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Until as recently as the mid-1990s, implantable cardioverter defibrillator (ICD) leads were placed through thoracotomy as anterior and/or posterolateral patches. The defibrillator patches have reportedly been associated with a number of relatively common mechanical complications as well as less common complications, including patch migration or erosion into contiguous structures. We report a previously unreported late complication of epicardial defibrillator patch placement in which patch migration and erosion through the gastric fundus resulted in fistulous tract formation from the mediastinum to the lumen of the stomach. Although surgically implanted epicardial patch defibrillator systems are relatively uncommon in current U.S. practice, these devices are still used when specific anatomic or electrophysiological considerations preclude the use of more common endocardial lead systems. Several thousand patients with epicardial patch leads in place are still believed to be alive in the United States. In these patients, continued vigilance for lead-related complications is appropriate. Prompt surgical intervention is usually warranted when patch migration or complications such as the one described occur.

Background: Few reports were found in the literature that examined predictors of physical functional disability after heart transplantation. Therefore, the purpose of this study was to (1) describe physical functional disability, (2) identify differences in physical functional disability by demographic and clinical variables, and (3) identify predictors of physical functional disability at 5 to 6 years after heart transplantation., Methods: A nonrandom sample of 311 patients (approximately 60 years of age, 78% male, and 90% Caucasian) who were 5 to 6 years post-heart transplantation were investigated. Patients completed 8 reliable and valid quality-of-life instruments via self-report. Data analyses included descriptive statistics, chi-square, independent t-tests, correlations, and stepwise multiple regression. Level of significance was set at p = 0.05., Results: The level of physical functional disability was low at 5 to 6 years after heart transplantation, yet 59% of patients reported having physical disability. Women experienced more functional disability than men, and patients with comorbidities (i.e., diabetes mellitus and orthopedic problems) experienced more functional disability than patients without these comorbidities. At 5 to 6 years after heart transplantation, 70% of variance in physical functional disability was explained by activities of daily living, symptoms, comorbidities, psychologic status, and resource utilization variables., Conclusions: At 5 to 6 years after heart transplantation, most patients experienced low levels of physical functional disability. Differences in physical functional disability were identified by both demographic characteristics and clinical variables. Predictors of physical functional disability included activities of daily living and symptoms, and clinical, psychologic, and resource utilization variables. Knowledge of factors related to physical disability long-term after heart transplantation provides direction for the development of strategies to assist patients to reduce their level of disability or function adequately despite their disability.

Background: Only a few researchers have examined quality of life (QOL) outcomes more than 5 years after heart transplantation. Therefore, the purpose of this study was to describe QOL (overall, satisfaction with, and perceived importance); identify differences in QOL by age, sex, and race; and identify predictors of QOL at 5 to 6 years after heart transplantation., Methods: A nonrandom sample of 231 patients (60 years of age, 76% men, 90% white, 79% married, and fairly well educated) who were 5 to 6 years after heart transplantation were investigated. Patients completed 12 QOL instruments via self-report. Data analyses included descriptive statistics, chi2, independent t-tests, correlations, and stepwise multiple regression. Level of significance was set at 0.05., Results: Patient satisfaction with all areas of life was high at 5 to 6 years after heart transplantation. Similarly, patients believed that these same areas of life were very important. Yet areas of QOL with lower levels of satisfaction were identified. Patients who were > or =60 years were more satisfied with their QOL than patients <60 years. At 5 to 6 years after heart transplantation, almost 80% of variance in QOL was explained by psychological, physical, social, clinical, and demographic variables., Conclusions: At 5 to 6 years after heart transplantation, patients were very satisfied with their QOL, although differences in level of satisfaction were identified by demographic variables, and areas of QOL with lower levels of satisfaction were identified. Understanding those variables that contribute to QOL in the long term after heart transplantation provides direction for assisting patients to improve their QOL.

