The time course of natriuretic hormones as plasma markers of myocardial recovery in heart transplant candidates during ventricular assist device support reveals differences among device types.

BACKGROUND: The natriuretic hormones ANP and BNP are expressed differently in the myocardium. Both hormones have compensatory diuretic activity during heart failure. Mechanical stretch of the myocardial walls induces the expression of these hormones. In failing human myocardium, both ANP and BNP are transcribed in the ventricular myocardium in high amounts. We measured the plasma concentrations of ANP and BNP in patients supported by various ventricular assist devices (VADs) at various times. We analyzed the time courses of ANP and BNP to determine (1) the time scale of their down-regulation as a marker of putative myocardial recovery, (2) their steady-state levels under VAD support and (3) differences caused by various VAD devices. METHODS: We analyzed ANP and BNP using commercially available radioimmune assays. We analyzed the time courses of patients supported by Thoratec (THO) LVAD (n = 8), TCI Heartmate (TCI) (n = 6), Novacor (NOV) (n = 7), and Lionheart (LIO) (n = 3). RESULTS: Patients supported with NOV and some patients with TCI showed down-regulation of BNP to a steady-state level at 30 to 50 days, following a single exponential decay. In contrast, patients supported by THO or LIO did not reveal a determined time course of the natriuretic hormones. Only a few patients reached normal plasma values during VAD support. CONCLUSION: The time courses of ANP and BNP differ among VAD types because of construction and/or driving mode, which might be important when considering patients for weaning from VAD without heart transplant.

Device and patient management in a bridge-to-transplant setting.

BACKGROUND: A variety of sophisticated devices have been developed for mechanical circulatory support in patients bridged to cardiac transplantation. Based on 13 years' experience, we have developed specific protocols for patient selection and management for different devices. METHODS: The principal systems applied in the bridge-to-transplant cohort are the Thoratec ventricular assist device (n = 144, mean duration of support 53 +/- 57 days), the Novacor left ventricular assist system (LVAS) (n = 85, mean duration of support 154 +/- 15 days), and the HeartMate LVAS (n = 54, mean duration of support 143 +/- 142 days). The Thoratec device is used for biventricular assistance or if the duration of support is expected to be less than 6 months. For long-term support, either the Novacor or HeartMate LVAS are preferred. RESULTS: Despite careful postoperative patient management, this group of patients is prone to a variety of complications. Bleeding occurred in 22% to 35%, right heart failure in 15% to 26%, neurologic disorders in 7% to 28%, infection in 7% to 30%, and liver failure in 11% to 20% of patients. Complications varied with the device applied and the patient's preoperative condition. A total of 73 patients were discharged from hospital for a mean period of 184 days; this cumulative experience amounted to 37.5 patient-years. CONCLUSIONS: The Novacor and the HeartMate systems offer the additional possibility of discharging patients during support if they fulfill certain criteria. The main reasons for rehospitalization were thromboembolic and infectious complications.

Midterm follow-up of patients discharged from hospital under left ventricular assistance.

BACKGROUND: Against the background of increasing demand for long-term mechanical circulatory support, discharging patients to their homes while on assist devices becomes more and more important. This report describes the midterm follow-up of 66 patients who were allowed to leave the hospital under left ventricular assist device (LVAD) support with Novacor or HeartMate systems. Between May 1994 and January 2000, 66 patients (9 women, 57 men, between 15 and 68 years old) under LVAD support fulfilled our criteria for being discharged home on the device. Intent to treat comprised bridging to transplantation in 59 patients, bridging to recovery in 5 patients, and alternative to transplantation in 2 patients. Forty-four patients received support with Novacor, 18 patients with the VE HeartMate, 2 patients with centrifugal pumps and Novacor, and 1 patient each with Novacor and Thoratec/Medos HIA-VAD. The mean out-of-hospital (OOH) follow-up period was 162 +/- 187 days, with a cumulative OOH experience of 30 patient years. Twenty-nine patients were not readmitted, and 37 patients were readmitted 54 times (23 patients were readmitted once, 11 patients twice, and 3 patients 3 times). The primary reasons for readmission included neurologic disorders and infection complications. At 229 days, 50% of all patients were free from readmission. The readmission rate was 1.8 patient/year. Sixteen patients died while on LVAD support (24%). Our midterm follow-up results show the safety and efficacy of this therapeutic option. Acceptable hospital readmission rates strongly support the future use of this technology as an alternative to transplantation in managing end-stage heart failure patients.

Morbidity and outcome after mechanical ventricular support using Thoratec, Novacor, and HeartMate for bridging to heart transplantation.

Between September 1989 and June 1999, 228 patients were supported with a ventricular assist device as a bridge to heart transplantation. In this study, the results of implantation were evaluated in patients supported with one type of device, including 85 supported with a Thoratec, 61 with a Novacor, and 37 with a HeartMate. The mean support time was 49, 148, and 124 days, respectively. Successful transplantation and weaning rates were 64. 7% with Thoratec, 59.0% with Novacor, and 62.0% with HeartMate. Cerebral embolism and drive-line and pocket infection were major causes of postoperative morbidity and mortality. We recommended that a Thoratec system be employed as a bridge to heart transplantation for patients with biventricular heart failure, and that a Novacor or HeartMate system be implanted in patients requiring a long-term circulatory support.

