doi: 10.1161/hc0502.103330
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(Circulation. 2002;105:589.)
© 2002 American Heart Association, Inc.
Clinical Investigation and Reports |
Quality of Life in the Antiarrhythmics Versus Implantable Defibrillators Trial
Impact of Therapy and Influence of Adverse Symptoms and Defibrillator Shocks
From the Clinical Trials Group, National Heart, Lung, and Blood Institute (E.B.S.), Bethesda, Md; University of Calgary (D.V.E.), Canada; University of Washington (Q.Y.), Seattle; and AVID clinical sites at the University of Maryland, Baltimore (L.S.J.), St Luke’s Medical Center, New York, NY (J.S.S.), Baystate Medical Center, Springfield, Mass (J.R.C.); MCP Hahnemann University Hospital, Philadelphia, Pa (S.P.K.); Brigham and Women’s Hospital, Boston, Mass (P.L.F.), University of Alabama at Birmingham (R.S.B.); UT Southwestern, Dallas, Tex (R.L.P.); and University of Seattle, Wash (J.P.).
Correspondence to Derek V. Exner, MD, 3330 Hospital Dr NW, Room G208, Calgary, AB, Canada T2N 4N1. E-mail exner{at}ucalgary.ca
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Abstract |
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Background— Implantable cardioverter defibrillator (ICD) use reduces mortality in patients with serious ventricular arrhythmias compared with antiarrhythmic drug (AAD) use. However, the relative impact of these therapies on self-perceived quality of life (QoL) is unknown.
Methods and Results— Three self-administered instruments were used to measure generic and disease-specific QoL in Antiarrhythmics Versus Implantable Defibrillators trial participants. Generalized linear models were used to assess the relationships between self-perceived QoL and treatment (AAD versus ICD) and adverse symptoms and ICD shocks. To minimize the impact of missing data, only patients surviving 1 year were included in the primary analyses. Baseline characteristics among QoL participants (n=905) and nonparticipants (n=111) were similar, but participants who survived 1 year (n=800) were healthier at baseline than nonsurvivors (n=105). Of the 800 patients in the primary analysis, characteristics of those randomized to AAD (n=384) versus ICD (n=416) were similar. Overall, ICD and AAD use were associated with similar alterations in QoL. The development of sporadic shocks and adverse symptoms were each associated with reduced physical functioning and mental well-being and increased concerns among ICD recipients, whereas development of adverse symptoms was associated with reduced physical functioning and increased concerns among AAD recipients.
Conclusions— ICD and AAD therapy are associated with similar alterations in self-perceived QoL over 1-year follow-up. Adverse symptoms were associated with reduced self-perceived QoL in both groups, and sporadic shocks were associated with reduced QoL in ICD recipients.
Key Words: quality of life • antiarrhythmia agents • heart arrest • tachyarrhythmias • defibrillation
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Introduction |
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Although the assessment of survival is vital to evaluating the efficacy of therapeutic strategies, quality of life (QoL) measurement is important for understanding how these strategies impact the daily lives of patients.1–4 Comprehensive QoL assessment includes the evaluation of physical, psychosocial, and emotional factors that contribute to an individual’s self-perceived QoL.5–10 To date, there is no randomized, prospective information regarding the impact of implantable cardioverter defibrillator (ICD) versus antiarrhythmic drug (AAD) therapy on the QoL of persons with serious ventricular arrhythmias. Moreover, although adverse symptoms related to either therapy would be anticipated to influence QoL, this has not been confirmed nor quantified. Likewise, the impact of shocks on the QoL of ICD recipients is an important aspect of the long-term care that merits additional study.
The Antiarrhythmics Versus Implantable Defibrillators (AVID) trial demonstrated improved survival with ICD compared with AAD therapy, primarily empiric amiodarone, in patients with ventricular fibrillation (VF) or symptomatic ventricular tachycardia (VT).11 Self-perceived QoL assessment was a predefined, secondary endpoint in the AVID trial. This analysis describes and contrasts temporal changes in QoL among AVID participants randomized to an ICD versus AAD and evaluates the impact of adverse symptoms and ICD shocks on self-perceived QoL.
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Methods |
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AVID Trial
AVID was a multicenter, randomized trial that compared ICD with AAD therapy in patients with VF or symptomatic VT. Symptomatic VT included sustained VT resulting in syncope or sustained VT in the setting of a left ventricular ejection fraction
0.40 and clinically important symptoms of hemodynamic compromise. A total of 1,016 patients were randomized before the early termination of AVID, when participants randomized to an ICD were shown to have significantly improved survival.11
QoL Measurement
In AVID, QoL was defined as a multidimensional construct that is individually perceived, dynamic, and quantifiable by self-report.12 Assessment of QoL began in June of 1993, concurrent with the onset of the overall trial. The initial year was used to evaluate instrument reliability,13 whereas the latter portion used a reduced set of 3 questionnaires to assess both generic and disease-specific QoL. Data were censored as of April 7, 1997, the date the main trial was terminated. Participants were encouraged to enroll in the QoL substudy; however, participation was not mandatory. Measurements were obtained at baseline (before randomization) and at 3, 6, and 12 months after randomization.
