Procedure- and device-related complications and psychological morbidity in implantable cardioverter defibrillator patients

Abstract

Despitetheunequivocalmedicalbene fitsofimplantablecardioverterdefibrillator(ICD)therapyforthepreventionofsuddencardiacdeath [1],there is a risk for procedure- (e.g. infection and bleeding) and device-related complications (e.g. inappropriate shocks and lead dysfunction)[2]. Such complications may not only in fluence morbidity and mortality[3,4] but also patient well being and quality of life [2,5].Todate,themajority of studies have focused on the separate impacts of shock anddevice advisories on patient well being rather than procedure- anddevice-related complications, with results being mixed [6,7].We examined whether procedure- and device-related complica-tions are associated with psychological morbidity in a consecutive co-hort of ICD patients (N=443; 78.5% men; mean age=58±12 years)implantedbetweenAugust2003andMay2010attheErasmusMedicalCenter, Rotterdam, the Netherlands, and participating in the Moodand personality as precipitants of arrhythmia in patients with anImplantable cardioverter Defibrillator: A prospective Study (MIDAS).The authors of this manuscript have certified that they comply withthe Principles of Ethical Publishing in the International Journal ofCardiology.Patients completed the 14-item Hospital Anxiety and DepressionScale (HADS) [8] and the 8-item ICD Patient Concerns questionnaire(ICDC) [9] at baseline, at 3-, 6-, and 12 months post implantation. In-formation on demographic and clinical characteristics was capturedfrom the patients' medicalrecords or purpose-designed questions.In-formation on ICD therapy during follow-up was obtained by means ofdevice interrogation. We used a composite of procedure- (i.e., anycomplication being directly or indirectly caused by the implantationprocedure and occurring up to 30 days post implantation) anddevice-related complications (i.e., an event related to the implantedICD system, including lead-related complications occurring also30 days post implantation). Inappropriate and appropriate shockswere also considered as device-related complications; appropriateshocks were only included if the shock was given for a ventriculartachycardia with a cycle length >250 ms, as these rhythm distur-bances essentially could have been terminated by anti tachycardiapacing. Others have used a similar distinction between procedure-and device-related complications [10,11]. The association betweenprocedure- and device-related complications and psychological mor-biditywasassessedwithrepeatedmeasuresunivariableandmultivar-iable analyses of variance using general linear mixed modelinganalysis, with an unstructured covariance structure.Wefound no systematic differenceson baselinecharacteristics be-tween patients with and without complications (all p>0.05). Of allpatients, 70 (15.8%) experienced a complication, with 3 patientsexperiencing 2complications duringthe 12 monthfollow-up, leadingto a total complication rate of 73 (16.5%). Of these, 18 patients (4.1%)experienced a procedure-related complication, while 52 patients(11.7%) experienced a device-related complication (Table 1).The course of symptoms of anxiety and depression, and ICD con-cerns during the 12-month follow-up stratified by complications aredisplayed in Fig. 1. In unadjusted analyses, there was a significantasso-ciation between complications and anxiety (estimate (e)=1.15; p=0.029) and ICD concerns (e=2.28; p=0.019), but not with depression(e=0.99; p=0.07). There was a significant time by complications in-teraction effect between baseline and 3 month follow-up for anxiety