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Aortic and vascular disease
Original research
Impact of serum haemoglobin-to-creatinine ratio after transcatheter aortic valve implantation
  1. Akihiro Ikuta1,
  2. Satoki Oka1,
  3. Shunsuke Matsushita1,
  4. Shingo Hirao2,
  5. Kazushige Kadota1,
  6. Tatsuhiko Komiya2 and
  7. Yasushi Fuku1
  1. 1Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Japan
  2. 2Department of Cardiovascular Surgery, Kurashiki Central Hospital, Kurashiki, Japan
  1. Correspondence to Dr Akihiro Ikuta; ai16142{at}kchnet.or.jp

Abstract

Objective The association between a combined anaemia and renal failure index and 1-year prognosis of patients undergoing transcatheter aortic valve implantation (TAVI) is unexplored. We aimed to investigate a simple risk score in patients undergoing TAVI.

Methods A total of 469 consecutive patients undergoing TAVI between 2015 and 2021 were enrolled. After excluding patients undergoing dialysis, the remaining 458 patients were classified according to three tertiles of the serum haemoglobin-to-creatinine (Hgb/Cr) ratio 1 day before TAVI. The primary clinical outcome measure was all-cause mortality and heart failure hospitalisation 1 year after TAVI.

Results In the first, second and third tertiles, the 1-year cumulative incidence of all-cause mortality was 16.9% versus 7.2% versus 2.0%, respectively (p<0.01), and that of heart failure hospitalisation was 10.7% versus 3.4% versus 0.7%, respectively (p<0.01). The indexes of the area under the curve of the Hgb/Cr ratio for all-cause mortality and heart failure hospitalisation 1 year after TAVI were both 0.73. Cut-off values were 10.1 for all-cause mortality 1 year after TAVI (OR, 4.78; 95% CI 2.43 to 9.74; p<0.01) and 10.4 for heart failure hospitalisation 1 year after TAVI (OR, 5.3; 95% CI 2.21 to 14.1; p<0.01). In the multivariate analysis, the Hgb/Cr ratio was an independent predictor of all-cause mortality and heart failure hospitalisation 1 year after TAVI.

Conclusions Hgb/Cr ratio calculation 1 day before TAVI may help predict midterm all-cause mortality and heart failure hospitalisation in patients with severe aortic valve stenosis undergoing TAVI.

Trial registration number 4143 (The Institutional Review Board of Kurashiki Central Hospital)

  • aortic valve stenosis
  • risk factors
  • death, sudden, cardiac
  • heart failure

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/openhrt-2023-002419

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    WHAT IS ALREADY KNOWN ON THIS TOPIC

    • Clinical adverse events following transcatheter aortic valve implantation (TAVI) are a significant issue, and anaemia and renal failure are associated with these events.

    WHAT THIS STUDY ADDS

    • The haemoglobin-to-creatinine (Hgb/Cr) ratio, a simple score, may be useful for predicting midterm adverse outcomes in patients with severe aortic stenosis undergoing TAVI.

    HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

    • We might predict the prognosis of TAVI more conveniently. Special attention should be paid to patients with lower Hgb/Cr ratio.

    Introduction

    Transcatheter aortic valve implantation (TAVI) is a well-established treatment option for severe aortic valve stenosis. The Society of Thoracic Surgeons (STS) score and EuroScore 2 have been used as predictive models of cardiac surgical risk.1 They are useful for predicting 30-day mortality but not long-term prognosis. Midterm prognostic models for TAVI include the Futile TAVI Simple score and TAVR risk score.2 3 As they need several items for calculation, insufficient data make them useless. Renal function and anaemia are both strong predictors of outcomes following TAVI.4 5 A combined anaemia and renal failure index have been reported to be associated with adverse outcomes following percutaneous coronary intervention.6 This study aimed to determine the predictive accuracy of a combined anaemia and renal failure index for predicting the 1-year prognosis of patients undergoing TAVI.

    Methods

    Study sample and protocol

    This study is a retrospective single-centre observational study. The study population consisted of 469 consecutive patients with severe aortic valve stenosis undergoing TAVI in our hospital between January 2015 and June 2021. After excluding patients undergoing dialysis (n=11), the remaining 458 patients were classified according to three tertiles of the serum haemoglobin-to-creatinine (Hgb/Cr) ratio 1 day before TAVI (figure 1). Patients with chronic kidney disease (CKD) were defined as those with an estimated glomerular filtration rate of <60 mL/min/1.73 m2. Each estimated glomerular filtration rate was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation.7 Patients with anaemia were defined as those with preoperative haemoglobin levels of <12.0 g/dL and <13.0 g/dL in women and men, respectively, according to the WHO criteria. All laboratory results were collected from both inpatient medical records and local medical facilities. Serum haemoglobin and creatinine were routinely measured 1 day before TAVI.