Instruments
The Medical Outcomes Short Form 36-item questionnaire (SF-36) measures generic health status.14,15 It evaluates several health dimensions, including limitations in physical, emotional, or social functioning because of health or emotional problems, bodily pain, general health perceptions, vitality (energy and fatigue), and general mental health (psychological distress and well-being). Four subscales measure physical health, whereas 4 others evaluate the impact of disease or treatment on an individual’s mental health. Each set of subscales can be reduced to a summary measure, a physical component summary (PCS) score, and a mental component summary (MCS) score.14,15 Overall SF-36 scores, PCS scores, and MCS scores each range from 0 to 100 points, with higher scores indicating superior QoL. The patient concerns checklist evaluates disease-specific aspects of QoL relevant to patients with VF or symptomatic VT. The 46-item checklist used in the present analysis13 was adapted from a 63-item assessment. Scores range from 0 to 46 points, with higher scores indicating increased concern and poorer QoL. The cardiac version of the QoL index (QL index) assesses issues relevant to persons with heart disease,16,17 including satisfaction and health perception, functioning, socioeconomic factors, psychological and spiritual well-being, and family life. Scores range from 0 to 30 points, with higher scores indicating superior QoL. The SF-36 and patient concerns checklist were administered at baseline and 3, 6, and 12 months, whereas the QL index was administered at baseline and 12 months after randomization.
Adverse Symptoms
Symptoms were assessed and recorded at baseline and at follow-up. Data were collected at each visit and when a long-term change in therapy occurred (eg, crossover, ICD reprogramming, or AAD dose alteration). Symptoms were labeled as cardiovascular, pulmonary, neurological, ocular, dermatological, gastrointestinal, genitourinary, musculoskeletal, endocrine, or infectious. Some prespecified ECG abnormalities were considered adverse symptoms (bradycardia causing a prompt change in therapy, advanced heart block, a QRS duration 
200 ms or 2 times the baseline value, or a corrected QT interval 500 ms), as were ICD complications or heart failure requiring the initiation of or a change in treatment. Local investigators categorized symptoms as mild to moderate or severe on the basis of prespecified descriptions. Noticeable, bothersome, or uncomfortable symptoms that resulted in minor change of study therapy or a change in other medications were categorized as mild or moderate, including those requiring AAD dose adjustments, ICD reprogramming, or a change in concurrent medications. Severe symptoms were those requiring temporary or permanent discontinuation of therapy, including ICD removal attributable to infection or alteration of ACE inhibitor dosage for increasing symptoms of heart failure.
Defibrillator Shocks
Shocks were assessed at the 3-, 6-, and 12-month visits or when participants developed symptoms that led to device interrogation. Shocks were categorized by a group of experienced cardiac electrophysiologists as appropriate or inappropriate on the basis of clinical presentation, RR intervals, and electrograms.18 Both appropriate and inappropriate shocks were included in the analysis.
Statistical Analysis
A 
2 test or t test was used for pair-wise comparisons. Because follow-up QoL values cannot be reliably defined for patients who die before reassessment, the primary analyses were limited to patients who survived 1 year after randomization. Secondary sensitivity analyses included all QoL substudy participants. Generalized estimating equations19,20 were used to model change in QoL scores over time to account for correlation of individual values and to deal with missing follow-up data.18,20 Separate models were used to assess PCS, MCS, and patient concerns checklist scores. Models were adjusted for relevant baseline characteristics (age, sex, race, living alone versus with a spouse or partner, index arrhythmia, ejection fraction, history of heart failure, and ß-blocker use) to assess the independent relationship of variables with QoL. All analyses were conducted on an intention-to-treat basis, and P0.05 was considered significant.
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Results |
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Study Population
Of the 1,016 patients randomized to ICD or AAD therapy, 905 patients (89%) completed at least one QoL assessment in the first year of follow-up (Figure 1). QoL substudy participants were younger on average (65 versus 68 years) and more likely to be male (81% versus 70%), be white (88% versus 70%), be living with a spouse or partner (71% versus 51%), and have graduated from high school (73% versus 42%) compared with the 111 nonparticipants. Most (800 of 905 [88%]) QoL substudy participants survived 1 year. As a group, those who survived were more likely to live with a spouse or partner (72% versus 62%) and to have graduated from high school (74% versus 65%) compared with the 105 participants who died in the first year after randomization. The 800 participants who survived 1 year had higher mean left ventricular ejection values (0.32 versus 0.27), were less likely to have a history of heart failure (43% versus 70%), were more likely to receive an ICD (52% versus 37%), and were more often discharged with a ß-blocker (30% versus 17%) compared with the 105 participants who died in the first year. Of the 800 patients included in the present analysis, 416 were randomized to an ICD and 384 were randomized to AAD therapy. Baseline characteristics of these groups were similar, except that the patients assigned to ICD therapy were more often discharged from hospital with ß-blocker therapy (Table 1).
