Annual IMACS Report
Second annual report from the ISHLT Mechanically Assisted Circulatory Support Registry

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The second annual IMACS registry report includes over 14, 000 patients from 35 countries. Survival, adverse events, and an updated risk model is presented. Continuous flow pumps continue to dominate the world’s experience. One and Two-year survival remains at 80% and 70%. Congenital heart disease and biventricular support are the most dominant risk factors. The database is poised for major novel analyses.

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Patients’ demographics and device types

Among device types represented in this database, left ventricular assist devices (LVADs) accounted for 13,102 (93%) implants, of which 99% were continuous-flow (CF) pumps. Total artificial hearts (TAHs) represented 2% (279 devices) of the experience and biventricular support 5% (refer to Supplementary Material Figure S1, available online at www.jhltonline.org/).

Patients’ demographics indicate 79% males, with 60% of patients between 50 and 60 years of age (Table 2). At the time of implant, 51%

Survival

Among all patients, survival at 1 and 2 years continued to be 79% and 70%, respectively (Supplementary Material Figure S2 online).5 The 3-year survival with CF durable devices (Figure 1) was just over 60%. Figure 1 shows hazard function6 had a rapidly decreasing risk, which merged with a constant phase at about 3 months. Survival was clearly superior for patients receiving isolated left ventricular support compared with biventricular support (Figure 2). The 1-year survival for isolated CF LVAD

Causes of death

The most frequent primary causes of death were multisystem organ failure (21% of mortality), cardiovascular causes (primarily right heart failure) (20%), and stroke (19%) (Supplementary Material Table S1 online).

Adverse events

Infection and bleeding affected the most patients, occurring in 40% and 35% of patients, respectively; 19% had neurologic events (Table 6). Bleeding was the most frequent adverse event during the first 3 months post-implant, followed by infection (Table 7). During the later phase (beyond 3 months), infection and internal bleeding had the highest incidence. Among patients with CF devices, freedom from first infection was 68% at 6 months (Supplementary Material Figure S6). The likelihood of

Risk factors for mortality

A detailed multivariable analysis identified risk factors for early and midterm mortality for patients receiving CF devices (Table 8). The 2 most dominant risk factors for early mortality were a diagnosis of congenital heart disease (hazard ratio [HR] 5.2) and the need for biventricular support (HR 3.4). The adverse effect of congenital heart disease was only evident during the first 2 months, after which patients with congenital heart disease did as well as those with other diagnoses (Figure 4

Summary

  • 1.

    The IMACS database now includes >14,000 patients with global representation.

  • 2.

    CF pumps currently constitute 97% of device implants.

  • 3.

    Patients with ambulatory heart failure account for only 16% of durable device implants.

  • 4.

    Overall 1- and 2-year survival have continued at 80% and 70%, respectively, in this international database.

  • 5.

    For the first time, we have identified a more favorable midterm survival among patients with ambulatory heart failure.

  • 6.

    Among the elderly, survival is particularly poor among

Disclosure statement

J.K.K. received partial support as principle investigator of the INTERMACS NHLBI-sponsored Registry for U.S. mechanical circulatory support (funding paid through institution) and is chair of the DSMB for a Xeltis Clinical Trial of a bioprosthetic heart conduit (receiving at 1-time fee of $2,500). J.C. received $5,000 for research-related travel support from Abbott and Medtronic and is on the steering committee for Medtronic and Abbott, Institutional Clinical Trial Support. S.S. works as a

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The second annual International Society for Heart and Lung Transplantation Mechanically Assisted Circulatory Support (IMACS) Registry report includes over 14,000 patients from 35 countries. Survival, adverse events, and an updated risk model are presented. Continuous-flow pumps continue to dominate the world’s experience. One- and 2-year survival remains at 80% and 70%, respectively. Congenital heart disease and biventricular support are the most prominent risk factors. The database is poised for major novel analyses.

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