Abstract
Objectives
This study aimed to evaluate the impact of the Charlson Comorbidity Index (CCI) on in-hospital outcomes in patients with aortic stenosis (AS) undergoing aortic valve replacement (AVR) and to compare the efficacy of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with different comorbidity burdens.
Setting
The National Clinical Research Center for Cardiovascular Diseases.
Participants
A retrospective analysis was conducted on 3380 AS patients who underwent AVR in Beijing Anzhen Hospital from January 2015 to October 2021.
Interventions
Patients were stratified into low (0–1) and high (≥2) CCI groups.
Primary and secondary outcome measures
The primary outcome was Valve Academic Research Consortium-2 (VARC-2) composite early safety endpoints.
Results
Patients with high CCI scores exhibited significantly higher rates of VARC-2 composite adverse outcomes compared with those with low scores (50.3% vs 44.2%, p=0.001). After adjusting for confounding factors, high CCI scores were independently associated with the VARC-2 composite adverse outcomes (OR=1.36, 95% CI 1.17 to 1.58, p<0.001). In patients aged ≥65 years, TAVR demonstrated lower composite event rates compared with SAVR, regardless of CCI score (low CCI: 17.6% vs 54.3%, p<0.001; high CCI: 33.7% vs 62.8%, p<0.001).
Conclusions
CCI is a significant predictor of in-hospital composite adverse events in AS patients undergoing AVR. TAVR may be preferred over SAVR for patients aged ≥65 years, irrespective of comorbidity burden, to minimise composite events risk. These findings underscore the importance of considering comorbidity burden in treatment decision-making for AS patients.
Trial registration number
Keywords: Adult cardiology, Coronary intervention, Valvular heart disease
STRENGTHS AND LIMITATIONS OF THIS STUDY.
A subgroup analysis was performed within an observational, the national clinical research centre for cardiovascular diseases based clinical trial.
Comprehensive investigation of transcatheter aortic valve replacement versus surgical aortic valve replacement outcomes in patients with varying comorbidity burdens was conducted.
Focused analysis on in-hospital adverse events, particularly during the peak period for surgery-related complications, was performed.
Post-procedural management factors influencing in-hospital adverse events were not considered, highlighting the need for future clinical studies.
Introduction
Aortic stenosis (AS) has been identified as the most prevalent valvular abnormality, with a reported incidence exceeding 2% in adults aged 65 and above.1 This condition is frequently accompanied by other valvular diseases. According to the 2017 valvular heart disease guideline, aortic valve replacement (AVR) was recommended as the standard therapeutic intervention for severe symptomatic AS, based on the favourable outcomes observed with surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).2 The 2020–2021 update to the valvular heart disease guideline expanded this recommendation, advocating for earlier intervention in asymptomatic patients with AS and valvular regurgitation.3
The prevalence of AS exhibits a positive correlation with advancing age,4 accompanied by an increased burden of comorbidities in the elderly population. Epidemiological data indicate that over 85% of patients aged 65 and above present with at least one major comorbidity, with a substantial proportion manifesting multiple comorbidities.5 Consequently, AS is frequently observed in elderly patients with concomitant comorbidities.6 These comorbid conditions have been demonstrated to exert significant influence on clinical outcomes and long-term prognosis.
The Charlson Comorbidity Index (CCI), a validated tool that assigns weighted scores to various comorbid conditions based on their impact on mortality, has been established as a significant predictor of in-hospital mortality.7 While previous studies primarily considered comorbidities as cardiac risk factors, recent research has shifted focus to evaluating the general comorbidity burden.8 9 A comparative study involving TAVR patients demonstrated an association between high CCI scores and increased 30-day mortality rates.10 Furthermore, Bouleti et al conducted a study on 123 patients discharged after TAVR, revealing that elevated CCI scores were predictive of late mortality following the procedure.11 However, the relationship between comorbid conditions and in-hospital clinical outcomes in patients undergoing AVR, as well as the optimal procedural strategy for elderly patients with high CCI scores, remains inadequately explored. To address this knowledge gap, the present study aims to evaluate the impact of CCI on in-hospital composite adverse events. Additionally, this research seeks to determine whether SAVR or TAVR represents the optimal therapeutic strategy for elderly patients with multiple comorbidities.
