Prognostic Utility of Left Ventricular Ejection Fraction in Patients Undergoing Transcatheter Aortic Valve Implantation　― A Systematic Review and Meta-Analysis ―

Abstract

Background: Left ventricular ejection fraction (LVEF) is widely used to assess systolic function and to predict cardiovascular outcomes, but its prognostic role in patients undergoing transcatheter aortic valve implantation (TAVI) remains uncertain.

Methods and Results: We performed a systematic review and meta-analysis of studies published from 2001 to 2024 that evaluated the association between preprocedural LVEF and post-TAVI outcomes. Eligible studies were identified via PubMed and Scopus, and included those reporting hazard ratios for preprocedural LVEF. A total of 92 studies comprising 98 patient cohorts and 75,085 individuals were included. Random-effects models were used for univariable and multivariable analyses. Subgroup and meta-regression analyses assessed effect modifiers, including ethnicity, LVEF classification, endpoints, and study design. Each 1% decrease in LVEF was associated with an increased risk of adverse events (hazard ratio 1.02, 95% confidence interval: 1.01–1.03), and this association remained significant after adjusting for confounders. Subgroup analyses confirmed the robustness of this association in various settings. In the multivariable meta-regression, studies with lower mean LVEF demonstrated a stronger association between reduced LVEF and adverse outcomes, but this association was attenuated or nonsignificant in cohorts with preserved systolic function. This suggests that the prognostic value of LVEF may depend on the baseline level of ventricular function and is subject to effect modification.

Conclusions: Reduced preprocedural LVEF is independently associated with worse prognosis after TAVI. These results highlight the continued importance of LVEF in risk stratification and clinical decision-making in TAVI candidates.

Central Figure

Aortic stenosis (AS) is the most common valvular heart disease in developed countries, affecting approximately 3% of those aged over 75 years.¹ Transcatheter aortic valve implantation (TAVI) has been increasingly adopted as an effective treatment option for patients with severe AS, regardless of surgical risk.^2–4 Recent refinements in valve design, delivery systems, and periprocedural management have markedly improved procedural success and early outcomes after TAVI. A recent Japanese multicenter registry reported high feasibility and low complication rates with current-generation devices.⁵ At the same time, the indication for TAVI continues to broaden, encompassing progressively younger and lower risk patients, prompting calls for structured lifetime management strategies to balance long-term benefits and costs.⁶ Concomitantly, a growing body of research seeks to identify postprocedural prognostic determinants: drug-related hemodynamic responses,⁷ frailty phenotype,⁸ invasive pressure gradients,⁹ and even dynamic pulmonary congestion trajectories during the index admission¹⁰ have all been linked to clinical outcomes. Although these studies enrich our understanding of TAVI physiology, the sheer variety of candidate markers can complicate risk stratification and cost-effective patient selection. Accordingly, there is merit in revisiting whether a simple, universally measured, and long-established parameter can still provide reliable prognostic insight.

Among various echocardiographic parameters, left ventricular ejection fraction (LVEF) is the most commonly used measurement to assess LV systolic function and is frequently used in clinical practice for prognostic estimation. However, the prognostic value of LVEF in patients undergoing TAVI remains controversial.

Reduced LVEF is generally associated with poor outcomes in patients with cardiovascular diseases, but previous studies of the TAVI population have yielded inconsistent results. Some studies reported that a baseline low LVEF does not negatively affect prognosis,^11,12 while other studies report that a lower LVEF predicts higher mortality or major adverse cardiovascular events (MACE) rates.^13,14 These differences may arise from variations in patient backgrounds, study designs, endpoints, and the degree of statistical adjustment for confounding factors.

Additionally, the prognostic value of LVEF may vary among subgroups, such as different ethnicities or regions.¹⁵ Differences in comorbidities, procedural approaches or healthcare systems may influence the apparent utility of LVEF as a prognostic factor, but the possible influence of such confounders remains uncertain. Furthermore, to clarify whether LVEF has independent predictive value, it is essential to assess other echocardiographic parameters, such as stroke volume index (SVi), aortic valve area (AVA), or mean pressure gradient (mPG). Therefore, we conducted a systematic review and meta-analysis to evaluate the prognostic value of the preprocedural LVEF in patients undergoing TAVI.

