Risk analysis in patients bridged to transplantation.

BACKGROUND: Efforts to predict mortality in bridge to cardiac transplant patients have concentrated on preventricular assist device (VAD) status. To more fully identify factors influencing survival to transplant, we reviewed the preoperative and postoperative VAD courses of 105 bridge to transplant patients. METHODS: Sixty-four parameters (34 pre-VAD, 30 post-VAD), including hemodynamics, complications, and evaluations of major organ function were examined and analyzed. RESULTS: Thirty-three patients (31%) died on VADs and 72 were transplanted. There were two posttransplant operative deaths (3%). By univariate analysis 23 of 64 factors were significant. These 23 factors were entered into a stepwise logistic regression analysis to identify predictors of survival to transplant. Four factors, including pre-VAD intubation (p < 0.005), cardiopulmonary bypass (CPB) time during VAD insertion (p < 0.0001), mean pulmonary artery pressure (first postoperative day after VAD) (p < 0.0002), and highest post-VAD creatinine (p < 0.01) were independent predictors of transplantation. CONCLUSIONS: Other than the need for intubation, pre-VAD variables were of little value in predicting survival to transplant. Problems during VAD insertion (long CPB time) and post-VAD renal insufficiency were independent predictors. Severe complications that developed during the interval of VAD support, including cerebrovascular accident, bleeding and infection, were surprisingly not predictors for transplantation.

Transfer of patients receiving advanced mechanical circulatory support.

OBJECTIVE: Improving results with ventricular assist devices have led to their wider clinical application. Centers can stabilize, support, and wean or transfer patients to regional transplant centers. METHODS: Prospectively collected data were reviewed to evaluate the clinical results of patients transferred to our institution while receiving advanced mechanical circulatory support. RESULTS: Since 1993, 16 patients were accepted while receiving support with either extracorporeal membrane oxygenation or a ventricular assist device. The 10 male and 6 female patients ranged in age from 9 to 60 years (mean, 42.1 years). Thirteen had had cardiac surgical procedures, two had acute myocardial infarctions, and one had myocarditis. The distance transported ranged from 0.2 to 309 miles (mean, 132 miles). Twelve patients were transferred by ground, and 4 were transported by air. Seven patients were originally supported with extracorporeal membrane oxygenation, 6 with centrifugal pumps, and 3 with ABIOMED ventricular assist devices (ABIOMED, Inc, Danvers, Mass). Two patients had clinical complications during transfer, and one had a cerebrovascular accident, recovered, was weaned, and survived. A second patient had hemodynamic deterioration. There were no technical complications associated with transport. Six patients were left on the original support device; 3 of the 6 were weaned and survived, and 3 died during support. The 10 remaining patients were switched to other ventricular assist devices: 9 patients to Thoratec devices (Thoratec Laboratories, Pleasanton, Calif) and 1 patient to a Novacor device (Baxter Healthcare Corp, Novacor Division, Oakland, Calif). Six of the 10 patients underwent transplantation and survived. Four patients died while being supported by the devices. Nine patients were discharged, with 1 late death at 29 months. Eight patients are alive 4 to 65 months after discharge. CONCLUSIONS: These data suggest that patients receiving advanced support can be moved between clinical centers with acceptable risks. Because 33% of the survivors were weaned, transplantation is not required for survival.

Clinical experience with 111 thoratec ventricular assist devices.

BACKGROUND: Ventricular assist devices (VADs) have gained wider acceptance due to refinements in patient selection and management and device availability. METHODS: To evaluate early and late results, we reviewed our first 111 patients with the Thoratec VAD. RESULTS: Forty-four patients were supported for myocardial recovery. The mean age in the recovery group was 51.9 years. There were 18 left VADs (LVADs), 17 biventricular VADs (BVADs), and nine right VADs (RVADs). Complications included bleeding in 20 patients (45%) and device-related infection in 1 patient (2%). Nineteen were weaned from the VAD, with 12 survivors. Sixty-seven patients were supported as a bridge to cardiac transplantation. The mean age was 41.5 years. There were 39 LVADs and 28 BVADs. Complications included bleeding in 21 patients (31%) and device-related infection in 12 (18%). Three patients were weaned and 39 patients were transplanted from the assist device, for a total of 42 bridge survivors. Device-related thromboembolism occurred in 9 patients (8.1%), 7 of whom were bridge to transplantation. The duration of VAD support ranged from 0.1 to 27 days (mean 4.5 days) in the recovery group and 0.2 to 184 days (mean 40.7 days) in the bridge to transplantation group. The 10-year actuarial survival was 16% for the recovery group, 22%, for the bridge group, and 33% for transplanted patients. CONCLUSIONS: Despite advances, VAD support remains associated with significant morbidity and operative mortality.

