Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices.

BACKGROUND: Vascular access site management is crucial to safe, efficient and comfortable diagnostic or interventional transfemoral percutaneous coronary procedures. Two new femoral access site closure devices, Perclose and Angio-Seal , have been proposed as alternative methods to manual compression (MC). We compared these two devices and tested them in reference to standard MC for safety, effectiveness and patient preference. METHODS: Prospective demographic, peri-procedural, and late follow-up data for 1,500 patients undergoing percutaneous coronary procedures were collected from patients receiving femoral artery closure by MC (n = 469), Perclose (n = 492), or Angio-Seal (n = 539). Peri-procedural, post-procedural, and post-hospitalization endpoints were: 1) safety of closure method; 2) efficacy of closure method; and 3) patient satisfaction. RESULTS: Patients treated with Angio-Seal experienced shorter times to hemostasis (p < 0.0001, diagnostic and interventional) and ambulation (diagnostic, p = 0.05; interventional, p < 0.0001) than those treated with Perclose. Those treated with Perclose experienced greater access site complications (Perclose vs. Angio-Seal, p = 0.008; Perclose vs. MC, p = 0.06). Patients treated with Angio-Seal reported greater overall satisfaction, better wound healing and lower discomfort (each vs. Perclose or vs. MC, all p < or = 0.0001). For diagnostic cath only, median post-procedural length of stay was reduced by Angio-Seal (Angio-Seal vs. MC, p < 0.0001; Angio-Seal vs. Perclose, p = 0.009). No difference was seen in length of stay for interventional cases. CONCLUSIONS: Overall, Angio-Seal performed better than Perclose or MC in reducing time to ambulation and length of stay among patients undergoing diagnostic procedures. There was a higher rate of successful deployment and shorter time to hemostasis for Angio-Seal, and this was accomplished with no increase in bleeding complications throughout the follow-up. Additionally, Angio-Seal performed better than Perclose in exhibiting a superior 30-day patient satisfaction and patient assessment of wound healing with less discomfort.

Lisinopril versus placebo in the treatment of heart failure: the Lisinopril Heart Failure Study Group.

Lisinopril, a long-acting, angiotensin-converting enzyme inhibitor, was compared with placebo in a randomized, parallel, double-blind, 12-week study of 193 patients with heart failure. All patients were New York Heart Association Functional Class II, III, or IV and had remained symptomatic despite optimal dosing with digoxin and diuretics. After 12 weeks of therapy, the improvement in treadmill exercise duration was greater in the lisinopril group (113 seconds) compared with the placebo group (86 seconds). This improvement in exercise duration was particularly evident in patients with left ventricular ejection fractions less than 35% (lisinopril = 130 seconds; placebo = 94 seconds). In patients receiving lisinopril, the increase in exercise duration was accompanied by an improvement in quality of life as measured by the Yale Scale Dyspnea/Fatigue Index and in signs and symptoms of heart failure. In addition, the lisinopril group had a larger mean increase (3.7%) in left ventricular ejection fraction when compared with the placebo group (1.3%). Thus, lisinopril, administered once daily for 12 weeks, was well tolerated and efficacious in the treatment of heart failure when used concomitantly with diuretics and digoxin.

Myocardial infarction in the 1990s. Complications, prognosis, and changing patterns of management.

Arrhythmias are the most common complications of acute myocardial infarction. However, other complications, such as ventricular free-wall rupture, thrombosis in locations other than the primary site of infarction, and thromboembolic strokes, also may occur. In addition, thrombolytic therapy given after infarction may cause intracranial hemorrhage, allergic reactions, and hypotension. To reduce the 1-year mortality rate in patients who survive hospitalization, an effort should be made to detect and treat residual ischemia, ventricular dysfunction, and electrical instability. Follow-up rehabilitation and prevention are essential. In this endeavor, primary care physicians, emergency personnel, specialists, nursing staff, and technicians form an integral team.

Myocardial infarction in the 1990s. The importance of early thrombolytic therapy.

Substantial advances in the diagnosis and treatment of ischemic heart disease, especially myocardial infarction, have reduced mortality rates during the past several years. This progress is tempered, however, by the continuing large overall incidence of myocardial infarction and cardiac death in persons in their prime years. Preventive measures are important and are usually best applied by primary care physicians. The acute crisis of coronary artery thrombosis demands accurate diagnosis and timely thrombolytic therapy, which has halved the mortality rate of myocardial infarction. Several effective thrombolytic agents are available; on the basis of several large international trials of these drugs, it appears that the benefits of early and appropriate use of any one of these agents outweigh any individual advantages. In addition to thrombolytics, aspirin and heparin are necessary adjunctive drugs for acute myocardial infarction. Nitroglycerin is helpful, but its essential role seems less evident. Earlier use of beta blockers and angiotensin-converting enzyme inhibitors has been proved effective in reducing mortality. Percutaneous transluminal coronary angioplasty is definitely as effective as thrombolytic therapy, but immediate application is logistically challenging in most US hospitals.