Methods

This systematic review and meta-analysis was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR; UMIN000057959) and was conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines.¹⁶ The search question was structured using the PICO format: Population – patients undergoing TAVI for aortic stenosis; Intervention/Exposure – preprocedural evaluation of LVEF using transthoracic echocardiography; Comparison – comparison of clinical outcomes according to LVEF levels; Outcome – mortality and major cardiovascular events.

Literature Search and Study Selection

We systematically searched PubMed and Scopus to identify eligible studies published between January 2001 and December 2024. Search terms included keywords related to TAVI, LVEF, and clinical outcomes. The detailed search strategy is described in Supplementary Table 1.

Only full-text original articles written in English were included if they met the following criteria: (1) adult patients with AS undergoing TAVI; (2) baseline LVEF assessed using transthoracic echocardiography; (3) clinical outcomes such as all-cause death (ACD), cardiovascular death (CD) or MACE reported; (4) availability of hazard ratios (HRs) and 95% confidence intervals (CIs) from univariable or multivariable Cox regression analysis; and (5) sufficient data to calculate effect sizes. If multiple publications involved overlapping cohorts, we included the study with the most detailed or recent data.

Three authors independently screened titles and abstracts to select articles for full-text evaluation, followed by 2 authors reviewing the selected articles for full-text evaluation, and selected studies that met the inclusion criteria. Any discrepancies in study selection were resolved through discussion.

Data Collection and Processing

We extracted information on study characteristics such as the first author, publication year, country, reported ethnicity, and study design. Patient demographic data included sample size, mean age, and proportion of female participants. Echocardiographic parameters such as LVEF, AVA, mPG, and SVi were also collected. HRs, 95% CIs, and types of endpoints were also extracted. When studies reported both univariable and multivariable HRs, we included both in the analysis. All extracted data were compiled into a CSV file.

Statistical Analysis

Pooled estimates for baseline characteristics, such as age, AVA, mPG, SVi, LVEF, and global longitudinal strain (GLS), were calculated using the metamean function of R with a random-effects model. Results are presented as pooled means and standard deviations (SDs).

HRs per 1% decrease in LVEF were pooled separately for the univariable and multivariable models using the metagen function of R for prognostic analysis. Between-study heterogeneity was assessed using the I² statistic, and the Hartung-Knapp adjustment was applied to estimate 95% CIs.

Publication bias was evaluated using contour-enhanced funnel plots and Egger’s test. The PET-PEESE method and a 3-parameter selection model (3PSM) were used for bias-adjusted effect size after accounting for potential small study or publication bias. Influence analysis included Baujat plots and leave-one-out diagnostics.

We also performed subgroup analyses according to ethnicity, including Asian, European, and North American populations; LVEF range, classified as preserved, impaired or diverse; clinical endpoint, defined as ACD, CD, or MACE; and study design, categorized as single-center or multicenter. Meta-regression analysis was conducted to assess the relationship between LVEF and the log-transformed HR. In studies that reported multivariable-adjusted results, additional analyses focused on those that accounted for echocardiographic parameters such as mPG, AVA, and SVi. For smaller subsets, bootstrap resampling with 1,000 repetitions was used to estimate the median HR, the 95 CI, and the two-sided P value. All analyses were conducted using R software (version 4.3.3), and P<0.05 was considered statistically significant.

Results

Study Selection and Characteristics

A total of 9,376 articles were initially identified through searches of PubMed and Scopus, using a predefined combination of keywords and MeSH terms related to TAVI, LV systolic function, and clinical outcomes (Supplementary Table 1). Full-text screening was performed after removing duplicates and excluding articles based on titles and abstracts. Following the inclusion criteria, 92 studies were finally selected for statistical analysis. Reasons for exclusion in the full-text review are summarized in Supplementary Table 2. Some studies reported data from separate patient cohorts, such as subgroups stratified by flow and pressure gradient status or ethnicity, which were treated as independent study arms in the meta-analysis. Finally, 98 patient groups, including 75,085 individuals, were selected for further analysis. Supplementary Figure 1 is a PRISMA diagram summarizing the screening and selection process.