Ventricular assist device support in patients with mechanical heart valves.

BACKGROUND: Due to potential thromboembolic complications, mechanical valves within the native heart are often considered contraindications to ventricular assist device (VAD) support. METHODS: A retrospective review of VAD cases between June 1982 and March 1998 showed 8 patients with mechanical valves who were supported with Thoratec (Pleasanton, CA) VADs. RESULTS: There were 6 males and 2 females ranging in age from 20 to 69 years (mean 49.8+/-5.6). Four patients were supported when they could not be weaned from cardiopulmonary bypass after reparative procedures and were thought to have reversible injuries. Four patients were supported as a bridge-to-cardiac transplantation. Two patients had mechanical mitral valves, 2 had aortic valve replacements, 1 had an aortic homograft and mechanical mitral valve, 2 had mechanical aortic and mitral prosthesis, and 1 patient had aortic, mitral, and tricuspid valves. The types of valvular prostheses were St. Jude (5 patients) and Bjork-Shiley (3 patients). Duration of support ranged from 3.0 to 150 days (mean 34 days). Four patients were supported with biventricular assist devices and 4 had left VADs. Dextran and intravenous heparin anticoagulation were used in the shorter duration patients, with warfarin being used in the bridge patients. One patient received warfarin and aspirin. At the time of autopsy or device removal, only 1 of the 12 mechanical intracardiac valves showed any evidence of thrombosis, including the aortic valves in 2 patients supported for 2 and 5 months. There were no clinical thromboembolic events. Four patients (50%) were discharged (1 weaned, 3 transplanted). CONCLUSIONS: The 50% (4 of 8) survival rate compares favorably with the 44% (41 of 92) overall survival rate for our Thoratec patients (bridge plus recovery) who did not have mechanical prosthetic valves. These data suggest that patients with mechanical intracardiac valves can be supported for short durations with some additional risk, which is yet to be determined.

Right ventricular infarction during left ventricular assist system support.

Left ventricular assist devices are frequently used to bridge patients to cardiac transplantation. As this experience grows, new and unanticipated complications will occur. This report describes a 50-year-old man with ischemic cardiomyopathy being bridged to cardiac transplantation who suffered an acute right ventricular infarction during the interval of support.

Outpatient use of left ventricular assist devices: nursing, technical, and educational considerations.

Improvements in technology and in the selection, care, and treatment of patients have led to wider clinical use of mechanical circulatory support. Considerable progress has been made with the use of left ventricular assist devices. Patients are currently maintained in outpatient facilities until a donor heart becomes available; recently, left ventricular assist devices have started to be used as permanent implants. This article outlines the steps that are taken to prepare the patient, the patient's family, and the medical staff for discharge from the hospital of a patient supported with a left ventricular assist device. Extensive technical and clinical training of the primary caregiver and the patient is required to prepare for discharge from the hospital. Data are rapidly accumulating that show that left ventricular assist devices are safe and efficacious for outpatient use. Similar success is expected in clinical trials of permanent left ventricular assist devices, suggesting that many more patients will benefit from this technology in the future.

Management of asymptomatic mild aortic stenosis during coronary artery operations.