Single-center experience with the thoratec ventricular assist device.

OBJECTIVE: The Thoratec ventricular assist device (Thoratec Laboratories, Pleasanton, Calif) is widely accepted for univentricular and biventricular support in patients with various indications. The aim of this study is to describe our experience with implantation of the Thoratec ventricular assist device in more than 100 patients. METHODS: From March 1992 to June 1998, 114 patients (98 men and 16 women; mean age, 47.9 years) received the Thoratec ventricular assist device for a mean duration of 44.9 days. The patients were divided into 3 groups. Group 1 included 84 patients in whom the system was applied as a bridge-to-transplant procedure. Group 2 included 17 patients with postcardiotomy cardiogenic shock, and group 3 included 13 patients with cardiogenic shock of other causes. RESULTS: Sixty-eight percent of patients in group 1 survived to transplantation with a posttransplant survival of 88%. The only independent risk factor affecting survival was age more than 60 years. Survivals in groups 2 and 3 were 47% and 31%, respectively. Main complications in all groups were bleeding, multiple organ failure, liver failure, sepsis, and neurologic disorders. CONCLUSIONS: The Thoratec ventricular assist device has proved to be a reliable device for bridge to transplantation and postcardiotomy support. Further studies are required on patient selection and on patient and device management to reduce the incidence of complications in these patient populations.

Bridging to cardiac transplantation with the Thoratec Ventricular Assist Device.

Mechanical circulatory support has become an established procedure for bridging patients to cardiac transplantation. One of the devices available is the Thoratec VAD, which can be applied for univentricular or biventricular support. Between March 1992 and June 1997, 74 patients were bridged with Thoratec VAD to cardiac transplantation. In 67 patients the system was applied exclusively (26 LVAD, 38 BVAD, 3 TAH), in 7 patients subsequently or in combination with another MCS device. 71.6% with exclusive Thoratec application underwent transplantation with a post-transplant survival rate of 90%, 4 patients are still waiting. Transplant rate in LVAD and BVAD patients was 84% and 71.4%, respectively, posttransplant survival 95.2% and 88%, respectively. 28.6% with a combined application of Thoratec and another MCS device survived to be discharged from hospital. Main complications were bleeding, liver failure, multiple organ failure, and infections. In terms of reliability and efficacy the Thoratec VAD is the system of choice for mid-term application in patients bridged to cardiac transplantation.

Long-term mechanical circulatory support.

Against the background of an increasing number of patients waiting for heart transplantation but a stagnating number of transplant procedures, long-term mechanical circulatory support is gaining major importance. We investigated the outcome of 20 patients (15 men, and 5 women, aged between 15 and 66 years) each supported for more than 100 days between September 1987 and August 1996. The indications for implantation were bridging in 17 patients, myocarditis in 2 patients, and postcardiotomy cardiogenic shock in one patient. 12 patients received the Novacor IVAD, 4 patients the Thoratec system, 3 patients the HeartMate device and one patient both Novacor and Thoratec. Mean duration of support was 178.1 days, 15 patients were transplanted, 14 of them could be discharged, 2 patients died, 4 patients are still waiting. The most frequent complication was device-related infection in 11 patients. The results have shown that all three systems are safe and reliable devices for supporting patients for more than 100 days.

Out-of-hospital experience in patients with implantable mechanical circulatory support: present and future trends.

From March 1993 to August 1995, 33 patients received implantable VAD systems at our center. Nineteen patients received the wearable Novacor LVAS and 14 patients the TCI HeartMate device. Both systems enable the patients to be mobilized very quickly and some of them even do not require critical care after a few days. In our series 17 patients (eight Novacor, nine TCI) could be transferred to the normal floor. The wearable electrically driven Novacor system opens the opportunity of sending patients out of hospital. Since July 1994 we have referred five patients to a rehabilitation center, and six patients were sent home, three of them for more than 70 days. A number of factors are necessary to prepare the patient for being discharged. One of the most important things is to guarantee ambulatory patient care and to find an easy way for effective home monitoring. Our experience has shown that discharging these patients means giving them a maximum in quality of life and decreasing the costs by more than 50% in comparison to a stay in hospital for the whole time. Our results are encouraging to improve this strategy in the future.

Mechanical circulatory support: lessons from a single centre.

Over recent years, a number of different mechanical circulatory support (MCS) products have been developed to a stage where they are no longer investigational devices. Registry data provide some information, but this is limited by the mix of historical and contemporary data and the voluntary nature of the contributions. As yet, there are no clear guidelines for patient selection, the differential application of generically different devices or for optimal patient management. Ours is a busy centre offering a comprehensive cardiovascular service. This review details our experience since 1987 and 189 patients supported with five different types of device, used in all of the common applications. Our experience has permitted the formulation of some general principles and guidelines. Data published by registries and by individual manufacturers are, as yet, not standardized. We hope that our experience will be of interest to those centres wishing to establish a mechanical assist service.