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1.  Prognostic Importance of Defibrillator Shocks in Patients with Heart Failure 
The New England journal of medicine  2008;359(10):1009-1017.
BACKGROUND
Patients with heart failure who receive an implantable cardioverter–defibrillator (ICD) for primary prevention (i.e., prevention of a first life-threatening arrhythmic event) may later receive therapeutic shocks from the ICD. Information about long-term prognosis after ICD therapy in such patients is limited.
METHODS
Of 829 patients with heart failure who were randomly assigned to ICD therapy, we implanted the ICD in 811. ICD shocks that followed the onset of ventricular tachycardia or ventricular fibrillation were considered to be appropriate. All other ICD shocks were considered to be inappropriate.
RESULTS
Over a median follow-up period of 45.5 months, 269 patients (33.2%) received at least one ICD shock, with 128 patients receiving only appropriate shocks, 87 receiving only inappropriate shocks, and 54 receiving both types of shock. In a Cox proportional-hazards model adjusted for baseline prognostic factors, an appropriate ICD shock, as compared with no appropriate shock, was associated with a significant increase in the subsequent risk of death from all causes (hazard ratio, 5.68; 95% confidence interval [CI], 3.97 to 8.12; P<0.001). An inappropriate ICD shock, as compared with no inappropriate shock, was also associated with a significant increase in the risk of death (hazard ratio, 1.98; 95% CI, 1.29 to 3.05; P = 0.002). For patients who survived longer than 24 hours after an appropriate ICD shock, the risk of death remained elevated (hazard ratio, 2.99; 95% CI, 2.04 to 4.37; P<0.001). The most common cause of death among patients who received any ICD shock was progressive heart failure.
CONCLUSIONS
Among patients with heart failure in whom an ICD is implanted for primary prevention, those who receive shocks for any arrhythmia have a substantially higher risk of death than similar patients who do not receive such shocks.
doi:10.1056/NEJMoa071098
PMCID: PMC2922510  PMID: 18768944
2.  Quality of Life and Cost Following Late Invasive Therapy for Occluded Infarct Arteries 
The New England journal of medicine  2009;360(8):774-783.
Background
The open artery hypothesis postulates that late opening of an infarct-related artery after myocardial infarction (MI) will improve clinical outcomes. The quality of life (QOL) and economic outcomes associated with this strategy have not been described.
Methods
The Occluded Artery Trial (OAT) compared percutaneous coronary intervention (PCI) plus stenting with medical therapy alone in stable, high-risk patients who had a totally occluded infarct-related artery at 3 to 28 days post-MI. In 951 patients (44% of those eligible), QOL was assessed by a battery that included two principal outcome measures, the Duke Activity Status Index (DASI) reflecting cardiac-related physical functioning, and the Rand Short-Form 36 Mental Health Inventory 5 reflecting psychological well-being. Structured QOL interviews were performed at baseline, 4, 12, and 24 months. Costs were measured in 458 of 469 U.S. patients (98%) and 2-year cost effectiveness was estimated.
Results
At 4 months, the medical therapy group showed a clinically marginal 3.4-point decline in DASI relative to the PCI group (p=0.007). At 1 and 2 years, the differences were smaller. No significant differences in psychological well-being were observed. In the 469 US OAT patients, cumulative 2-year costs were about $7,000 higher in the PCI group (p<0.0001) while quality-adjusted survival was marginally higher in the medical therapy group.
Conclusions
In this trial, PCI was associated with a marginal advantage in cardiac physical functioning at 4 months but not thereafter. At 2 years, medical therapy remained significantly less expensive than routine PCI and had higher quality-adjusted survival.
doi:10.1056/NEJMoa0805151
PMCID: PMC2724193  PMID: 19228620
Percutaneous coronary intervention; quality of life; costs; coronary artery disease; myocardial infarction
3.  Quality of Life with Defibrillator Therapy or Amiodarone in Heart Failure 
The New England journal of medicine  2008;359(10):999-1008.
