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. 2023 Jan 13;4(4):241–250. doi: 10.1016/j.hroo.2023.01.001

Association of late gadolinium enhancement in cardiac magnetic resonance with mortality, ventricular arrhythmias, and heart failure in patients with nonischemic cardiomyopathy: A systematic review and meta-analysis

Mohammed Al-Sadawi 1, Faisal Aslam 1, Michael Tao 1, Roger Fan 1, Abhijeet Singh 1, Eric Rashba 1,∗
PMCID: PMC10134398  PMID: 37124560

Abstract

Background

Late gadolinium enhancement (LGE) on cardiac magnetic resonance is a predictor of adverse events in patients with nonischemic cardiomyopathy (NICM).

Objective

This meta-analysis evaluated the correlation between LGE and mortality, ventricular arrhythmias (VAs) and sudden cardiac death (SCD), and heart failure (HF) outcomes.

Methods

A literature search was conducted for studies reporting the association between LGE in NICM and the study endpoints. The primary endpoint was mortality. Secondary endpoints included VA and SCD, HF hospitalization, improvement in left ventricular ejection fraction (LVEF) to >35%, and heart transplantation referral. The search was not restricted to time or publication status. The minimum follow-up duration was 1 year.

Results

A total of 46 studies and 10,548 NICM patients (4610 with LGE, 5938 without LGE) were included; mean follow-up was 3 years (range 13–71 months). LGE was associated with increased mortality (odds ratio [OR] 2.9; 95% confidence interval [CI] 2.3–3.8; P < .01) and VA and SCD (OR 4.6; 95% CI 3.5–6.0; P < .01). LGE was associated with an increased risk of HF hospitalization (OR 3.4; 95% CI 2.3–5.0; P < .01), referral for transplantation (OR 5.1; 95% CI 2.5–10.4; P < .01), and decreased incidence of LVEF improvement to >35% (OR 0.2; 95% CI 0.03–0.85; P = .03).

Conclusion

LGE in NICM patients is associated with increased mortality, VA and SCD, and HF hospitalization and heart transplantation referral during long-term follow up. Given these competing risks of mortality and HF progression, prospective randomized controlled trials are required to determine if LGE is useful for guiding prophylactic implantable cardioverter-defibrillator placement in NICM patients.

Keywords: LGE, CMR, Mortality, Ventricular arrhythmia

Key Findings.

  • ▪

    Late gadolinium enhancement in nonischemic cardiomyopathy (NICM) patients is associated with increased mortality, ventricular arrythmia and sudden cardiac death, heart failure hospitalization, and heart transplantation referral during long-term follow up.

  • ▪

    Prospective randomized controlled trials are required to determine if late gadolinium enhancement is useful for guiding prophylactic implantable cardioverter-defibrillator placement in NICM patients who meet current guideline indications and NICM patients with less severe left ventricular dysfunction.

Introduction

Nonischemic cardiomyopathy (NICM) is a highly prevalent chronic disease that has been associated with increased morbidity and mortality through progressive pump failure and life-threatening arrhythmias.1 With an estimated disease prevalence ranging between 0.05% to 5% of all patients seen in the inpatient and outpatient settings and accounting for 1% to 2% of all annual healthcare costs, NICM places a large burden on the healthcare system in the United States and worldwide.1,2 It is imperative to identify patients who are at elevated risk for disease progression and mortality.

Late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR) is a promising technique for risk stratification of patients with NICM. LGE is useful for the detection of myocardial scar and fibrosis in patients with ischemic cardiomyopathy (ICM).3,4 While LGE is present in approximately 30% to 35% of patients with NICM, studies evaluating its association with clinical outcomes have mostly been limited to single-center observational studies.5

The goal of this systematic review and meta-analysis was to conduct a comprehensive evaluation of the association between LGE and clinical outcomes in patients with NICM. We examined the association of LGE with all-cause mortality, ventricular arrhythmias (VAs) and sudden cardiac death (SCD), heart failure (HF) hospitalization, improvement of left ventricular ejection fraction (LVEF) to >35%, and referral for heart transplantation in NICM patients.

Methods

Data search

This systematic review was performed in adherence to the guidelines of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) statement. The review was performed using a preplanned protocol in January 2022. The primary endpoint was mortality. Secondary endpoints included the composite of VA and SCD, HF hospitalization, interval improvement in LVEF to >35%, and heart transplantation referral. VAs were defined as the combined incidence of premature ventricular contractions (PVCs), nonsustained and sustained ventricular tachycardia, and appropriate implantable cardioverter-defibrillator (ICD) shocks. The studies were inconsistent regarding the amount of PVCs that qualified as VAs.