Background: Left ventricular assist device (LVAD) failure and malfunction rates are critical gauges for establishing LVADs as a long-term therapy for end-stage heart failure patients. These device performance measures, however, have been inadequately characterized in the bridge-to-transplantation literature., Methods: REMATCH is a randomized trial that compares optimal medical management with LVAD implantation for patients with end-stage heart failure. An independent committee adjudicated patient outcomes. The primary endpoint--survival--was analyzed by intention to treat using the log-rank statistic. Frequency of event occurrence was analyzed by Poisson regression. The time to first event was analyzed by the product limit method. Device performance was disaggregated into confirmed malfunctions and system failures. The latter were events in which patients could not be rescued with backup circulatory support measures., Results: The 1-year survival rate was 52% (95% confidence limit [CL]; 40%-63%) for LVAD patients versus 28% (95% CL; 17%-39%) for medical patients and the 2-year survival rate was 29% (95% CL; 19%-40%) for LVAD patients versus 13% (95% CL; 5%-22%) for medical patients. System failure was 0.13 per patient per year and the confirmed LVAD malfunction rate was 0.90. Freedom from device replacement was 87% at 1 year and 37% at 2 years., Conclusions: Despite the observed rates of device malfunction and replacement, LVAD implantation confers clinically significant improvement with regard to survival as compared with medical management. Device modifications and innovations for infection management exhibit great promise of improving device performance in the near future.

Purpose: The Kantrowitz CardioVAD (KCV) is an electrically powered, pneumatically driven circulatory assist device which provides diastolic augmentation and systolic unloading to the failing heart. It consists of a 60cc-pumping chamber, a percutaneous access device (PAD), and an external controller. The pumping chamber, is surgically implanted in the descending thoracic aorta with the patient on cardiopulmonary bypass. Its physiologic function is analogous to that of the intra-aortic balloon pump (IABP)., Methods: Between 1997 and 2000, 5 men (age 59 to 73) with end-stage cardiomyopathy refractory to maximal drug treatment and with documented hemodynamic improvement on an IABP were enrolled in a feasibility study., Results: Mean bypass time was 157 minute (range 120 to 196 minute); mean cross-clamp time was 101 minute (range 69 to 144). Patient 1 died intra-operatively. Compared with preoperative values, at 1 month, cardiac index increased (1.7 to 2.6 L/min/m(2)) and there were significant decreases in creatinine (2.6 to 1.5 mg/dL), pulmonary capillary wedge pressure (PCWP) (32 to 14 mm Hg), and right atrial pressure (RA) (19 to 9 mm Hg). NYHA class improved (IV to II). The mean increase in cardiac index with the KCV OFF to ON was 0.53 L/min/m(2) (36%). Two patients were discharged home. The device was used intermittently without thromboembolic complications. The only device related complications were attributed to PAD design and have been corrected. CONCLUSION Our initial human trial demonstrates successful implantation of the KCV in end-stage patients, the ability of the device to be used intermittently without anticoagulation, and documents hemodynamic and functional improvement in the status of these patients.

Background: The successful use of left ventricular assist devices (LVADs) as a bridge to heart transplantation has prompted our examination of quality of life (QOL) outcomes. The purposes of this study are to describe QOL in patients 1 to 2 weeks after LVAD implantation and to compare QOL in a smaller cohort of patients from before to 1 to 2 weeks after surgery., Methods: Data were collected from a convenience sample of 81 patients who completed booklets of questionnaires that measure domains of QOL 1 to 2 weeks after LVAD insertion and from 30 of 81 patients who completed booklets at both the pre-implantation and post-implantation periods. Patients completed booklets of 6 to 8 self-reporting instruments, with acceptable reliability and validity. Data were analyzed using descriptive and comparative statistics (chi-square, Mann-Whitney U and Wilcoxon signed ranks tests) with p = 0.01 considered statistically significant., Results: One to 2 weeks after LVAD implantation, patients were quite satisfied with their lives, experienced moderately low amounts of stress, coped well, and perceived themselves as having good health and QOL, low symptom distress, and moderately low functional disability. Patients reported significantly better QOL, more satisfaction with health and functioning, and were significantly less distressed by symptoms from immediately pre-operatively to post-operatively. However, patients reported significantly more self-care disability and more dissatisfaction with socioeconomic areas of life from before to immediately after surgery. Psychological distress was low and did not change with time., Conclusion: Given that QOL improved from before to after LVAD implantation, our findings provide a springboard for investigation of the impact of LVADs on long-term QOL outcomes.