Study Characteristics and Patient Profiles

The majority of studies (51) were conducted in Europe, followed by 23 in North America, 15 in Asia, 2 in Africa, and 7 conducted in multiple regions. Most studies were single-center studies, with 73 using this design, and the remaining 25 studies were conducted as multicenter studies. Ethnicity was explicitly reported or inferred as Asian, European or North American in 84 cohorts. Regarding LVEF distribution, 89 cohorts included patients with diverse LVEF values, while 4 focused on impaired LVEF and 5 on preserved LVEF populations. The pooled mean age was 81.9 years. Female patients were 48.2% of the total population.

Regarding baseline echocardiographic parameters, the pooled mean AVA was estimated at 0.69 cm² in 68 cohorts, and the pooled mPG was 43.4 mmHg in 84 cohorts. SVi was reported in 23 cohorts, with a pooled mean of 34.6 mL/m². The pooled mean LVEF in 91 cohorts was 54.7%. Detailed characteristics of included studies and patient cohorts are summarized in Table 1 and Supplementary Table 3.

Table 1.

Characteristics of Study Population (n=75,085 From 98 Cohorts in 92 Studies)

Variable
Age, mean±SD years	82±6
Female population	48%
Follow-up duration median (ICR25th, ICR75th) months	23 (12, 31)
Study type
Single center	73 (74%)
Multicenter	25 (26%)
LVEF status
Impaired	4 (4%)
Preserved	5 (5%)
Diverse	89 (91%)
Endpoint
All-cause death	60 (61%)
Cardiac death	8 (8%)
Composite	30 (31%)
Region	27 (18, 46)
North America	23 (23%)
Europe	51 (52%)
Asia	15 (15%)
Africa	2 (2%)
Multi-region	7 (7%)
Aortic valve area, mean±SD	0.69±0.24 cm2
Mean pressure gradient, mean±SD	43.4±15.9 mmHg
Stroke volume index, mean±SD	34.6±9.9 mL/m2
LVEF, mean±SD	54.7±12.6%

LVEF, left ventricular ejection fraction.

Pooled Prognostic Impact of LVEF in the Univariable Analysis

In the univariable meta-analysis, 74 studies were included to examine the association between preprocedural LVEF and clinical outcomes after TAVI. The pooled analysis demonstrated that each 1% decrease in LVEF was significantly associated with an increased risk of adverse events (HR: 1.02, 95% CI: 1.01–1.03, P<0.001) (Figure 1A). Heterogeneity among studies was substantial (I²=100%, τ²=0.0017), suggesting considerable variation among the included cohorts.

Figure 1.

Forest plots of the hazard ratio (HR) of left ventricular ejection fraction (LVEF) in (A) univariable analysis and (B) multivariable analysis. Forest plots show HRs and 95% confidence intervals (CIs) for each 1% decrease in LVEF, based on subgroup analyses by study design (multicenter vs. single-center), clinical endpoints (major adverse cardiovascular events [MACE], cardiac death [CD], all-cause death [ACD]), LVEF classification (preserved, impaired, diverse), and study region (North America, Europe, Asia, Africa). se, standard error; TE, treatment effect.

A contour-enhanced funnel plot was generated to evaluate the risk of publication bias, showing no apparent asymmetry (Supplementary Figure 2). However, Egger’s test indicated significant small-study effects (P<0.001). Moreover, PET-PEESE analyses confirmed the robustness of the association even after accounting for potential bias, with the PET and PEESE models estimating HRs of 1.09 (95% CI: 1.05–1.14) and 1.05 (95% CI: 1.03–1.08), respectively (Table 2). The 3PSM was also applied and supported a statistically significant association between lower LVEF and worse prognosis (HR: 1.03, 95% CI: 1.01–1.04, P<0.001).

Table 2.

Random Effects and Publication Adjusted Model for Hazard Ratio of LVEF

Method	Effect size estimate [95% CI]	Test against no effect
Univariable analysis
Random-effects model	1.02 [1.01–1.03]	t=4.09, P<0.001
PET-PEESE	1.05 [1.03–1.08]	t=4.34, P<0.001
Selection model (3PSM)	1.03 [1.01–1.04]	z=3.38, P<0.001
Multivariable analysis
Random-effects model	1.03 [1.01–1.05]	t=2.75, P=0.009
PET-PEESE	1.05 [1.01–1.08]	t=2.90, P=0.006
Selection model (3PSM)	1.07 [1.04–1.10]	z=4.64, P<0.001

3PSM, 3-parameter selection model; CI, confidence interval; LVEF, left ventricular ejection fraction; PSM, parameter selection model.

