Gender differences in continuous-flow left ventricular assist device therapy as a bridge to transplantation: a risk-adjusted comparison using a propensity score-matching analysis.

The purpose of this study was to evaluate gender differences regarding outcome after continuous-flow left ventricular assist device (cfLVAD) implantation. The study was a retrospective review of prospectively collected data. Included were 24 consecutive female cfLVAD recipients and 24 male recipients (62.5% HeartMate II, 37.5% HeartWare) who received their devices between July 2007 and May 2013. Subjects were matched using propensity score analysis based on age, diagnosis, body surface area, preoperative mechanical circulatory support, heart failure severity score (INTERMACS class), and comorbidities. Female patients were significantly sicker before operation. After propensity score matching, there were no statistically significant differences in demographics or clinical baseline characteristics between male and female LVAD recipients. Also, there was a trend towards a longer postoperative intensive care unit stay in the female group (median 9 days [interquartile range 5-17] versus 15 days [interquartile range 8-33]; P < 0.061) and higher postoperative bilirubin values (median 14 mmol/L [interquartile range 10-17] versus 21 mmol/L [interquartile range 13-30]). However, there were no significant differences between the two groups in terms of outcome (P < 0.569). The overall survival was comparable between the two groups (log rank P < 0.389). Half (50%) of female patients required inotropic support for more than 7 days compared with 21.7% in the male group (P < 0.048). Half (50%) of female recipients required short-term postoperative right ventricular assist device implantation compared with 16.7% in the male group (P < 0.014). In conclusion, cfLVAD implantation as a bridge to transplantation is associated with longer duration of inotropic support and higher requirement for postoperative mechanical right ventricular support in women with similar survival rates. Further studies are required to identify additional demographic and clinical factors that modulate outcomes and will enhance the ability to risk-stratify cfLVAD recipients.

Weymann A ，Patil NP ，Sabashnikov A ，Mohite PN ，García Sáez D ，Amrani M ，Bahrami T ，De Robertis F ，Wahlers T ，Banner NR ，Popov AF ，Simon AR ... -  《-》

Outcomes after implantation of 139 full-support continuous-flow left ventricular assist devices as a bridge to transplantation.

Left ventricular assist devices (LVADs) are a routine treatment for patients with advanced heart failure as a bridge to transplantation. The aim of this study was to present our institutional experience and mid-term outcomes after implantation of 139 continuous-flow (cf) LVADs as a bridge to transplantation. One hundred and thirty-nine consecutive LVAD implantations were performed in our institution between July 2007 and August 2013. The mean age of the population was 44.0 ± 13.7 years and 24 (17%) of the patients were female. A substantial number of the patients were on preoperative mechanical support: 35 (25%) with an intra-aortic balloon pump, 9 (6.5%) with an extracorporeal membrane oxygenator and 25 (18%) with previous LVAD, for LVAD exchange. The mean support duration was 514 ± 481 days, whereas the longest support duration was 2493 days (>6 years). The overall cumulative survival rate following cfLVAD implantation was 89% at 30 days, 76% at 1 year and 66% at 2 years (Fig. 1). There was a statistically significant difference in survival in favour of first LVAD implantation compared with VAD exchange: 91 vs 80% at 30 days, 79 vs 57% at 1 year and 70 vs 43% at 2 years (log-rank P = 0.010). Postoperatively, patients had a significant improvement in end-organ function 1 month after LVAD implantation. In addition, comparison of two different devices [HeartMate II (HM II) and HeartWare] using propensity score matching showed no significant differences in survival and most postoperative adverse events. However, patients supported with HM II required significantly more units of fresh frozen plasma (P = 0.020) with a trend towards a higher use of red blood cells (P = 0.094), and were also more likely to develop percutaneous site infections (P = 0.022). HM II and HeartWare cfLVADs have excellent early postoperative outcomes and good mid-term survival, despite a considerable number of patients needing VAD exchange.

Sabashnikov A ，Mohite PN ，Weymann A ，Patil NP ，Hedger M ，Sáez DG ，Zych B ，Wahlers T ，Wippermann J ，De Robertis F ，Bahrami T ，Amrani M ，Simon AR ，Popov AF ... -  《-》

Improved survival and decreasing incidence of adverse events with the HeartMate II left ventricular assist device as bridge-to-transplant therapy.