    Figure 1
    Figure 1

    Distribution of the Hgb/Cr ratios before TAVI. Cr, creatinine; Hgb, haemoglobin; TAVI, transcatheter aortic valve implantation.

    This study was performed in accordance with the Declaration of Helsinki and the guidelines for epidemiological studies issued by the Ministry of Health, Labor and Welfare of Japan. Informed consent was obtained for the procedure and subsequent data collection and analysis for research purposes.

    Transcatheter aortic valve implantation

    The procedure was performed under general anaesthesia with endotracheal intubation or local anaesthesia with conscious sedation. Patients were premedicated with at least one antiplatelet drug. TAVI was performed using either balloon-expandable SAPIEN-XT/−3 (Edwards Lifesciences, Irvine, California) or self-expandable Evolut-R/-Pro (Medtronic, Minneapolis, Minnesota) valves. The size of the prosthesis was determined using multidetector CT findings. The valve was delivered through either the femoral, apical, subclavian, brachiocephalic or transaortic approach. To maintain coronary perfusion pressure during periods of haemodynamic instability, vasoconstrictors were used.

    Study endpoints

    The primary clinical outcome measure was all-cause mortality and heart failure hospitalisation 1 year after TAVI. Other clinical outcome measures included cardiovascular mortality and major bleeding 1 year after TAVI. All-cause mortality, cardiovascular mortality, heart failure hospitalisation and bleeding were based on the Valve Academic Research Consortium 3 criteria.8

    Statistical analysis

    Categorical variables were compared using the χ2 test. Continuous variables were expressed as means±SD and compared using Student’s t-test or Wilcoxon rank-sum test based on the distributions. Data were presented as means±SD for continuous variables. These measurements were subsequently compared between patients in the first (Hgb/Cr ratio <10.5), second (10.5≤Hgb/Cr ratio <15.5) and third (15.5 ≤Hgb/Cr ratio) tertiles. Variables with a p value of ≤0.10 in the univariate models were selected as candidates for the multivariate models. To obtain the final model for individuating independent variables associated with all-cause mortality and heart failure hospitalisation 1 year after TAVI, stepwise multivariate logistic regression analysis was applied. To assess the ability of morphological parameters for predicting all-cause mortality and heart failure hospitalisation 1 year after TAVI, a receiver operating characteristic (ROC) curve was used. The area under the curve (AUC) value was used as an indicator for predictive accuracy. The cumulative incidences of clinical events were estimated using the Kaplan-Meier method. Numbers with relative percentages were reported for categorical variables. Two-tailed p values of <0.05 were considered statistically significant. All statistical analyses were performed using JMP V.9.0 (JMP, Cary, North Carolina).

    Results

    Baseline patient characteristics and procedural results

    Baseline patient characteristics are summarised in table 1 and procedural results and medications in table 2. The distribution of Hgb/Cr ratios before TAVI is shown in figure 1.

    View this table:
    Table 1

    Baseline patient characteristics

    View this table:
    Table 2

    Procedural results and medications

    Patients with lower Hgb/Cr ratios had higher serum creatinine levels and higher prevalences of hypertension and moderate or severe aortic regurgitation than those with higher Hgb/Cr ratios. Conversely, patients with higher Hgb/Cr ratios had higher serum albumin levels, left ventricular ejection fraction and mean aortic gradient. The procedural success rate and length of hospital stay following TAVI were comparable between patients in the three tertiles.

    In-hospital and 1-year clinical outcomes

    In the first, second and third tertiles, the in-hospital mortality rates were 3.3% versus 0.7% versus 0%, respectively (p=0.04). Kaplan-Meier survival curves for the clinical outcomes of each tertile are shown in figure 2. In the first, second and third tertiles, the 1-year cumulative incidence of all-cause mortality was 16.9% versus 7.2% versus 2.0%, respectively (p<0.01), and that of heart failure hospitalisation was 10.7% versus 3.4% versus 0.7%, respectively (p<0.01). No significant differences in cardiovascular mortality and major bleeding between the three tertiles were observed (p=0.08 and p=0.053, respectively).

    Figure 2
    Figure 2

    Cumulative incidences of all-cause mortality (A), cardiovascular mortality (B), heart failure hospitalisation (C) and bleeding (D) 1 year following TAVI. Cr, creatinine; Hgb, haemoglobin; TAVI, transcatheter aortic valve implantation.

    Predictors of all-cause mortality and heart failure hospitalisation 1 year after TAVI

    The ROC curves of Hgb/Cr ratios for predicting all-cause mortality and heart failure hospitalisation 1 year after TAVI are shown in figure 3. The Hgb/Cr ratio exhibited a 64.1% sensitivity and a 72.8% specificity for predicting all-cause mortality 1 year after TAVI and a 73.9% sensitivity and a 69.8% specificity for predicting heart failure hospitalisation 1 year after TAVI. The ROC–AUC value for all-cause mortality 1 year after TAVI was 0.73, with a cut-off value of 10.1 (OR, 4.78; 95% CI 2.43 to 9.74; p<0.01). Furthermore, the ROC–AUC value for heart failure hospitalisation 1-year after TAVI was 0.73, with a cut-off value of 10.4 (OR, 5.3; 95% CI 2.21 to 14.1; p<0.01).

