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Utility of age, creatinine, and ejection fraction score in patients with type B aortic dissection undergoing thoracic endovascular aortic repair
IJCA-28068; No of Pages 5 International Journal of Cardiology xxx (xxxx) xxx
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Utility of age, creatinine, and ejection fraction score in patients with type B aortic dissection undergoing thoracic endovascular aortic repair Xue-biao Wei a,b,1, Yu Wang b,1, Jian-fang Luo b, ∗∗∗, Wan-zi Hong b, Zedazhong Su b, Chun-xiang Zhang c, Danqing Yu b, ∗∗, Lei Jiang a, ∗ a b c
Guangdong Provincial Geriatrics Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, 510080, China Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, 510080, China Department of Biomedical Engineering, School of Medicine, University of Alabama at Birmingham, Birmingham, Ala, UK
a r t i c l e
i n f o
Article history: Received 26 July 2019 Received in revised form 2 September 2019 Accepted 30 September 2019 Available online xxxx Keywords: Risk score ACEF Type B aortic dissection Thoracic endovascular aortic repair Prognosis
a b s t r a c t Background: Older age, renal and cardiac dysfunction are predictors of poor outcome in aortic dissection. The aim of this study was to evaluate the association of the age, creatinine and ejection fraction (ACEF) score with adverse events in patients with type B aortic dissection (TBAD) undergoing thoracic endovascular aortic repair (TEVAR). Methods: The study enrolled 605 patients from January 2010 to July 2015, who were classified into three groups according to the tertiles of ACEF score: Tertile 1 (≤0.77, n = 204), Tertile 2 (0.77–0.96, n = 205) and Tertile 3 (N0.96, n = 196). The association between ACEF, AGEF (age, glomerular filtration rate and ejection fraction) and the updated version of the ACEF (ACEF II) score with adverse events was analyzed. Results: After a median 3.4 years follow-up, 63 (10.4%) patients died. Multivariable analysis revealed that ACEF score was independently associated with long-term mortality (adjusted hazard ratio = 3.54; 95% confidence interval, 2.09–6.01; p b 0.001). ACEF, AGEF and ACEF II score had similar predictive ability for both in-hospital and long-term death. The in-hospital mortality (1.5% vs. 1.0% vs. 6.6%, p = 0.001) were significantly higher in Tertile 3. In addition, cumulative long-term mortality in Tertile 3 was significantly higher than that in Tertile 1 and 2 (Log-Rank = 23.74; p b 0.001). Conclusion: ACEF score could be served as an useful and relatively simple tool for pre-TEVAR risk stratification in TBAD patients. © 2019 Elsevier B.V. All rights reserved.
1. Introduction Type B aortic dissections (TBAD) are catastrophic conditions with high complication and mortality rates [1]. Thoracic endovascular aortic repair (TEVAR) is an emerging treatment approach, which has been rapidly accepted by clinicians for treating TBAD [2–4]. Compared to open surgery and medical treatment, TEVAR is regarded as a superior treatment strategy with lower mortality [5]. However, the postoperative mortality is still high during short- and long-term follow up [6,7]. Early identification of patients at high risk for poor outcomes remains urgent and important.
The age, creatinine, and ejection fraction (ACEF) score is a novel and simple risk assessment tool which includes only three variables. This score was first developed in patients undergoing elective cardiac operations to predict mortality risk [8] and further validated in other surgical procedures, such as percutaneous coronary interventions, valve surgery and surgical ventricular reconstruction [9–11]. Older age, renal and cardiac dysfunction were accepted prognostic markers in aortic dissection [12–14]. Therefore, we suspected that the ACEF score could show great performance as well in TBAD patients undergoing TEVAR. In consequence, the present study was conducted to test the predictive accuracy of the ACEF score in patients with TBAD undergoing TEVAR. 2. Methods
∗ Corresponding author. ∗∗ Corresponding author. ∗∗∗ Corresponding author. E-mail addresses: [email protected] (J. Luo), [email protected] (D. Yu), [email protected] (L. Jiang). 1 These authors are considered as co-first authors.
2.1. Patient population This was a single-center study conducted in Guangdong Provincial People's Hospital. Patients with acute and sub-acute TBAD undergoing TEVAR were consecutively enrolled from January 2010 to July 2015. TBAD was diagnosed according to multi-detector computed tomography scanning. The indication for TEVAR was described in our previous
https://doi.org/10.1016/j.ijcard.2019.09.076 0167-5273/© 2019 Elsevier B.V. All rights reserved.
