Обзор американских кардиологических журналов за неделю (ссылки)

[Chevychelov]

Title: Rosuvastatin for Primary Prevention in Older Persons With Elevated C-Reactive Protein and Low to Average Low-Density Lipoprotein Cholesterol Levels: Exploratory Analysis of a Randomized Trial
Topic: Prevention/Vascular
Date Posted: 5/7/2010
Author(s): Glynn RJ, Koenig W, Nordestgaard BG, Shepherd J, Ridker PM.
Citation: Ann Intern Med 2010;152:488-496.
Clinical Trial: No
Related Resources
Trial: Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER)

Study Question: Randomized data on statins for primary prevention in older persons are limited, and the relative hazard of cardiovascular disease associated with an elevated cholesterol level weakens with advancing age. What is the efficacy and safety of rosuvastatin in persons 70 years or older?
Methods: A secondary analysis was conducted in JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin), a randomized, double-blind, placebo-controlled trial in which the 17,802 participants were randomly assigned with low-density lipoprotein (LDL) cholesterol levels less than 130 mg/dl and high-sensitivity C-reactive protein (CRP) levels of 2.0 mg/L or more without cardiovascular disease. Participants were randomly assigned to receive 20 mg of rosuvastatin daily or placebo. The primary endpoint was the occurrence of a first cardiovascular event (myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes).
Results: In the 70 years or older group, the median age was 74 years (interquartile 72-77, range 70-97 years). Compared to those 50-69 years old, a higher percentage of older participants were women or had hypertension, and lower percentages were obese or smoked cigarettes, relative to younger participants. A total of 5,695 (32%) of trial participants were 70 years or older and accrued 49% (n = 194) of the 393 confirmed primary endpoints. The rates of the primary endpoint in this age group were 1.22 and 1.99 per 100 person-years of follow-up in the rosuvastatin and placebo groups, respectively (hazard ratio, 0.61; 95% confidence interval [CI], 0.46-0.82; p < 0.001). Corresponding rates of all-cause mortality in this age group were 1.63 and 2.04 (hazard ratio, 0.80; CI, 0.62-1.04; p = 0.090). Although no significant heterogeneity was found in treatment effects by age, absolute reductions in event rates associated with rosuvastatin were greater in older persons. The relative rate of any serious adverse event among older persons in the rosuvastatin versus placebo group was 1.05 (CI, 0.93-1.17).
Conclusions: In apparently healthy older persons without hyperlipidemia but with elevated high-sensitivity CRP levels, rosuvastatin reduces the incidence of major cardiovascular events. Effect estimates from this exploratory analysis with age cut-point chosen after trial completion should be viewed in the context of the overall trial results.
Perspective: Previous studies have shown only modest benefits of statins in the elderly without coronary heart disease, and that the risk attributable to total and LDL-C is less than in younger persons. Impressively, the estimated number of older persons who needed treatment for 4 years to prevent one primary endpoint was 24 compared with 36 in the younger age group. There are important differences in JUPITER including identifying a higher risk cohort by including the criteria of a CRP >2 mg/L (despite an LDL-C <130 mg/dl), and the 20 mg dose of rosuvastatin, which has a much greater effect on both LDL-C and CRP than standard statin dosing. Melvyn Rubenfire, M.D., F.A.C.C.

Title: Renal Outcomes With Different Fixed-Dose Combination Therapies in Patients With Hypertension at High Risk for Cardiovascular Events (ACCOMPLISH): A Prespecified Secondary Analysis of a Randomized Controlled Trial
Topic: Prevention/Vascular
Date Posted: 5/7/2010
Author(s): Bakris GL, Sarafidis PA, Weir MR, et al., on behalf of the ACCOMPLISH Trial Investigators.
Citation: Lancet 2010;375:1173-1181.
Clinical Trial: No
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Trial: Avoiding Cardiovascular Events Through COMbination Therapy in Patients LIving With Systolic Hypertension (ACCOMPLISH)

Study Question: What is the comparative efficacy of initial antihypertensive therapy with benazepril plus amlodipine versus benazepril plus hydrochlorothiazide on progression of chronic kidney disease?
Methods: ACCOMPLISH was a double-blind randomized trial undertaken in five countries (USA, Sweden, Norway, Denmark, and Finland). A total of 11,506 patients with hypertension who were at high risk for cardiovascular events were randomly assigned via a central, telephone-based interactive voice response system in a 1:1 ratio to receive benazepril (20 mg) plus amlodipine (5 mg; n = 5,744) or benazepril (20 mg) plus hydrochlorothiazide (12.5 mg; n = 5,762), orally once daily. Drug doses were force-titrated for patients to attain recommended blood pressure goals. Progression of chronic kidney disease, a prespecified endpoint, was defined as doubling of serum creatinine concentration or end-stage renal disease (estimated glomerular filtration rate <15 ml/min/1.73 m2 or need for dialysis). Analysis was by intention to treat.
Results: The trial was terminated early (mean follow-up 2.9 years [standard deviation 0.4]) because of superior efficacy of benazepril plus amlodipine compared with benazepril plus hydrochlorothiazide. There were 113 (2.0%) events of chronic kidney disease progression in the benazepril plus amlodipine group compared with 215 (3.7%) in the benazepril plus hydrochlorothiazide group (hazard ratio, 0.52; 0.41-0.65; p < 0.0001). The most frequent adverse event in patients with chronic kidney disease was peripheral edema (benazepril plus amlodipine, 189 of 561, 33.7%; benazepril plus hydrochlorothiazide, 85 of 532, 16.0%). In patients with chronic kidney disease, angio-edema was more frequent in the benazepril plus amlodipine group than in the benazepril plus hydrochlorothiazide group. In patients without chronic kidney disease, dizziness, hypokalemia, and hypotension were more frequent in the benazepril plus hydrochlorothiazide group than in the benazepril plus amlodipine group.
Conclusions: The authors concluded that initial antihypertensive treatment with benazepril plus amlodipine should be considered in preference to benazepril plus hydrochlorothiazide since it slows progression of nephropathy to a greater extent.
Perspective: This trial shows that in patients with hypertension at high risk for cardiovascular events, combination treatment with benazepril plus amlodipine reduces progression of chronic kidney disease more effectively than does benazepril plus hydrochlorothiazide. This benefit was also seen when cardiovascular or all-cause mortality was assessed. A limitation of the study is that the trial was not powered as a chronic kidney disease outcome study. A prospective adequately powered trial in patients with more advanced proteinuric nephropathy is needed to establish the superiority between these two different antihypertensive combination treatments on progression of chronic kidney disease. Debabrata Mukherjee, M.D., F.A.C.C.