Method
Study population
A retrospective cohort study was conducted using electronic medical records from Beijing Anzhen Hospital between January 2015 and October 2021. The study population comprised patients aged 18 years or older with moderate to severe AS who underwent AVR, specifically TAVR. Inclusion criteria encompassed left ventricular ejection fraction greater than 40% or sufficient cardiac function to tolerate the procedure. Patients with absolute contraindications to TAVR were excluded.
Data were extracted from individual hospital medical records, including patient demographics, primary and secondary diagnoses (coded according to International Classification of Diseases, 10th Revision), procedure codes, treating hospital departments, discharge status and length of stay. This study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology guidelines and the Declaration of Helsinki. The trial protocol was registered at ClinicalTrials.gov (NCT05797402) and published (online supplemental material).12
Multimorbidity measurement
Multimorbidity, defined as the co-occurrence of two or more chronic conditions within an individual, was quantified using the CCI. The CCI was initially described by Charlson et al.13 Additionally, the Hospital Frailty Risk Score (HFRS) was calculated for each patient based on established methodologies to assess frailty as a potential confounder.14
Indication of therapeutic procedures
Indications for therapeutic procedures were established based on current clinical guidelines and practices. Haemodialysis was initiated urgently in the presence of life-threatening disturbances in volume, electrolytes or acid-base balance.15 Transfusion was indicated when preoperative haematocrit values fell below 24% (approximately equivalent to a haemoglobin level of 8 g/dL) or in cases of significant surgical blood loss, regardless of haematocrit level.16 Intra-aortic balloon pump (IABP) was implemented under conditions including progressive blood pressure decline despite high-dose vasopressor therapy, reduced cardiac output (<2.0 L/m2·min), low mean arterial pressure (<50 mm Hg), elevated left atrial pressure (>20 mm Hg) or central venous pressure (>15 mm Hg), oliguria (<0.5 mL/kg·h), poor peripheral circulation, and signs of inadequate tissue oxygenation.17
Mechanical ventilation was indicated in cases of severe hypoxaemia or hypercapnia, impaired airway clearance, significant upper airway injury or obstruction, and respiratory arrest requiring urgent establishment of an artificial airway.18
Outcomes
The primary outcome was defined as the occurrence of any Valve Academic Research Consortium-2 (VARC-2) combined safety endpoint. These included all-cause mortality, all-cause stroke, VARC type 3–4 bleeding, major vascular complications, access-related complications, cardiac structural complications, acute kidney injury (including patients requiring renal replacement therapy) and new permanent pacemaker implantation. Clinical events related to the VARC-2 safety endpoints were identified through detailed retrospective review of medical records, including operative notes, imaging studies, laboratory data and discharge summaries. Each event was classified based on VARC-2 criteria. Although no formal external adjudication committee was used, all events were reviewed independently by two investigators experienced in structural heart disease, with any discrepancies resolved by consensus.
Patient and public involvement
Patients and the public were not involved in the design, conduct, reporting or dissemination plans of this research.
Statistical analysis
Statistical analyses were performed using IBM SPSS Statistics V.25. Continuous variables were expressed as mean±SD for normal distributions or median and IQR for skewed distributions. Comparisons between low and high CCI groups were conducted using unpaired Student’s t-test or Mann-Whitney U test, as appropriate.
A multiple logistic regression model was employed to predict in-hospital mortality and VARC-2 composite early safety, adjusting for potential confounders including age, sex, hypertension, atrial fibrillation, previous percutaneous coronary intervention (PCI), TAVR, extracorporeal membrane oxygenation (ECMO), IABP and HFRS.
To mitigate potential selection bias, a 1:1 propensity score matching analysis was performed for patients aged 65 and older, primarily focusing on age and gender matching. The MatchIt package in R (V.4.2.3) was used to implement the matching procedure. Statistical significance was set at a p value of less than 0.05 for all analyses.
Results
Patient characteristics and comorbidity burden
This study included 3380 patients with AS who underwent AVR at Beijing Anzhen Hospital from January 2015 to October 2021 (figure 1). The mean age was 60.8±10.9 years, with 59.8% being male. TAVR was performed in 348 (10.3%) cases. Common comorbidities included hypertension (34.3%), dyslipidaemia (13.1%), atrial fibrillation (12.4%) and diabetes (11.6%). A history of PCI was observed in 3.7% of patients, while 0.4% had prior permanent pacemaker implantation and 0.4% had undergone coronary artery bypass grafting (CABG). The mean length of hospital stay was 15.8±6.8 days, with an overall in-hospital mortality of 1.2%.