Search strategy

A systematic search was conducted using Ovid MEDLINE, EMBASE, Scopus, Web of Science, and Google Scholar for relevant literature that reported an association between LGE in CMR and VA, SCD, mortality, and HF outcomes. The search was not restricted to time or publication status. Two independent reviewers (M.A.-S. and M.T.) performed an electronic search using the following keywords: “late,” “gadolinium,” “enhancement,” “enhanced,” “enhance,” “enhancer,” “enhancers,” “enhances,” “enhancing,” “nonischaemic,” “nonischemic,” “nonischemics,” “cardiomyopathy,” “dilated,” “sensitivity,” “specificity,” “Predictive Value of Tests,” “Diagnostic Value,” and “Prediction.” The references of the included studies, other systematic reviews, and meta-analyses were also manually reviewed to obtain a comprehensive list of studies. After identifying relevant studies, the full texts of the selected articles were examined by both reviewers based on inclusion criteria. Disagreements were resolved by consensus.

Study selection

Studies were selected using the PICO (patient/population, intervention, comparison and outcomes) format to include those that studied patients with NICM (population), comparing LGE present (intervention) with LGE absent (comparison), and assessing for all-cause mortality, SCD, VA, appropriate ICD shock, SCD, HF hospitalization, referral for heart transplantation, and improvement in LVEF to >35% in subjects with baseline LVEF ≤35% (outcomes). Studies that did not separate mixed ICM and NICM patient populations were excluded. LGE presence was assessed either by visual estimation (present/absent) or quantitatively. When quantitative analysis was performed, the mean signal intensity and standard deviation of the region of interest were measured, and enhanced myocardium was defined as myocardium with signal intensity >5 SD above the remote normal myocardial signal. Patients with hypertrophic cardiomyopathy were excluded.

Data extraction

Two reviewers (M.A.-S. and M.T.) independently extracted the study data using a predefined data extraction sheet. Variables that were extracted from the studies included lead author, year of publication, study design, all-cause mortality, SCD, total patients with LGE, total patients without LGE, VAs, HF hospitalization, referral for transplantation, mean follow-up, mean age, mean LVEF, sex, left ventricular end-diastolic volume, and qualitative vs quantitative interpretation of LGE.

Statistical analysis

Meta-analysis was performed using Comprehensive Meta-Analysis software, version 3.6 We used a random-effects model to examine the association between LGE and outcomes, which were presented with an odds ratio (OR) with 95% confidence interval (CI) and Z value. The extent of heterogeneity was determined by I2 (ranging from 0% to 100%). Statistical significance was considered with a P value <.05, and all tests were 2-sided.

Results

Literature search and study selection

We identified 216 eligible studies from our literature search. After reviewing all studies in full text for relevance, 46 studies were identified to be eligible for meta-analysis for the outcomes of all-cause mortality (primary endpoint) and the composite of VAs, SCD, and appropriate ICD therapy (secondary endpoint). For the secondary endpoints of HF hospitalization, referral for heart transplantation, and LVEF improvement to >35%, 25 studies met inclusion criteria (Figure 1).

Figure 1.

Figure 1

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PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) flow chart. The flow diagram depicts study selection for inclusion in the meta-analysis according to the PRISMA statement for reporting systematic reviews and meta-analyses.

Study and patient characteristics

This meta-analysis included prospective and retrospective (Table 1). A total of 10,548 patients (4610 with LGE and 5938 without LGE) were reported in the studies evaluating the association between LGE and all-cause mortality, and the combined incidence of VAs, SCD, and appropriate ICD shocks. A total of 3039 patients (1265 with LGE and 1774 without LGE) were reported in the studies evaluating the association between LGE and HF hospitalization, referral for heart transplantation, and LVEF improvement. The mean duration of follow-up was 36 (range 13–71) months (Figure 1).

Table 1.

