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

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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.

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Site and patient enrollment

Between June 23, 2006, and June 30, 2012, 6,885 patients who received an FDA-approved durable mechanical circulatory support (MCS) device were entered in the database (Figure 1). Of the 145 participating hospitals, 131 of these have actively contributed data, including the 114 centers approved for destination therapy (DT) by CMS.

Of the 6,885 patients who received a durable MCS device, 72 were pediatric patients, 243 had a previous durable MCS device, and 9 received an isolated right ventricular

Approved devices

Table 1 lists the current FDA-approved durable MCS devices. The Berlin Heart Excor Pediatric VAD (Berlin Heart GmbH, Berlin, Germany) received FDA approval on December 16, 2011, and the Heartware HVAD (HeartWare International, Inc. Framingham, MA) was approved on November 20, 2012.

Evolution of device type

The dominance of continuous-flow technology2 has continued since the approval of the HeartMate II device (Thoratec, Pleasanton, CA) in 2008 for bridge-to-transplant (BTT) therapy and for DT in 2010 (Figure 3). Since 2010, among patients stratified to a DT designation, essentially 100% received a continuous-flow pump (Figure 4).

Device strategy

The application of MCS as long-term therapy (DT)3 has dramatically increased since the approval of a continuous-flow pump for DT in 2010 (Table 2). During 2012, more than 40% of implants have been designated as DT.

Survival

The overall survival curves, stratified by pulsatile-flow vs continuous-flow technology, are depicted in Figure 5. Among all continuous-flow pumps (Figure 6), actuarial survival was 80% at 1 year and 70% at 2 years.

Risk factors for mortality

An updated risk factor analysis for patients receiving continuous-flow left VADs (LVADs) is reported in Table 3.

Individual adverse events

Actuarial freedom from a major neurologic event was approximately 89% at 1 year and 83% at 2 years among all devices (Figure 15). Freedom from device malfunction leading to device exchange or death was dramatically different between continuous-flow and pulsatile intracorporeal devices (Figure 16). Pump interior infections and pocket infections were uncommon events (Figure 17). The risk of initial driveline infection continued as long as patients were monitored. Freedom from subsequent

Quality of life

Although quality of life data are somewhat limited in MCS patients, available data suggest an important and sustained improvement in general well-being (Figure 23), self-care (Figure 24), and usual activities (Figure 25) out to at least 1 year.

Pediatric MCS

The Pediatric Mechanically Assisted Circulatory Support (PEDIMACS) registry is a newly developed focused version of the registry that contains data elements and definitions tailored to pediatric patients who receive an MCSD. PEDIMACS was formally launched on September 20, 2012. In addition to FDA-approved durable devices, the PEDIMACS registry will also include FDA-approved temporary devices. The Pediatric Committee is actively recruiting all hospitals that implant pediatric devices.

Medical Therapy for INTERMACS Levels 4 to 6

During the

Summary

  • 1.

    The INTERMACS database now includes more than 6,800 patients and 145 participating hospitals.

  • 2.

    The Heartware HVAD and Berlin Heart Excor Pediatric VAD have recently received FDA approval.

  • 3.

    Greater than 95% of implants are currently continuous-flow devices.

  • 4.

    Current survival is approximately 80% at 1 year and 70% at 2 years.

  • 5.

    Elderly patients have generally favorable outcomes but have less tolerance for additional risk factors.

  • 6.

    Patients in INTERMACS Levels 1 and 2 have about a 5–8% decrease in 1-year

Disclosure statement

None of the authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose.

Disclosure statement

This analysis and the INTERMACS device database are funded by NHLBI contract #HHSN268201100025C.

Authors Kirklin, Kormos, Stevenson, Miller, and Baldwin have no financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose. Dr. Naftel is a consultant for HeartWare and Dr. Pagani does contract research with HeartWare managed by the University of Michigan.

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