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Incomplete Data
Complete QoL data were available for most patients at each of the specified time points (Table 2). A larger amount of information was missing at later compared with earlier assessments. Most (49%) incomplete data were considered missing because of their collection outside of specified time periods.
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Baseline Scores
Self-perceived physical functioning (PCS) and mental well-being (MCS) were significantly impaired in both treatment groups (Figure 2). Participants randomized to an ICD had mean PCS and MCS scores of 37.4±10.9 and 45.9±11.8, respectively, whereas those randomized to AAD therapy had scores of 36.5±11.2 and 47.5±11.5, respectively. High baseline patient concerns checklist (15.9±8.6 versus 16.2±8.9) and low QL index (22.1±4.9 versus 21.9±5.0) scores were also observed in patients randomized to ICD versus AAD therapy, respectively.
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Change in Scores Over Time
Baseline PCS scores were alike in the 2 treatment groups (P=0.3) and increased over time (P=0.01) similarly (P=0.3). When patients who died in the first year of follow-up were included, similar results in baseline scores (P=0.1), alteration in scores over time (P=0.01), and change in 2 treatment groups over time (P=0.3) were observed. Participants randomized to an ICD had lower mean MCS scores at baseline compared with AAD patients (P=0.006). No significant time trend in MCS scores was observed during follow-up (P=0.7). When participants who died in the first year were included, similar results in baseline scores (P=0.04) and temporal changes in MCS were observed (P=0.9). Patients who received an ICD and were discharged from hospital on ß-blocker therapy had similar MCS (P=0.9) and PCS (P=0.9) scores compared with patients who received an ICD and were not receiving ß-blockers at the time of hospital discharge. No significant differences in patient concerns checklist scores at baseline (P=0.6) or during follow-up (P=0.1) were observed between groups, but scores declined over time in the group as a whole (P<0.001). When participants who died in the first year were included, similar results in baseline (P=0.6) and follow-up (P=0.2) scores were observed. Similar mean baseline and follow-up QL index scores were observed in the 2 groups, and scores did not significantly change over time.
Adverse Symptoms
Adverse symptoms were reported in 49% of patients during the first 3 months, among 36% of patients at 6 months, and in 54% of patients at 1 year. The proportion of patients with adverse symptoms was similar in the 2 treatment groups (P=0.8). Most adverse symptoms (62%) were categorized as cardiovascular (34%) or relating to worsening heart failure (28%). Severe adverse symptoms were reported in 17% of patients at 3 months, 7% of patients at 6 months, and 14% of patients at 1 year. Most of these (69%) were categorized as ICD complication (35%), cardiovascular (18%), or related to worsening heart failure (16%). The occurrence of adverse symptoms was associated with significant reductions in PCS and MCS scores in patients randomized to ICD implantation and reduced PCS scores in patients randomized to AAD therapy on multivariate analysis. A similar relationship between severe adverse symptoms and alterations in QoL scores was observed. Significant increases in patient concerns were observed, independent of the randomized therapy (Table 3).
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ICD Shocks
Among the 416 ICD recipients, 373 (90%) had complete data on the development of shocks. Of these 373 patients, 144 (39%) experienced 1 shock during the initial year of follow-up. The majority of shocks (94%) were categorized as appropriate. Similar numbers of ICD recipients who experienced shocks had 1 or 2 shocks (n=71; 49%) versus 3 shocks (n=73; 51%). In the initial 3 months of follow-up, 85 patients experienced 1 shocks, whereas 52 patients suffered shocks between 3 to 6 months and 55 experienced shocks in the final 6 months of follow-up. The occurrence of 1 versus no shocks during these time periods was independently associated with significant reductions in mental well-being and physical functioning and an increase in patient concerns (Table 3). The development of more frequent shocks (3 versus <3) was associated with similar alterations in self-perceived QoL.
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Discussion |
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This analysis demonstrates that ICD and AAD therapy are associated with similar effects on self-perceived QoL in patients with serious ventricular arrhythmias. The development of adverse symptoms is associated with significant impairment in QoL, regardless of the therapeutic strategy, and the occurrence of sporadic shocks in ICD recipients.
Other Cardiac Populations
Data on QoL in patients with life-threatening arrhythmias are sparse. The data in the present analysis provide important information on baseline and serial QoL in a large group of patients with serious ventricular arrhythmias receiving contemporary therapy. Baseline physical function and mental well-being were lower than mean values (50.7±9.5 and 50.0±9.9, respectively) in the general adult population in the United States,21 indicating moderate to severe impairment in self-perceived QoL.22 Similar degrees of impairment have been reported in elderly patients with a recent myocardial infarction23 and in elderly persons with severe heart failure.24 These values are substantially lower than ambulatory patients with heart failure or hypertension,21 indicating that patients with serious ventricular arrhythmias have greater impairment in QoL when compared with patients with other forms of heart disease.
