Effects of left ventricular assist devices on outcomes in patients undergoing heart transplantation (original) (raw)
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Canadian Journal of Cardiology, 2012
Background-Current available treatment options for advanced heart failure include heart transplantation and ventricular assist device (VAD) therapy. This project aimed to evaluate the cost-effectiveness of a bridge-to-transplantation (BTT)-VAD approach relative to direct heart transplantation in transplant-eligible patients. Methods and Results-A Markov model was used to evaluate survival benefits and costs for BTT-VAD versus nonbridged heart transplant recipients. Three different scenarios were considered according to severity of patients' baseline hemodynamic status (high, medium, and low risk). Results are presented in terms of survival, costs, and cost-effectiveness ratio. Sensitivity analyses were used to analyze uncertainty in model estimates. Over a 20-year time horizon, BTT-VAD therapy increased survival at an increased cost relative to nonbridged heart transplant recipients: 100841moreincostsand1.19increasedlifeyears(LYs)inhigh−riskpatients(100 841more in costs and 1.19 increased life years (LYs) in high-risk patients (100841moreincostsand1.19increasedlifeyears(LYs)inhigh−riskpatients(84 964/LY), 112779moreincostsand1.14moreLYs(112 779 more in costs and 1.14 more LYs (112779moreincostsand1.14moreLYs(99 039/LY) in medium-risk patients, and an additional cost of 144334andincrementalclinicalbenefitof1.21moreLYs(144 334 and incremental clinical benefit of 1.21 more LYs (144334andincrementalclinicalbenefitof1.21moreLYs(119 574/LY) in low-risk patients. The sensitivity analysis estimated a 59%, 54%, and 43% chance of BTT-VAD therapy being cost-effective for high-, medium-, and low-risk patients at a willingness-to-pay level of $100 000/LY. Subgroup analyses indicated that risk of post-VAD and transplantation complications, waiting time, renal dysfunction, and patient age substantially affected the cost-effectiveness ratio. Conclusions-BTT-VAD therapy is associated with improved survival and increased costs. On the basis of commonly accepted willingness-to-pay thresholds, BTT-VAD therapy is likely to be cost-effective relative to nonbridged heart transplantation in specific circumstances. The online-only Data Supplement is available with this article at http://circ.ahajournals.org/lookup/suppl/
Impact of Left Ventricular Assist Device Exchange on Outcomes Following Heart Transplantation
The Annals of Thoracic Surgery, 2019
Background. Left ventricular assist devices (LVADs) are the most common mode of circulatory support for patients awaiting heart transplantation. Unfortunately, a fraction of these patients require pump exchange during their course for pump-related adverse events. This study examined whether LVAD exchanges affect posttransplantation outcomes. Methods. This study focused on adult patients in the Organ Procurement and Transplantation Network database who were bridged to transplant with a LVAD implanted between 2007 and 2017. Patients who underwent LVAD exchange were compared with those supported with a single device. The primary end point was all-cause mortality at 1, 2, and 5 years after transplantation. The impact of device exchange on risk-adjusted outcomes was examined using Cox proportional hazards models. Results. Among 8239 patients who met the inclusion criteria, there were 611 pump exchanges in 560 patients (7% of recipients). The pump exchange rate was 6.24 events per 100 patient-years. Survival at 5 years was lower for those who underwent LVAD exchange (69.4% vs 77.5%, log-rank P [ .027). This finding was similar for risk-adjusted 5-year mortality (hazard ratio, 1.36; 95% confidence interval, 1.11 to 1.67; P [ .003). Subgroup analysis revealed lower 5-year survival for female recipients who underwent LVAD exchange (55.4% vs 79.7%, log-rank P < .001). The interaction between female sex and LVAD exchange was associated with increased risk-adjusted 5-year mortality (hazard ratio, 1.65; 95% confidence interval, 1.05 to 2.59; P [ .030). Conclusions. Recipients who underwent pump exchange while awaiting heart transplantation had a higher mortality compared with those on a primary device. Subgroup analysis revealed a marked increase in mortality of female recipients who experienced LVAD exchange.
International Journal of Cardiology, 2021
Background: Geographic variations in management and outcomes of individuals supported by continuous-flow left ventricular assist devices (CF-LVAD) between the United States (US) and Europe (EU) is largely unknown. Methods: We created a retrospective, multinational registry of 524 patients who received a CF-LVAD (either HVAD or Heartmate II) between January 2008 and April 2017. Follow up spanned from date of CF-LVAD implant to post-HTx period with a median follow up of 44.8 months. Results: The cohort included 299 (57.1%) EU and 225 (42.9%) US patients. Although the US cohort was significantly older with a higher prevalence of comorbidities, survival was similar between the cohorts (US 63.1%, EU 68.4% at 5 years, unadjusted log-rank test p = 0.43).Multivariate analyses suggested that older age, higher body mass index, elevated creatinine, use of temporary mechanical circulatory support prior CF-LVAD, and implantation of HVAD were associated with increased mortality. Among CF-LVAD patients undergoing HTx, the median time on CF-LVAD support was shorter in the US, meanwhile US donors were younger. Finally, the pattern of adverse events (stroke, gastrointestinal bleedings, late right ventricular failure, and driveline infection) during support differed significantly between US and EU. Conclusions: Although waitlisted patients in the US on CF-LVAD have higher risk comorbid conditions, the overall outcome is similar in US and EU. Geographic variations with regards to donor characteristics, duration of CF-LVAD support prior to transplant, and adverse events on support can explain the disparity in the utilization of mechanical bridge to transplant strategy between US and EU.
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.
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 ...
International journal of cardiology, 2017
This systematic review aimed to evaluate the clinical outcomes and cost-effectiveness of left ventricular assist devices (LVADs) used as bridge to transplantation (BTT), compared to orthotopic heart transplantation (OHT) without a bridge. Systematic searches were performed in electronic databases with available data extracted from text and digitized figures. Meta-analysis of short and long-term term post-transplantation outcomes was performed with summation of cost-effectiveness analyses. Twenty studies reported clinical outcomes of 4575 patients (1083 LVAD BTT and 3492 OHT). Five studies reported cost-effectiveness data on 837 patients (339 VAD BTT and 498 OHT). There was no difference in long-term post-transplantation survival (HR 1.24, 95% CI 1.00-1.54), acute rejection (HR 1.10, 95% CI 0.93-1.30), or chronic rejection and cardiac allograft vasculopathy (HR 0.99, 95% CI 0.73-1.36). No differences were found in 30-day post-operative mortality (OR 0.91, 95% CI 0.42-2.00), stroke (O...
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.