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. 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.

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. Patients completed self-report questionnaires (with acceptable reliability and validity) at both time periods, including the Quality of Life Index, Rating Question Form, Heart Failure Symptom Checklist, Sickness Impact Profile, LVAD Stressor Scale (completed only after LVAD implant), Heart Transplant Stressor Scale (completed only after heart transplant) and Jalowiec Coping Scale. Descriptive analyses and comparative analyses using paired t-tests were performed with statistical significance set at 0.01. RESULTS: Patients were significantly more satisfied with their lives overall and with their health and functioning at 3 months after heart transplantation as compared with 3 months after LVAD implantation. Mobility, self-care ability, physical ability and overall functional ability improved from 3 months after LVAD implant to 3 months after heart transplant. There was significantly less symptom distress after LVAD implant as compared with after heart transplant for the neurologic, dermatologic and physical sub-scales. Work/school/financial stress was significantly lower after heart transplant vs after LVAD implant. In contrast, 2 other areas of stress were significantly lower after LVAD implant vs after heart transplant: self-care stress and hospital/clinic-related stress. CONCLUSIONS: Differences were found in QOL outcomes at 3 months after LVAD implant as compared with 3 months after heart transplant. Our findings point out specific areas of concern with respect to QOL after LVAD implant and post-transplant, some of which are amenable to health-care provider interventions.

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. The questionnaires (Quality of Life Index, Rating Question Form, Heart Failure Symptom Checklist, Sickness Impact Profile, LVAD Stressor Scale, Jalowiec Coping Scale), which were collated into booklets, had acceptable reliability and validity. Longitudinal analyses were performed in 2 steps using 1-sample t-tests and linear mixed effects modeling. RESULTS: Perception of QOL and health status were fairly good both before and after discharge of LVAD patients. Discharge predicted increased satisfaction with socioeconomic areas of life; decreased overall and psychologic stress and stress related to family and friends, self-care and work/school/finances; and decreased physical and self-care disability. CONCLUSIONS: QOL outcomes improved from before to after hospital discharge in LVAD patients awaiting heart transplantation. As LVADs potentially become available as destination therapy, in addition to being successful bridges to heart transplantation, QOL outcomes will become more important to study.

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. METHODS: A nonrandom sample of 78 patients who received a HeartMate vented electric left ventricular assist device (primarily middle-aged, white married males) who had quality-of-life data at 1, 2, 3, 6, 9, or 12 months after implant was the subject of this report. The sample size decreased with time primarily because of heart transplantation. Patients completed the following booklets of questionnaires: Quality of Life Index, Rating Question Form, Heart Failure Symptom Checklist, and Sickness Impact Profile. Analyses included both descriptive analyses and modeling procedures (mixed-effects models and Cox proportional hazards models). RESULTS: Quality-of-life outcomes were fairly good and stable from 1 month to 1 year after HeartMate vented electric left ventricular assist device implantation. Both positive and negative changes were detected in all quality-of-life domains (physical and occupational function, social interaction, somatic sensation, and psychological state) after left ventricular assist device insertion. Items from the physical domain of quality of life, specifically walking and dressing oneself, were significantly associated with the risk of dying after left ventricular assist device implantation. CONCLUSIONS: Identifying poor quality-of-life outcomes within 1 year after left ventricular assist device implantation provides direction to develop strategies to improve outcomes. Physical and occupational rehabilitation, psychosocial intervention, and monitoring symptom distress and physical disability may contribute to improved quality-of-life outcomes and survival after left ventricular assist device implantation.

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. RESULTS: Overall satisfaction with quality of life was quite high as determined from the total score on the Quality of Life Index (mean = 0.69). Patients were very satisfied with the implantation and thought that they would do well after future heart transplant surgery. Patients had a moderate level of stress. Significant predictors of overall quality of life were psychological symptoms, stress, and race; these accounted for 46% of variance in quality of life. CONCLUSIONS: Patients were satisfied with their quality of life at 1 month after implantation of a left ventricular assist device. However, they were least satisfied with their health and functioning and yet were optimistic about how well they thought they would do after heart transplantation. Psychological factors were the strongest predictors of satisfaction with overall quality of life.

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. 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.

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. 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.

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. 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.

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. 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.