Pulsatile left ventricular assist devices (LVADs) are effective as bridge-to-transplant therapy, but they are limited by their large size and lack of durability. Smaller, more durable, continuous flow devices such as the HeartMate II LVAD are increasingly being used. The aim of this study is to report our single-center experience with this device as bridge-to-transplant therapy. Overall, 47 patients received HeartMate II LVADs at our center from June 2005 to July 2007; 32 as bridge to transplant, 7 as destination therapy, and 8 as exchange therapy for a failed HeartMate XVE. We reviewed our experience with the device as bridge-to-transplant therapy and report on patient survival and adverse events. The mean age of the bridge-to-transplant patients was 50.75 +/- 13.78 years; 10 (31.3%) were female. The cause of the underlying disease was ischemic in 18 patients (56.3%), idiopathic in 11 (34.4%), myocarditis in 1 (3.1%), postpartum cardiomyopathy in 1 (3.1%), and congenital heart disease in 1 (3.1%). The mean duration of HeartMate II support was 193.2 +/- 139.9 days. At 30 days after HeartMate II placement, the patient survival was 96.9% by Kaplan-Meier analysis; at 6 months (alive or transplanted), 86.9%. Major adverse events included bleeding requiring reexploration in 5 patients (15.6%), right ventricular failure requiring right ventricular assist device support in 2 (6.3%), LVAD-related infections in 4 (12.5%), neurologic or thromboembolic events in 2 (6.3%), and gastrointestinal bleeding in 5 (15.6%). We noted one serious device malfunction (3.1%) resulting in the patient's death; in addition, 2 patients experienced pump thrombosis (6.3%). Despite morbidity, use of the HeartMate II LVAD as bridge-to-transplant therapy is associated with excellent survival and low mortality rates. We found a marked decrease in morbidity related to right ventricular failure, to device-related infections, and to thromboembolic events. However, the requirements for anticoagulation therapy may be associated with increased mediastinal and gastrointestinal bleeding. Strategies to optimize anticoagulation therapy may further improve results for these critically ill patients.

John R ，Kamdar F ，Liao K ，Colvin-Adams M ，Boyle A ，Joyce L ... -  《-》

Continuous flow left ventricular assist device technology has influenced wait times and affected donor allocation in cardiac transplantation.

Bridge to transplantation patients with continuous flow left ventricular assist devices (cfLVADs) are assigned United Network for Organ Sharing status 1A or 1B priority while awaiting orthotopic heart transplantation. We investigated the influence of cfLVAD on the waitlist times and organ allocation. The United Network for Organ Sharing database was examined from 2005 to 2012 for patients with cfLVAD and pulsatile flow LVAD (pLVAD). These 2 cohorts were compared with patients who did not receive LVAD. Of 16,476 total orthotopic heart transplantations, 3270 (19.8%) were performed on patients with an LVAD as a bridge to transplantation. The cfLVAD group had the longest total waitlist time (259.6 days) compared with the pLVAD (134.6 days) and non-LVAD (121.7 days) groups (P < .001). The cfLVAD group spent more time in status 1A (44.7 days) than did the pLVAD (32.1 days) and non-LVAD (16.4 days) cohorts (P < .001). The median waitlist survival was better for the cfLVAD group (1234.0 days) than in the pLVAD (441.0 days) and non-LVAD (471.0 days) groups (P < .001). The cfLVAD recipients were older, had a greater body mass index, and more often had diabetes than did pLVAD and non-LVAD patients. The cfLVAD cohort received hearts from older, more often male donors, with a greater body mass index. Post-transplant survival was not significantly different among the 3 groups on Kaplan-Meier analysis (P = .12). Despite being older, less favorable recipients, the cfLVAD patients spent more time in status 1A and had greater waitlist survival. This might allow cfLVAD patients to receive preferred donor hearts, which might allow for better post-transplant survival.

Taghavi S ，Jayarajan SN ，Komaroff E ，Mangi AA ... -  《-》

Postcardiac transplant survival in the current era in patients receiving continuous-flow left ventricular assist devices.

Continuous-flow left ventricular assist devices have become the standard of care for patients with heart failure requiring mechanical circulatory support as a bridge to transplant. However, data on long-term post-transplant survival for these patients are limited. We evaluated the effect of continuous-flow left ventricular assist devices on postcardiac transplant survival in the current era. All patients who received a continuous-flow left ventricular assist device as a bridge to transplant at a single center from June 2005 to September 2011 were evaluated. Of the 167 patients who received a continuous-flow left ventricular assist device as a bridge to transplant, 77 (46%) underwent cardiac transplantation, 27 died before transplantation (16%), and 63 (38%) remain listed for transplantation and continued with left ventricular assist device support. The mean age of the transplanted patients was 54.5 ± 11.9 years, 57% had an ischemic etiology, and 20% were women. The overall mean duration of left ventricular assist device support before transplantation was 310 ± 227 days (range, 67-1230 days). The mean duration of left ventricular assist device support did not change in patients who had received a left ventricular assist device in the early period of the study (2005-2008, n = 62) compared with those who had received a left ventricular assist device later (2009-2011, n = 78, 373 vs 392 days, P = NS). In addition, no difference was seen in survival between those patients supported with a left ventricular assist device for fewer than 180 days or longer than 180 days before transplantation (P = NS). The actuarial survival after transplantation at 30 days and 1, 3, and 5 years by Kaplan-Meier analysis was 98.7%, 93.0%, 91.1%, and 88.0%, respectively. The short- and long-term post-transplant survival for patients bridged with a continuous-flow left ventricular assist device in the current era has been excellent. Furthermore, the duration of left ventricular assist device support did not affect post-transplant survival. The hemodynamic benefits of ventricular unloading with continuous-flow left ventricular assist devices, in addition to their durability and reduced patient morbidity, have contributed to improved post-transplant survival.

Kamdar F ，John R ，Eckman P ，Colvin-Adams M ，Shumway SJ ，Liao K ... -  《-》