Novel method of coronary stent delivery.

Occasionally a coronary stent cannot be delivered. In this case, a dislodged stent was purposely pushed forward by the delivery balloon into position; a smaller, compliant balloon was used for initial deployment; and the original stent-delivery balloon was used for subsequent final deployment.

Safety and efficacy of epoprostenol in patients with severe congestive heart failure. Epoprostenol Multicenter Research Group.

Patients with advanced heart failure often remain severely symptomatic and have a high mortality rate despite currently available therapy. We studied the safety and efficacy of a new approach to the patient with refractory heart failure: continuous intravenous treatment via a portable infusion pump with epoprostenol (prostacyclin), a potent pulmonary and systemic vasodilator. A group of 33 patients with severe heart failure (64% New York Heart Association class IV and 36% class III) and profound ventricular dysfunction (median left ventricular ejection fraction, 0.15)--despite prior treatment with diuretics (100%), digitalis (91%), angiotensin-converting enzyme inhibitors (85%), and dobutamine (30%)--underwent a baseline 6-minute walk test prior to dose titration with epoprostenol during invasive hemodynamic monitoring. Subjects responding during the dose titration were randomized, on an open basis, to receive either continuous epoprostenol infusion via an indwelling central venous catheter plus conventional therapy or conventional therapy alone for 12 weeks. The initial dose-ranging study with epoprostenol produced a significant decline in systemic and pulmonary vascular resistance and a substantial increase in cardiac index despite a fall in pulmonary capillary wedge pressure. Symptoms related to vasodilation were noted within the first week after randomization to epoprostenol in 9 of 16 patients but resolved with adjustment of the infusion and concomitant medications in all but one subject. Dose adjustments during the chronic epoprostenol infusion were infrequent after the first week and complications related to the drug delivery system were rare. The change in distance walked from baseline to the last available 6-minute walk test was significantly greater in patients who received epoprostenol compared with patients assigned to standard therapy (72 +/- 40 vs -39 +/- 32 m, mean +/- SEM; p = 0.033). Our study suggests that long-term intravenous infusion of epoprostenol is feasible in patients with severe heart failure and our hemodynamic and functional results suggest clinical benefit as well. However, until recent results indicating an adverse effect of epoprostenol on survival are fully evaluated, the role of this drug in the treatment of advanced heart failure will remain uncertain.

Bedside cardiovascular examination in patients with severe chronic heart failure: importance of rest or inducible jugular venous distension.

OBJECTIVES: The aim of this study was to determine the sensitivity, specificity and utility of the cardiovascular examination in predicting cardiac hemodynamics in patients with advanced chronic congestive heart failure. BACKGROUND: Although the physical signs of acute left heart failure have been shown to correlate relatively well with cardiac hemodynamics, their reliability in estimating hemodynamics in patients with chronic heart failure has recently been questioned. METHODS: We prospectively recorded the history, cardiovascular physical signs present at bedside examination and the hemodynamic measurements obtained at right heart catheterization in 52 patients with chronic congestive heart failure undergoing in-hospital evaluation for possible heart transplantation. In addition, we obtained chest radiographs and multigated nuclear scans for the evaluation of left ventricular function. RESULTS: Pulmonary rales, a left ventricular third heart sound, jugular venous distension and the abdominojugular test, when positive, indicated higher right heart pressures and lower measures of cardiac performance. The presence of jugular venous distension, at rest or inducible, had the best combination of sensitivity (81%), specificity (80%) and predictive accuracy (81%) for elevation of the pulmonary capillary wedge pressure (> or = 18 mm Hg). Furthermore, in this population sample, the probability of an elevated wedge pressure was 0.86 when either variable was present. CONCLUSIONS: The bedside cardiovascular examination in the patient with chronic heart failure is extremely useful in identifying patients with elevation of right and left heart pressures. Examination for jugular venous distension at rest or by the abdominojugular test is simple and highly sensitive and specific in assessing left heart pressures in these patients.

