Comparison of total artificial heart and biventricular assist device support as bridge-to-transplantation.

The use of left ventricular assist devices (LVAD) has increased significantly in the last decade. However, right heart dysfunction remains a problem despite the improved outcomes with continuous-flow LVADs. Surgical options for bridge to transplantation (BTT) in patients with biventricular failure are total artificial heart (TAH) or biventricular support (BiVAD). This study examines the differences in pre- and post-transplantation outcomes and survival in patients with TAH or BiVAD support as BTT. The United Network of Organ Sharing database was retrospectively queried from January 2005 to December 2014 to identify adult patients undergoing heart transplantation (n = 17,022). Patients supported with either TAH (n = 212) or BiVAD (n = 366) at the time of transplantation were evaluated. Pre- and post-transplantation Kaplan-Meier survival curves were examined. Cox regression model was used to study the hazard ratios of the association between TAH versus BiVAD support and post-transplant survival. The median age of the study groups was 49.8 ± 12.9 (TAH) and 47.2 ± 13.9 (BiVAD) years (range 18-74 years). There were more men, 87% versus 74%, in the TAH group (p < 0.0001) with greater body mass index, 27.3 ± 5.2 versus 25.6 ± 4.7 (p < 0.0001), compared to those with BiVADs. Creatinine was higher, 1.7 + 1.2 versus 1.3 + 0.8 mg/dL (p < 0.0001), in the TAH group before transplant. The 30-day, one-, and three-year post-transplantation survival was 88%, 78%, and 67%, respectively, for patients with TAH support versus 93%, 83%, and 73% (p = 0.06) for patients with BiVAD support. Cox regression model shows pre-transplant creatinine (HR = 1.21, p = 0.008) is associated with a lower post-transplant survival. TAH is not associated with a worse post-transplant survival (p = 0.1). There was no difference in wait-list survival in patients supported with TAH or BiVAD (p = 0.8). Although there has been a recent increase in the use of the TAH as BTT, BiVAD support remains a viable option with similar post-transplant survival.

Cheng A ，Trivedi JR ，Van Berkel VH ，Massey HT ，Slaughter MS ... -  《-》

Bridge to transplantation using paracorporeal biventricular assist devices or the syncardia temporary total artificial heart: is there a difference?

Biventricular support can be achieved using paracorporeal ventricular assist devices (p-BiVAD) or the Syncardia temporary total artificial heart (t-TAH). The purpose of the present study was to compare survival and morbidity between these devices. Data from 2 French neighboring hospitals were reviewed. Between 1996 and 2009, 148 patients (67 p-BiVADs and 81 t-TAH) underwent primary, planned biventricular support. There were 128 (86%) males aged 44±13 years. Preoperatively, p-BiVAD recipients had significantly lower systolic and diastolic blood pressures, more severe hepatic cytolysis and higher white blood cell counts than t-TAH recipients. In contrast, t-TAH patients had significantly higher rates of pre-implant ECLS and hemofiltration. Mean support duration was 79±100 days for the p-BiVAD group and 71±92 for t-TAH group (P=0.6). Forty two (63%) p-BiVAD recipients were bridged to transplantation (39, 58%) or recovery (3, 5%), whereas 51 (63%) patients underwent transplantation in the t-TAH group. Death on support was similar between groups (p-BiVAD, 26 (39%); t-TAH, 30 (37%); P=0.87). Survival while on device was not significantly different between patient groups and multivariate analysis showed that only preimplant diastolic blood pressure and alanine amino-transferase levels were significant predictors of death. Post-transplant survival in the p-BiVAD group was 76±7%, 70±8%, and 58±9% at 1, 3, and 5 years after transplantation, respectively, and was similar to that of the t-TAH group (77±6%, 72±6%, and 70±7%, P=0.60). Survival while on support and up to 5 years after heart transplantation was not significantly different in patients supported by p-BiVADs or t-TAH. Multivariate analysis revealed that survival while on transplantation was not affected by the type of device implanted.

Nguyen A ，Pozzi M ，Mastroianni C ，Léger P ，Loisance D ，Pavie A ，Leprince P ，Kirsch M ... -  《-》

Outcomes in Patients Bridged With Univentricular and Biventricular Devices in the Modern Era of Heart Transplantation.