[Chevychelov]

Title: Deterioration of Blood Pressure Control After Discontinuation of a Physician-Pharmacist Collaborative Intervention
Topic: Prevention/Vascular
Date Posted: 5/10/2010
Author(s): Carter BL, Doucette WR, Franciscus CL, Ardery G, Kluesner KM, Chrischilles EA.
Citation: Pharmacotherapy 2010;30:228-235.
Clinical Trial: No
Study Question: Is blood pressure (BP) control maintained after discontinuation of a physician-pharmacist collaborative intervention?
Methods: A total of 104 patients (65 in the intervention group and 39 in the control group) participated in a 9-month prospective, cluster-randomized efficacy trial and then were evaluated at 9 and 18 months after completion of the trial based on BPs abstracted from the medical record. The intervention included pharmacist-patient interviews at baseline and up to six times during the 9-month follow-up period, as well as pharmacist recommendations for optimizing drug therapy to improve BP control (according to Joint National Committee 7 guidelines) and patient adherence. To evaluate the effect of discontinuation of the pharmacist intervention on BP, data from patients who received the intervention were compared with the controls 9 and 18 months after the intervention was discontinued.
Results: At baseline, no patients in either group had BP in control. By the end of the intervention period, BP was controlled in 78.5% and 48.7% of the intervention and control groups, respectively (p = 0.0017). By 9 months after the end of the intervention, BP control in the intervention and control groups had fallen to 53.9% and 30.8%, respectively (p = 0.02), whereas rates at 18 months post-intervention were 55.4% and 35.9% (p = 0.05).
Conclusions: There was a sustained positive effect up to 18 months after discontinuation of a physician-pharmacist collaborative intervention, compared with the control group. However, BP deteriorated at a similar rate in both groups over time.
Perspective: These results suggest that a collaborative intervention between physicians and pharmacists, focused on BP-lowering strategies, results in significant improvements in BP control compared with those who did not receive the intervention. Because there was deterioration of BP control over the subsequent 18 months, interventions which include collaborative team-based approaches may need to be continued to maintain high rates of BP control. Suzanne Hughes, MSN, RN

Title: Myocardial Fibrosis Identified by Cardiac Magnetic Resonance Late Gadolinium Enhancement Is Associated With Adverse Ventricular Mechanics and Ventricular Tachycardia Late After Fontan Operation
Topic: Congenital Heart Disease
Date Posted: 5/10/2010
Author(s): Rathod RH, Prakash A, Powell AJ, Geva T.
Citation: J Am Coll Cardiol 2010;55:1721-1728.
Clinical Trial: No
Study Question: What is the relationship between myocardial fibrosis as identified by cardiac magnetic resonance (CMR) and ventricular mechanics and arrhythmias after the Fontan procedure?
Methods: A retrospective review was performed at a single center. All patients following the Fontan procedure who underwent CMR with myocardial delayed-enhancement sequences were identified.
Results: A total of 90 patients with a mean age of 23.1 ± 10.9 years were studied. Positive late gadolinium enhancement (LGE) was seen in 25 (28%) patients, and was associated with lower mean ejection fraction (45% as compared with 56%; p < 0.001), increased median end-diastolic volume (100 ml/body surface area [BSA]1.3 vs. 82 ml/BSA1.3, and higher frequency of regional wall motion abnormalities (52% vs. 28%; p = 0.05). Increased frequency of nonsustained ventricular tachycardia (NSVT) was also seen in patients with LGE with a rate of 36% as compared with 11% in those without LGE (p = 0.01). Multivariate regression analysis showed that more extensive positive LGE (expressed as percent LGE of total myocardial mass) was associated with lower ejection fraction (p = 0.002), increased end-diastolic volume (p < 0.001), and a higher frequency of NSVT (odds ratio, 1.2; 95% confidence interval, 1.1-1.4; p = 0.006).
Conclusions: Myocardial fibrosis is common in patients following the Fontan procedure and is associated with impaired ventricular mechanics and higher rate of NSVT. Further studies are necessary to assess the utility of the role of this measure for risk stratification and management of ventricular arrhythmias.
Perspective: This study addresses the prevalence and implications of late gadolinium enhancement in patients following the Fontan procedure. The mechanisms for development of these abnormalities are unclear. While the role for routine assessment for LGE is unclear, it may prove a useful modality for identifying patients at risk for ventricular arrhythmias or significant myocardial dysfunction. More importantly, an understanding of the etiology of these changes will be important for attempts at decreasing the incidence of myocardial scarring in this complex patient population. Timothy B. Cotts, M.D., F.A.C.C.

[Chevychelov]

Title: Impact of High-Dose N-Acetylcysteine Versus Placebo on Contrast-Induced Nephropathy and Myocardial Reperfusion Injury in Unselected Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: The LIPSIA-N-ACC (Prospective, Single-Blind, Placebo-Controlled, Randomized Leipzig Immediate PercutaneouS Coronary Intervention Acute Myocardial Infarction N-ACC) Trial
Topic: Interventional Cardiology
Date Posted: 5/10/2010 5:00:00 PM
Author(s): Thiele H, Hildebrand L, Schirdewahn C, et al.
Citation: J Am Coll Cardiol 2010;55:2201-2209.
Clinical Trial: yes
Related Resources
JACC Article: Impact of High-Dose N-Acetylcysteine Versus Placebo on Contrast-Induced Nephropathy and Myocardial Reperfusion Injury in Unselected Patients With STEMI Undergoing Primary PCI: The LIPSIA-N-ACC Trial

Study Question: What is the effect of N-acetylcysteine on contrast-induced nephropathy (CIN) and reperfusion injury in ST-segment elevation myocardial infarction patients undergoing primary angioplasty with moderate contrast volumes?
Methods: Patients undergoing primary angioplasty were randomized to either high-dose N-acetylcysteine (2 x 1200 mg/day for 48 hours; n = 126) or placebo plus optimal hydration (n = 125). The two primary endpoints were: 1) the occurrence of >25% increase in serum creatinine level <72 hours after randomization; and 2) a reduction in reperfusion injury measured as myocardial salvage index by magnetic resonance imaging.
Results: The median volume of an iso-osmolar contrast agent during angiography was 180 ml (interquartile range [IQR], 140-230 ml) in the N-acetylcysteine and 160 (IQR, 120-220 ml) in the placebo group (p = 0.20). The primary endpoint, CIN, occurred in 14% of the N-acetylcysteine group and in 20% of the placebo group (p = 0.28). The myocardial salvage index was also not different between both treatment groups (43.5; IQR, 25.4-71.9 vs. 51.5; IQR, 29.5-75.3; p = 0.36). Activated oxygen protein products and oxidized low-density lipoprotein as markers for oxidative stress were reduced by as much as 20% in the N-acetylcysteine group (p < 0.05), whereas no change was evident in the placebo group.
Conclusions: The authors concluded that high-dose intravenous N-acetylcysteine does not provide an additional clinical benefit to placebo with respect to CIN and myocardial reperfusion injury in patients undergoing angioplasty with moderate doses of contrast medium and optimal hydration.
Perspective: In this prospective, randomized, single-blind trial, N-acetylcysteine was ineffective in preventing CIN and did not lead to a measurable benefit in reperfusion injury in patients undergoing primary percutaneous coronary intervention for acute myocardial infarction. Furthermore, this lack of efficacy of N-acetylcysteine was independent of typical risk factors for the development of CIN. Based on the totality of evidence from multiple analyses, it appears that any incremental benefit of intravenous N-acetylcysteine administration in addition to hydration is likely to be small and not clinically relevant. Debabrata Mukherjee, M.D., F.A.C.C.