Influence of Treatment
Self-perceived physical functioning was stable over time and did not differ between the 2 treatment groups. Stability in this aspect of QoL is not surprising given that neither therapy would be anticipated to alter physical functioning. Our results are consistent with smaller studies, which have demonstrated that physical functioning is frequently impaired in patients receiving an ICD.25–27 However, in contrast to smaller studies, which suggested that this impairment was a transient phenomenon,25 we found it to be relatively stable during follow-up. Thus, baseline physical functioning assessment seems to provide a reasonable measure of longer-term functioning. Self-perceived mental well-being scores were lower in patients randomized to ICD versus AAD therapy at baseline but were similar in the 2 groups at 1 year. This finding may reflect regression to the mean or simply a chance finding. The convergence of scores over time likely reflects regression to the mean rather than the influence of AAD versus ICD therapy, given that MCS scores were similar in the 2 groups by 3 months.
Adverse Symptoms
The development of adverse symptoms was associated with a significant reduction in physical functioning among participants randomized to AAD therapy and both physical functioning and mental well-being in participants randomized to an ICD. The development of severe adverse symptoms was also associated with significant reductions in physical functioning in both groups. Adverse symptoms were associated with a significant increase in patient concerns with both therapies. These data are not surprising given the presumed impact of adverse symptoms on patient’s daily lives.
ICD Shocks
The occurrence of ICD shocks is associated with increased psychological distress in both patients and their families.28–31 Past studies indicate that patients who experience frequent (>5) shocks have lower QoL compared with those who do not.26 The present analysis extends these findings by demonstrating that, independent of other markers of disease severity, the development of 1 shock in the initial year of follow-up is associated with significant declines in both physical functioning and mental well-being and increased patient concerns. This result has important implications, because the development of frequent ICD therapies is also associated with an increased risk of death,32 and therapies designed, in part, to reduce the frequency of recurrent VT and VF, such as sotalol, seem to reduce cardiovascular mortality.33 The present analysis raises the possibility that reducing ICD shock frequency may lead to an improvement in QoL as well. However, this remains to be prospectively evaluated.
Limitations
The primary results were based on excluding patients who died during the first year of follow-up and thus may provide a biased estimate of differences between ICD and AAD therapy. These patients were excluded because their QoL could not be reliably defined. It is unlikely that these deaths occurred independently of QoL. Arguably, QoL would be anticipated to be more significantly impaired in individuals who died before 1 year, and the QoL of these patients is likely to be lower than that of the overall group. By including only patients who survived 1 year, more reliable estimates of changes in QoL were obtained. Despite this, when all patients were analyzed, independent of their surviving 1 year, similar results were obtained. It is also important to note that QoL assessment was limited to the initial year of follow-up, and it is possible that long-term differences in QoL may exist because of more frequent ICD complications over time34 and higher rates of organ toxicity with long-term amiodarone usage.35
Clinical Significance
This is the first large, prospective evaluation of the effect of ICD versus AAD therapy on the self-perceived QoL of patients with serious ventricular arrhythmias. Although ICD and AAD therapy are associated with similar self-perceived QoL, the development of adverse symptoms and the occurrence of sporadic ICD shocks are each associated with significant impairment in QoL. Whether interventions aimed at limiting adverse symptoms or reducing shocks will result in improved QoL in individuals with serious ventricular arrhythmias requires prospective confirmation.
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Acknowledgments |
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This study was supported by a contract (N01 HC-25117) with the National Heart, Lung and Blood Institute. Dr Exner is a Clinician-Scientist of the Canadian Institutes of Health Research and a Clinical Investigator of the Alberta Heritage Foundation for Medical Research.
Received July 9, 2001; revision received November 19, 2001; accepted November 26, 2001.
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References |
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|---|
1. World Health Organization. Constitution of the World Health Organization Basic Document. Geneva, Switzerland: World Health Organization; 1948.
2.
Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med. 1993; 118: 622–629.
3. Kaplan RM, Feeny D, Revicki DA. Methods for assessing relative importance in preference based out-come measures. Qual Life Res. 1993; 2: 467–475.[CrossRef][Medline] [Order article via Infotrieve]
4. Patrick DL, Deyo RA. Generic and disease-specific measures in assessing health status and quality of life. Med Care. 1989; 27: S217–S232.[Medline] [Order article via Infotrieve]
5. Schron EB, Shumaker SA. The integration of health quality of life in clinical research: experiences from cardiovascular clinical trials. Prog Cardiovasc Nursing. 1992; 7: 21–28.
6. Naughton MJ, Shumaker SA. Assessment of health-related quality of life.In: Friedman LM, Furberg CD, DeMets DL, eds. Fundamentals of Clinical Trials. 3rd ed. London, England: Mosby; 1996: 185–203.
7. Czajkowski SM, Creamer J, Mebane-Sims I, et al. Health-Related Quality of Life: Findings From NHLBI-Supported Clinical Research. Bethesda, MD: National Institutes of Health, National Heart, Lung, and Blood Institute; 1995: 1–53.
