Abstract
Objective
To explore long-term physical activity (PA) among patients 2 years post-transcatheter aortic valve replacement (TAVR) and assess the impact of syncope history on post-TAVR activity.
Design
This was a cross-sectional study conducted using an on-site questionnaire.
Setting
In this cross-sectional study, we used convenience sampling to recruit participants from the outpatient department at a tertiary hospital in Shanghai, China, between July 2023 and December 2023.
Participants
Patients who had undergone TAVR for 2 years or more were included in the study.
Primary and secondary outcome measures
The self-reported PA levels were assessed using the validated Chinese version of the International Physical Activity Questionnaire-Short Form. Additionally, medical records of the patients were thoroughly reviewed to accurately document the history of syncope for everyone.
Result
Via convenience sampling, we recruited 179 consecutive participants aged 60 years and older who underwent TAVR. Only 36.31% (65/179) of patients remained physically active ≥2 years post-TAVR, with 27.37% having a syncope history. After adjusting for potential confounders, a history of syncope was independently associated with significantly lower levels of long-term PA (adjusted OR 0.287, 95% CI 0.122 to 0.675). This negative association was particularly pronounced among men and individuals with a normal body mass index (BMI).
Conclusion
A history of syncope is a strong independent predictor of reduced PA in the long term after TAVR. These findings highlight that patients with a history of syncope, especially men and those with normal BMI, represent a high-risk subgroup warranting particular attention in post-TAVR care. Targeted assessment and rehabilitation strategies should be considered for this population, and further research is needed to elucidate the underlying mechanisms.
Keywords: Nursing Care, Rehabilitation medicine, Exercise, Valvular heart disease
STRENGTHS AND LIMITATIONS OF THIS STUDY
This cross-sectional study used a consecutive sampling method to recruit eligible patients during routine clinic visits, enhancing participant representation within a single-centre setting.
The analysis used multivariate logistic regression adjusted for key clinical confounders and included subgroup analyses to explore potential effect modification.
The cross-sectional design precludes the determination of causal relationships between syncope history and physical activity (PA) levels.
The study primarily relies on self-reported data for PA, which may introduce bias or inaccuracies.
The study lacks a detailed exploration of other potential factors influencing physical inactivity post-transcatheter aortic valve replacement, which could limit the comprehensiveness of its conclusions.
Introduction
Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure in which interventional catheter techniques are used to replace a valve and restore its function. In recent years, it has become a focus of research in aortic stenosis and the latest breakthrough in treatment, saving numerous patients who are ineligible for surgical aortic valve replacement.1 However, while survival rates have significantly improved, the issue of persistently low out-of-hospital exercise capacity in post-TAVR patients has gradually become apparent, severely impacting disease prognosis. A previous study revealed that nearly one-third of patients who underwent TAVR did not experience an improvement in their exercise capacity after the procedure.2 Additionally, not attaining 20% improvement in 6 min walk distance was independently associated with higher risk of all-cause mortality, cardiovascular-related death or readmission due to cardiovascular causes.3 A notable lack of physical activity (PA) is common among elderly individuals with severe aortic stenosis who are awaiting TAVR. This could stem from self-limiting behaviour of patients or being advised against exertion to avoid triggering symptoms.3 Surprisingly, in patients who survived 12 months following TAVR, there was an average decrease of −126 kcal/week in habitual PA compared with baseline.4 Dennis van Erck5 also reported that there was no significant change in PA following the TAVR procedure. This suggests that solely relying on the effects of undergoing TAVR may not effectively boost PA of patients even after successfully addressing aortic stenosis. In addition, this finding underscores a critical bottleneck: while TAVR technology successfully addresses valve replacement challenges in elderly patients, it falls short in addressing subsequent low activity levels, significantly hampering the benefits of TAVR. Why are patients not becoming more active post-TAVR? Swift action is required to develop efficient strategies that promote PA to ensure enduring improvements in exercise capacity and long-term outcomes. Identifying the factors influencing participation in PA is a vital initial step. This will enable us to prioritise interventions effectively, ultimately enhancing post-TAVR PA, improving patient prognosis and optimising TAVR outcomes.
