retrospectively analyze the safety and efficacy of double arterial cannulation (DAC) compared with right axillary cannulation (RAC) for ATAAD. METHODS: From January 2016 to December 2018, 431 ATAAD patients were enrolled in the study. Patients were divided into DAC group (n = 341) and RAC group (n = 90). Propensity score matching analysis was performed to compare the early and mid-term outcomes between these two groups. To confirm the organ protection effect by DAC, intraoperative blood gas results and cardiopulmonary bypass parameters were compared between the two groups. RESULTS: Demographics and preoperative comorbidities were comparable between two groups, while patients in DAC group were younger than RAC group (51.55 ± 13.21 vs. 56.07 ± 12.16 years, P < 0.001). DAC had a higher incidence of limb malperfusion (18.2% vs. 10.0%, P = 0.063) and lower incidence of coronary malperfusion (5.3% vs. 12.2%, P = 0.019). No significant difference in cardiopulmonary bypass and cross-clamp time was found between the two groups. The in-hospital mortality was 13.5% (58/431), while there was no difference between the two groups (13.5% vs. 13.3%; P = 0.969). Patients who underwent DAC had higher incidence of postoperative stroke (5.9% vs. 0%, P = 0.019) and lower incidence of postoperative acute kidney injury (AKI) (24.7% vs. 40.3%; P = 0.015). During a mean follow-up period of 31.8 (interquartile range, 25-45) months, the overall survival was 81.5% for DAC group and 78.0% for RAC group (P = 0.560). Intraoperative blood gas results and cardiopulmonary bypass parameters showed that DAC group had more intraoperative urine output volume than RAC group (P = 0.05), and the time of cooling (P = 0.04) and rewarming (P = 0.04) were shorter in DAC group. CONCLUSIONS: DAC will not increase the surgical risks compared to RAC, but could reduce the incidence of postoperative AKI which may be benefit for renal protection.


Asunto(s)
Disección Aórtica , Arteria Axilar , Disección Aórtica/cirugía , Puente Cardiopulmonar , Cateterismo , Humanos , Estudios Retrospectivos , Resultado del Tratamiento
15.
BMC Cardiovasc Disord ; 21(1): 509, 2021 10 21.
Artículo en Inglés | MEDLINE | ID: mdl-34674651

RESUMEN

BACKGROUND: To investigate the risk factors for mortality in patients with acute kidney injury requiring continuous renal replacement therapy (AKI-CRRT) after cardiac surgery. METHODS: In this retrospective study, patients who underwent AKI-CRRT after cardiac surgery in our centre from January 2015 to January 2020 were included. Univariable and multivariable analyses were performed to identify the risk factors for in-hospital mortality. RESULTS: A total of 412 patients were included in our study. Of these, 174 died after AKI-CRRT, and the remaining 238 were included in the survival control group. Multivariable logistic regression analysis revealed that EuroSCORE > 7 (odds ratio [OR], 3.72; 95% confidence interval [CI], 1.92-7.24; p < 0.01), intraoperative bleeding > 1 L (OR, 2.14; 95% CI, 1.19-3.86; p = 0.01) and mechanical ventilation time > 70 h (OR, 5.03; 95% CI, 2.40-10.54; p < 0.01) were independent risk factors for in-hospital mortality in patients who had undergone AKI-CRRT. Our study also found that the use of furosemide after surgery was a protective factor for such patients (odds ratio, 0.48; 95% confidence interval, 0.25-0.92; p = 0.03). CONCLUSIONS: In summary, the mortality of patients with AKI-CRRT after cardiac surgery remains high. The EuroSCORE, intraoperative bleeding and mechanical ventilation time were independent risk factors for in-hospital mortality. Continuous application of furosemide may be associated with a better outcome.


Asunto(s)
Lesión Renal Aguda/mortalidad , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Terapia de Reemplazo Renal Continuo , Complicaciones Posoperatorias/mortalidad , Lesión Renal Aguda/etiología , Lesión Renal Aguda/terapia , Factores de Edad , Anciano , Femenino , Mortalidad Hospitalaria , Humanos , Complicaciones Intraoperatorias , Masculino , Persona de Mediana Edad , Análisis Multivariante , Complicaciones Posoperatorias/terapia , Análisis de Regresión , Respiración Artificial , Estudios Retrospectivos , Factores de Riesgo
16.
J Clin Anesth ; 75: 110489, 2021 12.
Artículo en Inglés | MEDLINE | ID: mdl-34481363