    Figure 3
    Figure 3

    ROC curves of the Hgb/Cr ratio for predicting all-cause mortality (A) and heart failure hospitalisation (B). The ROC–AUC value of all-cause mortality is 0.73, with a cut-off value of 10.1 (OR, 4.78; 95% CI, 2.43 to 9.74; p<0.01) and that of heart failure hospitalisation is 0.73, with a cut-off value of 10.4 (OR, 5.3; 95% CI, 2.21 to 14.1; p<0.01). AUC, area under the curve; Cr, creatinine; Hgb, haemoglobin; ROC, receiver operating characteristics.

    The univariate and multivariate variables of all-cause mortality 1 year after TAVI are presented in table 3. In the multivariate analysis, women (OR, 0.41; 95% CI 0.18 to 0.91; p=0.03), Hgb/Cr ratio ≤10.1 (OR, 3.35; 95% CI 1.51 to 7.45; p<0.01), clinical frailty scale score ≥4 (OR, 2.89; 95% CI 1.24 to 6.74; p=0.01) and dyslipidaemia (OR, 0.36; 95% CI 0.16 to 0.78; p=0.01) were independent predictors of all-cause mortality 1 year after TAVI. The univariate and multivariate variables of heart failure hospitalisation 1 year after TAVI are shown in table 4. In the multivariate analysis, the Hgb/Cr ratio 10.4 (OR, 4.21; 95% CI 1.49 to 11.9; p<0.01), clinical frailty scale score ≥4 (OR, 3.49; 95% CI 1.17 to 10.4; p=0.03) and atrial fibrillation (OR, 2.85; 95% CI 1.11 to 7.32; p=0.01) were independent predictors of heart failure hospitalisation 1 year after TAVI.

    View this table:
    Table 3

    Univariate and multivariate variables of all-cause mortality 1 year after TAVI

    View this table:
    Table 4

    Univariate and multivariate variables of heart failure hospitalisation 1 year after TAVI

    Discussion

    This study had three major findings. First, the 1-year cumulative incidence of all-cause mortality was 8.6% and that of heart failure hospitalisation was 5.2%. Second, the Hgb/Cr ratio was an independent predictor of all-cause mortality and heart failure hospitalisation 1 year after TAVI. Finally, the predictive model using the Hgb/Cr ratio had moderate accuracy for the risk stratification of all-cause mortality and heart failure hospitalisation 1 year after TAVI.

    Incidence of all-cause mortality and heart failure hospitalisation 1 year after TAVI

    The safety and usefulness of TAVI treatment have been widely recognised. In recent years, TAVI is performed not only on patients at high risk of aortic valve stenosis complications but also on those at intermediate risk. The 1-year cumulative incidences of all-cause mortality and heart failure hospitalisation have been reported to be 12.5%–17.9% and 19.9%–24.1%, respectively,9–12 and were 8.6% and 5.2%, respectively, in this study. The lower cumulative incidences in this study may be because of the differences in the proportion of patients with baseline New York Heart Association (NYHA) class III/IV, sex ratio and race specificity. Moreover, the high procedural success rate and low complication rate may be related to the low event rate.

    Predictors of all-cause mortality and heart failure hospitalisation 1 year after TAVI

    Approximately 60% of patients undergoing TAVI have CKD, and patients with CKD have worse midterm clinical outcomes following TAVI than those without CKD.5 Patients with CKD are more prone to adverse events since they are more susceptible to multiple comorbidities, are older and frailer and have higher STS scores.13–15 In this study, patients with lower renal function had more comorbidities. Auffret et al reported that approximately one-sixth of patients undergoing TAVI were hospitalised for heart failure within 1 year following TAVI and that CKD was considered one of the risk factors for heart failure hospitalisation.16 CKD causes heart failure because it is associated with neurohumoral activation and inflammation.

    Patients with comorbid anaemia have been reported to have higher rates of death and heart failure hospitalisation in midterm outcomes following TAVI.5 17 In previous studies, more than half of patients undergoing TAVI were anaemic5; in this study, patients with anaemia accounted for 73%. Patients undergoing TAVI are frequently older adults and have other comorbidities. Consequently, they are more prone to anaemia owing to chronic inflammatory diseases and nutritional deficiencies and have poor prognoses following TAVI.18 19 In this study, patients with anaemia were also prone to hypertension, hypoalbuminemia and chronic renal failure, which may be associated with increased events following TAVI. Additionally, patients with anaemia experience haemodynamic and neurohormonal changes owing to decreased oxygen supply to metabolic tissues, thereby resulting in increased myocardial workload.20 This places a greater burden on the heart and is presumably associated with cardiac death and heart failure hospitalisation.