PA is a crucial clinical and quality-of-life outcome for patients, as consistently low PA levels can have adverse effects on long-term mobility, morbidity, social interaction and independent living.6 In recent years, among guidelines and expert consensuses, there has been a growing focus on emphasising the importance of post-TAVR PA.17,10 Previous studies have thoroughly investigated the factors influencing participation in PA during cardiac rehabilitation among individuals with heart failure or coronary heart disease.11 12 These studies have identified various factors across personal, socio-environmental and intervention-related levels.13 Notably, factors influencing health behaviours often tend to be specific to the disease context.14 15 With respect to cutting-edge development, TAVR is predominantly used to treat symptomatic severe aortic stenosis in patients classified as having extreme, high or intermediate surgical risk.16 Patients with severe aortic stenosis are often advised to limit PA to avoid triggering symptoms such as syncope, dyspnoea, chest tightness and even sudden death.17 Syncope, a prevalent symptom in individuals with severe aortic stenosis, is a primary driver that prompts patients to seek medical attention prior to the procedure. Syncope often involves loss of consciousness and falls, causing significant fear in patients.17 In clinical practice, patients often express reluctance to go out alone or increase their activity levels due to past episodes of syncope. Thus, the objective of this study was to explore (a) PA levels in patients with TAVR who were ≥2-years-post-procedure and (b) the relationship between syncope history and PA levels in these patients. Previously, investigators often focused on PA levels in patients with TAVR within 6–12 months post-procedure. This ≥2 year follow-up design enables exploration of the association between a history of syncope and post-TAVR PA levels, providing valuable insights into the PA status of this population.
Methods
Design and participants
In this cross-sectional study, we consecutively recruited eligible participants via convenience sampling from the outpatient department of a grade A tertiary hospital in Shanghai, China, between July 2023 and December 2023. Patients who had undergone TAVR ≥2 years prior, were capable of independent walking, were capable of proficient communication in the Chinese language, and had adequate hearing and vision for assessment compliance were eligible for inclusion. Patients who were unwilling to participate or who had limb dysfunction, concurrent serious illnesses (such as acute infection, malignant tumour, acute cerebrovascular diseases or terminal illness), syncope after TAVR or severe mental disorders were excluded. A single population proportion formula was used to determine the sample size based on the following assumptions: since there were no existing studies using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) to assess PA in populations undergoing TAVR, we conducted a pilot study. In that pilot study, 30 patients were included, 11 of whom achieved either a ‘moderate’ or ‘high’ level of PA. The observed proportion of PA was 36.67%, with a 95% CI and an 8% margin of error (d). Additionally, we accounted for a 20% non-response rate, resulting in a minimum required sample size of 174 participants. Alternatively, we determined the sample size using the rule of thumb for logistic modelling. To ensure sufficient statistical power, a minimum of 10 events per predictor variable is advised for logistic modelling, as recommended by Vittinghoff and McCulloch.18 Considering the results of the pilot study and the incorporation of six variables into the logistic regression model, the estimated sample size for the study was determined to be 163. The patients enrolled in this preliminary pilot study constituted a separate cohort and were not included in the main analysis. During the study period, a total of 205 inpatients were deemed eligible to participate. Among them, 16 patients declined to participate, and 10 patients were excluded because data on more than three items were missing. Consequently, 179 patients were included in the analysis, ensuring adequate statistical power. Further information regarding participant enrolment is provided in figure 1.
Figure 1. Flow chart of enrolment of participants.
Data collection
We used a structured questionnaire and reviewed medical records to collect the data. Patients who met the inclusion criteria were selected from the outpatient visit list. When these eligible patients revisited the clinic, physicians or outpatient nurses referred them to us. Afterwards, we outlined the study goals and protocols. Patients who agreed to join and signed the consent form completed the questionnaires either on their own or with the help of a research aide.
