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changed on 10 December 2011 to a system based on the Lung Allocation Score (LAS). The aim of the present study is to determine whether this change has prolonged the survival of patients on the transplant waiting list and of those who have undergone lung transplantation (LTx). Method: We retrospectively compared data from the three-year periods before and after the change to an LAS-based allocation system (2009-2011 vs. 2012-2014). Results: The number of patients on the active waiting list declined from 606 on 12/31/2011 to 432 on 12/31/2014, a 29% decrease. The number of patients who died while on the waiting list fell from 306 in 2009-2011 to 226 in 2012-2014 (-26%, p = 0.04). Waiting-list mortality declined across all disease groups. Meanwhile, the number of lung transplantation procedures per year increased by 21% over the period of observation, from 865 to 1045. During the period in which the LAS was used, the proportion of transplant recipients with restrictive lung disease (46% vs. 31%; p<0.001) surpassed the proportion of those with a diagnosis of obstructive lung disease (33% vs. 40%; p = 0.003). The percentage of transplantations in patients treated with mechanical ventilation or extracorporeal respiratory support before transplantation rose from 9% to 13%. The one-year survival rate after lung transplantation was 76% in 2009-2011 and 81% in 2012-2014. Conclusion: The introduction of the LAS in Germany was associated with a decrease in the number of patients on the waiting list, and also in the number of deaths among patients on the waiting list. The distribution of primary diagnoses among transplant recipients shifted away from obstructive and toward restrictive lung diseases. In the future, additional parameters of patients on the waiting list should be considered to enable further improvement of the allocation model. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Ventricular blood stasis is a concern for continuous flow mechanical support devices and might contribute to the formation of thromboembolic events. The HeartWare® Ventricular Assist System (HVAD®) is equipped with the Lavare™ cycle that is a periodic speed modulation feature designed to alter flow patterns within the left ventricle and reduce areas of potential blood stasis. Here, we report in vitro and clinical findings on the effects of the Lavare cycle. METHODS: The effect of pump speed changes on the intraventricular flow field was examined with an in vitro particle image velocimetry model. The clinical impact of the Lavare cycle was evaluated through a retrospective review of the ReVOLVE study which includes 248 patients implanted with the HVAD following Conformité Européenne Mark in nine centres in Europe and Australia. Baseline characteristics, adverse event profiles and Kaplan–Meier survival estimates were stratified by patients using/not using the Lavare cycle. RESULTS: Particle image velocimetry showed increased ventricular washout with an active Lavare cycle as measured by the fluid velocities and angular dispersion parameters. With the Lavare cycle on, there was also a 22% decrease in the stagnation index compared with when the Lavare cycle was off. In the ReVOLVE registry, patients with the Lavare cycle turned on (n = 215) were supported for 497 patient-years, whereas patients who did not use the speed modulation (n = 33) were supported for 39.3 patient-years. The Lavare cycle did not significantly affect patient survival as both groups had approximately an 80% survival after 1 year. Patients using the Lavare cycle had significantly fewer rates of stroke [0.06 vs 0.20 events per patient-year (EPPY), P = 0.0008], sepsis (0.03 vs 0.15 EPPY, P = 0.0003) and right heart failure (0.03 vs 0.18 EPPY, P < 0.0001) with no difference in the transplant or recovery rates among the two cohorts. CONCLUSIONS: The Lavare cycle effectively generates ventricular washout and the adverse event profiles of ReVOLVE patients with the Lavare cycle on were better than those with the Lavare cycle off. Larger studies are warranted to verify the positive effect of the Lavare cycle and to optimize speed modulation settings, so additional clinically relevant improvements can be realized. [ABSTRACT FROM AUTHOR]

