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03.07.2019 | Original Article – Design Study Article Open Access

PREVENTION-ACHD: PRospEctiVE study on implaNTable cardioverter-defibrillator therapy and suddeN cardiac death in Adults with Congenital Heart Disease; Rationale and Design

Zeitschrift:
Netherlands Heart Journal
Autoren:
J. T. Vehmeijer, Z. Koyak, A. H. Zwinderman, L. Harris, R. Peinado, E. N. Oechslin, C. K. Silversides, B. J. Bouma, W. Budts, I. C. van Gelder, J. M. Oliver, B. J. M. Mulder, J. R. de Groot
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s12471-019-1297-3) contains supplementary material, which is available to authorized users.

Abstract

Background

Many adult congenital heart disease (ACHD) patients are at risk of sudden cardiac death (SCD). An implantable cardioverter-defibrillator (ICD) may prevent SCD, but the evidence for primary prevention indications is still unsatisfactory.

Study Design

PREVENTION-ACHD is a prospective study with which we aim to prospectively validate a new risk score model for primary prevention of SCD in ACHD patients, as well as the currently existing guideline recommendations. Patients are screened using a novel risk score to predict SCD as well as current ICD indications according to an international Consensus Statement. Patients are followed up for two years. The primary endpoint is the occurrence of SCD and sustained ventricular arrhythmias. The Study was registered at ClinicalTrials.gov (NCT03957824).

Conclusion

PREVENTION-ACHD is the first prospective study on SCD in ACHD patients. In the light of a growing and aging population of patients with more severe congenital heart defects, more robust clinical evidence on primary prevention of SCD is urgently needed.
Zusatzmaterial
Supplemental material to PREVENTION-ACHD: rationale and design contains a detailed description of the development of the PREVENTION-ACHD risk score, and its internal and external (retrospective) validation.
12471_2019_1297_MOESM1_ESM.docx
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