BACKGROUND: Management of asymptomatic mild aortic stenosis at the time of coronary artery bypass grafting (CABG) remains controversial. We have retrospectively analyzed a cohort of patients requiring aortic valve replacement (AVR) subsequent to CABG and compared their operative morbidity and mortality with that of a group receiving CABG and AVR simultaneously at the first operation. METHODS: Analysis is drawn from 28 patients who required AVR 8 +/- 4 years subsequent to CABG (group A) and 175 patients receiving AVR along with CABG at the primary operation (group B). Groups were similar with respect to age, sex, risk factors for cardiac disease, extent of coronary artery disease, left ventricular function, New York Heart Association class, aortic valve area, number of grafts, and size of prosthesis inserted. RESULTS: Patients having AVR subsequent to CABG had a significantly prolonged aortic cross-clamp time and global myocardial ischemic time and incurred a twofold increase in operative mortality. The actuarial survival at 10 years was not significantly different between cohorts. In the 28 patients in group A, the aortic valve area during the period between operations decreased 0.05 mm2/y. CONCLUSIONS: The operative mortality and morbidity of a second operation for AVR is high, but there is no significant difference in survival at 10 years. In at least a portion of patients having mild aortic stenosis at the time of CABG there will be progression of the stenosis necessitating reoperation at a later date.

Current status and future trends of mechanical circulatory support.

This article provides a brief overview of the ventricular assist devices (VADs) available for patients with severe ventricular failure. The history of VAD development and clinical results in the adult and pediatric population are reviewed. Because the VAD role is expanding, nursing implications and a critical analysis of the growing economic concerns regarding their use are discussed.

Infectious complications associated with ventricular assist devices.

Improvements in technology, patient selection, and patient management have led to a wider clinical application of mechanical circulatory support. Critically ill patients often develop multiorgan ischemia and are prone to multiple complications. Despite these advances, infection is a common and sometimes lethal complication of support with ventricular assist devices. This article provides guidelines for the prevention and management of infection in patients who require such support.

Double-valve replacement with Medtronic-Hall or St. Jude valve.

To define better the performance of the bileaflet St. Jude and the tilting-disc Medtronic-Hall valves, we retrospectively analyzed 122 patients (St. Jude, 80 patients; Medtronic-Hall, 42 patients) who received simultaneous aortic and mitral replacement from May 1984 until June 1994. The two groups were not different with respect to preoperative clinical and hemodynamic parameters and New York Heart Association functional class. The hospital mortality and late mortality were not significantly different. Risk analysis identified advanced age and previous myocardial revascularization as predictors of operative death. Follow-up was complete in 96 of 103 hospital survivors (93%) and was similar in both groups. The actuarial survival, linearized rates of valve-related complications, and actuarial freedom from valve-related complications were similar in both cohorts. The presence of coronary artery disease negatively influenced the actuarial survival after simultaneous aortic and mitral valve replacement. Postoperative New York Heart Association functional class was not significantly different in either group. These data indicate that the Medtronic-Hall and St. Jude prostheses are not significantly different with respect to their clinical performance and valve-related complications for simultaneous double-valve replacement.

Risk stratification in patients bridged to cardiac transplantation.

Patient selection is considered one of the most important factors influencing success in bridge to transplant procedures. However, to date it has been difficult to identify predictors of mortality in this population using univariate or multivariate analysis. In 1988, we developed a scoring system using 21 clinical variables that could be calculated rapidly at the bedside while evaluating potential candidates. Points were designated to these variables using a scale of 1 to 3, 1 having the least adverse effect on survival and 3 the most. Patients received a value of 0 for each variable that did not apply. This scoring system was used in a retrospective analysis for 15 bridge to transplant patients. The results showed a significant difference (p < 0.003) between the 8 survivors (mean score, 5.75 +/- 2.19) and the 7 nonsurvivors (mean score, 11.71 +/- 3.45). Since 1989, we have prospectively calculated the scores in an additional 27 patients. Based on the score, all 42 patients were divided into three groups: group I had scores of 1 to 5; group II, 6 to 10; and group III, 11 to 16. The mean score for group I (16 patients) was 3.69 +/- 1.25. All group I patients survived. Group II patients (n = 15) had a mean score of 7.87 +/- 1.36 and a survival rate of 53%. The mean score for group III (n = 11) was 13 +/- 1.73. Thirty-six percent of these patients survived. Comparison of survival and mean scores among the three groups was statistically significant (p < 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)

Understanding ventricular assist devices: a self-study guide.