Title: The Transradial Approach to Percutaneous Coronary Intervention: Historical Perspective, Current Concepts, and Future Directions
Topic: Interventional Cardiology
Date Posted: 5/10/2010 5:00:00 PM
Author(s): Rao SV, Cohen MG, Kandzari DE, Bertrand OF, Gilchrist IC.
Citation: J Am Coll Cardiol 2010;55:2187-2195.
Clinical Trial: No
Related Resources
JACC Article: The Transradial Approach to Percutaneous Coronary Intervention: Historical Perspective, Current Concepts, and Future Directions

Study Question: What is the current status of the transradial approach to percutaneous coronary intervention (PCI)?
Perspective: Periprocedural bleeding after PCI has been associated with increased short- and long-term morbidity and mortality. A growing body of evidence supports the use of the radial artery over the femoral artery to achieve lower bleeding rates, and data demonstrate an association between the transradial approach and reduced costs and post-procedural length of stay. Despite these advantages, there are some limitations to this approach, such as the potential impact on radial artery patency and greater radiation exposure during the learning curve, one of the factors that has limited adoption of this technique. Greater utilization of the transradial approach will depend on the availability of educational programs for interventionalists and fellows, commitment from professional societies to support transradial PCI, and the generation of high-quality evidence to determine its true comparative effectiveness against the traditional femoral approach. A potential benefit of the greater use of the transradial approach is that it may allow higher, more effective doses of antithrombotics, which in turn may result in improved outcomes. Debabrata Mukherjee, M.D., F.A.C.C.

[Chevychelov]

Title: Myocardial Iodine-123 Meta-Iodobenzylguanidine Imaging and Cardiac Events in Heart Failure: Results of the Prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) Study
Topic: Heart Failure/Transplant
Date Posted: 5/11/2010
Author(s): Jacobson AF, Senior R, Cerqueira MD, et al., on behalf of the ADMIRE-HF Investigators.
Citation: J Am Coll Cardiol 2010;55:2212-2221.
Clinical Trial: No
Related Resources
JACC Article: Myocardial Iodine-123 Meta-Iodobenzylguanidine Imaging and Cardiac Events in Heart Failure: Results of the Prospective ADMIRE-HF Study

Study Question: What is the role of iodine-123 meta-iodobenzylguanidine (123I-mIBG) imaging for identifying symptomatic heart failure (HF) patients most likely to experience cardiac events?
Methods: A total of 961 subjects with New York Heart Association (NYHA) functional class II/III HF and left ventricular ejection fraction (LVEF) ≤35% were studied. Subjects underwent 123I-mIBG myocardial imaging (sympathetic neuronal integrity quantified as the heart/mediastinum uptake ratio [H/M] on 4-hour delayed planar images) and myocardial perfusion imaging, and were then followed up for up to 2 years. Time to first occurrence of NYHA functional class progression, potentially life-threatening arrhythmic event, or cardiac death was compared with H/M (either in relation to estimated lower limit of normal [1.60] or as a continuous variable) using Cox proportional hazards regression. Multivariable analyses using clinical, laboratory, and imaging data were also performed.
Results: A total of 237 subjects (25%) experienced events (median follow-up 17 months). The hazard ratio for H/M ≥1.60 was 0.40 (p < 0.001); the hazard ratio for continuous H/M was 0.22 (p < 0.001). Two-year event rate was 15% for H/M ≥1.60 and 37% for H/M <1.60; hazard ratios for individual event categories were as follows: HF progression, 0.49 (p = 0.002); arrhythmic events, 0.37 (p = 0.02); and cardiac death, 0.14 (p = 0.006). Significant contributors to the multivariable model were H/M, LVEF, B-type natriuretic peptide, and NYHA functional class. 123I-mIBG imaging also provided additional discrimination in analyses of interactions between B-type natriuretic peptide, LVEF, and late H/M.
Conclusions: The authors concluded that 123I-mIBG scintigraphy provides independent prognostic value in assessment of patients with HF.
Perspective: This study demonstrates the capacity of quantitation of sympathetic innervation of the myocardium, measured by 123I-mIBG scintigraphy, for predicting prognosis in subjects with HF and significant LV dysfunction. The study showed a highly significant relationship between time to HF-related events and H/M, which was independent of other commonly measured parameters such as LVEF and BNP, as well as demographic parameters such as age and renal function. The study also showed a clear association between severity of myocardial sympathetic neuronal dysfunction and risk for subsequent cardiac death. In appropriately selected patients, this imaging procedure could alert clinicians to the potential need for considering additional treatments such as more aggressive medical therapy or earlier use of resynchronization therapy. Debabrata Mukherjee, M.D., F.A.C.C.

[Chevychelov]

Title: Triglyceride-Mediated Pathways and Coronary Disease: Collaborative Analysis of 101 Studies
Topic: Prevention/Vascular
Date Posted: 5/11/2010
Author(s): Sarwar N, Sandhu MS, Ricketts SL, et al., on behalf of the Triglyceride Coronary Disease Genetics Consortium and Emerging Risk Factors Collaboration.
Citation: Lancet 2010;375:1634-1639.
Clinical Trial: No
Study Question: Are triglyceride-mediated pathways causally relevant to coronary heart disease (CHD)?
Methods: The study assessed the –1131T>C (rs662799) promoter polymorphism of the apolipoprotein A5 (APOA5) gene in relation to triglyceride concentration, several other risk factors, and risk of CHD. The disease risk was assessed for genetically-raised triglyceride concentration (20,842 patients with CHD and 35,206 controls) with that recorded for equivalent differences in circulating triglyceride concentration in prospective studies (302,430 participants with no history of cardiovascular disease; 12,785 incident cases of CHD during 2.79 million person-years at risk). The authors also analyzed –1131T>C in 1,795 people without a history of cardiovascular disease who had information about lipoprotein concentration and diameter obtained by nuclear magnetic resonance spectroscopy.
Results: The minor allele frequency of –1131T>C was 8% (95% confidence interval, 7-9). –1131T>C was not significantly associated with several nonlipid risk factors or low-density lipoprotein (LDL) cholesterol; however, it was significantly but modestly associated with lower high-density lipoprotein cholesterol (HDL-C) (mean difference per C allele, 3.5%; lower apolipoprotein A-I [1.3%; 0.023 g/L]; and higher apolipoprotein B [3.2%; 0.027 g/L]). By contrast, for every C allele inherited, mean triglyceride concentration was 16.0% or 0.25 mmol/L, higher (p = 4.4 Ч 10–24). The odds ratio for CHD was 1.18 (p = 2.6 Ч 10–7) per C allele, which was concordant with the hazard ratio of 1.10 per 16% higher triglyceride concentration recorded in prospective studies. –1131T>C was significantly associated with higher very LDL (VLDL) particle concentration (mean difference per C allele, 12.2 nmol/L; p = 9.3 Ч 10–8) and smaller HDL particle size (0.14 nmol; p = 7.0 Ч 10–5), factors that could mediate the effects of triglyceride.
Conclusions: The authors concluded that these data are consistent with a causal association between triglyceride-mediated pathways and CHD.
Perspective: The mechanisms considered for triglycerides increasing risk for CHD and CV events are thought to be the increase in VLDL triglyceride-rich remnant particles, small highly atherogenic LDL particles, less efficient small dense HDL particles, and prothrombosis. The finding that a genetic determinant of triglyceride levels appears to increase risk independent of other known risk factors including diabetes further supports the rationale for considering targeting triglycerides. Future drug trials should consider the impact of the –1131T>C (rs662799) promoter polymorphism of the APOA5 gene, which appears to impact the effect of both statins and fibrates. Melvyn Rubenfire, M.D., F.A.C.C.