Figure 1. Flow chart of study selection. AS, aortic valve stenosis; AVR, aortic valve replacement.
Significant differences were observed between patients with low and high CCI scores in terms of age (60.0±10.8 vs 62.2±10.9 years, p<0.001), sex (57.5% vs 63.8% male, p<0.001), hypertension (29.8% vs 41.9%, p<0.001), atrial fibrillation (13.3% vs 10.9%, p=0.042), dyslipidaemia (11.2% vs 16.4%, p<0.001), diabetes (3.3% vs 25.8%, p<0.001) and history of PCI (2.5% vs 5.8%, p<0.001). No significant differences were found in permanent pacemaker implantation (0.3% vs 0.5%, p=0.487) and CABG (0.2% vs 0.6%, p=0.065). Patients with high CCI scores had a higher rate of TAVR (15.8% vs 7.1%, p<0.001) and longer hospital stays (17.1±7.8 vs . 15.0±5.9 days, p<0.001) compared with those with low CCI scores. The use of mechanical circulatory support was also higher in the high CCI group. Detailed baseline characteristics are presented in table 1.
Table 1. Characteristics of comorbidities and procedures.
| Variables | Whole cohort | CCI=0–1 | CCI≥2 | P value |
|---|---|---|---|---|
| (n=3380) | (n=2134) | (n=1246) | ||
| Patient characteristic | ||||
| Age | 60.79±10.91 | 59.97±10.83 | 62.20±10.92 | <0.001 |
| Male | 2021 (59.8) | 1226 (57.5) | 795 (63.8) | <0.001 |
| LOS | 15.76±6.75 | 14.98±5.90 | 17.11±7.81 | <0.001 |
| Comorbidities | ||||
| Hypertension | 1158 (34.3) | 636 (29.8) | 522 (41.9) | <0.001 |
| AF | 420 (12.4) | 284 (13.3) | 136 (10.9) | 0.042 |
| NYHA >II (%) | 1034 (30.6) | 475 (22.3) | 559 (44.9) | <0.001 |
| Dyslipidaemia | 443 (13.1) | 239 (11.2) | 204 (16.4) | <0.001 |
| Diabetes | 392 (11.6) | 71 (3.3) | 321 (25.8) | <0.001 |
| Procedures | ||||
| PPP | 13 (0.40) | 7 (0.3) | 6 (0.5) | 0.487 |
| PCI | 126 (3.7) | 54 (2.5) | 72 (5.8) | <0.001 |
| CABG | 13 (0.40) | 5 (0.2) | 8 (0.6) | 0.065 |
| TAVR | 348 (10.3) | 151 (7.1) | 197 (15.8) | <0.001 |
| Mechanical circulatory support | ||||
| ECMO | 50 (1.5) | 15 (0.7) | 35 (2.8) | <0.001 |
| CIV | 159 (4.7) | 68 (3.2) | 91 (7.3) | <0.001 |
| IABP | 99 (2.9) | 52 (2.4) | 47 (3.8) | 0.026 |
| RRT | 76 (2.2) | 16 (0.7) | 60 (4.8) | <0.001 |
| HFR score | 0.64±1.63 | 0.47±1.42 | 0.94±1.90 | <0.001 |
AF, atrial fibrillation; CABG, coronary artery bypass grafting; CCI, Charlson Comorbidity Index; CIV, continuous invasive mechanical ventilation (≥96 hours); ECMO, extracorporeal membrane oxygenation; HFR, hospital frailty risk; IABP, intra-aortic balloon pump; LOS, length of stay; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; PPP, previous permanent pacemaker; RRT, renal replacement therapy; TAVR, transcatheter aortic valve replacement.
Clinical outcomes and comorbidity burden
The prevalence of CCI components in our cohort revealed that the most common cardiovascular comorbidities were congestive heart failure (1953, 57.8%), diabetes mellitus (392, 11.6%) and history of myocardial infarction (47, 1.4%). Among non-cardiovascular comorbidities, peripheral vascular disease (1086, 32.1%) and cerebrovascular disease (295, 8.7%) were most prevalent (table 2). All risk factors, except HIV and metastatic cancer, were significantly more prevalent in the high CCI group. Multivariate analysis of individual CCI components showed that severe liver disease had the most significant impact on both in-hospital mortality (OR=15.578, 95% CI 3.992 to 60.786, p<0.001) and adverse events (OR=4.451, 95% CI 1.249 to 15.861, p=0.021) (onlinesupplemental figures 1 2undefined).
