American Heart Journal

A case where the principle of “one question, one answer” may work better

Tomohisa Tada, Robert A. Byrne, Adnan Kastrati — 2012-02-01

In the last decade, investigations on the use of drug-eluting stents (DES) for the treatment of coronary artery disease have generated 2 types of reaction: immense enthusiasm promoted by the ability of DES to substantially reduce the risk of restenosis compared with bare-metal stents (BMS) and a lot of caution caused by concern regarding an increased risk for late stent thrombosis with DES. The investigators of The BAsel Stent Kosten Effektivitäts Trial PROspective Validation Examination part II (BASKET-PROVE II) trial, the design of which is published in this issue of the journal, are to be commended for their significant contribution to both of these reactions. In the BASKET-LATE study, they reported an excess risk of thrombotic events after discontinuation of clopidogrel in the DES group as compared with the BMS, although overall, the 18-month incidence of these events was not significantly different between the 2 groups. The study was relatively small for the evaluation of rare adverse events (only 746 patients), yet it was instrumental in triggering a wave of critical reevaluation of the role of DES in contemporary clinical practice. In the more recent BASKET-PROVE trial, in which a larger cohort (2314 patients) with lesions in large coronary vessels (≥3 mm in size) was enrolled and a longer follow-up (24 months) was applied, the investigators were able to reassure concerned cardiologists regarding the risk of late ischemic events with DES: neither first-generation sirolimus-eluting stents (SES) nor second-generation everolimus-eluting stents (EES) increased the rates of death or myocardial infarction compared with BMS. Moreover, the rate of clinical restenosis was reduced by DES compared with BMS. This provided additional support to the enthusiasm surrounding the efficacy of DES because large vessels are known for their ability to blunt the advantages of DES over BMS in terms of restenosis.

Newest-generation drug-eluting and bare-metal stents combined with prasugrel-based antiplatelet therapy in large coronary arteries: The BAsel Stent Kosten Effektivitäts Trial PROspective Validation Examination part II (BASKET-PROVE II) trial design

2012-02-01

Background: In the BAsel Stent Kosten Effektivitäts Trial PROspective Validation Examination (BASKET-PROVE), drug-eluting stents (DESs) had similar 2-year rates of death and myocardial infarction but lower rates of target vessel revascularization and major adverse cardiac events compared with bare-metal stents (BMSs). However, comparative clinical effects of newest-generation DES with biodegradable polymers vs second-generation DES or newest-generation BMS with biocompatible coatings, all combined with a prasugrel-based antiplatelet therapy, on 2-year outcomes are not known.Methods: In BASKET-PROVE II, 2,400 patients with de novo lesions in native vessels ≥3 mm in diameter are randomized 1:1:1 to receive a conventional DES, a DES with a biodegradable polymer, or a BMS with biocompatible coating. In addition to aspirin, stable patients with BMS will receive prasugrel for 1 month, whereas all others will receive prasugrel for 12 months. The primary end point will be combined cardiac death, nonfatal myocardial infarction, and target vessel revascularization up to 2 years. Secondary end points include stent thrombosis and major bleeding. The primary aim is to test (1) the noninferiority of a biodegradable-polymer DES to a conventional DES and (2) the superiority of both DESs to BMS. A secondary aim is to compare the outcomes with those of BASKET-PROVE regarding the effects of prasugrel-based vs clopidogrel-based antiplatelet therapy.Results: By the end of 2010, 878 patients (37% of those planned) were enrolled.Conclusions: This study will test the comparative long-term safety and efficacy of newest-generation stents on the background of contemporary antiplatelet therapy in a large all-comer population undergoing large native coronary artery stenting.

Rationale and design of the TAXUS Libertē Post-Approval Study: Examination of patients receiving the TAXUS Liberté stent with concomitant prasugrel therapy in routine interventional cardiology practice

2012-02-01

Background: Observational studies of new coronary stents are necessary to assess performance in a variety of complex patient and lesion types. Furthermore, the optimal dose and duration of thienopyridine treatment is unclear, particularly in patients with complex clinical conditions. The TAXUS Libertē Post-Approval Study is designed to provide 5-year data on the TAXUS Liberté paclitaxel-eluting stent with concomitant prasugrel therapy in routine clinical practice and to contribute data to the DAPT study.Study Design: The TAXUS Libertē Post-Approval Study is a prospective, multicenter, observational study. Enrollment of approximately 4,200 patients receiving ≥1 TAXUS Liberté stents is planned. All patients without a contraindication will be prescribed prasugrel plus aspirin for 1 year. The 12-month primary end point of cardiac death or myocardial infarction in on-label stent patients will be compared with historical TAXUS Express stent data from the TAXUS ATLAS and TAXUS ARRIVE studies. Secondary clinical end points include stent thrombosis, all-cause death, stroke, revascularization, and bleeding in all patients. In addition, this study will be the first to evaluate prasugrel use in a routine practice setting (including 5 and 10 mg daily doses) and will contribute data to the DAPT Study, comparing 12 versus 30 months of dual antiplatelet therapy after drug-eluting stent placement.Summary: The TAXUS Libertē Post-Approval Study will be the first to provide long-term real-world data on use of the TAXUS Liberté Stent with prasugrel treatment. The study is currently enrolling, and primary end point data are expected in mid 2013.