Title: Association of Temporal Trends in Risk Factors and Treatment Uptake With Coronary Heart Disease Mortality, 1994-2005
Topic: Prevention/Vascular
Date Posted: 5/11/2010 4:00:00 PM
Author(s): Wijeysundera HC, Machado M, Farahati F, et al.
Citation: JAMA 2010;303:1841-1847.
Clinical Trial: No
Study Question: Are trends in coronary heart disease (CHD) risk factors and management associated with mortality?
Methods: This was a prospective analytic study of the general population (age 25-84 years) residing in Ontario, Canada between 1994 and 2005, using the IMPACT model (which integrates data on population size, CHD mortality, risk factors, and treatment uptake). The association between CHD mortality and risk factors for eight separate CHD populations, and population trends in six risk factors was quantified using relative risks and regression coefficients from published literature. The main outcome of interest was number of deaths prevented or delayed in 2005. Secondary outcomes included improvements in medical treatments and trends in risk factors.
Results: Age-adjusted CHD mortality decreased by 35%, from 191 to 125 deaths per 100,000 inhabitants over the time period examined (1994-2005). This translated into an estimated 7,585 fewer CHD deaths in 2005. Improvements in medical and surgical treatments were associated with 43% (range 11-124%) of the total mortality decrease, most notably for acute myocardial infarction (8%, range -5% to 40%), chronic stable coronary artery disease (17%, range 7-35%), and heart failure occurring while in the community (10%, range 6-31%). Trends in risk factors accounted for 48% (range 28-64%) prevented or delayed CHD deaths or 3,660 fewer deaths. Improvements in total cholesterol and systolic blood pressure accounted for much of this mortality reduction. Increases in diabetes and body mass index (BMI) were associated with higher CHD mortality (6%, range 4-8% for diabetes and 2%, range 1-4% for BMI).
Conclusions: The authors concluded that decreases in CHD mortality observed between 1994 and 2005 were associated primarily with improvements in CHD risk factors, but also with improvements in medical management of heart disease.
Perspective: These findings support the continued primary and secondary prevention efforts to improve traditional risk factors in our population. This together with continued advancement in the treatment of CHD will likely assist in the continued reduction of CHD mortality rates. However, the epidemic of obesity and associated medical problems such as diabetes will retard progress in reducing mortality and morbidity related to CHD. Elizabeth A. Jackson, M.D., F.A.C.C.

[Chevychelov]

Title: Antithrombotic Management of Atrial Fibrillation Patients Presenting with Acute Coronary Syndrome and/or Undergoing Coronary Stenting: Executive Summary—A Consensus Document of the European Society of Cardiology Working Group on Thrombosis, Endorsed by the European Heart Rhythm Association (EHRA) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)
Topic: Interventional Cardiology
Date Posted: 5/12/2010
Author(s): Lip GY, Huber K, Andreotti F, et al.
Citation: Eur Heart J 2010;May 6:[Epub ahead of print].
Clinical Trial: No
Perspective: The following are 10 points to remember from this consensus document:

1. Approximately 70-80% of patients with atrial fibrillation (AF) have an indication for oral anticoagulation therapy (OAT). Coronary artery disease co-exists in 20-30% of these patients.

2. Patients with AF on OAT are often bridged with unfractionated heparin or low molecular weight heparin if they need coronary angiography or percutaneous coronary intervention (PCI). Use of bridging therapy is associated with increased risk of access site complications in some studies. Some observational studies suggest that coronary angiography or PCI can be safely performed without interrupting OAT, and may be associated with a lower rate of complications compared with bridging therapy.

3. In small series, the rate of complications in patients on OAT who undergo angiography or PCI via the femoral route has been low. However, the radial route should be preferred in patients on OAT.

4. There is no need for additional heparin in patients who undergo PCI while therapeutic on OAT (international normalized ratio [INR] 2-3).

5. Aspirin and clopidogrel should be administered prior to the procedure when PCI is performed in a patient on OAT.

6. The use of platelet glycoprotein IIb/IIIa inhibitors increases the risk of bleeding in patients on OAT 3- to 13-fold and the routine use of these agents should be avoided in patients on OAT.

7. Use of aspirin and warfarin does not provide sufficient protection against risk of stent thrombosis. Patients undergoing stent-based PCI should be treated with triple therapy consisting of aspirin, clopidogrel, and warfarin. This combination is associated with an increased risk of bleeding, and use of bare-metal stents should be considered in these patients to limit the duration of triple therapy.

8. In patients who need long-term OAT, use of drug-eluting stents should be restricted to patients at very high risk of restenosis (long lesions, small vessels, diabetes). Alternative therapies (coronary artery bypass grafting [CABG], medical therapy, bare-metal stents) should be considered before implanting drug-eluting stents in a patient who needs long-term OAT.

9. In patients on triple therapy, closer monitoring of INR targeted to 2.0-2.5 and use of proton pump inhibitors may help reduce the risk of bleeding.

10. There are limited data on safety of cardiac surgery in patients who are on OAT. Currently, these patients are bridged with heparin prior to surgery. In the event of need for emergent CABG in a patient on OAT, fresh frozen plasma and vitamin K may be used to reverse OAT and reduce the risk of bleeding. Hitinder S. Gurm, M.B.B.S., F.A.C.C.

