sixth intermacs annual report: a 10,000-patient database

Keywords

The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS), 1 a National Heart, Lung and Blood Institute (NHLBI)-sponsored database and partnership between NHLBI, the U.S.

Patient and site enrollment

Between June 23, 2006 and June 30, 2013, 12,335 patients who received an FDA-approved durable mechanical circulatory support (MCS) device were entered into the INTERMACS database ( Figure 1 ). Of the 158 participating hospitals, data were contributed by 141 centers that had also been approved for destination therapy (DT).

Approved adult devices

Table 1 lists the current FDA-approved MCS devices used in adult patients. The HeartMate II (Thoratec, Pleasanton, CA) continuous-flow pump was approved for bridge-to-transplant (BTT) therapy in 2008 and for DT in 2010. The HeartWare HVAD (HeartWare International, Inc., Framingham, MA) was approved for BTT indications on November 20, 2012.

Adult durable devices: Continued dominance of continuous-flow technology

The dominance of continuous-flow technology has been evident since 2008, and in the USA includes the HeartMate II axial-flow pump (BTT and DT) and the HeartWare HVAD centrifugal-flow pump (BTT).

PEDIMACS: Initial data collection

PEDIMACS, the pediatric component of INTERMACS, began data collection on September 1, 2012. Prior to that, patients <18 years of age were entered into INTERMACS with pediatric-specific data elements.

Device strategy

Mechanical circulatory support as a DT strategy 2, 3 continues to represent a major proportion of overall implants. Comparing three eras of continuous-flow technology in the USA, the proportion of patients receiving a durable device as DT increased from 14.7% in 2006–2007 to 41.6% in 2011–2013 ( Table 4 ).

Survival with continuous-flow pumps

Survival for continuous-flow devices through December, 2013 is shown in Figure 8 with the accompanying hazard function. The hazard function shows a rapidly decreasing early phase of risk that merges with a constant phase at about 3 months. We identified a late phase of gradually increasing risk out to 5 years.

Abstract

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.

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