Biventricular support before orthotopic heart transplantation (OHT) has been shown to adversely affect short- and long-term outcomes, but the comparative effect of support type is largely unknown. This study determined the comparative effect of univentricular and biventricular support on survival in bridged patients after OHT. The United Network of Organ Sharing database was queried for adult patients bridged to OHT with a univentricular (left ventricular assist device [LVAD]), biventricular (biventricular assist device [BiVAD]), or total artificial heart ([TAH]) device between 2004 and 2012. Unconditional and conditional survivals were compared with the Kaplan-Meier method. Cox proportional hazards regression models were constructed to determine the risk-adjusted influence of support type on death. Of the 4,177 patients identified, 3,457 (20.4%), 575 (3.4%), and 145 (0.9%) were bridged with an LVAD, BiVAD, and TAH, respectively. Unadjusted 30-day, 1-year, and 5-year estimated survival was greater in LVAD patients than in the BiVAD and TAH cohorts. After risk-adjustment, BiVAD and TAH were associated with an increased risk of death at all time points. Unadjusted and adjusted 5-year survival, conditional on 1-year survival, was worse, however, in only TAH patients. Patients with biventricular failure bridged to OHT with a TAH or BiVAD experience worse short- and long-term survival comparison with those with an LVAD. This difference is most likely due to an increase in early death and depends on the type of BiVAD device implanted.

Grimm JC ，Sciortino CM ，Magruder JT ，Dungan SP ，Valero V 3rd ，Sharma K ，Tedford RJ ，Russell SD ，Whitman GJ ，Silvestry SC ，Shah AS ... -  《-》

Survival after biventricular assist device implantation: an analysis of the Interagency Registry for Mechanically Assisted Circulatory Support database.

Patients requiring biventricular assist device (BiVAD) for mechanical circulatory support (MCS) have substantially worse outcomes than patients requiring left VAD (LVAD) support only. Patient-specific risk factors have yet to be consistently identified in a large, multicenter registry, which may underlie the poorer outcomes for BiVAD patients. The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) is a registry of U.S. Food and Drug Administration-approved durable MCS devices used for bridge-to-transplantation, destination therapy, or recovery. The purposes of this study were to 1) identify the underlying pre-implant characteristics of the population requiring BiVAD support that contribute to reduced survival, and 2) identify differences in postoperative outcomes with respect to adverse events compared with patients supported with LVAD alone. From June 2006 to September 2009, 1,646 patients were entered into the INTERMACS database in which adverse events and outcomes were recorded for primary implants with LVAD or BiVAD. Competing outcomes methodology was used to estimate the time-related probability of death, transplant, or recovery. Overall survival for all groups was analyzed with Kaplan-Meier methods and Cox proportional regression analysis. The distribution of primary device implants included 1,440 LVADs and 206 BiVADs. BiVAD patients presented with a lower INTERMACS profile 93% in INTERMACS 1 or 2, compared with 73% for LVAD patients (p < 0.001). Survival at 6 months was 86% for LVADs and 56% for BiVADs (p < .0001). Adverse event rates, expressed as episodes/100 patient-months for the BiVAD group compared with LVAD, were significantly higher for infection (33.2 vs 14.3), bleeding (71.6 vs 15.5), neurologic events (7.9 vs 2.6), and for device failure (4.9 vs 2.0). Patients requiring BiVAD support at the time of durable MCS implant are more critically ill at the time of MCS implant. BiVAD patients experience worse survival than patients supported with LVAD alone and higher rates of serious adverse events. Characteristics of the population present at the time of BiVAD implant likely influence post-implant MCS outcomes.

Cleveland JC Jr ，Naftel DC ，Reece TB ，Murray M ，Antaki J ，Pagani FD ，Kirklin JK ... -  《-》

Outcomes of contemporary mechanical circulatory support device configurations in patients with severe biventricular failure.

Severe right ventricular failure often is considered a contraindication for left ventricular assist device (LVAD) therapy and necessitates use of biventricular assist devices (BiVADs). Available options for BiVADs are limited, and comparative outcomes are largely unknown. Heart transplant candidates who were registered on the United Network for Organ Sharing waitlist and underwent long-term contemporary LVAD (n = 3195) or BiVAD (n = 408) implantation, from January 2010 through June 2014, were retrospectively analyzed. We evaluated clinical characteristics and outcomes of patients requiring a BiVAD, as well as regional differences in utilization of this technology. Patients requiring a BiVAD were younger (48.9 vs 53.3 years), had a higher proportion of nonischemic disease (69.1% vs 58.2%), a higher bilirubin level (0.9 vs 0.7 mg/dL), and a lower 6-month survival rate (68.1% vs 92.7%) after device implantation (all P < .05). Postimplantation and posttransplantation survival was comparable for commonly used BiVAD configurations, including total artificial heart, continuous flow BiVAD, a continuous-flow LVAD coupled with a right-sided device, and pulsatile flow. Significant variation was found in regional utilization of these devices, regardless of differences in transplantation waitlist times. A large body surface area was an independent predictor of mortality on a BiVAD (hazard ratio = 2.12, P = .017). Outcomes of patients requiring a BiVAD remain poor in the contemporary device era, regardless of the configuration used. Among other clinical factors, body surface area should be incorporated into decision making for device selection in these patients.

Levin AP ，Jaramillo N ，Garan AR ，Takeda K ，Takayama H ，Yuzefpolskaya M ，Mancini DM ，Naka Y ，Colombo PC ，Topkara VK ... -  《-》