Clinical significance of weight difference between donor and recipient in heart transplantation.

A standard and important criterion for donor acceptance is to match the donor's body weight to within 20% of the recipient's body weight. However, to meet the increasing demand of patients who need heart transplantation, frequently a heart that is below the standard criteria for donation is accepted. Of the 200 consecutive patients who underwent heart transplantation at the University of Arizona, 27 patients received a heart from a smaller donor with a weight difference of more than 30% (range 30% to 46%). The early mortality and late survival of these 27 patients were not different when compared with those of the patients who received transplants from donors with a weight difference of less than 30%. The probability of freedom from rejection and infection and postoperative ejection fraction were also similar between the two groups. Therefore, we believe that the widely accepted donor-recipient weight-match criterion of 20% can be safely extended.

Dose-related efficacy and bleeding complications of double-chain tissue plasminogen activator in acute myocardial infarction. The Wellcome Tissue Plasminogen Activator Study Group.

Although the efficacy of recombinant tissue-type plasminogen activator (rt-PA) in acute myocardial infarction has been demonstrated, little formal dose-ranging information is available. This study examined the use of duteplase, the double-chain rt-PA subsequently used in the Third International Study of Infarct Survival, in a multicenter trial of 267 patients with evolving acute myocardial infarction assigned to receive 1 of 6 weight-adjusted doses. The primary end point was infarct vessel patency after 90 minutes of drug infusion. Patency was defined as Thrombolysis in Myocardial Infarction trial grade 2 or 3 perfusion, and was determined by an independent core laboratory masked to treatment assignment. Patency was present in 48% of patients receiving the lowest dose range and 78% of those receiving the highest, with an association between thrombolytic dose and patency (p = 0.009). The frequency of serious bleeding complications also correlated with the total dose of rt-PA infused (p = 0.003). Bleeding complications were primarily related to instrumentation; blood loss requiring transfusion or otherwise deemed clinically significant occurred in 12% of patients (central nervous system hemorrhage occurred in 1.1%). Thus, higher doses of rt-PA are associated both with increased efficacy and increased risk of serious bleeding complications. Weight-adjusted dosing may provide an optimal risk-benefit ratio for thrombolysis during acute myocardial infarction.

Futility of yearly heart biopsies in patients undergoing heart transplantation.

Three hundred thirty-eight endomyocardial biopsies, performed as part of the routine annual evaluation at 1 or more years after transplantation in 211 patients, were reviewed. In only two instances (0.6%) were the histologic findings suggestive, but not pathognomonic, of acute rejection. Both patients were treated for rejection and are doing well at 4 and 6 years postoperatively. On the basis of the results of this study, we believe that routine yearly heart biopsies in asymptomatic patients are not necessary for long-term care of patients after heart transplantation, and we believe they should be performed only if there is clinical suspicion of rejection or as part of a research protocol.

Prospective study of the safety and financial benefit of ketoconazole as adjunctive therapy to cyclosporine after heart transplantation.

In a prospective study of the relative safety and potential benefit of concomitant ketoconazole and cyclosporine after heart transplantation, 15 transplant recipients were followed up for up to 1 year (mean, 10.7 months) after ketoconazole was added to their immunosuppressive regimen of cyclosporine, prednisone, and azathioprine, and these patients were compared with a matched cohort over the same time. There was an 88% reduction in the mean (+/- SD) dose of cyclosporine, from 394 (115) mg/day to 47 (21) mg/day (p less than 0.0005) in the ketoconazole group, compared with an insignificant change in the control group. The projected annual cost of cyclosporine was reduced by 88%, with a 72% reduction in the projected cost of immunosuppressive drugs and prophylactic antifungal therapy, from a mean of $6800 to $1862 per year per transplant recipient in the ketoconazole-treated group. Other beneficial effects found over the study period included a significant reduction in the mean and diastolic systemic arterial pressure and a significant reduction in serum cholesterol. The mean total serum cholesterol fell from 265 (44) to 204 (38) mg/dl in the ketoconazole group but did not change significantly in the control group (p less than 0.005). Low-density lipoprotein cholesterol also fell from a mean of 167 (32) mg/dl to 112 (28) mg/dl (p less than 0.005). Renal function was not significantly affected by ketoconazole when compared with the control group. Ketoconazole and other drugs of potential use in organ transplant recipients should be evaluated for financial as well as for other potential clinical benefits in the long-term management of these patients.