Ethical considerations
This study strictly adhered to the principles outlined in the Declaration of Helsinki. Approval for the study was obtained from the Ethics Committee of Zhongshan Hospital, Fudan University, with the ethics approval code B2022-062R. Before initiating participant recruitment, the questionnaire underwent a thorough approval process. On starting the study, the researchers provided a detailed participant information sheet, along with verbal communication, explaining the voluntary nature of participation and the right to withdraw at any time without providing a reason. The information sheet also clarified the purpose, significance and potential benefits of the research. All participants provided formal written consent before participating. To maintain anonymity, no demographic information that could identify participants was collected.
Patient and public involvement
We involved a diverse group of patients to assess the comprehensibility and usability of our data collection tools.
Data analysis
We conducted all the statistical analyses using SPSS V.26.0 (IBM Corp, Armonk, New York, USA). Missing data were handled using multiple imputation by chained equations. We generated 20 imputed datasets, a standard number sufficient for achieving stable estimates. The overall proportion of missing data was low (<5% for any variable included in the final model). Given the low percentage and the absence of an identifiable systematic pattern (eg, missingness not associated with the outcome variable), the data were assumed to be missing at random for the purpose of imputation. All analyses were performed on the pooled results from the 20 imputed datasets. We also referred to the statistical analysis methods reported in the literature.19 Continuous variables are expressed as either the mean and SD or the median and IQR, while categorical variables are presented as percentages. The normality of distribution for continuous variables was assessed using the Shapiro-Wilk test. We used independent-samples t-tests for normally distributed continuous variables and the Mann‒Whitney U test for non-normally distributed continuous variables. The Pearson χ2 test was applied to analyse categorical variables. In the univariate analysis, potential confounding factors were assessed, and variables with p values less than 0.1 were chosen for inclusion in the multivariate analysis. Multivariate logistic regression models adjusted for age, gender, body mass index (BMI), hypertension status and haemoglobin levels were used to investigate the impact of a history of syncope on PA following TAVR. Subgroup analysis was also applied to explore the impact of syncope history on PA in post-TAVR patients of different ages, genders and BMIs. The logistic regression analysis results are presented as ORs along with their corresponding 95% CIs.
Measurement
The validated Chinese version of the IPAQ-SF was used to measure self-reported PA levels.20 21 The IPAQ-SF gathers data on the frequency and duration of walking, moderate-intensity activities, vigorous-intensity activities and sitting over the past 7 days. This information is then used to calculate energy expenditure in metabolic equivalents (METs). The continuous score of the IPAQ-SF is computed by multiplying the MET level by the min of activity per day and the days per week, resulting in a measurement expressed in METs-min/week. This calculation applies to walking (3.3 METs), moderate PA (4 METs) and vigorous PA (8 METs).22 The categorical score of the IPAQ-SF categorises a patient’s PA level as ‘low’, ‘moderate’ or ‘high’. These classifications can be further interpreted as ‘physically active’ (group A, corresponding to ‘moderate’ or ‘high’ PA levels) and ‘physically inactive’ (group B, associated with a ‘low’ PA level; online supplemental file 1).
Syncope is a symptom that presents with an abrupt, transient, complete loss of consciousness associated with the inability to maintain postural tone and rapid and spontaneous recovery.17 The underlying mechanism is believed to be cerebral hypoperfusion. Clinical manifestations should not align with other non-syncope causes of unconsciousness, such as seizures, prior head trauma or simulated loss of consciousness (pseudosyncope). Each patient who underwent TAVR in our hospital was assessed by a doctor to determine if they had a history of syncope. The syncope history was clearly recorded in the medical records. Therefore, we reviewed the medical records to obtain the syncope history of each patient. At our hospital, all patients being considered for TAVR underwent a comprehensive assessment by a team of 2–3 senior cardiothoracic surgeons. As part of the routine clinical workup to determine the aetiology of syncope and its link to severe aortic stenosis, these surgeons differentiated between cardiogenic syncope (primarily attributed to aortic stenosis after considering other cardiac causes) and other types (eg, neurally mediated). This differentiation was based on a thorough review of the history of the patient, physical examination and available diagnostic tests. When indicated by clinical presentation, further investigations such as neurological imaging were pursued to exclude non-cardiac causes.