Please cite this article as: X. Wei, Y. Wang, J. Luo, et al., Utility of age, creatinine, and ejection fraction score in patients with type B aortic dissection un..., International Journal of Cardiology, https://doi.org/10.1016/j.ijcard.2019.09.076
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X. Wei et al. / International Journal of Cardiology xxx (xxxx) xxx
study [15]. The exclusion criteria were as follows: 1) age b18 years; 2) malignant tumor; 3) chronic AD (onset of symptoms to treatment N 90 days); 4) AD caused by trauma, iatrogenic injury or Marfan syndrome; and 5) missed admission serum creatinine or left ventricular ejection fraction (LVEF) records. The detailed selection process is shown in Fig. S1. After exclusions, 605 patients were included in the analysis. The study was approved by the Institutional Ethics Committee, with a waiver of informed consent due to retrospective study design. 2.2. Data collection and calculation Clinical data were collected from electronic medical records by one researcher, and these data were randomly checked by another researcher. The ACEF score was calculated as originally described by Ranucci M et al., using the formula: age/LVEF+1 point for serum creatinine N2 mg/dL [8]. The age, glomerular filtration rate and ejection fraction (AGEF) score was calculated according to the following formula: age/LVEF (%)+1 point, for every 10-ml/min reduction in estimated glomerular filtration rate (eGFR) b 60 mL/min/ 1.73 m2 (up to a maximum of 6 points) [16]. ACEF II score is also developed by Ranucci M et al., using the formula: age/LVEF +2 points for serum creatinine level N2 mg/dL + 3 points for emergency surgery +0.2 points*(36%-haematocrit) [17]. LVEF, serum creatinine and haematocrit used in the formula were the values recorded before TEVAR. The eGFR was calculated using the equation of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) [18]. 2.3. Clinical outcomes All in-hospital survival patients were followed up via telephone interviews after discharge. We also reviewed hospital readmission records and outpatient clinic interviews for possible events. The primary endpoint was long-term all-cause mortality. In addition, the incident of in-hospital spinal cord ischemia, stroke and post-TEVAR endoleak were also recorded. Spinal cord ischemia was defined as any new onset of paraplegia or paraparesis, manifested as 1) deficit in motor or sensory function of the lower extremities; or 2) urinary or bowel incontinence. 2.4. Statistical analysis Continuous variables were reported as mean ± SD or median and quartile range, and compared using analysis of variance or Wilcoxon rank-sum test, respectively. Categorical variables were expressed as percentages and compared by chi-square analysis. Univariate Cox proportional hazards model analysis was conducted to determine the independent predictors of long-term death. The variables whose p b 0.1, except the variables of ACEF score, were included in a multivariate model for further analysis. Discrimination performance of ACEF, AGEF and ACEF II score in predicting mortality was evaluated by receiver-operating characteristic (ROC) curve analysis and their areas under the curve (AUCs) were compared using the nonparametric approach. Survival analysis was also performed using the Kaplan-Meier method. All statistical analysis was performed using SPSS version 19.0 (Chicago, IL, USA). A value of p b 0.05 was considered significant. 3. Results 3.1. Baseline characteristics A total of 605 TBAD patients undergoing TEVAR were analyzed. They were classified into three groups according to the tertiles of ACEF score: Tertile 1 ≤ 0.77 (n = 204), Tertile 2 (0.77–0.96, n = 205) and Tertile 3 (N0.96, n = 196). The baseline characteristics according to ACEF score groups are described in Table 1. Significant differences were observed among tertiles in age, serum creatinine, eGFR and LVEF. In addition, the maximum aortic diameter in lesion was significant higher in patients with a high ACEF score (36.0 ± 8.6 vs. 38.0 ± 9.5 vs. 39.6 ± 9.9, p = 0.001), in whom the hemoglobin (129.4 ± 17.4 vs. 128.5 ± 17.1 vs. 122.3 ± 19.9, p b 0.001) level and hematocrit (38.4 ± 5.0 vs. 38.0 ± 5.2 vs. 36.2 ± 5.8, p b 0.001) was lower. 3.2. ACEF score and adverse events The median follow-up time was 3.4 years. In this period, 63 (10.4%) patients died and 73 (12.1%) lost follow up. Univariate Cox survival analysis revealed that ACEF score (per 1-point increase) was associated with long-term death (unadjusted odds ratio [OR], 4.67; 95% confidence interval [CI], 2.90 to 7.53; p b 0.001). After adjusting for potential risk factors (female gender, anemia, lg D-Dimer and maximum aortic diameter), ACEF score remained an independent predictor for long-term mortality (adjusted hazard ratio = 3.54; 95% CI, 2.09–6.01; p b 0.001; Table 2). 