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Ventricular tachyarrhythmia detection by implantable loop recording in patients with heart failure and preserved ejection fraction: the VIP-HF study.

ABSTRACT: Aims: The primary aim of the VIP-HF study was to examine the incidence of sustained ventricular tachyarrhythmias (VTs) in heart failure (HF) with mid-range (HFmrEF) or preserved ejection fraction (HFpEF). Secondary aims were to examine the incidence of non-sustained VTs, bradyarrhythmias, HF hospitalizations and mortality.

Methods and results: This was an investigator-initiated, prospective, multicentre, observational study of patients with HF and left ventricular ejection fraction (LVEF) >40%. Patients underwent extensive phenotyping, after which an implantable loop recorder was implanted. We enrolled 113 of the planned 250 patients [mean age 73?±?8?years, 51% women, New York Heart Association class II/III 54%/46%, median N-terminal pro B-type natriuretic peptide 1367 (710-2452) pg/mL and mean LVEF 54?±?6%; 75% had LVEF >50%]. Eighteen percent had non-sustained VTs and 37% had atrial fibrillation on Holter monitoring. During a median follow-up of 657 (219-748) days, the primary endpoint of sustained VT was observed in one patient. The incidence of the primary endpoint was 0.6 (95% confidence interval 0.2-3.5) per 100 person-years. The incidence of the secondary endpoint of non-sustained VT was 11.5 (7.1-18.7) per 100 person-years. Five patients developed bradyarrhythmias [3.2 (1.4-7.5) per 100 person-years], three were implanted with a pacemaker. In total, 23 patients (20%) were hospitalized for HF [16.3 (10.9-24.4) per 100 person-years]. Fourteen patients (12%) died [8.7 (5.2-14.7) per 100 person-years]; 10 due to cardiovascular causes, and four sudden deaths, one with implantable loop recorder-confirmed bradyarrhythmias as terminal event, three others undetermined.

Conclusion: Despite the lower than expected number of included patients, the incidence of sustained VTs in HFmrEF/HFpEF was low. Clinically relevant bradyarrhythmias were more often observed than expected.

SUBMITTER: van Veldhuisen DJ

PROVIDER: S-EPMC7693069 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Ventricular tachyarrhythmia detection by implantable loop recording in patients with heart failure and preserved ejection fraction: the VIP-HF study.

van Veldhuisen Dirk J DJ van Woerden Gijs G Gorter Thomas M TM van Empel Vanessa P M VPM Manintveld Olivier C OC Tieleman Robert G RG Maass Alexander H AH Vernooy Kevin K Westenbrink B Daan BD van Gelder Isabelle C IC Rienstra Michiel M

European journal of heart failure 20200821 10

<h4>Aims</h4>The primary aim of the VIP-HF study was to examine the incidence of sustained ventricular tachyarrhythmias (VTs) in heart failure (HF) with mid-range (HFmrEF) or preserved ejection fraction (HFpEF). Secondary aims were to examine the incidence of non-sustained VTs, bradyarrhythmias, HF hospitalizations and mortality.<h4>Methods and results</h4>This was an investigator-initiated, prospective, multicentre, observational study of patients with HF and left ventricular ejection fraction ...[more]

PMID: 32683763

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Project description:BackgroundHeart failure with preserved ejection fraction is associated with significant functional limitations, yet treatments for improving exercise performance have been elusive. We sought to explore the association between prespecified patient characteristics and changes in 6-minute walk distance that constitute a clinically significant response to dapagliflozin.MethodsWe performed a responder analysis to understand patient characteristics associated with clinically meaningful improvement in 6-minute walk test (6MWT) distance ≥15 m among patients randomized to 12 weeks of dapagliflozin versus placebo in the double-blind PRESERVED-HF trial (Effects of Dapagliflozin on Biomarkers, Symptoms and Functional Status in Patients With Preserved Ejection Fraction Heart Failure).ResultsA total of 289 randomized patients had 6MWT distance completed at baseline and 12 weeks. Patients randomized to dapagliflozin improved walking distance by ≥15 m more frequently than those on placebo (n=64, 44% versus n=48, 34%). After adjusting for baseline covariates, patients randomized to dapagliflozin were more likely to experience a clinically meaningful improvement in 6MWT distance compared with those that received placebo (adjusted odds ratio, 1.66 [95% CI, 1.00-2.75]; P=0.05). Dapagliflozin-treated patients were also less likely to have a ≥15 m reduction in 6MWT distance compared with placebo-treated patients (adjusted odds ratio, 0.56 [95% CI, 0.33-0.94]; P=0.03). These results were consistent across all prespecified subgroups (all P values for interaction were not significant).ConclusionsCompared with those on placebo, patients with heart failure with preserved ejection fraction randomized to dapagliflozin were more likely to experience a clinically meaningful improvement and less likely to experience a deterioration in physical function over 12 weeks as measured by 6MWT distance. Beneficial response to dapagliflozin was consistent across prespecified subgroups.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifier: PRESERVED-HF NCT03030235.

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Dataset Information

Ventricular tachyarrhythmia detection by implantable loop recording in patients with heart failure and preserved ejection fraction: the VIP-HF study.

Publications

Ventricular tachyarrhythmia detection by implantable loop recording in patients with heart failure and preserved ejection fraction: the VIP-HF study.

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