[Chevychelov]

Title: An Entirely Subcutaneous Implantable Cardioverter-Defibrillator
Topic: Arrhythmias
Date Posted: 5/12/2010 4:00:00 PM
Author(s): Bardy GH, Smith WM, Hood MA, et al.
Citation: N Engl J Med 2010;May 12:[Epub ahead of print].
Clinical Trial: No
Study Question: How effectively does a subcutaneous implantable cardioverter-defibrillator (ICD) system detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF)?
Methods: This study describes the results of two short-term trials of a subcutaneous electrode system and two long-term trials of the subcutaneous ICD system. In the short-term trials, the best electrode configuration was identified in 78 patients and then compared to a transvenous ICD system in 49 patients. In the long-term trials, 61 patients underwent implantation of the subcutaneous ICD. The subcutaneous ICD system consisted of a pulse generator implanted in the anterior axillary region and a parasternal 8-cm tripolar electrode. The pulse generator delivered 80-J shocks, had a rate cut-off of 170 bpm, and was able to pace for ≤30 seconds after a shock if there was a >3.5 second pause after a shock.
Results: The mean defibrillation threshold was 11.1 J with the transvenous ICD and 31.1 J with the subcutaneous ICD. Among the 61 patients who received the subcutaneous ICD, two consecutive episodes of induced VF were successfully sensed and terminated by 65-J shocks in all but one patient. During a mean of 10 months of follow-up, a total of 12 episodes of VT in three patients were detected and successfully terminated by the subcutaneous ICD. Complications included lead dislodgement requiring repositioning in four patients.
Conclusions: The subcutaneous ICD system tested in this study accurately senses and terminates VT/VF in approximately 98% of patients.
Perspective: Elimination of radiation exposure and the need for vascular access make the subcutaneous ICD an attractive option. However, it is not capable of long-term pacing, antitachycardia pacing, or detection of VT <170 bpm. Further evaluation is needed to determine its clinical reliability and utility. Fred Morady, M.D., F.A.C.C.

Title: 22q11.2 Deletion Syndrome Is Under-Recognised in Adult Patients With Tetralogy of Fallot and Pulmonary Atresia
Topic: Congenital Heart Disease
Date Posted: 5/12/2010
Author(s): van Engelen K, Topf A, Keavney BD, et al.
Citation: Heart 2010;96:621-624.
Clinical Trial: No
Study Question: What is the prevalence of 22q11.2 Deletion Syndrome (22q11.2DS) in adults with pulmonary atresia with ventricular septal defect (PA/VSD) and tetralogy of Fallot (TOF)?
Methods: A review of the Dutch CONCOR (CONgenital CORvitia) registry was performed. The CONCOR registry includes both a clinical database and a DNA bank. The registry was searched for patients with TOF and PA/VSD, with DNA available for analysis. Multiplex ligation-dependent probe amplification was used to detect 22q11.2 microdeletions.
Results: A total of 558 patients (479 with TOF and 79 with PA/VSD) with a median age of 34.7 years were studied. In addition to 20 patients already known to be positive, 24 (54%) patients were found to have a previously unidentified 22q11.2 microdeletion. The prevalence of 22q11.2 deletion was 6.5% in patients with TOF and 16.5% in patients with PA/VSD.
Conclusions: 22q11.2 deletion is undiagnosed in more than one half of adult patients. Testing for 22q11.2 deletion should be considered.
Perspective: This study reports both the incidence of 22q11.2 deletion syndrome and the degree to which it remains diagnosed in adults with TOF and PA/VSD. The prevalence is similar to what has been previously reported (Beauchesne LM, et al., J Am Coll Cardiol 2005;45:595-8). Testing for 22q11.2 deletion should be considered in all adults, particularly those considering having children, given the 50% chance of transmission to offspring. Timothy B. Cotts, M.D., F.A.C.C.

[Chevychelov]

Title: 1) The Case for Routine Genotyping in Dual-Antiplatelet Therapy. 2) Genotyping: One Piece of the Puzzle to Personalize Antiplatelet Therapy.
Topic: General Cardiology
Date Posted: 5/13/2010
Author(s): 1) Damani SB, Topol EJ. 2) Gurbel PA, Tantry US, Shuldiner AR, Kereiakes DJ.
Citation: 1) J Am Coll Cardiol 2010;May 12:[Epub ahead of print]. 2) J Am Coll Cardiol 2010;May 12:[Epub ahead of print].
Clinical Trial: No
Study Question: What is the current role of routine genotyping and platelet function testing for dual antiplatelet therapy?
Perspective: Recent data suggest that there are altered active metabolite levels of clopidogrel in patients harboring hepatic cytochrome gene variants. These variants, identified through genome-wide association as the dominant explanation for the marked heterogeneity of clopidogrel response, are linked to a significant increase in the risk for bleeding, stent thrombosis, myocardial infarction, and death. The impact of having two loss-of-function alleles [P450 (CYP) 2C19*2] has been recently highlighted in the ‘boxed warning’ issued by the U.S. Food and Drug Administration. In addition to genetic subtypes, high on-treatment platelet reactivity to adenosine diphosphate (ADP) during clopidogrel therapy is also a well-documented predictor of recurrent ischemic events in the percutaneous coronary intervention population. With several alternatives to clopidogrel now available, including higher clopidogrel maintenance and loading doses, prasugrel, and potentially ticagrelor in the future, clinicians may be able to effectively guide therapy in those with at-risk gene variants by simple genotyping. Based on available data, it seems reasonable to consider both genotyping and platelet function measurement to assess ischemic risk and to guide antiplatelet therapy. Ultimately, prospective randomized clinical trials will be needed to test specific personalized antiplatelet algorithms to provide the evidence base necessary prior to widespread adoption into clinical practice. Debabrata Mukherjee, M.D., F.A.C.C.

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Eating Nuts Improves Cholesterol Levels
Radiation Exposure from Noninvasive Imaging Studies
[Ссылки доступны только зарегистрированным пользователям ]

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Title: Early Identification of Mutation Carriers in Familial Hypertrophic Cardiomyopathy by Combined Echocardiography and Tissue Doppler Imaging
Topic: Heart Failure/Transplant
Date Posted: 5/13/2010
Author(s): Gandjbakhch E, Gackowski A, Tezenas du Montcel S, et al.
Citation: Eur Heart J 2010;May 3: [Epub ahead of print].
Clinical Trial: No
Study Question: Can hypertrophic cardiomyopathy (HCM) mutation status be predicted by echocardiography and tissue Doppler imaging (TDI) before the onset of hypertrophy?
Methods: Three subject groups were analyzed: HCM patients with hypertrophy (left ventricular hypertrophy [LVH]+, n = 48), mutation carriers without hypertrophy (LVH-/G+, n = 24), and normal control subjects (n = 48).
Results: Multivariate logistic regression identified only three independent echocardiographic/TDI parameters associated with genetic status: the interventricular septum/left posterior wall ratio (p = 0.006), relative wall thickness (p = 0.026), and septal E/Ea ratio (p = 0.008). An echo/TDI score determined after receiver operating characteristic analysis identified mutation carriers with 67% sensitivity and 96% specificity. In comparison, only 29% were identified by the previously proposed TDI criterion (lateral Ea velocity <14 cm/s) and only 33% by major electrocardiogram abnormalities.
Conclusions: The authors concluded that TDI velocities alone were not reliable enough to identify LVH-free mutation carriers in HCM. In contrast, abnormal LV remodeling was a frequent early manifestation of HCM. A new score was developed, combining echocardiographic and TDI parameters, that identifies mutation carriers before and independently of hypertrophy with high accuracy.
Perspective: Phenotypic heterogeneity of hypertrophy in patients with HCM often delays ability to establish genotype-phenotype correlations. Early identification of HCM in mutation carriers by improved myocardial imaging techniques could aid in genetic testing and management strategies. Previous studies have indicated that tissue Doppler characteristics are present in HCM mutation carriers before the onset of hypertrophy; however, this is controversial. Although this study did not find TDI velocities alone to be reliable, the authors did identify early remodeling changes in mutation carriers that may be useful with TDI parameters in predicting mutation status. Additional large studies in genetically diverse HCM populations are necessary to confirm these findings. Daniel T. Eitzman, M.D., F.A.C.C.