RESUMEN

STUDY OBJECTIVE: A lateral mini-thoracotomy approach to cardiac surgery causes severe and complicated postoperative pain compared to the sternotomy approach. In this study we assessed the benefits and risks of intermittent bolus erector spinae plane block (ESPB) via a catheter for patients who underwent cardiac surgery through a lateral mini-thoracotomy. DESIGN: A propensity score-matched retrospective cohort study. SETTING: University hospital. PATIENTS: 452 consecutive patients that underwent cardiac surgery through a lateral mini-thoracotomy from 2018 to 2020. INTERVENTIONS: Patients who received intermittent bolus ESPB through a catheter for 3 days (ESPB group, n = 93) were compared with patients who did not receive any regional anesthesia (Control group, n = 174) after propensity score matching. MEASUREMENTS: The primary endpoint was postoperative in-hospital cumulative opioid consumption (calculated as oral morphine milligram equivalents, MME). The secondary outcomes were intraoperative sufentanil doses, therapeutic use of antiemetic, pulmonary infection (assessed using a modified clinical pulmonary infection score, CPIS), durations of ICU and hospital stays, and ESPB related/unrelated complications. MAIN RESULTS: There is a lower oral MME in the ESPB group, 266 ± 126 mg in the ESPB group vs. 346 ± 105 mg in the control group (95% CI -113 to -46; P < 0.01). Fewer patients received therapeutic antiemetic agents in the ESPB group (30% vs. 42%, odds ratio 0.58; 95% CI 0.34 to 0.99; P = 0.04). The modified CPIS in the ESPB group is lower: 1.4 ± 0.9 vs. 2.0 ± 1.0 (95% CI -0.9 to -0.3; P < 0.01) on postoperative day 1; 1.6 ± 0.9 vs. 2.0 ± 0.9 (95% CI -0.7 to -0.2; P < 0.01) on postoperative day 2. The observed complications associated with ESPB include pneumothorax (1%), staxis around stomas (5%), hypotension (1%), catheter displacement (3%), and catheter obstruction (2%). None of the patients had any adverse outcomes. CONCLUSION: Intermittent bolus ESPB is relatively safe and correlated with a reduction in the use of opioids and antiemetics for cardiac surgery through a lateral mini-thoracotomy.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Bloqueo Nervioso , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Catéteres , Humanos , Bloqueo Nervioso/efectos adversos , Dolor Postoperatorio/etiología , Dolor Postoperatorio/prevención & control , Puntaje de Propensión , Estudios Retrospectivos , Medición de Riesgo , Toracotomía/efectos adversos
17.
BMJ Open ; 11(9): e048310, 2021 09 21.
Artículo en Inglés | MEDLINE | ID: mdl-34548352

RESUMEN

INTRODUCTION: Postoperative infection (PI) is one of the main severe complications after cardiovascular surgery. Therefore, antibiotics are routinely used during the first 48 hours after cardiovascular surgery. However, there is no effective method for early diagnosis of infection after cardiovascular surgery, particularly, to determine whether postoperative patients need to prolong the use of antibiotics after the first 48 hours. In this study, we aim to develop and validate a diagnostic model to help identify whether a patient has been infected after surgery and guide the appropriate use of antibiotics. METHODS AND ANALYSIS: In this prospective study, we will develop and validate a diagnostic model to determine whether the patient has a bacterial infection within 48 hours after cardiovascular surgery. Baseline data will be collected through the electronic medical record system. A total of 2700 participants will be recruited (n=2000 for development, n=700 for validation). The primary outcome of the study is the newly PI during the first 48 hours after cardiovascular surgery. Logistic regression penalised with elastic net regularisation will be used for model development and bootstrap and k-fold cross-validation aggregation will be performed for internal validation. The derived model will be also externally validated in patients who are continuously included in another time period (N=700). We will evaluate the calibration and differentiation performance of the model by Hosmer-Lemeshow good of fit test and the area under the curve, respectively. We will report sensitivity, specificity, positive predictive value and negative predictive value in the validation data-set, with a target of 80% sensitivity. ETHICS AND DISSEMINATION: Ethical approval was obtained from Medical Ethics Committee of Affiliated Nanjing Drum Tower Hospital, Nanjing University Medical College (2020-249-01). TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Register (www.chictr.org.cn, ChiCTR2000038762); Pre-results.


Asunto(s)
Proyectos de Investigación , Diagnóstico Precoz , Humanos , Modelos Logísticos , Estudios Observacionales como Asunto , Estudios Prospectivos
18.
J Cardiothorac Surg ; 16(1): 238, 2021 Aug 23.
Artículo en Inglés | MEDLINE | ID: mdl-34425880

RESUMEN

OBJECTIVE: Hyperbilirubinemia after cardiac surgery increases in-hospital mortality and is associated with poor prognosis. Our present study aimed to compare the efficacy of bilirubin adsorption (BA) and plasma exchange (PEX) in patients with hyperbilirubinemia after cardiac surgery. METHODS: We retrospectively included patients who underwent BA treatment or PEX treatment due to severe hyperbilirubinemia after cardiac surgery at our center from 2015 to 2020. We collected results from urine and liver function tests before and after treatment and compared the in-hospital mortality and morbidity between the two treatment groups. RESULTS: A total of 56 patients were enrolled in this study: 14 patients received BA treatment, and 42 patients received PEX treatment. Compared to the PEX group, the BA group exhibited a statistically significant reduction in total bilirubin (p = 0.016) and direct bilirubin (p = 0.036) levels. The in-hospital mortality was 85.7% (48/56) in the whole group, and the BA group had a lower mortality than the PEX group (71.4% vs. 90.5%, p = 0.078). The BA group showed better circulatory support, including lower risks of IABP (21.4% vs. 52.4%, p = 0.044), ECMO (21.4% vs. 50.0%, p = 0.061), reintubation (64.3% vs. 40.5%, p = 0.122) and ventricular arrhythmias (64.3% vs. 45.2%, p = 0.217). The in-hospital mortality was still lower in the BA treatment group than in the PEX treatment group (71.4% vs. 100%, p = 0.049) in the matched cohort. CONCLUSIONS: Compared to PEX treatment, BA treatment had a higher bilirubin removal ability in patients with hyperbilirubinemia and could reduce the mortality and risks of poor clinical outcomes. BA treatment should be considered an effective treatment method for patients with higher total bilirubin or direct bilirubin levels.