Table 2. Charlson Comorbidity Index (CCI) variables for participants.
| Variables in CCI | Whole cohort | CCI=0–1 | CCI≥2 | P value |
|---|---|---|---|---|
| (n=3380) | (n=2134) | (n=1246) | ||
| OMI | 47 (1.4) | 5 (0.2) | 42 (3.2) | <0.001 |
| CHF | 1953 (57.8) | 916 (42.9) | 1037 (83.2) | <0.001 |
| PVD | 1086 (32.1) | 304 (14.2) | 782 (62.8) | <0.001 |
| CBD | 295 (8.7) | 42 (2.0) | 253 (20.3) | <0.001 |
| Dementia | 4 (0.1) | 0 (0) | 4 (0.3) | 0.009 |
| CPD | 135 (4.0) | 16 (0.7) | 119 (9.6) | <0.001 |
| CTD | 19 (0.6) | 2 (0.1) | 17 (1.4) | <0.001 |
| PUD | 26 (0.8) | 5 (0.2) | 21 (1.7) | <0.001 |
| MLD | 130 (3.8) | 13 (0.6) | 117 (9.4) | <0.001 |
| DM_n | 380 (11.2) | 71 (3.3) | 309 (24.8) | <0.001 |
| Paraplegia | 3 (0.1) | 0 (0) | 3 (0.2) | 0.023 |
| RD | 116 (3.4) | 0 (0) | 116 (9.3) | <0.001 |
| DM_c | 12 (0.4) | 0 (0) | 12 (1.0) | <0.001 |
| Cancer | 46 (1.4) | 0 (0) | 46 (3.7) | <0.001 |
| SLD | 18 (0.5) | 0 (0) | 18 (1.4) | <0.001 |
| MST | 0 (0) | 0 (0) | 0 (0) | 1 |
| HIV | 0 (0) | 0 (0) | 0 (0) | 1 |
CBD, cerebrovascular disease; CHF, congestive heart failure; CPD, chronic pulmonary disease; CTD, connective tissue disorder; DM_c, diabetes complications; DM_n, diabetes mellitus; MLD, mild liver disease; MST, metastatic cancer; OMI, old myocardial infarction; PUD, peptic ulcer disease; PVD, peripheral vascular disease; RD, renal disease; SLD, severe liver disease.
Patients in the low CCI group exhibited lower in-hospital mortality compared with those in the high CCI group (0.6% vs 2.3%, p<0.001). The high CCI group experienced significantly lower VARC-2 composite early safety (44.2% vs 50.3%, p=0.001), including higher rates of all-cause mortality (2.3% vs 0.6%, p<0.001), all-cause stroke (4.7% vs 0.2%, p<0.001), major vascular complications (1.3% vs 0.2%, p<0.001), cardiac structural complications (5.1% vs 1.9%, p<0.001), acute kidney injury (5.7% vs 0.8%, p<0.001) and new permanent pacemaker implantation (2.2% vs 1.1%, p=0.011) (table 3).
Table 3. The clinical profile of endpoint events.
| VARC-2 composite early safety | Total | CCI=0–1 | CCI≥2 | P value |
|---|---|---|---|---|
| All-cause mortality | 42 (1.2) | 13 (0.6) | 29 (2.3) | <0.001 |
| All stroke | 64 (1.9) | 5 (0.2) | 59 (4.7) | <0.001 |
| VARC type 3–4 bleeding | 1423 (42.1) | 900 (42.2) | 523 (42.0) | 0.910 |
| Major vascular complication | 21 (0.6) | 5 (0.2) | 16 (1.3) | <0.001 |
| Access-related complication | 1 (0) | 1 (0) | 0 (0) | 0.445 |
| Cardiac structural complication | 103 (3.0) | 40 (1.9) | 63 (5.1) | <0.001 |
| AKI | 89 (2.6) | 18 (0.8) | 71 (5.7) | <0.001 |
| PP | 50 (1.5) | 23 (1.1) | 27 (2.2) | 0.011 |
AKI, acute kidney injury; CCI, Charlson Comorbidity Index; PP, permanent pacemaker; VARC, Valve Academic Research Consortium.