8. Wenger NK, Naughton MJ, Furburg CD. Cardiovascular disorders.In: Spilker B, ed. Quality of Life and Pharmacoeconomics in Clinical Trial. 2nd ed. Philadelphia, Pa: Lippincott-Raven; 1996: 883–902.
9. Croog SH. Current issues in conceptualizing and measuring quality of life. In: Quality of Life Assessment: Practice, Problems, and Promise. Proceedings of a workshop sponsored by the Office of the Director, National Institutes of Health. NIH Publication No. 93-3503; 1990.
10.
Gill TM, Feinstein AR. A critical appraisal of quality of quality of life measurements. JAMA. 1994; 272: 619–626.
11.
Antiarrhythmics Versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997; 337: 1576–1583.
12. Jenkins LS. Quality of life in survivors of sudden cardiac death entering treatment.In: Dunbar SB, Ellenbogen KA, Epstein AE, eds. Sudden Cardiac Death: Past, Present, and Future. Armonk, NY: Futura Publishing; 1997: 289–305.
13. Brooks MM, Jenkins LS, Schron EB, et al. Quality of life at baseline: is assessment after randomization valid? Med Care. 1998; 36: 1515–1519.[CrossRef][Medline] [Order article via Infotrieve]
14.
Tarlov AR, Ware JE, Greenfield S, et al. The medical outcomes study: an application of methods for monitoring the results of medical care. JAMA. 1989; 262: 925–930.
15. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey. Med Care. 1992; 30: 473–483.[Medline] [Order article via Infotrieve]
16. Ferrans C, Powers M. Quality of life index: development and psychometric properties. Adv Nursing Sci. 1985; 8: 15–24.
17. Ferrans CE, Powers MJ. Psychometric assessment of the Quality of Life Index. Res Nurs Health. 1992; 15: 29–38.[Medline] [Order article via Infotrieve]
18. Swerdlow CD, Chen PS, Kass RM, et al. Discrimination of ventricular tachycardia from sinus tachycardia and atrial fibrillation in a tiered-therapy cardioverter-defibrillator. J Am Coll Cardiol. 1994; 23: 1342–1355.[Abstract]
19. Liang KY, Zeger SL. Longitudinal data analyses using generalized linear models. Biometrika. 1989; 73: 13–22.[CrossRef]
20. Albert PS. Longitudinal data analysis (repeated measures) in clinical trials. Stat Med. 1999; 18: 1707–1732.[CrossRef][Medline] [Order article via Infotrieve]
21. Ware JE Jr. Validity: norm-based interpretation.In: SF-36 Health Survey: Manual and Interpretation Guide. Boston, Mass: The Health Institute, New England Medical Center; 1997: 10–38.
22.
Stewart AL, Greenfield S, Hays RD, et al. Functional status and well-being of patients with chronic conditions: results from the Medical Outcomes Study. JAMA. 1989; 262: 907–913.
23.
Brown N, Melville M, Gray D, et al. Quality of life four years after acute myocardial infarction: short form 36 scores compared with a normal population. Heart. 1999; 81: 352–358.
24.
Jenkinson C, Jenkinson D, Shepperd S, et al. Evaluation of treatment for congestive heart failure in patients aged 60 years and older using generic measures of health status (SF-36 and COOP charts). Age Ageing. 1997; 26: 7–13.
25. May CD, Smith PR, Murdock CJ, et al. The impact of the implantable cardioverter defibrillator on quality-of-life. Pacing Clin Electrophysiol. 1995; 18: 1411–1418.[CrossRef][Medline] [Order article via Infotrieve]
26. Heller SS, Ormont MA, Lidagoster L, et al. Psychosocial outcome after ICD implantation: a current perspective. Pacing Clin Electrophysiol. 1998; 21: 1207–1215.[CrossRef][Medline] [Order article via Infotrieve]
27.
Arteaga WJ, Windle JR. The quality of life of patients with life-threatening arrhythmias. Arch Intern Med. 1995; 155: 2086–2091.
28. Herbst JH, Goodman M, Feldstein S, et al. Health-related quality-of-life assessment of patients with life-threatening ventricular arrhythmias. Pacing Clin Electrophysiol. 1999; 22: 915–926.[CrossRef][Medline] [Order article via Infotrieve]
29. Dunbar S, Warner C, Purcell J. Internal cardioverter defibrillator device discharge: experiences of patients and family members. Heart Lung. 1993; 22: 494–501.[Medline] [Order article via Infotrieve]
30. Dougherty CM. Psychological reactions and family adjustment in shock versus no shock groups after implantation of internal cardioverter defibrillator. Heart Lung. 1995; 24: 281–291.[CrossRef][Medline] [Order article via Infotrieve]
31. Hegel MT, Griegel LE, Black C, et al. Anxiety and depression in patients receiving implanted cardioverter-defibrillators: a longitudinal investigation. Int J Psychiatry Med. 1997; 78: 581–583.
32.
