INTERMACS DATA SHOWS PROGRESS USING MCS DEVICES IN DESTINATION THERAPY AS A PERMANENT TREATMENT OPTION FOR HEART FAILURE
Initial Results of the Destination Therapy Post-FDA-Approval Study with a Continuous Flow Left Ventricular Assist Device: A Prospective Study using the INTERMACS
Prague, Czech Republic, April 18, 2012 – Today researchers will report initial findings of a post-FDA-approval study using Left Ventricular Assist Devices as destination therapy for heart failure patients. The findings show signs that destination therapy may soon be a permanent treatment option for patients as an alternative to transplantation.
A report from the U.S. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database will be presented by James K. Kirklin, M.D., Professor and Director, Division of Cardiothoracic Surgery, University of Alabama at Birmingham. This report is part of today’s Concurrent Session 5 during the International Society for Heart and Lung Transplantation (ISHLT) 32ndAnnual Meeting and Scientific Sessions in Prague, Czech Republic.
INTERMACS is a database supported by the U.S. National Institutes of Health (NIH)/ National Heart, Lung, and Blood Institute (NHLBI) to track the use of MCS (mechanical circulatory support) devices in patients in U.S. hospitals. To date, more than 5,000 MCS patients from over 100 hospitals are registered in INTERMACS.
Dr. Kirklin says that data collected in INTERMACS demonstrates a rapid transition away from pulsatile flow devices towards the emerging technology of continuous flow devices.
In 2006, there were no continuous flow devices approved for implantation in the U.S. Devices must be approved for use in the U.S. by the Food and Drug Administration (FDA) in order to be registered in INTERMACS; therefore, there were no continuous flow devices registered. Since then, the industry has witnessed an evolution from 100 percent pulsatile flow devices to total domination of continuous flow devices, which were approved for implantation for bridge to transplant in 2008 and for destination therapy in 2010. INTERMACS data shows that greater than 95 percent of the devices used now are continuous flow devices.
INTERMACS data also shows a progressive increase in the use of devices for destination therapy, as a permanent treatment for patients with heart failure. Previously, MCS devices were used as a bridge for patients awaiting transplantation. According to INTERMACS, one out of three devices are now used for destination therapy, up from 15 percent in previous years.
Currently, the FDA and Centers for Medicare and Medicaid Services (CMS) mandate that only those patients who are ineligible for transplantation can receive devices as destination therapy. This mandate was primarily because the data was not strong enough to support destination therapy as an alternative to transplantation. Therefore the use of devices for destination therapy has been rather restricted.
“For some patients, who may have difficulty with transplantation, physicians may soon be able to offer destination therapy as an alternative,” said Dr. Kirklin. “This has the potential to shorten the transplant waiting lists and offer patients and physicians an alternative option, not just as a bridge to transplant, but as a permanent therapy.”
NEW INTERNATIONAL DATABASE
This year’s INTERMACS report is of great importance to ISHLT, because there is considerable interest in starting an international database to track similar MCS. Last April (2011), the ISHLT Board approved a proposal to create an ISHLT international database, IMACS (ISHLT Mechanically Assisted Circulatory Support.)
“The IMACS effort ensures that we [ISHLT] as a society are an international leader in the clinical science of mechanical support,” said Dr. Kirklin, also a former President of ISHLT.
Dr. Kirklin’s report today will also include progress on the launch of this worldwide registry. Data collection for IMACS will begin later this year.
INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) is a national registry for patients who are receiving mechanical circulatory support device therapy to 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), the Food and Drug Administration (FDA), clinicians, scientists and industry representatives. Analysis of the data collected is expected to facilitate improved patient evaluation and management while aiding in better device development. Registry results are also expected to influence future research and facilitate appropriate regulation and reimbursement of MCSD implantations. For more information, visit www.intermacs.org.
The International Society for Heart and Lung Transplantation (ISHLT) is a not-for-profit professional organization with more than 2,700 members from over 45 countries dedicated to improving the care of patients with advanced heart or lung disease through transplantation, mechanical support and innovative therapies via research, education and advocacy. For more information, visit www.ishlt.org.
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