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 ... -  《-》

Right ventricular dysfunction in children supported with pulsatile ventricular assist devices.

To describe the incidence and severity of right ventricular dysfunction (RVD) in pediatric ventricular assist device (VAD) recipients and to identify the preoperative characteristics associated with RVD and their effect on outcomes. Children bridged to transplantation from 2004 to 2011 were included. RVD was defined as the use of a left VAD (LVAD) with an elevated central venous pressure of >16 mm Hg with inotropic therapy and/or inhaled nitric oxide for >96 hours or biventricular assist (BiVAD). A total of 57 children (median age, 2.97 years; range 35 days to 15.8 years) were supported. Of the 57, 43 (75%) had an LVAD, and of those, 10 developed RVD. The remaining 14 (25%) required BiVAD. Thus, RVD occurred in 24 of 57 patients (42%). Preoperative variables such as younger age (P = .01), use of extracorporeal mechanical support (P = .006), and elevated urea (P = .03), creatinine (P = .02), and bilirubin (P = .001) were associated with RVD. Multiple logistic regression analysis indicated that elevated urea and extracorporeal mechanical support (odds ratio, 26.4; 95% confidence interval, 2.3-307.3; and odds ratio, 27.8; 95% confidence interval, 2.5-312.3, respectively) were risk factors for BiVAD. The patients who developed RVD on LVAD had a complicated postoperative course but excellent survival (100%), comparable to those with preserved right ventricular function (91%). The survival for those requiring BiVAD was reduced (71%). RVD occurred in approximately 40% of pediatric VAD recipients and affects their peri-implantation morbidity and bridging outcomes. Preoperative extracorporeal membrane oxygenation and elevated urea were risk factors for BiVAD. Additional studies of the management of RVD in children after VAD implantation are warranted.

Karimova A ，Pockett CR ，Lasuen N ，Dedieu N ，Rutledge J ，Fenton M ，Vanderpluym C ，Rebeyka IM ，Dominguez TE ，Buchholz H ... -  《-》

Durability and clinical impact of tricuspid valve procedures in patients receiving a continuous-flow left ventricular assist device.

Patients evaluated for a continuous-flow left ventricular assist device frequently present with severe right ventricular dysfunction with tricuspid regurgitation. Long-term outcomes of concurrent tricuspid valve procedures in continuous-flow left ventricular assist device implantation are unclear. From May 2004 to December 2013, 336 patients received continuous-flow left ventricular assist devices. Among these, 8 patients with prior tricuspid valve procedures were excluded. At continuous-flow left ventricular assist device implantation, 76 patients underwent tricuspid valve procedures (group A), including 68 repairs and 8 replacements. The remaining 252 patients did not receive concurrent tricuspid valve procedures (group B). Preoperatively, group A had higher central venous pressure/pulmonary capillary wedge pressure (P = .032), total bilirubin (P = .009), and percentage of moderate or greater tricuspid regurgitation (98.7% vs 18.8%; P < .001). In group A, cardiopulmonary bypass time (136 ± 52.0 minutes vs 83.9 ± 38.8 minutes; P < .001), intraoperative platelet use (13.6 ± 6.70 units vs 11.7 ± 5.92 units; P = .042), and bleeding requiring reoperation (27.5% vs 16.7%; P = .046) were significantly increased. In-hospital mortality was similar (10.5% vs 6.4%; P = .22). On-device 2-year survival was 73.9% in group A and 74.2% in group B (P = .24). At 2 years, mean cumulative readmissions for right heart failure was 0.21 in group A and 0.27 in group B (P = .95). A generalized linear mixed-effects model showed that tricuspid valve procedures are protective for developing future significant tricuspid regurgitation (odds ratio, 0.38; 95% confidence interval, 0.19-0.76; P = .006). Concomitant tricuspid valve procedures at continuous-flow left ventricular assist device implantation can be performed safely and are protective against worsening tricuspid regurgitation during the first 2 years of support.

Han J ，Takeda K ，Takayama H ，Kurlansky PA ，Mauro CM ，Colombo PC ，Yuzefpolskaya M ，Fukuhara S ，Truby LK ，Topkara VK ，Garan AR ，Mancini DM ，Naka Y ... -  《-》

Outcome of unplanned right ventricular assist device support for severe right heart failure after implantable left ventricular assist device insertion.

