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PREVENTION-ACHD: PRospEctiVE study on implaNTable cardioverter-defibrillator therapy and suddeN cardiac death in Adults with Congenital Heart Disease; Rationale and Design |
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| Authors: | Vehmeijer J T Koyak Z Zwinderman A H Harris L Peinado R Oechslin E N Silversides C K Bouma B J Budts W van Gelder I C Oliver J M Mulder B J M de Groot J R |
| Institution: | 1.Heart Center, Department of Cardiology, Academic Medical Center—University of Amsterdam, Amsterdam, The Netherlands ;2.Department of Clinical Epidemiology and Biostatistics, Academic Medical Center—University of Amsterdam, Amsterdam, The Netherlands ;3.Division of Cardiology, Peter Munk Cardiac Center, Toronto Congenital Cardiac Center of Adults, University of Toronto, Toronto, Canada ;4.Department of Cardiology, La Paz University Hospital, Autonomous University of Madrid, Madrid, Spain ;5.Department of Cardiology, Universitair Ziekenhuis Leuven, Department of Cardiovascular Sciences, Katholieke Universiteit Leuven, Leuven, Belgium ;6.Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands ;7.Department of Cardiology, Gregorio Marañon University Hospital and CIBERCV, Madrid, Spain ;8.Netherlands Heart Institute, Utrecht, The Netherlands ; |
| 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 DesignPREVENTION-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). ConclusionPREVENTION-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. |
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