Interagency Registry For Mechanical Circulatory Support Research Articles

Heart Failure Severity Stratification Beyond INTERMACS Profiles: A Step Toward Optimal Left Ventricular Assist Device Timing.

The purpose of this analysis is to determine whether pectoralis muscle measures quantified on pre left ventricular assist device (LVAD) computerized tomography (CT) scans can identify subgroups of patients with differential disease severity within each Interagency Registry for Mechanical Circulatory Support (INTERMACS) profile. Patients with chest CTs performed ≤3 months before LVAD implantation at University of Minnesota (n = 143) and Houston Methodist Hospital (n = 133) were identified from the larger LVAD cohorts (University of Minnesota n = 353, Houston Methodist =278). Unilateral Pectoralis muscle mass indexed to body surface area and pectoralis muscle attenuation were measured on preoperative chest CT scans. Patients within each INTERMACS profile were separated into HIGH and LOW PEC muscle groups. Kaplan-Meier and multivariable cox regression analyses were performed to compare mortality among INTERMACS profiles by HIGH and LOW PEC muscle groups. INTERMACS 3 and 4 patients in the HIGH PEC groups had the highest survival on LVAD support (1 year survival 85% vs. 68%, log rank P = 0.0001). Being in this group was associated with a 60% reduction in the hazards rate (HR) of death after LVAD (adjusted HR 0.40, 95% confidence interval 0.25-0.62). Additionally, renal function deterioration in the year before LVAD was associated with lower INTERMACS profiles and lower measured pectoralis muscle tissue attenuation at the time of LVAD implantation. INTERMACS 3 and 4 patients with the highest pectoralis muscle measures had the best survival after LVAD. The association between renal function deterioration and sarcopenia suggests these muscle changes are progressive. Computerized tomography quantification of sarcopenia may help identify optimal LVAD implantation timing.

The impact of pre-implant illness severity on the outcomes of pediatric patients undergoing durable ventricular assist device

Durable ventricular assist devices (VADs) are increasingly used to treat children with heart failure. Studies demonstrate worse outcomes for those in cardiogenic shock at the time of VAD, but limited data exist on less acutely ill children. We describe the association between illness severity and outcomes in this population. Data were analyzed from 373 children (aged <19 years) receiving durable VADs from 46 centers in the Pediatric Interagency Registry for Mechanical Circulatory Support. Outcomes were compared by Interagency Registry for Mechanical Circulatory Support (INTERMACS) Patient Profile (PP) and pre-implant characteristics using competing risks methodology. Analyses identified 97 patients in cardiogenic shock (PP 1), 222 with progressive decline (PP 2), and 42 stable on inotropes (PP 3). There were 39 infants, 124 were aged 1 to 9 years and 210 were aged 10 to 19 years. A majority had cardiomyopathy and 66 had congenital heart disease (CHD). There were 224 (62%) continuous-flow VADs. Before implant, 40% received mechanical ventilation (MV). Within 6 months post-implant, 57% underwent transplant and 14% died. PP 1 mortality was highest (25% vs 10% for PP 2, hazard ratio [HR]: 2.5, 95% CI: 1.4-4.4, p = 0.02). In PP 1, CHD was an independent mortality risk factor (HR: 2.9, 95% CI: 1.1-7.8, p = 0.03). In PP 2, pulsatile VADs were associated with death (HR: 3.9, 95% CI: 1.6-9.5, p = 0.003). Patients on MV had high mortality (20%-30%) across PP 1 to PP 3 (HR: 3.0 vs no MV, p < 0.001). Children in shock at the time of VAD implant have poor outcomes. MV is associated with increased mortality even in lower acuity INTERMACS profiles. Further study is needed to identify modifiable risk factors in this population.

Extracorporeal resuscitation as a further modifier of clinical outcome in patients with left ventricular assist device implantation and Interagency Registry for Mechanically Assisted Circulatory Support level 1.