Development and validation of the questionnaire
A structured questionnaire focusing on PA-relevant factors was developed based on a literature review23,25 and clinical expertise. The questionnaire included demographic characteristics, medical indices and laboratory data. Patient demographic data were self-reported, while medical indices and laboratory data were extracted from medical records. To ensure its validity and appropriateness for our study population, a two-step validation process was conducted.
First, content validity was assessed via a two-round Delphi survey. A panel of 12 experts, each with over 10 years of clinical experience in managing TAVR patients, evaluated the relevance and clarity of each questionnaire item. Items with a content validity index (CVI) <0.80 were removed or revised. After the second round, the average CVI for the entire questionnaire reached 0.928, indicating excellent expert consensus on its content validity.
Subsequently, face validity and comprehensibility were tested in a pilot study. Fifteen patients with diverse backgrounds (eg, varying age and education level) completed the questionnaire and were interviewed to provide feedback on item wording, interpretation and overall ease of completion. The questionnaire was refined iteratively based on their input to enhance clarity and minimise ambiguity.
Therefore, the final questionnaire demonstrated good content validity, face validity and feasibility for use in this specific patient population.
The finalised questionnaire consisted of two primary sections: (1) sociodemographic characteristics (eg, age, gender and marital status); and (2) TAVR procedure-related characteristics and medical history (including comorbidities, perioperative data and other relevant clinical factors). A complete blank version of the questionnaire is available in online supplemental file 2.
Results
Participant characteristics
The analysis included a total of 179 patients who were categorised into two groups based on their PA post-TAVR. Table 1 outlines the demographic characteristics and factors affecting PA levels. The average age of the participants was 79.11 years (SD, 7.21), with women accounting for 44.13% of the sample. Patients with low PA levels, in contrast to those who maintained an active lifestyle, exhibited a greater incidence of hypertension, lower recent haemoglobin levels and a history of syncope.
Table 1. Baseline characteristics of all eligible participants.
| Variable | Total | Physical activity after TAVR | P value | |
|---|---|---|---|---|
| Inactive group (n=114) |
Active group (n=65) |
|||
| n (%) | 179 | 114 (63.69) | 65 (36.31) | |
| Age, years | 79.11±7.21 | 79.69±7.69 | 78.10±6.23 | 0.156* |
| Female, n (%) | 79 (44.13) | 55 (69.62) | 24 (30.38) | 0.142† |
| Married‡ | 160 (89.39) | 105 (65.63) | 55 (34.38) | 0.118† |
| Nicotine use, n (%) | 24 (13.41) | 18 (75) | 6 (25) | 0.216† |
| Months after TAVR, months | 45.89±20.78 | 46.63±21.28 | 44.60±19.96 | 0.5§ |
| BMI, kg/m2 | 23.39±3.42 | 23.39±3.41 | 23.37±3.58 | 0.964* |
| Hypertension, n (%) | 98 (54.75) | 69 (70.41) | 29 (29.59) | 0.04† |
| Diabetes mellitus, n (%) | 43 (24.02) | 30 (69.77) | 13 (30.23) | 0.342† |
| Coronary artery disease, n (%) | 132 (73.74) | 88 (66.67) | 44 (33.33) | 0.165† |
| Pulmonary disease¶, n (%) | 96 (53.63) | 64 (66.67) | 32 (33.33) | 0.373† |