Exner DV, Pinski SL, Wyse DG, et al. Electrical storm presages nonsudden death: the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial. Circulation. 2001; 103: 2066–2071.
33.
Pacifico A, Hohnloser SH, Williams JH, et al for the d, l-sotalol Implantable Cardioverter-Defibrillator Study Group. Prevention of implantable-defibrillator shocks by treatment with sotalol. N Engl J Med. 1999; 340: 1855–1862.
34. Mehta D, Nayak HM, Singson M, et al. Late complications in patients with pectoral defibrillator implants with transvenous defibrillator lead systems: high incidence of insulation breakdown. Pacing Clin Electrophysiol. 1998; 21: 1893–1900.[CrossRef][Medline] [Order article via Infotrieve]
35. Vorperian VR, Havighurst TC, Miller S, et al. Adverse effects of low dose amiodarone: a meta-analysis. J Am Coll Cardiol. 1997; 30: 791–798.[Abstract]
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 D. L. Carroll and G. A. Hamilton Long-term Effects of Implanted Cardioverter-Defibrillators on Health Status, Quality of Life, and Psychological State Am. J. Crit. Care., May 1, 2008; 17(3): 222 - 230. [Abstract] [Full Text] [PDF]
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 L. van Erven and M. J Schalij Troubleshooting implantable cardioverter-defibrillator related problems Heart, May 1, 2008; 94(5): 649 - 660. [Full Text] [PDF]
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J. P. Daubert, W. Zareba, D. S. Cannom, S. McNitt, S. Z. Rosero, P. Wang, C. Schuger, J. S. Steinberg, S. L. Higgins, D. J. Wilber, et al. Inappropriate Implantable Cardioverter-Defibrillator Shocks in MADIT II: Frequency, Mechanisms, Predictors, and Survival Impact J. Am. Coll. Cardiol., April 8, 2008; 51(14): 1357 - 1365. [Abstract] [Full Text] [PDF]
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S. Nazarian and J. A.C. Lima Cardiovascular Magnetic Resonance for Risk Stratification of Arrhythmia in Hypertrophic Cardiomyopathy J. Am. Coll. Cardiol., April 8, 2008; 51(14): 1375 - 1376. [Full Text] [PDF]
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 A. Sarkozy, P. Brugada, L. Mont, and J. Brugada Optimizing the clinical use of implantable defibrillators in patients with Brugada syndrome Eur. Heart J. Suppl., December 1, 2007; 9(suppl_I): I74 - I80. [Abstract] [Full Text] [PDF]
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 R. Passman, H. Subacius, B. Ruo, A. Schaechter, A. Howard, S. F. Sears, and A. Kadish Implantable Cardioverter Defibrillators and Quality of Life: Results From the Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation Study Arch Intern Med, November 12, 2007; 167(20): 2226 - 2232. [Abstract] [Full Text] [PDF]
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J. A. Salerno-Uriarte, G. M. De Ferrari, C. Klersy, R. F.E. Pedretti, M. Tritto, L. Sallusti, L. Libero, G. Pettinati, G. Molon, A. Curnis, et al. Prognostic Value of T-Wave Alternans in Patients With Heart Failure Due to Nonischemic Cardiomyopathy: Results of the ALPHA Study J. Am. Coll. Cardiol., November 6, 2007; 50(19): 1896 - 1904. [Abstract] [Full Text] [PDF]
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J. Almendral and M. E. Josephson All Patients With Hemodynamically Tolerated Postinfarction Ventricular Tachycardia Do Not Require an Implantable Cardioverter-Defibrillator Circulation, September 4, 2007; 116(10): 1204 - 1212. [Full Text] [PDF]
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S. S Pedersen, D. A. Theuns, A. Muskens-Heemskerk, R. A. Erdman, and L. Jordaens Type-D personality but not implantable cardioverter-defibrillator indication is associated with impaired health-related quality of life 3 months post-implantation Europace, August 1, 2007; 9(8): 675 - 680. [Abstract] [Full Text] [PDF]
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R. Passman and A. Kadish Sudden Death Prevention With Implantable Devices Circulation, July 31, 2007; 116(5): 561 - 571. [Full Text] [PDF]
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W. G. Stevenson and K. Soejima Catheter Ablation for Ventricular Tachycardia Circulation, May 29, 2007; 115(21): 2750 - 2760. [Full Text] [PDF]
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 P. J. Zimetbaum A 59-Year-Old Man Considering Implantation of a Cardiac Defibrillator JAMA, May 2, 2007; 297(17): 1909 - 1916. [Abstract] [Full Text] [PDF]
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A. K. Gehi, D. Mehta, and J. A. Gomes Evaluation and Management of Patients After Implantable Cardioverter-Defibrillator Shock JAMA, December 20, 2006; 296(23): 2839 - 2847. [Abstract] [Full Text] [PDF]