Demographic data of the included studies

First author Year Type LGE No LGE Mean follow-up (mo) Mean Age (y) Mean LVEF (%) Male (%) LGE reading
Park37 2006 pro 24 22 8.1 55.9 26.3 58.7 V
Assomull33 2006 pro 35 66 32 51 35.6 69.3 V
Wu3 2008 pro 27 38 17 55 24 64.6 SD
Cheong38 2009 retro 37 178 52.8 51 52 57 V
Yokokawa39 2009 retro 18 11 20 65 24 58.6 SD
Cho40 2010 retro 42 37 33.4 56 26.6 60.8 V
Kono41 2010 pro 18 14 30.8 61 21.3 59.4 SD
Looi42 2010 pro 31 72 32 58 32 75.7 V
Shimizu31 2010 pro 11 40 14.1 59 30 76.7 V
Iles43 2011 retro 31 30 19 53 25 68.9 SD
Lehrke20 2011 retro 72 112 22 52 39 75 SD
Fernández-Armenta44 2012 pro 15 22 25 64 22 83 SD
Gao45 2012 pro 46 19 21 61 26.2 81 V
Klem46 2012 pro 37 27 24 52 41 50 V
Leyva47 2012 pro 20 77 35 66 22.3 61.9 V
Masci48 2012 pro 50 75 14.2 58.2 34 65.6 SD
Gulati19 2013 pro 142 330 64 51 37.2 68.6 V
Kubanek49 2013 pro 30 14 12 43 23 71 V
Masci50 2013 pro 26 32 24 55 37 33 SD
Müller51 2013 pro 94 91 21 51 43.3 71.4 V
Neilan21 2013 pro 81 81 29 55 26 65 V
Šramko52 2013 retro 28 14 25 44 26 68.2 V
Almehmadi53 2014 retro 107 62 15.6 62 33 73 SD
Hasselberg54 2014 retro 4 9 29 52 32 — V
Machii55 2014 retro 48 24 36.2 64 24.8 72 V
Perazzolo Marra56 2014 pro 76 61 36 49 32.5 78.8 V
Masci57 2014 pro 61 167 23 50 43 79 V
Mordi58 2014 pro 76 20 30.5 46 27 78.1 SD
Nabeta59 2014 pro 36 39 11 56 30.2 65 SD
Rodríguez-Capitán60 2014 retro 23 41 31.5 56.2 29.1 75 V
Yamada61 2014 pro 25 32 71 55 33.5 70 V
Amzulescu62 2015 pre 63 99 41 55 25 63 V
Barison63 2015 pro 39 50 24 59 41 X V
Chimura64 2015 retro 122 53 61 60 29 63 V
Piers65 2015 pro 55 32 45 56 29 62 V
Tateishi66 2015 pro 105 102 44 50 27 80 V
Venero67 2015 pro 21 10 12 45 17.6 67.7 V
Gaztanaga68 2016 retro 71 34 27 50 25.3 56.2 SD
Hu69 2016 pro 35 50 42.7 55 84 75.3 V
Ishii70 2016 retro 37 41 47.7 56 31 68 SD
Mikami71 2016 pro 66 52 25.2 57 32 57.6 SD
Shin72 2016 retro 261 104 44.3 54.1 26.5 61.9 SD
Tachi73 2016 pro 22 19 — 60 19.5 83 SD
Voskoboinik74 2016 retro 17 11 32 44.2 20.3 64 V
Riffel75 2016 retro 64 82 51.6 53 29.3 80 V
Halliday28 2017 pro 101 298 55.2 49.9 49.6 63.7 V
Chimura77 2017 retro 100 79 45.6 61 33 68 V
Acosta76 2018 pros 22 109 35.5 65.1 24 72 SD
Marume78 2018 pro 118 162 45.6 52.2 27.6 73.6 V
Muthalaly79 2018 retro 62 68 38.4 54.8 29.4 83 V
Voskoboinik80 2018 retro 147 189 39 50.7 36.8 67.3 SD
Zhang81 2018 pro 101 119 61 49.6 25.6 73.2 SD
Gutman12 2019 retro 174 72 37.9 52.4 24.3 74.8 V
Halliday34 2019 pro 300 574 58.8 52.1 39 67.3 V
Alba82 2020 retro 650 1022 60 57 33 71 V
Barison83 2020 pro 116 77 30 66 27 73.2 V
Behera22 2020 pro 44 68 24.8 43.3 24.6 64.2 V
Yi84 2020 pro 258 120 40.8 55 24.1 62.7 SD
Chen85 2021 retro 121 36 13 52.3 27 70.7 SD
Di Marco14 2021 retro 486 679 36 58 39 66 V
Guarici86 2021 pro 457 543 32 56.7 33 68.6 V
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LGE = late gadolinium enhancement; LVEF = left ventricular ejection fraction; pro = prospective; retro = retrospective; V = visual estimation.

Association of LGE with all-cause mortality and VAs, SCD, and appropriate ICD shocks

LGE was associated with an increased risk of all-cause mortality (OR 2.9; 95% CI 2.3–3.8; P < .01) (Figure 2). There was low heterogeneity (χ232 = 51.26; P = .017; I2 = 37%). LGE was also associated with an increased risk for the combined incidence of VAs, SCD, and appropriate ICD shocks (OR 4.6; 95% CI 3.5–6.0; P < .01) (Figure 3). There was low to moderate heterogeneity (χ245 = 82.2; P = .001; I2 = 45%).

