Emergency Use of Wearable Left Ventricular Assist Devices in Patients Not Eligible for Heart Transplantation (original) (raw)
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European Journal of Internal Medicine, 2014
Heart transplantation (HTx) is considered the "gold standard" therapy of refractory heart failure (HF), but it is accessible only to few patients because of the paucity of suitable heart donors. On the other hand, left ventricular assist devices (LVADs) have proven to be effective in improving survival and quality of life in patients with refractory HF. The challenge encountered by multidisciplinary teams in dealing with advanced HF lies in identifying patients who could benefit more from HTx as compared to LVAD implantation and the appropriate timing. The decision-making is based on clinical parameters, imaging-based data and risk scores. Current outcome of HF patients supported by LVAD (2-year survival around 70%) is rapidly improving and leads the way to a new therapeutic strategy. Patients who have a low likelihood to gain access to the heart graft pool could benefit more from LVAD implantation (defined as bridge to transplantation indication) than from remaining on HTx waiting list with the likely risk of clinical deterioration or removal from the list because patients are no longer suitable for transplantation. LVAD has also demonstrated to be effective in patients who are not considered eligible candidates for HTx with a destination therapy indication. HTx should be reserved to those patients for whom the maximum clinical benefit can be expected, such as young patients with no comorbidities. Here we discuss the current listing criteria for HTx and indications to implant of LVAD for patients with refractory acute and chronic HF based on the guidelines and the practical experience of our center.
Left Ventricular Assist Devices as Bridge to Heart Transplantation: The Niguarda Experience
Journal of Cardiac Surgery, 2003
Background: Congestive heart failure is the leading cause of death in Western countries. Heart transplantation currently is the only accepted therapy for patients with end-stage heart failure, but the supply of donor hearts is inadequate, and different mechanical circulatory support systems have been investigated as bridges to heart transplant. Methods: Since April 1992, 53 patients (47 men, 6 women, aged 12 to 61 years) received left ventricle mechanical circulatory support as bridge to heart transplant. The two principal devices used were: the Novacor LVAS in 31 patients and the DeBakey VAD in 11 patients. Results: All patients survived the operation. Mean duration of LVAD support was 2.8 ± 5.6 months. Thirty-seven patients (71.1%) underwent heart transplantation. Twelve major bleeding episodes occurred in nine patients (16.9%). Globally, major and minor neurologic events occurred in 13 patients (24.5%). Ten patients (19.9%) assisted with the Novacor Wearable LVAS device were discharged at home while waiting for heart transplant (HTx). The mean follow-up of the 34 discharged transplanted patients was 45.3 ± 37 months. Actuarial survival of transplanted patients while on LVAD was 91.0 ± 4.9% and 83.4 ± 8.5% at 1 and 5 years, respectively. No differences in post-transplant long-term survival and rejection and allograft vasculopathy occurred between patients transplanted with or without LVAD implanted. Conclusions: LVAD therapy proved to be effective in bridging patients with endstage heart failure to HTx. While on LVAD support, patients assisted with implantable wearable devices could be discharged at home, ameliorating their quality of life. The excellent survival rate after HTx is concomitant with a low incidence of rejection and cardiac allograft vasculopathy. (J Card Surg 2003;18:107-113) Congestive heart failure (CHF) is recognized as a major public health issue and is the leading cause of death in Western countries. The American Heart Association estimates that at least 400,000 new cases of CHF are diagnosed each year. 1 Modern medical treatment with angiotensin-converting enzyme inhibitors, beta-blocking agents, and diuretics is able to confer only up to a 16% survival benefit at
The Journal of Thoracic and Cardiovascular Surgery, 2013
Objectives: Continuous-flow left ventricular assist devices have become the standard of care for patients with heart failure requiring mechanical circulatory support as a bridge to transplant. However, data on long-term posttransplant survival for these patients are limited. We evaluated the effect of continuous-flow left ventricular assist devices on postcardiac transplant survival in the current era. Methods: All patients who received a continuous-flow left ventricular assist device as a bridge to transplant at a single center from June 2005 to September 2011 were evaluated. Results: Of the 167 patients who received a continuous-flow left ventricular assist device as a bridge to transplant, 77 (46%) underwent cardiac transplantation, 27 died before transplantation (16%), and 63 (38%) remain listed for transplantation and continued with left ventricular assist device support. The mean age of the transplanted patients was 54.5 AE 11.9 years, 57% had an ischemic etiology, and 20% were women. The overall mean duration of left ventricular assist device support before transplantation was 310 AE 227 days (range, 67-1230 days). The mean duration of left ventricular assist device support did not change in patients who had received a left ventricular assist device in the early period of the study (2005-2008, n ¼ 62) compared with those who had received a left ventricular assist device later (2009-2011, n ¼ 78, 373 vs 392 days, P ¼ NS). In addition, no difference was seen in survival between those patients supported with a left ventricular assist device for fewer than 180 days or longer than 180 days before transplantation (P ¼ NS). The actuarial survival after transplantation at 30 days and 1, 3, and 5 years by Kaplan-Meier analysis was 98.7%, 93.0%, 91.1%, and 88.0%, respectively.