Title: Dronedarone in Patients With Congestive Heart Failure: Insights From ATHENA
Topic: Arrhythmias
Date Posted: 5/13/2010
Author(s): Hohnloser SH, Crijns HJ, van Eickels M, et al., on behalf of the ATHENA Investigators.
Citation: Eur Heart J 2010;April 30: [Epub ahead of print].
Clinical Trial: No
Related Resources
Trial: Effect of Dronedarone on Cardiovascular Outcomes in High-Risk Patients With Atrial Fibrillation or Atrial Flutter (ATHENA)

Study Question: Does dronedarone increase mortality or morbidity in patients with atrial fibrillation (AF) and congestive heart failure (CHF)?
Methods: This was a post-hoc analysis of a randomized clinical trial that compared dronedarone to placebo in 4,628 patients with AF. The 1° endpoint was a composite of time to first cardiovascular hospitalization or death.
Results: A total of 209 patients in the trial had New York Heart Association (NYHA) functional class II or III CHF and a left ventricular ejection fraction (LVEF) ≤40%. Dronedarone decreased the 1° endpoint by 22% in patients with CHF and by 24% in patients without CHF. The adverse events in patients with CHF who received dronedarone included bradycardia (3.2%), QT-prolongation (4.2%), and creatinine increase (10.5%). The prevalence of these adverse events did not differ significantly between patients with and without CHF. NYHA class IV CHF occurred during follow-up in 54 placebo patients and 42 dronedarone patients, with no difference in the mean time to hospitalization for CHF.
Conclusions: In the ATHENA trial, the reduction in time to first cardiovascular hospitalization or death associated with the use of dronedarone was not attenuated by the presence of class II-III CHF.
Perspective: Dronedarone is contraindicated in patients with NYHA class IV CHF or a recent episode of class II-III CHF. This is because mortality was increased by dronedarone when it was administered to patients with unstable CHF in the ANDROMEDA trial. The results of the present study suggest that dronedarone is safe in patients with stable class II-III CHF, with 'stable' generally defined as no exacerbation of CHF within the prior 3 months. Fred Morady, M.D., F.A.C.C.

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Title: Effect of Early Cerebral Magnetic Resonance Imaging on Clinical Decisions in Infective Endocarditis: A Prospective Study
Topic: Noninvasive Cardiology
Date Posted: 5/14/2010
Author(s): Duval X, Iung B, Klein I, et al., on behalf of the IMAGE (Resonance Magnetic Imaging at the Acute Phase of Endocarditis) Study Group.
Citation: Ann Intern Med 2010;152:497-504.
Clinical Trial: No
Study Question: Does early cerebral magnetic resonance imaging (MRI) affect the diagnosis and management of infective endocarditis in hospitalized adults?
Methods: In a single-center (tertiary care hospital in France) prospective study performed between June 2005 and October 2008, cerebral MRI with angiography was performed in 130 patients hospitalized with infective endocarditis up to 7 days after admission and before any surgical intervention. Two experts jointly established the endocarditis diagnostic classification (modified Duke criteria), and therapeutic plans just before and after MRI.
Results: Endocarditis was initially classified as definite in 77 patients, possible in 50, and was excluded in 3. Acute neurologic symptoms were present in 16 patients (12%). Cerebral lesions were detected on MRI in 106 patients (82% [95% confidence interval, 75-89%]), including ischemic lesions in 68, micro-hemorrhages in 74, and silent aneurysms in 10. Solely on the basis of MRI results and excluding micro-hemorrhages, diagnostic classification of 17 of 53 (32%) cases of nondefinite endocarditis was changed to either definite (14 patients) or possible (3 patients). MRI results led to modification of endocarditis therapeutic plan in 24 (18%) of 130 patients, including surgical plan modifications for 18 (14%). Overall, early MRI led to modifications of diagnosis or therapeutic plan in 36 patients (28% [confidence interval, 20-36%]). (Investigators did not assess whether MRI-related changes in diagnosis and therapeutic plans improved patient outcomes, or led to additional and potentially unnecessary procedures, and/or increased costs.)
Conclusions: Cerebral lesions were identified on MRI in many patients with endocarditis, but no neurologic symptoms. The MRI findings affected both diagnostic classifications and clinical management plans.
Perspective: Other recently published data similarly found very high rates of both subclinical brain embolus (~48%) and any acute brain embolus (~80%) among patients with left-sided infective endocarditis (Circulation 2009;120:585-91). The present study used these data to show an increase in the rate of diagnosis of infective endocarditis, and altered medical and/or surgical management in patients with evidence of subclinical brain pathology (ischemic lesions, aneurysms). However, as the authors note, it is not known whether the additional data actually should have altered therapy, or in any way improved outcomes. If existing diagnostic criteria and therapeutic recommendations include the presence or absence of clinically apparent embolic events, it does not logically follow that management necessarily should be altered by extrapolation to include subclinical events. It is clear that doing more tests will result in the detection of more abnormalities. However, improved clinical outcomes should remain the relevant endpoint. David S. Bach, M.D., F.A.C.C.

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Title: Prevention of Atrial Fibrillation by Renin-Angiotensin System Inhibition: A Meta-Analysis
Topic: Arrhythmias
Date Posted: 5/17/2010 5:00:00 PM
Author(s): Schneider MP, Hua TA, Bohm M, Wachtell K, Kjeldsen SE, Schmieder RE.
Citation: J Am Coll Cardiol 2010;55:2299-2307.
Clinical Trial: No
Study Question: Do angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin-receptor blockers (ARBs) prevent atrial fibrillation (AF)?
Methods: This was a meta-analysis of 23 randomized trials in which the effects of ACEIs or ARBS on AF were evaluated in a total of 87,048 patients. Eleven were 1° prevention studies (six hypertension trials, two post-infarction trials, and three heart failure trials) and 12 were 2° prevention trials (eight studies after cardioversion and four studies in patients on medical therapy for AF).
Results: Overall, ACEIs and ARBs significantly decreased the odds of AF by 33%. The effects of ACEIs/ARBs were not uniform in all subgroups. In the hypertension and post-infarction trials, treatment with ACEIs/ARBs did not significantly reduce the odds of developing AF. In contrast, there was a 48% reduction in the probability of AF in the three heart failure trials, a 45% reduction in the eight post-cardioversion studies, and a 63% reduction in the four medical therapy studies. In the medical therapy studies, ACEIs or ARBs were used in combination with rhythm-control antiarrhythmic drugs.
Conclusions: The most consistent evidence that ACEIs and ARBs prevent AF is in studies on the 1° prevention of AF in patients with heart failure and on the 2° prevention of AF post-cardioversion and during medical therapy for paroxysmal AF.
Perspective: The results of this meta-analysis are consistent with a large body of experimental evidence indicating that the renin-angiotensin system plays a role in atrial structural and electrophysiological remodeling. For example, angiotensin II activates pathways leading to atrial fibrosis, and can affect outward potassium currents involved in the pathogenesis of AF. Fred Morady, M.D., F.A.C.C.

