Age and Outcome After Continuous-Flow Left Ventricular Assist Device Implantation as Bridge to Transplantation (original) (raw)
Interactive CardioVascular and Thoracic Surgery, 2016
OBJECTIVES: In Europe, the age of heart donors is constantly increasing. Ageing of heart donors limits the probability of success of heart transplantation (HTx). The aim of this study is to compare the outcome of patients with advanced heart failure (HF) treated with a continuous-flow left ventricular assist device (CF-LVAD) with indication as bridge to transplantation (BTT) or bridge to candidacy (BTC) versus recipients of HTx with the donor's age above 55 years (HTx with donors >55 years). METHODS: we prospectively evaluated 301 consecutive patients with advanced HF treated with a CF-LVAD (n = 83) or HTx without prior bridging (n = 218) in our hospital from January 2006 to January 2015. We compared the outcome of CF-LVAD-BTT (n = 37) versus HTx with donors >55 years (n = 45) and the outcome of CF-LVAD-BTT plus BTC (n = 62) versus HTx with donors >55 years at the 1-and 2-year follow-up. Survival was evaluated according to the first operation. RESULTS: The perioperative (30-day) mortality rate was 0% in the LVAD-BTT group vs 20% (n = 9) in the HTx group with donors >55 years (P = 0.003). Perioperative mortality occurred in 5% of the LVAD-BTT/BTC patients (n = 3) and in 20% of the HTx with donors >55 year group (P = 0.026). Kaplan-Meier curves estimated a 2-year survival rate of 94.6% in CF-LVAD-BTT vs 68.9% in HTx with donors >55 years [ageand sex-adjusted hazard ratio (HR) 0.25; 95% confidence interval (CI) 0.08-0.81; P = 0.02 in favour of CF-LVAD]. Considering the post-HTx outcome, a trend in favour of CF-LVAD-BTT was also observed (age-and sex-adjusted HR 0.45; 95% CI 0.17-1.16; P = 0.09 in favour of CF-LVAD), whereas CF-LVAD-BTT/BTC showed a similar survival at 2 years compared with HTx with donors >55 years, both censoring the follow-up at the time of HTx and considering the post-HTx outcome. CONCLUSIONS: Early and mid-term outcomes of patients treated with a CF-LVAD with BTT indication seem better than HTx with old donors. It must be emphasized that up to 19% of patients in the CF-LVAD/BTT group underwent transplantation in an urgent condition due to complications related to the LVAD. At the 2-year follow-up, CF-LVAD with BTT and BTC indications have similar outcome than HTx using old heart donors. These results must be confirmed in a larger and multicentre population and extending the follow-up.
ASAIO Journal, 2014
Left ventricular assist devices (LVADs) are fast becoming standard of care for patients with advanced heart failure. However, despite continuous improvement in VAD technology, there remains a significant early postoperative morbidity and mortality in this extreme patient group. The aim of the current study was to explore the short-term outcomes and predictors for 90 day mortality in the patients after implantation of continuous-flow LVAD. Perioperative clinical, echocardiographic, hemodynamic, and laboratory data of 90 day survivors and nonsurvivors were collected and compared retrospectively. Multivariate logistic regression analysis was performed on univariate predictors for 90 day mortality with an entry criterion of p < 0.1. Between July 2006 and May 2012, 117 patients underwent implantation of a continuous-flow LVAD as a bridge to transplantation: 71 (60.7%) HeartMate II (Thoratec Corp, Pleasanton, CA) and 46 (39.3%) HVAD (HeartWare International, Framingham, MA). All-cause 90 day mortality was 17.1%. Multivariate analysis revealed higher preoperative central venous pressure (odds ratio [OR], 1.18; 95% confidence interval [CI], 1.014-1.378; p = 0.033) and higher age (OR, 1.14; 95% CI, 1.01-1.38; p = 0.045) as the only independent predictors for 90 day mortality. Optimization of preoperative volume status, preload, and right heart function as well as age-based selection of candidates for LVAD support are the critical factors influencing early outcome after continuous-flow LVAD implantation. ASAIO Journal 2014; 60:162-169.