    In general, patients with CKD tend to have lower haemoglobin levels than those without CKD because of renal anaemia.21 Some patients with anaemia have normal renal function, and some patients with CKD do not have anaemia. The reason that the combined haemoglobin and renal function index is associated with midterm all-cause mortality in patients undergoing TAVI is unclear. Anaemia is correlated with poorer outcomes in patients with CKD, and CKD is correlated with poorer outcomes in patients with anaemia.21 22 Furthermore, Numasawa et al reported that the combined haemoglobin and renal function index was correlated with the short-term prognosis of patients undergoing percutaneous coronary intervention.6 Therefore, we speculate that renal function combined with anaemia would be a strong prognostic factor in patients undergoing TAVI.

    Sex, general anaesthesia, NYHA class III/IV and low left ventricular ejection function have been reported to be predictors of all-cause mortality following TAVI.21 22 In this study, sex and general anaesthesia were predictors of all-cause mortality as in previous studies; however, NYHA class III/IV and low left ventricular ejection fraction were not. The difference may be because of the low proportion of NYHA class III/IV and better left ventricular ejection fraction in this study.

    Atrial fibrillation, diabetes mellitus, chronic obstructive pulmonary disease, STS score, left ventricular ejection fraction and blood transfusion have been reported to be predictors of heart failure hospitalisation following TAVI.5 23 24 In this study, diabetes mellitus and left ventricular ejection fraction were not significant predictors of heart failure hospitalisation. Better cardiac function and lower diabetes mellitus prevalence may have contributed to this result.

    Risk prediction models for adverse outcomes after TAVI

    Adverse events following TAVI are a significant issue because patients undergoing TAVI are older and have more comorbidities.25 Adverse events are primarily related to the presence of untreated cardiac and non-cardiac comorbidities at the time of TAVI.26 Since various risk assessment models have been proposed for predicting adverse events following TAVI, using them for predicting the prognosis before performing TAVI is significant.27

    The CAPRI score, the combined frailty score and the score from the J-TVT registry are useful for predicting 1-year mortality following TAVI.2 3 11 The modified SHFM score and the utility risk model are predictive scores for heart failure hospitalisation 1 year following TAVI.28 29 In this study, the Hgb/Cr ratio had a predictive accuracy of 0.73 for both mortality and heart failure hospitalisation 1 year following TAVI. The predictive score reported by Yamamoto et al has a predictive accuracy of 0.76 for mortality 1 year following TAVI30; however, it needs the following eight items for calculation: sex, body mass index, clinical frailty scale score, atrial fibrillation, peripheral artery disease, prior cardiac death, serum albumin level and renal function. Although our combined haemoglobin and renal function index has slightly less predictive accuracy than other scores, its simplicity of requiring only two items is a major advantage. Serum haemoglobin and creatinine are routinely measured before TAVI, making the score available at any facility.

    Limitations

    This study had four major limitations. First, this was a retrospective single-centre observational study with a relatively small study population and was not free from bias. Therefore, a large-scale, multicentre studies are needed in the future. Second, this study included only Japanese. Their smaller body size than other racial groups may have affected creatinine levels. Third, the causes of anaemia and renal failure were not investigated. It is difficult to determine them in older adults owing to their background factors, including nutritional deficiencies, chronic diseases and inflammation. Finally, no direct comparison was made between this index and other risk assessment scores. However, we believe that this index is useful because it has a moderate level of correlation with the midterm prognosis of patients undergoing TAVI.

    Conclusions

    Hgb/Cr ratio calculation 1 day before TAVI may help predict midterm all-cause mortality and heart failure hospitalisation in patients with severe aortic valve stenosis undergoing TAVI.

    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information.

    Ethics statements

    Patient consent for publication

    Ethics approval

    This study was approved by the Institutional Review Board of Kurashiki Central Hospital (reference number 4143). Participants gave informed consent to participate in the study before taking part.

    Acknowledgments

    The authors are grateful to the staff members of the cardiac catheterisation laboratory, and Miho Kobayashi, Makiko Kanaike and Takako Yukiyoshi for their assistance with the manuscript.

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    Supplementary materials

    • Supplementary Data

      This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

    Footnotes

    • Contributors AI and YF: conceived the research idea and contributed to the data acquisition. SO, SM, SH, KK and TK: contributed to the design. AI: conducted the analyses, drafted the manuscript, and is responsible for the overall content as guarantor. All the authors contributed to the interpretation of the work and made critical revision of the manuscript for key intellectual content. All the authors have read and approved the submitted version of the manuscript.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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