Short summary

The implantable cardioverter-defibrillator (ICD) is the treatment of choice for the primary and secondary prevention of sudden cardiac death in high-risk patients, due to superior risk reductions in mortality as compared to anti-arrhythmic drugs. Of all ICD recipients, approximately 24%-33% are women. However, little systematic evidence is available on potential gender differences in patients with an ICD from a real-world cohort. 

Rationale

Background:

The evidence for gender differences in patient reported outcomes (PROs), procedure- and device-related complications, and survival benefits post ICD implant are inconsistent. This may be attributed to these studies not having been designed and powered a priori to examine gender differences in PROs and clinical outcomes. In addition, we do not know whether the determinants of poor outcomes differ in women and in men with and ICD, while this has shown to be the case in patients treated with percutaneous coronary intervention with drug-eluting stenting and in patients undergoing cardiac catheterization. 

Purpose of the study:

The DEFIB-WOMEN study will examine gender differences on (i) patient reported outcomes (PROs), (ii) procedure- and device-related complications, and (iii) ventricular tachyarrhythmia and mortality in a national Danish cohort of patients with a first-time implantable cardioverter defibrillator. 

Description of the cohort

Patients implanted consecutively with a first-time ICD or cardiac resynchronization therapy device with defibrillator (CRT-D) between June 2010 and April 2013 at one of the five implanting centers in Denmark were eligible for inclusion if they fulfilled all of th inclusion criteria and none of the exclusion criteria as listed below.

Inclusion criteria: Patients receiving a first-time ICD or CRT-D implantation, above 18 years of age, speaking and understanding Danish, and providing written informed consent. 

Exclusion criteria: Patients with a history of severe psychiatric illness (e.g. schizophrenia), on the waiting list for heart transplantation, with a left ventricular assist device, or with insufficient knowledge of the Danish language. 

Data and biological material

Questionnaire data and information on clinical and demographic characteristics from registries.

Collaborating researchers and departments

Department of Cardiology, Odense University Hospital

• Professor Susanne S. Pedersen, PhD, Cand.Psych.
• Consultant in cardiology Jens Brock Johansen, MD, PhD

Department of Psychology, University of Southern Denmark

• Professor Susanne S. Pedersen, PhD, Cand.Psych.

Department of Cardiology, Aarhus University Hospital (Skejby)

• Professor Jens Cosedis Nielsen, MD, DMSCi, PhD

Department of Cardiology, Aalborg University Hospital

• Professor Sam Riahi, MD, PhD
• Professor Mogens Lytken Larsen, MD, DMSCi 

Department of Cardiology, Gentofte Hospital, Copenhagen University Hospital

• Dr. Jens Haarbo, MD

Department of Cardiology, Rigshospitalet, Copenhagen University Hospital

• Berit Thornvig Philbert, MD, PhD

Publications associated with the project

Frydensberg V, Johansen JB, Möller S, Riahi S, Wehberg S, Haarbo J, Philbert BT, Jørgensen OD, Larsen ML, Nielsen JC, Pedersen SS (2020). Anxiety and depression symptoms in Danish patients with an implantable cardioverter defibrillator: Prevalence and association with indication and sex up to two years of follow-up (Data from the national DEFIB-WOMEN study). Europace, 22:1830-1840

Pedersen SS, Nielsen JC, Wehberg S, Jørgensen OD, Riahi S, Haarbo J, Philbert BT, Larsen ML, Johansen JB (2021). New onset anxiety and depression in patients with an implantable cardioverter defibrillator during 24 months of follow-up (Data from the national DEFIB-WOMEN study). General Hospital Psychiatry, 72:59-65.