OBJECTIVES: The Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE) is an investigator-initiated multicentre, prospective, single-arm database established to collect post-Conformité Européenne Mark clinical information on patients receiving the HeartWare® Ventricular Assist System (HVAD®). The number of patients requiring longer periods of mechanical circulatory support is ever increasing and so further investigation into long-term outcomes in bridge-to-transplant populations is necessary. METHODS: Data were collected on 254 commercial implants performed between February 2009 and March 2012 from nine centres in Europe (7 centres) and Australia (2 centres). Patients were followed to device explant, heart transplant or death, and the outcomes of patients who remained on support longer than 2 years were analysed. Summary statistics were used to describe patient demographics, adverse events, length of support and outcomes for this long-term cohort. RESULTS: A total of 124 patients (49% of the original ReVOLVE population) were on support for more than 2 years (range: 731-2108 days), 76 of whom are still alive on support. Overall survival through 5 years was 59%. CONCLUSIONS: Owing to the low rate of heart transplants, a significant number of patients receiving a left ventricular assist device as a bridge to transplant remain on support for prolonged periods, often exceeding 2, 3 and even 4 years. Real-world use of the HVAD system continues to show excellent outcomes for patients on the device, including those on support beyond 2 years. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Experimental and clinical studies have indicated a beneficial effect of retrograde lung preservation on post-transplant results. Accordingly, we conducted a non-randomized trial. METHODS: A total of 209 consecutive recipients transplanted with low-potassium dextrane (LPD)-preserved lungs were eligible for analysis. Antegrade lung preservation (AP) was performed in 173 patients and retrograde in situ perfusion (RP) in 36 patients using low-potassium dextrane solution in all cases. The prostacycline was added to preservation solution. RESULTS: The main donor, graft and recipient characteristics did not differ significantly between groups. There was a beneficial trend toward improved oxygenation indices in the RP cohort within the initial 48 post-transplant hours. The incidence of severe primary graft dysfunction was comparable up to 48 h post-transplant and was significantly increased in the RP cohort 72 h post-transplant (2.2% AP vs 14.8% RP, P = 0.016). Fatal bronchial dehiscences occurred more often in RP recipients (5.6% RP vs 0.6% AP, P = 0.067). The occurrence of bronchial stenoses revealed a slightly improved trend in the RP group (24.9% AP vs 13.9% RP, P = 0.218). Survival (P = 0.927) and bronchiolitis obliterans syndrome-free survival (P = 0.337) were comparable between groups. CONCLUSION: In our clinical survey, this analysis does not confirm the beneficial results of retrograde lung preservation alone, as was previously observed in experimental studies. [ABSTRACT FROM AUTHOR]

Background: The purpose of the study was to investigate the impact of the lung allocation score (LAS) on mortality among highly urgent (HU) and urgent (U) lung transplant (LTx) candidates in Eurotransplant (ET) and to identify useful additional parameters (LASplus). Methods: All adult LTx candidates for whom a first request for HU or U status was made in 2008 in ET were included (N = 317). Patients were followed until LTx, death on the waiting list (WL), delisting, or closure date (i.e., January 10, 2010). The relationship between the LAS/LASplus and waiting list, post-transplant, and overall mortality was assessed with a multivariate regression model. The LAS and LASplus were decomposed into their basic waitlist and post-transplant components. Results: Waiting list mortality rate was 22% and 1-year post-transplant mortality rate was 34%. The waitlist component of the LASplus was significantly associated with waiting list mortality (hazard ratio [HR] 1.91, p = 0.021), whereas the LAS was not (p = 0.063). The post-transplant components of both scores were significantly associated with 1-year post-transplant mortality (LAS: HR 2.69, p = 0.005; LASplus: HR 2.55, p = 0.004). Both scores strongly predicted overall mortality (LAS: HR 1.65, p = 0.008; LASplus: HR 1.72, p = 0.005). Conclusion: LAS accurately predicts overall mortality in critically ill transplant candidates and should therefore be considered as the basis for a new lung allocation policy in ET. An adjustment of the original LAS may be indicated to accurately predict waiting list mortality. [ABSTRACT FROM AUTHOR]

Background: Health-related quality of life (HRQoL) has increasingly been accepted as a supplementary outcome measure for patients after lung transplantation (LTx). Methods: Using a retrospective cross-sectional study design, 280 LTx recipients (3 months to 14 years after LTx) were asked to assess their HRQoL using a generic (Quality of Life Profile for Chronic Diseases) questionnaire, which was previously validated for this specific population. In addition, the questionnaire was also performed by 155 healthy participants. Results: All sub-scale findings ranged from 2.40 to 3.08 (0 to 4) for all patients after LTx. A significantly reduced HRQoL was reported by the sub-cohort of patients living 5 to 6 years with the allograft for all sub-scales (p < 0.006), except for Social Functioning, and was associated with the incidence of bronchiolitis obliterans syndrome (BOS; p < 0.05). Cystic fibrosis patients (p < 0.05), single-lung transplant recipients (p < 0.05) and patients of older age (p < 0.05) showed significantly decreased physical ability ratings. Patients who remained free of infection and late acute rejection episodes scored themselves significantly higher with regard to their Relaxation Capabilities (p < 0.05 for rejection; p < 0.05 for infection) and Social Functioning (p < 0.01 for rejection; p < 0.05 for infection) vs patients who experienced infection or rejection episodes. Comparisons with a normative cohort showed similar HRQoL scales for LTx patients and the healthy population, except with regard to Social Functioning (p < 0.01). Conclusions: Self-ratings for HRQoL were high for all dimensions for the entire sample, and remained relatively similar even for medium- and long-term survivors. HRQoL was dependent on incidence of infections, rejections and the onset of BOS. Despite differences in life expectancy of LTx patients compared with the healthy population, HRQoL self-ratings were within similar ranges. [Copyright &y& Elsevier]