Title: The Long- and Short-Term Impact of Elevated Body Mass Index on the Risk of New Atrial Fibrillation: The WHS (Women’s Health Study)
Topic: Arrhythmias
Date Posted: 5/17/2010 5:00:00 PM
Author(s): Tedrow UB, Conen D, Ridker PM, et al.
Citation: J Am Coll Cardiol 2010;55:2319-2327.
Clinical Trial: No
Related Resources
For Patients: Weight Gain Increases Risk of Atrial Fibrillation
Trial: Women's Health Study: Low-Dose Aspirin in Primary Prevention
Trial: Women's Health Study: Vitamin E in Primary Prevention

Study Question: Is body mass index (BMI) associated with risk of atrial fibrillation (AF)?
Methods: Data from the Women’s Health Study (WHS) were used for the present analysis. WHS was a randomized controlled trial of low-dose aspirin and vitamin E. A total of 39,876 women with no evidence of cardiovascular disease at baseline comprised the study population. After the randomized controlled trial ended, 35,545 continued to be followed in an observation cohort. Women with AF at baseline were excluded. Baseline and follow-up questionnaires were used to assess self-reported BMI and occurrence of AF. Women who reported having AF, had medical charts reviewed for confirmation of the arrhythmia.
Results: A total of 34,309 women were included in the present study. Over the mean 12.9 years of follow-up, 834 confirmed cases of AF occurred. BMI was associated with AF risk with an increase of 4.7% (95% confidence interval [CI], 3.4-6.1) for each kg/m2. After adjustment for inflammatory markers, the risk was attenuated. Short-term risk of AF was highest for women who were obese (hazard ratio [HR], 1.65; 95% CI, 1.36-2.00), followed by women who were overweight (HR, 1.22; 95% CI, 1.02-1.45) compared to those who were normal weight, after adjustment of updated measures of BMI over time. Women who become obese during the first 60 months had a 41% adjusted increased risk for developing AF as compared to women who maintained a BMI <30 kg/m2. The adjusted proportion of incident AF attributable to short-term elevations in BMI was 18.3%.
Conclusions: The investigators concluded that BMI is associated with risk of AF among apparently healthy women.
Perspective: These findings add further evidence to the importance of maintaining a healthy weight. Additional information on the impact of fitness in relation to BMI and incident AF would provide further clinically relevant information. Elizabeth A. Jackson, M.D., F.A.C.C.

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Title: Metabolic Syndrome and Risk of Acute Myocardial Infarction: A Case-Control Study of 26,903 Subjects From 52 Countries
Topic: Prevention/Vascular
Date Posted: 5/18/2010
Author(s): Mente A, Yusuf S, Islam S, et al., on behalf of the INTERHEART Investigators.
Citation: J Am Coll Cardiol 2010;55:2390-2398.
Clinical Trial: No
Related Resources
JACC Article: Metabolic Syndrome and Risk of Acute Myocardial Infarction: A Case-Control Study of 26,903 Subjects From 52 Countries
Trial: A Study of Risk Factors for First Myocardial Infarction in 52 Countries and Over 27,000 Subjects (INTERHEART)

Study Question: What is the risk of acute myocardial infarction (MI) conferred by the metabolic syndrome (MS) and its individual factors in multiple ethnic populations?
Methods: Participants in the INTERHEART study (n = 26,903) involving 52 countries were classified using the World Health Organization (WHO) and International Diabetes Federation (IDF) criteria for MS, and their odds ratios (ORs) for MI were compared with the individual MS component factors.
Results: The MS is associated with an increased risk of MI, both using the WHO (OR, 2.69; 95% confidence interval [CI], 2.45-2.95) and IDF (OR, 2.20; 95% CI, 2.03-2.38) definitions, with corresponding population attributable risks of 14.5% (95% CI, 12.7-16.3%) and 16.8% (95% CI, 14.8-18.8%), respectively. The associations are directionally similar across all regions and ethnic groups. Using the WHO definition, the association with MI by the MS is similar to that of diabetes mellitus (OR, 2.72; 95% CI, 2.53-2.92) and hypertension (OR, 2.60; 95% CI, 2.46-2.76), and significantly stronger than that of the other component risk factors. The clustering of ≥3 risk factors with subthreshold values is associated with an increased risk of MI (OR, 1.50; 95% CI, 1.24-1.81) compared with having component factors with “normal” values. The IDF definition showed similar results.
Conclusions: In this large-scale, multi-ethnic, international investigation, the risk of MS on MI is generally comparable to that conferred by some, but not all, of its component risk factors. The characterization of risk factors, especially continuous variables, as dichotomous will underestimate risk and decrease the magnitude of association between MS and MI.
Perspective: The risk of MI was not significantly associated with MS among North Americans, although subanalyses by ethnicity show that MS is consistently associated with MI. The authors suggested this may reflect the heterogeneity of the subjects recruited from Canada and the United States. Because fasting samples were not available, it is not possible to draw conclusions about the value of triglycerides as used in the Adult Treatment Panel III definition for the MS. An interesting and intuitive finding is that clinical clustering of subthreshold values for MS parameters is associated with an increased risk of MI, a finding that has considerable importance when discussing potential value of lifestyle changes in men and women. Melvyn Rubenfire, M.D., F.A.C.C.

Title: Intravascular Ultrasound-Derived Measures of Coronary Atherosclerotic Plaque Burden and Clinical Outcome
Topic: Noninvasive Cardiology
Date Posted: 5/18/2010
Author(s): Nicholls SJ, Hsu A, Wolski K, et al.
Citation: J Am Coll Cardiol 2010;55:2399-2407.
Clinical Trial: No
Related Resources
JACC Article: Intravascular Ultrasound-Derived Measures of Coronary Atherosclerotic Plaque Burden and Clinical Outcome

Study Question: What is the relationship between intravascular ultrasound (IVUS)-derived measures of atherosclerosis and cardiovascular outcomes?
Methods: The authors evaluated coronary plaque progression as assessed by IVUS in 4,137 patients enrolled in six clinical trials, and assessed the association between baseline and change in percent atheroma volume (PAV) and total atheroma volume with incident major adverse cardiovascular events (MACE).
Results: There was an increase in PAV by 0.3% (p < 0.001) over the study period. MACE occurred in 19.9% of subjects, with most of the events being coronary revascularization (0.9% death, 1.8% myocardial infarction, 18.9% coronary revascularization). Patients with evidence of greater baseline PAVs were more likely to experience a myocardial infarction (PAV 42.2% vs. 38.6%), and coronary revascularization (41.2% vs. 38.1%). The average follow-up was 21 months. Greater increases in PAV were observed in subjects who experienced coronary revascularization compared with those who did not (0.96% vs. 0.46%, p < 0.001). After adjusting for other factors, independent predictors of MACE were baseline PAV, change in PAV, smoking, and hypertension.
Conclusions: There is a direct association between baseline burden of atherosclerosis, its progression, and occurrence of MACE.
Perspective: Multiple trials have used IVUS to assess change in plaque burden as a surrogate for anti-atherosclerotic efficacy of various therapeutic agents, although there are limited data to suggest that these changes in plaque correlate with reduction in hard clinical events. This study provides some evidence that slower progression of plaque may be associated with a reduction in clinical events, although this was driven predominantly by fewer myocardial revascularizations. Further studies are needed to clarify if plaque imaging can help predict hard events and whether it can be used as a surrogate marker for evaluation of hard clinical events. Hitinder S. Gurm, M.B.B.S., F.A.C.C.