Considerable progress has been made over the past several decades in development of ventricular assist device (VAD) technology. Initially, failure to wean from cardiopulmonary bypass was the primary indication for VAD support. However, VAD role has expanded to include patients with ventricular failure due to myocardial infarction and patients awaiting cardiac transplantation. A greater number of nurses, both in the intensive care and general floors, are required to care for patients supported with VADs. Therefore, a self-study guide was developed to facilitate learning. Heart failure physiology, mechanical device descriptions, patient selection, potential complications, and nursing care of patients who require VAD support are reviewed.

Nursing care of the patient with an intravascular oxygenator.

Conventional therapy in the management of adult respiratory distress syndrome is often associated with an increased mortality rate. Several methods to improve survival in patients with severe respiratory insufficiency are under evaluation. One recently developed method of treatment is an implantable intravascular oxygenator, which provides supplemental gas exchange for failing lungs. This device can provide temporary ventilatory support in patients with acute, potentially reversible respiratory insufficiency. Reduction in ventilator settings such as airway pressure, oxygen concentration, positive end-expiratory pressure and minute volume can be achieved, decreasing the likelihood of oxygen toxicity and barotrauma. Success of the intravascular oxygenator in adult respiratory distress syndrome is dependent in part on critical care staff expertise. Therefore, a thorough understanding of the operation of this device and its role in acute respiratory failure is necessary for optimal care.

Synthesis and in vivo evaluation of [18F]-N-(p-nitrobenzyl)spiperone ([18F]PNBS) in rats.

[18F]-N-(p-nitrobenzyl)spiperone, [18F]PNBS, was prepared and its in vivo uptake in rat brain was measured. A temporal increase in striatum:cerebellum ratio and frontal cortex:cerebellum (FC:Cb) ratio was observed. Blocking studies suggested the formation of a radiolabeled metabolite, presumably [18F]spiperone, that is capable of crossing the blood-brain barrier and labeling cortical 5-HT2 receptors. This was confirmed using the ISRP method of metabolite analysis indicating [18F]PNBS is not a suitable tracer for studying D2 receptors in vivo with PET.

The importance of patient mobility with ventricular assist device support.

Patients bridged to transplantation with ventricular assist devices (VADs) often require prolonged support. To reduce complications associated with bed rest, the authors developed a program to mobilize patients with VADs. Between August 1986 and May 1992, 25 men and 7 women aged 12-65 years (mean: 42.4 years) were bridged for possible transplantation. The 32 patients were supported with either a Novacor (n = 9) or a Thoratec (n = 23) VAD. Thirty-one patients were turned within 2-12 hr of VAD insertion and received range of motion therapy. Twenty-six patients sat in a chair 2-16 days (mean: 5 days) after VAD insertion. Twenty-one patients used a stationary bicycle, and 23 patients were ambulatory 3-57 days (mean: 11 days) after VAD insertion. Two patients were transplanted within 72 hr of device insertion. Twenty-one of the 23 ambulatory patients were successfully transplanted or weaned from the VAD and discharged from the hospital. Two ambulatory patients who were difficult to rehabilitate (ambulatory 22 and 57 days, respectively, after VAD insertion) died before transplantation. In conclusion, VAD patients should be mobilized early because the VAD can improve exercise capability and survival rate.

Importance of ventricular arrhythmias in recovery patients with ventricular assist devices.

The effect of ventricular arrhythmias (VA) on survival was retrospectively reviewed in 41 patients (33 men, 8 women) who were supported with Thoratec ventricular assist devices (VAD [Thoratec Medical Inc., Berkeley, CA]) (17 left, 9 right, and 15 biventricular). Ages ranged from 15 to 71 years (mean, 56 years), and duration of support was 0.1-17 days (mean, 4.7 days). There was no significant difference in age, gender, or type of support between survivors and nonsurvivors, and no correlation between the type of support and incidence of VA. Only two patients (both on left ventricular assist devices [LVAD]) died as a direct result of VA. There was no significant difference in the occurrence of VA before or during VAD support between survivors and nonsurvivors. These data show that evidence of VA is not a predictor of survival in patients in whom myocardial recovery is expected.