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Although opening an occluded infarct-related artery >24 hours after myocardial infarction in stable patients in the Occluded Artery Trial (OAT) did not reduce events over 7 years, there was a suggestion that the effect of treatment might differ by patient age. Baseline characteristics and outcomes by treatment with percutaneous coronary intervention (PCI) versus optimal medical therapy alone were compared by prespecified stratification at age 65 years. A p value <0.01 was prespecified as significant for OAT secondary analyses. The primary outcome was death, myocardial infarction, or New York Heart Association class IV heart failure. Patients aged >65 years (n = 641) were more likely to be female, to be nonsmokers, and to have hypertension, lower estimated glomerular filtration rates, and multivessel disease compared to younger patients (aged ≤65 years, n = 1,560) (p <0.001). There was no significant observed interaction between treatment assignment and age for the primary outcome after adjustment (p = 0.10), and there was no difference between PCI and optimal medical therapy observed in either age group. At 7-year follow-up, younger patients tended to have angina more often compared to the older group (hazard ratio 1.21, 99% confidence interval 1.00 to 1.46, p = 0.01). The 7-year composite primary outcome was more common in older patients (p <0.001), and age remained significant after covariate adjustment (hazard ratio 1.42, 99% confidence interval 1.09 to 1.84). The rate of early PCI complications was low in the 2 age groups. The trend toward a differential effect of PCI in the young versus the old for the primary outcome was likely driven by measured and unmeasured confounders and by chance. PCI reduces angina to a similar degree in the young and old. In conclusion, there is no indication for routine PCI to open a persistently occluded infarct-related artery in stable patients after myocardial infarction, regardless of age. © 2012 Elsevier Inc.

Aims Previous experimental and clinical studies have consistently suggested that right ventricular (RV) apical pacing has important adverse effects. Ventricular pacing (VP), however, is required, and cannot be reduced in many patients with atrioventricular (AV) block. The PREVENT-HF study was an international randomized trial that explored differences in left ventricular (LV) remodelling during RV apical vs. biventricular (BIV) pacing in patients with AV block. Methods and Results Patients with an expected VP prevalence ≥80% were assigned to RV apical or BIV pacing. The primary endpoint was the change in LV end-diastolic volume (EDV) >12 months. Secondary endpoints were LV end-systolic volume (ESV), LV ejection fraction (EF), mitral regurgitation (MR), and a combination of heart failure (HF) events and cardiovascular hospitalizations. Overall, 108 patients were randomized (RV: 58; BIV: 50). Intention to treat and on-treatment analyses revealed no significant differences in any of the outcomes. Analysis of covariance (ANCOVA) difference for treatment according to randomization (in mL): LVEDV −3.92 (−18.71 to 10.85), P= 0.6; LVESV −1.38 (−12.07 to 9.31), P= 0.80; LVEF 2.47 (−3.00 to 7.94), P= 0.37. Analysis of covariance difference for the on-treatment analysis: LVEDV −4.90 (−20.02 to 10.22, PP= 0.52; LVESV −6.45 (−17.28 to 4.38), P= 0.24, LVEF 2.18 (−3.37 to 7.73), P= 0.44. Furthermore, secondary endpoints did not differ significantly. Conclusion This study did not demonstrate significant LV volume differences >12 months between RV apical and BIV pacing for AV block. Thus, BIV pacing cannot be recommended as a routine treatment for AV block in these patients. However, the results encourage and inform the design of subsequent larger trials with higher power for detecting small volume changes. ClinicalTrials.gov Identifier: NCT00170326., Peer Reviewed, Postprint (published version)