3.3. Clinical application of ACEF score In ROC curve analysis, ACEF, AGEF and ACEF II score presented excellent discrimination in predicting in-hospital death. The AUC of ACEF score for predicting in-hospital mortality was 0.725 (95% CI, 0.602 to 0.849; p b 0.001; sensitivity, 72.2%; specificity, 72.7%), and the optimum cut-off value was 1.0 (Fig. 1A). For AGEF and ACEF II score, the AUC was 0.702 (95% CI, 0.569 to 0.834; p = 0.003; Figs. 1A) and 0.764 (95% CI, 0.658 to 0.869; p b 0.001; Fig. 1A), respectively. Although the predictive ability of ACEF II score
Table 1 Baseline demographics and clinical characteristics. Clinical variables
Age (years) Gender, n (%) Male Female Current smoke, n (%) Concomitant disorders, n (%) Hypertension Diabetes Admission SBP (mmHg) Admission DBP (mmHg) Heart rate (bpm) Hemoglobin (g/L) Hematocrit (%) Serum creatinine (mg/dL) eGFR (mL/min/1.73m2) lg (D-Dimer) LVEF (%) Pleural effusion, n (%) Maximum aortic diameter in lesion (mm) False lumen thrombosis Post-TEVAR endoleak In-hospital events Spinal cord ischemia Stroke Death
ACEF score tertiles ≤0.77 (n = 204)
0.77–0.96 (n = 205)
N0.96 (n = 196)
P
44.5 ± 6.0
57.3 ± 5.8
62.7 ± 10.4
b0.001
173 (84.8) 170 (82.9) 31 (15.2) 35 (17.1) 86 (42.2) 78 (38.0)
177 (90.3) 0.088 19 (9.7) 83 (42.3) 0.609
169 (82.8) 9 (4.4) 135.3 ± 20.2 79.0 ± 13.0 78.7 ± 11.2 129.4 ± 17.4 38.4 ± 5.0 1.0 (0.8,1.2) 88.4 ± 23.9 3.1 ± 0.5 67.0 ± 5.5 102 (50.0) 36.0 ± 8.6
175 (85.4) 14 (6.8) 136.2 ± 21.6 79.7 ± 13.2
171 (87.2) 16 (8.2) 137.0 ± 21.8 79.1 ± 13.4 76.0 ± 11.3 77.3 ± 12.5 128.5 ± 122.3 ± 17.1 19.9 38.0 ± 5.2 36.2 ± 5.8 1.0 1.2 (0.8,1.2) (0.9,2.2) 82.5 ± 21.5 59.6 ± 29.5 3.1 ± 0.5 3.2 ± 0.5 65.8 ± 5.6 61.7 ± 7.4 86 (42.0) 99 (50.5) 38.0 ± 9.5 39.6 ± 9.9
0.462 0.300 0.734
48 (23.5) 17 (8.3)
63 (30.7) 15 (7.3)
68 (34.7) 13 (6.6)
0.046 0.808
5 (2.5) 4 (2.0) 3 (1.5)
3 (1.5) 8 (3.9) 2 (1.0)
4 (2.0) 8 (4.1) 13 (6.6)
0.772 0.416 0.001
0.840 0.068 b0.001 b0.001 b0.001 b0.001 0.035 b0.001 0.153 0.001
Abbreviations: SBP, systolic blood pressure; DBP, diastolic blood pressure; eGFR, estimated glomerular filtration rate; LVEF, left ventricular ejection fraction; TEVAR, thoracic endovascular aortic repair.
was higher, there was no significant difference when comparing with ACEF and AGEF score (p N 0.05). The in-hospital mortality was 3.0%, which was significantly higher in Tertile 3 (1.5% vs. 1.0% vs. 6.6%, p = 0.001, Table 1). In addition, we also divided the patients into 2 risk levels using the ACEF score cut-off 1.0 selected according to the ROC curve. The in-hospital mortality (1.2% vs. 7.5%, p b 0.001) were significant higher in patients with ACEF score≥1.0.
Table 2 Cox proportional Hazard analysis for long-term mortality. Clinical variables
Age Females Smoke Hypertension Diabetes Admission SBP Admission DBP Heart rate Anemia lg (D-Dimer) Serum creatinine LVEF Pleural effusion Maximum aortic diameter in lesion False lumen thrombosis ACEF score
Univariate analysis
Multivariate analysis
HR
P
HR
95% CI
P
1.04 1.78 0.82 1.41 0.97 1.00 1.01 1.01 2.29 1.60 1.25 0.97 1.25 1.04 1.29 4.67
0.001 0.065 0.453 0.391 0.952 0.942 0.453 0.429 0.001 0.049 b0.001 0.089 0.385 b0.001 0.325 b0.001
2.07
1.11,3.88
0.023
1.29 1.31
0.74,2.24 0.82,2.08
0.368 0.261
1.03
1.01,1.06
0.001
3.54
2.09,6.01
b0.001
Abbreviations: HR, Hazard ratio; CI, confidence interval; SBP, systolic blood pressure; DBP, diastolic blood pressure; LVEF, left ventricular ejection fraction.
Please cite this article as: X. Wei, Y. Wang, J. Luo, et al., Utility of age, creatinine, and ejection fraction score in patients with type B aortic dissection un..., International Journal of Cardiology, https://doi.org/10.1016/j.ijcard.2019.09.076
X. Wei et al. / International Journal of Cardiology xxx (xxxx) xxx
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Fig. 1. ROC curves of ACEF score and the updated version in predicting in-hospital (A) and long-term mortality (B). The AUC for long-term mortality was 0.703, 0.687 and 0.716 for ACEF, AGEF and ACEF II score, respectively (Fig. 1B). This was not statistically significant when comparing the discriminatory power of the scores (p N 0.05). Kaplan-Meier curve indicated that the cumulative long-term mortality in Tertile 3 was significantly higher than that in Tertile 1 and 2 (Log-Rank = 23.74; p b 0.001, Fig. 2A). In addition, patients with ACEF score≥1.0 had higher long-term mortality than those without (Log-rank = 26.17, p b 0.001, Fig. 2B).