Influence analysis revealed that some studies, including those by Schewel et al.,¹⁷ had disproportionately large effects on the pooled results. These cohorts were excluded from sensitivity analyses to ensure stability of the findings. Despite these exclusions, the overall trend remained consistent, supporting the reliability of the observed association.

Subgroup analyses were conducted to explore consistency of the prognostic value of LVEF. When stratified by ethnicity, the relationship between lower LVEF and increased risk of adverse outcomes remained statistically significant in Asian, European, and North American populations. When examining different outcome definitions, the association remained significant for ACD and MACE, but did not reach statistical significance for CD (P=0.326). Analyses based on LVEF range showed consistent results among cohorts with preserved, impaired, and mixed LVEF. Furthermore, study design appeared to influence the magnitude of effect, with a statistically significant difference observed between single-center and multicenter studies (P=0.023).

Pooled Prognostic Impact of LVEF in the Multivariable Analysis

In the multivariable meta-analysis, 44 studies were included, each reporting HRs adjusted for ≥1 clinical or echocardiographic covariates. The pooled HR per 1% decrease in LVEF was 1.01 (95% CI: 1.00–1.02, P=0.009), indicating that even after statistical adjustment, lower baseline LVEF remained a modest, but significant predictor of adverse outcomes following TAVI (Figure 1B). Notably, between-study heterogeneity remained high (I²=100%, τ²=0.0032), suggesting continued variation in study populations, endpoints or modeling strategies.

To evaluate the risk of publication bias, a contour-enhanced funnel plot was constructed, and Egger’s test was conducted, yielding a P value <0.001 (Supplementary Figure 3). Correction using PET and PEESE regression techniques showed consistent results (PET HR: 1.07, 95% CI: 1.02–1.13, P=0.011; PEESE HR: 1.05, 95% CI: 1.01–1.08, P=0.006), indicating the robustness of the observed results (Table 2). The 3PSM similarly supported the prognostic significance of LVEF after accounting for outcome-dependent reporting bias (HR: 1.07, 95% CI: 1.04–1.10, P<0.001). Influence analysis, including Baujat and leave-one-out diagnostics, identified no dominant outliers, and exclusion of individual studies had minimal impact on the pooled estimate.

The prognostic impact of LVEF remained consistent in European and North American cohorts. When stratified by endpoint, the association was significant for both ACD and MACE, but not for CD. Regarding LVEF classification, cohorts with preserved LVEF showed no significant association. Similarly, subgrouping by study design (single vs. multicenter) revealed consistent HRs across both categories (P=0.668).

To further examine whether LVEF provided prognostic information independent of other echocardiographic parameters, separate multivariable meta-analyses were conducted for studies adjusting for mPG, SVi, and AVA. These analyses showed that LVEF remained statistically significant in each model: mPG-adjusted HR was 1.01 (95% CI: 1.01–1.02, P<0.001); SVi-adjusted HR was 1.01 (95% CI: 1.00–1.01, P=0.024); and AVA-adjusted HR was 1.01 (95% CI: 1.00–1.02, P=0.022) (Figure 2). Notably, in all 3 models, heterogeneity was low to negligible (I² <1%), further strengthening the validity of these estimates. To assess stability of these results, we also performed bootstrap resampling with 1,000 repetitions for the mPG-adjusted models. The bootstrapped 95% CI was 1.007 to 1.014 (P<0.001). Bootstrap analysis was not performed for AVA and SVi, due to the small number of included studies (k=3 or 4). These results further solidified the robustness of LVEF as an independent prognostic factor.

Figure 2.

Multivariable meta-analysis of left ventricular ejection fraction (LVEF) adjusted for mean pressure gradient (mPG), stroke volume index (SVi), and aortic valve area (AVA). Observed and estimated hazard ratios (HRs) and their 95% confidence intervals (CIs) are shown in each study. Pooled estimates are shown by random models. se, standard error; TE, treatment effect.