Aims Previous experimental and clinical studies have consistently suggested that right ventricular (RV) apical pacing has important adverse effects. Ventricular pacing (VP), however, is required, and cannot be reduced in many patients with atrioventricular (AV) block. The PREVENT-HF study was an international randomized trial that explored differences in left ventricular (LV) remodelling during RV apical vs. biventricular (BIV) pacing in patients with AV block. Methods and Results Patients with an expected VP prevalence ≥80% were assigned to RV apical or BIV pacing. The primary endpoint was the change in LV end-diastolic volume (EDV) >12 months. Secondary endpoints were LV end-systolic volume (ESV), LV ejection fraction (EF), mitral regurgitation (MR), and a combination of heart failure (HF) events and cardiovascular hospitalizations. Overall, 108 patients were randomized (RV: 58; BIV: 50). Intention to treat and on-treatment analyses revealed no significant differences in any of the outcomes. Analysis of covariance (ANCOVA) difference for treatment according to randomization (in mL): LVEDV −3.92 (−18.71 to 10.85), P= 0.6; LVESV −1.38 (−12.07 to 9.31), P= 0.80; LVEF 2.47 (−3.00 to 7.94), P= 0.37. Analysis of covariance difference for the on-treatment analysis: LVEDV −4.90 (−20.02 to 10.22, PP= 0.52; LVESV −6.45 (−17.28 to 4.38), P= 0.24, LVEF 2.18 (−3.37 to 7.73), P= 0.44. Furthermore, secondary endpoints did not differ significantly. Conclusion This study did not demonstrate significant LV volume differences >12 months between RV apical and BIV pacing for AV block. Thus, BIV pacing cannot be recommended as a routine treatment for AV block in these patients. However, the results encourage and inform the design of subsequent larger trials with higher power for detecting small volume changes. ClinicalTrials.gov Identifier: NCT00170326., Peer Reviewed, Postprint (published version)

BackgroundIn the Mode Selection Trial (MOST) of 2,010 patients with sinus node dysfunction, dual-chamber-paced patients had less atrial fibrillation (AF) and heart failure and had slightly improved health-related quality of life (QOL) compared with rate modulated right ventricular-paced patients. Our objective was to assess the impact of AF on QOL within MOST.MethodsWe analyzed serial QOL measures (Short Form-36, Specific Activity Scale, time trade-off) in 3 groups: (1) those without AF; (2) those with paroxysmal AF (PAF), but not chronic AF (CAF); and (3) those with CAF. We carried forward the last known QOL before crossover for all subsequent time points in patients randomized to rate modulated right ventricular pacing who crossed over to dual-chamber pacing for severe pacemaker syndrome.ResultsThree hundred seventeen patients (15.8%) had AF in the year after implantation, 206 patients within 3 months (191 PAF, 15 CAF), and another 159 (124 PAF, 35 CAF) between 3 and 12 months. There were no significant differences among groups in individual Short Form-36 subscales or time trade-off scores at 12 months as compared with baseline or 3 months. Cardiovascular health status was better at 12 months as compared with baseline or 3 months in those without AF.ConclusionsAtrial fibrillation after pacemaker implantation in elderly patients with sick sinus syndrome was not a major determinant of QOL. However, there was a trend toward better cardiovascular functional status in patients without AF.

Background We analyzed a prespecified hypothesis of the Occluded Artery Trial (OAT) that late percutaneous coronary intervention (PCI) of the infarct-related artery (IRA) would be most beneficial for patients with anterior myocardial infarction (MI). Methods Two thousand two hundred one stable, high-risk patients with total occlusion of the IRA (793 left anterior descending [LAD]) on days 3 to 28 (minimum of 24 hours) after MI were randomized to PCl and stenting with optimal medical therapy (1, 10 1 patients) or to optimal medical therapy alone (1, 100 patients). The primary end point was a composite of death, recurrent MI, or hospitalization for class IV heart failure. Results The 5-year cumulative primary end point rate was more frequent in the LAD group (19.5%) than in the non-LAD group (16.4%) (HR 1.34, 99% Cl 1.00-1.81, P = .01). Within the LAD group, the HR for the primary end point in the PCI group (22.7%) compared with the medical therapy group (16.4%) was 1.35 (99% Cl 0.86-2.13, P = .09), whereas in the non-LAD group the HR for the primary end point in PCI (116.9%) compared with medical therapy (15.8%) was 1.03 (99% CI 0.70-1.52, P = .83) (interaction P = .24). The results were similar when the effect of PCI was assessed in patients with proximal LAD occlusion. Conclusions In stable patients, persistent total occlusion of the LAD post MI is associated with a worse prognosis compared with occlusion of the other IRAs. A strategy of PCI of occluded LAD IRA >24 hours post MI in stable patients is not beneficial and may increase risk of adverse events in comparison to optimal medical treatment alone. (Am Heart J 2009; 157:724-32.)

