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CONTEXT - Previous studies using autologous bone marrow mononuclear cells (BMCs) in patients with ischemic cardiomyopathy have demonstrated safety and suggested efficacy.
OBJECTIVE - To determine if administration of BMCs through transendocardial injections improves myocardial perfusion, reduces left ventricular end-systolic volume (LVESV), or enhances maximal oxygen consumption in patients with coronary artery disease or LV dysfunction, and limiting heart failure or angina.
DESIGN, SETTING, AND PATIENTS - A phase 2 randomized double-blind, placebo-controlled trial of symptomatic patients (New York Heart Association classification II-III or Canadian Cardiovascular Society classification II-IV) with a left ventricular ejection fraction of 45% or less, a perfusion defect by single-photon emission tomography (SPECT), and coronary artery disease not amenable to revascularization who were receiving maximal medical therapy at 5 National Heart, Lung, and Blood Institute-sponsored Cardiovascular Cell Therapy Research Network (CCTRN) sites between April 29, 2009, and April 18, 2011.
INTERVENTION - Bone marrow aspiration (isolation of BMCs using a standardized automated system performed locally) and transendocardial injection of 100 million BMCs or placebo (ratio of 2 for BMC group to 1 for placebo group).
MAIN OUTCOME MEASURES - Co-primary end points assessed at 6 months: changes in LVESV assessed by echocardiography, maximal oxygen consumption, and reversibility on SPECT. Phenotypic and functional analyses of the cell product were performed by the CCTRN biorepository core laboratory.
RESULTS - Of 153 patients who provided consent, a total of 92 (82 men; average age: 63 years) were randomized (n = 61 in BMC group and n = 31 in placebo group). Changes in LVESV index (-0.9 mL/m(2) [95% CI, -6.1 to 4.3]; P = .73), maximal oxygen consumption (1.0 [95% CI, -0.42 to 2.34]; P = .17), and reversible defect (-1.2 [95% CI, -12.50 to 10.12]; P = .84) were not statistically significant. There were no differences found in any of the secondary outcomes, including percent myocardial defect, total defect size, fixed defect size, regional wall motion, and clinical improvement.
CONCLUSION - Among patients with chronic ischemic heart failure, transendocardial injection of autologous BMCs compared with placebo did not improve LVESV, maximal oxygen consumption, or reversibility on SPECT.
TRIAL REGISTRATION - clinicaltrials.gov Identifier: NCT00824005.
Myocardial bridging is characterized by intra-myocardial course of a segment of an epicardial coronary artery, leading to systolic compression. In most cases, it is considered a benign condition but rarely has been associated with serious cardiac events like myocardial infarction and sudden death. We describe a 25-year-old man with known d-transposition of the great arteries (d-TGA) status post-Mustard procedure who presented with palpitations and chest pain. Cardiac catheterization revealed complete systolic compression of a myocardial bridging segment of the left anterior descending artery and also complete compression of the first septal perforator during episodes of ectopic atrial tachycardia. No percutaneous or surgical interventions were performed. Symptoms improved after cautious use of beta-blockers. This appears to be the first report of symptomatic myocardial bridging in an adult patient with d-TGA.
© 2011 Copyright the Authors. Congenital Heart Disease © 2011 Wiley Periodicals, Inc.
OBJECTIVE - To determine whether information from the physician's initial evaluation of patients with suspected coronary artery disease predicts coronary anatomy at catheterization and 3-year survival.
DESIGN - Prospective validation of regression model estimates in an outpatient cohort.
SETTING - University medical center.
PATIENTS - A total of 1030 consecutive outpatients referred for noninvasive testing for suspected coronary artery disease; 168 of these patients subsequently underwent catheterization within 90 days.
MEASUREMENTS - Information from the initial history, physical examination, electrocardiogram, and chest radiograph was used to predict coronary anatomy (the likelihood of any significant coronary disease, severe disease [left main or three-vessel], and significant left main disease) among 168 catheterized patients and to estimate 3-year survival among all patients. These estimates were compared with those based on treadmill testing. Cardiovascular testing charges were calculated for all patients.
RESULTS - Predicted coronary anatomy and survival closely corresponded to actual findings. Compared with the treadmill exercise test, initial evaluation was slightly better able to distinguish patients with or without any coronary disease and was similar in the ability to identify patients at increased risk for dying or with anatomically severe disease. Based on arbitrary definitions, 37% to 66% of patients were at low risk and responsible for 31% to 56% of the charges for cardiovascular testing.