Relation of baseline characteristics to suppression of ventricular arrhythmias during placebo and active antiarrhythmic therapy in patients after myocardial infarction.

In the Cardiac Arrhythmia Pilot Study (CAPS), patients early (6-60 days) after acute myocardial infarction (MI) with ventricular premature complexes (VPCs) of over 10 per hour were randomized to receive, unaware, therapy with one of four antiarrhythmic drugs (n = 402) or placebo (n = 100). Treatment success was defined as 70% or more decrease in VPC rate and 90% or more decrease in VPC runs. If the first active drug was ineffective, a second drug was given. If placebo was ineffective, a second placebo was given. To determine whether or not baseline clinical characteristics predict the response to antiarrhythmic therapy, 10 baseline variables were selected for investigation: age, prior MI, time from CAPS MI to randomization, ejection fraction, baseline VPC frequency, presence of runs (greater than or equal to 3 consecutive VPCs, greater than or equal to 100 beats/min), beta-blocker therapy, digitalis therapy, MI transmurality, and MI location. At the end of the first drug treatment, apparent treatment success in patients receiving placebo was associated on univariate analysis with absence of prior MI, with trends for younger age and Q wave MI, whereas in patients receiving active therapies, higher ejection fraction and younger age were associated with better suppression. In the encainide and flecainide treatments, where the greatest response was observed, absence of prior MI, higher ejection fraction, and younger age were associated with more successful treatment. In a multivariate analysis with these variables, ejection fraction and age remained significant for all active therapies, absence of prior MI and ejection fraction remained significant in the encainide and flecainide treatments, and absence of prior MI in the placebo treatment. Few variables except ejection fraction were associated with VPC suppression during the 1-year follow-up, and only lower ejection fraction and older age related to loss of long-term suppression. Thus, there are only a few independent baseline clinical variables (notably, ejection fraction) that substantially affect antiarrhythmic drug efficacy in suppressing VPCs in patients early after MI. Some variables, however, may be associated with spontaneous arrhythmia variability, leading to an apparent (placebo) response. These findings will be helpful in designing and interpreting treatment studies in patients after MI.

Endomyocardial biopsy.

Endomyocardial biopsy is an accepted, useful invasive tool for the analysis of human endomyocardium at the cellular and subcellular levels. It is applicable in the evaluation of specific diseases including cardiac allograft rejection, myocarditis, anthracycline cardiotoxicity, and infiltrative cardiomyopathies. The procedure can be performed in a cardiac catheterization room on an outpatient basis. The technique is quite safe when performed by trained cardiologists. Left ventricular biopsies are also safe but require systemic heparinization to prevent thromboembolization. The clinical indications for performing an endomyocardial biopsy include routine followup and suspected rejection of cardiac allograft, suspected myocarditis, monitoring or diagnosis of suspected anthracycline cardiotoxicity, and suspected secondary cardiomyopathies. Left ventricular endomyocardial biopsy is indicated for diseases that predominantly involve the left side of the heart, including left heart irradiation, cardiac fibroelastosis in infants, endomyocardial fibrosis, and scleroderma heart disease, and when right ventricular biopsy is unsuccessful. Endomyocardial biopsy is increasingly being used for research in the areas of tissue biochemistry, primary and valvular cardiomyopathies, immunology, beta receptor enzymology, drug interactions, and myocardial fibrosis. Endomyocardial biopsy has not been shown to be clinically useful in the evaluation of primary, dilated, hypertrophic, or alcoholic cardiomyopathies. These disease processes all lack pathognomomic microscopic abnormalities, and subclassification has neither been successful nor therapeutically useful. In addition, this technique is limited in diagnosing any cardiac abnormality that is not diffuse, inasmuch as only a few samples of the endomyocardial layer are obtained for evaluation. Therefore, a negative biopsy result is not 100 percent specific in excluding certain diseases. A further limitation of this technique is the need for an experienced cardiac pathologist who is well versed in interpretation of biopsy specimens. Finally, there should be a sufficiently large case load to train and to maintain skilled practitioners so that the procedure can be performed with little risk. The role of endomyocardial biopsy will continue to expand as research continues to find more uses for the technique and as more clinicians become skilled in its use.

Noninvasive evaluation of the severity of aortic stenosis in adult patients.