We further compared outcomes between the high CCI group and low CCI group (reference group). Multivariable adjustment for VARC-2 composite early safety and in-hospital mortality included age, sex, hypertension, AF, HFRS, previous PCI, TAVR, ECMO and IABP. After adjustment, increases in CCI were significantly associated with adverse outcomes, underscoring the impact of a higher comorbidity burden on in-hospital outcomes (table 4).
Table 4. The predictors of clinical adverse events.
| Outcome from logistic regression | N | OR (95% CI) | P value |
|---|---|---|---|
| In-hospital mortality | 42 | ||
| Unadjusted | 3.89 (2.01 to 7.51) | <0.001 | |
| Age adjusted | 3.42 (1.76 to 6.65) | <0.001 | |
| Age and sex adjusted | 3.57 (1.84 to 6.95) | <0.001 | |
| Multivariable adjusted* | 2.17 (1.02 to 4.61) | 0.044 | |
| VARC-2 composite early safety | 1571 | ||
| Unadjusted | 1.28 (1.11 to 1.47) | 0.001 | |
| Age adjusted | 1.24 (1.08 to 1.43) | 0.003 | |
| Age and sex adjusted | 1.33 (1.15 to 1.54) | <0.001 | |
| Multivariable adjusted | 1.36 (1.17 to 1.58) | <0.001 |
Multivariable adjusted: age, sex, hypertension, atrial fibrillation, Hospital Frailty Risk Score, previous percutaneous coronary intervention, transcatheter aortic valve replacement, extracorporeal membrane oxygenation and intra-aortic balloon pump. The ORs represent the comparison of outcomes between the high Charlson Comorbidity Index (CCI) group and low CCI group.
VARC-2, Valve Academic Research Consortium-2.
Subgroup analysis of age and TAVR
In patients aged ≥65 years with low CCI scores, VARC-2 composite early safety events occurred in 24 (17.6%) patients undergoing TAVR and 352 (54.3%) patients undergoing SAVR. In patients with high CCI scores, these events occurred in 61 (33.7%) patients after TAVR and 231 (62.8%) patients after SAVR. For patients aged ≥65 years, TAVR was associated with a lower risk of composite early safety events, irrespective of CCI score.
In patients aged <65 years with low CCI scores, VARC-2 composite early safety events occurred in 3 (20.0%) patients undergoing TAVR and 565 (42.3%) patients undergoing SAVR (p=0.082). In patients with high CCI scores, these events occurred in 8 (50.0%) patients after TAVR and 327 (48.0%) patients after SAVR (p=0.875). Detailed results are presented in figure 2. In addition, we conducted a 1:1 propensity score matching analysis among patients aged over 65 years to adjust for potential baseline differences. Propensity scores were estimated using a logistic regression model with age and gender as covariates. Matching was performed using the nearest-neighbour method without replacement, with a 1:1 matching ratio. The matched dataset was then used for subsequent outcome comparisons. The analysis showed no significant difference in mortality between TAVR and SAVR (1.6% vs 3.5%, p=0.129). However, TAVR demonstrated notably lower VARC-2 composite early safety endpoints (26.8% vs 60.6%, p<0.001). Additionally, to further assess the potential impact of the COVID-19 pandemic, we performed a stratified analysis comparing key outcomes between the pre-pandemic and pandemic periods. These results are provided in online supplemental material and demonstrate that the primary findings remained consistent across time periods
Figure 2. The in-hospital composite events of patients in different age stages. To patients aged 65 or more, TAVR was associated with a lower risk of composite early safety events, irrespective of CCI score. CCI, Charlson Comorbidity Index; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement; VARC-2, Valve Academic Research Consortium-2.
Discussion
The main findings of this study are as follows: (a) AS patients undergoing AVR demonstrated higher comorbidity burdens, as indicated by elevated CCI scores; (b) patients with high CCI scores exhibited significantly higher rates of in-hospital adverse events compared with those with low scores; (c) after adjusting for confounding factors, CCI was identified as a key predictor of composite events; (d) age-stratified analysis revealed that TAVR should be preferred for patients aged 65 years or older to minimise composite events, regardless of CCI score.
