Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)

Background:

Over the last several decades, MCSDs have been developed to augment or supplant failing
myocardial performance. This therapy has been used successfully as a bridge to heart
transplantation, a bridge to recovery, and as permanent implantation or "destination therapy"
for intractable heart failure. Although heart transplantation offers life-saving therapy for
selected patients, its use is limited by a supply of donor organs that currently meets less
than one-tenth the need. As a consequence, the number of MCSD implantations has increased in
recent years.

Despite favorable survival and quality of life outcomes, MCSDs do have severe and sometimes
life-threatening complications, including infection, thrombosis, and device failure. The
development of new procedures and devices to reduce these complications will be expedited by
the work of the registry involving the systematic, independent analysis of MCSD implantation
procedures and outcomes. The National Heart, Lung, and Blood Institute (NHLBI) will
collaborate with the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug
Administration (FDA) in monitoring the work of the registry to permit the development of
standard reporting of patient characteristics, indications, implantation procedures, and
adverse events.

Intermacs Design Narrative:

The goals of the registry include the following:

1. Develop standard methods to collect data used to characterize heart failure patients
receiving MCSDs, and develop methods of collecting demographic data of device use
patient outcomes

2. Collect, process, and store patients' clinical data

3. Analyze collected data

4. Provide these resources to researchers outside the registry

5. Publish and disseminate results

Intermacs has included pediatric patients since the inception of the registry in 2006 with an
increased effort in September 2012 to include pediatric subjects. This focus is called
Pedimacs. Pedimacs utilizes the Intermacs protocol. Due to collection of pediatric-only data
elements, a separate Users' Guide has been developed for Pedimacs.

Intermacs now serves as the national quality improvement system to assess the
characteristics, treatments and outcomes of patients receiving legally utilized mechanical
circulatory support devices. The protocol has undergone several changes since its inception
in 2006. The Current protocol (Protocol 5.0) reflects the latest changes and the necessity
for a waiver of informed consent and authorization for participants.

In January 2013 the Medical Arm of the Interagency Registry for Mechanically Assisted
Circulatory Support (Medamacs) was established to capture data on patients with advanced
heart failure who were not receiving mechanical circulatory support devices. The aims of
Medamacs are to:

1. Identify prospectively a population of ambulatory patients on optimal medical therapy
for whom chronic heart failure limits both function and survival to a range where
elective implantation of left ventricular assist devices should offer meaningful
benefit.

2. Design an integrated endpoint of survival and objective functional assessment that
provides more discrimination between chronic ambulatory heart failure and current device
outcomes than survival alone.

3. Evaluate patient perceptions about their cardiac condition, ventricular assist device
technology, preferences for their care, and thresholds for considering device implant.

Enrollment in Medamacs has closed.

The clinicaltrials.gov identification number for Medamacs is NCT01932294.

Inclusion Criteria:

- Legally utilized MCSD implanted on or after March 1, 2006; every consented patient who
receives an eligible MCSD at a participating center will be enrolled, regardless of
reason (i.e., bridge-to-recovery, bridge-to-alternative bridge, bridge-to-clinical
improvement for transplant eligibility, bridge-to-transplant, destination therapy).
Beginning June 1, 2014, and with lnstitutional Review Board approval, participating
sites may enroll patients under a waiver of informed consent and authorization.

- Eligible devices include all of the following: 1) approved devices for any
indications; 2) Intermacs-linked trial of investigational device or approved device
for investigational indications, for which data will be entered via the Intermacs
framework; 3) external trial of investigational device or approved device for
investigational indications, for which data will be collected by an external group; 4)
compassionate use of investigational devices or approved devices outside of approved
indications or clinical trials

Exclusion Criteria:

- Currently incarcerated