| Atrial fibrillation, n (%) | 34 (18.99) | 21 (61.76) | 13 (38.24) | 0.796† |
| Perivalvular leakage, n (%) | 26 (14.53) | 18 (69.23) | 8 (30.77) | 0.523† |
| Permanent pacemaker, n (%) | 25 (13.97) | 17 (68) | 8 (32) | 0.629† |
| NYHA functional classification, n (%) | 0.871** | |||
| I | 5 (2.79) | 4 (2.23) | 1 (0.56) | |
| II | 122 (68.16) | 77 (43.02) | 45 (25.14) | |
| III | 30 (16.76) | 20 (11.17) | 10 (5.59) | |
| IV | 22 (12.29) | 13 (7.26) | 9 (5.03) | |
| eGFR (recent), mL/min/1.73 m2 | 75.05±16.66 | 74.96±16.95 | 75.20±16.26 | 0.854§ |
| Haemoglobin (recent), g/L | 127.57±16.28 | 125.84±15.47 | 130.62±17.31 | 0.059* |
| LVEF (recent), n (%) | 61.80±8.04 | 61.57±8.54 | 62.23±7.13 | 0.667§ |
| LVEF before TAVR, n (%) | 57.26±11.80 | 57.00±12.3 | 57.74±10.93 | 0.996§ |
| Perioperative complications, n (%) | 29 (16.2) | 18 (62.07) | 11 (37.93) | 0.843† |
| Symptoms before TAVR, n (%) | ||||
| Chest tightness | 141 (78.77) | 93 (65.96) | 48 (34.04) | 0.224† |
| Palpitation | 25 (13.97) | 14 (56) | 11 (44) | 0.389† |
| Shortness of breath | 91 (50.84) | 62 (68.13) | 29 (31.87) | 0.209† |
| Chest pain | 25 (13.97) | 17 (68) | 8 (32) | 0.136† |
| Syncope history | 49 (27.37) | 41 (83.67) | 8 (16.33) | 0.001† |
As this was a single-centre study conducted in China, the study population was homogeneous with all participants being of Asian/Han Chinese ethnicity
Independent-sample t-test
Pearson χ2 test
Other patients, including unmarried, divorced and widowed.
Mann–Whitney U test.
Pulmonary arterial hypertension and chronic obstructive pulmonary disease.
Fisher’s exact test
BMI, body mass index; eGFR, estimated glomerular filtration rate; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; TAVR, transcatheter aortic valve replacement.
PA levels in patients after TAVR
Based on the IPAQ-SF scale scoring results, we classified the PA level of the participants: only 36.31% (65/179) were categorised as PA (moderate/high level), whereas 63.69% (114/179) were deemed inactive (low level). We further stratified the active group: 12.29% attained a ‘high’ PA level and 24.02% a ‘moderate’ level, with the low-activity group accounting for the remaining 63.69% of the cohort.
This distribution highlights the high prevalence of physical inactivity among long-term TAVR survivors.
Prevalence of syncope history in patients after TAVR
In this study, among patients who underwent TAVR, 27.37% (49/179) had a history of syncope.
Syncope history and post-TAVR PA
Table 2 displays the outcomes of multivariate regression concerning the impact of syncope history on post-TAVR PA levels. Even after adjusting for five related factors, a significant association was found between syncope history and PA levels among patients who underwent TAVR more than 2 years ago, with an OR (95% CI) of 0.287 (0.122 to 0.675).
Table 2. Multivariate regression for the effect of syncope history on post-transcatheter aortic valve replacement physical activity.
| Variables | Multivariable analysis | ||
|---|---|---|---|
| OR | 95% CI | P value | |
| Female, n (%) | 0.722 | 0.35 to 1.49 | 0.379 |
| Age, years | 0.98 | 0.934 to 1.028 | 0.407 |
| BMI, kg/m2 | 0.99 | 0.897 to 1.092 | 0.842 |
| Hypertension, n (%) | 0.607 | 0.313 to 1.176 | 0.139 |
| Haemoglobin (recent), g/L | 1.004 | 0.98 to 1.029 | 0.728 |
| Syncope history, n (%) | 0.287 | 0.122 to 0.675 | 0.004 |
BMI, body mass index.