To determine if a combination of noninvasive variables would be useful in the prediction of the severity of isolated aortic stenosis (AS), 53 patients (mean age 63.4 = 11 years) were evaluated by the following criteria: (1) aortic valve calcification in the plain chest x-ray film; (2) left ventricular hypertrophy by ECG and M-mode echocardiography; (3) faint or absent aortic closure sound; (4) timing of the peak of the systolic murmur; (5) half rise time (T time) of the carotid pulse; and (6) ejection time index. A numeric scoring system and a logistic regression model employing these variables were developed. The total maximum score was 16 points. Sensitivity and specificity for each variable were determined. Patients with clinically evident coronary artery disease (CAD) and significant aortic regurgitation were excluded. All patients underwent hemodynamic studies and coronary arteriography. Thirty-two patients had severe AS (aortic valve area less than 0.75 cm2) and 21 had mild to moderate AS (aortic valve area greater than 0.75 cm2). Significant CAD (greater than or equal to 50% reduction in luminal diameter) was present in 55% of patients. A total score of greater than or equal to 5 occurred in 59% (19 of 32) of patients with severe AS compared to 5% (1 of 21) of patients with mild AS. The presence of subclinical CAD moderately reduced the accuracy of the scoring system principally by its effect upon the timing of the systolic murmur and the ejection time. Combining the scoring system with the presence or absence of symptoms improved the identification of severe AS in patients with a low score.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical and pathologic findings of myocarditis in two families with dilated cardiomyopathy.

The use of endomyocardial biopsy and gallium-67 scans in patients with dilated cardiomyopathy (DCM) has demonstrated the presence of myocardial inflammation in a subset of patients. A family with DCM was studied with endomyocardial biopsy and gallium-67 scanning; both identified the presence of myocarditis in the proband. Evaluation of histologic sections from decreased family members revealed myocarditis as the principal pathologic finding. This patient identified during life demonstrated a defect in suppressor lymphocytic function and improved with immunosuppressive therapy. A second family with DCM was discovered when postmortem examination of the proband and his father's heart showed myocarditis. A living sibling was identified with asymptomatic myocardial dysfunction. Longitudinal follow-up of surviving members of both families are in progress. This study indicates that thorough diagnostic evaluation of all patients with familial DCM should be pursued to identify subgroups with potentially treatable inflammation.

Left ventricular function at high altitude examined by systolic time intervals and M-mode echocardiography.

To better understand the effects of high-altitude hypoxia on cardiac performance, healthy lowland-residing volunteers were studied in 2 groups: 10 subjects after acute ascent to 12,500 ft (3,810 m) (acute group) and 9 subjects after chronic exposure for 6 weeks to 17,600 ft (5,365 m) and 11,000 ft (3,353 m) (chronic group). Systolic time intervals and M-mode echocardiograms were recorded at low and high altitudes. Heart rate was 21% greater at high altitude for all subjects. Preejection period/left ventricular ejection time (PEP/LVET) increased by 16% in the acute group and by 22% in the chronic group. Heart size was smaller at high altitude in both groups, with left atrial and left ventricular (LV) diameters decreasing by 10 to 12%. These changes were statistically significant (p less than or equal to 0.01). Despite the increase in PEP/LVET, echocardiographic measurements of LV function (percent fractional shortening and mean normalized velocity of circumferential fiber shortening) remained normal. LV isovolumic contraction time was shorter at high altitude, suggesting heightened, rather than depressed, contractility. LV function does not appear to deteriorate at high altitude. Alterations in systolic time intervals probably result from decreased preload, as reflected by smaller heart size, rather than from heart failure or depressed LV contractility.

Endomyocardial biopsy.

Endomyocardial biopsy has been used more frequently over the past 10 years in an increasing number of centers in this country and abroad. When done by an experienced physician, it is as safe as routine cardiac catheterization. Although biopsy is not yet applicable in all cases of myocardial disease, many investigators have found this procedure valuable in specific circumstances, including cardiac allograft rejection, anthracycline-induced cardiomyopathy, and myocarditis. With this technique diagnoses can be made for various disorders including cardiac amyloidosis, sarcoidosis, hemochromatosis, and endomyocardial fibrosis. Although helpful in detecting an unsuspected condition or in formulating prognosis in some patients, biopsy is not diagnostically specific in patients with dilated or hypertrophic cardiomyopathy, because these diseases have no completely pathognomonic features under current examination methods. The proper practice of endomyocardial biopsy requires both technical proficiency and expert pathologic interpretation. As a research tool, biopsy will continue to yield new knowledge about myocardial disease and its treatment.

Relation of P-S4 interval to left ventricular end-diastolic pressure.