Precertification for percutaneous transluminal coronary angioplasty in Medicare beneficiaries: a melting pot or a need for better national standards?

The Health Care Financing Administration has contracted with state peer review organizations (PROs) in its effort to assure the quality of services and eliminate unreasonable and inappropriate care provided Medicare beneficiaries. By law, each state PRO must select 10 procedures for precertification. Coronary angioplasty has been chosen by 45 PROs for precertification and criteria in each state were developed with the advice of local physicians. This report describes the findings of a survey of these precertification criteria in an effort to determine their variability and to compare the PRO criteria to published national criteria created by expert panels. Current precertification criteria of Medicare beneficiaries show significant variability in the priorities and the clinical practice of cardiologists in performing coronary angioplasty, despite established and published guidelines for its safe and efficacious use. It is likely that the establishment of locally based criteria for coronary angioplasty will be geographically uneven and probably have a less than expected impact on the care provided to Medicare beneficiaries.

One heart, two bodies: insight from the transplanted heart and its new electrocardiogram.

Cardiac transplantation provides a unique opportunity to record the electric field generated by a human heart in a new somatic environment. By examining pre- and posttransplantation electrocardiograms (ECGs), it is possible to address questions on the effect of rotation of the heart on its long axis on the surface ECG, the effect of thoracic anatomy on ECG voltage and predisposing factors for conduction defects observed after transplant surgery. To examine these questions, we reviewed a series of 35 matched donor and recipient ECGs. There were no differences in the mean height of the donors and recipients, but age, weight and body surface area were higher in the recipients (p less than 0.025). We found no significant differences in the mean heart rate or precordial voltage but the PR and QT intervals were shorter (p less than 0.025), and the precordial transitional zone was more to the left after transplantation (p less than 0.0005). New evidence of right bundle branch delay was found in 11 recipients and this was not related to pretransplantation hemodynamic factors or the period of ischemic arrest. Thus, there is indeed an anatomic basis for the ECG determination of clockwise rotation of the heart when the precordial transition zone is to the left. Age and body habitus, per se, do not appear to affect precordial voltage and evidence of right bundle delay in the transplant recipient appears to be related to the altered position of the heart and not to injury or changes in right ventricular hemodynamics.

Rabbit antithymocyte globulin. A 10-year experience in cardiac transplantation.

Rabbit antithymocyte globulin, a "custom-made" pan-anti-T-cell antibody produced in rabbits, is currently being evaluated in the United States and may, within several years, become approved by the Food and Drug Administration. Because we have used this agent for induction of immunosuppression for 10 years in cardiac recipients and because the results appear to be more favorable than those obtained with other agents (horse antithymocyte globulin, antilymphocyte globulin, OKT3), we have reviewed our experience. For the purpose of analysis, all non-bridge-to-transplant cardiac recipients have been divided into three groups on the basis of immunosuppression protocol: group I (March 1979 to January 1983), 28 patients treated with rabbit antithymocyte globulin, steroids, and azathioprine; group II (January 1983 to March 1985), 29 patients treated with rabbit antithymocyte globulin, cyclosporine, and steroids; and group III (March 1985 to January 1989), 98 patients treated with rabbit antithymocyte globulin, cyclosporine, steroids, and azathioprine. Actuarial data showed advantage for group III in survival rate (1 year 94%, 2 years 91%, 3 years 88%), freedom from rejection (30% free at 1 year), freedom from infection (50% free at 1 year), freedom from death from rejection (99% free at 1 year), and freedom from death from infection (97% freedom at 1 year). Actuarial survival rates and freedom from death from rejection and infection are comparable for any of our groups with contemporary published data. In the past 3 years, we have had no death from acute rejection or from posttransplant infection. Time-related rates of infection by etiologic agents have shown a significant reduction in early bacterial, viral, and nocardial infections between groups I and III. With rabbit antithymocyte globulin 200 mg intramuscularly every day for 3 days, our current protocol, T-cells are significantly reduced and local and systemic toxicity is almost unnoticeable. A progressively increasing cyclosporine dose along with rapid tapering steroid and maintenance azathioprine immunosuppressive induction appears to be the therapy of choice in cardiac transplantation.