4. Discussion In present study, we are first to validate the use of ACEF score in TBAD patients undergoing TEVAR. Our findings demonstrated that ACEF score was independently associated with long-term mortality. ACEF, AGEF and ACEF II score had similar predictive ability for both inhospital and long-term death. Therefore, ACEF score could be considered as a useful and relatively simple tool for pre-TEVAR risk stratification. TBAD of the descending aorta or arch is a life-threatening pathology. Open surgical treatment has high mortality and significant late complications and has gradually been replaced by TEVAR [5,19]. The epidemiological data indicate that the in-hospital mortality is 32% in TBAD patients treated with surgery, 7% for those managed with TEVAR, and 10% for those treated by medicine alone [20]. In our study, the longterm mortality was 10.4%, which was similar to previous data [2]. Though death rates declined with TEVAR, a significant number still
suffer death after this intervention. Therefore, there is a pressing need to identify the patients with a high risk of mortality. Recently, a plenty variety of risk factors have been discovered to be associated with adverse prognosis in TBAD. Ray HM et al. demonstrated that aortic diameter N44 mm and ageN60 years were predictors of longterm mortality in patients with uncomplicated acute TBAD [21]. In another research on TBAD, peak C-reactive protein level was independently associated with adverse long-term events [22]. In addition, Khoynezhad A found that chronic obstructive pulmonary disease, postoperative myocardial infarction, and acute renal failure were independent risk factors of late mortality after TEVAR [23]. However, the discrimination ability of a single factor was proved to be insufficient. The ACEF score, comprising only three variables (age, creatinine and LVEF), was first established in patients undergoing elective cardiac surgery and its accuracy and clinical applicability was validated in cardiac interventional therapy. For patients with or without acute coronary syndromes referred for coronary revascularization, it was possible to stratify risk of events using the ACEF score [10,24]. In addition, this risk score was also a good predictor of fatal or non-fatal complications after percutaneous coronary intervention (PCI) for different lesions, such as chronic total occlusion and bifurcation lesions [25,26]. Due to its good discrimination, this simple score was considered as a guidelinesuggested risk stratification tool in patients undergoing PCI [27].
Fig. 2. Kaplan-Meier curve for cumulative rate of long-term mortality according to different levels of the ACEF score.
Please cite this article as: X. Wei, Y. Wang, J. Luo, et al., Utility of age, creatinine, and ejection fraction score in patients with type B aortic dissection un..., International Journal of Cardiology, https://doi.org/10.1016/j.ijcard.2019.09.076
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X. Wei et al. / International Journal of Cardiology xxx (xxxx) xxx
Besides, the predictive power of this score was enhanced in numerous studies [17,28,29]. Capodanno et al. incorporated glomerular filtration rate into the ACEF score and demonstrated that the AGEF score exhibited superior discriminative ability to the ACEF score, in patients undergoing percutaneous coronary intervention [16]. The AGEF score was also suitable for risk assessing patients receiving transcatheter aortic valve implantation [30]. TEVAR is also an interventional surgery that involves placing a stent-graft in the thoracic or thoracoabdominal aorta for the treatment of TBAD. Previous studies showed that older age, renal and cardiac dysfunction are predictors of poor outcomes in patients with aortic dissection [12–14]. We thus believed that ACEF score could be considered as a risk-stratified tool in TBAD patients undergoing TEVAR. The present study indicated that ACEF, AGEF and ACEF II score present excellent discriminative abilities for in-hospital and long-term mortality. ACEF score was a relatively simple tool for pre-TEVAR risk stratification. 5. Limitation The present study has several limitations that need to be taken into account. First, this study could not establish causal relationships due to the inherent weakness of retrospective study design. Second, due to the inclusion of patients undergoing TEVAR only, our conclusions may not be applicable to patients with conservative treatment. Third, the data on follow up imaging for progression of aortic growth after TEVAR was missed. We did not further analysis its effect on the outcomes in present study. 6. Conclusion ACEF, a simple score, was found to be an independent predictor for long-term mortality for TBAD patients undergoing TEVAR, and could thus be considered as a method for pre-TEVAR risk stratification. In addition, ACEF, AGEF and ACEF II score had similar discriminative ability for in-hospital and long-term death. Contributions Jian-fang Luo and Lei Jiang contributed to the conception or design of the study. Xue-biao Wei, Yu Wang, Wan-zi Hong, Da-zhong Suze and Chun-xiang Zhang contributed to the acquisition, analysis, or interpretation of data. Xue-biao Wei and Yu Wang drafted the manuscript. Lei Jiang and Danqing Yu critically revised the manuscript. All the authors gave final approval and agreed to be accountable for all aspects of work ensuring integrity and accuracy. Funding This study was supported by Science and Technology Planning Project of Guangzhou (grant no. 201704020124 and grant no. 201903010005), Natural Science Foundation of Guangdong Province (grant no. 2018A030313029) and Lisheng Cardiovascular Health Foundation of Beijing (grant no. LHJJ20155517) and National Natural Science Foundation of China (grant no. 81800262 and grant no. 81670334). The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The work was not funded by any industry sponsors. Conflict of interest disclosures None. Acknowledgments None.
