Table 3.
Characteristics and primary results from the included studies.
| Study, year, country, type of study | Type of prevention: primary/secondary, inclusion and exclusion criteriaa | Controlb | No. of patients in study (ICD group, control group), enrollment (E), follow-up (FU) | Conclusion: ICD patients’ QoL compared to control group |
LOE/study qualityc | ||
|---|---|---|---|---|---|---|---|
| Worse | Neutral | Better | |||||
| Mark et al. (20) 2008 USA, Canada, New Zealand Multicenter RCT (SCD-HeFT) |
Prevention: prim. Inclusion: NYHA class II or III, chronic, stable congestive heart failure due to either ischemic or non-ischemic causes, LVEF ≤ 35% Exclusion: n.r. |
Med. (830 patients: conventional medical therapy plus amiodarone, and 833 patients: conventional medical therapy plus amiodarone placebo) | 2479 (816, 1663) E: 1997–2001 FU: 30 months |
✓ | |||
|
“In a large primary prevention population with moderately symptomatic heart failure, single lead ICD therapy was not associated with any detectable adverse quality-of-life effects over 30 months of follow-up” |
2b++ | ||||||
| Noyes et al. (21) 2007 USA Multicenter RCT (MADIT II) |
Prevention: prim. Inclusion: prior MI, LVEF ≤ 30% Exclusion: Europeans, missing baseline QoL data, patients from study centers with poor data quality |
Med. (conventional medical treatment) | 1089 (658, 431) E: 1997–2001 FU: maximum 48 months |
✓ | |||
| “strong evidence […] [that] the ICD provides little or no quality of life benefits” | 2b++ | ||||||
| Passman et al. (22) 2007 USA Multicenter RCT (DEFINITE) |
Prevention: prim. Inclusion: LVEF ≤ 35% (not caused by CAD), history of symptomatic heart failure, either non-sustained VT or ≥10 premature ventricular depolarizations per hour at baseline Exclusion: n.r. |
Med. (conventional medical therapy) | 453 (227, 226) E: 1998–2002 FU: maximum 63 months |
✓ | |||
| “HRQL (health-related QoL) was not affected by ICD implantation in patients in the defibrillators in Non-ischemic Cardiomyopathy Treatment Evaluation study” | 2b++ | ||||||
| Irvine et al. (19) 2002 Canada Multicenter RCT (CIDS) |
Prevention: sec. Inclusion: documented sustained ventricular arrhythmias Exclusion: recent or acute MI or electrode imbalance, not able to read English |
Med. (amiodarone) | 317 (157, 160) E: 1990–1997 FU: 12 months |
✓ | |||
| “Quality of life is better with ICD therapy than with amiodarone therapy” | 2b+ | ||||||
| Hsu et al. (26) 2002 USA Cohort study |
Prevention: sec. Inclusion: discharged alive after hospitalization for a live-threatening ventricular arrhythmia, primary diagnosis of cardiac arrest or VT or VF Exclusion: no evidence of cardiac arrest, sustained VT or VF in clinical chart, arrhythmia occurred during the first 48 h after acute MI, non-sustained VT as the only arrhythmia, transient and reversible cause of arrhythmia (drug toxicity, hypoxia, electrolyte imbalance), <18 years, non-English speaking, severe or moderate dementia, life expectancy <6 months, AIDS, discharged to somewhere else but home, no member of Kaiser Northern California System |
Med. (91 patients: amiodarone, and 79 patients: antiarrhythmic medications other than amiodarone) | 264 (94, 179) E: 1995–1998 FU: 24 months |
✓ | |||
| “QOL improves more after ICD than after amiodarone therapy” | 2b+ | ||||||
| Schron et al. (23) 2002 USA Multicenter RCT (AVID) |
Prevention: sec. Inclusion: VF or symptomatic VT (including sustained VT resulting in syncope or sustained VT in the setting of LVEF ≤ 40% and clinically important symptoms of hemodynamic compromise), survival of at least 1 year Exclusion: n.r. |
Med. (antiarrhythmic drugs) | 800 (416, 384) E: n.r. FU: 12 months |
✓ | |||
| “ICD and AAD (antiarrhythmic drugs) therapy are associated with similar alterations in self-perceived QoL over 1-year follow-up” | 2b− | ||||||
| Leosdottir et al. (28) 2006 Iceland Cross-sectional study |
Prevention: n.r. Inclusion: all ICD patients living in Iceland at the beginning of 2002 Exclusion: not able to complete questionnaires due to mental or physical disabilities (assessed by caring physician) |
PM | 108 (41, 67) E: 2002–2003 FU: n.a. |
✓ | |||