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 F. S. Luyster, J. W. Hughes, D. Waechter, and R. Josephson Resource loss predicts depression and anxiety among patients treated with an implantable cardioverter defibrillator. Psychosom Med, September 1, 2006; 68(5): 794 - 800. [Abstract] [Full Text] [PDF]
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B. L. Wilkoff, K. T. Ousdigian, L. D. Sterns, Z. J. Wang, R. D. Wilson, J. M. Morgan, and for the EMPIRIC Trial Investigators A Comparison of Empiric to Physician-Tailored Programming of Implantable Cardioverter-Defibrillators: Results From the Prospective Randomized Multicenter EMPIRIC Trial J. Am. Coll. Cardiol., July 18, 2006; 48(2): 330 - 339. [Abstract] [Full Text] [PDF]
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S. A. Thomas, E. Friedmann, C.-W. Kao, P. Inguito, M. Metcalf, F. J. Kelley, and S. S. Gottlieb Quality of life and psychological status of patients with implantable cardioverter defibrillators. Am. J. Crit. Care., July 1, 2006; 15(4): 389 - 398. [Abstract] [Full Text] [PDF]
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J. Baumert, C. Schmitt, and K.-H. Ladwig Psychophysiologic and Affective Parameters Associated With Pain Intensity of Cardiac Cardioverter Defibrillator Shock Discharges Psychosom Med, July 1, 2006; 68(4): 591 - 597. [Abstract] [Full Text] [PDF]
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M. O. Sweeney Overcoming the Defects of a Virtue: Dual-Chamber Versus Single-Chamber Detection Enhancements for Implantable Defibrillator Rhythm Diagnosis: The Detect Supraventricular Tachycardia Study Circulation, June 27, 2006; 113(25): 2862 - 2864. [Full Text] [PDF]
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P. A. Friedman, R. L. McClelland, W. R. Bamlet, H. Acosta, D. Kessler, T. M. Munger, N. G. Kavesh, M. Wood, E. Daoud, A. Massumi, et al. Dual-Chamber Versus Single-Chamber Detection Enhancements for Implantable Defibrillator Rhythm Diagnosis: The Detect Supraventricular Tachycardia Study Circulation, June 27, 2006; 113(25): 2871 - 2879. [Abstract] [Full Text] [PDF]
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M. Leosdottir, E. Sigurdsson, G. Reimarsdottir, G. Gottskalksson, B. Torfason, M. Vigfusdottir, S. Eggertsson, and D. O. Arnar Health-related quality of life of patients with implantable cardioverter defibrillators compared with that of pacemaker recipients. Europace, March 1, 2006; 8(3): 168 - 174. [Abstract] [Full Text] [PDF]
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D. M. Bloomfield, J. T. Bigger, R. C. Steinman, P. B. Namerow, M. K. Parides, A. B. Curtis, E. S. Kaufman, J. M. Davidenko, T. S. Shinn, and J. M. Fontaine Microvolt T-Wave Alternans and the Risk of Death or Sustained Ventricular Arrhythmias in Patients With Left Ventricular Dysfunction J. Am. Coll. Cardiol., January 17, 2006; 47(2): 456 - 463. [Abstract] [Full Text] [PDF]
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S. J. Connolly, P. Dorian, R. S. Roberts, M. Gent, S. Bailin, E. S. Fain, K. Thorpe, J. Champagne, M. Talajic, B. Coutu, et al. Comparison of {beta}-Blockers, Amiodarone Plus {beta}-Blockers, or Sotalol for Prevention of Shocks From Implantable Cardioverter Defibrillators: The OPTIC Study: A Randomized Trial JAMA, January 11, 2006; 295(2): 165 - 171. [Abstract] [Full Text] [PDF]
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R. L. Page Antiarrhythmic Drugs for All Patients With an ICD? JAMA, January 11, 2006; 295(2): 211 - 213. [Full Text] [PDF]
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 S. F. Sears, T. Saia Lewis, E. A. Kuhl, and J. B. Conti Predictors of Quality of Life in Patients With Implantable Cardioverter Defibrillators Psychosomatics, October 1, 2005; 46(5): 451 - 457. [Abstract] [Full Text] [PDF]
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E. M. Ohman and P. P. Chang Improving Quality of Life After Cardiogenic Shock: Do More Revascularization! J. Am. Coll. Cardiol., July 19, 2005; 46(2): 274 - 276. [Full Text] [PDF]
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S. B. Dunbar Psychosocial Issues of Patients With Implantable Cardioverter Defibrillators Am. J. Crit. Care., July 1, 2005; 14(4): 294 - 303. [Abstract] [Full Text] [PDF]
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S. F. Sears Jr, J. B. Shea, and J. B. Conti How to Respond to an Implantable Cardioverter-Defibrillator Shock Circulation, June 14, 2005; 111(23): e380 - e382. [Full Text] [PDF]
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M. O. Sweeney, M. S. Wathen, K. Volosin, I. Abdalla, P. J. DeGroot, M. F. Otterness, and A. J. Stark Appropriate and Inappropriate Ventricular Therapies, Quality of Life, and Mortality Among Primary and Secondary Prevention Implantable Cardioverter Defibrillator Patients: Results From the Pacing Fast VT REduces Shock ThErapies (PainFREE Rx II) Trial Circulation, June 7, 2005; 111(22): 2898 - 2905. [Abstract] [Full Text] [PDF]
