Mark J. Russo

Clinical outcomes for continuous-flow left ventricular assist device patients stratified by pre-operative INTERMACS classification

BACKGROUND Risk stratification for mechanical circulatory support (MCS) has emerged as an important tool in patient selection and outcomes assessment. Most studies examining risk stratification have been limited to pulsatile devices. We use the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) to stratify patients with continuous-flow devices and assess outcomes in less severe, but functionally impaired, heart failure patients. METHODS This study included 101 bridge-to-transplant and destination-therapy patients at 3 centers. Three groups were studied: Group 1, cardiogenic shock (INTERMACS Profile 1); Group 2, inotrope-dependent (INTERMACS Profile 2 or 3); and Group 3, ambulatory advanced heart failure (INTERMACS Profiles 4 to 7). The outcomes of interest were actuarial survival, survival to discharge and length of stay. RESULTS Survival at 36 months was better in Group 3 than in Group 1 (95.8% vs 51.1%, p = 0.011), but not between Groups 2 and 3 (68.8 vs 95.8%, p = 0.065). Lengths of stay for Groups 1 to 3 were 44, 41 and 17 days: Groups 1 vs 3, p < 0.001; Groups 2 vs 3, p < 0.001; and Groups 1 vs 2, p = 0.62. Lengths of stay for survivors were 49, 39 and 14 for the 3 groups: Groups 1 vs 3, p < 0.001; Groups 2 vs 3, p < 0.001; and Groups 1 vs 2, p = 0.28. CONCLUSION INTERMACS classification is a useful metric for risk-stratifying candidates for MCS. Less acutely ill but functionally impaired heart failure patients receiving continuous-flow LVADs had longer short- and long-term survival and shorter lengths of stay compared with patients who were more acutely ill.

Factors Associated With Primary Graft Failure After Heart Transplantation

Background. Primary graft failure (PGF) is the most common cause of short-term mortality after cardiac transplantation. The low prevalence of PGF has limited efforts at identifying risk factors for its development. The purpose of this study was to evaluate risk factors associated with PGF after heart transplantation. Methods. Deidentified data were obtained from United Network for Organ Sharing. Analysis included heart transplant recipients more than or equal to 18 years transplanted between January 1, 1999, and December 31, 2007 (n=16,716). PGF was studied from the perspective of “hard outcomes” including death or retransplantation within 90 days of transplant due to graft failure, not related to rejection or infection. Multivariate regression analysis was performed (backward, remove P>0.15) to assess the simultaneous effect of multiple variables on PGF. The odds ratio and 95% confidence interval were reported for each factor. Results. Among the 414 heart transplants complicated by PGF, 354 (85.5%) recipients died and 60 (14.5%) were retransplanted. PGF accounted for 23.4% (n=364) of all deaths (n=1555) in the first 90 days posttransplant. Categories of pretransplant variables associated with PGF included: ischemic time, donor gender, donor age, multiorgan donation, center volume, extracorporeal membrane oxygenation, mechanical circulatory support, etiology of heart failure, and reoperative heart transplant. The area under the receiver operative characteristic curve for the multivariate model was 0.764 (0.733–0.796). Conclusions. Pretransplant recipient and donor characteristics are associated with PGF. Identification of risk factors may aid in understanding the mechanisms underlying PGF and in matching recipients with donors in efforts to diminish the high mortality associated with this complication.

Listing and Transplanting Adults With Congenital Heart Disease

Background— An increasing number of patients with congenital heart disease (CHD) are reaching adulthood and may require heart transplantation. The survival of these patients after listing and transplantation has not been evaluated. Methods and Results— A total of 41 849 patients (aged >18 years) were listed for primary transplantation during 1995–2009. Patients with a history of CHD (n=1035; 2.5%) were compared with those with other causes (non-CHD group) (n=40 814; 97.5%); 26 055 (62.3%) reached transplantation and were subdivided into those with (reoperation group; n=10 484; 40.2%) and without (nonreoperation group; n=15 571; 59.8%) a previous sternotomy. Survival on the waiting list was similar between groups, but mechanical ventricular assistance was not associated with superior survival to transplantation among CHD patients. CHD patients were more likely to have body mass index <18.5 at transplantation (P<0.0001), were younger, and had fewer comorbidities. Early mortality among patients with CHD was high (reoperation, 18.9% versus 9.6%; P<0.0001; nonreoperation, 16.6% versus 6.3%; P<0.0001), but by 10 years, overall survival was equivalent (53.8% versus 53.6%). Analysis was limited by the lack of specific information regarding the CHD diagnosis in most patients. Conclusions— Adults with CHD have high 30-day mortality but better late survival after heart transplantation. Mechanical circulatory assistance does not improve waiting list survival in these patients. This may be due to a combination of highly complex reoperative surgery and often poor preoperative systemic health.