Asunto(s)
Bilirrubina , Procedimientos Quirúrgicos Cardíacos , Adsorción , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Humanos , Hiperbilirrubinemia/terapia , Intercambio Plasmático , Estudios Retrospectivos
19.
BMC Cardiovasc Disord ; 20(1): 379, 2020 08 20.
Artículo en Inglés | MEDLINE | ID: mdl-32819270

RESUMEN

BACKGROUND: Preoperative low left ventricular ejection fraction (LVEF) has been reported as an independent risk factor for in-hospital mortality. However, there were few studies evaluating the long-term mortality in these patients. We, therefore, conducted this study to investigate long-term outcomes of surgery on patients with LVEF≤35% undergoing a broad range of cardiac procedures. METHODS: We performed a retrospective cohort study in 510 patients from January 1, 2007 to September 1, 2019. These patients were divided into survival group (n = 386) and non-survival group (n = 124). The multivariate Cox analysis was used to estimate the risk factors for survival. In Cox analysis, ß-blockers were indicated to be associated with long-term mortality. To further address bias, we derived a propensity score predicting the function of ß-blockers on survival, and matched 52 cases to 52 controls with similar risk profiles. RESULTS: Patients were followed for a median period of 24 months (interquartile range: 11-44 months). Multivariate Cox regression analysis indicated that the non-survival group had higher weight, higher EuroSCORE, more smoking patients, longer time of cardiopulmonary bypass (CPB), more intra-aortic balloon pump (IABP) use, and more patients who always used ß-blocker (HR: 2.056, 95%CI:1.236-3.420, P = 0.005) compared with survival group. After propensity matching, the group which always used ß-blocker showed higher rate of all-cause death compare with the control group (61.54% vs 80.77%, P = 0.030). CONCLUSIONS: The risk factors for long-term survival were weight, EuroSCORE, smoking, CPB, IABP, always used ß-blockers in patients with LVEF≤35%. The discharge prescription of ß-blocker should be cautiously administrated in those patients.


Asunto(s)
Antagonistas Adrenérgicos beta/uso terapéutico , Procedimientos Quirúrgicos Cardíacos , Cardiopatías/cirugía , Volumen Sistólico/efectos de los fármacos , Función Ventricular Izquierda/efectos de los fármacos , Antagonistas Adrenérgicos beta/efectos adversos , Adulto , Anciano , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/mortalidad , Femenino , Cardiopatías/diagnóstico , Cardiopatías/mortalidad , Cardiopatías/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
20.
J Card Surg ; 35(9): 2168-2174, 2020 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-32652637

RESUMEN

BACKGROUND: In this study, we compare the clinical characteristics, intraoperative management, and postoperative outcomes of patients with acute type A aortic dissection (ATAAD) between two academic medical hospitals in the United States and China. METHODS: From January 2011 to December 2017, 641 and 150 patients from Nanjing Drum Tower Hospital (NDTH) and Massachusetts General Hospital (MGH) were enrolled. Patient demographics, clinical features, surgical techniques, and postoperative outcomes were compared. RESULTS: The annual number of patients presenting with ATAAD at MGH remained relatively stable, while the number at NDTH increased significantly over the study period. The average age was 51 years at NDTH and 61 years at MGH (P < .001). The percentage of patients with known hypertension at the two centers was similar. The time interval from onset of symptoms to diagnosis was significantly longer at NDTH than MGH (11 vs 3.5 hours; P < .001). Associated complications at presentation were more common at NDTH than MGH. More than 90% of patients (91% NDTH and 92% MGH) underwent surgery. The postoperative stroke rate was higher at MGH (12% vs 4%; P < .001); however, the 30-day mortality rate was lower (7% vs 16%; P = .006). CONCLUSIONS: There was a significant increase in the number of ATAAD at NDTH during the study period while the number at MGH remained stable. Hypertension was a common major risk factor; however, the onset of ATAAD at NDTH was nearly one decade earlier than MGH. Chinese patients tended to have more complicated preoperative pathophysiology at presentation and underwent more extensive surgical repair.


Asunto(s)
Disección Aórtica , Enfermedad Aguda , Disección Aórtica/epidemiología , Disección Aórtica/cirugía , China/epidemiología , Hospitales , Humanos , Massachusetts , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Estados Unidos/epidemiología
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