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W. Whang, C. M. Albert, S. F. Sears Jr, R. Lampert, J. B. Conti, P. J. Wang, J. P. Singh, J. N. Ruskin, J. E. Muller, M. A. Mittleman, et al. Depression as a predictor for appropriate shocks among patients with implantable cardioverter-defibrillators: Results from the Triggers of Ventricular Arrhythmias (TOVA) study J. Am. Coll. Cardiol., April 5, 2005; 45(7): 1090 - 1095. [Abstract] [Full Text] [PDF]
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 C. L. Sola and J. M. Bostwick Implantable Cardioverter-Defibrillators, Induced Anxiety, and Quality of Life Mayo Clin. Proc., February 1, 2005; 80(2): 232 - 237. [Abstract] [PDF]
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W. G. Stevenson, B. R. Chaitman, K. A. Ellenbogen, A. E. Epstein, W. L. Gross, D. L. Hayes, S. A. Strickberger, M. O. Sweeney, and for the Subcommittee on Electrocardiography and Ar Clinical Assessment and Management of Patients With Implanted Cardioverter-Defibrillators Presenting to Nonelectrophysiologists Circulation, December 21, 2004; 110(25): 3866 - 3869. [Abstract] [Full Text] [PDF]
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M. M. Burg, R. Lampert, T. Joska, W. Batsford, and D. Jain Psychological Traits and Emotion-Triggering of ICD Shock-Terminated Arrhythmias Psychosom Med, November 1, 2004; 66(6): 898 - 902. [Abstract] [Full Text] [PDF]
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M. S. Wathen, P. J. DeGroot, M. O. Sweeney, A. J. Stark, M. F. Otterness, W. O. Adkisson, R. C. Canby, K. Khalighi, C. Machado, D. S. Rubenstein, et al. Prospective Randomized Multicenter Trial of Empirical Antitachycardia Pacing Versus Shocks for Spontaneous Rapid Ventricular Tachycardia in Patients With Implantable Cardioverter-Defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) Trial Results Circulation, October 26, 2004; 110(17): 2591 - 2596. [Abstract] [Full Text] [PDF]
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D. M. Bloomfield, R. C. Steinman, P. B. Namerow, M. Parides, J. Davidenko, E. S. Kaufman, T. Shinn, A. Curtis, J. Fontaine, D. Holmes, et al. Microvolt T-Wave Alternans Distinguishes Between Patients Likely and Patients Not Likely to Benefit From Implanted Cardiac Defibrillator Therapy: A Solution to the Multicenter Automatic Defibrillator Implantation Trial (MADIT) II Conundrum Circulation, October 5, 2004; 110(14): 1885 - 1889. [Abstract] [Full Text] [PDF]
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S. S. Pedersen, R. T. van Domburg, D. A. M. J. Theuns, L. Jordaens, and R. A. M. Erdman Type D Personality Is Associated With Increased Anxiety and Depressive Symptoms in Patients With an Implantable Cardioverter Defibrillator and Their Partners Psychosom Med, September 1, 2004; 66(5): 714 - 719. [Abstract] [Full Text] [PDF]
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S F Sears and J B Conti Implantable cardioverter-defibrillators for children and young adolescents: mortality benefit confirmed--what's next? Heart, March 1, 2004; 90(3): 241 - 242. [Full Text] [PDF]
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C. T. Sinclair, J. H. Marymount III, M. A. Rozner, and J. P. DiMarco Implantable Cardioverter-Defibrillators and Complications N. Engl. J. Med., February 12, 2004; 350(7): 734 - 735. [Full Text] [PDF]
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J. P. DiMarco Implantable Cardioverter-Defibrillators N. Engl. J. Med., November 6, 2003; 349(19): 1836 - 1847. [Full Text] [PDF]
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 E. S. Antezano and M. Hong Sudden Cardiac Death J Intensive Care Med, November 1, 2003; 18(6): 313 - 329. [Abstract] [PDF]
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D. J. Bradley Combining Resynchronization and Defibrillation Therapies for Heart Failure JAMA, May 28, 2003; 289(20): 2719 - 2721. [Full Text] [PDF]
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 J. A. Ezekowitz, P. W. Armstrong, and F. A. McAlister Implantable Cardioverter Defibrillators in Primary and Secondary Prevention: A Systematic Review of Randomized, Controlled Trials Ann Intern Med, March 18, 2003; 138(6): 445 - 452. [Abstract] [Full Text] [PDF]
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H. C. M. Kamphuis, J. R. J. de Leeuw, R. Derksen, R. N. W. Hauer, and J. A. M. Winnubst Implantable cardioverter defibrillator recipients: quality of life in recipients with and without ICD shock delivery: A prospective study Europace, January 1, 2003; 5(4): 381 - 389. [Abstract] [Full Text] [PDF]
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