Development and validation of the ITG Health-Related Quality-of-Life Short-Form measure for use in patients with coronary artery disease. Integrated Therapeutics Group.

BACKGROUND: Available coronary artery disease (CAD)-specific health-related quality-of-life (HRQL) measures are not ideally suited for routine clinical practice. We report development of a valid and reliable CAD-specific short-form measure. HYPOTHESIS: The Integrated Therapeutics Group (ITG) CAD-specific short-form HRQL measure is reliable and valid for assessing the health status of patients with CAD. METHODS: In all, 409 patients (mean age 62.4 years) completed the 24-item CAD-specific HRQL questionnaire. Factor analysis was used to identify the scaling of the 24 CAD-specific items. Analysis of variance was used to reduce the number of items within each scale, and reliability (Cronbach's alpha), discriminant validity, and ceiling and floor effects of short-form scales were evaluated. Short-form scales were compared with the longer scales using relative validity coefficients. The CAD severity was assessed using New York Heart Association criteria, physician assessment, electrocardiogram results, the number of myocardial infarctions, and the number of CAD-specific medications. Clinical validity of short-form scales was then assessed based on their ability to discriminate across severity levels of these clinical criteria. RESULTS: Four scales were identified: Extent of Chest Pain, Functioning and Well-Being, Activities Level-Physical, and Activities Level-Social. The 24-item questionnaire was reduced to a 13-item short form, with reliability exceeding 0.70 for all four scales. Relative validity estimates comparing short-form to original scales ranged from 0.68 to 2.58. Mean scores varied significantly (p < 0.05) by clinical severity, supporting the discriminant validity of the ITG CAD short-form scales. CONCLUSIONS: The ITG CAD short form (used alone or with a general HRQL measure) is valid and practical for assessing patients with CAD.

Exercise performance-based outcomes of medically treated patients with coronary artery disease and profound ST segment depression.

OBJECTIVES: We sought to determine the relationship between exercise duration and cardiovascular outcomes in patients with profound (> or =2 mm) ST segment depression during exercise treadmill testing (ETT). BACKGROUND: Patients with stable symptoms but profound ST segment depression during ETT are often referred for a coronary intervention on the basis that presumed severe coronary artery disease (CAD) will lead to unfavorable cardiovascular outcomes, irrespective of symptomatic and functional status. We hypothesized that good exercise tolerance in such patients treated medically is associated with favorable long-term outcomes. METHODS: We prospectively followed 203 consecutive patients (181 men; mean age 73 years) with known stable CAD and > or =2 mm ST segment depression who are performing ETT according to the Bruce protocol for an average of 41 months. The primary end point was occurrence of myocardial infarction (MI) or death. RESULTS: Eight (20%) of 40 patients with an initial ETT exercise duration < or =6 min developed MI or died, as compared with five (6%) of 84 patients who exercised between 6 and 9 min and three (3.8%) of 79 patients who exercised > or =9 min (p = 0.01). Compared with patients who exercised < or =6 min, increased ETT duration was significantly associated with a reduced risk of MI/death (6 to 9 min: relative risk [RR] = 0.25, 95% confidence interval [CI] 0.08 to 0.76; >9 min: RR = 0.14, 95% CI 0.04 to 0.53). This protective effect persisted after adjustment for potentially confounding variables. We observed a 23% reduction in MI/death for each additional minute of exercise the patient was able to complete during the index ETT. CONCLUSIONS: Optimal medical management in stable patients with CAD with profound exercise-induced ST segment depression but good ETT duration is an appropriate alternative to coronary revascularization and is associated with low rates of MI and death.

Discrepancies in the use of medications: their extent and predictors in an outpatient practice.