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Please cite this article as: X. Wei, Y. Wang, J. Luo, et al., Utility of age, creatinine, and ejection fraction score in patients with type B aortic dissection un..., International Journal of Cardiology, https://doi.org/10.1016/j.ijcard.2019.09.076
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Utility of age, creatinine, and ejection fraction score in patients with type B aortic dissection undergoing thoracic endovascular aortic repair Xue-biao Wei a,b,1, Yu Wang b,1, Jian-fang Luo b, ∗∗∗, Wan-zi Hong b, Zedazhong Su b, Chun-xiang Zhang c, Danqing Yu b, ∗∗, Lei Jiang a, ∗ a b c
Guangdong Provincial Geriatrics Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, 510080, China Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, 510080, China Department of Biomedical Engineering, School of Medicine, University of Alabama at Birmingham, Birmingham, Ala, UK
a r t i c l e
i n f o
Article history: Received 26 July 2019 Received in revised form 2 September 2019 Accepted 30 September 2019 Available online xxxx Keywords: Risk score ACEF Type B aortic dissection Thoracic endovascular aortic repair Prognosis
a b s t r a c t Background: Older age, renal and cardiac dysfunction are predictors of poor outcome in aortic dissection. The aim of this study was to evaluate the association of the age, creatinine and ejection fraction (ACEF) score with adverse events in patients with type B aortic dissection (TBAD) undergoing thoracic endovascular aortic repair (TEVAR). Methods: The study enrolled 605 patients from January 2010 to July 2015, who were classified into three groups according to the tertiles of ACEF score: Tertile 1 (≤0.77, n = 204), Tertile 2 (0.77–0.96, n = 205) and Tertile 3 (N0.96, n = 196). The association between ACEF, AGEF (age, glomerular filtration rate and ejection fraction) and the updated version of the ACEF (ACEF II) score with adverse events was analyzed. Results: After a median 3.4 years follow-up, 63 (10.4%) patients died. Multivariable analysis revealed that ACEF score was independently associated with long-term mortality (adjusted hazard ratio = 3.54; 95% confidence interval, 2.09–6.01; p b 0.001). ACEF, AGEF and ACEF II score had similar predictive ability for both in-hospital and long-term death. The in-hospital mortality (1.5% vs. 1.0% vs. 6.6%, p = 0.001) were significantly higher in Tertile 3. In addition, cumulative long-term mortality in Tertile 3 was significantly higher than that in Tertile 1 and 2 (Log-Rank = 23.74; p b 0.001). Conclusion: ACEF score could be served as an useful and relatively simple tool for pre-TEVAR risk stratification in TBAD patients. © 2019 Elsevier B.V. All rights reserved.
1. Introduction Type B aortic dissections (TBAD) are catastrophic conditions with high complication and mortality rates [1]. Thoracic endovascular aortic repair (TEVAR) is an emerging treatment approach, which has been rapidly accepted by clinicians for treating TBAD [2–4]. Compared to open surgery and medical treatment, TEVAR is regarded as a superior treatment strategy with lower mortality [5]. However, the postoperative mortality is still high during short- and long-term follow up [6,7]. Early identification of patients at high risk for poor outcomes remains urgent and important.
The age, creatinine, and ejection fraction (ACEF) score is a novel and simple risk assessment tool which includes only three variables. This score was first developed in patients undergoing elective cardiac operations to predict mortality risk [8] and further validated in other surgical procedures, such as percutaneous coronary interventions, valve surgery and surgical ventricular reconstruction [9–11]. Older age, renal and cardiac dysfunction were accepted prognostic markers in aortic dissection [12–14]. Therefore, we suspected that the ACEF score could show great performance as well in TBAD patients undergoing TEVAR. In consequence, the present study was conducted to test the predictive accuracy of the ACEF score in patients with TBAD undergoing TEVAR. 2. Methods
∗ Corresponding author. ∗∗ Corresponding author. ∗∗∗ Corresponding author. E-mail addresses: [email protected] (J. Luo), [email protected] (D. Yu), [email protected] (L. Jiang). 1 These authors are considered as co-first authors.
