Marissa A. Miller

Seventh INTERMACS annual report: 15,000 patients and counting

The seventh annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) summarizes the first 9 years of patient enrollment. The Registry includes >15,000 patients from 158 participating hospitals. Trends in device strategy, patient profile at implant and survival are presented. Risk factors for mortality with continuous-flow pumps are updated, and the major causes/modes of death are presented. The adverse event burden is compared between eras, and health-related quality of life is reviewed. A detailed analysis of outcomes after mechanical circulatory support for ambulatory heart failure is presented. Recent summary data from PediMACS and MedaMACS is included. With the current continuous-flow devices, survival at 1 and 2 years is 80% and 70%, respectively.

Sixth INTERMACS annual report: a 10,000-patient database.

The sixth annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) summarizes the first 8 years of patient enrollment. The analysis is based on data from >10,000 patients and updates demographics, survival, adverse events and risk factors. Among patients with continuous-flow pumps, actuarial survival continues to be 80% at 1 year and 70% at 2 years. The report features a comparison of two eras of continuous-flow durable devices in the USA in terms of device strategy, patient profiles, adverse event burden, survival and quality of life.

Fifth INTERMACS annual report: Risk factor analysis from more than 6,000 mechanical circulatory support patients

The 5th annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) summarizes and analyzes the first 6 years of patient and data collection. The current analysis includes more than 6000 patients and updated risk factors for continuous flow pumps. Among continuous flow pumps, actuarial survival is 80% at 1 year and 70% at 2 years. Quality of life indicators are generally favorable and adverse event burden will likely influence patient selections of advanced heart failure therapies.

Mitral-Valve Repair versus Replacement for Severe Ischemic Mitral Regurgitation

BACKGROUND Ischemic mitral regurgitation is associated with a substantial risk of death. Practice guidelines recommend surgery for patients with a severe form of this condition but acknowledge that the supporting evidence for repair or replacement is limited. METHODS We randomly assigned 251 patients with severe ischemic mitral regurgitation to undergo either mitral-valve repair or chordal-sparing replacement in order to evaluate efficacy and safety. The primary end point was the left ventricular end-systolic volume index (LVESVI) at 12 months, as assessed with the use of a Wilcoxon rank-sum test in which deaths were categorized below the lowest LVESVI rank. RESULTS At 12 months, the mean LVESVI among surviving patients was 54.6±25.0 ml per square meter of body-surface area in the repair group and 60.7±31.5 ml per square meter in the replacement group (mean change from baseline, -6.6 and -6.8 ml per square meter, respectively). The rate of death was 14.3% in the repair group and 17.6% in the replacement group (hazard ratio with repair, 0.79; 95% confidence interval, 0.42 to 1.47; P=0.45 by the log-rank test). There was no significant between-group difference in LVESVI after adjustment for death (z score, 1.33; P=0.18). The rate of moderate or severe recurrence of mitral regurgitation at 12 months was higher in the repair group than in the replacement group (32.6% vs. 2.3%, P<0.001). There were no significant between-group differences in the rate of a composite of major adverse cardiac or cerebrovascular events, in functional status, or in quality of life at 12 months. CONCLUSIONS We observed no significant difference in left ventricular reverse remodeling or survival at 12 months between patients who underwent mitral-valve repair and those who underwent mitral-valve replacement. Replacement provided a more durable correction of mitral regurgitation, but there was no significant between-group difference in clinical outcomes. (Funded by the National Institutes of Health and the Canadian Institutes of Health; ClinicalTrials.gov number, NCT00807040.).

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.

The Fourth INTERMACS Annual Report: 4,000 implants and counting

The Fourth Annual Report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) summarizes and analyzes the first 5 years of patient and data collection. With more than 4,000 patients entered into the database, the evolution of pump technology, strategy at implant, and pre-implant patient profiles are chronicled. A risk factor analysis of the entire adult primary implant population is provided, and the recent composition of patient profiles is examined. Current actuarial survival with continuous-flow pumps exceeds 80% at 1 year and 70% at 2 years.

Third INTERMACS Annual Report: The evolution of destination therapy in the United States

The third annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) provides documentation of the current landscape of durable mechanical circulatory support in the United States. With nearly 3,000 patients entered into the database, the transition to continuous-flow pump technology is evident and dramatic. This report focuses on the rapidly expanding experience with mechanical circulatory support as destination therapy. The current 1-year survival of 75% with continuous-flow destination therapy provides a benchmark for the evolving application of this therapy.

Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device

BACKGROUND Pump thrombosis remains an uncommon but potentially catastrophic complication of durable continuous-flow left ventricular assist devices (LVAD). A perceived increase in the incidence of pump thrombosis in the HeartMate II (HMII) LVAD (Thoratec, Pleasanton, CA) by clinicians prompted this analysis of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database. METHODS Between 2006 and June 2013, 8,988 United States patients aged older than 18 years received a durable LVAD. Of these, 6,910 adult patients from 132 institutions who received a HMII LVAD were entered in the INTERMACS database and constitute the study group for this analysis. RESULTS Overall survival (with censoring at transplant or explant for recovery) with the HMII LVAD was 80% at 1 year and 69% at 2 years and was not significantly different when stratified by era of implant. Freedom from device exchange or death due to thrombosis decreased from 99% at 6 months in 2009 to 94% in 2012 (p < 0.0001). Multivariable hazard function analysis showed risk factors for pump thrombosis included later implant year (p < 0.0001), younger age (p < 0.0001), higher creatinine (p = 0.002), larger body mass index (p = 0.004), white race (p = 0.0004), left ventricular ejection fraction above 20% (p = 0.02), and higher lactate dehydrogenase level at 1 month (p < 0.0001). Survival (p < 0.0001) and freedom from infection (p = 0.008) and cerebrovascular accident (p < 0.0001) were lower after pump exchange than after primary implant. CONCLUSIONS Pump exchange or death due to pump thrombosis increased during 2011 and 2012, but the magnitude of the increase remained relatively small. Survival remains high (80% at 1 year) with the HMII LVAD. Risk factor analysis suggests that a number of patient-related factors contribute to the risk of thrombosis. Markedly elevated lactate dehydrogenase in the first month is a predictor of pump thrombosis. This analysis could not examine the potential role of technical factors during implant, such as sub-optimal pump or graft positioning, changes in patient management paradigms with pump speed settings, improved recognition and change in the threshold for pump exchange, or design or production changes with the pump, as contributors to the risk of pump thrombosis.

INTERMACS database for durable devices for circulatory support: first annual report.

T i p a l s he Interagency Registry for Mechanically Assisted Cirulatory Support (INTERMACS) database, funded by the nited States National Heart, Lung and Blood Institute NHLBI), is a registry for patients who receive durable nited States Food and Drug Administration (FDA)pproved mechanical circulatory support devices (see he Appendix for the list of approved devices) for the reatment of advanced heart failure. This first report will riefly review the background of INTERMACS and report he data analysis for the first 18 months of data collection.

Two-Year Outcomes of Surgical Treatment of Severe Ischemic Mitral Regurgitation

BACKGROUND In a trial comparing coronary-artery bypass grafting (CABG) alone with CABG plus mitral-valve repair in patients with moderate ischemic mitral regurgitation, we found no significant difference in the left ventricular end-systolic volume index (LVESVI) or survival after 1 year. Concomitant mitral-valve repair was associated with a reduced prevalence of moderate or severe mitral regurgitation, but patients had more adverse events. We now report 2-year outcomes. METHODS We randomly assigned 301 patients to undergo either CABG alone or the combined procedure. Patients were followed for 2 years for clinical and echocardiographic outcomes. RESULTS At 2 years, the mean (±SD) LVESVI was 41.2±20.0 ml per square meter of body-surface area in the CABG-alone group and 43.2±20.6 ml per square meter in the combined-procedure group (mean improvement over baseline, -14.1 ml per square meter and -14.6 ml per square meter, respectively). The rate of death was 10.6% in the CABG-alone group and 10.0% in the combined-procedure group (hazard ratio in the combined-procedure group, 0.90; 95% confidence interval, 0.45 to 1.83; P=0.78). There was no significant between-group difference in the rank-based assessment of the LVESVI (including death) at 2 years (z score, 0.38; P=0.71). The 2-year rate of moderate or severe residual mitral regurgitation was higher in the CABG-alone group than in the combined-procedure group (32.3% vs. 11.2%, P<0.001). Overall rates of hospital readmission and serious adverse events were similar in the two groups, but neurologic events and supraventricular arrhythmias remained more frequent in the combined-procedure group. CONCLUSIONS In patients with moderate ischemic mitral regurgitation undergoing CABG, the addition of mitral-valve repair did not lead to significant differences in left ventricular reverse remodeling at 2 years. Mitral-valve repair provided a more durable correction of mitral regurgitation but did not significantly improve survival or reduce overall adverse events or readmissions and was associated with an early hazard of increased neurologic events and supraventricular arrhythmias. (Funded by the National Institutes of Health and Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00806988.).