Hazard Ratio According to the Mean Value of LVEF

We conducted meta-regression analyses to evaluate whether the prognostic impact of LVEF varies depending on the mean baseline LVEF level reported in each study.

In the univariate meta-regression using unadjusted hazard ratios (k=70), there was no significant association between study-level mean LVEF and the hazard ratio per 1% LVEF decrease (slope=0.0004, 95% CI: −0.0014 to 0.0021, P=0.672). This result suggested that the crude prognostic effect of LVEF reduction did not differ substantially between studies with low vs. high average LVEF (Supplementary Figure 4).

In contrast, the multivariable meta-regression based on adjusted hazard ratios (k=41) revealed a significant negative association between the mean LVEF and the effect of LVEF reduction (slope=−0.0041, 95% CI: −0.0077 to −0.0005, P=0.025). To improve interpretability, we centered the mean LVEF at 60%, a value representative of preserved LVEF cohorts (Figure 3). In the centered model, the estimated log hazard ratio per 1% LVEF decrease was 0.0048 (95% CI: −0.0198 to 0.0295, P=0.69) at 60% mean LVEF, corresponding to a nonsignificant HR of 1.005.

Figure 3.

Meta-regression between baseline left ventricular ejection fraction and log-transformed hazard ratio (HR) in the multivariable analysis showing the predicted HR per 1% decrease in left ventricular ejection fraction (LVEF) plotted against the study-level mean LVEF (%), based on multivariable meta-regression analysis. The model was centered at a mean LVEF of 60%.

Discussion

This comprehensive meta-analysis, which is the largest to date on this topic, provided robust evidence supporting the prognostic value of the LVEF in patients undergoing TAVI.

Previous Studies

The prognostic significance of LVEF in patients with AS undergoing TAVI has been explored in numerous observational studies. Although LVEF is widely used to assess systolic function and to guide therapeutic decisions in structural heart disease, its predictive utility in TAVI remains uncertain.

More recently, attention has shifted toward use of advanced echocardiographic parameters, such as GLS, which may offer superior prognostic ability.¹⁸ Several papers have shown that GLS can detect subclinical myocardial dysfunction and is more closely associated with adverse outcomes than LVEF, even when LVEF is preserved.^19–21 However, we could not compare the prognostic significance between LVEF and GLS due to the limited number of papers regarding the predictive value of GLS.

In addition to methodological and clinical heterogeneity, geographic and ethnic variations potentially affect post-TAVI outcomes. For example, papers from East Asia reported higher incidences of low-flow, low-gradient AS compared with Western populations, as well as differing responses to valve intervention.^22,23 Furthermore, registry data suggest that Asian TAVI recipients may have distinct baseline characteristics and postprocedural outcomes, possibly related to differences in body habitus, access to care or operator experience.^15,23 However, few studies have systematically examined whether the prognostic value of LVEF itself varies among racial or regional subgroups.

Together, the findings highlight the complexity of LVEF interpretation in TAVI and underscore the need for refined risk assessment tools that account for both patient-specific and population-level differences.

Current Study

Our comprehensive systematic review and meta-analysis examined the prognostic value of preprocedural LVEF in patients undergoing TAVI. We found that a lower baseline LVEF was consistently associated with an increased risk of adverse clinical outcomes, including ACD and MACE. The observed pooled HR of 1.02 per 1% decrease in LVEF from the univariable analyses is modest in magnitude, but consistent across subgroups and analytical methods. Importantly, even after multivariable adjustment for various clinical and echocardiographic parameters, the association between reduced LVEF and poorer prognosis remained statistically significant, suggesting that LVEF is an independent prognostic factor in this patient population. These findings are particularly important in the context of the current trend toward expanded use of TAVI in lower risk and younger patients, as they highlight the continued clinical relevance of LVEF assessment in risk stratification and procedural decision-making.

Our study also adds new insight by evaluating potential effect modifiers of the relationship between LVEF and outcomes. Subgroup analyses revealed that the association between LVEF and prognosis was broadly consistent among different geographic regions, endpoint definitions, and study designs, although some variation in the magnitude of effect was observed. Those results suggested that the prognostic value of LVEF may be generalizable across diverse patient populations and healthcare settings, underscoring its utility as a risk assessment tool.