2.1. Patient population This was a single-center study conducted in Guangdong Provincial People's Hospital. Patients with acute and sub-acute TBAD undergoing TEVAR were consecutively enrolled from January 2010 to July 2015. TBAD was diagnosed according to multi-detector computed tomography scanning. The indication for TEVAR was described in our previous
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Please cite this article as: X. Wei, Y. Wang, J. Luo, et al., Utility of age, creatinine, and ejection fraction score in patients with type B aortic dissection un..., International Journal of Cardiology, https://doi.org/10.1016/j.ijcard.2019.09.076
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X. Wei et al. / International Journal of Cardiology xxx (xxxx) xxx
study [15]. The exclusion criteria were as follows: 1) age b18 years; 2) malignant tumor; 3) chronic AD (onset of symptoms to treatment N 90 days); 4) AD caused by trauma, iatrogenic injury or Marfan syndrome; and 5) missed admission serum creatinine or left ventricular ejection fraction (LVEF) records. The detailed selection process is shown in Fig. S1. After exclusions, 605 patients were included in the analysis. The study was approved by the Institutional Ethics Committee, with a waiver of informed consent due to retrospective study design. 2.2. Data collection and calculation Clinical data were collected from electronic medical records by one researcher, and these data were randomly checked by another researcher. The ACEF score was calculated as originally described by Ranucci M et al., using the formula: age/LVEF+1 point for serum creatinine N2 mg/dL [8]. The age, glomerular filtration rate and ejection fraction (AGEF) score was calculated according to the following formula: age/LVEF (%)+1 point, for every 10-ml/min reduction in estimated glomerular filtration rate (eGFR) b 60 mL/min/ 1.73 m2 (up to a maximum of 6 points) [16]. ACEF II score is also developed by Ranucci M et al., using the formula: age/LVEF +2 points for serum creatinine level N2 mg/dL + 3 points for emergency surgery +0.2 points*(36%-haematocrit) [17]. LVEF, serum creatinine and haematocrit used in the formula were the values recorded before TEVAR. The eGFR was calculated using the equation of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) [18]. 2.3. Clinical outcomes All in-hospital survival patients were followed up via telephone interviews after discharge. We also reviewed hospital readmission records and outpatient clinic interviews for possible events. The primary endpoint was long-term all-cause mortality. In addition, the incident of in-hospital spinal cord ischemia, stroke and post-TEVAR endoleak were also recorded. Spinal cord ischemia was defined as any new onset of paraplegia or paraparesis, manifested as 1) deficit in motor or sensory function of the lower extremities; or 2) urinary or bowel incontinence. 2.4. Statistical analysis Continuous variables were reported as mean ± SD or median and quartile range, and compared using analysis of variance or Wilcoxon rank-sum test, respectively. Categorical variables were expressed as percentages and compared by chi-square analysis. Univariate Cox proportional hazards model analysis was conducted to determine the independent predictors of long-term death. The variables whose p b 0.1, except the variables of ACEF score, were included in a multivariate model for further analysis. Discrimination performance of ACEF, AGEF and ACEF II score in predicting mortality was evaluated by receiver-operating characteristic (ROC) curve analysis and their areas under the curve (AUCs) were compared using the nonparametric approach. Survival analysis was also performed using the Kaplan-Meier method. All statistical analysis was performed using SPSS version 19.0 (Chicago, IL, USA). A value of p b 0.05 was considered significant. 3. Results 3.1. Baseline characteristics A total of 605 TBAD patients undergoing TEVAR were analyzed. They were classified into three groups according to the tertiles of ACEF score: Tertile 1 ≤ 0.77 (n = 204), Tertile 2 (0.77–0.96, n = 205) and Tertile 3 (N0.96, n = 196). The baseline characteristics according to ACEF score groups are described in Table 1. Significant differences were observed among tertiles in age, serum creatinine, eGFR and LVEF. In addition, the maximum aortic diameter in lesion was significant higher in patients with a high ACEF score (36.0 ± 8.6 vs. 38.0 ± 9.5 vs. 39.6 ± 9.9, p = 0.001), in whom the hemoglobin (129.4 ± 17.4 vs. 128.5 ± 17.1 vs. 122.3 ± 19.9, p b 0.001) level and hematocrit (38.4 ± 5.0 vs. 38.0 ± 5.2 vs. 36.2 ± 5.8, p b 0.001) was lower. 