Reports have suggested that the interval between P wave onset and the fourth heart sound (P-S4 interval) reflects changes in left ventricular myocardial stiffness. We made simultaneous measurements of the P-S4 or atrial electrogram to S4 (A-S4) interval and left ventricular pressure in 19 patients with coronary artery disease who were studied before and after atrial pacing. Thirteen patients developed angina accompanied by significant rises in their end-diastolic pressure and a consistent decrease in P-S4 or A-S4 interval; whereas the six patients who had atrial pacing without the development of angina had no change in end-diastolic pressure, P-S4, or A-S4 interval. The resting data showed in inverse correlation between left ventricular end-diastolic pressure and the P-S4 interval. In addition, the P-S4 interval let us discriminate between patients with normal and abnormal end-diastolic pressure (greater than 15 mmHg).

Aortitis in ankylosing spondylitis: early detection of aortic root abnormalities with two dimensional echocardiography.

Mild aortic root dilatation, cusp thickening and subvalvular fibrous ridges have been reported as characteristic in patients with ankylosing spondylitis and aortic regurgitation. Thirty-five patients with ankylosing spondylitis (10 also had Reiter's syndrome) without clinically apparent cardiac involvement were studied using phased array two dimensional and sector-directed M mode echocardiography to determine the prevalence of aortic abnormalities. Aortic root dimensions were measured at the aortic anulus, at the tip of the cusps and 0.5 to 1.5 cm above the cusps. The two dimensional echocardiographic study was also analyzed for qualitative abnormalities. The dimensions were compared with those in 20 normal men and among patient subgroups separated according to age, duration and severity of ankylosing spondylitis and presence of qualitative abnormalities. With one exception, no abnormally increased aortic dimensions suggestive of aortic dilatation were found in any group. However, two patients had aortic dimensions greater than 4.2 cm at the valve (normal 4.0 cm or less). Also, six patients had discrete areas of increased bright echoes below the left or noncoronary cusps suggestive of a subaortic "bump" and two of the six patients had increased aortic cusp echoes suggestive of thickening or fibrosis, or both. These changes tended to occur more commonly in older patients and those with more severe disease. It is concluded that aortic root changes suggestive of inflammation or fibrosis, or both, occur in asymptomatic patients with ankylosing spondylitis and are detectable on two dimensional echocardiography. Dilatation usually does not occur without aortic regurgitation.

Spontaneous dissection of the ascending aorta diagnosed by two-dimensional echocardiography.

In two patients with acute dissection of the ascending aorta, the diagnosis was made with two-dimensional echocardiography and confirmed by aortography. The echocardiograms localized the intimal flap and false channel in both cases. Although clinical evaluation and indicated radiologic studies remain the primary modalities of diagnosis in acute aortic dissection, two-dimensional echocardiography may be a useful additional diagnostic technique.

Patients with congestive cardiomyopathy as cardiac transplant recipients. Indications for and results of cardiac transplantation and comparison with patients with coronary artery disease.

In recent years end-stage congestive cardiomyopathy has become an increasingly frequent clinical diagnosis in candidates for cardiac transplantation. Forty-six patients who underwent transplantation because of congestive cardiomyopathy and 59 because of coronary artery disease were studied between 1971 and 1978 at Stanford University. The overall 1 year survival rate was similar in the two groups: cardiomyopathy-transplant, 64 percent and coronary artery disease-transplant, 55 percent. The survival rate has improved substantially for both groups within the last decade: The 3 year survival rate for cardiomyopathy-transplant patients undergoing cardiac transplantation since 1974 is nearly 60 percent. In contrast, 36 similarly ill patients with cardiomyopathy not undergoing transplantation had a 1 year survival rate of 23 percent and a 3 year survival rate of 4 percent (p less than 0.001). Survival rates in the cardiomyopathy-transplant group were unaffected by age (greater or less than 40 years). Patients in this group under age 40 had a lower frequency of infection (1 per 313 patient-days versus 1 per 195 patient-days in the older group, p less than 0.05) and a significantly longer interval to second rejection episodes (p less than 0.05), a measure of rejection frequency. Cardiomyopathy-transplant patients under age 40 had fewer deaths due to rejection (17 percent) compared with older patients in this group (36 percent). Cardiac transplantation is an effective treatment for end-stage congestive cardiomyopathy.

Coronary artery spasm in the denervated transplanted human heart: a clue to underlying mechanisms.

The mechanism of coronary artery spasm has been poorly understood but there has been some suggestion that cardiac autonomic innervation may play an important role. We report coronary artery spasm in a 43 year old man two years after he had received a transplant. Provocative pharmacologic testing suggested functional denervation of the patient's heart. Thus, coronary artery spasm can occur in the transplanted, denervated human heart. Autonomic innervation of the heart is not essential in all cases of coronary spasm, and circulating catecholamines and/or metabolic of hormonal products may play an important role.