Background
Implantable cardioverter defibrillator (ICD) therapy significantly prolongs life in patients at increased risk of sudden cardiac death from depressed left ventricular function. However, it is unclear whether this increased longevity is accompanied by deterioration in quality of life.
Methods
The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) compared ICD therapy or amiodarone versus state-of-the-art medical therapy alone in 2521 stable heart failure patients with depressed left ventricular function. Quality of life, a secondary end point of the trial, was prospectively measured at baseline, 3, 12, and 30 months and was 93% to 98% complete. The Duke Activity Status Index (which measures cardiac physical functioning) and the SF-36 Mental Health Inventory (which measures psychological well-being or distress) were prespecified principal quality-of-life outcomes. Multiple additional quality-of-life outcomes were also examined.
Results
Compared with medical therapy alone, psychological well-being in the ICD arm significantly improved at 3 months (p=0.01) and 12 months (p=0.004) but not at 30 months. No clinically or statistically significant differences in physical functioning by treatment were observed. Some other quality-of-life measures improved in the ICD arm at 3 and/or 12 months but none differed significantly at 30 months. ICD shocks within the month preceding a scheduled assessment were associated with decreased quality of life in multiple domains. Amiodarone had no significant effects on the principal quality-of-life outcomes.
Conclusions
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.
doi:10.1056/NEJMoa0706719
PMCID: PMC2823628  PMID: 18768943
Sudden cardiac death; congestive heart failure; implantable cardioverter-defibrillator; quality of life
4.  Coronary Intervention for Persistent Occlusion after Myocardial Infarction 
The New England journal of medicine  2006;355(23):2395-2407.
BACKGROUND
It is unclear whether stable, high-risk patients with persistent total occlusion of the infarct-related coronary artery identified after the currently accepted period for myocardial salvage has passed should undergo percutaneous coronary intervention (PCI) in addition to receiving optimal medical therapy to reduce the risk of subsequent events.
METHODS
We conducted a randomized study involving 2166 stable patients who had total occlusion of the infarct-related artery 3 to 28 days after myocardial infarction and who met a high-risk criterion (an ejection fraction of <50% or proximal occlusion). Of these patients, 1082 were assigned to routine PCI and stenting with optimal medical therapy, and 1084 were assigned to optimal medical therapy alone. The primary end point was a composite of death, myocardial reinfarction, or New York Heart Association (NYHA) class IV heart failure.
RESULTS
The 4-year cumulative primary event rate was 17.2% in the PCI group and 15.6% in the medical therapy group (hazard ratio for death, reinfarction, or heart failure in the PCI group as compared with the medical therapy group, 1.16; 95% confidence interval [CI], 0.92 to 1.45; P = 0.20). Rates of myocardial reinfarction (fatal and nonfatal) were 7.0% and 5.3% in the two groups, respectively (hazard ratio, 1.36; 95% CI, 0.92 to 2.00; P = 0.13). Rates of nonfatal reinfarction were 6.9% and 5.0%, respectively (hazard ratio, 1.44; 95% CI, 0.96 to 2.16; P = 0.08); only six reinfarctions (0.6%) were related to assigned PCI procedures. Rates of NYHA class IV heart failure (4.4% vs. 4.5%) and death (9.1% vs. 9.4%) were similar. There was no interaction between treatment effect and any subgroup variable (age, sex, race or ethnic group, infarct-related artery, ejection fraction, diabetes, Killip class, and the time from myocardial infarction to randomization).
CONCLUSIONS
PCI did not reduce the occurrence of death, reinfarction, or heart failure, and there was a trend toward excess reinfarction during 4 years of follow-up in stable patients with occlusion of the infarct-related artery 3 to 28 days after myocardial infarction. (ClinicalTrials.gov number, NCT00004562.)
doi:10.1056/NEJMoa066139
PMCID: PMC1995554  PMID: 17105759

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