Design of the RELAXin in Acute Heart Failure Study

2012-02-01

Background: Acute heart failure (AHF) remains a major public health burden with a high prevalence and poor prognosis. Relaxin is a naturally occurring peptide hormone that increases cardiac output, arterial compliance, and renal blood flow during pregnancy. The RELAX-AHF-1 study will evaluate the effect of RLX030 (recombinant form of human relaxin 2) on symptom relief and clinical outcomes in patients with AHF.Methods: The protocol includes a completed phase 2 234-patient dose-finding study (Pre-RELAX-AHF) and an ongoing phase 3 1,160-patient trial (RELAX-AHF-1). Patients with AHF and systolic blood pressure >125 mm Hg are randomized within 16 hours of presentation to a 48-hour IV infusion of RLX030 or placebo. The 30 μg/kg per day dose of RLX030 was chosen for RELAX-AHF-1 based on effects on dyspnea, clinical outcomes, and safety observed in Pre-RELAX-AHF. Primary efficacy end points in RELAX-AHF-1 are (1) the area under the curve of change of the dyspnea Visual Analog Scale from baseline through day 5 and (2) whether the patient reports moderately to markedly better dyspnea at 6, 12, and 24 hours. Secondary efficacy end points include days alive and out of the hospital through day 60 and cardiovascular death or rehospitalization for heart failure or renal failure through day 60. Patients will be followed up through day 180 for mortality. As of September 19, 2011, 978 patients have been enrolled.Conclusions: Pre-RELAX-AHF results suggested that infusion of RLX030 may accelerate dyspnea relief and improve prognosis in patients hospitalized with AHF. RELAX-AHF-1 will further evaluate these effects.

Management of cardiac toxicity in patients receiving vascular endothelial growth factor signaling pathway inhibitors

2012-02-01

Background: Interfering with angiogenesis is an effective, widely used approach to cancer therapy, but antiangiogenic therapies have been associated with important systemic cardiovascular toxicities such as hypertension, left ventricular dysfunction, heart failure, and myocardial ischemia and infarction. As the use of vascular endothelial growth factor signaling pathway (VSP) inhibitors broadens to include older patients and those with existing cardiovascular disease, the adverse effects are likely to be more frequent, and cardiologists will increasingly be enlisted to help oncologists manage patients who develop adverse cardiovascular effects.Methods: The Cardiovascular Toxicities Panel of the National Cancer Institute reviewed the published literature and abstracts from major meetings, shared experience gained during clinical development of VSP inhibitors, and contributed extensive clinical experience in evaluating and treating patients with cancer with cardiovascular disease. This report was edited and approved by the National Cancer Institute Investigational Drug Steering Committee. It presents the panel's expert opinion on the current clinical use and future investigation for safer, more expansive use of these drugs.Results and Conclusions: The panel recommends that physicians (1) conduct and document a formal risk assessment for existing cardiovascular disease and potential cardiovascular complications before VSP inhibitor treatment recognizing that preexisting hypertension and cardiovascular disease are common in patients with cancer, (2) actively monitor for blood pressure elevations and cardiac toxicity with more frequent assessments during the first treatment cycle, and (3) aggressively manage blood pressure elevations and early symptoms and signs of cardiac toxicity to prevent clinically limiting complications of VSP inhibitor therapy.

Detection of periodontal bacteria in thrombi of patients with acute myocardial infarction by polymerase chain reaction

2012-02-01

Backgrounds: Numerous reports have demonstrated that periodontal bacteria are present in plaques from atherosclerotic arteries. Although periodontitis has recently been recognized as a risk factor for coronary artery disease, the direct relationship between periodontal bacteria and coronary artery disease has not yet been clarified. It has been suggested that these bacteria might contribute to inflammation and plaque instability. We assumed that if periodontal bacteria induce inflammation of plaque, the bacteria would be released into the bloodstream when vulnerable plaque ruptures. To determine whether periodontal bacteria are present in thrombi at the site of acute myocardial infarction, we tried to detect periodontal bacteria in thrombi of patients with acute myocardial infarction by polymerase chain reaction (PCR).Methods: We studied 81 consecutive adults with ST-segment elevation acute myocardial infarction who underwent primary percutaneous coronary intervention (PCI). All patients underwent removal of thrombus with aspiration catheters at the beginning of percutaneous coronary intervention, and a small sample of thrombus was obtained for PCR.Results: The detection rates of periodontal bacteria by PCR were 19.7% for Aggregatibacter actinomycetemcomitans, 3.4% for Porphyromonas gingivalis, and 2.3% for Treponema denticola.Conclusions: Three species of periodontal bacteria were detected in the thrombi of patients with acute myocardial infarction. This raises the possibility that such bacteria are latently present in plaque and also suggests that these bacteria might have a role in plaque inflammation and instability.

High-concentration versus titrated oxygen therapy in ST-elevation myocardial infarction: A pilot randomized controlled trial

2012-01-16

Background: The optimal approach to oxygen therapy in ST-elevation myocardial infarction (STEMI) is uncertain.Methods: A randomized controlled trial was undertaken in which 136 patients presenting with their first STEMI uncomplicated by cardiogenic shock or marked hypoxia were randomized to receive high-concentration (6 L/min via medium concentration mask) or titrated oxygen (to achieve oxygen saturation 93%-96%) for 6 hours after presentation. The main outcome variables were 30-day mortality and infarct size assessed by troponin T level at 72 hours. Secondary outcomes included a meta-analysis of mortality data from this study and previous randomized controlled trials, and infarct size was assessed by magnetic resonance imaging at 4 to 6 weeks.Results: There were 1 of 68 and 2 of 68 deaths in the high-concentration and titrated oxygen groups, respectively; a meta-analysis including these data with those from the 2 previous studies showed an odds ratio for mortality of high-concentration oxygen compared with room air or titrated oxygen of 2.2 (95% CI 0.8-6.0). There was no significant difference between high-concentration versus titrated oxygen in troponin T (ratio of mean levels 0.74, 95% CI 0.50-1.1, P = .14), infarct mass (mean difference −0.8 g, 95% CI −7.6 to 6.1, P = .82), or percent infarct mass (mean difference −0.6%, 95% CI −5.6 to 4.5, P = .83).Conclusion: This study found no evidence of benefit or harm from high-concentration compared with titrated oxygen in initially uncomplicated STEMI. However, our estimates have wide CIs, and as a result, large randomized controlled trials are required to resolve the clinical uncertainty.