Background: A multicenter, randomized, controlled, open-label trial was conducted to evaluate the safety and efficacy of Celsior when used for flush and hypothermic storage of donor hearts before transplantation., Methods: Heart transplant recipients were randomized to one of two treatment groups in which donor hearts were flushed and stored in either Celsior or conventional preservation solution(s) (control). Study subjects were followed for 30 days after transplantation., Results: A total of 131 heart transplant recipients were enrolled (Celsior, n = 64; control, n = 67). The treatment groups were evenly distributed in donor and recipient base line characteristics. Graft loss rate was lower in the Celsior group on day 7 (3% versus 9%) and on day 30 (6% versus 13%), but the difference was not statistically significant based on 95% confidence interval analysis. No significant difference was measured between the Celsior and control groups in 7-day patient survival (97% versus 94%) and the proportion of patients with one or more adverse events (Celsior, 88%; control 87%) or serious adverse events (Celsior, 38%; control, 46%). Significantly fewer patients in the Celsior group developed at least one cardiac-related serious adverse event (13% versus 25%)., Conclusions: Celsior was demonstrated to be as safe and effective as conventional solutions for flush and cold storage of cardiac allografts before transplantation.

Long-term implanted left ventricular assist devices (LVADs) have significantly improved the care of patients awaiting heart transplantation and will provide an alternative therapy to select patients with heart failure. However, although the technology and clinical results continue to improve, LVAD implantation is still associated with a significant level of complications. Left ventricular assist device-associated complications can be broadly divided by their temporal occurrence. Early complications include perioperative hemorrhage, air embolism, and right ventricular failure. Beyond the perioperative period, late complications consist primarily of infection, thromboembolism, and primary device failure. An improved understanding of the mechanisms involved should aid the clinician in further reducing the incidence of these occurrences.

Objective: This study was designed with two aims: 1) to determine if the coronary artery bypass graft (CABG) procedure alters plasma vitamin E and C concentrations of adult patients through repeated determinations of vitamin levels at time points before, during and following CABG, and 2) to assess whether plasma vitamin E concentrations reflect myocardial tissue content., Methods: A consecutive sample of 38 patients undergoing CABG surgery at a Midwest tertiary care hospital was enrolled. Patients receiving blood transfusions before or during surgery were excluded., Results: Plasma vitamin E/total lipid ratios rose with reperfusion, remained elevated immediately following bypass, and fell to preoperative concentrations by 24 hours. Plasma vitamin E/total cholesterol levels varied little throughout this time course. Both plasma uric acid and ascorbate concentrations (corrected for hemodilution) also rose by the preischemic interval, and remained elevated until a return to preoperative levels by 24 hours. Corrected malondialdehyde (MDA) concentrations rose by pre-ischemia but returned more quickly to preoperative levels. Atrial appendage tissue vitamin E concentrations bore a significant relationship to those of plasma prior to surgery (r=+0.49, p=0.004). Reported supplement use, plasma concentrations and body mass index contributed to the variability in atrial tissue concentrations of vitamin E., Conclusions: In short, when not confounded by transfusions or hemodilution, several peripheral indices of antioxidants increase with the reperfusion segment of CABG procedure and return to baseline levels within 24 hours of surgery. Parallel changes in MDA were observed. The observed changes are consistent with the hypothesis that oxidative stress accompanies the ischemia-reperfusion components of the CABG procedure.

The previously high rates of morbidity and mortality associated with implantation of LVADs for long-term support have continued to decline through design improvements, better patient selection criteria, and greater clinical experience. Patients which chronic heart failure awaiting transplantation should be considered for LVAD placement early in their clinical course, before irreversible end-organ dysfunction occurs. Both the Novacor and the vented electric HeartMate LVADs are currently being evaluated under "discharge to home" protocols for patients awaiting heart transplantation; the results will have tremendous economic and quality-of-life implications. Currently available devices have achieved a level of reliability that will allow for protocols involving device implantation as an alternative to transplantation in the near future. Physicians will then have an effective therapy available for the increasing number of heart failure patients awaiting a limited number of donor hearts, as well as for those patients not considered to be candidates for transplantation by traditional criteria.

