Clinical investigations
Effect of an implantable cardioverter defibrillator with atrial detection and shock therapies on patient-perceived, health-related quality of life

Presented in part at the 73rd Scientific Sessions of the American Heart Association, November 12-15, 2000, New Orleans, La.
https://doi.org/10.1016/S0002-8703(02)94817-9Get rights and content

Abstract

Background

This study used a device (DDD implantable cardioverter defibrillator [ICD]) capable of delivering pacing and shock therapies to restore normal sinus rhythm in patients with atrial tachycardias or atrial fibrillation (AF). The purpose of this study was to assess the effect of the device on patient-perceived, health-related quality of life (QOL).

Methods

The DDD ICD was implanted in 267 patients with drug refractory, symptomatic AF from 45 centers across Europe, the United States, and Canada. Patients completed self-reported, validated QOL assessments at baseline and at 3- and 6-month follow-up visits (The Medical Outcomes Short Form 36 [SF-36] and the Symptom Checklist [SCL]).

Results

The mean age of the study group was 62 ± 12 years, and 73% of the patients were male. A total of 150 patients completed SF-36 assessments, and 138 patients completed SCL assessments at all 3 times. Baseline scores were more impaired (P < .05) on most SF-36 scales compared with norms for a general population, but were similar to a comparison group of patients with AF who were referred to tertiary care centers. The role-physical, physical functioning, vitality, mental health, and social functioning scales all improved significantly with time (all P < .04). Similarly, symptom frequency and severity (SCL) also improved significantly from baseline to 6 months (both P < .01). Shock therapy was delivered in 86 of the 150 patients (57%) with complete SF-36 evaluations. There was no evidence that receiving shocks decreased the relative improvement in QOL associated with implantation of the device.

Conclusions

In a 6-month period, QOL improves after implantation of a DDD ICD with atrial shock and pacing therapies. These improvements were not attenuated by receipt of shocks.

Section snippets

Device

After review and approval by each participating institution’s local ethics review committee, a Medtronic model 7250 dual-chamber ICD was evaluated in 267 patients from 45 centers (Europe, United States, and Canada). This is a multiprogrammable device capable of DDD pacing while detecting and treating episodes of either atrial or ventricular tachyarrhythmias. The device is able to store information on both treated and untreated detected arrhythmias. The device discriminates atrial tachycardias

Results

Most patients in the study group were male (73%), and the mean patient age was 62 ± 12 years. Eighty-seven patients (32%) had a history of coronary artery disease, and 52 patients (19%) had a prior myocardial infarction. Patient characteristics, including ejection fraction and NYHA classification, are presented in Table I. In the 12 months before implantation, patients experienced a mean ± SD of 11.3 ± 20 episodes of AF and 2.0 ± 8.9 episodes of atrial flutter.

Of the 267 patients who underwent

Discussion

This is the first study to demonstrate that implantation of a dual-chamber ICD with atrial pacing and defibrillation therapies is associated with an improvement in patient-perceived, health-related QOL. The overall magnitude of this improvement ranged from 0.11 to 0.63 SD units. The benefit of improved QOL persisted across NYHA classes (I and II vs III), shock delivery (1-4 shocks vs ≥5 shocks), and mode of shock delivery (patient-activated shock therapy vs automatic shocks). The observed

References (11)

There are more references available in the full text version of this article.

Cited by (46)

  • Symptom challenges after atrial fibrillation ablation

    2017, Heart and Lung: Journal of Acute and Critical Care
    Citation Excerpt :

    These subjects had increased health care utilization in an effort to manage the recurrent AF or other atrial arrhythmias, including electrical cardioversions, multiple office visits, as well as numerous additional medication changes. Although fatigue is commonly reported as a symptom in other types of cardiac patients and with AF unrelated to ablation,18–23 the severity and duration of fatigue reported by the post AF-ablation patients in this study has not previously been reported. In 40% of the sample, fatigue prevented return to even part time work at three weeks after ablation, which differs greatly from ablation recovery for other types of arrhythmias where patients return to full time work in two to four days.6,7,24,25

  • Effects of short-term exercise training on symptoms and quality of life in patients with chronic atrial fibrillation

    2007, International Journal of Cardiology
    Citation Excerpt :

    The eight AF-specific symptoms were tiredness/lack of energy, heart fluttering/skipping, heart racing, lightheadedness/dizziness, hard-to-catch breath, shortness of breath, chest pain when heart is racing and chest pain when heart is not racing. Two prior studies demonstrate the superior sensitivity of these eight AF-related symptoms of the SSCL [17,18]. Activities of Daily Living (ADL) comprises six questions and the subjects were asked to grade activity limitations on a 0–3 scale: (1) vigorous exercise, (2) moderate exercise, (3) carrying groceries, (4) climbing stairs, (5) walking on level surface and (6) bathing/dressing.

  • Pacing for Sinus Node Disease: Indications, Techniques, and Clinical Trials

    2007, Clinical Cardiac Pacing, Defibrillation, and Resynchronization Therapy
  • Pacing for sinus node disease: Indications, techniques, and clinical trials

    2006, Clinical Cardiac Pacing, Defibrillation and Resynchronization Therapy
View all citing articles on Scopus

Supported in part by grants from Medtronic, Minneapolis, Minn.

View full text