Data Comparing Mechanical Circulatory Support Devices - INTERMACS
INTERMACS is the national registry for patients with FDA-approved mechanical circulatory support (MCS) devices that treat advanced heart failure.
This registry was devised as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA), in conjunction with the University of Alabama at Birmingham (UAB) and United Network for Organ Sharing (UNOS).
By applying uniform definitions and standards, INTERMACS levels the playing field for mechanical circulatory support devices. INTERMACS tracks patient survival, adverse events and cause of death over time by patient profile, device and device category.
Data released on June 2, 2009
The INTERMACS data used in the chart below were released June 2, 2009. These data include devices implanted June 23, 2006-March 31, 2009. This was the last report in which INTERMACS publicly published bridge-to-transplant rates and patient profile status for left ventricular assist devices (LVADs), biventricular assist devices (BiVADs) and the Total Artificial Heart (TAH).
SynCardia Total Artificial Heart Patients are the Sickest of the Sick
Patients Bridged to Transplant at 6 Months - INTERMACS
- 74% (1089/1476) of all INTERMACS patients were in the two sickest categories.
- *90% (46/51) of all Total Artificial Heart patients were in the two sickest categories.
- *73% (1043/1425) of LVAD/BiVAD patients were in the two sickest categories.
2014 INTERMACS Annual Report
The Registry's Sixth Annual Report summarizes eight years of patient data, from June 26, 2006 through June 13, 2013.
Key: CF LVAD, continuous left ventricular assist device; PF, pulsatile flow
INTERMACS data show that the SynCardia Heart and LVADs have nearly identical percentage of survival and deaths among their implant patients. However, more SynCardia Heart patients are among the sickest of the sick compared to the patient profile for LVADs.
FDA Warning Letter to LVAD Manufacturers, Physicians and Patients
›› Read the FDA Safety Communication: “Serious Adverse Events with Implantable Left Ventricle Assist Devices (LVADs)”
On August 5, 2015, the FDA issued an alert regarding “serious adverse effects” in the two FDA-approved continuous flow LVADs. The U.S. regulatory agency said the HeartWare HVAD and the Thoratec HeartMate II are associated with bleeding complications, as well as pump thrombosis or stroke, depending on the device.
The FDA said it felt “the benefits of these LVADs continue to outweigh the risks,” but recommended that patients and health care providers be aware of the effects.
Acquired von Willebrand Syndrome
From Executive Summary: “Our findings demonstrate that patients with an implanted VAD experience a rapid onset of AVWS that is quickly and completely reversed after device explantation. In addition, TAH patients do not develop AVWS.”