Subgroup analysis of the effect of syncope history on post-TAVR PA
The subgroup analysis results are detailed in table 3 and figure 2. We observed that among men and individuals with a normal BMI, a history of syncope had a more pronounced impact on post-TAVR PA, with ORs (95% CIs) of 0.258 (0.078 to 0.847) and 0.321 (0.106 to 0.977), respectively. No significant heterogeneity was detected across age groups. Figure 3 also shows the ‘moderate’ or ‘high’ PA levels in different subgroups.
Table 3. Subgroup multivariate regression analysis of the effect of syncope history on post-transcatheter aortic valve replacement physical activity.
| Variables | Multivariable analysis | ||
|---|---|---|---|
| OR | 95% CI | P value | |
| Male (n=100) | |||
| Age, years | 0.999 | 0.932 to 1.07 | 0.97 |
| BMI, kg/m2 | 1.024 | 0.907 to 1.157 | 0.7 |
| Hypertension, n (%) | 0.793 | 0.339 to 1.855 | 0.593 |
| Haemoglobin (recent), g/L | 1.009 | 0.978 to 1.041 | 0.559 |
| Syncope history, n (%) | 0.258 | 0.078 to 0.847 | 0.026 |
| Female (n=79) | |||
| Age, years | 0.961 | 0.896 to 1.03 | 0.26 |
| BMI, kg/m2 | 0.949 | 0.793 to 1.136 | 0.568 |
| Hypertension, n (%) | 0.426 | 0.139 to 1.310 | 0.137 |
| Haemoglobin (recent), g/L | 1.002 | 0.961 to 1.044 | 0.94 |
| Syncope, n (%) | 0.359 | 0.103 to 1.25 | 0.107 |
| Age ≥80 years (n=94) | |||
| Female, n (%) | 0.464 | 0.165 to 1.306 | 0.146 |
| BMI, kg/m2 | 0.965 | 0.837 to 1.112 | 0.624 |
| Hypertension, n (%) | 0.471 | 0.179 to 1.24 | 0.127 |
| Haemoglobin (recent), g/L | 0.996 | 0.965 to 1.029 | 0.824 |
| Syncope history, n (%) | 0.286 | 0.086 to 0.956 | 0.042 |
| Age ＜80 years (n=85) | |||
| Female, n (%) | 1.202 | 0.420 to 3.445 | 0.732 |
| BMI, kg/m2 | 1.021 | 0.886 to 1.176 | 0.778 |
| Hypertension, n (%) | 0.831 | 0.325 to 2.124 | 0.699 |
| Haemoglobin (recent), g/L | 1.018 | 0.980 to 1.058 | 0.360 |
| Syncope history, n (%) | 0.279 | 0.082 to 0.956 | 0.042 |
| BMI 18.5–24.9 kg/m2 (n=106) | |||
| Female, n (%) | 1.118 | 0.462 to 2.705 | 0.805 |
| Age, years | 0.973 | 0.914 to 1.037 | 0.402 |
| Hypertension, n (%) | 0.627 | 0.271 to 1.451 | 0.275 |
| Haemoglobin (recent), g/L | 1.001 | 0.975 to 1.029 | 0.915 |
| Syncope history, n (%) | 0.321 | 0.106 to 0.977 | 0.045 |
| BMI <18.5 or ≥25 kg/m2 (n=73) | |||
| Female, n (%) | 0.461 | 0.146 to 1.448 | 0.185 |
| Age, years | 0.981 | 0.895 to 1.075 | 0.679 |
| Hypertension, n (%) | 0.611 | 0.196 to 1.901 | 0.394 |
| Haemoglobin (recent), g/L | 1.029 | 0.991 to 1.068 | 0.135 |
| Syncope, n (%) | 0.251 | 0.058 to 1.096 | 0.066 |
BMI, body mass index.
Figure 2. Subgroup analysis of the effect of syncope history on post-transcatheter aortic valve replacement physical activity. BMI, body mass index.
Figure 3. Moderate or high physical activity levels in sub-groups. BMI, body mass index.