Figure 2.

Figure 2

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Association between late gadolinium enhancement (LGE) and mortality. LGE was associated with an increased risk of all-cause mortality (odds ratio 2.9; 95% confidence interval [CI] 2.3–3.8; P < .01). There was low heterogeneity (χ232 = 51.26; P = .017; I2 = 37%).

Figure 3.

Figure 3

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Association between late gadolinium enhancement (LGE) and ventricular arrhythmias/sudden cardiac death. LGE was associated with an increased risk for the combined incidence of ventricular arrhythmias, sudden cardiac death, and appropriate implantable cardioverter-defibrillator shocks (odds ratio 4.6; 95% confidence interval [CI] 3.5–6.0; P < .01). Heterogeneity was low to moderate (χ245 = 82.2; P = .001; I2 =45%).

Association of LGE with HF hospitalization, referral for transplantation, and recovery of LVEF

LGE was associated with an increased risk of HF hospitalization (OR 3.4; 95% CI 2.3–5.0; P < .01) (Figure 4). The heterogeneity was moderate (χ221 = 49.5; P = .001; I2 = 57%). LGE was associated with increased referral for heart transplantation (OR 5.1; 95% CI 2.5–10.4; P < .01) (Figure 5). The heterogeneity was low (χ29 = 4; P = .87; I2 = 0%). LGE was associated with an increased risk for lack of improvement in LVEF to >35% (OR 0.2; 95% CI 0.03–0.85; P = .03) (Figure 6). The heterogeneity was moderate to high (χ24 = 30; P = .001; I2 = 86%).

Figure 4.

Figure 4

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Association between late gadolinium enhancement (LGE) and heart failure hospitalization. LGE was associated with an increased risk of heart failure hospitalization (odds ratio 3.4; 95% confidence interval [CI] 2.3–5.0; P < .01). The heterogeneity was moderate (χ221 = 49.5; P = .001; I2 = 57%).

Figure 5.

Figure 5

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Association between late gadolinium enhancement (LGE) and referral for heart transplantation. LGE was associated with increased referral for heart transplantation (odds ratio 5.1; 95% confidence interval [CI] 2.5–10.4; P < .01). The heterogeneity was low (χ29 = 4; P = .87; I2 = 0%).

Figure 6.

Figure 6

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Association between late gadolinium enhancement (LGE) and ejection fraction improvement to >35%. LGE was associated with an increased risk for lack of improvement in left ventricular ejection fraction to >35% (odds ratio 0.2; 95% confidence interval [CI] 0.03–0.85; P = .03). The heterogeneity was moderate to high (χ24 = 30; P = .001; I2 = 86%).

Discussion

The major findings of this study are that LGE identifies NICM patients who are at increased risk for all-cause mortality and the combined incidence of VAs, SCD, and appropriate ICD shocks. LGE also identified NICM patients who are at increased risk for HF hospitalization, referral for heart transplantation, and lack of improvement in LVEF. To our knowledge, this meta-analysis is the most comprehensive evaluation to date of the association of LGE and clinical outcomes in NICM.

The initial American Heart Association/American College of Cardiology/Heart Rhythm Society guidelines recommending defibrillator implantation in NICM were primarily based on the results of The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) published over a decade ago.7,8 However, the SCD-HeFT trial was conducted on a mixed population (52% ICM and 48% NICM). At 10-year follow-up of the SCD-HeFT population, there was no mortality benefit for ICD placement in the patients with NICM.9 Similarly, the Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure (DANISH) trial demonstrated no significant difference in all-cause mortality with ICD implantation in patients with NICM.10 However, in the Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial, ICD placement did not reduce mortality but was associated with a reduction in sudden death from arrhythmia.11 One possible explanation for these findings may be that NICM represents a heterogeneous group of diseases in which certain disease etiologies place patients at higher cardiovascular risk than others.10 The lack of benefit of prophylactic ICD implantation in these studies highlights the need for additional risk stratification beyond LVEF, such as LGE. In one study, ICD placement was associated with a reduction in mortality only in patients with LGE (hazard ratio 0.45 vs 1.22 for LGE and no LGE, respectively; P < .05).12

LGE may also be utilized to identify high-risk patients that are excluded from current guidelines for ICD implantation. Although LVEF <35% is the current standard for recommending ICD implantation in NICM patients, it has low sensitivity (71.7%) and specificity (50.5%) for identifying patients at risk for SCD.13 As a result, some high-risk patients are not receiving ICD implantation due to not meeting LVEF criteria, while other low-risk patients with LVEF <35% and no LGE are having ICDs implanted and are exposed to device complications such as inappropriate shocks, lead or pulse generator malfunction, and infection. One study demonstrated that LGE is associated with VAs and SCD even in patients with LVEF >35%.14