BACKGROUND: Misuse of medications is a major cause of morbidity and mortality. Few studies have examined the frequency of, and factors associated with, discrepancies between what doctors prescribe and what patients take in actual practice. PATIENTS AND METHODS: Patients' medication bottles and their reported use of medications were compared with physicians' records of outpatients seen between November 1997 and February 1998 in a private practice affiliated with an academic medical center in Boston, Mass. Three hundred twelve patients from the practices of 5 cardiologists and 2 internists who were returning for their routine follow-up visits were included. MAIN OUTCOME MEASURE: The presence of discrepancies based on comparing medication bottles with medical records. RESULTS: Discrepancies were present in 239 patients (76%). The 545 discrepancies in these patients were the result of patients taking medications that were not recorded (n = 278 [51%]); patients not taking a recorded medication (n = 158 [29%]); and differences in dosage (n = 109 [20%]). Overall, discrepancies were randomly distributed among different drugs and discrepancy types with no discernible pattern. On multivariate analysis, patient age and number of recorded medications were the 2 most significant predictors of medication discrepancy. CONCLUSIONS: Discrepancies among recorded and reported medications were common and involved all classes of medications, including cardiac and prescription drugs. Older age and polypharmacy were the most significant correlates of discrepancy. The pervasiveness of discrepancies can have significant health care implications, and action is urgently needed to address their causes. Such action would likely have a positive impact on patient care.

Results of a second-opinion trial among patients recommended for coronary angiography.

OBJECTIVE: To assess the feasibility of carrying out a second-opinion trial for patients urged to undergo coronary angiography and to assess the long-range outcome of such patients denied that procedure, and the criteria evolved for reaching such a conclusion. DESIGN: A case series of patients referred for a second opinion as to the need for coronary angiography. Patients were followed up by questionnaire, telephone call, and center visits. SETTING: Cardiovascular referral center and teaching hospital in Boston, Mass. PATIENTS: One hundred seventy-one patients with coronary artery disease (144 men, average age 60 years; range, 36 to 88 years). Three patients became unavailable for follow-up during a mean of 46.5 months. OUTCOME MEASURES: Concordant-discordant outcome as to the second opinion, cardiac events, invasive interventions, quality of life questionnaire, and level of symptoms. RESULTS: One hundred thirty-four (80%) of the 168 patients were judged not to require angiography; it was recommended in six. In 28 (16%) recommendation was deferred pending further studies. At a mean follow-up of 46.5 months among the 168 patients, there were seven cardiac deaths (annualized cardiac mortality of 1.1%); 19 patients experienced a new myocardial infarction (2.7% annualized rate), while 27 patients (4.3%) were judged to have developed unstable angina. Twenty-six patients (15.4%) ultimately underwent either coronary bypass or angioplasty. CONCLUSIONS: In a large fraction of medically stable patients with coronary disease who are urged to undergo coronary angiography, the procedure can be safely deferred. While there may be a limitation in terms of generalizing this experience to all patients with coronary disease, we reasonably conclude that an estimated 50% of coronary angiography currently being undertaken in the United States is unnecessary, or at least could be postponed.

The prevalence of proarrhythmic events during moricizine therapy and their relationship to ventricular function.

The prevalence of proarrhythmic events during moricizine therapy was studied in 144 patients who were treated for symptomatic ventricular tachycardia or ventricular fibrillation. The overall incidence of proarrhythmia was 15.3%. (Twenty-two patients exhibited 23 events.) Ventricular fibrillation occurred in six patients (which led to three deaths), incessant ventricular tachycardia occurred in seven, and new sustained ventricular tachycardia in four. Patients with proarrhythmia had significantly lower left ventricular ejection fraction (24% vs 39%; p less than 0.0001), higher prevalence of congestive heart failure (68% vs 36%; p less than 0.005), and higher incidence of previous proarrhythmia (45% vs 9%; p less than 0.0001). No significant difference between the two groups was found in respect to age, arrhythmia at presentation, underlying heart disease, moricizine dose, or concomitant drug therapy.

Appropriate indications for ambulatory electrocardiographic monitoring. A clinical perspective.

This article summarizes the clinical indications for ambulatory monitoring using current information from the Cardiac Arrhythmia Suppression Trial and utility of the procedure to detect both drug efficacy and proarrhythmia. It also discusses silent ischemia detection and heart rate variability as an indicator of autonomic tone.