Efficacy and safety of enoxaparin compared with unfractionated heparin in the pharmacoinvasive management of acute ST-segment elevation myocardial infarction: Insights from the TRANSFER-AMI trial

2012-02-01

Aims: An early invasive strategy after fibrinolysis for ST-elevation myocardial infarction (STEMI) improves outcomes, but the relative efficacy and safety of enoxaparin compared with unfractionated heparin (UFH) as part of this approach are unknown.Methods and Results: In the TRANSFER-AMI trial, patients with high-risk STEMI received fibrinolysis and were then randomized to either standard treatment or to immediate transfer for coronary angiography. In this substudy, the outcome of patients aged <75 years treated with enoxaparin is compared with that of patients who received UFH. Logistic regression and propensity score models were used to evaluate the efficacy and safety of these anticoagulants. Enoxaparin was administered to 498 patients, and UFH, to 448 patients, at the time of fibrinolysis. Approximately 50% in each group were randomized to the early invasive strategy. The primary composite end point of death, reinfarction, recurrent ischemia, new or worsening heart failure, or cardiogenic shock at 30 days occurred in 11.9% and 11.6% of the patients who received enoxaparin and UFH, respectively (adjusted odds ratio 0.95 [95% CI 0.60-1.51], P = .84). Enoxaparin use was associated with more access site bleeding (5.0% vs 2.9%, P = .04) and mild bleeding (12.1% vs 7.8%, P = .03).Conclusions: Among high-risk patients with STEMI undergoing early or late transfer for cardiac catheterization after fibrinolysis, enoxaparin was associated with similar efficacy compared with UFH, but there was more minor bleeding with enoxaparin (ClinicalTrials.gov no. NCT00164190).

Reduced immediate ischemic events with cangrelor in PCI: A pooled analysis of the CHAMPION trials using the universal definition of myocardial infarction

2012-02-01

Background: There is a clinical need for an intravenous P2Y12 inhibitor in patients with acute coronary syndromes (ACS) for patients who are unable to take oral medications or might benefit from a rapidly reversible compound. As the time from admission to percutaneous coronary intervention (PCI) shortens, establishing the benefit of novel therapies impacting ischemic events is increasingly challenging. Cangrelor, an intravenous potent rapidly acting P2Y12 inhibitor, bolus 30 μg/Kg plus infusion of 4 μg/Kg/min, was compared to a 600-mg loading dose of clopidogrel either before or early after PCI in patients with ACS undergoing PCI in The CHAMPION (Cangrelor versus standard tHerapy to Achieve optimal Management of Platelet InhibitiON) PLATFORM and PCI studies.Methods: As both CHAMPION studies used similar inclusion/exclusion criteria and death, myocardial infarction, or ischemia-driven revascularization (including stent thrombosis) at 48 hours as their primary end points, the studies were pooled. The clinical events committee adjudicated myocardial infarction. The universal definition was used to define myocardial infarction.Results: A total of 13 049 patients were included. Cangrelor had no effect on the primary end point with the original MI definition (P = .646). With the use of the universal definition, the primary end point was decreased with cangrelor (odds ratio 0.82, 95% confidence interval 0.68-0.99, P = .037). Stent thrombosis was reduced from 0.4% to 0.2% (odds ratio 0.44, 95% confidence interval 0.22-0.87, P = .018). Thrombolysis in Myocardial Infarction major bleeding and transfusions were not increased with cangrelor.Conclusion: With the use of the universal definition of myocardial infarction, cangrelor was associated with a significant reduction in early ischemic events when compared with clopidogrel in patients with non–ST-elevation ACS undergoing PCI.

Statin treatment for coronary artery plaque composition based on intravascular ultrasound radiofrequency data analysis

2012-02-01

Background: Systemic therapy with statin has been shown to lower the risk of coronary events; however, the in vivo effects of statin therapy on plaque volume and composition are less understood.Methods: We conducted a prospective, open-labeled, randomized, multicenter study in 11 centers in Japan. A total of 164 patients were randomized to receive either 4 mg/d of pitavastatin (intensive lipid-lowering therapy) or 20 mg/d of pravastatin (moderate lipid-lowering therapy). Analyzable intravascular ultrasound data were obtained for 119 patients at baseline and at 8-month follow-up. The primary end point was the difference of volume changes in each of the 4 main plaque components (fibrosis, fibrofatty, calcium, and necrosis), assessed by virtual histology intravascular ultrasound, between the 2 groups.Results: The mean low-density lipoprotein cholesterol level at follow-up was significantly lower in the pitavastatin than in the pravastatin group (74 vs 95 mg/dL, P < .0001). During the 8-month follow-up period, statin therapy reduced the absolute and relative amount of fibrofatty component (pitavastatin: from 1.09 to 0.81 mm3/mm, P = .001; pravastatin: from 1.05 to 0.83 mm3/mm, P = .0008) and increased in the amount of calcium (pitavastatin: from 0.42 to 0.55 mm3/mm, P < .0001; pravastatin: from 0.44 to 0.55 mm3/mm, P = .005), whereas volume changes in both plaque components were not statistically different between the 2 groups.Conclusions: Both pitavastatin and pravastatin altered coronary artery plaque composition by significantly decreasing the fibrofatty plaque component and increasing the calcified plaque component.