Angioplasty of recent total coronary occlusions: cardiac death can occur in "low-risk" cases.

Revascularization by angioplasty of total coronary artery occlusions is generally thought to be relatively safe in experienced hands. Although success rates are lower than with diseased but patent vessels, reasonable success can be expected. In this report, different events led to a sudden and fatal outcome in two patients with total coronary occlusions subtending recently infarcted, but still viable, areas of myocardium. The cases and procedural details are presented.

Successful coronary artery bypass grafting for high-risk left main coronary artery atherosclerosis after cardiac transplantation.

Severe stenosis of the left main coronary artery developed in a 58-year-old woman 9 years after orthotopic heart transplantation. Because of serious reversible myocardial ischemia and the high-risk nature of the coronary disease, coronary artery bypass grafting was performed, with no complications. Possible risk factors for the development of coronary arterial disease and its management in the transplant population are discussed.

Combined aortic and mitral valve replacement in an adult with Scheie's disease.

Mitral, aortic, and coronary arterial disease have been described in the various mucopolysaccharidoses. We report the first successful combined aortic and mitral valve replacement in an adult female patient with severe aortic and mitral stenosis due to Scheie's syndrome, a mucopolysaccharide storage disease. Both annulae were of sufficient integrity for good prosthetic placement, and the patient had an uneventful postoperative recovery.

Fibrin metabolism in patients with acute myocardial infarction during and after treatment with tissue-type plasminogen activator.

In order to define some of the determinants of successful thrombolysis and reocclusion during fibrinolytic therapy for acute myocardial infarction (AMI), specific molecular markers of fibrin metabolism were serially measured in 15 patients with AMI treated with tissue-type plasminogen activator (t-PA). Fibrin formation was assessed by measurement of fibrinopeptide A (FpA) and fibrinolysis by assay of B-beta peptides 1-42 and 15-42 and crosslinked fibrin degradation products (XDP). At baseline, FpA levels were high while markers of fibrinolysis were near normal. Following a 90-minute infusion of t-PA (0.5-1.1 mg kg-1 hr-1), all markers of fibrinolysis increased. Levels of FpA remained elevated despite heparin at the initiation of cardiac catheterization. None of these markers discriminated between patients with successful reperfusion from those without. At 4 hours, B-beta 15-42 peptide and XDP levels remained elevated suggesting persistence of fibrinolysis beyond the short circulatory half-life of t-PA. FpA levels at 4 hours were lower in patients who underwent acute coronary angioplasty compared to those who received additional low dose t-PA (12.3 +/- 4.5 vs. 30.4 +/- 5.5 ng/ml, p less than 0.05). By 48 hours, markers of fibrinolysis had returned toward normal except in 2 patients with persistently elevated B-beta 15-42 peptide levels who suffered reocclusion on days 5 and 6 (75 and 44 vs. 29 +/- 3 nM, p less than 0.005). In conclusion, molecular markers of fibrin metabolism during fibrinolytic therapy may provide clinically relevant data.