Recurrent significant aortic valvular stenosis or regurgitation, or both, after balloon or open valvotomy in pediatric patients often necessitates aortic valve replacement. In an attempt to preserve the aortic valve, we performed extended aortic valvuloplasty in 21 children with recurrent aortic valve stenosis or regurgitation from January 1989 to March 1993. Previous related procedures were one open aortic valvotomy or more (n = 15), balloon valvotomy (n = 4), balloon valvotomy after surgical valvotomy (n = 1), and repair of iatrogenic valve tear (n = 1). Mean age at the time of the extended aortic valvuloplasty was 6 +/- 3.4 years. Mean pressure gradient across the aortic valve was 56 +/- 12 torr. Regurgitation was moderate (grade 2 to 3) in nine and severe (grade 4) in 12 patients. Extended aortic valvuloplasty techniques consisted of thinning of valve leaflets (n = 15), augmentation of scarred and retracted leaflets with autologous pericardium (n = 11), resuspension of the augmented leaflet (n = 14), release of the rudimentary commissure from the aortic wall (n = 5), extension of the valvotomy incision into the aortic wall on both sides of the commissure (n = 20), patch repair of the sinus of Valsalva perforation (n = 1), reapproximation of tears (n = 5), and narrowing of the ventriculoaortic junction (n = 2). No operative deaths occurred. The postoperative mean pressure gradient, assessed by most recent Doppler echocardiography or cardiac catheterization at a follow-up of 18 +/- 6 months, was 19 +/- 6 torr (p < 0.01 versus the preoperative gradient). Aortic regurgitation was absent in 13, mild in 6, and moderate-to-severe, necessitating subsequent aortic valve replacement, in 2. This short-term experience indicates that extended aortic valvuloplasty is a safe and effective surgical approach that minimizes the need for aortic valve replacement in children with significant recurrent aortic valve stenosis or regurgitation.

A modified median sternotomy incision that results in a cosmetically appealing scar is described. It includes the use of a low-lying short skin incision and partial transection of the sternum. The outcome in 182 infants and children indicates that this approach is safe, provides adequate exposure, and has excellent cosmetic results.

Special problems exist in the study and intraoperative monitoring of patients with severe occlusive vascular disease involving all extremities and with symptomatic brachiocephalic or coronary artery disease. We report 3 such patients who underwent arteriography via a percutaneous translumbar aortic catheter. All patients then underwent successful arterial reconstructive procedures utilizing the same translumbar catheter for arterial pressure monitoring and blood gas analysis. Percutaneous translumbar aortic catheters provide both a safe method for studying patients with four extremity occlusive vascular disease and reliable arterial access to monitor these patients intraoperatively.

Tumor involvement of the superior vena cava can occur either by direct extension of the primary tumor or by invasion of superior mediastinal lymph nodes. Removal of a portion of the caval wall may be required to allow adequate margins of resection. The technique described involves placement of an intraluminal shunt and resection of the involved caval wall with reconstruction using autologous pericardium.

Two patients had resection of a middle mediastinal neurilemmoma of the vagus nerve. Twenty-seven other neurogenic tumors of the intrathoracic vagus are reviewed. These tumors are generally asymptomatic except for hoarseness in an occasional patient.

Pulmonary sequestration is a congenital anomaly resulting in nonfunctioning lung tissue in either the "extralobar" or "intralobar" position. Both forms derive their blood supply from the systemic circulation. Large pulmonary sequestrations can present in the newborn with potentially fatal respiratory distress. Surgical resection is the treatment of choice.