BackgroundIn the Mode Selection Trial (MOST) of 2,010 patients with sinus node dysfunction, dual-chamber-paced patients had less atrial fibrillation (AF) and heart failure and had slightly improved health-related quality of life (QOL) compared with rate modulated right ventricular-paced patients. Our objective was to assess the impact of AF on QOL within MOST.MethodsWe analyzed serial QOL measures (Short Form-36, Specific Activity Scale, time trade-off) in 3 groups: (1) those without AF; (2) those with paroxysmal AF (PAF), but not chronic AF (CAF); and (3) those with CAF. We carried forward the last known QOL before crossover for all subsequent time points in patients randomized to rate modulated right ventricular pacing who crossed over to dual-chamber pacing for severe pacemaker syndrome.ResultsThree hundred seventeen patients (15.8%) had AF in the year after implantation, 206 patients within 3 months (191 PAF, 15 CAF), and another 159 (124 PAF, 35 CAF) between 3 and 12 months. There were no significant differences among groups in individual Short Form-36 subscales or time trade-off scores at 12 months as compared with baseline or 3 months. Cardiovascular health status was better at 12 months as compared with baseline or 3 months in those without AF.ConclusionsAtrial fibrillation after pacemaker implantation in elderly patients with sick sinus syndrome was not a major determinant of QOL. However, there was a trend toward better cardiovascular functional status in patients without AF.

BackgroundDual-chamber pacemakers restore AV synchrony compared with ventricular pacemakers, but the effects on health-related quality of life (QOL) are uncertain.ObjectivesThe purpose of this study was to assess the effect of pacemaker implantation, clinical factors, and pacing mode on QOL.MethodsThe Mode Selection Trial (MOST) randomized 2,010 patients with sinus node dysfunction to rate-modulated right ventricular (VVIR) or dual-chamber (DDDR) pacing. A longitudinal analysis of serial QOL measures (Short Form-36 [SF-36], Specific Activity Scale, and time trade-off utility) was performed. In patients who crossed over from VVIR to DDDR because of severe pacemaker syndrome, the last known QOL prior to crossover was carried forward.ResultsPacemaker implantation resulted in substantial improvement in almost all QOL measures. Subjects 75 years or older experienced significantly less improvement in functional status and physical component summary scores than did younger subjects. In longitudinal analyses of the effect of pacing mode on QOL, significant improvement in three SF-36 subscales was observed with DDDR pacing compared with VVIR pacing: role physical [62.8 points (95% confidence interval [CI] 60.2, 65.5) vs 56.4 (95% CI 53.7, 59.1)], role emotional [85.0 (95% CI 82.9, 87.0) vs 81.9 (95% CI 79.9, 84.0)], and vitality [51.8 (95% CI 50.3, 53.3) vs 49.3 (95% CI 47.8, 50.7)], but not in other SF-36 subscales, the Specific Activity Scale, or utilities. The gains in QOL were larger than the declines associated with 1 year of aging but smaller than those associated with heart failure.ConclusionPacemaker implantation improved health-related QOL. The mode selected was associated with much smaller, but significant, improvements in several domains, particularly role physical function.