Journal of the American College of Cardiology, 1997
Objectives. Our recent experience with outpatient left ventricular assist device (LVAD) support is presented to demonstrate the possibilities and limitations of long-term outpatient mechanical circulatory assistance. Background. The experience with inpatient LVAD support as a bridge to transplantation has proved the efficacy of such therapy in improving circulatory hemodynamic status, restoring normal end-organ function and facilitating patient rehabilitation. With miniaturization of the power supplies and controllers, such mechanical circulatory support can now be accomplished in an outpatient setting. Methods. Between March 1993 and February 1997, 32 patients (26 male, 6 female, mean [؎SEM] age 49 ؎ 15 years) underwent implantation of the ThermoCardiosystems (TCI) Heartmate vented electric (VE) LVAD. The VE LVAD is powered by batteries worn on shoulder holsters and is operated by a belt-mounted system controller, allowing unrestricted patient ambulation and hospital discharge. Results. Mean duration of support was 122 ؎ 26 days (range 3 to 605), with a survival rate to transplantation or explantation of 78%. Nineteen patients were discharged from the hospital on mean postoperative day 41 ؎ 4 (range 17 to 68), for an outpatient support time of 108 ؎ 30 days (range 2 to 466). Four patients underwent early transplantation and could not participate in the discharge program, and three patients currently await discharge. The complication rate was not statistically different from that encountered in our previous 52 patients with a pneumatic LVAD. Conclusions. Outpatient LVAD support is safe and provides improved quality of life for patients awaiting transplantation. Wearable and totally implantable LVADs should be studied as permanent treatment options for patients who are not candidates for heart transplantation.
European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 2014
Left ventricular assist devices (LVADs) are a routine treatment for patients with advanced heart failure as a bridge to transplantation. The aim of this study was to present our institutional experience and mid-term outcomes after implantation of 139 continuous-flow (cf) LVADs as a bridge to transplantation. One hundred and thirty-nine consecutive LVAD implantations were performed in our institution between July 2007 and August 2013. The mean age of the population was 44.0 ± 13.7 years and 24 (17%) of the patients were female. A substantial number of the patients were on preoperative mechanical support: 35 (25%) with an intra-aortic balloon pump, 9 (6.5%) with an extracorporeal membrane oxygenator and 25 (18%) with previous LVAD, for LVAD exchange. The mean support duration was 514 ± 481 days, whereas the longest support duration was 2493 days (>6 years). The overall cumulative survival rate following cfLVAD implantation was 89% at 30 days, 76% at 1 year and 66% at 2 years (Fig. ...
Journal of Surgical Research, 2020
Background: The use of left ventricular assist devices (LVADs) as a bridge to heart transplantation has increased rapidly over the last 2 decades. We aim to explore the effect of pretransplant systemic and device-related complications on posttransplant survival for patients bridged with LVADs. Materials and methods: The United Network of Organ Sharing (Organ Procurement and Transplantation Network) database was queried for all adult heart transplant recipients (aged ! 18 y) transplanted from April 1, 2015, to June 31, 2018. Device-related complications included thrombosis, device infection, device malfunction, life-threatening arrhythmia, and other device complications. Systemic complications included a new dialysis need or ventilator dependence between the time of listing and transplantation, transfusion, or systemic infection requiring treatment with intravenous antibiotics within 2 wk of transplantation. Results: A total of 2131 patients were identified as requiring LVAD support before transplantation. LVAD patients had high rates of preoperative systemic complications (53%) and high rates of device-related complications (42.7% experienced at least one device-related complication). KaplaneMeier analysis revealed a significantly decreased 1-y survival for LVAD patients bridged to transplantation who experienced a pretransplant systemic complication (P ¼ 0.041). Interestingly, preoperative device-related complications had no effect on 1-y posttransplantation survival (P ¼ 0.93). Multivariate Cox modeling revealed
Transplantation Proceedings, 2019
Background. Continuous flow left ventricular assist devices (CF-LVAD) are widely used as a bridge to transplantation (BTT) among patients with advanced heart failure. The primary outcome of the current study was to study the incidence of waitlist mortality and morbidity of CF-LVAD patients bridged to heart transplantation in the current BTT era and to determine the factors that increased their risk of delisting. Methods. Patients who were bridged to heart transplant with a CF-LVAD between April 2008 and September 2015 were identified from the United Network for Organ Sharing heart transplant registry. They were then categorized based on the development of complications. Cox proportional hazards and Kaplan-Meier survival curves were used for time-to-event analysis for the primary outcome. Results. Out of 7070 patients who were bridged to heart transplant, 2510 (36%) developed device-related complications. The primary outcome was present in 1631 of 7070 patients (23%). Independent predictors of primary outcome were age, ABO blood group, etiology of cardiomyopathy, and history of diabetes mellitus. Developing one device-related complication was associated with a hazard ratio (HR) of 2.59 of having the primary outcome. The HR increased to 3.45 when !2 of the defined complications occurred. In patients who developed the primary outcome, they most likely had a device infection (odds ratio 2.51). Conclusion. Findings from the current study add to the existing literature about the incidence of morbidity and mortality in the current BTT era. Development of one devicerelated complication increases the risk of death or delisting among patients on the heart transplant waitlist; however, this risk almost doubles when 2 or more complications occur.