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Multicenter Study
. 2024 Jun 4;13(11):e032465.
doi: 10.1161/JAHA.123.032465. Epub 2024 May 28.

Lack of Prognostic Value of T-Wave Alternans for Implantable Cardioverter-Defibrillator Benefit in Primary Prevention

Ari Pelli  1 , Tuomas V Kenttä  1 , M Juhani Junttila  1   2 , Cynthia Huber  3 , Simon Schlögl  3   4 , Markus Zabel  3   4 , Marek Malik  5   6 , Rik Willems  7 , Marc A Vos  8 , Markus Harden  9 , Tim Friede  9   4 , Christian Sticherling  10 , Heikki V Huikuri  1 ; EU‐CERT‐ICD Study Investigators
Affiliations
Multicenter Study

Lack of Prognostic Value of T-Wave Alternans for Implantable Cardioverter-Defibrillator Benefit in Primary Prevention

Ari Pelli et al. J Am Heart Assoc. .

Abstract

Background: New methods to identify patients who benefit from a primary prophylactic implantable cardioverter-defibrillator (ICD) are needed. T-wave alternans (TWA) has been shown to associate with arrhythmogenesis of the heart and sudden cardiac death. We hypothesized that TWA might be associated with benefit from ICD implantation in primary prevention.

Methods and results: In the EU-CERT-ICD (European Comparative Effectiveness Research to Assess the Use of Primary Prophylactic Implantable Cardioverter-Defibrillators) study, we prospectively enrolled 2327 candidates for primary prophylactic ICD. A 24-hour Holter monitor reading was taken from all recruited patients at enrollment. TWA was assessed from Holter monitoring using the modified moving average method. Study outcomes were all-cause death, appropriate shock, and survival benefit. TWA was assessed both as a contiguous variable and as a dichotomized variable with cutoff points <47 μV and <60 μV. The final cohort included 1734 valid T-wave alternans samples, 1211 patients with ICD, and 523 control patients with conservative treatment, with a mean follow-up time of 2.3 years. TWA ≥60 μV was a predicter for a higher all-cause death in patients with an ICD on the basis of a univariate Cox regression model (hazard ratio, 1.484 [95% CI, 1.024-2.151]; P=0.0374; concordance statistic, 0.51). In multivariable models, TWA was not prognostic of death or appropriate shocks in patients with an ICD. In addition, TWA was not prognostic of death in control patients. In a propensity score-adjusted Cox regression model, TWA was not a predictor of ICD benefit.

Conclusions: T-wave alternans is poorly prognostic in patients with a primary prophylactic ICD. Although it may be prognostic of life-threatening arrhythmias and sudden cardiac death in several patient populations, it does not seem to be useful in assessing benefit from ICD therapy in primary prevention among patients with an ejection fraction of ≤35%.

Keywords: T‐wave alternans; appropriate shock; death; heart failure; implantable cardioverter‐defibrillator.

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Figures

Figure 1
Figure 1. Flowchart of study data.
EU‐CERT‐ICD indicates European Comparative Effectiveness Research to Assess the Use of Primary Prophylactic Implantable Cardioverter‐Defibrillators; and VT, ventricular tachycardia.
Figure 2
Figure 2. Kaplan–Meier curve of all‐cause death in patients with an ICD with TWA<47 μV and TWA≥47 μV (A) and with TWA<60 μV and TWA≥60 μV (B).
TWA is not associated with death among patients with a primary prophylactic ICD. HR indicates hazard ratio; ICD, implantable cardioverter‐defibrillator; and TWA, T‐wave alternans.
Figure 3
Figure 3. Kaplan–Meier curve of all‐cause death in control patients with TWA<47 μV and TWA≥47 μV (A) and with TWA<60 μV and TWA≥60 μV (B).
TWA is not associated with death among patients with primary prophylactic ICD indication with conservative treatment. HR indicates hazard ratio; ICD, implantable cardioverter‐defibrillator; and TWA, T‐wave alternans.
Figure 4
Figure 4. Cumulative incidence of appropriate shock in patients with an ICD with TWA<47 μV and TWA≥47 μV (A) and with TWA<60 μV and TWA≥60 μV (B).
TWA is not associated with appropriate shocks among patients with a primary prophylactic ICD. HR indicates hazard ratio; ICD, implantable cardioverter‐defibrillator; and TWA, T‐wave alternans.
See this image and copyright information in PMC

References

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