Single high-dose erythropoietin administration immediately after reperfusion in patients with ST-segment elevation myocardial infarction: results of the Erythropoietin in Myocardial Infarction Trial

2012-02-01

Background: Preclinical studies and pilot clinical trials have shown that high-dose erythropoietin (EPO) reduces infarct size in acute myocardial infarction. We investigated whether a single high-dose of EPO administered immediately after reperfusion in patients with ST-segment elevation myocardial infarction (STEMI) would limit infarct size.Methods: A total of 110 patients undergoing successful primary coronary intervention for a first STEMI was randomized to receive standard care either alone (n = 57) or combined with intravenous administration of 1,000 U/kg of epoetin β immediately after reperfusion (n = 53). The primary end point was infarct size assessed by gadolinium-enhanced cardiac magnetic resonance after 3 months. Secondary end points included left ventricular (LV) volume and function at 5-day and 3-month follow-up, incidence of microvascular obstruction (MVO), and safety.Results: Erythropoietin significantly decreased the incidence of MVO (43.4% vs 65.3% in the control group, P = .03) and reduced LV volume, mass, and function impairment at 5-day follow-up (all P < .05). After 3 months, median infarct size (interquartile range) was 17.5 g (7.6-26.1 g) in the EPO group and 16.0 g (9.4-28.2 g) in the control group (P = .64); LV mass, volume, and function were not significantly different between the 2 groups. The same number of major adverse cardiac events occurred in both groups.Conclusions: Single high-dose EPO administered immediately after successful reperfusion in patients with STEMI did not reduce infarct size at 3-month follow-up. However, this regimen decreased the incidence of MVO and was associated with transient favorable effects on LV volume and function.

Circadian variations of ischemic burden among patients with myocardial infarction undergoing primary percutaneous coronary intervention

2012-02-01

Background: Several parameters of cardiovascular physiology and pathophysiology exhibit circadian rhythms. Recently, a relation between infarct size and the time of day at which it occurs has been suggested in experimental models of myocardial infarction. The aim of this study is to investigate whether circadian rhythms could cause differences in ischemic burden in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).Methods: In 353 consecutive patients with STEMI treated by PPCI, time of symptom onset, peak creatine kinase (CK), and follow-up at 30 days were obtained. We divided 24 hours into 4 time groups based on time of symptom onset (00:00-05:59, 06:00-11:59, 12:00-17:59, and 18:00-23:59).Results: There was no difference between the groups regarding baseline patients and management's characteristics. At multivariable analysis, there was a statistically significant difference between peak CK levels among patients with symptom onset between 00:00 and 05:59 when compared with peak CK levels of patients with symptom onset in any other time group (mean increase 38.4%, P < .05). Thirty-day mortality for STEMI patients with symptom onset occurring between 00:00 and 05:59 was significantly higher than any other time group (P < .05).Conclusion: This study demonstrates an independent correlation between the infarct size of STEMI patients treated by PPCI and the time of the day at which symptoms occurred. These results suggest that time of the day should be a critical issue to look at when assessing prognosis of patients with myocardial infarction.

Indications for percutaneous coronary interventions performed in US hospitals: a report from the NCDR®

2012-02-01

Background: There are many factors hypothesized as contributing to overuse of percutaneous coronary intervention (PCI) in the United States, including financial ties between physicians and hospitals, but empirical data are lacking. We examined PCI indications in not-for-profit (NFP), major teaching, for-profit (FP), and physician-owned specialty hospitals.Methods: A retrospective cohort study of 1,113,554 patients who underwent PCI in 694 hospitals (NFP 471, teaching 131, FP 79, specialty 13) participating in the CathPCI Registry® between January 1, 2004, and December 31, 2007. Percutaneous coronary intervention indications derived from American College of Cardiology Guidelines were classified as survival benefit (patients with primary reperfusion for ST-elevation myocardial infarction), potential quality of life benefit (patients with non–ST-elevation myocardial infarction, acute coronary syndrome (ACS), positive stress test, or chest pain), or unclear indications (patients receiving PCI without an obvious potential survival or quality of life benefit).Results: The percentage of PCI performed for unclear indications was somewhat higher for specialty hospitals (5.1% of all procedures) as compared with other hospital categories (FP 4.7%, NFP 4.2%, major teaching 4.5%; P < .001). Overall, 17% of hospitals had ≥20% of their total PCI procedures performed for unclear indications, but the proportion of FP, NFP, major teaching, and specialty hospitals reaching this threshold was not statistically different (20%, 16%, 17%, and 15%, respectively; P = .84).Conclusions: A small proportion of PCI procedures were performed in patients with unclear indications, but there was wide variation across hospitals. On average, specialty hospitals performed more PCIs for unclear indications. Efforts to reduce variability should be pursued.

Percutaneous coronary intervention outcomes in US hospitals with varying structural characteristics: Analysis of the NCDR®

