What is the clinical evidence from this study?

Study design: Cohort. Population: Non-ischemic dilated cardiomyopathy (n=118). Intervention: Septal fibrosis burden >2.74% of LV mass (>5SD threshold) vs. Septal fibrosis burden ≤2.74% of LV mass. Primary outcome: Composite of cardiac mortality or appropriate implantable cardioverter-defibrillator (ICD) therapy (HR 8.65, 95% CI 3.06-24.51, p=<0.001).

What question did this study set out to answer?

To establish and validate objective signal-threshold criteria for non-expert quantification of septal fibrosis on late gadolinium enhancement cardiovascular magnetic resonance to predict adverse cardiovascular events in non-ischemic dilated cardiomyopathy.

January 1, 2016Journal of Cardiovascular Magnetic ResonanceOpen Access

Objective criteria for septal fibrosis in non-ischemic dilated cardiomyopathy: validation for the prediction of future cardiovascular events

Q: What are the key findings of this study?

Patients with non-ischemic dilated cardiomyopathy and a septal fibrosis burden >2.74% of the left ventricular mass were at a nearly 9-fold higher risk of cardiac death or appropriate ICD therapy (HR 8.65).

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Key result

Patients with non-ischemic dilated cardiomyopathy and a septal fibrosis burden >2.74% of the left ventricular mass were at a nearly 9-fold higher risk of cardiac death or appropriate ICD therapy (HR 8.65).

Why the study?

Does objective quantification of septal fibrosis by novice readers using CMR improve prediction of cardiovascular events compared to expert visual scoring in patients with NIDCM?

Key Points

To establish and validate objective signal-threshold criteria for non-expert quantification of septal fibrosis on late gadolinium enhancement cardiovascular magnetic resonance to predict adverse cardiovascular events in non-ischemic dilated cardiomyopathy.
Evaluated 118 consecutive patients with non-ischemic dilated cardiomyopathy (mean age 57 ± 14 years, 42% female) undergoing late gadolinium enhancement cardiovascular magnetic resonance.
Compared visual scoring by expert readers against signal threshold-based quantification (2SD, 3SD, and 5SD above remote myocardium) performed by novice readers.
Tracked patients over a median follow-up of 1.9 years for the primary composite outcome of cardiac mortality or appropriate implantable cardioverter-defibrillator therapy.
Over a median 1.9 years, 20 patients (17%) experienced the primary endpoint; expert visual scoring identified 55 patients with fibrosis and predicted outcomes with HR 5.3 (p=0.001).
Novice threshold quantification at >5SD (>2.74% of left ventricular mass) yielded the strongest prognostic utility (HR 8.7, p<0.001) compared to >3SD (HR 5.7, p=0.001) and >2SD (HR 6.1, p=0.001).
In adjusted analysis, the >5SD novice metric remained the strongest independent predictor of events (HR 8.7) and significantly improved risk reclassification beyond left ventricular ejection fraction alone (NRI 0.54, 95% CI 0.16–0.92, p=0.005).

Study Design

Type

Cohort (n=118)

Multicenter

Structured PICO

Does objective quantification of septal fibrosis by novice readers using CMR improve prediction of cardiovascular events compared to expert visual scoring in patients with NIDCM?

Population

118 patients with non-ischemic dilated cardiomyopathy, mean age 57 years and 42% female, followed for a median of 1.9 years.

Exposure

Objective quantification of septal fibrosis on late gadolinium enhancement (LGE) cardiovascular magnetic resonance (CMR) by novice readers (undergraduate students with no prior CMR experience) using a Signal Threshold versus Reference Mean (STRM) approach (>5SD, 3SD, >2SD above the mean of remote reference myocardium).

Comparator

Expert visual scoring of the presence or absence of non-ischemic LGE and its geographic distribution (septal mid-wall striae, RV insertion site, sub-epicardial, and diffuse) by an experienced CMR expert.

Outcome

Composite of cardiac mortality or appropriate implantable cardioverter-defibrillator (ICD) therapy at median 1.9 years follow-up.composite

Main Result

Hazard Ratio: 8.65 (95% CI 3.06–24.51)

Absolute Event Rate: 22.6% vs 3.2%

p-value: p=<0.001

Objective, threshold-based quantification of septal fibrosis on CMR by novice readers provides superior risk stratification for future cardiovascular events in NIDCM patients compared to expert visual assessment.

Limitations

Single center design
Limited sample size
Appropriate ICD therapy is an imperfect clinical outcome
Did not evaluate novel emerging CMR techniques such as T1 mapping

Discussion

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Implication

May support septal fibrosis quantification for risk stratification in non-ischemic cardiomyopathy; leaves open prospective validation for ICD decisions.

Cite This Study

Mikami et al. (2016) conducted a cohort in Non-ischemic dilated cardiomyopathy (n=118). Septal fibrosis burden >2.74% of LV mass (>5SD threshold) vs. Septal fibrosis burden ≤2.74% of LV mass was evaluated on Composite of cardiac mortality or appropriate implantable cardioverter-defibrillator (ICD) therapy (HR 8.65, 95% CI 3.06-24.51, p=<0.001). Patients with non-ischemic dilated cardiomyopathy and a septal fibrosis burden >2.74% of the left ventricular mass were at a nearly 9-fold higher risk of cardiac death or appropriate ICD therapy (HR 8.65).

synapsesocial.com/papers/6a7067ed6c240de38cdbcb7c https://doi.org/10.1186/s12968-016-0300-z

Topics

Cardiac MRI Cardiac device therapy

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Implication

May support septal fibrosis quantification for risk stratification in non-ischemic cardiomyopathy; leaves open prospective validation for ICD decisions.

Objective criteria for septal fibrosis in non-ischemic dilated cardiomyopathy: validation for the prediction of future cardiovascular events

Key Points

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Cite This Study

Topics

Objective criteria for septal fibrosis in non-ischemic dilated cardiomyopathy: validation for the prediction of future cardiovascular events

Key Points

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Cite This Study

Also Consider

Topics

Also Consider