In cardiogenic shock patients with Interagency Registry for Mechanical Circulatory Support (INTERMACS) level 1, the need for temporary circulatory support is a predictor and modifier of patient outcome. Because this group includes patients with and without cardiopulmonary resuscitation (CPR) and is thus very heterogeneous, we investigated whether a further subclassification is useful. We compared 30-day and 1-year mortality of patients who underwent left ventricular assist device implantation after extracorporeal CPR with the aid of an extracorporeal life support system (CPR+ group; n = 40) with cardiogenic shock patients in which the extracorporeal life support system was implanted under non-CPR conditions (CPR- group, n = 68). In the CPR+ and CPR- groups, 30-day mortality was 27.5% (n = 11) and 8.8% (n = 6), respectively (P = 0.014). The values for 1-year mortality were 57.5% (n = 23) and 36.8% (n = 25), respectively (P = 0.023). The age- and gender-adjusted hazard ratios of 30-day and 1-year mortality for the CPR+ group versus the CPR- group were 3.88 (95% confidence interval 1.29-11.7; P = 0.016) and 1.79 (95% confidence interval 1.01-3.17; P = 0.045), respectively. In conclusion, our data show that left ventricular assist device implantation with extracorporeal life support following CPR is associated with high 30-day and 1-year mortality. Further multicentre studies are needed to confirm these results and potentially add CPR as a new modifier to the INTERMACS profile.

86: Outcomes of Children Implanted with Ventricular Assist Device Therapy: Analysis of the Interagency Registry for Mechanical Circulatory Support (INTERMACS)

INTERMACS, a federally-supported national registry for FDA-approved durable VADs, is a unique collaboration with the central purpose of improving pt outcomes. While the number of pediatric registrants in INTERMACS is limited, an overview of the pediatric experience provides an opportunity to review the potentials and challenges of employing INTERMACS in the pediatric population.

Second INTERMACS annual report: More than 1,000 primary left ventricular assist device implants

The Interagency Registry For Mechanical Circulatory Support (INTERMACS)1 an NHLBI-sponsored collaboration between the National Heart, Lung, and Blood Institute (NHLBI), the Food and Drug Administration (FDA), the Center for Medicaid and Medicare Services (CMS), and the advanced heart failure/mechanical circulatory support professional community, began prospective patient enrollment and data collection on June 23, 2006. On 3/27/09, CMS mandated that all United States hospitals approved for mechanical circulatory support as Destination Therapy (DT) must enter mechanical circulatory support patient data into a national database, INTERMACS. The power of INTERMACS data stems from the mandatory data submission on all durable mechanical circulatory devices, a formal process for adverse event adjudication, dedicated innovative electronic data submission, data element design to create a template for comparison with medical therapy, rigorous data monitoring, hospital auditing through the United Network of Organ Sharing, and a formal process for data access and publications. Since the inception of INTERMACS, an ongoing evolution of both strategies for device application and the types of available devices has continued to refine the landscape of mechanical circulatory support. Throughout this experience, the only device approved in the United States for permanent “destination” therapy was the HeartMate XVE2, a pulsatile ventricular assist device which is now known to frequently develop bearing wear and require device replacement within 2 years of implantation. Yet, in many countries outside the United States, newer axial flow and centrifugal flow rotary pumps provide chronic circulatory support. INTERMACS only collects data on devices which are FDA-approved for clinical use, and no adult rotary pump was approved in the United States for the first several years of the INTERMACS experience. The spectrum of devices entered into INTERMACS must also be viewed in the context of multiple concurrent U.S. clinical trials of continuous flow pumps implanted as bridge-to-transplant therapy as well as permanent support. Thus, for the first 2 years, despite the rigorous requirements for data completeness and accuracy, INTERMACS suffered from its inability to collect data on newer, more promising rotary pumps which were not yet FDA approved. The INTERMACS playing field changed dramatically in April of 2008, when the HeartMate II axial flow pump received FDA approval for clinical use as bridge-to-transplant therapy in the United States. A portion of this report will examine the changing practice patterns in the application of device type (continuous flow vs. pulsatile) and device strategies over the past three years. In fact, the genesis of INTERMACS, partly by chance and partly by design, uniquely positioned this database to observe, record, and analyze this historical transition (at least for the immediate future) from larger, powerful pulsatile pumps to the world of continuous flow technology, with the unproven promise of greater durability while retaining long-term patient functionality. This report begins the process of long-term evaluation of continuous flow technology against the background of a large registry of detailed patient and device data based on pulsatile pump technology.