Appropriate and Inappropriate Ventricular Therapies, Quality of Life, and Mortality Among Primary and Secondary Prevention Implantable Cardioverter Defibrillator Patients

Abstract

Background-Implantable cardioverter defibrillators (ICDs) reduce mortality in primary and secondary prevention.Quality of life, mortality, appropriate therapies for specific ventricular rhythms, and inappropriate therapies for supraventricular tachycardia (SVT) were compared among 582 patients (primary preventionϭ248; secondary preventionϭ334) in PainFREE Rx II, a 634-patient prospective, randomized study of antitachycardia pacing or shocks for fast ventricular tachycardia (FVT). Methods and Results-ICDs were programmed identically with 3 zones (ventricular tachycardia [VT] Ͻ188 bpm;FVTϭ188 to 250 bpm; ventricular fibrillation [VF] Ͼ250 bpm) but randomized to antitachycardia pacing or shock as initial therapy for FVT. All treated episodes with electrograms were adjudicated. Primary prevention patients had lower ejection fractions and more coronary artery disease. ␤-Blocker use, antiarrhythmic drug use, and follow-up duration were similar. Over 11Ϯ3 months, 1563 treated episodes were classified as VT (nϭ740), FVT (nϭ350), VF (nϭ77), and SVT (nϭ396). The distribution of VT, FVT, and VF was not different between primary and secondary prevention patients (respectively, VT 52% versus 54%, FVT 35% versus 35%, and VF 14% versus 10%). More secondary prevention patients had appropriate therapies (26% versus 18%, Pϭ0.02), but among these patients, the median number of episodes per patient was similar. Inappropriate therapies occurred in 15% of both groups and accounted for similar proportions of all detected and treated episodes (46% in primary prevention patients versus 34% in secondary prevention patients, Pϭ0.09). Quality of life improved modestly in both groups, and mortality was similar. Conclusions-Primary prevention patients are slightly less likely to have appropriate therapies than secondary prevention patients, but episode density is similar among patients with appropriate therapies. SVT resulted in more than one third of therapies in both groups, but quality of life and mortality were similar. (Circulation. 2005;111:2898-2905.)

Factors related to quality-of-life pattern changes in recipients of implantable defibrillators

“…22 In another clinical trial of 800 patients assigned to antiarrhythmic drugs vs. ICD groups, at 1-year follow-up, both groups had alterations in QOL related to adverse symptoms, and the ICD patients' sporadic shocks were associated with reduced QOL. 21 However, in 3 other long-term follow-up studies (n = 59, 22 n = 634, 19 and n = 35, 23 ) no significant difference in overall perceptions of QOL was evident. Conversely, in a study of implants after 1 to 6 years (n = 89), researchers reported significantly worse health changes in physical functioning, social functioning, and restricted roles because of physical problems.…”

“…Examples include Shortform 36, which was used in many ICD intervention trials, [18][19][20][21][22] the Ferrans and Powers Quality of Life Index (Cardiac Version), [22][23][24]25 QOL OVER TIME Research suggests that patients experience greater psychological distress during the early recovery periods 26 and when receiving device discharges. 27 At implant, factors such as age, gender, optimism, functional status, and history of sudden cardiac death influence mood disturbance.…”

Feasibility and efficacy of a remote real-time wireless ECG monitoring and stimulation system for management of ventricular arrhythmia in rabbits with myocardial infarction

“…In addition to the ECG monitoring function, the ATP function is another method of managing VAs with this system. Numerous clinical studies have shown that the majority of VA events resulting from VT are terminated by ventricular pacing (11,12,18,19). In the present study, induced VAs were effectively terminated by ATP in the rabbit model.…”

“…An ICD with a remote monitoring function has been successfully used to effectively terminate VAs by anti-tachycardia pacing (ATP) and shocks, and manages alarm messages from patients (9–11). The PainFREE Rx and PainFREE Rx II trials showed that ATP terminates the majority of malignant ventricular tachycardias (VTs) (11,12). Animal models are helpful for testing the efficacy of novel drugs and the feasibility of using novel implantable electronic cardiovascular devices (IECDs) with telecommunications technologies for monitoring and terminating VAs.…”

Initial experience with the subcutaneous implantable cardioverter-defibrillator with the real costs of hospitalization analysis in a single Polish center

“…The Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (Pain-FREE Rx II) trial [32] showed that patients randomized to receive shock-only, 34% of fast VT episodes terminated spontaneously before therapy, suggesting that a considerable proportion of ATP intervention, which is delivered before a shock, may be unnecessary. Furthermore, ATP is not without risk; it is possible for ATP to accelerate VT to polymorphic VT or VF [33][34][35] which has been associated with a higher mortality risk [36]. In conclusion, the lack of ATP function in the S-ICD is a contentious one [37].…”