2012-02-01

Background: In the United States, there continues to be debate about whether certain types of hospitals deliver improved patient outcomes. We sought to assess the association between hospital organizational characteristics and in-hospital outcomes for percutaneous coronary intervention (PCI).Methods: Retrospective analysis of 2004 to 2007 data for 694 US hospitals participating in the CathPCI Registry®. Our analysis focused on 1,113,554 patients who underwent PCI in 471 not-for-profit (NFP) hospitals, 131 major teaching hospitals, 79 for-profit (FP) hospitals, and 13 physician-owned specialty hospitals. Outcomes included in-hospital mortality, stroke, bleeding, vascular injury, and a composite representing one or more of the individual complications. We used the current CathPCI Registry mortality risk model to calculate risk-standardized mortality ratios (RSMRs) for each category of hospital and compared hospital groupings for all patients in aggregate and in subgroups stratified by patients' indications for PCI.Results: Patients treated in major teaching hospitals were younger, whereas FP hospitals performed a greater proportion of PCI for patients with ST-elevation myocardial infarction (P < .0001). Specialty hospitals treated patients with less acuity, including a lower proportion of patients with ST-elevation myocardial infarction. In unadjusted analyses, specialty hospitals had significantly lower rates of all adverse outcomes compared with NFP, teaching, and FP hospitals including in-hospital mortality (0.7%, 1.2%, 1.4%, and 1.4%, respectively; P < .001) and the composite end point (2.4%, 4.1%, 4.6%, and 4.3%, respectively; P < .001). In adjusted analyses, RSMR was significantly lower for specialty hospitals when compared with the other 3 groups for all patients in aggregate (RSMR 1.05%, 1.30%, 1.38%, 1.39%; P < .001); these differences remained clinically significant but were no longer statistically significant in subgroup analyses.Conclusions: Specialty hospitals appear to have lower rates of most adverse outcomes for PCI. Specialty hospitals may have developed expertise in narrow procedural areas that could be adapted to the larger population of general hospitals.

Vascular complications and access crossover in 10,676 transradial percutaneous coronary procedures

2012-01-16

Background: Randomized trials have shown that transradial approach, compared with transfemoral, reduces vascular complications (VCs) of coronary procedures in selected patients. Yet, radial approach is associated to a variety of access-site VC as well as to a higher failure rate compared with femoral access.Methods: At our institution, from May 2005 to May 2010, we prospectively assessed the occurrence and outcome of VC in consecutive patients undergoing transradial percutaneous coronary procedures performed by trained radial operators. The need of access crossover to complete the procedure was also prospectively investigated. Vascular complications were classified as “radial related” or “nonradial related” (in the case of access crossover). Vascular complications were also classified “major” if requiring surgery and/or blood transfusions or causing hemoglobin drop >3 g/dL.Results: Ten thousand six hundred seventy-six procedures were performed using a right radial (87.5%), left radial (12.4%), or ulnar (0.1%) artery as primary access. A total of 53 VCs (0.5%) were observed: 44 (83%) radial related and 9 (17%) nonradial related. Major VCs occurred in 16 patients only (0.2%) and were radial related in 10 (62.5%) and nonradial related in 6 (37.5%) patients. Vascular complications rate was stable during the study and independent of operator's experience. Access crossover rate was 4.9%, differed according to the operator radial experience and significantly decreased over time.Conclusions: The present study, conducted in a center with high volume of radial procedures, shows that transradial approach is associated with a very low rate of VC, which is stable over time. On the contrary, access crossover rate decreased over time and differed according to operator (radial) experience.

Patient and hospital characteristics associated with traditional measures of inpatient quality of care for patients with heart failure

2012-02-01

Background: The purpose of this study was to determine patient and hospital characteristics associated with 4 measures of quality of inpatient heart failure care used by both the primary payer of heart failure care in the United States (Center for Medicare and Medicaid Services) and the main hospital accrediting organization (The Joint Commission).Methods: We used data from Get With The Guidelines Program for patients hospitalized with heart failure. Eligibility for receiving care based on the Center for Medicare and Medicaid Services performance measures was determined for assessment of left ventricular ejection fraction (LVEF; n = 60,601), use of angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) if LVEF<40% and no contraindications (24,130), discharge instructions (49,383), and smoking cessation counseling (10,152). Patient and hospital characteristics that were significantly associated with performance measures in univariate analyses were entered into multivariate logistic regression models.Results: Overall, documentation for LVEF assessment was noted in 95%, ACEi/ARB use in 87%, discharge instruction in 82%, and smoking cessation counseling in 91% of eligible patients. In adjusted analyses, older patients and those with evidence of renal failure were significantly less likely to receive each care measure except for discharge instructions (no age effect). Patients with higher body mass index were more likely to receive ACEi/ARB and discharge instructions but less likely to have LVEF documented or to receive smoking cessation counseling. Small hospitals (<200 beds) were less likely to provide each of the performance measures compared with larger hospitals.Conclusion: Recommended heart failure care is less likely in patients with certain characteristics (older age and abnormal renal function) and those cared for in smaller hospitals. Programs to improve evidence-based care for heart failure should consider interventions specifically targeting and tailored to smaller facilities and patients who are older with comorbidities.

Perceived sexual difficulties and associated factors in patients with heart failure

2012-02-01

Background: Sexual dysfunction is a common problem of increasing incidence in patients with heart failure (HF). However, there is no knowledge on which demographic, clinical, and quality of life (QoL) aspects are related to difficulties in sexual activity nor on the course of sexual difficulties in patients with HF.Methods: Data on sexual difficulties were collected at 1 and 18 months after an HF hospitalization (n = 792, mean age 69 ± 12 years, 35% female, mean left ventricular ejection fraction 33% ± 14%) by the question on sexuality of the Minnesota living with HF questionnaire. Demographic and clinical factors were assessed from medical records and QoL by Minnesota living with HF questionnaire, Medical Outcome Study 36-item General Health Survey, and Ladder of Life.Results: In total, 48% (n = 380) of the patients perceive difficulties in sexual activity at 1 month after discharge, and 70% continued to perceive this at 18 months. Furthermore, 27% of the patients without difficulties at 1 month developed them during follow-up. Living with a partner (OR 3.76, 95% CI 2.58-5.48), younger age (OR 0.96, 95% CI 0.94-0.97)), male gender (OR 3.08, 95% CI 2.10-4.43), overall well-being (OR 1.13, 95% CI 1.00-1.27), and physical (OR 1.06, 95% CI 1.06-1.08) and emotional (OR 1.07, 95% CI 1.03-1.10) QoL were independently associated with perceived difficulties in sexual activity.Conclusions: Perceived difficulties in sexual activity are common in patients with HF, particularly in younger and male patients and continue over time. Patients who perceive difficulties in sexual activity report a significant lower QoL and overall well-being than those who do not.