CONCLUSIONS - The physician's initial evaluation, despite the subjective nature of much of the information gathered, can be used to identify patients likely to benefit from further testing. The development of strategies for cost-conscious quality care must begin with the history, physical examination, and simple laboratory testing.
Thromboxane A2 (TxA2), an arachidonic acid metabolite causing vasoconstriction and platelet aggregation, is a putative mediator of coronary-artery vasospasm. To determine whether platelet-released TxA2 causes coronary arterial vasospasm, we measured plasma thromboxane B2 (TxB2, the inactive hydration product of TxA2) in the radial-artery and coronary-sinus blood of seven patients and performed therapeutic trials of antiplatelet agents in nine. Although coronary-sinus TxB2 levels rose from the base line approximately fivefold with spontaneous ischemia, samples drawn early in ischemia showed no rise over base-line values. Although a 150 mg dose of aspirin reduced urinary dinor-TxB2 levels by over 75 per cent, it had no effect on the course of the chronic recurrent form of angina pectoris due to vasospasm ("vasotonic angina"). Similarly, indomethacin had no effect on the frequency or duration of ischemia. TxA2 is unlikely to cause vasotonic angina, but it may be released during coronary vasospasm.
We analyzed the clinical outcomes in 688 patients with isolated stenosis of one major coronary artery. The survival rate among patients with disease of the right coronary artery (RCA) was higher than that among patients with left anterior descending (LAD) or left circumflex coronary artery (LCA) disease. The survival rate among patients in all three anatomic subgroups exceeded 90% at 5 years. The presence of a lesion proximal to the first septal perforator of the LAD was associated with decreased survival compared with the presence of a more distal lesion. For the entire group of one-vessel disease patients, total ischemic events (death and nonfatal infarction) occurred at similar rates regardless of the anatomic location of the lesion. Left ventricular ejection fraction was the baseline descriptor most strongly associated with survival, and the characteristics of the angina had the strongest relationship with nonfatal myocardial infarction. No differences in survival or total cardiac event rates were found with surgical or nonsurgical therapy. The relief of angina was superior with surgical therapy, although the majority of nonsurgically treated patients had significant relief of angina. The survival rate of patients with one-vessel coronary disease is excellent, and the risk of nonfatal infarction is low. Clinical strategies for the care of these patients must consider the long-term clinical course of one-vessel coronary disease.
We studied 109 consecutive patients with variant angina who underwent cardiac catheterization over an 11 year period. All patients were followed for at least 6 months or until death, and 46 patients (22 treated medically and 24 treated surgically) were followed for 5 years or more. Of the 62 patients initially treated medically, 14 had nonfatal myocardial infarctions (12 within 1 month of catheterization) and 12 died (six within 6 months). Survival probabilities at 1, 3, and 5 years were 0.88, 0.84, and 0.77, respectively. Of the 48 surgically treated patients (including four patients initially treated medically and one initially treated with coronary angioplasty), four had nonfatal infarctions (three in the perioperative period) and three died (all in the perioperative period). The survival probability in these patients at 1 year was 0.94 and remained unchanged at 3 and 5 years. Only one nonfatal infarction and no deaths have occurred in the group of surgically treated patients subsequent to hospital discharge. Three additional patients were treated with coronary angioplasty. The single most important prognostic factor in medically treated patients was the presence or absence of fixed obstructive coronary artery disease. Infarction-free survival probabilities at 1 and 3 years in the 23 patients without significant coronary artery disease were 1.0 and 0.89, compared with 0.51 and 0.46 in the 39 patients with significant coronary disease. Analysis by the Cox model showed that variant angina patients had a higher probability of death and nonfatal infarction than did those with nonvariant angina coronary disease if other important prognostic variables were held constant.(ABSTRACT TRUNCATED AT 250 WORDS)
Among 23 clinical characteristics examined in 3,627 consecutive, symptomatic patients referred for cardiac catheterization between 1969 and 1979, nine were found to be important for estimating the likelihood a patient had significant coronary artery disease. A model using these characteristics accurately estimated the likelihood of disease when applied prospectively to 1,811 patients referred since 1979 and when used to estimate the prevalence of disease in subgroups reported in the literature. Since accurate estimates of the likelihood of significant disease that are based on clinical characteristics are reproducible, they should be used in interpreting the results of additional noninvasive tests and in quantitating the added diagnostic value.