Optimal timing for heart transplantation in patients bridged with left ventricular assist devices: Is timing of the essence? (original) (raw)
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513: One Year Followup with a Continuous Flow LVAD as a Bridge to Heart Transplantation
The Journal of Heart and Lung Transplantation, 2008
Purpose: Despite the high priority allocation and availability of mechanical circulatory support (MCS), 18% of the medically managed UNOS status 1A candidates die without MCS while awaiting heart transplantation (HT). Decision to advance therapy to MCS is often difficult, as there are no strict criteria who and when would be most likely to benefit from BTT. In order to identify pts, for whom MCS would be favored over waiting for HT, we analyzed outcomes of the U.S. population of medically managed status 1A candidates. Methods and Materials: Between Jan 2000 and Dec 2006, a total of 3,711 pts were listed de novo as UNOS status 1A candidates in the U.S., including 2,208 (59%) who were initially treated medically and 1,503 (41%) rescued with BTT before the day of listing. Of the 2,208 medically managed pts, 451 (20%) subsequently underwent BTT. Pts were followed until HT, death, removal from the waiting list or Sept 1, 2007. Results: The use of MCS in medically managed status 1A candidates was associated with increased probability of survival and/or HT from 66.5% to 87.1% at 3-months*. By multivariate analysis the risk factors for death and/or not receiving HT within 24 days (median time to HT) in medically managed pts included the presence of intra-aortic balloon pump* or ventilator support*, SCr Ͼ 1.5 mg%*, age Ͼ 60 yrs*, albumin Յ 2.5 g%*, ABO blood type O* and weight Ͼ 89 kg*. The time when the predicted probability of 1-month survival and/or HT decreased below the average 85% 1-month survival benefit of MCS alone, varied between days and weeks depending on the pts risk profile. Conclusions: Elective MCS implantation as BTT should be strongly considered in medically managed UNOS status 1A candidates at high risk of death and/or anticipated long waiting time to HT. The predicted 1-month survival in pts with the identified risk factors for death or with projected long wait times to HT may help guide the optimal timing for device implantation. * pϽ0.001.
The Journal of Heart and Lung Transplantation, 2016
In this cohort, there was equivalent mortality (UOR 1.08, 95% CI 0.51-2.25, p= 0.8) but increased major morbidity (UOR 2.13, 95% CI 1.20-3.77, p= 0.01). In the subset analysis of matched non-emergent patients, odds of operative mortality were equivalent (UOR 1.0, 95% CI 0.40-2.53, p= 1.0) but major morbidity remained higher in the tMCS group (UOR 2.94, 95% CI 1.58-5.46, p= 0.001). Postoperative length of stay was significantly longer in the non-emergent tMCS group (29 vs. 21 days, p= 0.006) as well. Conclusion: This study demonstrates equivalent mortality for risk-matched patients receiving bridging tMCS devices, contrary to our hypothesis. Despite this encouraging finding, early referral for durable LVAD support should be considered in non-emergent patients to avoid a need for tMCS devices, which result in increased morbidity.
Mid-term survival after continuous-flow left ventricular assist device versus heart transplantation
Heart and Vessels, 2015
Background-There is a paucity of data about mid-term outcome of patients with advanced heart failure (HF) treated with left ventricular assist device (LVAD) in Europe, where donor shortage and their aging limit the availability and the probability of success of heart transplantation (HTx). The aim of this study is to compare Italian single-centre mid-term outcome in prospective patients treated with LVAD versus HTx.
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.
The Annals of thoracic surgery, 2014
Continued donor organ shortage and improved outcomes with current left ventricular assist device (LVAD) technology have increased the number of patients supported with bridge-to-transplantation (BTT) therapy. Using the United Network of Organ Sharing (UNOS) database, we assessed the impact on survival in patients supported with BTT while on the heart transplant waiting list. The UNOS database was queried from January 2005 to June 2012 to identify patients listed for heart transplantation as UNOS status 1A or 1B. Patients implanted with a pulsatile-flow device or an LVAD other than the HeartMate II (HM II; Thoratec Inc, Pleasanton, CA) were excluded. Patients were divided into LVAD and non-LVAD groups based on status at the time of listing. Patients were propensity matched (LVAD -non-LVAD = 1:2) for age, sex, weight, presence of diabetes, creatinine levels, mean pulmonary artery pressure, and UNOS status. Kaplan-Meier curves were analyzed for survival. A total of 8,688 patients were ...
The Effect of Ventricular Assist Devices on Post-Transplant Mortality
Journal of the American College of Cardiology, 2009
This study sought to determine the relationship between pre-transplant ventricular assist device (VAD) support and mortality after heart transplantation. Background Increasingly, VADs are being used to bridge patients to heart transplantation. The effect of these devices on post-transplant mortality is unclear. Methods Patients 18 years or older who underwent first-time, single-organ heart transplantation in the U.S. between 1995 and 2004 were included in the analyses. This study compared 1,433 patients bridged with intracorporeal and 448 patients bridged with extracorporeal VADs with 9,455 United Network for Organ Sharing status 1 patients not bridged with a VAD with respect to post-transplant mortality. Because the proportional hazards assumption was not met, hazard ratios (HRs) for different time periods were estimated. Results Intracorporeal VADs were associated with an HR of 1.20 (95% confidence interval [CI]: 1.02 to 1.43; p ϭ 0.03) for mortality in the first 6 months after transplant and an HR of 1.99 (95% CI: 1.44 to 2.75; p Ͻ 0.0001) beyond 5 years. Between 6 months and 5 years, the HRs were not significantly different from 1. Extracorporeal VADs were associated with an HR of 1.91 (95% CI: 1.53 to 2.37; p Ͻ 0.0001) for mortality in the first 6 months and an HR of 2.93 (95% CI: 1.19 to 7.25; p ϭ 0.02) beyond 5 years. The HRs were not significantly different from 1 between 6 months and 5 years, except for an HR of 0.23 (95% CI: 0.06 to 0.91; p ϭ 0.04) between 24 and 36 months. Conclusions Extracorporeal VADs are associated with higher mortality within 6 months and again beyond 5 years after transplantation. Intracorporeal VADs are associated with a small increase in mortality in the first 6 months and a clinically significant increase in mortality beyond 5 years. These data do not provide evidence supporting VAD implantation in stable United Network for Organ Sharing status I patients awaiting heart transplantation.