Comparison of processes of care and clinical outcomes for patients newly hospitalized for heart failure attended by different physician specialists

Nicole K. Boom, Douglas S. Lee, Jack V. Tu — 2012-02-01

Background: Previous studies suggest that patients with heart failure (HF) treated by cardiologists have improved outcomes compared with patients treated by other physicians. It remains unclear whether these findings reflect differences in patient characteristics, processes of care, practice setting, or a combination of these factors.Methods: We examined physician specialty-related differences in processes of care and clinical outcomes for 7,634 patients newly hospitalized for HF in Ontario, Canada, who were included in the EFFECT study between April 2004 and March 2005. Patients were categorized according to whether they received cardiologist, generalist (e.g., internist or family doctor), or generalist care with cardiology consultation.Results: Multivariable hierarchical modeling demonstrated that patients treated by generalists alone had higher risk of 30-day (odds ratio [OR] 1.50, 95% CI 1.18-1.91) and 1-year mortality (OR 1.29, 95% CI 1.10-1.50), as well as the 1-year composite outcome of death and readmission, compared with patients treated by cardiologists. These differences were significantly attenuated if patients who had “do not resuscitate” orders were excluded. Patients who had a cardiologist involved in their care were more likely to undergo diagnostic procedures, such as echocardiography, and had higher rates of certain evidence-based pharmacologic therapy such as β-blockers.Conclusion: Physician specialty-related differences in HF outcomes appear to reflect a combination of both case-mix differences and differences in the use of certain heart failure processes of care. These findings suggest that it may be possible to improve HF outcomes in patients receiving care from generalist physicians.

Effect of QRS morphology on clinical event reduction with cardiac resynchronization therapy: Meta-analysis of randomized controlled trials

2012-02-01

Background: Cardiac resynchronization therapy (CRT) is effective in reducing clinical events in systolic heart failure patients with a wide QRS. Previous retrospective studies suggest only patients with QRS prolongation due to a left bundle-branch block (LBBB) benefit from CRT. Our objective was to examine this by performing a meta-analysis of all randomized controlled trials of CRT.Methods: Systematic searches of MEDLINE and the Food and Drug Administration official website were conducted for randomized controlled CRT trials. Trials reporting adverse clinical events (eg, all-cause mortality, heart failure hospitalizations) according to QRS morphology were included in the meta-analysis.Results: Four randomized trials totaling 5,356 patients met the inclusion criteria. In patients with LBBB at baseline, there was a highly significant reduction in composite adverse clinical events with CRT (RR = 0.64 [95% CI (0.52-0.77)], P = .00001). However no such benefit was observed for patients with non-LBBB conduction abnormalities (RR = 0.97 [95% CI (0.82-1.15)], P = .75). When examined separately, there was no benefit in patients with right-bundle branch block (RR = 0.91 [95% CI (0.69-1.20)], P = .49) or non-specific intraventricular conduction delay (RR = 1.19 [95% CI (0.87-1.63)], P = .28). There was no heterogeneity among the clinical trials with regards to the lack of benefit in non-LBBB patients (I2 = 0%). When directly compared, the difference in effect of CRT between LBBB versus non-LBBB patients was highly statistically significant (P = .0001 by heterogeneity analysis).Conclusions: While CRT was very effective in reducing clinical events in patients with LBBB, it did not reduce such events in patients with wide QRS due to other conduction abnormalities.

Frequency and impact of lifestyle modification in patients with coronary artery disease: The Japanese Coronary Artery Disease (JCAD) Study

Takeki Suzuki, Takahide Kohro, Doubun Hayashi, Tsutomu Yamazaki, Ryozo Nagai — 2012-02-01

Background: Lifestyle modifications such as exercise and diet interventions in patients with coronary artery disease (CAD) are widely regarded as important, but little is known about their frequency in clinical practice and their impact on all-cause mortality.Methods: The JCAD study is a cohort study of 13,812 patients with CAD (≥75% stenosis in ≥1 of 3 major coronary arteries). Patients were enrolled from April 2000 through March 2001 at 202 institutions throughout Japan. Exercise and diet interventions were defined based on Japanese national guidelines. Cox proportional hazards models were used to calculate hazard ratios (HRs) for all-cause mortality with 95% CIs.Results: We studied 11,893 patients in the JCAD study. Over 3 years of follow-up, there were 474 deaths; 4,237 patients (35.6%) underwent exercise intervention, and 8,642 patients (72.7%) underwent diet intervention from the time of discharge. Mortality was lower in patients who underwent an exercise or diet intervention than in patients who did not: HR 0.68 (95% CI 0.56-0.84) and 0.75 (95% CI 0.62-0.91), respectively. After adjustment for age, sex, institution, hypertension, hyperlipidemia, diabetes, obesity, current drinking, current smoking, and the use of antiplatelet agents, β-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and statins, the associations with these interventions remain statistically significant: HR 0.73 (95% CI 0.55-0.96) for exercise and 0.74 (95% CI 0.58-0.95) for diet interventions.Conclusions: Exercise and diet interventions have a beneficial impact on all-cause mortality in patients with CAD, yet these interventions are surprisingly infrequent. Lifestyle interventions should be more actively promoted.