3.2. ACEF score and adverse events The median follow-up time was 3.4 years. In this period, 63 (10.4%) patients died and 73 (12.1%) lost follow up. Univariate Cox survival analysis revealed that ACEF score (per 1-point increase) was associated with long-term death (unadjusted odds ratio [OR], 4.67; 95% confidence interval [CI], 2.90 to 7.53; p b 0.001). After adjusting for potential risk factors (female gender, anemia, lg D-Dimer and maximum aortic diameter), ACEF score remained an independent predictor for long-term mortality (adjusted hazard ratio = 3.54; 95% CI, 2.09–6.01; p b 0.001; Table 2). 3.3. Clinical application of ACEF score In ROC curve analysis, ACEF, AGEF and ACEF II score presented excellent discrimination in predicting in-hospital death. The AUC of ACEF score for predicting in-hospital mortality was 0.725 (95% CI, 0.602 to 0.849; p b 0.001; sensitivity, 72.2%; specificity, 72.7%), and the optimum cut-off value was 1.0 (Fig. 1A). For AGEF and ACEF II score, the AUC was 0.702 (95% CI, 0.569 to 0.834; p = 0.003; Figs. 1A) and 0.764 (95% CI, 0.658 to 0.869; p b 0.001; Fig. 1A), respectively. Although the predictive ability of ACEF II score
Table 1 Baseline demographics and clinical characteristics. Clinical variables
Age (years) Gender, n (%) Male Female Current smoke, n (%) Concomitant disorders, n (%) Hypertension Diabetes Admission SBP (mmHg) Admission DBP (mmHg) Heart rate (bpm) Hemoglobin (g/L) Hematocrit (%) Serum creatinine (mg/dL) eGFR (mL/min/1.73m2) lg (D-Dimer) LVEF (%) Pleural effusion, n (%) Maximum aortic diameter in lesion (mm) False lumen thrombosis Post-TEVAR endoleak In-hospital events Spinal cord ischemia Stroke Death
ACEF score tertiles ≤0.77 (n = 204)
0.77–0.96 (n = 205)
N0.96 (n = 196)
P
44.5 ± 6.0
57.3 ± 5.8
62.7 ± 10.4
b0.001
173 (84.8) 170 (82.9) 31 (15.2) 35 (17.1) 86 (42.2) 78 (38.0)
177 (90.3) 0.088 19 (9.7) 83 (42.3) 0.609
169 (82.8) 9 (4.4) 135.3 ± 20.2 79.0 ± 13.0 78.7 ± 11.2 129.4 ± 17.4 38.4 ± 5.0 1.0 (0.8,1.2) 88.4 ± 23.9 3.1 ± 0.5 67.0 ± 5.5 102 (50.0) 36.0 ± 8.6
175 (85.4) 14 (6.8) 136.2 ± 21.6 79.7 ± 13.2
171 (87.2) 16 (8.2) 137.0 ± 21.8 79.1 ± 13.4 76.0 ± 11.3 77.3 ± 12.5 128.5 ± 122.3 ± 17.1 19.9 38.0 ± 5.2 36.2 ± 5.8 1.0 1.2 (0.8,1.2) (0.9,2.2) 82.5 ± 21.5 59.6 ± 29.5 3.1 ± 0.5 3.2 ± 0.5 65.8 ± 5.6 61.7 ± 7.4 86 (42.0) 99 (50.5) 38.0 ± 9.5 39.6 ± 9.9
0.462 0.300 0.734
48 (23.5) 17 (8.3)
63 (30.7) 15 (7.3)
68 (34.7) 13 (6.6)
0.046 0.808
5 (2.5) 4 (2.0) 3 (1.5)
3 (1.5) 8 (3.9) 2 (1.0)
4 (2.0) 8 (4.1) 13 (6.6)
0.772 0.416 0.001
0.840 0.068 b0.001 b0.001 b0.001 b0.001 0.035 b0.001 0.153 0.001
Abbreviations: SBP, systolic blood pressure; DBP, diastolic blood pressure; eGFR, estimated glomerular filtration rate; LVEF, left ventricular ejection fraction; TEVAR, thoracic endovascular aortic repair.
was higher, there was no significant difference when comparing with ACEF and AGEF score (p N 0.05). The in-hospital mortality was 3.0%, which was significantly higher in Tertile 3 (1.5% vs. 1.0% vs. 6.6%, p = 0.001, Table 1). In addition, we also divided the patients into 2 risk levels using the ACEF score cut-off 1.0 selected according to the ROC curve. The in-hospital mortality (1.2% vs. 7.5%, p b 0.001) were significant higher in patients with ACEF score≥1.0.
Table 2 Cox proportional Hazard analysis for long-term mortality. Clinical variables
Age Females Smoke Hypertension Diabetes Admission SBP Admission DBP Heart rate Anemia lg (D-Dimer) Serum creatinine LVEF Pleural effusion Maximum aortic diameter in lesion False lumen thrombosis ACEF score
Univariate analysis
Multivariate analysis
HR
P
HR
95% CI
P
1.04 1.78 0.82 1.41 0.97 1.00 1.01 1.01 2.29 1.60 1.25 0.97 1.25 1.04 1.29 4.67
0.001 0.065 0.453 0.391 0.952 0.942 0.453 0.429 0.001 0.049 b0.001 0.089 0.385 b0.001 0.325 b0.001
2.07
1.11,3.88
0.023
1.29 1.31
0.74,2.24 0.82,2.08
0.368 0.261
1.03
1.01,1.06
0.001
3.54
2.09,6.01
b0.001
Abbreviations: HR, Hazard ratio; CI, confidence interval; SBP, systolic blood pressure; DBP, diastolic blood pressure; LVEF, left ventricular ejection fraction.
Please cite this article as: X. Wei, Y. Wang, J. Luo, et al., Utility of age, creatinine, and ejection fraction score in patients with type B aortic dissection un..., International Journal of Cardiology, https://doi.org/10.1016/j.ijcard.2019.09.076
X. Wei et al. / International Journal of Cardiology xxx (xxxx) xxx
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Fig. 1. ROC curves of ACEF score and the updated version in predicting in-hospital (A) and long-term mortality (B). The AUC for long-term mortality was 0.703, 0.687 and 0.716 for ACEF, AGEF and ACEF II score, respectively (Fig. 1B). This was not statistically significant when comparing the discriminatory power of the scores (p N 0.05). Kaplan-Meier curve indicated that the cumulative long-term mortality in Tertile 3 was significantly higher than that in Tertile 1 and 2 (Log-Rank = 23.74; p b 0.001, Fig. 2A). In addition, patients with ACEF score≥1.0 had higher long-term mortality than those without (Log-rank = 26.17, p b 0.001, Fig. 2B).