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 reinfarcti

BackgroundDual-chamber pacemakers restore AV synchrony compared with ventricular pacemakers, but the effects on health-related quality of life (QOL) are uncertain.ObjectivesThe purpose of this study was to assess the effect of pacemaker implantation, clinical factors, and pacing mode on QOL.MethodsThe Mode Selection Trial (MOST) randomized 2,010 patients with sinus node dysfunction to rate-modulated right ventricular (VVIR) or dual-chamber (DDDR) pacing. A longitudinal analysis of serial QOL measures (Short Form-36 [SF-36], Specific Activity Scale, and time trade-off utility) was performed. In patients who crossed over from VVIR to DDDR because of severe pacemaker syndrome, the last known QOL prior to crossover was carried forward.ResultsPacemaker implantation resulted in substantial improvement in almost all QOL measures. Subjects 75 years or older experienced significantly less improvement in functional status and physical component summary scores than did younger subjects. In longitudinal analyses of the effect of pacing mode on QOL, significant improvement in three SF-36 subscales was observed with DDDR pacing compared with VVIR pacing: role physical [62.8 points (95% confidence interval [CI] 60.2, 65.5) vs 56.4 (95% CI 53.7, 59.1)], role emotional [85.0 (95% CI 82.9, 87.0) vs 81.9 (95% CI 79.9, 84.0)], and vitality [51.8 (95% CI 50.3, 53.3) vs 49.3 (95% CI 47.8, 50.7)], but not in other SF-36 subscales, the Specific Activity Scale, or utilities. The gains in QOL were larger than the declines associated with 1 year of aging but smaller than those associated with heart failure.ConclusionPacemaker implantation improved health-related QOL. The mode selected was associated with much smaller, but significant, improvements in several domains, particularly role physical function.

Octogenarians are the fastest growing segment of the population and little is known about the results of cardiopulmonary resuscitation (CPR) after in-hospital cardiac arrest in this population.We sought to investigate the clinical benefit and cost-effectiveness of CPR after in-hospital cardiac arrest in octogenarians.Years of life saved.Effectiveness data were obtained from a review of 91,372 hospital discharges from January 1st, 1993 until June 30th, 1996. Cardiac arrest was reported in 956 patients. The study group consisted of 474 patients > or = 80 years old. CPR costs included equipment and training, physician and nursing time and medications. Post-CPR expenses included in-hospital true cost, repeat hospitalizations, physician office visits, nursing home, rehabilitation, and chronic care hospital costs. Life expectancy of the patients who were still alive at the end of the study was estimated from census data. A utility of 0.8 was used to calculate quality-adjusted-life years saved (QALYS). We used a societal perspective for analysis.The study population was 86 +/- 4.8 years old (range 80-103), and 42% were male. Fifty-four patients (11%) were discharged alive, 35 to a chronic care facility and 19 to their home. Assuming that a cardiac arrest without CPR has 100% mortality, 12 octogenarians required treatment with CPR in order to save one life to hospital discharge. Similarly, 29 octogenarian patients with cardiac arrest have to be treated with CPR to net one long-term survivor (mean survival 21 months, with a range from 9 to 48 months). The cost-effectiveness ratio, after estimating the life expectancy of octogenarian survivors, was USD 50,412 per year of life saved, and USD 63,015 per QALYS. However, a utility of 0.5 yielded a cost of USD 100,825 per QALYS.In comparison with other life-saving strategies, CPR in octogenarians is effective. The favorable cost-effectiveness ratio is highly dependent on the patients' preference for quality rather than quantity

BackgroundHealth value or utility is the abstracted magnitude of a person's preference for quality and quantity of life. It reflects how much lifetime with the patient's current health condition a patient is willing to exchange for a life in excellent health. Health values are used in cost-effectiveness analysis as a means of calculating quality-adjusted years of life.ObjectiveThis study assessed the health values of elderly patients before and after pacemaker implantation.MethodsWe prospectively examined 398 patients from the Pacemaker Selection in the Elderly study, in which patients were randomized to either VVIR or DDDR mode. Health values were estimated with the time tradeoff method before implantation and at 3, 9, and 18 months after implantation.ResultsThe mean age of patients was 76 +/- 6 years; 234 patients (59%) were male. At baseline, patients were, on average, willing to exchange 5 years of current health for approximately 4 years in perfect health (value 0.76 +/- 0.06). There was no difference in baseline health values with implant diagnosis (sinus node dysfunction n = 172, 0.72, atrioventricular block n = 227, 0.75, other diagnoses n = 39, 0.78, P = not significant). The overall improvement in health values at 3 months after pacemaker implantation was 0.165 +/- 0.4 (P =.0001). The improvement in health values was independent of pacing mode (P =.6). The time tradeoff score was modestly correlated with other measurements of health-related quality of life. The change in time tradeoff score with time was not influenced by demographic characteristics such as age and sex, diagnoses, pacing mode, employment status, or history of angina. Patients with a lower functional class at enrollment (III or IV on the Specific Activity Scale) demonstrated an absolute improvement of 23% in their health values, whereas patients in class I or II improved only by 12%, (P =.03).ConclusionsPermanent pacemaker implantation for standard indications improves health values and des