The use of a right ventricular assist device (RVAD) becomes necessary for severe right ventricular (RV) failure after left ventricular assist device (LVAD) insertion. Although temporary support could lead to successful RVAD weaning in certain patients, the data remain scarce. We retrospectively reviewed 398 patients who underwent implantable LVAD insertion between January 2000 and December 2012. Of these patients, 44 (11%) required unplanned RVAD support due to severe RV failure after LVAD insertion. For comparison, 37 patients who underwent planned biventricular assist device (BiVAD) insertion were identified during the same study period. We analyzed the early and late outcomes in these patients. The mean duration of RVAD support was 21 ± 23 days. Of the 44 patients, 21 (49%) were weaned from the RVAD (weaning group), whereas 23 (51%) required continued biventricular support (failure group). The failure group had ongoing end-organ dysfunction after RVAD insertion. Hospital mortality was significantly lower in the weaning group (24%) and in the planned BiVAD group (30%) as compared to the failure group (74%, p = 0.0009). The 6-month actuarial survival rate was 75% in the weaning group, 62% in the planned BiVAD group and 13% in the failure group (p < 0.0001). Successful bridge to transplant was achieved in 14 patients (67%) in the weaning group as compared with 8 patients (35%) in the failure group (p = 0.03). On multivariate logistic regression analyses, pre-operative white blood cell (odds ratio [OR] 1.3, 95% confidence interval [CI] 1.04 to 1.50, p = 0.016) and creatinine (OR 0.26, 95% CI 0.079 to 0.88, p = 0.03) levels were significant predictors for RVAD removal. Among patients who developed acute RV failure after LVAD insertion, only half could be weaned from the temporary RVAD support. An alternative strategy is necessary in patients who require continuous RVAD support.

Takeda K ，Naka Y ，Yang JA ，Uriel N ，Colombo PC ，Jorde UP ，Takayama H ... -  《-》

Right ventricular failure in patients with the HeartMate II continuous-flow left ventricular assist device: incidence, risk factors, and effect on outcomes.

The aim of this study was to evaluate the incidence, risk factors, and effect on outcomes of right ventricular failure in a large population of patients implanted with continuous-flow left ventricular assist devices. Patients (n = 484) enrolled in the HeartMate II left ventricular assist device (Thoratec, Pleasanton, Calif) bridge-to-transplantation clinical trial were examined for the occurrence of right ventricular failure. Right ventricular failure was defined as requiring a right ventricular assist device, 14 or more days of inotropic support after implantation, and/or inotropic support starting more than 14 days after implantation. Demographics, along with clinical, laboratory, and hemodynamic data, were compared between patients with and without right ventricular failure, and risk factors were identified. Overall, 30 (6%) patients receiving left ventricular assist devices required a right ventricular assist device, 35 (7%) required extended inotropes, and 33 (7%) required late inotropes. A significantly greater percentage of patients without right ventricular failure survived to transplantation, recovery, or ongoing device support at 180 days compared with patients with right ventricular failure (89% vs 71%, P < .001). Multivariate analysis revealed that a central venous pressure/pulmonary capillary wedge pressure ratio of greater than 0.63 (odds ratio, 2.3; 95% confidence interval, 1.2-4.3; P = .009), need for preoperative ventilator support (odds ratio, 5.5; 95% confidence interval, 2.3-13.2; P < .001), and blood urea nitrogen level of greater than 39 mg/dL (odds ratio, 2.1; 95% confidence interval, 1.1-4.1; P = .02) were independent predictors of right ventricular failure after left ventricular assist device implantation. The incidence of right ventricular failure in patients with a HeartMate II ventricular assist device is comparable or less than that of patients with pulsatile-flow devices. Its occurrence is associated with worse outcomes than seen in patients without right ventricular failure. Patients at risk for right ventricular failure might benefit from preoperative optimization of right heart function or planned biventricular support.

Kormos RL ，Teuteberg JJ ，Pagani FD ，Russell SD ，John R ，Miller LW ，Massey T ，Milano CA ，Moazami N ，Sundareswaran KS ，Farrar DJ ，HeartMate II Clinical Investigators ... -  《-》