Associations of pentraxin-3 with cardiovascular events, incident heart failure, and mortality among persons with coronary heart disease: Data from the Heart and Soul Study

2012-02-01

Background: Pentraxin-3 (PTX3) is an inflammatory marker thought to be more specific to vascular inflammation than C-reactive protein (CRP). Whether PTX3 is independently associated with adverse events among persons with stable coronary heart disease (CHD), independently of CRP, and whether kidney dysfunction influences these associations are not known.Methods: We evaluated the associations of baseline PTX3 levels with all-cause mortality, cardiovascular (CV) events (myocardial infarction, stroke, or CHD death), and incident heart failure (HF) during 37 months among ambulatory persons with stable CHD participating in the Heart and Soul Study. Cox proportional hazards models were adjusted for age, sex, race, hypertension, diabetes, smoking, and CRP.Results: Among 986 persons with stable CHD, each 1 unit increase in log PTX3 at baseline was associated with an 80% increased risk of all-cause mortality (hazard ratio [HR] 1.8, 95% CI 1.5-2.1), a 50% increased risk of CV events (HR 1.5, 95% CI, 1.2-1.9), and an 80% greater risk of incident HF (HR 1.8, 95% CI, 1.3-2.5). Further adjustment for estimated glomerular filtration rate (eGFR) attenuated these associations to 1.6 (1.3-1.9) for mortality, 1.3 (1.0-1.6) for CV events and 1.5 (1.1-2.1) for incident HF. Stratification by eGFR >60 mL/min per 1.73m2 or <60 mL/min per 1.73m2 did not affect these associations (P interaction > .3 for all outcomes).Conclusions: Among persons with stable CHD, higher PTX3 concentrations were associated with increased risk for all-cause mortality, CV events, and incident HF independently of systemic inflammation. Adjustment for eGFR modestly attenuated these associations, suggesting that future studies of PTX3 should adjust for kidney function.

Cardiopulmonary exercise function among patients undergoing transcatheter pulmonary valve implantation in the US Melody valve investigational trial

2012-02-01

Objectives: We assessed the hypothesis that there is an improvement in clinical and physiologic parameters of cardiopulmonary exercise testing (CPET) after implantation of a transcatheter pulmonary valve (TPV).Background: Transcatheter pulmonary valve provides a new tool for treating conduit stenosis and regurgitation in patients with right ventricle (RV) to pulmonary artery conduit dysfunction.Methods: Patients who underwent a TPV placement between January 2007 and January 2010 (N = 150) were investigated with a standardized CPET protocol before and at 6 months after TPV placement. Cardiopulmonary exercise testing was performed on a mechanically braked cycle ergometer with respiratory gas exchange analysis.Results: Six months post TPV, small but statistically significant improvements were observed in the maximum workload (65.0% ± 18.8% to 68.3% ± 20.3% predicted, P < .001) and the ratio of minute ventilation to CO2 production at the anaerobic threshold (30.8 ± 4.7 to 29.1 ± 4.1, P < .001). There was no significant change in peak oxygen consumption (VO2). Patients with pre-TPV hemodynamics consistent with RV dysfunction and patients with a lower pre-TPV peak VO2 tended to have the greatest improvement in peak VO2. The correlation between TPV-related improvements in peak VO2 and baseline clinical variables were weak, however, and these variables could not be used to reliably identify patients likely to have improved peak VO2 after TPV.Conclusion: In patients with RV to pulmonary artery conduit dysfunction, TPV is associated with modest improvement in exercise capacity and gas exchange efficiency during exercise.

Survival and predictive factors of mortality after 30 days in patients treated with percutaneous implantation of the CoreValve aortic prosthesis

2012-02-01

Background: Few data exist on the clinical impact of transcatheter aortic valve implantation (TAVI) in patients with symptomatic aortic stenosis and a high surgical risk. The aim of this study was to determine the survival and the factors predicting mortality after 30 days post-TAVI with the CoreValve prosthesis (Medtronic, Minneapolis, MN).Methods: From April 2008 to October 2010, the CoreValve prosthesis (Medtronic) was implanted in 133 consecutive high-risk surgical patients with symptomatic severe aortic stenosis.Results: The mean age was 79.5 ± 6.7 years. The logistic European System for Cardiac Operative Risk Evaluation was 21.5% ± 14%. The implantation success rate was 97.7%. In-hospital mortality was 4.5%, and the combined end point of death, vascular complications, myocardial infarction, or stroke had a rate of 9%. Survival at 12 and 24 months was 84.5% and 79%, respectively, after a mean follow-up of 11.3 ± 8 months. The New York Heart Association functional class improved from 3.3 ± 0.5 to 1.18 ± 0.4 and remained stable at 1 year. A high Charlson index (hazard ratio [HR] 1.44, 95% CI 1.09-1.89, P < .01) and a worse Karnofsky score before the procedure (HR 0.95, 95% CI 0.92-0.99, P = .021) were predictors of mortality after 30 days.Conclusions: Transcatheter aortic valve implantation with the CoreValve prosthesis for patients with aortic stenosis and a high surgical risk is a safe, efficient option resulting in a medium-term clinical improvement. Survival during follow-up depends on the associated comorbidities. Early mortality beyond 30 days is predicted by preoperative comorbidity scores and the functional status of the patient.