The Annals of Thoracic Surgery, 2012
Background. Although left ventricular assist devices (LVADs) are now commonly used as a bridge to orthotopic heart transplantation (OHT), the upper patient age limit for this therapy has not been defined. Smaller studies have suggested that advanced age should not be a contraindication to bridge to transplantation (BTT) LVAD placement. The purpose of this study was to examine outcomes in patients 60 years and older undergoing BTT with continuous-flow LVADs. Methods. The United Network for Organ Sharing (UNOS) database was reviewed to identify first-time OHT recipients 60 years of age and older (2005-2010). Patients were stratified by preoperative support: continuous-flow LVAD, intravenous inotropic agents, and direct transplantation. Survival after OHT was modeled using the Kaplan-Meier method. All-cause mortality was examined using multivariable Cox proportional hazard regression. Results. Of 2,554 patients, 1,142 (44.7%) underwent direct transplantation, 264 (10.3%) had LVAD BTT, and 1,148 (45.0%) had BTT with inotropic agents. The mean age was 64 ؎ 3 years, and 460 (18.0%) patients were women. Mean follow-up was 29 ؎ 19 months. Survival differed significantly among the 3 groups. Patients with LVAD BTT had significantly lower survival after OHT compared with the other groups at 30 days and 1 year. This survival difference was no longer significant at 2 years after OHT or when deaths in the first 30 days were censored. LVAD BTT increased the hazard of death at 1 year by 50% (hazard ratio [HR], 1.50; 95% confidence interval [CI], 1.05-2.15; p ؍ 0.03), compared with patients who underwent direct transplantation. Conclusions. This study represents the largest modern cohort in which survival after OHT has been evaluated in patients 60 years or older who received BTT. Older patients have lower short-term survival after OHT when BTT is carried out with a continuous-flow LVAD compared with inotropic agents or direct transplantation.
Journal of Cardiac Failure, 2014
Published data on mechanical circulatory support for elderly patients in continuous flow devices are sparse and suggest relatively poor survival. This study investigated whether LVADs can be implanted in selected patients over the age of 65 years with acceptable survival compared with published outcomes. A single-center retrospective analysis was conducted in 64 consecutive patients ≥65 years of age implanted with a continuous-flow left ventricular assist device (CF-LVAD) as either bridge to transplantation or destination therapy from August 2005 to January 2012. Baseline laboratory and hemodynamic characteristics and follow-up data were obtained. Median survival was 1,090 days. Survival was 85%, 74%, 55%, and 45% at 6 months and 1, 2, and 3 years, respectively. Our cohort had a baseline mean Seattle Heart Failure Model (SHFM) score of 2.6 ± 0.9. Observed survival was significantly better than SHFM-predicted medical survival. Stratification by age subsets, renal function, SHFM, implantation intention, or etiology did not reveal significant differences in survival. The most common cause of death was sepsis and nonlethalcomplication was bleeding. Our experience with patients over the age of 65 receiving CF-LVADs suggests that this group demonstrates excellent survival. Further research is needed to discern the specific criteria for risk stratification for LVAD support in the elderly.
European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 2014
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. ...
The Journal of Thoracic and Cardiovascular Surgery, 2008
Objective: Left ventricular assist devices are increasingly used as a bridge to transplantation. It remains unclear whether the use of pretransplant left ventricular assist devices adversely affects short-term survival after cardiac transplantation. Methods: A retrospective review of 317 consecutive patients undergoing cardiac transplantation at an academic center between 1986 and 2006 was undertaken. Left ventricular assist devices were used pretransplant in 23 of these 317 patients, and 294 patients did not require left ventricular assist device support. Patients with a left ventricular assist device were supported with a Heartmate VE or Heartmate XVE (Thoratec Corp, Pleasanton, Calif). Kaplan-Meier survival estimates were compared between the left ventricular assist device group and the non-left ventricular assist device group using the log-rank test. In addition, occurrence of death was analyzed between the 2 groups with a chi-square analysis. The results are expressed as 1-year survival with 95% confidence intervals in parentheses. Results: The 1-year survival for all 317 patients was 0.86 (0.82-0.90). The patient survival for the group without a left ventricular assist device before cardiac transplant was 0.87 (0.83-0.90), and the survival for the group with a left ventricular assist device as bridge to transplantation was 0.83 (0.67-0.98; P 5 .77). For the deaths that occurred in all 317 patients, 19% of the patients without left ventricular assist devices died within 30 days of transplant, whereas 80% of the patients with left ventricular assist devices died within 30 days of transplant (P , .01). Conclusion: When used as a bridge to transplantation, left ventricular assist devices do not compromise 1-year survival after cardiac transplantation. Of the patients who die after transplantation, patients bridged with left ventricular assist devices are at higher risk for death within 30 days of transplant. These data suggest that left ventricular assist devices as a bridge to transplantation should be considered for appropriately selected patients awaiting cardiac transplantation.