| “ICD patients had a comparable QoL with pacemaker recipients and were not more likely to suffer from anxiety, depression, or general psychiatric distress” | 4+ | ||||||
| Newall et al. (29) 2007 New Zealand Cross-sectional study |
Prevention: n.r. Inclusion: ≥18 years, able to comprehend English Exclusion: taking antidepressant medications for pre-existing depression |
PM | 95 (46, 49) E: 2005 FU: n.a. |
✓ | |||
| “Quality-of-life scores were normal for all ICD patients with respect to both mental and physical component scores, and not different from the pacemaker group” | 4+ | ||||||
| Czosek et al. (31) 2012 USA Multicenter cross-sectional study |
Prevention: prim. and sec. Inclusion: children between 8 and 18 and their parents Exclusion: n.r. |
PM | 173 (40, 133) E: 2004–2008 FU: n.a. |
✓ | |||
| “Patient- and parent-proxy-reported QOL is significantly affected by the presence of cardiac rhythm devices and is worsened in those patients with CHD (congenital heart disease) and ICD systems as opposed to pacing systems” | 4− | ||||||
| Duru et al. (27) 2001 Switzerland Cross-sectional study |
Prevention: n.r. Inclusion: 40–70 years, first pectoral implantation of ICD or PM Exclusion: n.r. |
PM | 152 (76, 76) E: 1993–1999 FU: n.a. |
✓ | |||
| “There was no difference between the three groups (ICD with experienced shock, ICD without experienced shock, PM), with respect to scores on any aspect of the HAD and SF-36” | 4− | ||||||
| Redhead et al. (30) 2010 UK Cross-sectional study |
Prevention: sec. Inclusion: first ICD implanted between April 2004 and March 2007 after MI Exclusion: n.r. |
PM & Oth. (49 patients: PM, 50 patients: angioplasty, and 50 patients: catheter ablation for drug-resistant atrial fibrillation) | 249 (100, 149) E: 2010 FU: n.a. |
✓ | |||
| “Mean scores for each assessment were similar for each group” | 4+ | ||||||
| Kamphuis et al. (25) 2002 The Netherlands Observational study |
Prevention: n.r. Inclusion: survived an out-of-hospital cardiac arrest due to VT, ≥16 years, able to comprehend Dutch Exclusion: n.r. |
Oth. (antiarrhythmic drugs, angioplasty, or surgical revascularization) | 168 (133, 35) E: n.r. FU: 12 months |
✓ | |||
| “In general, OT (other treatment) patients achieved a better quality of life than ICD patients” | 2b− | ||||||
| Probst et al. (32) 2011 France Cross-sectional study |
Prevention: n.r. Inclusion: Brugada Syndrome (Type 1 ECG before or after a sodium channel blocker challenge) Exclusion: <18 years, no valid mailing address |
Oth. (asymptomatic patients without an ICD) | 190 (138, 52) E: n.r. FU: n.a. |
✓ | |||
| “BrS (Brugada Syndrome) patients have a good quality of life with no difference between implanted and non-implanted patients” | 4− | ||||||
| Opic et al. (33) 2012 The Netherlands, Belgium Multicenter cross-sectional study |
Prevention: n.r. Inclusion: young adults with ToF Exclusion: n.r. |
Oth. (ToF patients without an ICD) | 54 (26, 28) E: n.r. FU: n.a. |
✓ | |||
| “ToF patients with an ICD show less favorable psychosocial functioning compared to ToF patients without ICD” | 4− | ||||||
| Cross et al. (24) 2010 USA Observational study |
Prevention: n.r. Inclusion: ICD therapy and/or diagnosis of CAD Exclusion: obstructive sleep apnea, restless legs syndrome |
Oth. (patients with CAD) | 60 (30, 30) E: n.r. FU: 14 days |
✓ | |||
| “The purpose of this study was to compare sleep patterns between CAD and ICD patients […]. The primary and surprising finding was that CAD patients had poorer sleep compared with ICD patients in terms of sleep efficiency and total sleep time” | 4− | ||||||
an.r., not reported; n.a., not applicable; NYHA, New York Heart Association Functional Classification; LVEF, left ventricular ejection fraction; MI, myocardial infarction; CAD, coronary artery disease; VT, ventricular tachycardia; VF, ventricular fibrillation; ToF, Tetralogy of Fallot.
bMed., medical treatment; PM, pacemaker implantation; Oth., others or treatment not specified.
cLOE, level of evidence; 2b, low-level RCT (e.g., no confidence intervals) or individual cohort study; 4, case-series and cross-sectional studies; ++/+/−, high/good/poor methodological quality.