Discussion
This study is the first to explore the relationship between syncope history and the level of PA in patients who underwent TAVR 2 years ago or more, aiming for a comprehensive understanding of PA in this population. The results showed that only 36.31% (65 out of 179) of patients who underwent TAVR maintained a moderate to high level of PA for more than 2 years. This finding is consistent with the study by Chung et al,4 even though they investigated PA 12 months after TAVR. These findings indicate that despite effective treatment for aortic stenosis and improvements in cardiac function, most patients tend to maintain a physically inactive lifestyle after TAVR. Recent studies have focused more on implementing cardiac rehabilitation for patients after TAVR.10 However, before proceeding with this step, we must first understand why patients are reluctant to engage in more PA. Through our clinical practice, we have observed that patients with a history of syncope tend to avoid going out alone or engaging in any form of exercise, even when encouraged by medical staff. Therefore, we conducted this study to validate our hypothesis that a history of syncope can indeed influence the level of PA in patients post-TAVR. After adjusting for related factors (gender, age, BMI, hypertension and haemoglobin), a significant association was found between syncope history and PA levels among patients who underwent TAVR more than 2 years ago. Delbaere et al26 conducted a prospective community-based cohort study and found that a significant consequence of fear of falling is the avoidance of activities, which can have long-term negative effects on physical abilities. Syncope often occurs during outdoor activities or physical exertion, resulting in falls, fractures and other serious accidents.17 In patients, these incidents can instil fear-driven avoidance of activities. Building on this observation, we hypothesised that the association between syncope history and PA in post-TAVR patients may be mediated by the fear-induced avoidance of activities triggered by past syncope episodes. This hypothesis is supported by the well-documented impact of the fear of movement as a significant barrier to activity attendance and rehabilitation management in patients with cardiovascular disease. This phenomenon has been consistently confirmed in both qualitative and quantitative studies.27 28 Fear of movement often arises from a perceived lack of safety during PA. Patients may fear the recurrence of syncope following PAs after TAVR. Negative experiences and perceptions can fuel doubts and concerns about the safety of engaging in activities, leading to an association between PA and potential heart deterioration and adverse outcomes in the long term.29 However, this study solely confirmed the connection between the syncope history of the patient and their PA post-TAVR. We did not explore the relationship between syncope and fear-driven avoidance of activities, such as fear of movement (kinesiophobia),30 or the correlation between fear-driven avoidance of activities and actual PA levels. Nonetheless, we anticipate that this study will emphasise the importance of evaluating the syncope history of patients during TAVR procedures.
According to the subgroup analysis, PA in men and those with a BMI ≤24.9 kg/m2 was more likely to be affected by syncope history. Typically, men engage in greater levels of PA than women, which is likely influenced by societal expectations, biological factors and lifestyle preferences.13 However, when considering a history of syncope, men exhibit increased vulnerability to its impact on PA levels. Syncope history can evoke feelings of fear and caution, leading men to reduce their activity levels or avoid certain activities altogether. This heightened susceptibility underscores the significant influence of syncope history on the behaviour of men, highlighting the importance of addressing such concerns in healthcare and rehabilitation settings. Furthermore, our observations indicate a distinct impact of syncope history on the PA levels of individuals with a normal BMI who underwent TAVR. Those with a normal BMI exhibit a heightened focus on health and recovery, maintaining a keen awareness of exercise-related risks and complications that may limit their activity levels. This heightened awareness underscores their dedication to optimising recovery and minimising potential setbacks associated with post-TAVR PA. Although our subgroup analysis lacks direct references to support these findings, the observed trends indicate that we may have identified a unique subset of individuals or a specific context in which men exhibit heightened fear-induced avoidance of activities related to syncope history. Further research is warranted to delve deeper into these observations and validate our findings across broader populations.
Limitations
This study has several limitations that should be considered when interpreting the findings. First, the cross-sectional design inherently precludes the determination of causal direction between a history of syncope and reduced PA; the observed association may also reflect reverse causality or shared underlying factors.