The Journal of Heart and Lung Transplantation, 2005
Background: Left ventricular assist device (LVAD) support has become an accepted means of successful bridging to transplantation (BTT) for patients with end-stage cardiomyopathy. Although results have been encouraging, little is known about outcomes in older patients who undergo LVAD BTT. Methods: A prospective analysis was performed on our population of LVAD recipients. Older patients were defined as age ϭ 60 years. Statistical analysis was performed using the Kaplan-Meier method with logrank test comparison of time-to-events. A Cox's regression model was employed in order to adjust for covariates. Results: Between October 1996 and May 2004, a total of 139 intraand para-corporeal LVADs have been implanted at UMHS. Of these patients, 33 (24%) were 60 years or older. For the period of LVAD support, older patients had significantly inferior survival as compared to younger patients (pϭ0.02). For the combined (LVAD support plus post-transplant) time period, older patients had significantly inferior survival (pϭ0.002). However, for LVAD supported patients who survived to transplant, there was no significant difference in conditional post-transplant survival between older and younger patients (pϭ0.37). Covariates associated with decreased LVAD survival include male sex (pϭ0.002), pre-LVAD need for IABP, hemodialysis, ECMO, or mechanical ventilation (pϭ0.02), and higher pre-LVAD heart rate (pϭ0.02). Conclusion: LVAD implantation in older patients is associated with a statistically significant reduction in survival as compared to younger patients. However, for those older patients who survive the period of LVAD support, post-transplant survival appears to be equivalent to that of younger patients. In conclusion, LVAD BTT in older patients is associated with excellent conditional post-transplant survival.
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 Journal of Thoracic and Cardiovascular Surgery, 1996
Objectives: We sought to determine whether cardiac transplant recipients who required a bridge to transplantation with an implantable left ventricular assist device had a different outcome than patients who underwent transplantation without such a bridge. Methods: A retrospective study of 256 cardiac transplants from 1992 to 1996 included 53 patients who received the HeartMate left ventricular assist device and 203 patients who had no left ventricular assist device support. Results: Left ventricular assist device transplants increased from 8% of all transplants in 1992 (n = 63) to 32% in 1995 (n = 65) and 43% in 1996 (n = 14 year to date). Patients with and without left ventricular assist device had similar age and sex distributions. Left ventricular assist device recipients were larger (body surface area 1.96 vs 1.86 m 2, p = 0.004). They were more likely to have ischemic cardiomyopathy (70% vs 45%, p = 0.001) and type O blood group (51% vs 34%, p = 0.06). All patients with left ventricular assist device and 42% of those without had undergone previous cardiac operations by the time of transplantation (mean number per patient 1.5 vs 0.3, p < 0.001). More patients in the left ventricular assist device group had anti-HLA antibodies before transplantation (T-cell panel reactive antibody level > 10% in 66% of left ventricular assist device group vs 15% of control group, p < 0.0001). Waiting time was longer for the left ventricular assist device than for patients in status I without a left ventricular assist device (median 88 vs 37 days, p = 0.002). There was no difference in length of posttransplantation hospital stay (median 15 days for each) or operative mortality (3.8% vs 4.4%). Mean follow-up averaged 22 months. No significant difference was found in Kaplan-Meier survival estimates. One-year survival was 94% in the left ventricular assist device group and 88% in the control group (difference not significant). Comparison of posttransplantation events showed no significant difference in actuarial rates of cytomegalovirus infection (20% vs 17%) or vascular rejection (15% vs 12%) at 1 year of follow-up. Similar percentages of patients were free from cellular rejection at 1 year of follow-up (12% vs 22%, p = 0.36).