Erosion of an extrapericardial implantable cardioverter defibrillator patch through the gastric fundus with fistulous tract formation.

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.

Predictors of physical functional disability at 5 to 6 years after heart transplantation.

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.

Predictors of quality of life at 5 to 6 years after heart transplantation.

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.

Left ventricular assist device performance with long-term circulatory support: lessons from the REMATCH trial.

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.

Longitudinal change in quality of life and impact on survival after left ventricular assist device implantation.

Background: The HeartMate vented electric left ventricular assist device has been approved for use as destination therapy. Thus, the study of quality-of-life outcomes, as well as morbidity and mortality, is imperative. The purpose of our study was to describe change with time (from 1 month to 1 year) in patients who received a HeartMate vented electric left ventricular assist device as a bridge to heart transplantation and to identify quality-of-life predictors of survival after left ventricular assist device implantation.

Change in quality of life from after left ventricular assist device implantation to after heart transplantation.

Background: No studies have analyzed quality of life (QOL) from before to after heart transplantation in patients with a left ventricular assist device (LVAD). Therefore, the purpose of this longitudinal, multi-site study was to compare QOL outcomes of patients listed for heart transplantation who required a left ventricular assist device (LVAD) at 3 months after implantation of an LVAD vs 3 months after heart transplantation.

Methods: A non-random sample of 40 patients (predominantly middle-aged, married, white men), who had paired data at both 3 months after LVAD implantation and 3 months after heart transplantation, were investigated.

Change in quality of life from before to after discharge following left ventricular assist device implantation.

Background: Quality of life (QOL) outcomes after left ventricular assist device (LVAD) implantation from before to after hospital discharge have been examined only in a very small sample of patients. The purposes of this study are to describe change in QOL from before to after hospital discharge in LVAD patients and to determine whether being discharged with an LVAD predicts better QOL than being hospitalized with an LVAD.

Methods: A non-random sample of 62 LVAD patients (approximately 50 years old, male, white, married, fairly well-educated) completed self-report questionnaires at >or=2 timepoints post-implant.

Circulatory assistance with a permanent implantable IABP: initial human experience.

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.

Predictors of quality of life at 1 month after implantation of a left ventricular assist device.

Objectives: To describe quality-of-life outcomes; determine relationships between quality of life and demographic, physical, psychosocial, and clinical variables; and identify predictors of quality of life at 1 month after implantation of a left ventricular assist device.

Methods: Patients who received either an implantable pneumatic (n = 38) or a vented electric (n = 54) left ventricular assist device as a bridge to heart transplantation between August 1, 1994, and August 31, 1999, completed 6 instruments used to measure quality of life andfactors related to quality of life. Data were analyzed by using descriptive statistics, Pearson correlations, Mann-Whitney U tests, and forward, stepwise multiple regression.

Bridge to transplant with the HeartMate device.

The incidence and prevalence of chronic heart failure continues to increase, with an estimated 400,000 new cases per year in the United States. Cardiac transplantation is an effective therapy but is severely limited to approximately 2300 patients per year due to the donor shortage. With ever increasing waiting times, a significant number of patients become severely debilitated or expire prior to transplantation.

Hypotension, acidosis, and vasodilatation syndrome post-heart transplant: prognostic variables and outcomes.

Background: In recent years a syndrome characterized by hypotension, acidosis, and vasodilatation, which we have designated HAV syndrome, has been reported to occur more frequently after heart transplantation (HT), but its pathogenesis is unknown.

Methods: We analyzed consecutive patients undergoing HT between January 1994 and June 1998 (aged 50 +/- 8 years; 87% male; 40% African American; ischemia time, 190 +/- 20 minutes; given triple immunosuppression without anti-lymphocyte antibodies) in 2 groups: 38 (54%) who developed HAV (systemic vascular resistance < or = 800 dines x sec x cm(-5) and serum bicarbonate < or = 20 mEq/liter) and 32 (46%) who did not. To identify causes of HAV, we compared 113 pre-HT donor and recipient variables, 28 peri-HT variables, and 46 post-HT variables between groups.

Improvement in quality of life outcomes 2 weeks after left ventricular assist device implantation.

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.

A multicenter, randomized, controlled trial of Celsior for flush and hypothermic storage of cardiac allografts.

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.

Left ventricular assist device implantation: short and long-term surgical complications.

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.

The use of APACHE II scores to select candidates for left ventricular assist device placement. Acute Physiology and Chronic Health Evaluation.

Background: The growth in left ventricular assist device (LVAD) use has been hampered by high morbidity and mortality rates and cost. The purpose of this study was to help improve patient selection for LVAD placement by determining whether the Acute Physiology and Chronic Health Evaluation II (APACHE II) scoring system, a multiparameter, physiology-based predictor of outcome, could be used to predict outcome after LVAD placement and thus help determine optimum timing of LVAD placement.

Methods: This was a retrospective analysis of a prospective cohort observational study consisting of 2 groups: (1) 50 patients with severe heart failure who did not receive LVAD placement after initial evaluation and (2) 31 patients who did receive LVAD placement.

Assessment of small-diameter aortic mechanical prostheses: physiological relevance of the Doppler gradient, utility of flow augmentation, and limitations of orifice area estimation.

Background: Noninvasive assessment of functionally stenotic small-diameter aortic mechanical prostheses is complicated by theoretical constraints relating to the hemodynamic relevance of Doppler-derived transprosthetic gradients. To establish the utility of Doppler echocardiography for evaluation of these valves, 20-mm Medtronic Hall and 19-mm St Jude prostheses were studied in vitro and in vivo.

Methods And Results: Relations between the orifice transprosthetic gradient (equivalent to Doppler), the downstream gradient in the zone of recovered pressure (equivalent to catheter), and fluid mechanical energy losses were examined in vitro.

Plasma vitamins E and C concentrations of adult patients during cardiopulmonary bypass.

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.

Mechanical circulatory assistance: changing indications and options.

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.

Role of maximal oxygen consumption in establishment of heart transplant candidacy for heart failure patients with intermediate exercise tolerance.

Maximal exercise oxygen consumption (VO2max) was measured in patients with chronic congestive heart failure undergoing evaluation for heart transplantation. Although VO2max correlated with survival for the group as a whole, it did not demonstrate survival discrimination for patients in the intermediate range (VO2max = 12 to 17 ml/kg/min) and should therefore not be used as a benchmark test for determination of appropriateness for cardiac transplantation in this group of patients.

Infectious complications in left ventricular assist device recipients.

The left ventricular assist device (LVAD) has revolutionized the care of patients with heart failure who are awaiting transplantation. Despite reports of significant infection rates associated with LVAD implantation, few data are available concerning the management of LVAD-related infections and their impact on transplantation. Eight (40%) of our first 20 LVAD recipients developed infections.