The CCI has been established as a critical prognostic tool in patient management19 and is closely associated with adverse clinical events. Previous studies have demonstrated correlations between high CCI scores and prolonged hospital stays, increased age, and a greater number of comorbidities.20 21 Consistent with these findings, our study revealed that patients with high CCI scores (CCI score ≥2) were significantly more likely to be older, have multiple comorbidities and experience extended hospital stays.
Kearney et al demonstrated that a higher age-adjusted CCI is associated with increased long-term mortality in patients with severe AS.22 Our study extends this research by focusing on short-term outcomes, particularly in-hospital events. The observed in-hospital mortality rate of 1.2% in our study is comparable to rates reported in previous studies.23 24 While George et al found no relationship between CCI and combined safety endpoints in TAVR patients.25 Our study suggested that patients with high CCI scores had an increased risk of in-hospital death and safety endpoints. This discrepancy may be attributed to differences in sample size and patient populations.
The CCI has been validated as an independent predictor of long-term outcomes in patients undergoing TAVR or SAVR.25,27 Previous research has primarily focused on the association between CCI and adverse outcomes over mid-term to long-term periods.28 Patients with high CCI scores exhibit significant quality of life impairment and increased mortality after 2 years.26 TAVR patients often present with a high burden of comorbid conditions, impacting clinical and procedural outcomes.25 Pinon et al identified comorbidity as an independent risk factor for 1-year and 3-year mortality in SAVR patients with advanced comorbidity.27 Our study extends these findings by demonstrating that among elderly patients aged 65 and older with a high CCI, TAVR is associated with more favourable safety endpoints compared with SAVR, particularly regarding immediate postoperative safety.
Frailty, a clinical syndrome characterised by reduced physiological reserve in response to stress, is prevalent among elderly individuals, particularly those with comorbidities and chronic diseases. In cardiovascular disease, frailty is associated with poorer clinical outcomes and increased morbidity and mortality.29 Our study emphasises the importance of accurately identifying and assessing frailty in treatment planning. Multivariate analysis revealed frailty score as an independent risk factor for mortality (OR=1.320, 95% CI 1.173 to 1.485, p<0.001) and safety endpoint events (OR=1.121, 95% CI 1.070 to 1.174, p<0.001).
This study establishes the CCI score as an independent predictor of composite events in adults with AS following AVR. High CCI scores were identified as a significant predictor of in-hospital composite events. To reduce composite event rates, TAVR is recommended over SAVR for patients aged 65 years or older, regardless of their comorbidity burden, while the choice between TAVR and SAVR for younger patients may depend on individual clinical factors.
Study limitations
This study has several limitations. First, as a single-centre, retrospective study, it is subject to potential selection bias. Second, post-procedural management factors that might have influenced in-hospital mortality or other endpoints could not be accounted for. Finally, the retrospective nature of the study introduces inherent biases and lacks the randomised control typical of randomised controlled trials, potentially affecting the interpretation of the findings.
Conclusion
In conclusion, this study underscores the significance of CCI in predicting clinical outcomes for AS patients undergoing AVR. Elevated CCI scores were found to correlate with increased in-hospital composite adverse events. Our findings support TAVR as the preferred strategy for patients aged 65 or older, regardless of CCI scores, to minimise composite events risk. Despite the limitations inherent in a single-centre retrospective study, this research emphasises the value of CCI in personalising treatment strategies for AS patients with significant comorbidities.
Supplementary material
Footnotes
Funding: This work was supported by the National Key Research and Development Project, the Ministry of Science and Technology of the People's Republic of China (2020YFC2004800), Research and cultivation fund of Capital Medical University (PYZ22168). The Capital Medical University Affiliated Beijing Shijitan Hospital Youth Foundation (2023-q06). The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding agency.
Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2023-083677).
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient consent for publication: Not applicable.
Patient and public involvement: Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.
Ethics approval: This study involves human participants. Ethical approval was obtained from the Ethics Committee of Beijing Anzhen Hospital, Capital Medical University (approval number: 2021156X). This study does not involve animal subjects. Written informed consent was obtained from all participants prior to their inclusion in the study, in accordance with institutional guidelines and ethical standards.
Data availability free text: The datasets generated and analysed for this study are available from the corresponding author upon reasonable request.
Data availability statement
Data are available upon reasonable request.
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