Effect of the combination of low-dose mexiletine and metoprolol on ventricular arrhythmia.

Antiarrhythmic drug therapy is often ineffective or poorly tolerated. Combining antiarrhythmic agents with different electrophysiologic properties may have a synergistic antiarrhythmic effect when compared with each drug alone. If a lower dose of each drug can be used, combination therapy may also result in lower incidence of side effects. The goal of our study was to assess the complementary effect of low-dose mexiletine and metoprolol, when compared with either drug alone. Ten patients with frequent ventricular arrhythmias including 7 patients with nonsustained ventricular tachycardia were evaluated in an open-label sequential study. The response to drug therapy was evaluated by 24-h continuous EKG monitoring, exercise stress testing, and echocardiogram after each treatment. Combination therapy effectively reduced ventricular arrhythmias in 8 patients (80%) in contrast to only 1 patient (10%) on metoprolol alone and 4 patients (40%) on mexiletine alone. In 5 patients (71%) ventricular tachycardia was abolished. The number of couplets was reduced from 51 +/- 39 to 1.9 +/- 2.4 (p less than 0.01) and total premature ventricular beats from 7790 +/- 9047 to 597 +/- 515 (p = 0.06). Combination therapy was well tolerated without proarrhythmia or precipitation of congestive heart failure. It is concluded that low-dose mexiletine combined with metoprolol is effective in suppressing ventricular arrhythmias in selected patients, and enhances the antiarrhythmic effect of either drug alone without significant side effects.

Ethics in cardiovascular medicine. Task Force II: The relation of cardiovascular specialists to patients, other physicians and physician-owned organizations.

1. The American College of Cardiology acknowledges the continuum of changing societal, medical and economic perspectives affecting traditional medical ethics. Primacy of patient responsibility remains paramount to the cardiovascular specialist who at the same time should participate in the development of broader societal programs. 2. Medical decisions should be freely and jointly formulated by the patient and the cardiovascular specialist with appropriate sensitivity to such matters as mental competence, pertinent medical information and standards of care, sufficient time for contemplation, informed consent, patient right of refusal, physician right to refuse to provide inappropriate care and the right of patient, physician or third party payer to seek consultation or additional opinions. 3. The cardiovascular specialist should make a special effort to clarify and document patient preferences regarding end-of-life treatment through some form of advance directive. 4. The cardiovascular specialist bears a moral obligation to provide medical care to any patient who is HIV positive or has AIDS. 5. A conflict of interest occurs when a cardiovascular specialist places personal or financial interest ahead of the welfare and health of a patient. Professional accountability should be established through local or regional peer review. 6. The American College of Cardiology encourages and supports a renewed dedication to the principles of medical ethics, particularly in the field of cardiovascular disease. Cardiovascular specialists are encouraged to participate in the promulgation of medical ethics by teaching and by example, individually and with others.

Conflicts of interest in the management of silent ischemia.

KIE: Nonclinical factors that may pressure physicians to intervene when a patient presents with so-called silent ischemia, and that may compel a management course not necessarily in the patient's best interest, are explored. These factors include the public's "obsession" with cardiac health, the enormous potential market for pharmaceuticals and medical devices, the funding of ischemia research by drug and medical device companies, the growth of "interventional cardiology" as a subspecialty, the increasingly entrepreneurial approach to medical care on the part of physicians and hospitals, and the fear of malpractice litigation. Given the financial advantage to health facilities and practitioners in recommending an interventionist rather than a conservative approach to silent ischemia, Graboys questions whether studies to determine the optimal management of this condition will ever be undertaken.^ieng

The effect of caffeine on ventricular ectopic activity in patients with malignant ventricular arrhythmia.