Aggregating traditional cardiovascular disease risk factors to assess the cardiometabolic health of childhood cancer survivors: An analysis from the Cardiac Risk Factors in Childhood Cancer Survivors Study

2012-02-01

Background: Childhood cancer survivors are at increased risk of cardiovascular disease (CVD), which may be associated with traditional CVD risk factors. We used CVD risk aggregation instruments to describe survivor cardiometabolic health and compared their results with sibling controls.Methods: Traditional CVD risk factors measured in 110 survivors and 31 sibling controls between 15 and 39 years old were aggregated using Pathobiological Determinants of Atherosclerosis in Youth (PDAY) scores and the Framingham Risk Calculator (FRC) and expressed as ratios. The PDAY odds ratio represents the increased odds of currently having an advanced coronary artery lesion, and the FRC risk ratio represents the increased risk of having a myocardial infarction, stroke, or coronary death in the next 30 years. Ratios are relative to an individual of similar age and sex without CVD risk factors.Results: The median PDAY odds ratio for survivors was 2.2 (interquartile range 1.3-3.3), with 17% >4. The median FRC risk ratio was 1.7 (interquartile range 1.0-2.0), with 12% >4. Survivors and siblings had similar mean PDAY odds ratios (2.33 vs 2.29, P = .86) and FRC risk ratios (1.72 vs 1.53, P = .24). Cancer type and treatments were not associated with cardiometabolic health. There was a suggested association for physical inactivity with PDAY odds ratios (r = 0.17, P = .10) and FRC risk ratios (r = 0.19, P = .12).Conclusions: Cardiometabolic health is poor in childhood cancer survivors but not different than that of their siblings, highlighting the importance of managing traditional CVD risk factors and considering novel exposures in survivors.

Obesity and physical fitness in California school children

Melanie Aryana, Zhongmin Li, William J. Bommer — 2012-02-01

Background: Obesity rates have reached epidemic proportions in the United States and California. Thus, the California Department of Education began a series of steps to address the increase in obesity and decline in fitness in the 6.3 million public school children in California. We evaluated serial changes in obesity and fitness in California school children following implementation of prevention steps in all California public schools.Methods: The California Department of Education implemented changes in school nutrition and exercise programs aimed at reducing obesity and improving fitness. Outcome results were monitored by performing Physical Fitness Testing on 8.4 million students (5th, 7th, and 9th grade) for body composition, aerobic capacity, flexibility, and upper body, abdominal, and truncal strength using the Cochran-Armitage trend test and multivariable logistic regression models.Results: Overall fitness improved from 2003 to 2008. Serial changes in body composition, aerobic capacity, flexibility, and upper body, abdominal, and truncal strength improved or remained stable within school as students progressed from 5th to 7th to 9th grade. However, students entering 5th grade were more obese every year, and this early obesity was not reversible within the school programs.Conclusions: Following prevention measures within California public schools, obesity and fitness levels have stabilized. However, continued increases in early entrance (5th grade) obesity will require additional efforts directed at preschool and elementary students to completely stop and reverse this obesity epidemic.

2012-02-01

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2012-02-01

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2012-02-01

American Heart Journal

A case where the principle of “one question, one answer” may work better

Newest-generation drug-eluting and bare-metal stents combined with prasugrel-based antiplatelet therapy in large coronary arteries: The BAsel Stent Kosten Effektivitäts Trial PROspective Validation Examination part II (BASKET-PROVE II) trial design

Rationale and design of the TAXUS Libertē Post-Approval Study: Examination of patients receiving the TAXUS Liberté stent with concomitant prasugrel therapy in routine interventional cardiology practice

Design of the RELAXin in Acute Heart Failure Study

Management of cardiac toxicity in patients receiving vascular endothelial growth factor signaling pathway inhibitors

Detection of periodontal bacteria in thrombi of patients with acute myocardial infarction by polymerase chain reaction

High-concentration versus titrated oxygen therapy in ST-elevation myocardial infarction: A pilot randomized controlled trial

Efficacy and safety of enoxaparin compared with unfractionated heparin in the pharmacoinvasive management of acute ST-segment elevation myocardial infarction: Insights from the TRANSFER-AMI trial

Reduced immediate ischemic events with cangrelor in PCI: A pooled analysis of the CHAMPION trials using the universal definition of myocardial infarction

Statin treatment for coronary artery plaque composition based on intravascular ultrasound radiofrequency data analysis

Single high-dose erythropoietin administration immediately after reperfusion in patients with ST-segment elevation myocardial infarction: results of the Erythropoietin in Myocardial Infarction Trial

Circadian variations of ischemic burden among patients with myocardial infarction undergoing primary percutaneous coronary intervention

Indications for percutaneous coronary interventions performed in US hospitals: a report from the NCDR®

Percutaneous coronary intervention outcomes in US hospitals with varying structural characteristics: Analysis of the NCDR®

Vascular complications and access crossover in 10,676 transradial percutaneous coronary procedures

Patient and hospital characteristics associated with traditional measures of inpatient quality of care for patients with heart failure

Perceived sexual difficulties and associated factors in patients with heart failure

Comparison of processes of care and clinical outcomes for patients newly hospitalized for heart failure attended by different physician specialists

Effect of QRS morphology on clinical event reduction with cardiac resynchronization therapy: Meta-analysis of randomized controlled trials

Frequency and impact of lifestyle modification in patients with coronary artery disease: The Japanese Coronary Artery Disease (JCAD) Study

Associations of pentraxin-3 with cardiovascular events, incident heart failure, and mortality among persons with coronary heart disease: Data from the Heart and Soul Study

Cardiopulmonary exercise function among patients undergoing transcatheter pulmonary valve implantation in the US Melody valve investigational trial

Survival and predictive factors of mortality after 30 days in patients treated with percutaneous implantation of the CoreValve aortic prosthesis

Aggregating traditional cardiovascular disease risk factors to assess the cardiometabolic health of childhood cancer survivors: An analysis from the Cardiac Risk Factors in Childhood Cancer Survivors Study

Obesity and physical fitness in California school children

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