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Title: Dual Antiplatelet Therapy and Heparin “Bridging” Significantly Increase the Risk of Bleeding Complications After Pacemaker or Implantable Cardioverter-Defibrillator Device Implantation
Topic: Arrhythmias
Date Posted: 5/18/2010
Author(s): Tompkins C, Cheng A, Dalal D, et al.
Citation: J Am Coll Cardiol 2010;55:2376-2382.
Clinical Trial: No
Related Resources
JACC Article: Dual Antiplatelet Therapy and Heparin “Bridging” Significantly Increase the Risk of Bleeding Complications After Pacemaker or Implantable Cardioverter-Defibrillator Device Implantation

Study Question: Do antiplatelet agents and heparin increase the risk of bleeding complications at the time of cardiac device implantation?
Methods: This was a retrospective study of 1,388 patients (mean age 65 years) who underwent implantation of a pacemaker or implantable cardioverter defibrillator (ICD). Antiplatelet therapy consisted of aspirin in 536 patients and the combination of aspirin plus clopidogrel in 139. Anticoagulant therapy consisted of warfarin with an international normalized ratio (INR) ≥1.5 in 45 patients and heparin in 155. A significant bleeding complication was defined as a pocket hematoma or other bleeding complication requiring a blood transfusion, pressure dressing, change in medical therapy, or prolonged hospitalization.
Results: A bleeding complication occurred in 5.1% of patients. The incidence was significantly higher in patients receiving aspirin plus clopidogrel (7.2%) than in patients receiving neither agent. Aspirin by itself did not significantly increase the bleeding risk. The strongest independent predictor of a bleeding complication was the use of heparin (odds ratio [OR], 9.9), followed by warfarin (OR, 5.6) and the combination of aspirin plus clopidogrel (OR, 3.8). The type of device implanted did not affect the bleeding risk.
Conclusions: Heparin, warfarin, and the combination of aspirin and clopidogrel significantly increase the risk of significant bleeding at the time of pacemaker or ICD implantation.
Perspective: The findings make a strong case for avoiding the use of heparin bridging in patients undergoing device implantation. In patients at high risk of thromboembolism, warfarin should be continued without interruption. Regarding aspirin plus clopidogrel, this combination increases the risk of bleeding and should be avoided unless needed because of a drug-eluting stent. Fred Morady, M.D., F.A.C.C.

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Title: ACCF/ACR/AHA/NASCI/SAIP/SCAI/SCCT 2010 Expert Consensus Document on Coronary Computed Tomographic Angiography: A Report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents
Topic: Noninvasive Cardiology
Date Posted: 5/17/2010 2:00:00 PM
Author(s): Mark DB, Berman DS, Budoff MJ, et al.
Citation: J Am Coll Cardiol 2010;May 17:[Epub ahead of print].
Clinical Trial: No
Perspective: Advances in computed tomography (CT) imaging technology, including the introduction of multi-detector row systems with electrocardiographic gating, have made imaging of the heart and the coronary arteries feasible. The potential to noninvasively obtain information comparable to that provided by invasive coronary angiography has been the major driving force behind the growth and dissemination of cardiac CT imaging. This expert consensus document focuses on the perspective of clinicians caring for patients with suspected or known coronary artery disease (CAD) in evaluating the potential current uses for cardiac CT angiography (CTA). The following are points to remember.

1. The best results are achieved with a slow, steady heart rate; intravenous contrast is administered, and periprocedural beta-adrenergic antagonists and/or nitroglycerin can help enhance image quality.

2. Coronary CTA provides information about the coronary lumen that attempts to approximate the information available from invasive coronary angiography. In addition, it provides information about the presence of nonobstructive plaque in the vessel walls.

3. Left ventricular (LV) systolic function can be estimated using CTA. LV assessment by CTA is based on use of retrospective gating with reconstruction of up to 20 phases of the cardiac cycle, including end-systole and end-diastole. Many of the desired LV functional calculations can be automated, although operator interaction with manual correction often is required.

4. Compared to invasive coronary angiography, studies evaluating the diagnostic accuracy of coronary CTA suggest that:
Studies demonstrating poorer performance are much less likely to be submitted to journals or favorably received by the peer review process.
≤5% of patients had nonevaluable scans.
Average per-patient sensitivity for identifying obstructive CAD was 98%, with average per-patient specificity of 88%.
Among populations tested with a mean prevalence of obstructive CAD of 61%, post-test probabilities for a negative test (negative predictive values) averaged 96%, and post-test probabilities for a positive test averaged 93% (range 64-100%).

5. Studies assessing the prognostic power of CTA among stable patients with suspected CAD suggest that the presence of plaque in greater numbers of coronary arteries, along with the severity of stenosis observed and the presence of plaque in the left main coronary artery, were predictors of mortality. A summary measure of the extent and severity of CAD (a modified Duke Coronary Disease Index) also has been shown to have independent prognostic power. Among patients with no detectable plaque by coronary CTA, mortality rate was 0.3% over the subsequent 15 months, suggesting that a completely negative study was associated with a very low risk of death.

6. Studies evaluating the use of coronary CTA among patients with acute chest pain were useful to reinforce data from the stable angina studies, showing that a negative coronary CTA study improves diagnostic certainty for ruling out significant CAD in a low-risk population.

7. Emerging applications of coronary CTA include assessment of noncalcified coronary plaque, assessing atherosclerotic burden, identification of vulnerable plaque, and assessment of LV enhancement patterns.

8. A substantial number of coronary CTA imaging studies result in incidental extracardiac findings. The literature describing the prevalence of extracardiac abnormalities in cardiac CT studies, the extent of their clinical significance, and the impact on patient health remains insufficient to answer important clinical and policy questions raised by this aspect of the test. Similarly, there is not a consensus regarding the use of coronary CTA as a screening test among people with known risk factors for, but no symptoms of, CAD.

9. Safety considerations associated with the use of coronary CTA include issues related to radiation exposure and radiation dose, and exposure to intravenous contrast agents.

10. The cost-effectiveness of coronary CTA could be favorable among low-risk patients presenting to the emergency department with chest pain, when compared with alternative management comprising observation, assessment of biomarkers, and stress testing. However, the overall cost-effectiveness of coronary CTA in a variety of clinical scenarios still requires evaluation. David S. Bach, M.D., F.A.C.C.