Several recent studies have suggested that a paradoxically higher risk of adverse outcomes may be observed in patients with supranormal LVEF (snLVEF) following TAVR. Imamura et al. reported that patients with snLVEF (LVEF >65%) had a significantly higher risk of death or heart failure readmission compared with those with normal LVEF (50–65%), even after multivariable adjustment.²⁴ Similarly, Martínez Gómez et al. demonstrated a J-shaped relationship between LVEF and death after TAVR, with worse prognosis observed not only in the reduced but also the supranormal LVEF groups.²⁵

In our study, univariable meta-regression analysis did not reveal a significant association between the study-level mean LVEF and the effect size of preprocedural LVEF on prognosis. However, this relationship became significant in the multivariable meta-regression analysis after adjusting for study-level covariates. Specifically, the prognostic impact of LVEF reduction was attenuated in cohorts with higher mean LVEF. To enhance interpretability, the mean LVEF was centered at 60% in our model, which suggests that in patients with preserved systolic function, LVEF may have limited prognostic relevance, at least in aggregate study-level analysis. The discrepancy between the univariable and multivariable meta-regression underscores the importance of accounting for potential confounding factors, especially in observational prognostic research. Moreover, this finding implies a potential nonlinear relationship between LVEF and outcomes, which cannot be adequately assessed using aggregated data. Investigation of such nonlinearity would require an individual patient data meta-analysis (IPD-MA), in which patient-level covariates and their interactions can be explicitly modeled. It is also noteworthy that in our multivariable meta-regression, only 2 studies exclusively enrolled patients with preserved LVEF. This limited representation may have biased the interaction term and contributed to the attenuation of the effect in high-LVEF populations. Future studies targeting patients with preserved or supranormal LVEF are warranted to better delineate their risk profiles.

We hope that these findings will provide valuable information to clinicians in determining appropriate indications and risk-benefit considerations for TAVI in their patient population.

Study Limitations

Several limitations of this meta-analysis should be acknowledged. First, the majority of included studies were observational in nature, which means that residual confounding cannot be entirely excluded, despite the use of multivariable-adjusted analyses. Second, the pooled analysis exhibited high heterogeneity. Although we conducted subgroup and sensitivity analyses to address this issue, the presence of unexplained confounding factors may still influence interpretation of our results. Third, the significant interobserver and interinstitutional variabilities in LVEF measurements must be considered when integrating findings from multiple research studies. Additionally, the use of different cutoff values for categorizing LVEF across studies could have affected the results. Fourth, only a small subset of studies reported GLS, a more sensitive measure of LV function, which precluded direct comparison of LVEF and GLS in this analysis. Fifth, some subgroup analyses, particularly those involving preserved or impaired LVEF groups, were based on a limited number of cohorts, potentially reducing the reliability of those findings. Finally, although we assessed the risk of publication bias using multiple statistical methods, the potential for selection bias cannot be entirely excluded.

Conclusions

Our comprehensive meta-analysis found that lower preprocedural LVEF was significantly associated with an increased risk of adverse clinical outcomes, including ACD and MACE in patients undergoing TAVI. Importantly, this association remained statistically significant even after adjusting for various clinical and echocardiographic covariates, suggesting that LVEF is an independent prognostic factor in this patient population.

These findings highlight the continued clinical relevance of LVEF assessment in risk stratification and procedural decision-making for TAVI, particularly in the context of the expanding use of this therapy in lower risk and younger patients. However, further prospective studies are required to clarify the optimal integration of LVEF and other advanced echocardiographic parameters, such as GLS, into contemporary risk models for TAVI candidates. Additionally, future research should seek to determine which specific LVEF and advanced echocardiographic parameters are most useful for accurately predicting prognosis in TAVI patients.

Disclosures

K.N. is a member of Circulation Reports’ Editorial Team.

IRB Information

This study was determined by the Ethics Committee of Saga University to be exempt from IRB approval because it did not involve any personally identifiable information or human biological specimens.

Data Availability

All data relevant to this study are included in the article or uploaded as online supplemental information.

Supplementary Files

Please find supplementary file(s);

https://doi.org/10.1253/circrep.CR-25-0126

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