We evaluated the effect of caffeine on ventricular ectopic activity in a group of 50 consecutive patients with malignant ventricular arrhythmia. The clinical arrhythmia in these patients (mean age, 61 years) was recurrent ventricular tachycardia in 21 (42%), ventricular fibrillation in three (6%), and symptomatic nonsustained ventricular tachycardia in 26 (52%). Forty-two (84%) had either ischemic heart disease or cardiomyopathy. Each patient underwent two short-term drug trials on successive days, receiving either decaffeinated coffee mixed with 200 mg of caffeine or the decaffeinated drink alone. Continuous electrocardiographic recordings were made during the 30-minute control period, the three-hour observation period, and the hourly bicycle exercise tests. Forty-five patients (90%) exhibited ventricular couplets and 29 patients (58%) had salvos of ventricular tachycardia during the testing. However, no differences between the caffeine and decaffeinated trials were observed in either individual or group data on total or repetitive ventricular arrhythmia. Serum catecholamine levels reflected the average increase in serum caffeine level but were not associated with enhanced arrhythmia. We found no evidence that a modest dose of caffeine is arrhythmogenic, even among patients with known life-threatening arrhythmia.

Reproducibility of exercise-induced ventricular arrhythmia in patients undergoing evaluation for malignant ventricular arrhythmia.

In patients with malignant ventricular arrhythmia, the utility of exercise testing for exposing arrhythmias and guiding antiarrhythmic drug selection and dosage is not yet generally accepted. A major reservation relates to the issue of reproducibility of arrhythmia provocation. This prospective study comprised 28 patients referred for evaluation of ventricular arrhythmia. In half of these subjects the clinical arrhythmia was sustained ventricular tachycardia or ventricular fibrillation. Maximal exercise testing adhering to a Bruce protocol was performed on 2 separate days. No antiarrhythmic drugs were administered at the time of testing. Of the 28 patients, 27 had an increase in arrhythmia with exercise. The prevalence rates of arrhythmia were greater than 80% and did not significantly differ between test 1 and test 2. Excluding infrequent single ventricular premature complexes, the reproducibility of a test with positive outcome was 76%. Similarly, test-retest agreement, a bidirectional measure of reproducibility, was greater than 74%. Kappa coefficients ranged from 0.26 to 0.36 for all grades of arrhythmia, indicating that reproducibility was consistently greater than by chance alone. Linear regression analysis of arrhythmia frequency in the 2 tests yielded R values of 0.76 to 0.96 and slopes of 0.82 to 1.2. No patient had enough spontaneous variability in repetitive forms to suggest spurious efficacy or aggravation. For ventricular premature complexes there was an 8 to 14% incidence of spurious efficacy and a 4 to 7% incidence of spurious aggravation. These results suggest that exercise-induced ventricular arrhythmia is sufficiently reproducible to serve as an adjunct method in the evaluation and management of patients with potentially life-threatening ventricular arrhythmias.

Combination antiarrhythmic therapy for management of malignant ventricular arrhythmia.

The efficacy of combination drug therapy in the suppression of ambient ventricular arrhythmia was retrospectively evaluated in a study of 49 patients discharged from the hospital taking 2 membrane-active antiarrhythmic agents. Thirty-one patients (63%) had ischemic heart disease, 15 had miscellaneous cardiac disorders and 3 were free of ostensible heart disease. Therapy in all patients had previously been unsuccessful with an average of 3.7 single membrane-active drugs. Antiarrhythmic agents were discontinued for at least 48 hours to determine baseline arrhythmia levels by Holter monitoring and maximal exercise treadmill testing. Ventricular premature beats were evaluated according to the grading system of Lown and Wolf. Data on ventricular ectopic activity were obtained during Holter monitoring and exercise testing for both a control ("drug-free") period and for a period of combination therapy. During the control period, ventricular tachycardia was recorded during 23% of monitored hours, and the level was nearly twofold greater during stress testing. After institution of combined therapy, the percent of monitored hours of arrhythmia were reduced during Holter monitoring, with a greater reduction in couplets and ventricular tachycardia than in single ventricular premature beats. Ventricular tachycardia was more difficult to provoke by exercise testing in patients taking combination therapy than in control subjects. These data indicate that combination therapy can significantly reduce the density of ventricular ectopic activity in patients refractory to monotherapy. During an average follow-up of 26 months, 23 patients (47%) were able to receive decreased drug dosages, affording diminished adverse effects and improved tolerance to long-term use.