The etiologic relationship between parathyroid and thyroid disease is controversial and still not well defined. An increased incidence of parathyroid adenomas with thyroid disease has been suggested by some researchers. Other authors are unable to confirm this and maintain that the major factor contributing to the coexistence of parathyroid adenomas and thyroid disease is the prevalence of these conditions, independently, in middle-aged women. Serum parathyroid hormone levels are generally lower in patients with thyrotoxicosis and higher in patients with hypothyroidism. The simultaneous occurrence of thyrotoxicosis and symptomatic hyperparathyroid crisis has been reported previously only once in the American literature. We report a case of a 32-year-old woman with documented uncontrolled Graves' disease (T4 = 20 micrograms/dl [normal = 4.5 to 11.5 micrograms/dl], total T3 = 361 ng/dl [normal = 115 to 190 ng/dl], T3RU = 53% [normal = 35% to 45%]), who developed parathyroid crisis (serum calcium = 15 mg/dl [normal = 9 to 11 mg/dl], N-terminal parathyroid hormone = 121 pg/ml [normal = 11 to 24 pg/ml], C-terminal parathyroid hormone = 9416 pg/ml [normal = 60 to 450 pg/ml]). After a turbulent 10-day period to achieve a euthyroid state with propranolol, propylthiouracil, and a saturated solution of potassium iodide, operation revealed a large parathyroid adenoma (2 by 2 by 3 cm) and a diffusely hyperplastic thyroid gland. Adenoma excision and bilateral subtotal thyroidectomy were performed. This case illustrates management guidelines of a true endocrine emergency in which prompt operation for acute hyperparathyroidism could not be undertaken until a euthyroid state and reduction in serum calcium levels were achieved with aggressive medical management.

Amiodarone is an effective agent in the treatment of life-threatening ventricular arrhythmias. However, there are numerous side effects associated with this drug, including pulmonary toxicity. This report describes a pulmonary mass that developed in a patient receiving amiodarone and was initially thought to be a lung cancer. Complete resolution occurred after cessation of the drug.

Cryoablation is recognized as a useful modality for diagnostic mapping, as well as for permanent obliteration of arrhythmogenic foci. This technique has been used to eradicate irritable foci at the base of papillary muscles. We report a case of mitral valve dysfunction requiring valve replacement following cryoablation of the posterior papillary muscle. Based on this experience, we caution against extensive cryoablation of papillary muscle tissue because of the possibility of disrupting mitral valve function.

To test the effectiveness of adrenergic agonists in correcting the vascular sequelae of spinal anesthesia, we used venous reservoir volume (RV) and mean arterial pressure (MAP) as indices of the changes in venous capacitance and arterial resistance produced by adrenergic agonists in dogs anesthetized with pentobarbital and undergoing cardiopulmonary bypass (CPB). A CPB-based technique was chosen both to prevent drug and reflex effects on the heart from influencing the results and to provide a convenient means by which to monitor venous capacitance. Total spinal anesthesia significantly decreased both RV and MAP relative to steady-state CPB values. Return of these hemodynamic alterations to baseline was attempted using pure alpha- and beta-adrenergic agonists, and a mixed adrenergic agonist (phenylephrine, isoproterenol, and ephedrine, respectively). Isoproterenol increased RV, but further decreased MAP. Phenylephrine increased MAP but not RV. Ephedrine increased both MAP and RV. We conclude that a mixed adrenergic agonist such as ephedrine more ideally corrects the noncardiac circulatory sequelae of spinal anesthesia than does either a pure alpha- or beta-adrenergic agonist.

Systemic perfusion, myocardial contractility, and morphological changes during and after cardiopulmonary bypass (CPB) were investigated in 22 greyhounds; Fluosol-DA 20% (FDA) and normal saline (NaCl) were compared as priming solutions for hypothermic (25 degrees C) CPB. Hemodynamic and oxygenation indices were similar in all groups. Animals with fluorocarbon primes had higher serum lactate concentrations (mean +/- standard error of the mean [SEM]) during CPB (NaCl 1.64 +/- 0.2, FDA 2.39 +/- 0.3, p less than 0.01), representing an increase over the control of 12% and 319% in the NaCl and FDA groups, respectively. After CPB, serum lactate concentration remained elevated in the FDA group, but it returned to the level of the control in the NaCl group (NaCl 1.49 +/- 0.5, FDA 2.29 +/- 1.1, p less than 0.01); increases over the control level were 7% and 302% in the NaCl and FDA groups, respectively. Myocardial contractility after CPB, expressed as dP/dt[40], was similar in the two experimental groups. Three weeks after CPB, a histological examination by light microscopy of multiple organs obtained from a separate group of 12 animals treated similarly was performed, demonstrating no significant morphological differences between animals primed with fluorocarbon or with saline. The results suggest that FDA is a satisfactory priming agent for hypothermic CPB. It adequately preserves myocardial function and causes no adverse morphological changes, but a persistent, as yet unexplained, elevation in serum lactate concentration occurs.