High Lung Allocation Score Is Associated With Increased Morbidity and Mortality Following Transplantation

BACKGROUND The lung allocation score (LAS) was initiated in May 2005 to allocate lungs based on medical urgency and posttransplant survival. The purpose of this study was to determine if there is an association between an elevated LAS at the time of transplantation and increased postoperative morbidity and mortality. METHODS The United Network for Organ Sharing provided de-identified patient-level data. Analysis included lung transplant recipients aged >or= 12 years who received transplants between April 5, 2006, and December 31, 2007 (n = 3,836). Recipients were stratified into three groups: LAS < 50 (n = 3,161, 83.87%), LAS 50 to 75 (n = 411, 10.9%), and LAS >or= 75 (n = 197, 5.23%), referred to as low LAS (LLAS), intermediate LAS (ILAS), and high LAS (HLAS), respectively. The primary outcome was posttransplant graft survival at 1 year. Secondary outcomes included length of stay and in-hospital complications. RESULTS HLAS recipients had significantly worse actuarial survival at 90 days and 1 year compared with LLAS recipients. When transplant recipients were stratified by disease etiology, a trend of decreased survival with elevated LAS was observed across all major causes of lung transplant. HLAS recipients were more likely to require dialysis or to have infections compared with LLAS recipients (P < .001). In addition, length of stay was higher in the HLAS group when compared with the LLAS group (P < .001). CONCLUSIONS HLAS is associated with decreased survival and increased complications during the transplant hospitalization. Whereas the LAS has improved organ allocation through decreased waiting list deaths and waiting list times, lower survival and higher morbidity among HLAS recipients suggests that continued review of LAS scoring is needed to ensure optimal long-term transplant survival.

Survival After Heart Transplantation Is Not Diminished Among Recipients With Uncomplicated Diabetes Mellitus An Analysis of the United Network of Organ Sharing Database

Background— This study compares posttransplantation outcomes of survival and morbidity among recipients with and without diabetes mellitus (DM). Methods and Results— The United Network of Organ Sharing (UNOS) provided deidentified patient-level data. Primary analysis focused on 20 412 first-time heart transplant recipients aged ≥18 years who underwent transplantation between January 1, 1995, and December 31, 2005. To determine severity of DM, DM recipients were stratified by their aggregate number of diabetes-related complications (DRCs), including pretransplantation history of renal failure (serum creatinine=2.5 mg/dL), peripheral vascular disease, cerebrovascular accident, and severe obesity (body mass index ≥35 kg/m2). Kaplan-Meier analysis was performed to compare time to event. Although posttransplantation survival was significantly better (P<0.001) among patients without DM (median survival 10.1 years) than among those with DM (9.0 years), survival did not differ (P=0.08) between those without DM (10.1 years) and those with uncomplicated DM (0 DRCs; 9.3 years). Among those with DM, survival was worse with each additional DRC: 0 DRC, 9.3 years; 1 DRC, 6.7 years; and ≥2 DRCs, 3.6 years. Although acute rejection and transplant coronary artery disease–free survival did not differ between groups, renal failure and severe infection-free survival were worse in those with DM and were inversely related to the number of DRCs. Conclusions— Posttransplantation survival among patients with uncomplicated DM was not significantly different than that among nondiabetics. However, when stratified by disease severity, recipients with more severe diabetes had significantly worse survival than nondiabetics. Therefore, although DM alone should not be a contraindication to heart transplantation, given the critical shortage of transplantable organs, maximal benefit may be achieved by exploring alternative treatment options in patients with severe DM. These include use of high-risk transplant lists and destination therapy.

The cost of medical management in advanced heart failure during the final two years of life.

OBJECTIVE To examine patterns of resource use and the cost of care for patients with advanced heart failure treated with medical management (MM) during the final 2 years of life. METHODS AND RESULTS The study population (n=47, mean age 70.4 years+/-7.06) included patients randomized to the MM arm of the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure trial. Inpatient and outpatient use data were obtained from the clinical dataset and Centers for Medicare and Medicaid Services (beginning January 1, 1998). Cost and resource use were tracked from the date of death (t(d)) backward in 3-month intervals (eg, t(d-1), t(d-2)). In the primary analysis, costs were summed across intervals. The mean cost of MM in the final 2 years of life was

Minimally invasive versus sternotomy approach for mitral valve surgery: a propensity analysis.

156,169, with 50.5% (

The use of mechanical circulatory support as a bridge to transplantation in pediatric patients: An analysis of the United Network for Organ Sharing database

78,880.39) expended in the final 6 months. The mean quarterly cost increased (P < .01) 4.9-fold from t(d-8) (

Posttransplant survival is not diminished in heart transplant recipients bridged with implantable left ventricular assist devices

8,816 +/-

Standard versus bicaval techniques for orthotopic heart transplantation: an analysis of the United Network for Organ Sharing database.

14,270) to t(d-1) (