BackgroundHealth value or utility is the abstracted magnitude of a person's preference for quality and quantity of life. It reflects how much lifetime with the patient's current health condition a patient is willing to exchange for a life in excellent health. Health values are used in cost-effectiveness analysis as a means of calculating quality-adjusted years of life.ObjectiveThis study assessed the health values of elderly patients before and after pacemaker implantation.MethodsWe prospectively examined 398 patients from the Pacemaker Selection in the Elderly study, in which patients were randomized to either VVIR or DDDR mode. Health values were estimated with the time tradeoff method before implantation and at 3, 9, and 18 months after implantation.ResultsThe mean age of patients was 76 +/- 6 years; 234 patients (59%) were male. At baseline, patients were, on average, willing to exchange 5 years of current health for approximately 4 years in perfect health (value 0.76 +/- 0.06). There was no difference in baseline health values with implant diagnosis (sinus node dysfunction n = 172, 0.72, atrioventricular block n = 227, 0.75, other diagnoses n = 39, 0.78, P = not significant). The overall improvement in health values at 3 months after pacemaker implantation was 0.165 +/- 0.4 (P =.0001). The improvement in health values was independent of pacing mode (P =.6). The time tradeoff score was modestly correlated with other measurements of health-related quality of life. The change in time tradeoff score with time was not influenced by demographic characteristics such as age and sex, diagnoses, pacing mode, employment status, or history of angina. Patients with a lower functional class at enrollment (III or IV on the Specific Activity Scale) demonstrated an absolute improvement of 23% in their health values, whereas patients in class I or II improved only by 12%, (P =.03).ConclusionsPermanent pacemaker implantation for standard indications improves health values and des

Octogenarians are the fastest growing segment of the population and little is known about the results of cardiopulmonary resuscitation (CPR) after in-hospital cardiac arrest in this population.We sought to investigate the clinical benefit and cost-effectiveness of CPR after in-hospital cardiac arrest in octogenarians.Years of life saved.Effectiveness data were obtained from a review of 91,372 hospital discharges from January 1st, 1993 until June 30th, 1996. Cardiac arrest was reported in 956 patients. The study group consisted of 474 patients > or = 80 years old. CPR costs included equipment and training, physician and nursing time and medications. Post-CPR expenses included in-hospital true cost, repeat hospitalizations, physician office visits, nursing home, rehabilitation, and chronic care hospital costs. Life expectancy of the patients who were still alive at the end of the study was estimated from census data. A utility of 0.8 was used to calculate quality-adjusted-life years saved (QALYS). We used a societal perspective for analysis.The study population was 86 +/- 4.8 years old (range 80-103), and 42% were male. Fifty-four patients (11%) were discharged alive, 35 to a chronic care facility and 19 to their home. Assuming that a cardiac arrest without CPR has 100% mortality, 12 octogenarians required treatment with CPR in order to save one life to hospital discharge. Similarly, 29 octogenarian patients with cardiac arrest have to be treated with CPR to net one long-term survivor (mean survival 21 months, with a range from 9 to 48 months). The cost-effectiveness ratio, after estimating the life expectancy of octogenarian survivors, was USD 50,412 per year of life saved, and USD 63,015 per QALYS. However, a utility of 0.5 yielded a cost of USD 100,825 per QALYS.In comparison with other life-saving strategies, CPR in octogenarians is effective. The favorable cost-effectiveness ratio is highly dependent on the patients' preference for quality rather than quantity