The stark contrast in the utility of LVEF for predicting risk in NICM and ICM may be due to the fact that in ICM, a significant reduction in LVEF represents more extensive myocardial injury and scar formation. Several previous studies have suggested a strong correlation between reduction in LVEF and the extent of myocardial scarring in patients with ICM.15,16 In comparison, the pathogenesis of myocardial fibrosis in NICM remains unclear and may occur in varying distributions of myocardial tissue.17 While this development of fibrosis may not significantly impact LVEF, it may still place patients at risk for adverse events. In one study, the presence of LGE was not associated with initial low LVEF, but it predicted subsequent worsening of LVEF over time.18

The existing literature has been mixed regarding whether LGE is associated with adverse left ventricular remodeling and differences in left ventricular dimensions.5,19, 20, 21, 22 In the present study, LGE identified NICM patients who are at increased risk for HF hospitalization, referral for heart transplantation, and lack of improvement in LVEF. The clinical implications of these results are 2-fold. First, patients at high risk for HF progression may require close monitoring by an HF specialist and earlier referral to specialty centers for evaluation of advanced therapeutic options. Second, patients with LVEF <35% who do not have LGE may not need a prophylactic ICD or could be considered for a cardiac resynchronization therapy (CRT) pacemaker if they meet CRT criteria, given the higher likelihood for left ventricular reverse remodeling. These findings await confirmation in adequately powered, prospective studies before withholding ICD therapy from patients that meet current guidelines. The available data on the utility of adding ICD therapy to CRT in NICM patients is conflicting, as several studies have demonstrated no added mortality benefit,23, 24, 25 while the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial reported the opposite result.26

Study limitations

There are several limitations that need to be taken into consideration when assessing the results of this present study. Given that currently there are no standardized methods for defining the presence or extent of LGE, the interpretation of LGE varied across the studies included in this meta-analysis. The presence of LGE was defined in several ways, ranging from visual estimation to different threshold-based methods of analysis where the signal intensity of contrast-enhanced areas was compared with nonenhanced areas of myocardium.

While our results suggest that the presence of LGE has significant associations with clinical outcomes, we did not evaluate whether patterns of LGE result in differences in associated risk. There have been several studies demonstrating septal, subepicardial, and multiple LGE lesions to be independent predictors of cardiovascular outcomes.22,27,28 However, we could not identify enough current literature on this topic to further investigate in this meta-analysis.

Because there is a lack of standardization for defining the extent of LGE, we could not evaluate whether the extent of LGE correlates with differences in clinical outcomes. LGE extent can be interpreted in various ways, including summation of segments with hyperenhancement, percentage of involved myocardium, or absolute weight of enhanced myocardium.29 Interpretation is further complicated, as different LGE quantification techniques have been shown to cause wide variations in results in a single patient.30 Perhaps it is because of these reasons that there is no current consensus on what extent of LGE is predictive of clinical events. Cutoff values of significance for LGE extent range as broadly as >5% to >17%, and even results on the clinical significance of small areas of LGE have been mixed.22,31, 32, 33, 34

LGE on CMR is only able to detect regional myocardial fibrosis. While this pattern is typical in ICM, in which regional fibrosis is present, fibrosis patterns in NICM can occur either regionally or diffusely.22,35 Studies that utilized T1 mapping and extracellular volume fraction to detect diffuse myocardial fibrosis have shown this pattern to be significantly associated with adverse cardiovascular outcomes as well.36 Future studies should examine whether combined assessment of regional and diffuse fibrosis is useful for risk stratifying NICM patients.

The definition of VAs varied between studies, and some studies included VAs that are not life threatening in the composite endpoint, such as PVCs and nonsustained ventricular tachycardia.

Conclusion

LGE in NICM patients is associated with increased mortality, VA and SCD, HF hospitalization, and heart transplantation referral during long-term follow up. Given these competing risks of mortality and HF progression, prospective randomized controlled trials are required to determine if LGE is useful for guiding prophylactic implantable cardioverter-defibrillator placement in NICM patients who meet current guideline indications and NICM patients with less severe left ventricular dysfunction.

Funding Sources

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Disclosures

The authors report no relevant conflicts of interest.

Authorship

All authors attest they meet the current ICMJE criteria for authorship.

Ethics Statement

This systematic review was performed in adherence to the guidelines of the PRISMA statement (Preferred Reporting Items for Systematic Reviews and Meta-analyses).

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