4. Discussion In present study, we are first to validate the use of ACEF score in TBAD patients undergoing TEVAR. Our findings demonstrated that ACEF score was independently associated with long-term mortality. ACEF, AGEF and ACEF II score had similar predictive ability for both inhospital and long-term death. Therefore, ACEF score could be considered as a useful and relatively simple tool for pre-TEVAR risk stratification. TBAD of the descending aorta or arch is a life-threatening pathology. Open surgical treatment has high mortality and significant late complications and has gradually been replaced by TEVAR [5,19]. The epidemiological data indicate that the in-hospital mortality is 32% in TBAD patients treated with surgery, 7% for those managed with TEVAR, and 10% for those treated by medicine alone [20]. In our study, the longterm mortality was 10.4%, which was similar to previous data [2]. Though death rates declined with TEVAR, a significant number still
suffer death after this intervention. Therefore, there is a pressing need to identify the patients with a high risk of mortality. Recently, a plenty variety of risk factors have been discovered to be associated with adverse prognosis in TBAD. Ray HM et al. demonstrated that aortic diameter N44 mm and ageN60 years were predictors of longterm mortality in patients with uncomplicated acute TBAD [21]. In another research on TBAD, peak C-reactive protein level was independently associated with adverse long-term events [22]. In addition, Khoynezhad A found that chronic obstructive pulmonary disease, postoperative myocardial infarction, and acute renal failure were independent risk factors of late mortality after TEVAR [23]. However, the discrimination ability of a single factor was proved to be insufficient. The ACEF score, comprising only three variables (age, creatinine and LVEF), was first established in patients undergoing elective cardiac surgery and its accuracy and clinical applicability was validated in cardiac interventional therapy. For patients with or without acute coronary syndromes referred for coronary revascularization, it was possible to stratify risk of events using the ACEF score [10,24]. In addition, this risk score was also a good predictor of fatal or non-fatal complications after percutaneous coronary intervention (PCI) for different lesions, such as chronic total occlusion and bifurcation lesions [25,26]. Due to its good discrimination, this simple score was considered as a guidelinesuggested risk stratification tool in patients undergoing PCI [27].
Fig. 2. Kaplan-Meier curve for cumulative rate of long-term mortality according to different levels of the ACEF score.
Please cite this article as: X. Wei, Y. Wang, J. Luo, et al., Utility of age, creatinine, and ejection fraction score in patients with type B aortic dissection un..., International Journal of Cardiology, https://doi.org/10.1016/j.ijcard.2019.09.076
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Besides, the predictive power of this score was enhanced in numerous studies [17,28,29]. Capodanno et al. incorporated glomerular filtration rate into the ACEF score and demonstrated that the AGEF score exhibited superior discriminative ability to the ACEF score, in patients undergoing percutaneous coronary intervention [16]. The AGEF score was also suitable for risk assessing patients receiving transcatheter aortic valve implantation [30]. TEVAR is also an interventional surgery that involves placing a stent-graft in the thoracic or thoracoabdominal aorta for the treatment of TBAD. Previous studies showed that older age, renal and cardiac dysfunction are predictors of poor outcomes in patients with aortic dissection [12–14]. We thus believed that ACEF score could be considered as a risk-stratified tool in TBAD patients undergoing TEVAR. The present study indicated that ACEF, AGEF and ACEF II score present excellent discriminative abilities for in-hospital and long-term mortality. ACEF score was a relatively simple tool for pre-TEVAR risk stratification. 5. Limitation The present study has several limitations that need to be taken into account. First, this study could not establish causal relationships due to the inherent weakness of retrospective study design. Second, due to the inclusion of patients undergoing TEVAR only, our conclusions may not be applicable to patients with conservative treatment. Third, the data on follow up imaging for progression of aortic growth after TEVAR was missed. We did not further analysis its effect on the outcomes in present study. 6. Conclusion ACEF, a simple score, was found to be an independent predictor for long-term mortality for TBAD patients undergoing TEVAR, and could thus be considered as a method for pre-TEVAR risk stratification. In addition, ACEF, AGEF and ACEF II score had similar discriminative ability for in-hospital and long-term death. Contributions Jian-fang Luo and Lei Jiang contributed to the conception or design of the study. Xue-biao Wei, Yu Wang, Wan-zi Hong, Da-zhong Suze and Chun-xiang Zhang contributed to the acquisition, analysis, or interpretation of data. Xue-biao Wei and Yu Wang drafted the manuscript. Lei Jiang and Danqing Yu critically revised the manuscript. All the authors gave final approval and agreed to be accountable for all aspects of work ensuring integrity and accuracy. Funding This study was supported by Science and Technology Planning Project of Guangzhou (grant no. 201704020124 and grant no. 201903010005), Natural Science Foundation of Guangdong Province (grant no. 2018A030313029) and Lisheng Cardiovascular Health Foundation of Beijing (grant no. LHJJ20155517) and National Natural Science Foundation of China (grant no. 81800262 and grant no. 81670334). The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The work was not funded by any industry sponsors. Conflict of interest disclosures None. Acknowledgments None.
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Please cite this article as: X. Wei, Y. Wang, J. Luo, et al., Utility of age, creatinine, and ejection fraction score in patients with type B aortic dissection un..., International Journal of Cardiology, https://doi.org/10.1016/j.ijcard.2019.09.076