Second, potential sources of bias must be acknowledged. While consecutive sampling was used, the single-centre setting may introduce selection bias, limiting the generalisability of our results to other healthcare environments. Specifically, although consecutive enrolment of eligible outpatients aimed to enhance representativeness within our centre, this convenience sampling approach means our cohort may not fully represent the broader national TAVR population, including those lost to follow-up, from rural areas or treated at non-tertiary centres. Although the syncope history was based on expert clinical adjudication, the retrospective extraction of this information from records means that details on episode frequency or severity were not systematically available for analysis, and some degree of misclassification is possible.
Third, regarding our analytical model, the variables for adjustment (age, gender, BMI, hypertension and haemoglobin) were selected a priori based on their established clinical relevance to cardiovascular outcomes and PA, complemented by a univariate screen (p<0.1). While this approach is common, we recognise that residual confounding may persist due to unmeasured or imperfectly measured variables, such as psychosocial factors (eg, depression and social support), specific cardiac rehabilitation participation. These unaccounted-for factors could influence both the historical occurrence of syncope and current activity levels. Additionally, the potential impact of the chosen imputation method for handling missing data was not tested via sensitivity analyses (eg, complete case analysis), which should be considered when interpreting the results.
Therefore, our results should be interpreted as identifying a significant and clinically relevant association, which underscores the need for future longitudinal or interventional studies to explore causality and underlying mechanisms.
Relevance to clinical practice
Our findings have several implications for clinical practice. Given the observed impact of syncope history on post-TAVR PA levels, healthcare professionals should prioritise comprehensive assessments and tailored interventions for patients with a history of syncope. Understanding the specific factors contributing to reduced PA in patients who have previously experienced syncope is crucial for optimising patient outcomes. Subsequent research efforts should delve deeper into the mechanisms underlying this relationship, exploring potential physiological, psychological and behavioural factors that influence activity levels in these individuals. By uncovering these nuances, medical experts can develop targeted strategies such as personalised rehabilitation programmes, cognitive-behavioural interventions or specialised monitoring protocols to address and mitigate the impact of syncope on long-term PA and overall quality of life in TAVR patients.
Conclusion
A history of syncope is independently associated with lower levels of PA (adjusted OR 0.287, 95% CI 0.122 to 0.675) in patients ≥2 years after TAVR, with the association being particularly pronounced among men and those with a normal BMI. Medical staff should give greater attention to patients with a history of syncope who are undergoing TAVR. Strategies such as health education, motivational interviewing and peer support should be implemented to prevent postsyncope-related conditions such as fear of movement.
Supplementary material
Acknowledgements
We extend our heartfelt gratitude to all participants and their families. Special acknowledgment goes to the researchers for their dedicated efforts in conducting this study.
Footnotes
Funding: This study was supported by the Key Discipline of the Three-Year Action Plan for Strengthening the Public Health System Construction in Shanghai (2023–2025) (GWVI-11.1-46—Health Education and Health Promotion—Direction 20: Strategies, Research and Evaluation of Health Education, Health Promotion and Health Communication in the Context of Media Convergence), the Clinical Research Fund of Zhongshan Hospital, Fudan University (ZSLCYJ202358) and Shanghai Health Science Popularization Special Project Plan (JKKPYL-2025-A01). Additional sources of support for this research and manuscript development include the Shanghai Municipal Health Commission Special Project for Clinical Research in the Health Industry (20234Y0183). The funders had no role in the study design, data collection and analysis, decision to publish or preparation of the manuscript. The funders did not influence the results or outcomes of the study despite affiliations of authors (ZS, ZZ, CH, DZ, YL and YZ) with the funding organisations.
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-2024-094395).
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient consent for publication: Consent obtained directly from patient(s).
Ethics approval: Approval for the study was obtained from the Ethics Committee of Zhongshan Hospital, Fudan University, with the ethics approval code B2022-062R. Participants gave informed consent to participate in the study before taking part.
Data availability free text: The datasets generated and analysed during the current study are not publicly available to ensure patient privacy and comply with ethical guidelines regarding informed consent for online raw data. However, interested researchers may request access to the data from the corresponding author, subject to reasonable requests.
Patient and public involvement: Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Data availability statement
No data are available.
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